國家衛生研究院 NHRI:Item 3990099045/14619
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    题名: Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high risk, early breast cancer
    作者: Geyer, CE, Jr.;Garber, JE;Gelber, RD;Yothers, G;Taboada, M;Ross, L;Rastogi, P;Cui, K;Arahmani, A;Aktan, G;Armstrong, AC;Arnedos, M;Balmaña, J;Bergh, J;Bliss, J;Delaloge, S;Domchek, SM;Eisen, A;Elsafy, F;Fein, LE;Fielding, A;Ford, JM;Friedman, S;Gelmon, KA;Gianni, L;Gnant, M;Hollingsworth, SJ;Im, SA;Jager, A;Jóhannsson, Ó;Lakhani, SR;Janni, W;Linderholm, B;Liu, TW;Loman, N;Korde, L;Loibl, S;Lucas, PC;Marmé, F;Martinez de Dueñas, E;McConnell, R;Phillips, KA;Piccart, M;Rossi, G;Schmutzler, R;Senkus, E;Shao, Z;Sharma, P;Singer, CF;Španić, T;Stickeler, E;Toi, M;Traina, TA;Viale, G;Zoppoli, G;Park, YH;Yerushalmi, R;Yang, H;Pang, D;Jung, KH;Mailliez, A;Fan, Z;Tennevet, I;Zhang, J;Nagy, T;Sonke, GS;Sun, Q;Parton, M;Colleoni, MA;Schmidt, M;Brufsky, AM;Razaq, W;Kaufman, B;Cameron, D;Campbell, C;Tutt, ANJ
    贡献者: National Institute of Cancer Research
    摘要: BACKGROUND: The randomized, double-blind OlympiA trial compared one year of the oral poly(adenosine diphosphate-ribose) polymerase) inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2 (HER2)-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive-disease-free survival (IDFS) and distant-disease-free survival (DDFS). The olaparib-group had fewer deaths than the placebo-group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. PATIENTS AND METHODS: 1,836 patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy (N)ACT, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone-receptor-positive-cancers. Statistical significance for OS at this IA required P<0.015. RESULTS: With median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib-group relative to the placebo-group (HR, 0.68; 98.5% CI 0.47 to 0.97; P=0.009). Four-year OS was 89.8% in the olaparib-group and 86.4% in the placebo-group (Δ 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for olaparib-group versus placebo-group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myelogenous leukemia or myelodysplastic syndrome (AML/MDS). CONCLUSION: With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals.
    日期: 2022-12
    關聯: Annals of Oncology. 2022 Dec;33(12):1250-1268.
    Link to: http://dx.doi.org/10.1016/j.annonc.2022.09.159
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000898986900006
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85141805158
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