ESMO real world data and digital oncology · 2026
Real-world outcomes in patients with advanced epithelial ovarian cancer receiving niraparib as first-line maintenance: a European retrospective cohort study.
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Fagotti A, Frenel J-S, Saint-Ghislain M, Lim J T, Calderón Boyle T A, Golembesky A K, Hogg C, Arnold K, Braicu E I
Аннотация
BACKGROUND: In this real-world study, outcomes were evaluated in patients with stage III advanced epithelial ovarian cancer (EOC) with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS), a subgroup excluded from the phase III PRIMA trial.
MATERIALS AND METHODS: The noninterventional, retrospective EUROPA study included patients with advanced (stage III or IV) EOC who initiated first-line maintenance (1LM) niraparib monotherapy (index date) between 1 October 2018 and 31 March 2023 in France, Germany, and Italy. Real-world time to treatment discontinuation (rwTTD) and real-world progression-free survival (rwPFS) were assessed among all patients and in a subgroup of patients with stage III disease and NVRD after PCS (stage III NVRD subgroup).
RESULTS: Among 186 patients in this study, 48 were included in the stage III NVRD subgroup. Median (95% CI) rwTTD in the overall cohort versus stage III NVRD subgroup was 10.6 (7.8-18.6) versus 26.2 (8.9-not reached) months. In the overall cohort, median (95% CI) rwPFS was 14.7 (10.1-29.3) months but not reached in the stage III NVRD subgroup. rwTTD and rwPFS probabilities were higher for the stage III NVRD subgroup versus overall cohort at 12, 24, and 36 months after index date.
CONCLUSIONS: In the real-world setting, patients with stage III advanced EOC and NVRD after PCS had descriptively better clinical outcomes than those in the overall cohort with advanced EOC. The use of 1LM niraparib in these patients, a subgroup excluded from the PRIMA trial, appeared to be associated with clinically meaningful real-world outcomes.
MATERIALS AND METHODS: The noninterventional, retrospective EUROPA study included patients with advanced (stage III or IV) EOC who initiated first-line maintenance (1LM) niraparib monotherapy (index date) between 1 October 2018 and 31 March 2023 in France, Germany, and Italy. Real-world time to treatment discontinuation (rwTTD) and real-world progression-free survival (rwPFS) were assessed among all patients and in a subgroup of patients with stage III disease and NVRD after PCS (stage III NVRD subgroup).
RESULTS: Among 186 patients in this study, 48 were included in the stage III NVRD subgroup. Median (95% CI) rwTTD in the overall cohort versus stage III NVRD subgroup was 10.6 (7.8-18.6) versus 26.2 (8.9-not reached) months. In the overall cohort, median (95% CI) rwPFS was 14.7 (10.1-29.3) months but not reached in the stage III NVRD subgroup. rwTTD and rwPFS probabilities were higher for the stage III NVRD subgroup versus overall cohort at 12, 24, and 36 months after index date.
CONCLUSIONS: In the real-world setting, patients with stage III advanced EOC and NVRD after PCS had descriptively better clinical outcomes than those in the overall cohort with advanced EOC. The use of 1LM niraparib in these patients, a subgroup excluded from the PRIMA trial, appeared to be associated with clinically meaningful real-world outcomes.