SOLO1: Olaparib Reduces Progression Risk by 70% in Ovarian Cancer

Theme

Maintenance Olaparib Reduces Risk of Progression or Death by 70% in Newly Diagnosed, BRCA-Mutated Advanced Ovarian Cancer

Source
Source: Moore K, Colombo N, Scambia G, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018;379:2495-2504. (SOLO1 ClinicalTrials.gov number, NCT01844986).
SOLO1 Phase 3 Trial N=391 41-Month Median Follow-up
Hazard Ratio
0.30
70% Risk Reduction
Disease Progression or Death
(P<0.001)

Study Design

  • Population: Newly diagnosed, advanced (FIGO III/IV) ovarian cancer w/ BRCA1/2 mutation.
  • Comparison (2:1):
    • Olaparib: 300 mg BID (n=260)
    • Placebo: (n=131)
  • Duration: Until progression or 2 years.

Safety Signal

Grade 3/4 Anemia

12% discontinuation rate in Olaparib arm due to adverse events.

Median Progression-Free Survival (PFS)

*Median not reached for Olaparib in primary analysis; ~36 months est. via sensitivity analysis.

3-Year Sustained Remission Rates

Percentage of patients free from disease progression and death at 36 months.

Clinical Recommendation: Standard of Care

Adopt Olaparib maintenance therapy for newly diagnosed, advanced ovarian cancer (BRCA1/2m). Immediate maintenance following first-line chemotherapy offers a potentially curative shift—sustaining long-term progression-free survival.

Monitor: Watch closely for hematologic toxicity, specifically anemia.
AbbreviationsQuick
CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; NC, not calculated; PARP, poly(adenosine diphosphate–ribose) polymerase; RECIST, Response Evaluation Criteria in Solid Tumors; ULN, upper limit of the normal range.
Bibliography8
  1. Moore K, Colombo N, Scambia G, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018;379:2495. (link)
  2. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: ovarian cancer version 2. 2018. (link)
  3. Ledermann JA, Raja FA, Fotopoulou C, Gonzalez-Martin A, Colombo N, Sessa C. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2013; 24:Suppl 6: vi24-vi32.
  4. Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011;365:2473-83.
  5. Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 2011;365:2484-96.
  6. Burger RA, Enserro D, Tewari KS, et al. Final overall survival (OS) analysis of an international randomized trial evaluating bevacizumab (BEV) in the primary treatment of advanced ovarian cancer: a NRG oncology/Gynecologic Oncology Group (GOG) study. J Clin Oncol 2018; 36:5517. abstract.
  7. O’Connor MJ. Targeting the DNA damage response in cancer. Mol Cell 2015; 60: 547-60.
  8. AstraZeneca. Lynparza (olaparib) tablets, for oral use: prescribing information. 2018. (link)
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