Theme

Olaparib Maintenance Therapy in Relapsed Ovarian Cancer

Source
Source: 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. (ClinicalTrials.gov number, NCT00753545.)

Phase 2 RCT Analysis • Ledermann et al. (NEJM)

Population

N=265
Platinum-sensitive, relapsed, high-grade serous ovarian cancer.

Design

RCT (1:1)
Double-blind, Placebo-controlled.
Olaparib 400mg BID vs Placebo

Exposure

Median Duration
Olaparib: 206.5 days
Placebo: 141 days

Risk Reduction (Progression/Death)
65%
Hazard Ratio: 0.35
(95% CI, 0.25–0.49; P<0.001)

Clinical Efficacy (Months)

Key Findings

  • Significant PFS Benefit: Olaparib nearly doubled median PFS (8.4 vs 4.8 months).
  • Superior Time to Progression: Consistent benefit seen using RECIST or CA-125 criteria.
  • Universal Effect: Lower risk of progression observed regardless of BRCA mutation status.

Median Treatment Exposure

Clinical Recommendation

Implement Olaparib as a maintenance standard of care for platinum-sensitive, relapsed high-grade serous ovarian cancer. The data supports significantly prolonged disease control with a manageable toxicity profile.

AbbreviationsQuick
ADP = adenosine diphosphate; CA-125 = cancer antigen 125; CI = confidence interval; CTCAE = Common Terminology Criteria for Adverse Events; ECOG = Eastern Cooperative Oncology Group; FACT = Functional Assessment of Cancer Therapy; GCIG = Gynecological Cancer InterGroup; NA = not available; PARP = poly(adenosine diphosphate–ribose) polymerase; RECIST = Response Evaluation Criteria in Solid Tumors.
Bibliography8
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