Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trial
- PMID: 41861615
- DOI: 10.1016/j.ijgc.2026.104556
Adverse event profile following maintenance olaparib in patients with BRCA-mutated platinum-sensitive relapsed serous ovarian cancer in the phase III SOLO2 trial
Abstract
Objective: To characterize the occurrence, duration, and outcomes of the most common non-hematological (nausea, vomiting, fatigue/asthenia) and hematological (anemia, neutropenia) adverse events experienced by patients receiving olaparib in the phase III SOLO2 trial.
Methods: SOLO2 (NCT01874353) is a randomized, double-blind, placebo-controlled trial. Eligible patients had histologically confirmed relapsed high-grade serous ovarian cancer or high-grade endometrioid cancer with a BRCA mutation and were in response after platinum-based chemotherapy. Patients were randomized 2:1 to olaparib tablets 300 mg twice daily (N = 196) or placebo (N = 99). Safety outcomes were analyzed in all randomized patients who received ≥1 dose of study drug (olaparib, n = 195; placebo, n = 99).
Results: The most common adverse events of interest (nausea, vomiting, fatigue/asthenia, anemia, and neutropenia) were generally reported early, within the first 1 to 3 months of olaparib treatment, and were mostly grade 1/2. For all adverse events of interest, the risk of experiencing an event was statistically significantly higher with olaparib than with placebo (nausea hazard ratio [HR] 3.38, p <.001; vomiting HR 1.86, p =.016; fatigue/asthenia HR 2.11, p <.001; anemia HR 5.80, p <.001; and neutropenia HR 2.66, p =.027). Of these adverse events, only nausea had a statistically significantly higher risk of experiencing a second event with olaparib than with placebo (HR 3.62, p <.001). The prevalence of nausea, fatigue/asthenia, and anemia was higher with olaparib than with placebo across all time points. The median time to resolution of the first adverse event for olaparib versus placebo was 1.7 versus 0.4 months (nausea), 2 versus 2 days (vomiting), 6.4 versus 2.3 months (fatigue/asthenia), 3.2 versus 2.9 months (anemia), and 29 versus 14 days (neutropenia). Fatigue/asthenia was the slowest adverse event to resolve.
Conclusion: These data confirm that the use of olaparib as long-term maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer is tolerable. Adverse events occurred early, were manageable, and few occurred with late onset.
Keywords: Olaparib; Ovarian Cancer; Platinum-Sensitive Relapsed; SOLO2; Tolerability.
Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of Competing Interests JAL reports grants and personal fees from AstraZeneca and MSD/Merck Research, outside the submitted work; advisory board and speaker fees from AstraZeneca, GSK, Merck/MSD, Immagene, Novocure, Seagen, ImmunoGen/AbbVie, and Medison; and Independent Data Monitoring Committee fees from Mersana, Sutro Bio, Zentalis, and AstraZeneca. RTP reports personal fees from AstraZeneca during the conduct of the study and personal fees from Aadi Bioscience, GSK, ImmunoGen, Merck & Co., Mersana, Novocure, Roche Pharma, and Sutro Biopharma outside the submitted work. VG reports grants from The University of Sydney during the conduct of this study. DP reports participation in advisory boards for GSK, AstraZeneca, Eisai, and AbbVie. MPB-G reports personal fees from AstraZeneca, Clovis, Eisai, GSK, Roche, Pharma&, Regeneron, and PharmaMar outside the submitted work. NC reports grants and personal fees from AstraZeneca during the conduct of the study and has acted as a consultant/advisor for AstraZeneca, Clovis Oncology, Eisai, GSK, Immunogen, Mersana, MSD/Merck, Nuvation Bio, OncXerna, Pieris, Roche, Novocure, Biontech, and Gilead; as a promotional speaker for AstraZeneca, Clovis, MSD/Merck, GSK, and Eisai; and as an investigator/researcher for AstraZeneca, GSK, and Roche. Non-financial interests include acting as a Steering Committee Member for ESMO Clinical Guidelines and as Chair of the Scientific Committee for ACTO Onlus. T-WP-S reports personal fees/grants from Roche, AstraZeneca, GSK, Pfizer, Lilly, MSD, Exact Sciences, Daiichi Sankyo, Seagen, Novartis, Gilead Science, NCO, and Onkowissen. KM reports contracts for registration trials for the institution at Daiichi Sankyo, MSD, Eli Lilly, Gilead Sciences, and BMS, and honoraria from MSD, Kyowa Kirin, Daiichi Sankyo, Eli Lilly, and Chugai. J-WK reports personal fees from AstraZeneca outside the submitted work. IV reports consulting advice for Akesobio, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffmann-La Roche, Genmab, GSK, ITM, Jazz Pharmaceuticals, Karyopharm, MSD, Novocure, Oncoinvent, Sanofi, Regeneron, Seagen, Sotio, and Zentalis, and consultancy for Data Monitoring Committees for Agenus, AstraZeneca, Corcept, Daiichi, Exelixis, Genmab, F. Hoffmann-La Roche, Immunogen, Kronos Bio, Mersana, Novartis, OncXerna, and Verastem Oncology. DC and ESL report full-time employment from AstraZeneca during the conduct of this study. EP-L reports personal fees from AstraZeneca, Roche, and Pfizer outside the submitted work. AL, RA, IBr, TH, SP, LM, IBo, OM, and GG have no conflict of interest to declare.
LinkOut - more resources
Full Text Sources
