Final results from GCIG/ENGOT/AGO-OVAR 12, a randomised placebo-controlled phase III trial of nintedanib combined with chemotherapy for newly diagnosed advanced ovarian cancer

International Journal of Cancer. Journal International Du Cancer
Isabelle Ray-CoquardAGO Study Group-led GCIG/ENGOT Intergroup Consortium

Abstract

AGO-OVAR 12 investigated the effect of adding the oral triple angiokinase inhibitor nintedanib to standard front-line chemotherapy for advanced ovarian cancer. At the primary analysis, nintedanib demonstrated significantly improved progression-free survival (PFS; primary endpoint) compared with placebo. We report final results, including overall survival (OS). Patients with primary debulked International Federation of Gynaecology and Obstetrics (FIGO) stage IIB-IV newly diagnosed ovarian cancer were randomised 2:1 to receive carboplatin (area under the curve 5 or 6) plus paclitaxel (175 mg/m2 ) on day 1 every 3 weeks for six cycles combined with either nintedanib 200 mg or placebo twice daily on days 2-21 every 3 weeks for up to 120 weeks. Between December 2009 and July 2011, 1,366 patients were randomised (911 to nintedanib, 455 to placebo). Disease was considered as high risk (FIGO stage III with >1 cm residuum, or any stage IV) in 39%. At the final analysis, 605 patients (44%) had died. There was no difference in OS (hazard ratio 0.99, 95% confidence interval [CI] 0.83-1.17, p = 0.86; median 62.0 months with nintedanib vs. 62.8 months with placebo). Subgroup analyses according to stratification factors, clinical characterist...Continue Reading

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Citations

Oct 11, 2020·Journal of Hematology & Oncology·Meinusha GovindarajanThomas Kislinger
Jan 4, 2021·Critical Reviews in Oncology/hematology·J Alejandro Perez-FidalgoAna Oaknin
Dec 6, 2020·Obstetrics and Gynecology·Katherine C KurnitErnst Lengyel
Jun 15, 2021·Current Oncology Reports·Osnat ElyashivJonathan A Ledermann
Oct 31, 2021·British Journal of Cancer·Alexander D MurphyGordon C Jayson

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