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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

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@article{e0a8aee7464441e5b6cab7b34e32d939,
title = "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",
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 characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95{\%} CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.",
author = "Isabelle Ray-Coquard and David Cibula and Mirza, {Mansoor R} and Alexander Reuss and Caterina Ricci and Nicoletta Colombo and Horst Koch and Fr{\'e}d{\'e}ric Goffin and Antonio Gonz{\'a}lez-Martin and Ottevanger, {Petronella B} and Klaus Baumann and Line Bj{\o}rge and Anne Lesoin and Alexander Burges and Per Rosenberg and Martina Gropp-Meier and Maija Harrela and Philipp Harter and Jean-S{\'e}bastien Frenel and Tomas Minarik and Carmela Pisano and Annette Hasenburg and Michael Merger and {du Bois}, Andreas and {AGO Study Group-led GCIG/ENGOT Intergroup Consortium}",
note = "{\circledC} 2019 UICC.",
year = "2020",
month = "1",
day = "15",
doi = "10.1002/ijc.32606",
language = "English",
volume = "146",
pages = "439--448",
journal = "International Journal of Cancer",
issn = "0020-7136",
publisher = "JohnWiley & Sons, Inc",
number = "2",

}

RIS

TY - JOUR

T1 - 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

AU - Ray-Coquard, Isabelle

AU - Cibula, David

AU - Mirza, Mansoor R

AU - Reuss, Alexander

AU - Ricci, Caterina

AU - Colombo, Nicoletta

AU - Koch, Horst

AU - Goffin, Frédéric

AU - González-Martin, Antonio

AU - Ottevanger, Petronella B

AU - Baumann, Klaus

AU - Bjørge, Line

AU - Lesoin, Anne

AU - Burges, Alexander

AU - Rosenberg, Per

AU - Gropp-Meier, Martina

AU - Harrela, Maija

AU - Harter, Philipp

AU - Frenel, Jean-Sébastien

AU - Minarik, Tomas

AU - Pisano, Carmela

AU - Hasenburg, Annette

AU - Merger, Michael

AU - du Bois, Andreas

AU - AGO Study Group-led GCIG/ENGOT Intergroup Consortium

N1 - © 2019 UICC.

PY - 2020/1/15

Y1 - 2020/1/15

N2 - 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 characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

AB - 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 characteristics and risk status showed no OS difference between treatments. The previously reported PFS improvement seen with nintedanib did not translate into an OS benefit in the nonhigh-risk subgroup. Updated PFS results were consistent with the primary analysis (hazard ratio 0.86, 95% CI 0.75-0.98; p = 0.029) favouring nintedanib. The safety profile was consistent with previous reports.

U2 - 10.1002/ijc.32606

DO - 10.1002/ijc.32606

M3 - Journal article

VL - 146

SP - 439

EP - 448

JO - International Journal of Cancer

JF - International Journal of Cancer

SN - 0020-7136

IS - 2

ER -

ID: 59075866