Safety evaluation of olaparib for treating ovarian cancer

Expert Opinion on Drug Safety

Volumn 14, Issue 8, 2015, Pages 1305-1316

  Lheureux, Stephanie ^a,b   Bowering, Valerie ^a,b   Karakasis, Katherine ^a,b   Oza, Amit M ^a,b  

^a UNIVERSITY OF TORONTO   (Canada)

^b PRINCESS MARGARET HOSPITAL   (Canada)

Author keywords

BRCA1 2; Olaparib; Ovarian cancer; Safety

Indexed keywords

ALANINE AMINOTRANSFERASE; BEVACIZUMAB; CARBOPLATIN; CEDIRANIB; CISPLATIN; DACARBAZINE; GEMCITABINE; INIPARIB; NIRAPARIB; OLAPARIB; PACLITAXEL; RUCAPARIB; TALAZOPARIB; TOPOTECAN; VELIPARIB; ANTINEOPLASTIC AGENT; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE INHIBITOR; PHTHALAZINE DERIVATIVE; PIPERAZINE DERIVATIVE;

ABDOMINAL PAIN; ACUTE MYELOBLASTIC LEUKEMIA; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW TOXICITY; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER FATIGUE; CANCER PATIENT; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL EVALUATION; COLON CANCER; COMPARATIVE EFFECTIVENESS; CONSTIPATION; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUCED CANCER; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LEUKOPENIA; LUNG CANCER; LYMPHOBLASTOMA; MAINTENANCE CHEMOTHERAPY; MONOTHERAPY; MULTIPLE MYELOMA; MUSCLE CANCER; MYELODYSPLASTIC SYNDROME; NEUTROPENIA; OVARY CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; POSTMARKETING SURVEILLANCE; PRIMARY TUMOR; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK MANAGEMENT; SKIN CANCER; STOMACH CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; UPPER ABDOMINAL PAIN; DRUG MONITORING; GENETICS; ORAL DRUG ADMINISTRATION; OVARIAN NEOPLASMS; PATHOLOGY; PERSONALIZED MEDICINE; PROCEDURES; TUMOR RECURRENCE;

ADMINISTRATION, ORAL; ANTINEOPLASTIC AGENTS; DRUG MONITORING; FEMALE; HUMANS; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PHTHALAZINES; PIPERAZINES; POLY(ADP-RIBOSE) POLYMERASE INHIBITORS; PRECISION MEDICINE;

EID: 84937219401     PISSN: 14740338     EISSN: 1744764X     Source Type: Journal    
DOI: 10.1517/14740338.2015.1045875     Document Type: Article

References (57)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin 2013;63:11-30
2. Chen S, Parmigiani G. Meta-analysis of brca1 and brca2 penetrance. J Clin Oncol 2007;25:1329-33
3. Alsop K, Fereday S, Meldrum C, et al. Brca mutation frequency and patterns of treatment response in brca mutationpositive women with ovarian cancer: A report from the Australian ovarian cancer study group. J Clin Oncol 2012;30:2654-63
4. Ledermann JA, Raja FA, Fotopoulou C, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: Esmo clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol 2013;24(Suppl 6):24-32
5. Coleman RL, Monk BJ, Sood AK, et al. Latest research and treatment of advanced-stage epithelial ovarian cancer. Nat Rev Clin Oncol 2013;10:211-24
6. Friedlander ML, Stockler MR, Butow P, et al. Clinical trials of palliative chemotherapy in platinum-resistant or-refractory ovarian cancer: Time to think differently? J Clin Oncol 2013;31:2362
7. Colombo N, Gore M. Treatment of recurrent ovarian cancer relapsing 6-12 months post platinum-based chemotherapy. Crit Rev Oncol Hematol 2007;64:129-38
8. Parmar MK, Ledermann JA, Colombo N, et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: The icon4/ago-ovar-22 trial. Lancet 2003;361:2099-106
9. Pfisterer J, Plante M, Vergote I, et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: An intergroup trial of the agoovar, the ncic ctg, and the eortc gcg. J Clin Oncol 2006;24:4699-707
10. Pujade-Lauraine E, Wagner U, Aavall-Lundqvist E, et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. J Clin Oncol 2010;28:3323-9
11. Naumann RW, Coleman RL. Management strategies for recurrent platinum-resistant ovarian cancer. Drugs 2011;71:1397-412
12. Banerjee S, Kaye SB. New strategies in the treatment of ovarian cancer: Currentclinical perspectives and future potential. Clin Cancer Res 2013;19:961-8
13. Banerjee S, Kaye S. The role of targeted therapy in ovarian cancer. Eur J Cancer 2011;47 (Suppl 3):S16-30
14. Ratner ES, Sartorelli AC, Lin ZP. Poly (adp-ribose) polymerase inhibitors: On the horizon of tailored and personalized therapies for epithelial ovarian cancer. Curr Opin Oncol 2012;24:564-71
15. Rouleau M, Patel A, Hendzel MJ, et al. Parp inhibition: Parp1 and beyond. Nat Rev Cancer 2010;10:293-301
16. Murai J, Huang SY, Das BB, et al. Trapping of PARP1 and PARP2 by Clinical PARP Inhibitors. Cancer Res 2012;72:5588-99
17. Farmer H, McCabe N, Lord CJ, et al. Targeting the DNA repair defect in brca mutant cells as a therapeutic strategy. Nature 2005;434:917-21
18. Javle M, Curtin NJ. The role of PARP in DNA repair and its therapeutic exploitation. Br J Cancer 2011;105(8):1114-22
19. Deeks ED. Olaparib: first global approval. Drugs 2015;75(2):231-40
20. Lheureux S, Oza A. Olaparib for the treatment of ovarian cancer. Expert Opin Orphan Drugs 2014;2(5):497-508
21. Fong PC, Boss DS, Yap TA, et al. Inhibition of poly(adp-ribose) polymerase in tumors from brca mutation carriers. N Engl J Med 2009;361:123-34
22. Bundred N, Gardovskis J, Jaskiewicz J, et al. Evaluation of the pharmacodynamics and pharmacokinetics of the PARP inhibitor olaparib: A phase I multicentre trial in patients scheduled for elective breast cancer surgery. Invest New Drugs 2013;31(4):949-58
23. Murai J, Zhang Y, Morris J, et al. Rationale for poly(ADP-ribose) polymerase (PARP) inhibitors in combination therapy with camptothecins or temozolomide based on PARP trapping versus catalytic inhibition. J Pharmacol Exp Ther 2014;349(3):408-16
24. Vergote I, Rutten A, Rolfo CD, et al. Effect of food on the pharmacokinetics (PK) of olaparib after oral dosing of the capsule formulation. J Clin Oncol, 32(5s Suppl): Abstract 2599
25. Molife LR, Forster MD, Krebs M, et al. A phase 1 study to determine the comparative bioavailability of two different oral formulations of the parp inhibitor, olaparib (azd2281), in patients with advanced solid tumors. ASCO Meeting Abstracts 2010;28:2599
26. Gupta A, Moreno V, Dean EJ, et al. Phase 1 study to determine the bioavailability and tolerability of a tablet formulation of the parp inhibitor olaparib in patients with advanced solid tumors: Dose-escalation phase. ASCO Meeting Abstracts 2012;30:3051
27. Molife LR, Mateo J, McGoldrick T, et al. Safety and efficacy results from two randomized expansions of a phase I study of a tablet formulation of the PARP inhibitor, olaparib, in ovarian and breast cancer patients with BRCA1/2 mutations. ASCO Meeting Abstracts 2012;30:3048
28. Mateo J, Friedlander M, Sessa C, et al. Administration of continuous/ intermittent olaparib in ovarian cancer patients with a germline brca1/2 mutation to determine an optimal dosing schedule for the tablet formulation [abstract 801]. The European Journal of Cancer 2013;49(9):S161
29. Audeh MW, Carmichael J, Penson RT, 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;376:245-51
30. Kaye SB, Lubinski J, Matulonis U, et al. Phase 2, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (adpribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with brca1 or brca2 mutations and recurrent ovarian cancer. J Clin Oncol 2012;30:372-9
31. Gordon AN, Fleagle JT, Guthrie D, et al. Recurrent epithelial ovarian carcinoma: A randomized phase 3 study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 2001;19:3312-22
32. Adams SF, Marsh EB, Elmasri W, et al. A high response rate to liposomal doxorubicin is seen among women with brca mutations treated for recurrent epithelial ovarian cancer. Gynecol Oncol 2011;123:486-91
33. Gelmon KA, Tischkowitz M, Mackay 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
34. Kaufman B, Shapira-Frommer R, Schmutzler RK, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol 2015;33(3):244-50
35. Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012;366:1382-92
36. Ledermann JA, Harter P, Gourley C, 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 randomised phase 2 trial. Lancet Oncol 2014;15(8):852-61
37. Oza AM, Cibula D, Benzaquen AO, et al. Olaparib combined with chemotherapy for recurrent platinumsensitive ovarian cancer: A randomised phase 2 trial. Lancet Oncol 2015;16(1):87-97
38. AstraZenecaAB. Lynparza 50 mg hard capsules: EU summary of product characteristics. 2014. Available from: http://www. ema. europa. eu/ema
39. AstraZeneca Global. Lynparza approved in the European Union as first-in-class treatment for advanced BRCA-mutated ovarian cancer [media release]. 2014. Available from: http://astrazeneca. com
40. AstraZeneca Pharmaceuticals LP. Lynparza (olaparib) capsules, for oral use: US prescribing information. 2014. Available from: http://www. accessdata. fda. gov/scripts/cder/ drugsatfada/index. cfm
41. US FDA. FDA approves Lynparza to treat advanced ovarian cancer [media release]. 2014. Available from: http://www. fda. gov/newsevents/newsroom/ pressannoucements/ucm427554. htm
42. Ledermann JA, Harter P, Gourley C, et al. Health-related quality of life (HRQoL) during olaparib maintenance therapy in patients with platinumsensitive relapsed serous ovarian cancer (PSR SOC) and a BRCA mutation (BRCAm). Ann Oncol 2014;25:Suppl-4
43. Samol J, Ranson M, Scott E, et al. Safety and tolerability of the poly(adp-ribose) polymerase (parp) inhibitor, olaparib (azd2281) in combination with topotecan for the treatment of patients with advanced solid tumors: A phase 1 study. Invest New Drugs 2012;30:1493-500
44. Khan OA, Gore M, Lorigan P, et al. A phase 1 study of the safety and tolerability of olaparib (azd2281, ku0059436) and dacarbazine in patients with advanced solid tumours. Br J Cancer 2011;104:750-5
45. Dent RA, Lindeman GJ, Clemons M, et al. Phase 1 trial of the oral parp inhibitor olaparib in combination with paclitaxel for first-or second-line treatment of patients with metastatic triple-negative breast cancer. Breast Cancer Res 2013;15:R88
46. Lee J, Annunziata CM, Minasian LM, et al. Phase 1 study of the parp inhibitor olaparib (o) in combination with carboplatin (c) in brca1/2 mutation carriers with breast (br) or ovarian (ov) cancer (ca). ASCO Meeting Abstracts 2011;29:2520
47. Rajan A, Carter CA, Kelly RJ, et al. A phase 1 combination study of olaparib with cisplatin and gemcitabine in adults with solid tumors. Clin Cancer Res 2012;18:2344-51
48. van der Noll R, Ang JE, Jager A, et al. Phase 1 study of olaparib in combination with carboplatin and/or paclitaxel in patients with advanced solid tumors. ASCO Meeting Abstracts 2013;31:2579
49. Dean E, Middleton MR, Pwint T, et al. Phase 1 study to assess the safety and tolerability of olaparib in combination with bevacizumab in patients with advanced solid tumours. Br J Cancer 2012;106:468-74
50. Liu JF, Barry WT, Birrer M, et al. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: A randomized phase 2 study. Lancet Oncol 2014;15(11):1207-14
51. Del Conte G, Sessa C, von Moos R, et al. Phase I study of olaparib in combination with liposomal doxorubicin in patients with advanced solid tumours. Br J Cancer 2014;111(4):651-9
52. Yamamoto N, Nokihara H, Yamada Y, et al. A phase 1, dose-finding and pharmacokinetic study of olaparib (azd2281) in Japanese patients with advanced solid tumors. Cancer Sci 2012;103:504-9
53. Coleman RL, Sill M, Aghajanian C, et al. A phase II evaluation of the potent, highly selective PARP inhibitor veliparib in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who carry a germline BRCA1 or BRCA2 mutation-a Gynecologic Oncology Group study. Gynecol Oncol 2014;133:56-7
54. Liu JF, Konstantinopoulos PA, Matulonis UA. PARP inhibitors in ovarian cancer: current status and future promise. Gynecol Oncol. 2014;133(2):362-9
55. Walsh CS. Two decades beyond BRCA1/2: Homologous recombination, hereditary cancer risk and a target for ovarian cancer therapy. Gynecol Oncol 2015;pii: S0090-8258(15)00657-5; In press
56. Bhatia S. Therapy-related myelodysplasia and acute myeloid leukemia. Semin Oncol 2013;40(6):666-75
57. Travis LB, Holowaty EJ, Bergfeldt K, et al. Risk of leukemia after platinumbased chemotherapy for ovarian cancer. N Engl J Med 1999;340(5):351-7