(Ovarian Cancer) Is Olaparib Effective as Maintenance Therapy After Platinum-Based Chemotherapy?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On October 26, 2021, Susana Banerjee et al. from The Royal Marsden NHS Foundation Trust and Institute of Cancer Research published 5-year follow-up efficacy and safety results from the SOLO1/GOG 3004 Phase III clinical trial in The Lancet, evaluating olaparib as maintenance therapy after platinum-based chemotherapy in BRCA-mutated high-grade serous ovarian cancer patients.
SOLO1/GOG 3004 was an international multicenter, randomized, double-blind Phase III clinical trial that randomly assigned BRCA-mutated high-grade serous ovarian cancer patients to either the olaparib maintenance therapy group (300mg twice daily, maximum treatment duration 2 years) or the placebo group. The primary endpoint was progression-free survival.
At a median follow-up of 4.8 years for the olaparib group and 5.0 years for the placebo group, the median PFS (primary endpoint) was 56.0 months for the olaparib group versus 13.8 months for the placebo group. Olaparib reduced the risk of disease progression or death by 67%.
Grade 3-4 adverse events confirmed in most patients included anemia (olaparib group 22%, N=57/260 vs. placebo 2%, N=2/130) and neutropenia (olaparib group 22%, N=22/260 vs. placebo 5%, N=6/130). The serious adverse event rate was 21% (N=55/260) in the olaparib group vs. 13% (N=17/130) in the placebo group.
Based on the 5-year follow-up results from the SOLO1/GOG 3004 trial, Susana Banerjee et al. stated: "In BRCA-mutated high-grade serous ovarian cancer patients, olaparib maintenance therapy after platinum-based chemotherapy confirmed that the effect persists after treatment completion, extending progression-free survival by 4-5 years, supporting the use of olaparib as maintenance therapy."
Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00531-3/fulltext#%20
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