دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Geyer, CE, 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, S-A, Jager, A, Jóhannsson, ÓÞ, Lakhani, SR, Janni, W, Linderholm, B, Liu, T-W, Loman, N, Korde, L, Loibl, S, Lucas, PC, Marmé, F, Martinez de Dueñas, E, McConnell, R, Phillips, K-A, 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, OlympiA Clinical Trial Steering Committee and Investigators |
| المساهمون: | Bliss, Judith, Tutt, Andrew |
| بيانات النشر: | ELSEVIER |
| سنة النشر: | 2022 |
| المجموعة: | The Institute of Cancer Research (ICR): Publications Repository |
| مصطلحات موضوعية: | BRCA1/2, Breast cancer, PARP inhibition, adjuvant therapy, olaparib |
| جغرافية الموضوع: | England |
| الوصف: | BACKGROUND: The randomized, double-blind OlympiA trial compared 1 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-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: One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, 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 a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; 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 the 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 myeloid leukemia or myelodysplastic syndrome. CONCLUSION: With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Print-Electronic; S0923-7534(22)04165-5 -; application/pdf |
| اللغة: | English |
| تدمد: | 0923-7534 1569-8041 |
| العلاقة: | S0923-7534(22)04165-5; Annals of Oncology, 2022, pp. S0923-7534(22)04165-5 -; https://repository.icr.ac.uk/handle/internal/5532Test |
| DOI: | 10.1016/j.annonc.2022.09.159 |
| الإتاحة: | https://doi.org/10.1016/j.annonc.2022.09.159Test https://repository.icr.ac.uk/handle/internal/5532Test |
| حقوق: | http://creativecommons.org/licenses/by/4.0Test/ |
| رقم الانضمام: | edsbas.F8CE3E3B |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 09237534 15698041 |
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| DOI: | 10.1016/j.annonc.2022.09.159 |