5-Year Follow-Up of the SOLO1/GOG 3004 Trial of Maintenance Olaparib for Patients with Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation

2021 Year in Review - Ovarian Cancer —March 21, 2022


Ovarian Cancer

Five-year follow-up results of the SOLO1 trial indicate that 2 years of maintenance olaparib provides sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer harboring BRCA1 and/or BRCA2 mutations, with no emergence of new safety signals.

Primary analysis of the phase 3 SOLO1 trial (NCT01844986; GOG-3004) demonstrated that maintenance olaparib in patients with newly diagnosed advanced ovarian cancer harboring BRCA1 and/or BRCA2 mutations (BRCAm), who responded to first-line platinum-based chemotherapy provides significant progression-free survival (PFS) benefit compared with placebo. The long-term efficacy and safety data of maintenance olaparib after 5 years of follow-up in the SOLO1 trial were published in the October 26, 2021, issue of Lancet Oncology.

The study enrolled patients aged ≥18 years with BRCA-mutated, newly diagnosed, advanced, high-grade serous or endometrioid ovarian cancer, who responded to platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group performance status of 0-1. Eligible patients were randomized (2:1) to receive maintenance olaparib (300 mg twice a day) or placebo for up to 2 years. The primary end point was investigator-assessed PFS. The data cutoff for this analysis was March 5, 2020.

Of the total of 391 patients enrolled in the trial, 260 received olaparib and 131 received placebo, with a median treatment duration of 24.6 months and 13.9 months, respectively. In the intention-to-treat population, median PFS was 56 months in the olaparib cohort (median follow-up of 4.8 years) compared with 14 months in the placebo cohort (median follow-up of 5.0 years).

The safety profile of olaparib was consistent with that previously described. The most frequent grade 3/4 adverse events in the olaparib cohort were anemia (22%) and neutropenia (8%). Serious adverse events occurred in 21% of patients in the olaparib group and 13% in the placebo group. No treatment-related adverse events (that occurred during study treatment or up to 30 days after discontinuation) led to death. The current analysis found no new cases of myelodysplastic syndrome or acute myeloid leukemia.

Long-term safety and efficacy results of the SOLO1 trial demonstrate that 2 years of maintenance olaparib provide sustained PFS benefit. Patients with olaparib-treated, newly diagnosed, advanced ovarian cancer with a BRCAm were progression-free past 4.5 years, with the emergence of no new safety signals.

Source: Banerjee S, Moore KN, Colombo N, et al. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021;22:1721-1731.

Related Articles
2021 in Review
2021 Year in Review - Ovarian Cancer
In 2021, the COVID-19 pandemic continued to impact the practice of medicine and dissemination of treatment advances presented in scientific forums.
Phase 3b OPINION Primary Analysis of Olaparib Maintenance Monotherapy for Nongermline BRCA1/2-Mutated Platinum-Sensitive Relapsed Ovarian Cancer
2021 Year in Review - Ovarian Cancer
Results of the primary analysis of the phase 3b OPINION study supported the use of olaparib maintenance therapy in patients with nongermline BRCA1/2-mutated platinum-sensitive relapsed ovarian cancer.
Final Overall Survival Results from the LIGHT Study of Olaparib Treatment in Platinum-Sensitive Relapsed Ovarian Cancer by BRCA Mutation and Homologous Recombination Deficiency Status
2021 Year in Review - Ovarian Cancer
The final overall survival analysis of the phase 2 LIGHT study indicates that olaparib therapy in patients with platinum-sensitive relapsed ovarian cancer provides overall survival benefit across patient cohorts, regardless of BRCA mutation and homologous recombination deficiency status, with a safety profile consistent with that previously described.
Last modified: April 7, 2022

Subscribe to the Journal of Oncology Navigation & Survivorship®

To sign up for our print publication or e-newsletter, please enter your contact information below.

  • First Name *
    Last Name *
    Profession or Role
    Primary Specialty or Disease State

    Please enter your mailing address.

    Address Line 2
    Zip Code