| Title: |
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 |
| Authors: |
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, SA; Jager, A; Jóhannsson; 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; Sevelda, P; Haslbauer, F; Penzinger, M; Öhler, L; Tinchon, C; Greil, R; Heibl, S; Bartsch, R; Wette, V; Pasterk, C; Helfgott, R; Pristauz-Telsnigg, G; Stöger, H; Weltermann, A; Egle, D; Thiel, I; Fuchs, D; Rumpold, H; Strasser-Weippl, K; Rautenberg, B; Müller, V; Paepke, S |
| Publisher Information: |
ELSEVIER |
| Publication Year: |
2022 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0923-7534 |
| Relation: |
https://hdl.handle.net/11343/335010 |
| Availability: |
https://hdl.handle.net/11343/335010 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 ; CC BY |
| Accession Number: |
edsbas.CC596F4F |
| Database: |
BASE |