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Maintenance olaparib monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) without a germline BRCA1/BRCA2 mutation (non-gBRCAm): Final overall survival (OS) results from the OPINION trial

Autores: Poveda-Velasco, A. M.; Lheureux, S.; Colombo, N.; Cibula, D.; Elstrand, M.; Weberpals, J.; Bjurberg, M.; Oaknin, A.; Sikorska, M.; González Martín, Antonio; Madry, R.; Rubio-Pérez, M. J.; Ledermann, J. A.; Ozgoren, O.; Barnicle, A.; Marshall, H.; Bashir, Z.; Skof, E.
Título de la revista: ANNALS OF ONCOLOGY
ISSN: 0923-7534
Volumen: 33
Número: SUPPL 7
Páginas: S790
Fecha de publicación: 2022
Resumen:
Background The Phase IIIb, single-arm OPINION study reported a median progression-free survival (PFS) of 9.2 months (mo) with maintenance olaparib in pts with non-gBRCAm PSR OC (Poveda et al. Gynecol Oncol 2022). Here, we report final OS and updated safety data. Methods Pts with non-gBRCAm PSR OC and ¿2 prior lines of platinum-based chemotherapy (PBC) in complete or partial response to their last PBC received maintenance olaparib (300 mg bid) until progression/unacceptable toxicity. OS was a secondary endpoint. Ad hoc subgroup analyses included OS by homologous recombination deficiency (HRD) and somatic BRCA mutation (sBRCAm) status according to central Myriad tumor and germline testing. Results In total, 279 pts were enrolled and received olaparib (median [range] age: 65 [40¿85] years); 253 (90.7%) pts were retrospectively confirmed as non-gBRCAm. At data cutoff (Sep 17, 2021), 46 (16.5%) pts remained on therapy; discontinuation was mainly due to disease progression (n=196; 70.3%). Overall, there were 146 deaths (52.3% maturity); median follow-up in censored pts was 33.1 mo. Median OS was 32.7 (95% confidence interval [CI], 29.5¿35.3) mo; 24- and 30-mo Kaplan¿Meier OS rates were 65.8% and 54.9%, respectively. OS by HRD status and platinum sensitivity is in the Table. With a median total duration of therapy of 9.6 mo, grade ¿3 treatment-emergent adverse events (TEAEs) occurred in 82 (29.4%) pts, and serious TEAEs in 58 (20.8%). TEAEs led to dose interruption and reduction in 139 (49.8%) and 65 (23.3%) pts, respectively; TEAEs led to olaparib discontinuation in 23 (8.2%) pts. In total, two cases of myelodysplastic syndrome were reported, with no new cases since the primary analysis. There were no new safety findings (Table: 531P). Conclusions OS and updated safety data from OPINION further support the use of maintenance olaparib in pts with non-gBRCAm PSR OC. Clinical trial identification NCT03402841.
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