Profile of olaparib in the treatment of advanced ovarian cancer

Figures & data

Table 1 Major study results and toxicities

	Kaye et al^Citation14		Audeh et al^Citation6		Gelmon et al^Citation8	Kaufman et al^Citation10	Oza et al^Citation11		Ledermann et al^Citation9
Population (n)	BRCA mutation, recurrent HGSOC, platinum sensitive (97)		BRCA mutation, recurrent HGSOC (57)		+/− BRCA, recurrent HGSOC, sensitive (65)	BRCA mutation, HGSOC, platinum resistant (193)	+/− BRCA, recurrent HGSOC, platinum sensitive (162)		+/− BRCA, recurrent HGSOC, platinum sensitive (265)
Olaparib dose	400 mg bid, 200 mg bid		400 mg bid, 100 mg bid		400 mg bid	400 mg bid	200 mg bid with chemo, 400 mg bid maintenance		400 mg bid maintenance
Toxicities (%)	200 mg	400 mg	100 mg	400 mg			200 mg	400 mg
Nausea	59	78	37	48	66	61.7	69	50	68.4
Vomiting	34	50	0	12	39	38.9	26	29	31.6
Diarrhea	19	38	13	15	23	29	42	15	22.8
Anorexia	NA	NA	NA	NA	30	18.7	26	17	18.4
Fatigue	41	21	38	33	70	60.1	64	20	48.5
Dysgeusia	NA	NA	NA	NA	21	20.2	25	8	14
Dyspepsia	NA	NA	13	6	NA	19.7	26	8	16.2
Anemia	12	32	17	18	NA	32.1	26	12	16.9
Outcome	PFS 6.5 mo (200 mg), 8.8 mo (400 mg), and 7.1 mo (PLD)		ORR 33% in 400 mg bid and 13% in 100 mg bid groups		ORR 29% (41% in BRCA mutated, 24% WT)	PFS 7 mo, OS 16.6 mo, TRR 31.3%	PFS 12.2 mo in olaparib plus chemo group versus 9.6 mo in chemo-alone group		PFS 8.4 mo in olaparib group versus 4.8 mo in placebo group

Abbreviations: HGSOC, high-grade serous ovarian cancer; PFS, progression-free survival; mo, month; PLD, pegylated liposomal doxorubicin; ORR, objective response rate; OS, overall survival; TRR, tumor response rate; WT, wild type; NA, no data.

KayeSBLubinskiJAngJEPhase 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 BRCA 1 or BRCA2 mutations and recurrent ovarian cancerJ Clin Oncol201230437237922203755

 PubMed Web of Science ®Google Scholar

AudehMWCarmichaelJPensonRTOral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trialLancet2010376973724525120609468

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GelmonKATischkowitzMMackayHOlaparib 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 studyLancet Oncol201112985286121862407

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KaufmanBShapira-FrommerRSchmutzlerRKOlaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutationJ Clin Oncol201533324425025366685

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OzaAMCibulaDBenzaquenAOOlaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trialLancet Oncol2015161879725481791

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LedermannJHarterPGourleyCOlaparib 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 trialLancet Oncol201415885286124882434

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