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Document metadata

Olaparib

ID
134
Parsed title
Olaparib
Template profile
NCBI Bookshelf Template
Strict template mode
Yes
Source file
Olaparib.docx
Stored path
docx/134/master.docx
Status
parsed
Notes
Parsed 12 headings, 75 blocks, 50 references, 0 citations, 0 citation issues, 45 preflight issues.
Uploaded
2026-06-23 13:21:04
Extracted front matter Metadata candidates
Parsed summary

Block counts

Headings
12
Paragraphs
24
Tables
1
References
50
Citations
0
Matched citations
0
Open issues
0
Blocking pre-flight issues
0
Warning pre-flight issues
45
Validation status

Pre-flight decision

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Blocking issues: 0 | warnings: 45 | total: 45

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paragraph Order 1 Style Comment word/document.xml:/w:document[1]/w:body[1]/w:p[1]

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paragraph Order 8 Style Comment word/document.xml:/w:document[1]/w:body[1]/w:p[6]

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heading Order 13 Level 1 Style Heading1 word/document.xml:/w:document[1]/w:body[1]/w:p[9]

H1. Olaparib

heading Order 16 Level 2 Style Heading2 word/document.xml:/w:document[1]/w:body[1]/w:p[12]

H2. OVERVIEW

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H3. Introduction

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<?pubmed-excerpt?>

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Olaparib is a small molecule inhibitor of poly ADP-ribose polymerase and is used as an antineoplastic agent in the therapy of refractory and advanced ovarian carcinoma. Olaparib therapy is associated with a low rate of transient elevations in serum aminotransferase during therapy and has been linked to several instances of clinically apparent liver injury which can be severe and even fatal.

heading Order 21 Level 3 Style Heading3 word/document.xml:/w:document[1]/w:body[1]/w:p[17]

H3. Background

paragraph Order 22 word/document.xml:/w:document[1]/w:body[1]/w:p[18]

Olaparib (oh lap' a rib) is a small molecule inhibitor of poly adenine diphosphate (ADP)-ribose polymerase (PARP), an enzyme involved in DNA transcription and repair. Patients with mutations of the BRCA 1 and 2 genes are at increased risk for cancer, particularly ovarian and breast cancer in women. The BRCA gene encodes DNA repair enzymes, and tumor cells with BRCA mutations are dependent upon other DNA repair pathways and thus have an increased sensitivity to inhibition of PARP. Clinical trials of olaparib in women with BRCA 1 and 2 germline mutations and advanced, refractory ovarian carcinoma have shown response rates of 30% to 40% and prolongation of progression-free survival. Olaparib is also under evaluation as therapy for advanced breast cancer and other malignant diseases associated with mutations in BRCA or other DNA repair enzymes. Olaparib received approval for use in the United States in 2014 for therapy of advanced and refractory ovarian carcinoma in women with BRAC 1 and 2 mutations. Subsequently, indications were expanded to other refractory tumors (pancreatic and prostate cancers) with BRAC mutations. Olaparib is available in 100 and 150 mg tablets under the brand name Lynparza. The recommended dose is 300 mg by mouth twice daily. Lower doses are recommended for patients with renal impairment. Common side effects include anemia, fatigue, nausea, diarrhea, dyspepsia, abdominal pain, anorexia, cough, muscle and join pain, headache and rash. Uncommon, but potentially severe side effects include pneumonitis, venous thrombosis and thromboembolic events, myelodysplastic syndromes, acute myelogenous leukemia, acute liver injury, and embryo-fetal toxicity.

heading Order 24 Level 3 Style Heading3 word/document.xml:/w:document[1]/w:body[1]/w:p[20]

H3. Hepatotoxicity

paragraph Order 25 word/document.xml:/w:document[1]/w:body[1]/w:p[21]

In pre-registration clinical trials of olaparib, abnormalities in routine liver tests were uncommon with serum aminotransferase elevations occurring in 4% of patients and values above 5 times the upper limit of normal (ULN) in 1% or less. In early trials of olaparib in patients with various advanced solid tumors there were no reports of hepatitis with jaundice or liver failure. However, after its approval and more widescale use, there have been several published reports of clinically apparent liver injury attributed to olaparib, some of which have been severe and some fatal. The onset of injury arose after 2 to 3 months of therapy and was typically hepatocellular with marked elevations in serum ALT and AST but only modest elevations in alkaline phosphatase levels. Rash and fever were uncommon, but low titers of ANA and SMA were reported, and clinical features as well as a rapid response to corticosteroid therapy were typical. Liver biopsies demonstrated hepatocellular injury with variable amounts of lobular necrosis and intense portal infiltration with lymphocytes and eosinophils with rare plasma cells. Thus, olaparib appears to be a definite cause of idiosyncratic liver injury and regular monitoring of liver tests is now recommended.

paragraph Order 26 word/document.xml:/w:document[1]/w:body[1]/w:p[22]

Likelihood score: C (probable rare cause of clinically apparent liver injury).

heading Order 28 Level 3 Style Heading3 word/document.xml:/w:document[1]/w:body[1]/w:p[24]

H3. Mechanism of Injury

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The mechanism of injury with olaparib therapy is not known but it appears to be immune mediated. Olaparib is metabolized in the liver largely through the CYP 3A4 pathway and liver injury may be related to production of a toxic or immunogenic intermediate. Because it is a substrate for CYP 3A4, olaparib is susceptible to drug-drug interactions with agents that inhibit or induce hepatic CYP 3A activity.

heading Order 31 Level 3 Style Heading3 word/document.xml:/w:document[1]/w:body[1]/w:p[27]

H3. Outcome and Management

paragraph Order 32 word/document.xml:/w:document[1]/w:body[1]/w:p[28]

Serum aminotransferase elevations above 5 times the upper limit of normal (if confirmed) during olaparib therapy should lead to dose reduction or temporary cessation. Patients with severe or symptomatic liver injury should avoid rechallenge as recurrent injury is typically more rapid in onset and worse in severity. Interestingly, there does not appear to be cross reactivity in risk for hepatic injury between olaparib and other PARP inhibitors such as rucaparib or niraparib, but switching to another PARP inhibitor after olaparib hepatotoxicity should be done with caution and with careful monitoring for recurrence.

paragraph Order 34 word/document.xml:/w:document[1]/w:body[1]/w:p[30]

Other PARP Drugs: Niraparib, Rucaparib

heading Order 36 Level 2 Style Heading2 word/document.xml:/w:document[1]/w:body[1]/w:p[32]

H2. PRODUCT INFORMATION

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REPRESENTATIVE TRADE NAMES

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Olaparib – Lynparza®

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DRUG CLASS

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Antineoplastic Agents

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paragraph Order 42 word/document.xml:/w:document[1]/w:body[1]/w:p[38]

Product labeling at DailyMed, National Library of Medicine, NIH

heading Order 44 Level 2 Style Heading2 word/document.xml:/w:document[1]/w:body[1]/w:p[40]

H2. CHEMICAL FORMULA AND STRUCTURE

table Order 46 word/document.xml:/w:document[1]/w:body[1]/w:tbl[4]

Table.

DRUG

CAS REGISTRY NO.

MOLECULAR FORMULA

STRUCTURE

Olaparib

763113-22-0

C24-H23-F-N4-O3

SID: 135261055

Table footprint: 2 rows, 8 cells

heading Order 49 Level 2 Style Heading2 word/document.xml:/w:document[1]/w:body[1]/w:p[44]

H2. ANNOTATED BIBLIOGRAPHY

reference Order 50 word/document.xml:/w:document[1]/w:body[1]/w:p[45]

References updated: 18 May 2026

reference Order 51 word/document.xml:/w:document[1]/w:body[1]/w:p[46]

Abbreviations used: PARP, poly adenine diphosphate-ribose polymerase

reference Order 52 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[47]

Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.

reference Order 53 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[48]

(Review of hepatotoxicity published in 1999 before the availability of protein kinase or PARP inhibitors such as olaparib).

reference Order 54 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[49]

DeLeve LD. Kinase inhibitors. Cancer chemotherapy. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 556.

reference Order 55 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[50]

(Review of hepatotoxicity of cancer chemotherapeutic agents discusses several kinase inhibitors including gefitinib, erlotinib and crizotinib, but not the PARP inhibitors such as olaparib).

reference Order 56 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[51]

Chabner BA, Barnes J, Neal J, Olson E, Mujagic H, Sequist L, Wilson W, et al. Targeted therapies: tyrosine kinase inhibitors, monoclonal antibodies, and cytokines. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 1731-54.

reference Order 57 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[52]

(Textbook of pharmacology and therapeutics).

reference Order 58 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[53]

Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet 2010; 376 (9737): 245-51. PMID: 20609468

reference Order 59 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[54]

(Among 57 women with BRAC 1 or 2 mutations and advanced, refractory ovarian carcinoma treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 33% vs 13%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity).

reference Order 60 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[55]

Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet 2010; 376 (9737): 235-44. PMID: 20609467

reference Order 61 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[56]

(Among 54 women with BRCA 1 or 2 mutations and advanced, refractory breast cancer treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 41% and 22%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity).

reference Order 62 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[57]

Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, et al. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol 2011; 12: 852-61. PMID: 21862407

reference Order 63 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[58]

(In an open label trial of olaparib [400 mg twice daily] in women with advanced ovarian or breast cancer, objective responses occurred in 18 of 63 [29%] women with ovarian carcinoma, but none of 26 with breast cancer; no mention of ALT elevations or hepatotoxicity).

reference Order 64 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[59]

Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382-92. PMID: 22452356

reference Order 65 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[60]

(Among 265 women with advanced ovarian cancer who had a partial or complete response to platinum based chemotherapy, progression free survival was higher with olaparib than placebo [8.4 vs 4.8 months], and adverse events included nausea [68% vs 35%], fatigue [49% vs 38%] and anemia [17% vs 5%], and "there were no unexpected changes in biochemical laboratory measurements").

reference Order 66 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[61]

Kaye SB, Lubinski J, Matulonis U, Ang JE, Gourley C, Karlan BY, Amnon A, et al. Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. J Clin Oncol 2012; 30: 372-9. PMID: 22203755

reference Order 67 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[62]

(Among 97 women with BRCA 1 or 2 mutations and advanced ovarian cancer treated with olaparib [200 or 400 mg twice daily] or doxorubicin [intravenously every 28 days], progression free survival was similar in all 3 groups and specific adverse events were not mentioned).

reference Order 68 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[63]

Garnett MJ, Edelman EJ, Heidorn SJ, Greenman CD, Dastur A, Lau KW, Greninger P, et al. Systematic identification of genomic markers of drug sensitivity in cancer cells. Nature 2012; 483 (7391): 570-5. PMID: 22460902

reference Order 69 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[64]

(Correlation of mutated cancer genes identified in cancer cell lines with their sensitivity to growth inhibition by antineoplastic agents revealed the possible role of PARP inhibition in several tumors including Ewing sarcoma).

reference Order 70 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[65]

Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial. Lancet Oncol 2014; 15: 852-61. PMID: 24882434

reference Order 71 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[66]

(Among 265 women with BRCA 1 or 2 mutations and relapsed, platinum-sensitive ovarian cancer treated with olaparib or placebo [Ledermann 2012], further follow up showed prolongation of progression free, but not overall survival with olaparib therapy and adverse events were similar to those previously reported).

reference Order 72 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[67]

Ledford H. Resurrected cancer drug faces regulators. Nature 2014; 510 (7506): 454. PMID: 24965630

reference Order 73 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[68]

(News report on olaparib, the initial PARP inhibitor, which in early clinical trials showed little effect on survival in women with ovarian carcinoma, but on reassessment limiting analysis to cases with BRCA mutations found evidence of an effect on cancer growth, reviving interest in pursuing olaparib as therapy of selected patients with ovarian cancer).

reference Order 74 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[69]

Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol 2015; 33: 244-50. PMID: 25366685

reference Order 75 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[70]

(Among 298 patients with refractory advanced cancers and BRCA 1 or 2 mutations treated with olaparib [400 mg twice daily], the overall objective response rate was 26% and was higher in women with ovarian [31%] than breast cancer [13%]; there were no liver related serious adverse events).

reference Order 76 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[71]

Gunderson CC, Moore KN. Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. Future Oncol 2015; 11: 747-57. PMID: 25757679

reference Order 77 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[72]

(Review of the development, mechanism of action, clinical efficacy and safety of olaparib in ovarian cancer; mentions that the most frequent adverse events are gastrointestinal toxicity and myelosuppression; no mention of ALT elevations or hepatotoxicity).

reference Order 78 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[73]

Bao Z, Cao C, Geng X, Tian B, Wu Y, Zhang C, Chen Z, Li W, et al. Effectiveness and safety of poly (ADP-ribose) polymerase inhibitors in cancer therapy: A systematic review and meta-analysis. Oncotarget 2016; 7: 7629-39. PMID: 26399274

reference Order 79 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[74]

(Systematic review of the efficacy and safety of PARP inhibitors in cancer chemotherapy mentioned that in 5 placebo controlled trials, ALT elevations were no more frequent with the PARP inhibitors than in “controls”, but neither were any other adverse events).

reference Order 80 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[75]

Konecny GE, Kristeleit RS. PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions. Br J Cancer 2016; 115: 1157-73. PMID: 27736844

reference Order 81 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[76]

(Review of role of BRCA 1 and 2 mutations in tumorigenesis and the mechanism of action of PARP inhibitors).

reference Order 82 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[77]

Ledermann JA. PARP inhibitors in ovarian cancer. Ann Oncol 2016; 27 Suppl 1: i40-i44. PMID: 27141070

reference Order 83 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[78]

(Review of possible role of PARP inhibitors in ovarian cancer; mentions that cells with defective BRCA proteins are deficient in repair of double-stranded breaks in DNA by homologous recombination and rely on other pathways, notably PARP that detects single DNA strand breaks and activates effector proteins to initiate repair).

reference Order 84 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[79]

Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol 2016; 17: 1579-89. PMID: 27617661

reference Order 85 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[80]

(Among 265 women with platinum-sensitive recurrent ovarian carcinoma treated with olaparib [400 mg twice daily] or placebo [Ledermann 2012], 5 year follow up showed little effect on median overall survival [29.8 vs 27.8 months]; there were no liver related severe adverse events requiring discontinuation).

reference Order 86 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[81]

Olaparib (Lynparza) for advanced ovarian cancer. Med Lett Drugs Ther 2016; 58 (1489): e32-3. PMID: 26938702

reference Order 87 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[82]

(Concise review of the mechanism of action, clinically efficacy, safety and costs of olaparib shortly after its approval in the US; does not mention ALT elevations or hepatotoxicity).

reference Order 88 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[83]

Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, et al. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol 2016; 140: 199-203. PMID: 26723501

reference Order 89 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[84]

(Among 193 women with BRCA 1 or 2 mutations and advanced refractory ovarian cancer treated with olaparib [400 mg twice daily], 34% had an objective response and side effects were common, but only 3 patients [2%] developed ALT elevations above 5 times ULN and none had clinically apparent liver injury).

reference Order 90 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[85]

Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, et al. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18:1637-1651. PMID: 29103871

reference Order 91 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[86]

(Among 525 Asian adults with advanced, refractory gastric cancer treated with paclitaxel with either olaparib [100 mg] or placebo twice daily, median overall survival was similar in both groups [8.8 vs 6.9 months] but serious adverse events were more frequent with olaparib [35% vs 25%] including ALT elevations in 12% vs 6%, above 5 times ULN in 1.5% vs 0.7%, and 1 olaparib recipient died of acute liver failure [no details provided]).

reference Order 92 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[87]

Tufoni M, Serena Ricci C, Zaccherini G. A case of immune-mediated liver injury induced by olaparib. Hepatology. 2018;68:2039-2041. PMID: 30070367.

reference Order 93 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[88]

(61 year old Italian woman with ovarian cancer developed abnormal liver tests 3 months after starting olaparib [bilirubin 1.7 rising to 3.8 mg/dL, ALT 1453 U/L, Alk P 275 U/L, GGT 364 U/L, ANA 1:160] and liver biopsy showing acute hepatitis with eosinophils and rare plasma cells, enzymes rapidly improving with prednisone therapy, and all tests falling to normal within 2 months and remaining normal despite stopping corticosteroids).

reference Order 94 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[89]

Rolfo C, Isambert N, Italiano A, Molife LR, Schellens JHM, Blay JY, Decaens T, et al. Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment. Br J Clin Pharmacol. 2020;86:1807-1818. PMID: 32227355

reference Order 95 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[90]

(Pharmacokinetic study in 31 patients with advanced cancer with or without liver disease found no differences in peak olaparib levels or total concentration in patients with either mild or moderate hepatic impairment compared to controls without liver abnormalities).

reference Order 96 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[91]

Alshelleh M, Park J, John V, Rishi A, Bernstein D, Roth N. Olaparib-induced immune-mediated liver injury. ACG Case Rep J. 2022;9:e00735. PMID: 35028326

reference Order 97 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[92]

(56 year old woman with endometrial cancer developed jaundice 3.5 months after starting olaparib [bilirubin 11.4 mg/dL, ALT 3350 U/L, Alk P 215 U/L, INR 1.9], biopsy showing submassive necrosis; prednisone therapy led to rapid improvement, and all liver tests were normal 2 months later and remained normal after stopping corticosteroids).

reference Order 98 Style Suggestedreading word/document.xml:/w:document[1]/w:body[1]/w:p[93]

Zhu K, Drew Y, Jayakumar S. Challenges in PARP inhibitor therapy: A case of olaparib-induced liver injury and successful rechallenge with niraparib. Gynecol Oncol Rep. 2024;54:101439. PMID: 39035031

reference Order 99 Style Reference-annotation word/document.xml:/w:document[1]/w:body[1]/w:p[94]

(70 year old woman with ovarian cancer developed serum enzyme abnormalities without jaundice or symptoms 3 months after starting olaparib, 300 mg twice daily, [bilirubin 0.6 mg/dL, ALT 871 U/L, Alk P 163 U/L, GGT 139 U/L], improving on stopping but worsening again on restarting at half dose [ALT 878 U/L, bilirubin 2.8 mg/dL], resolving again on stopping, and not recurring on niraparib).

heading Order 102 Level 2 Style Heading2 word/document.xml:/w:document[1]/w:body[1]/w:p[97]

H2. OTHER REFERENCE LINKS

paragraph Order 103 Style Processinginstruction word/document.xml:/w:document[1]/w:body[1]/w:p[98]

<?sec-type link-group?>

heading Order 106 Level 2 Style FiguresTablesBoxesSectionHeading word/document.xml:/w:document[1]/w:body[1]/w:p[101]

H2. [figs-and-tables] Figures, Tables and Boxes Appendix (do not delete)

paragraph Order 107 Style Comment word/document.xml:/w:document[1]/w:body[1]/w:p[102]

Place numbered figures, tables and boxes (referred to from the main text) below.

paragraph Order 108 Style Comment word/document.xml:/w:document[1]/w:body[1]/w:p[103]

“In-line” figures (e.g. equations) and tables should be placed within the main text in their desired final location.

References Reference list and validation

Review the reference list in document order, confirm whether each entry is cited in text, and inspect local citation matching plus DOI or PubMed-backed validation details from one place.

Normalized reference fields are shown for authors, year, title, DOI, PMID, and external validation status.

Local citation coverage

Counts below summarize citations resolved to these reference entries.

Validated 0 Needs review 0 Not found 0 Not applicable 0

External outcomes

PubMed and DOI validation outcomes are listed on each reference row below.

Validated 0 Probable 0 Ambiguous 0 Not found 0 Not applicable 0 Pending 0
reference Order 1 No in-text citation match not applicable

References updated: 18 May 2026

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: References updated: 18 May | Year: 2026 | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 2 No in-text citation match not applicable

Abbreviations used: PARP, poly adenine diphosphate-ribose polymerase

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Abbreviations used: PARP, poly adenine diphosphate-ribose polymerase | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 3 No in-text citation match not found

Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Zimmerman HJ | Year: 1999 | Title: Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver

DOI: n/a | PMID: n/a

External validation: not found via title_author_year_search

No PubMed-backed source match was found for this matched reference.

External validation was recorded without a normalized source summary

No PubMed search candidates were returned for the normalized reference metadata.

reference Order 4 No in-text citation match not found

(Review of hepatotoxicity published in 1999 before the availability of protein kinase or PARP inhibitors such as olaparib).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Review of hepatotoxicity published in | Year: 1999 | Title: before the availability of protein kinase or PARP inhibitors such as olaparib)

DOI: n/a | PMID: n/a

External validation: not found via title_author_year_search

No PubMed-backed source match was found for this matched reference.

External validation was recorded without a normalized source summary

No PubMed search candidates were returned for the normalized reference metadata.

reference Order 5 No in-text citation match not found

DeLeve LD. Kinase inhibitors. Cancer chemotherapy. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 556.

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: DeLeve LD | Year: 2013 | Title: Kinase inhibitors

DOI: n/a | PMID: n/a

External validation: not found via title_author_year_search

No PubMed-backed source match was found for this matched reference.

External validation was recorded without a normalized source summary

No PubMed search candidates were returned for the normalized reference metadata.

reference Order 6 No in-text citation match not applicable

(Review of hepatotoxicity of cancer chemotherapeutic agents discusses several kinase inhibitors including gefitinib, erlotinib and crizotinib, but not the PARP inhibitors such as olaparib).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Review of hepatotoxicity of cancer chemotherapeutic agents discusses several kinase inhibitors including gefitinib, erlotinib and crizotinib, but not the PARP inhibitors such as olaparib) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 7 No in-text citation match not found

Chabner BA, Barnes J, Neal J, Olson E, Mujagic H, Sequist L, Wilson W, et al. Targeted therapies: tyrosine kinase inhibitors, monoclonal antibodies, and cytokines. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 1731-54.

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Chabner BA, Barnes J, Neal J, Olson E, Mujagic H, Sequist L, Wilson W, et al | Year: 2011 | Title: Targeted therapies: tyrosine kinase inhibitors, monoclonal antibodies, and cytokines

DOI: n/a | PMID: n/a

External validation: not found via title_author_year_search

No PubMed-backed source match was found for this matched reference.

External validation was recorded without a normalized source summary

No PubMed search candidates were returned for the normalized reference metadata.

reference Order 8 No in-text citation match not applicable

(Textbook of pharmacology and therapeutics).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: n/a | Year: n/a | Title: (Textbook of pharmacology and therapeutics)

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 9 No in-text citation match validated

Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet 2010; 376 (9737): 245-51. PMID: 20609468

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, et al | Year: 2010 | Title: Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial

DOI: 10.1016/S0140-6736(10)60893-8 | PMID: 20609468

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. | Audeh MW, Carmichael J, Penson RT, et al | 2010 | PMID 20609468

Parsed author summary differs from the returned PubMed authors.

reference Order 10 No in-text citation match not applicable

(Among 57 women with BRAC 1 or 2 mutations and advanced, refractory ovarian carcinoma treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 33% vs 13%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 57 women with BRAC 1 or 2 mutations and advanced, refractory ovarian carcinoma treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 33% vs 13%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 11 No in-text citation match validated

Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet 2010; 376 (9737): 235-44. PMID: 20609467

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, et al | Year: 2010 | Title: Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial

DOI: 10.1016/S0140-6736(10)60892-6 | PMID: 20609467

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. | Tutt A, Robson M, Garber JE, et al | 2010 | PMID 20609467

Parsed author summary differs from the returned PubMed authors.

reference Order 12 No in-text citation match not applicable

(Among 54 women with BRCA 1 or 2 mutations and advanced, refractory breast cancer treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 41% and 22%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 54 women with BRCA 1 or 2 mutations and advanced, refractory breast cancer treated with 400 vs 100 mg of olaparib twice daily, objective response rates were 41% and 22%, while dose interruptions and reductions for adverse events were more frequent with the higher dose; no mention of ALT elevations or hepatotoxicity) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 13 No in-text citation match validated

Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, et al. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol 2011; 12: 852-61. PMID: 21862407

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, et al | Year: 2011 | Title: Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study

DOI: 10.1016/S1470-2045(11)70214-5 | PMID: 21862407

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. | Gelmon KA, Tischkowitz M, Mackay H, et al | 2011 | PMID 21862407

Parsed author summary differs from the returned PubMed authors.

reference Order 14 No in-text citation match not applicable

(In an open label trial of olaparib [400 mg twice daily] in women with advanced ovarian or breast cancer, objective responses occurred in 18 of 63 [29%] women with ovarian carcinoma, but none of 26 with breast cancer; no mention of ALT elevations or hepatotoxicity).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (In an open label trial of olaparib [400 mg twice daily] in women with advanced ovarian or breast cancer, objective responses occurred in 18 of 63 [29%] women with ovarian carcinoma, but none of 26 with breast cancer; no mention of ALT elevations or hepatotoxicity) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 15 No in-text citation match validated

Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012; 366: 1382-92. PMID: 22452356

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al | Year: 2012 | Title: Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer

DOI: 10.1056/NEJMoa1105535 | PMID: 22452356

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. | Ledermann J, Harter P, Gourley C, et al | 2012 | PMID 22452356

Parsed author summary differs from the returned PubMed authors.

reference Order 16 No in-text citation match not applicable

(Among 265 women with advanced ovarian cancer who had a partial or complete response to platinum based chemotherapy, progression free survival was higher with olaparib than placebo [8.4 vs 4.8 months], and adverse events included nausea [68% vs 35%], fatigue [49% vs 38%] and anemia [17% vs 5%], and "there were no unexpected changes in biochemical laboratory measurements").

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 265 women with advanced ovarian cancer who had a partial or complete response to platinum based chemotherapy, progression free survival was higher with olaparib than placebo [8.4 vs 4.8 months], and adverse events included nausea [68% vs 35%], fatigue [49% vs 38%] and anemia [17% vs 5%], and "there were no unexpected changes in biochemical laboratory measurements") | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 17 No in-text citation match validated

Kaye SB, Lubinski J, Matulonis U, Ang JE, Gourley C, Karlan BY, Amnon A, et al. Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. J Clin Oncol 2012; 30: 372-9. PMID: 22203755

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Kaye SB, Lubinski J, Matulonis U, Ang JE, Gourley C, Karlan BY, Amnon A, et al | Year: 2012 | Title: Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer

DOI: 10.1200/JCO.2011.36.9215 | PMID: 22203755

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. | Kaye SB, Lubinski J, Matulonis U, et al | 2012 | PMID 22203755

Parsed author summary differs from the returned PubMed authors.

reference Order 18 No in-text citation match not applicable

(Among 97 women with BRCA 1 or 2 mutations and advanced ovarian cancer treated with olaparib [200 or 400 mg twice daily] or doxorubicin [intravenously every 28 days], progression free survival was similar in all 3 groups and specific adverse events were not mentioned).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 97 women with BRCA 1 or 2 mutations and advanced ovarian cancer treated with olaparib [200 or 400 mg twice daily] or doxorubicin [intravenously every 28 days], progression free survival was similar in all 3 groups and specific adverse events were not mentioned) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 19 No in-text citation match validated

Garnett MJ, Edelman EJ, Heidorn SJ, Greenman CD, Dastur A, Lau KW, Greninger P, et al. Systematic identification of genomic markers of drug sensitivity in cancer cells. Nature 2012; 483 (7391): 570-5. PMID: 22460902

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Garnett MJ, Edelman EJ, Heidorn SJ, Greenman CD, Dastur A, Lau KW, Greninger P, et al | Year: 2012 | Title: Systematic identification of genomic markers of drug sensitivity in cancer cells

DOI: 10.1038/nature11005 | PMID: 22460902

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Systematic identification of genomic markers of drug sensitivity in cancer cells. | Garnett MJ, Edelman EJ, Heidorn SJ, et al | 2012 | PMID 22460902

Parsed author summary differs from the returned PubMed authors.

reference Order 20 No in-text citation match not applicable

(Correlation of mutated cancer genes identified in cancer cell lines with their sensitivity to growth inhibition by antineoplastic agents revealed the possible role of PARP inhibition in several tumors including Ewing sarcoma).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: n/a | Year: n/a | Title: (Correlation of mutated cancer genes identified in cancer cell lines with their sensitivity to growth inhibition by antineoplastic agents revealed the possible role of PARP inhibition in several tumors including Ewing sarcoma)

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 21 No in-text citation match probable

Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial. Lancet Oncol 2014; 15: 852-61. PMID: 24882434

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, et al | Year: 2014 | Title: Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial

DOI: 10.1016/S1470-2045(14)70228-1 | PMID: 24882434

External validation: probable via pmid_exact

A likely external source match was found, but some parsed fields still disagree or need confirmation.

Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. | Ledermann J, Harter P, Gourley C, et al | 2014 | PMID 24882434

Parsed title differs from the returned PubMed title. Parsed author summary differs from the returned PubMed authors.

reference Order 22 No in-text citation match not applicable

(Among 265 women with BRCA 1 or 2 mutations and relapsed, platinum-sensitive ovarian cancer treated with olaparib or placebo [Ledermann 2012], further follow up showed prolongation of progression free, but not overall survival with olaparib therapy and adverse events were similar to those previously reported).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 265 women with BRCA 1 or 2 mutations and relapsed, platinum-sensitive ovarian cancer treated with olaparib or placebo [Ledermann 2012], further follow up showed prolongation of progression free, but not overall survival with olaparib therapy and adverse events were similar to those previously reported) | Year: 2012 | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 23 No in-text citation match validated

Ledford H. Resurrected cancer drug faces regulators. Nature 2014; 510 (7506): 454. PMID: 24965630

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Ledford H | Year: 2014 | Title: Resurrected cancer drug faces regulators

DOI: 10.1038/510454a | PMID: 24965630

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Resurrected cancer drug faces regulators. | Ledford H | 2014 | PMID 24965630

reference Order 24 No in-text citation match not applicable

(News report on olaparib, the initial PARP inhibitor, which in early clinical trials showed little effect on survival in women with ovarian carcinoma, but on reassessment limiting analysis to cases with BRCA mutations found evidence of an effect on cancer growth, reviving interest in pursuing olaparib as therapy of selected patients with ovarian cancer).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (News report on olaparib, the initial PARP inhibitor, which in early clinical trials showed little effect on survival in women with ovarian carcinoma, but on reassessment limiting analysis to cases with BRCA mutations found evidence of an effect on cancer growth, reviving interest in pursuing olaparib as therapy of selected patients with ovarian cancer) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 25 No in-text citation match validated

Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol 2015; 33: 244-50. PMID: 25366685

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, et al | Year: 2015 | Title: Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation

DOI: 10.1200/JCO.2014.56.2728 | PMID: 25366685

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. | Kaufman B, Shapira-Frommer R, Schmutzler RK, et al | 2015 | PMID 25366685

Parsed author summary differs from the returned PubMed authors.

reference Order 26 No in-text citation match not applicable

(Among 298 patients with refractory advanced cancers and BRCA 1 or 2 mutations treated with olaparib [400 mg twice daily], the overall objective response rate was 26% and was higher in women with ovarian [31%] than breast cancer [13%]; there were no liver related serious adverse events).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 298 patients with refractory advanced cancers and BRCA 1 or 2 mutations treated with olaparib [400 mg twice daily], the overall objective response rate was 26% and was higher in women with ovarian [31%] than breast cancer [13%]; there were no liver related serious adverse events) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 27 No in-text citation match validated

Gunderson CC, Moore KN. Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. Future Oncol 2015; 11: 747-57. PMID: 25757679

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Gunderson CC, Moore KN | Year: 2015 | Title: Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer

DOI: 10.2217/fon.14.313 | PMID: 25757679

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib: an oral PARP-1 and PARP-2 inhibitor with promising activity in ovarian cancer. | Gunderson CC, Moore KN | 2015 | PMID 25757679

reference Order 28 No in-text citation match not applicable

(Review of the development, mechanism of action, clinical efficacy and safety of olaparib in ovarian cancer; mentions that the most frequent adverse events are gastrointestinal toxicity and myelosuppression; no mention of ALT elevations or hepatotoxicity).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Review of the development, mechanism of action, clinical efficacy and safety of olaparib in ovarian cancer; mentions that the most frequent adverse events are gastrointestinal toxicity and myelosuppression; no mention of ALT elevations or hepatotoxicity) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 29 No in-text citation match validated

Bao Z, Cao C, Geng X, Tian B, Wu Y, Zhang C, Chen Z, Li W, et al. Effectiveness and safety of poly (ADP-ribose) polymerase inhibitors in cancer therapy: A systematic review and meta-analysis. Oncotarget 2016; 7: 7629-39. PMID: 26399274

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Bao Z, Cao C, Geng X, Tian B, Wu Y, Zhang C, Chen Z, Li W, et al | Year: 2016 | Title: Effectiveness and safety of poly (ADP-ribose) polymerase inhibitors in cancer therapy: A systematic review and meta-analysis

DOI: 10.18632/oncotarget.5367 | PMID: 26399274

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Effectiveness and safety of poly (ADP-ribose) polymerase inhibitors in cancer therapy: A systematic review and meta-analysis. | Bao Z, Cao C, Geng X, et al | 2016 | PMID 26399274

Parsed author summary differs from the returned PubMed authors.

reference Order 30 No in-text citation match not applicable

(Systematic review of the efficacy and safety of PARP inhibitors in cancer chemotherapy mentioned that in 5 placebo controlled trials, ALT elevations were no more frequent with the PARP inhibitors than in “controls”, but neither were any other adverse events).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Systematic review of the efficacy and safety of PARP inhibitors in cancer chemotherapy mentioned that in 5 placebo controlled trials, ALT elevations were no more frequent with the PARP inhibitors than in “controls”, but neither were any other adverse events) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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reference Order 31 No in-text citation match validated

Konecny GE, Kristeleit RS. PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions. Br J Cancer 2016; 115: 1157-73. PMID: 27736844

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Konecny GE, Kristeleit RS | Year: 2016 | Title: PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions

DOI: 10.1038/bjc.2016.311 | PMID: 27736844

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

PARP inhibitors for BRCA1/2-mutated and sporadic ovarian cancer: current practice and future directions. | Konecny GE, Kristeleit RS | 2016 | PMID 27736844

reference Order 32 No in-text citation match not applicable

(Review of role of BRCA 1 and 2 mutations in tumorigenesis and the mechanism of action of PARP inhibitors).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: n/a | Year: n/a | Title: (Review of role of BRCA 1 and 2 mutations in tumorigenesis and the mechanism of action of PARP inhibitors)

DOI: n/a | PMID: n/a

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reference Order 33 No in-text citation match validated

Ledermann JA. PARP inhibitors in ovarian cancer. Ann Oncol 2016; 27 Suppl 1: i40-i44. PMID: 27141070

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Ledermann JA | Year: 2016 | Title: PARP inhibitors in ovarian cancer

DOI: 10.1093/annonc/mdw094 | PMID: 27141070

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

PARP inhibitors in ovarian cancer. | Ledermann JA | 2016 | PMID 27141070

reference Order 34 No in-text citation match not applicable

(Review of possible role of PARP inhibitors in ovarian cancer; mentions that cells with defective BRCA proteins are deficient in repair of double-stranded breaks in DNA by homologous recombination and rely on other pathways, notably PARP that detects single DNA strand breaks and activates effector proteins to initiate repair).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Review of possible role of PARP inhibitors in ovarian cancer; mentions that cells with defective BRCA proteins are deficient in repair of double-stranded breaks in DNA by homologous recombination and rely on other pathways, notably PARP that detects single DNA strand breaks and activates effector proteins to initiate repair) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

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reference Order 35 No in-text citation match validated

Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol 2016; 17: 1579-89. PMID: 27617661

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, et al | Year: 2016 | Title: Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial

DOI: 10.1016/S1470-2045(16)30376-X | PMID: 27617661

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. | Ledermann JA, Harter P, Gourley C, et al | 2016 | PMID 27617661

Parsed author summary differs from the returned PubMed authors.

reference Order 36 No in-text citation match not applicable

(Among 265 women with platinum-sensitive recurrent ovarian carcinoma treated with olaparib [400 mg twice daily] or placebo [Ledermann 2012], 5 year follow up showed little effect on median overall survival [29.8 vs 27.8 months]; there were no liver related severe adverse events requiring discontinuation).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 265 women with platinum-sensitive recurrent ovarian carcinoma treated with olaparib [400 mg twice daily] or placebo [Ledermann 2012], 5 year follow up showed little effect on median overall survival [29.8 vs 27.8 months]; there were no liver related severe adverse events requiring discontinuation) | Year: 2012 | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 37 No in-text citation match validated

Olaparib (Lynparza) for advanced ovarian cancer. Med Lett Drugs Ther 2016; 58 (1489): e32-3. PMID: 26938702

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: n/a | Year: 2016 | Title: Olaparib (Lynparza) for advanced ovarian cancer

DOI: n/a | PMID: 26938702

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib (Lynparza) for advanced ovarian cancer. | 2016 | PMID 26938702

reference Order 38 No in-text citation match not applicable

(Concise review of the mechanism of action, clinically efficacy, safety and costs of olaparib shortly after its approval in the US; does not mention ALT elevations or hepatotoxicity).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Concise review of the mechanism of action, clinically efficacy, safety and costs of olaparib shortly after its approval in the US; does not mention ALT elevations or hepatotoxicity) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 39 No in-text citation match validated

Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, et al. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol 2016; 140: 199-203. PMID: 26723501

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, et al | Year: 2016 | Title: Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy

DOI: 10.1016/j.ygyno.2015.12.020 | PMID: 26723501

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. | Domchek SM, Aghajanian C, Shapira-Frommer R, et al | 2016 | PMID 26723501

Parsed author summary differs from the returned PubMed authors.

reference Order 40 No in-text citation match not applicable

(Among 193 women with BRCA 1 or 2 mutations and advanced refractory ovarian cancer treated with olaparib [400 mg twice daily], 34% had an objective response and side effects were common, but only 3 patients [2%] developed ALT elevations above 5 times ULN and none had clinically apparent liver injury).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 193 women with BRCA 1 or 2 mutations and advanced refractory ovarian cancer treated with olaparib [400 mg twice daily], 34% had an objective response and side effects were common, but only 3 patients [2%] developed ALT elevations above 5 times ULN and none had clinically apparent liver injury) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 41 No in-text citation match validated

Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, et al. Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18:1637-1651. PMID: 29103871

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Bang YJ, Xu RH, Chin K, Lee KW, Park SH, Rha SY, Shen L, et al | Year: 2017 | Title: Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial

DOI: 10.1016/S1470-2045(17)30682-4 | PMID: 29103871

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy (GOLD): a double-blind, randomised, placebo-controlled, phase 3 trial. | Bang YJ, Xu RH, Chin K, et al | 2017 | PMID 29103871

Parsed author summary differs from the returned PubMed authors.

reference Order 42 No in-text citation match not applicable

(Among 525 Asian adults with advanced, refractory gastric cancer treated with paclitaxel with either olaparib [100 mg] or placebo twice daily, median overall survival was similar in both groups [8.8 vs 6.9 months] but serious adverse events were more frequent with olaparib [35% vs 25%] including ALT elevations in 12% vs 6%, above 5 times ULN in 1.5% vs 0.7%, and 1 olaparib recipient died of acute liver failure [no details provided]).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (Among 525 Asian adults with advanced, refractory gastric cancer treated with paclitaxel with either olaparib [100 mg] or placebo twice daily, median overall survival was similar in both groups [8.8 vs 6.9 months] but serious adverse events were more frequent with olaparib [35% vs 25%] including ALT elevations in 12% vs 6%, above 5 times ULN in 1.5% vs 0.7%, and 1 olaparib recipient died of acute liver failure [no details provided]) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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reference Order 43 No in-text citation match validated

Tufoni M, Serena Ricci C, Zaccherini G. A case of immune-mediated liver injury induced by olaparib. Hepatology. 2018;68:2039-2041. PMID: 30070367.

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Tufoni M, Serena Ricci C, Zaccherini G | Year: 2041 | Title: A case of immune-mediated liver injury induced by olaparib

DOI: 10.1002/hep.30119 | PMID: 30070367

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

A Case of Immune-Mediated Liver Injury Induced by Olaparib. | Tufoni M, Serena Ricci C, Zaccherini G | 2018 | PMID 30070367

Parsed publication year differs from the returned PubMed year.

reference Order 44 No in-text citation match not applicable

(61 year old Italian woman with ovarian cancer developed abnormal liver tests 3 months after starting olaparib [bilirubin 1.7 rising to 3.8 mg/dL, ALT 1453 U/L, Alk P 275 U/L, GGT 364 U/L, ANA 1:160] and liver biopsy showing acute hepatitis with eosinophils and rare plasma cells, enzymes rapidly improving with prednisone therapy, and all tests falling to normal within 2 months and remaining normal despite stopping corticosteroids).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (61 year old Italian woman with ovarian cancer developed abnormal liver tests 3 months after starting olaparib [bilirubin 1.7 rising to 3.8 mg/dL, ALT 1453 U/L, Alk P 275 U/L, GGT 364 U/L, ANA 1:160] and liver biopsy showing acute hepatitis with eosinophils and rare plasma cells, enzymes rapidly improving with prednisone therapy, and all tests falling to normal within 2 months and remaining normal despite stopping corticosteroids) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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reference Order 45 No in-text citation match validated

Rolfo C, Isambert N, Italiano A, Molife LR, Schellens JHM, Blay JY, Decaens T, et al. Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment. Br J Clin Pharmacol. 2020;86:1807-1818. PMID: 32227355

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Rolfo C, Isambert N, Italiano A, Molife LR, Schellens JHM, Blay JY, Decaens T, et al | Year: 2020 | Title: Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment

DOI: 10.1111/bcp.14283 | PMID: 32227355

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Pharmacokinetics and safety of olaparib in patients with advanced solid tumours and mild or moderate hepatic impairment. | Rolfo C, Isambert N, Italiano A, et al | 2020 | PMID 32227355

Parsed author summary differs from the returned PubMed authors.

reference Order 46 No in-text citation match not applicable

(Pharmacokinetic study in 31 patients with advanced cancer with or without liver disease found no differences in peak olaparib levels or total concentration in patients with either mild or moderate hepatic impairment compared to controls without liver abnormalities).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: n/a | Year: n/a | Title: (Pharmacokinetic study in 31 patients with advanced cancer with or without liver disease found no differences in peak olaparib levels or total concentration in patients with either mild or moderate hepatic impairment compared to controls without liver abnormalities)

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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External validation was recorded without a normalized source summary

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reference Order 47 No in-text citation match validated

Alshelleh M, Park J, John V, Rishi A, Bernstein D, Roth N. Olaparib-induced immune-mediated liver injury. ACG Case Rep J. 2022;9:e00735. PMID: 35028326

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Alshelleh M, Park J, John V, Rishi A, Bernstein D, Roth N | Year: 2022 | Title: Olaparib-induced immune-mediated liver injury

DOI: 10.14309/crj.0000000000000735 | PMID: 35028326

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Olaparib-Induced Immune-Mediated Liver Injury. | Alshelleh M, Park J, John V, et al | 2022 | PMID 35028326

Parsed author summary differs from the returned PubMed authors.

reference Order 48 No in-text citation match not applicable

(56 year old woman with endometrial cancer developed jaundice 3.5 months after starting olaparib [bilirubin 11.4 mg/dL, ALT 3350 U/L, Alk P 215 U/L, INR 1.9], biopsy showing submassive necrosis; prednisone therapy led to rapid improvement, and all liver tests were normal 2 months later and remained normal after stopping corticosteroids).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (56 year old woman with endometrial cancer developed jaundice 3.5 months after starting olaparib [bilirubin 11.4 mg/dL, ALT 3350 U/L, Alk P 215 U/L, INR 1.9], biopsy showing submassive necrosis; prednisone therapy led to rapid improvement, and all liver tests were normal 2 months later and remained normal after stopping corticosteroids) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

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Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

reference Order 49 No in-text citation match validated

Zhu K, Drew Y, Jayakumar S. Challenges in PARP inhibitor therapy: A case of olaparib-induced liver injury and successful rechallenge with niraparib. Gynecol Oncol Rep. 2024;54:101439. PMID: 39035031

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: Zhu K, Drew Y, Jayakumar S | Year: 2024 | Title: Challenges in PARP inhibitor therapy: A case of olaparib-induced liver injury and successful rechallenge with niraparib

DOI: 10.1016/j.gore.2024.101439 | PMID: 39035031

External validation: validated via pmid_exact

A PubMed-backed source record was validated for this matched reference.

Challenges in PARP inhibitor therapy: A case of Olaparib-induced liver injury and successful rechallenge with Niraparib. | Zhu K, Drew Y, Jayakumar S | 2024 | PMID 39035031

reference Order 50 No in-text citation match not applicable

(70 year old woman with ovarian cancer developed serum enzyme abnormalities without jaundice or symptoms 3 months after starting olaparib, 300 mg twice daily, [bilirubin 0.6 mg/dL, ALT 871 U/L, Alk P 163 U/L, GGT 139 U/L], improving on stopping but worsening again on restarting at half dose [ALT 878 U/L, bilirubin 2.8 mg/dL], resolving again on stopping, and not recurring on niraparib).

This reference was extracted successfully, but no in-text citation currently resolves to it.

Authors: (70 year old woman with ovarian cancer developed serum enzyme abnormalities without jaundice or symptoms 3 months after starting olaparib, 300 mg twice daily, [bilirubin 0.6 mg/dL, ALT 871 U/L, Alk P 163 U/L, GGT 139 U/L], improving on stopping but worsening again on restarting at half dose [ALT 878 U/L, bilirubin 2.8 mg/dL], resolving again on stopping, and not recurring on niraparib) | Year: n/a | Title: n/a

DOI: n/a | PMID: n/a

External validation: not applicable via skipped

This matched reference is not currently expected to validate against PubMed.

External validation was recorded without a normalized source summary

Reference looks non-PubMed-oriented or lacks enough normalized metadata for lookup.

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