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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 06705naa a2201273 4500 | |
| 001 | oai:gup.ub.gu.se/324088 | |
| 003 | SwePub | |
| 008 | 240528s2022 | |||||||||||000 ||eng| | |
| 009 | oai:prod.swepub.kib.ki.se:151557370 | |
| 024 | 7 | a https://gup.ub.gu.se/publication/3240882 URI |
| 024 | 7 | a https://doi.org/10.1016/j.annonc.2022.09.1592 DOI |
| 024 | 7 | a http://kipublications.ki.se/Default.aspx?queryparsed=id:1515573702 URI |
| 040 | a (SwePub)gud (SwePub)ki | |
| 041 | a eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a Geyer, C. E.4 aut |
| 245 | 1 0 | a 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 |
| 264 | 1 | b Elsevier BV,c 2022 |
| 520 | a 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. | |
| 650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe |
| 650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng |
| 653 | a breast cancer | |
| 653 | a BRCA1/2 | |
| 653 | a PARP inhibition | |
| 653 | a olaparib | |
| 653 | a adjuvant therapy | |
| 700 | 1 | a Garber, J. E.4 aut |
| 700 | 1 | a Gelber, R. D.4 aut |
| 700 | 1 | a Yothers, G.4 aut |
| 700 | 1 | a Taboada, M.4 aut |
| 700 | 1 | a Ross, L.4 aut |
| 700 | 1 | a Rastogi, P.4 aut |
| 700 | 1 | a Cui, K.4 aut |
| 700 | 1 | a Arahmani, A.4 aut |
| 700 | 1 | a Aktan, G.4 aut |
| 700 | 1 | a Armstrong, A. C.4 aut |
| 700 | 1 | a Arnedos, M.4 aut |
| 700 | 1 | a Balmana, J.4 aut |
| 700 | 1 | a Bergh, J.u Karolinska Institutet4 aut |
| 700 | 1 | a Bliss, J.4 aut |
| 700 | 1 | a Delaloge, S.4 aut |
| 700 | 1 | a Domchek, S. M.4 aut |
| 700 | 1 | a Eisen, A.4 aut |
| 700 | 1 | a Elsafy, F.4 aut |
| 700 | 1 | a Fein, L. E.4 aut |
| 700 | 1 | a Fielding, A.4 aut |
| 700 | 1 | a Ford, J. M.4 aut |
| 700 | 1 | a Friedman, S.4 aut |
| 700 | 1 | a Gelmon, K. A.4 aut |
| 700 | 1 | a Gianni, L.4 aut |
| 700 | 1 | a Gnant, M.4 aut |
| 700 | 1 | a Hollingsworth, S. J.4 aut |
| 700 | 1 | a Im, S. A.4 aut |
| 700 | 1 | a Jager, A.4 aut |
| 700 | 1 | a Lakhani, S. R.4 aut |
| 700 | 1 | a Janni, W.4 aut |
| 700 | 1 | a Linderholm, Barbro,d 1959u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology4 aut0 (Swepub:gu)xlibar |
| 700 | 1 | a Liu, T. W.4 aut |
| 700 | 1 | a Loman, N.4 aut |
| 700 | 1 | a Korde, L.4 aut |
| 700 | 1 | a Loibl, S.4 aut |
| 700 | 1 | a Lucas, P. C.4 aut |
| 700 | 1 | a Marme, F.4 aut |
| 700 | 1 | a de Duenas, E. M.4 aut |
| 700 | 1 | a McConnell, R.4 aut |
| 700 | 1 | a Phillips, K. A.4 aut |
| 700 | 1 | a Piccart, M.4 aut |
| 700 | 1 | a Rossi, G.4 aut |
| 700 | 1 | a Schmutzler, R.4 aut |
| 700 | 1 | a Senkus, E.4 aut |
| 700 | 1 | a Shao, Z.4 aut |
| 700 | 1 | a Sharma, P.4 aut |
| 700 | 1 | a Singer, C. F.4 aut |
| 700 | 1 | a Spanic, T.4 aut |
| 700 | 1 | a Stickeler, E.4 aut |
| 700 | 1 | a Toi, M.4 aut |
| 700 | 1 | a Traina, T. A.4 aut |
| 700 | 1 | a Viale, G.4 aut |
| 700 | 1 | a Zoppoli, G.4 aut |
| 700 | 1 | a Park, Y. H.4 aut |
| 700 | 1 | a Yerushalmi, R.4 aut |
| 700 | 1 | a Yang, H.4 aut |
| 700 | 1 | a Pang, D.4 aut |
| 700 | 1 | a Jung, K. H.4 aut |
| 700 | 1 | a Mailliez, A.4 aut |
| 700 | 1 | a Fan, Z.4 aut |
| 700 | 1 | a Tennevet, I.4 aut |
| 700 | 1 | a Zhang, J.4 aut |
| 700 | 1 | a Nagy, T.4 aut |
| 700 | 1 | a Sonke, G. S.4 aut |
| 700 | 1 | a Sun, Q.4 aut |
| 700 | 1 | a Parton, M.4 aut |
| 700 | 1 | a Colleoni, M. A.4 aut |
| 700 | 1 | a Schmidt, M.4 aut |
| 700 | 1 | a Brufsky, A. M.4 aut |
| 700 | 1 | a Razaq, W.4 aut |
| 700 | 1 | a Kaufman, B.4 aut |
| 700 | 1 | a Cameron, D.4 aut |
| 700 | 1 | a Campbell, C.4 aut |
| 700 | 1 | a Tutt, A. N. J.4 aut |
| 700 | 1 | a Johannsson, O. T.4 aut |
| 710 | 2 | a Karolinska Institutetb Institutionen för kliniska vetenskaper, Avdelningen för onkologi4 org |
| 773 | 0 | t Annals of Oncologyd : Elsevier BVg 33:12, s. 1250-1268q 33:12<1250-1268x 0923-7534 |
| 773 | 0 | t Annals of oncology : official journal of the European Society for Medical Oncologyd : Elsevier BVg 33:12, s. 1250-1268q 33:12<1250-1268x 1569-8041 |
| 856 | 4 8 | u https://gup.ub.gu.se/publication/324088 |
| 856 | 4 8 | u https://doi.org/10.1016/j.annonc.2022.09.159 |
| 856 | 4 8 | u http://kipublications.ki.se/Default.aspx?queryparsed=id:151557370 |
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- Geyer, C. E.
- Garber, J. E.
- Gelber, R. D.
- Yothers, G.
- Taboada, M.
- Ross, L.
- visa fler...
- Rastogi, P.
- Cui, K.
- Arahmani, A.
- Aktan, G.
- Armstrong, A. C.
- Arnedos, M.
- Balmana, J.
- Bergh, J.
- Bliss, J.
- Delaloge, S.
- Domchek, S. M.
- Eisen, A.
- Elsafy, F.
- Fein, L. E.
- Fielding, A.
- Ford, J. M.
- Friedman, S.
- Gelmon, K. A.
- Gianni, L.
- Gnant, M.
- Hollingsworth, S ...
- Im, S. A.
- Jager, A.
- Lakhani, S. R.
- Janni, W.
- Linderholm, Barb ...
- Liu, T. W.
- Loman, N.
- Korde, L.
- Loibl, S.
- Lucas, P. C.
- Marme, F.
- de Duenas, E. M.
- McConnell, R.
- Phillips, K. A.
- Piccart, M.
- Rossi, G.
- Schmutzler, R.
- Senkus, E.
- Shao, Z.
- Sharma, P.
- Singer, C. F.
- Spanic, T.
- Stickeler, E.
- Toi, M.
- Traina, T. A.
- Viale, G.
- Zoppoli, G.
- Park, Y. H.
- Yerushalmi, R.
- Yang, H.
- Pang, D.
- Jung, K. H.
- Mailliez, A.
- Fan, Z.
- Tennevet, I.
- Zhang, J.
- Nagy, T.
- Sonke, G. S.
- Sun, Q.
- Parton, M.
- Colleoni, M. A.
- Schmidt, M.
- Brufsky, A. M.
- Razaq, W.
- Kaufman, B.
- Cameron, D.
- Campbell, C.
- Tutt, A. N. J.
- Johannsson, O. T ...
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