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Overall survival in...
Overall survival in the OlympiA phase Ill trial of adjuvant olaparib in patients with germime pathogenic variants in BRCA1/2 and high-risk, early breast cancer
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Geyer, C. E. (author)
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Garber, J. E. (author)
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Gelber, R. D. (author)
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show more...
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Yothers, G. (author)
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Taboada, M. (author)
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Ross, L. (author)
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Rastogi, P. (author)
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Cui, K. (author)
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Arahmani, A. (author)
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Aktan, G. (author)
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Armstrong, A. C. (author)
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Arnedos, M. (author)
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Balmana, J. (author)
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- Bergh, J. (author)
- Karolinska Institutet
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Bliss, J. (author)
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Delaloge, S. (author)
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Domchek, S. M. (author)
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Eisen, A. (author)
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Elsafy, F. (author)
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Fein, L. E. (author)
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Fielding, A. (author)
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Ford, J. M. (author)
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Friedman, S. (author)
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Gelmon, K. A. (author)
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Gianni, L. (author)
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Gnant, M. (author)
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Hollingsworth, S. J. (author)
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Im, S. A. (author)
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Jager, A. (author)
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Lakhani, S. R. (author)
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Janni, W. (author)
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- Linderholm, Barbro, 1959 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology
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Liu, T. W. (author)
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Loman, N. (author)
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Korde, L. (author)
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Loibl, S. (author)
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Lucas, P. C. (author)
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Marme, F. (author)
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de Duenas, E. M. (author)
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McConnell, R. (author)
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Phillips, K. A. (author)
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Piccart, M. (author)
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Rossi, G. (author)
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Schmutzler, R. (author)
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Senkus, E. (author)
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Shao, Z. (author)
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Sharma, P. (author)
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Singer, C. F. (author)
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Spanic, T. (author)
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Stickeler, E. (author)
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Toi, M. (author)
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Traina, T. A. (author)
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Viale, G. (author)
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Zoppoli, G. (author)
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Park, Y. H. (author)
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Yerushalmi, R. (author)
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Yang, H. (author)
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Pang, D. (author)
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Jung, K. H. (author)
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Mailliez, A. (author)
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Fan, Z. (author)
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Tennevet, I. (author)
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Zhang, J. (author)
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Nagy, T. (author)
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Sonke, G. S. (author)
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Sun, Q. (author)
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Parton, M. (author)
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Colleoni, M. A. (author)
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Schmidt, M. (author)
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Brufsky, A. M. (author)
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Razaq, W. (author)
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Kaufman, B. (author)
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Cameron, D. (author)
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Campbell, C. (author)
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Tutt, A. N. J. (author)
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Johannsson, O. T. (author)
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(creator_code:org_t)
- Elsevier BV, 2022
- 2022
- English.
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In: Annals of Oncology. - : Elsevier BV. - 0923-7534. ; 33:12, s. 1250-1268
- Related links:
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Subject headings
Close
- 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 (Delta 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% (Delta 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Delta 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 35 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 IDES and DDFS with no new safety signals.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- breast cancer
- BRCA1/2
- PARP inhibition
- olaparib
- adjuvant therapy
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
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Geyer, C. E.
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Garber, J. E.
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Gelber, R. D.
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Yothers, G.
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Taboada, M.
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Ross, L.
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show more...
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Rastogi, P.
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Cui, K.
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Arahmani, A.
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Aktan, G.
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Armstrong, A. C.
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Arnedos, M.
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Balmana, J.
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Bergh, J.
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Bliss, J.
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Delaloge, S.
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Domchek, S. M.
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Eisen, A.
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Elsafy, F.
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Fein, L. E.
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Fielding, A.
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Ford, J. M.
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Friedman, S.
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Gelmon, K. A.
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Gianni, L.
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Gnant, M.
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Hollingsworth, S ...
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Im, S. A.
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Jager, A.
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Lakhani, S. R.
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Janni, W.
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Linderholm, Barb ...
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Liu, T. W.
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Loman, N.
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Korde, L.
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Loibl, S.
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Lucas, P. C.
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Marme, F.
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de Duenas, E. M.
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McConnell, R.
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Phillips, K. A.
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Piccart, M.
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Rossi, G.
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Schmutzler, R.
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Senkus, E.
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Shao, Z.
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Sharma, P.
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Singer, C. F.
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Spanic, T.
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Stickeler, E.
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Toi, M.
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Traina, T. A.
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Viale, G.
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Zoppoli, G.
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Park, Y. H.
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Yerushalmi, R.
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Yang, H.
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Pang, D.
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Jung, K. H.
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Mailliez, A.
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Fan, Z.
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Tennevet, I.
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Zhang, J.
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Nagy, T.
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Sonke, G. S.
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Sun, Q.
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Parton, M.
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Colleoni, M. A.
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Schmidt, M.
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Brufsky, A. M.
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Razaq, W.
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Kaufman, B.
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Cameron, D.
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Campbell, C.
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Tutt, A. N. J.
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Johannsson, O. T ...
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Annals of Oncolo ...
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Annals of oncolo ...
- By the university
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University of Gothenburg
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Karolinska Institutet