Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2-associated high-risk HER2-negative early breast cancer: updated results from the OlympiA phase III trial.
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Garber J E, Cameron D, Campbell C, Yothers G, Taboada M, El-Abed S, Rastogi P, McConnell R, Correa A, Delaloge S, Liu W T, Sharma P, Bergh J, Janni W, Balmaña J, Loman N, Španić T, Friedman S, Freeman T, Armstrong A, Korde L, Im S, Sagara Y, Viale G, Bliss J, Gianni L, Jóhannsson Ó, Zoppoli G, Martinez De Dueñas E, Marmé F, Fein L, Arnedos M, Ford J, Schmutzler R, Loibl S, Linderholm B, Lakhani S R, Gnant M, Gelmon K, Domchek S M, Senkus E, Eisen A, Jager A, Piccart M, Phillips K A, Traina T, Stickeler E, Singer C F, Shao Z, Liu X, Tipping H, Aktan G, Martinez M, Canon J L, Takahashi M, Yasojima H, Middleton K, Pristauz-Telsnigg G, Pfeiler G, Virani S, Valdes-Albini F, Wolmark N, Diaz Mesa I, Paterson V, Gelber R D, Geyer C E, Tutt A N J
Аннотация
PATIENTS AND METHODS: Descriptive analyses are presented for the primary endpoint IDFS and key secondary endpoints of DDFS and OS. Estimates of the hazard ratio (HR) based on the stratified Cox's proportional hazards model and 95% confidence intervals (CIs) are presented with yearly event rates at an MFU of ≤6.1 years. Safety analyses included adverse events of special interest (AESIs).
RESULTS: Olaparib benefits were maintained in IDFS (HR 0.65, 95% CI 0.53-0.78), DDFS (HR 0.65, 95% CI 0.53-0.81) and OS (HR 0.72, 95% CI 0.56-0.93). The 6-year OS for olaparib versus placebo was 87.5% versus 83.2% (difference 4.4%, 95% CI 0.9% to 6.7%). Olaparib benefit was consistent across all key subgroups, including patients with high-risk hormone receptor-positive disease. There were fewer BRCA-associated new BC and ovarian/fallopian tube cancer cases and there was no increase in AESI risks (6.3% versus 9.3%), including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) (0.4% versus 0.7%), with olaparib versus placebo.
CONCLUSIONS: At an MFU of 6.1 years, 1 year of adjuvant olaparib after (neo)adjuvant chemotherapy demonstrated ongoing clinically meaningful improvements in IDFS, DDFS and OS in patients with gBRCApvs and high-risk, HER2-negative early BC, with acceptable toxicity and without increased risk of MDS/AML. These data continue to provide support for adjuvant olaparib in the treatment of gBRCApv-associated high-risk, HER2-negative early BC.