Adverse events in the placebo arm of SOLO2/ENGOT-Ov21 maintenance trial of olaparib in recurrent ovarian cancer
Abstract
BACKGROUND: In women with platinum sensitive recurrent ovarian cancer (PSROC) undergoing maintenance treatment, adverse events (AEs) not attributable to the current treatment are not well understood. We used data from SOLO2/ENGOT-Ov21 to evaluate AEs reported in the placebo arm and to explore their longitudinal trajectories. METHODS: SOLO2/ENGOT-Ov21 (NCT01874353) randomly assigned 295 PSROC participants with a BRCA1/2 mutation to maintenance olaparib tablets (N = 196) or matching placebo (N = 99). For those assigned to placebo, we analyzed the AE (CTCAE v4.0) data including type, grade, time of onset and resolution, and attribution by investigator. RESULTS: Amongst 99 participants who received placebo 788 AEs were reported (95 % reporting ≥1 AE). Twenty-two percent of participants reported at least one grade ≥ 3 AE. Grade ≥ 2 AEs that persisted for over 100 days affected 21 % of participants. Recurring grade ≥ 1 AEs were experienced by 44 % of participants. Study investigators attributed 25 % of all AEs to the placebo treatment, with neutropenia (88 %), nausea (52 %) and thrombocytopenia (50 %) most attributed. Three percent of participants had a dose reduction, 19 % had treatment delays, and 2 % had permanent treatment discontinuation, due to AEs attributed to placebo. CONCLUSION: Virtually all PSROC participants in the SOLO2/ENGOT-Ov21 experienced one or more AE whilst on placebo. Furthermore, study investigators attributed one quarter of AEs to be related to placebo therapy and dose alterations and treatment changes were made based on these AE. Further work is needed to improve measurement and categorization of AEs in trials of maintenance therapy in PSROC.
Related
- Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial
- Olaparib plus tremelimumab in women with recurrent ovarian cancer and a germline BRCA1 or BRCA2 mutation: a phase I/II study
- Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial
- Phase I/II Study of the PARP Inhibitor Olaparib and Irinotecan in Children and Young Adults with Recurrent/Refractory Malignancies: Arm D of the AcSé-ESMART Trial
- Ferroportin deficiency drives olaparib resistance in ovarian cancer via the cGAS-STING-STAT3 survival axis.
BibTeX
@article{francis2026adverse,
title = {{Adverse events in the placebo arm of SOLO2/ENGOT-Ov21 maintenance trial of olaparib in recurrent ovarian cancer}},
author = {Katherine Elizabeth Francis and Sandy Simon and Val Gebski and Florence Joly and Jonathan Ledermann and Richard Penson and Amit Oza and Jacob Korach and Nuria Lainez and Sabrina Chiara Cecere and Giulia Tasca and Martina Gropp-Meier and Keiichi Fujiwara and Elizabeth Lowe and Michael Friedlander and Eric Pujade-Lauraine and Chee Khoon Lee},
journal = {Gynecologic Oncology},
year = {2026},
month = sep,
doi = {10.1016/j.ygyno.2024.11.004},
url = {https://hal.science/hal-05745960v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - Adverse events in the placebo arm of SOLO2/ENGOT-Ov21 maintenance trial of olaparib in recurrent ovarian cancer
AU - Katherine Elizabeth Francis
AU - Sandy Simon
AU - Val Gebski
AU - Florence Joly
AU - Jonathan Ledermann
AU - Richard Penson
AU - Amit Oza
AU - Jacob Korach
AU - Nuria Lainez
AU - Sabrina Chiara Cecere
AU - Giulia Tasca
AU - Martina Gropp-Meier
AU - Keiichi Fujiwara
AU - Elizabeth Lowe
AU - Michael Friedlander
AU - Eric Pujade-Lauraine
AU - Chee Khoon Lee
PY - 2026
DA - 2026/09/10
JO - Gynecologic Oncology
DO - 10.1016/j.ygyno.2024.11.004
UR - https://hal.science/hal-05745960v1
AB - BACKGROUND: In women with platinum sensitive recurrent ovarian cancer (PSROC) undergoing maintenance treatment, adverse events (AEs) not attributable to the current treatment are not well understood. We used data from SOLO2/ENGOT-Ov21 to evaluate AEs reported in the placebo arm and to explore their longitudinal trajectories. METHODS: SOLO2/ENGOT-Ov21 (NCT01874353) randomly assigned 295 PSROC participants with a BRCA1/2 mutation to maintenance olaparib tablets (N = 196) or matching placebo (N = 99). For those assigned to placebo, we analyzed the AE (CTCAE v4.0) data including type, grade, time of onset and resolution, and attribution by investigator. RESULTS: Amongst 99 participants who received placebo 788 AEs were reported (95 % reporting ≥1 AE). Twenty-two percent of participants reported at least one grade ≥ 3 AE. Grade ≥ 2 AEs that persisted for over 100 days affected 21 % of participants. Recurring grade ≥ 1 AEs were experienced by 44 % of participants. Study investigators attributed 25 % of all AEs to the placebo treatment, with neutropenia (88 %), nausea (52 %) and thrombocytopenia (50 %) most attributed. Three percent of participants had a dose reduction, 19 % had treatment delays, and 2 % had permanent treatment discontinuation, due to AEs attributed to placebo. CONCLUSION: Virtually all PSROC participants in the SOLO2/ENGOT-Ov21 experienced one or more AE whilst on placebo. Furthermore, study investigators attributed one quarter of AEs to be related to placebo therapy and dose alterations and treatment changes were made based on these AE. Further work is needed to improve measurement and categorization of AEs in trials of maintenance therapy in PSROC.
SN - 0090-8258
SN - 1095-6859
ER -