Olaparib Maintenance: 65% Risk Reduction in Ovarian Cancer

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
  1. 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. (link)
  2. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011;61:69-90.
  3. Fung-Kee-Fung M, Oliver T, Elit L, Oza A, Hirte HW, Bryson P. Optimal chemotherapy treatment for women with recurrent ovarian cancer. Curr Oncol 2007;14:195-208.
  4. 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-2.2 trial. Lancet 2003;361:2099-106.
  5. Pfisterer J, Ledermann JA. Management of platinum-sensitive recurrent ovarian cancer. Semin Oncol 2006;33:Suppl:S12-S16.
  6. Pujade-Lauraine E, Wagner U, Avall-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.
  7. 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 AGO-OVAR, the NCIC CTG, and the EORTC GCG. J Clin Oncol 2006;24:4699-707.
  8. Markman M, Liu PY, Moon J, et al. Impact on survival of 12 versus 3 monthly cycles of paclitaxel (175 mg/m2) administered to patients with advanced ovarian cancer. [Citation incomplete in source text]
👀 View Mode