I Vergote1, A du Bois2, A Floquet3, J Rau4, J-W Kim5, J M Del Campo6, M Friedlander7, S Pignata8, K Fujiwara9, N Colombo10, M R Mirza11, B J Monk12, I Tsibulak13, P M Calvert14, T J Herzog15, L C Hanker16, J Meunier17, J-Y Lee18, A Bologna19, M J Carrasco-Alfonso20, P Harter2. 1. Department of Gynaecological Oncology, BGOG & University Hospitals Leuven, Leuven, Belgium. Electronic address: Ignace.vergote@uzleuven.be. 2. Department of Gynecology and Gynecologic Oncology, AGO & Kliniken Essen Mitte-Evang, Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany. 3. GINECO & Institut Bergonié, Bordeaux, France. 4. Coordinating Center for Clinical Trials, AGO & Philipps-University of Marburg, Marburg, Germany. 5. Department of Obstetrics and Gynecology, KGOG & Seoul National University, Seoul, Republic of Korea. 6. GEICO & Vall d'Hebron University Hospital, Barcelona, Spain. 7. ANZGOG & Department of Medical Oncology, Prince of Wales Clinical School, UNSW, Randwick, NSW, Australia. 8. MITO and Department of Uro-gynaecological Oncology, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G Pascale", IRCCS, Naples, Italy. 9. Department of Gynecologic Oncology, JGOG & Saitama Medical University International Medical Center, Saitama, Japan. 10. MaNGO & IEO, European Institute of Oncology, IRCCS, Milan and University of Milano-Bicocca, Milan, Italy. 11. Department of Oncology, NSGO & Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 12. Division of Gynecologic Oncology, Californian Consortium & University of Arizona and Creighton University, Phoenix, AZ, USA. 13. Department of Gynecology and Obstetrics, AGO Austria & Medical University Innsbruck, Innsbruck, Austria. 14. Cancer Trials Ireland, Innovation House, Glasnevin, Dublin, Ireland. 15. NYGOG & University of Cincinnati (UC) College of Medicine, UC Cancer Institute, Cincinnati, OH, USA. 16. Department of Gynecology & Obstetrics, AGO & University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany; Department of Gynecology and Obstetrics, Goethe-University Frankfurt, Frankfurt, Germany. 17. Hôpital de La Source, service d'oncologie médicale, Centre Hospitalier Régional d'Orléans, Orléans, France. 18. Department of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Republic of Korea. 19. MaNGO & Azienda Unità Sanitaria Locale di Reggio Emilia IRCCS, UO di Oncologia Medica, Reggio Emilia, Italy. 20. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Abstract
OBJECTIVE: The AGO-OVAR16 study was designed to test the efficacy, safety, and tolerability of pazopanib maintenance after first-line chemotherapy in patients with newly diagnosed advanced ovarian cancer (AOC). METHODS:Nine hundred and forty patients with histologically confirmed AOC, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV, were randomized in a 1:1 ratio to receive either 800 mg pazopanib once daily or placebo for up to 24 months, unless there was disease progression, toxicity, withdrawal of consent, or death. The primary endpoint (investigator-assessed progression-free survival [PFS]) was met and previously reported. The results of final analyses of overall survival (OS) are reported here. RESULTS: A third OS interim analysis showed futility and led to study closure and a final OS analysis after last patient last visit. At the time of the final OS analysis, 494 (89.7% of the planned 551) events had occurred. No difference was observed in OS between pazopanib and placebo. The hazard ratio (HR) was 0.960 (95% confidence interval [CI]: 0.805-1.145), and the median OS from randomization was 59.1 months in pazopanib and 64.0 months in placebo arms. For the East Asian patients, similar to the first three interim OS analyses, a numerical negative trend was observed favoring placebo (HR, 1.332; 95% CI: 0.863-2.054). Exploratory analyses showed a trend for a longer time to first subsequent anti-cancer therapy or death with pazopanib over placebo (HR, 0.829; 95% CI: 0.713-0.965), with a median estimate of 19.0 and 14.5 months, respectively. No new safety signals were observed. CONCLUSION: Although pazopanib prolonged PFS, this was not associated with improvement in median OS. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov: NCT00866697.
RCT Entities:
OBJECTIVE: The AGO-OVAR16 study was designed to test the efficacy, safety, and tolerability of pazopanib maintenance after first-line chemotherapy in patients with newly diagnosed advanced ovarian cancer (AOC). METHODS: Nine hundred and forty patients with histologically confirmed AOC, International Federation of Gynecology and Obstetrics (FIGO) stage II-IV, were randomized in a 1:1 ratio to receive either 800 mg pazopanib once daily or placebo for up to 24 months, unless there was disease progression, toxicity, withdrawal of consent, or death. The primary endpoint (investigator-assessed progression-free survival [PFS]) was met and previously reported. The results of final analyses of overall survival (OS) are reported here. RESULTS: A third OS interim analysis showed futility and led to study closure and a final OS analysis after last patient last visit. At the time of the final OS analysis, 494 (89.7% of the planned 551) events had occurred. No difference was observed in OS between pazopanib and placebo. The hazard ratio (HR) was 0.960 (95% confidence interval [CI]: 0.805-1.145), and the median OS from randomization was 59.1 months in pazopanib and 64.0 months in placebo arms. For the East Asian patients, similar to the first three interim OS analyses, a numerical negative trend was observed favoring placebo (HR, 1.332; 95% CI: 0.863-2.054). Exploratory analyses showed a trend for a longer time to first subsequent anti-cancer therapy or death with pazopanib over placebo (HR, 0.829; 95% CI: 0.713-0.965), with a median estimate of 19.0 and 14.5 months, respectively. No new safety signals were observed. CONCLUSION: Although pazopanib prolonged PFS, this was not associated with improvement in median OS. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov: NCT00866697.
Authors: Chen-Yu Huang; Min Cheng; Na-Rong Lee; Hsin-Yi Huang; Wen-Ling Lee; Wen-Hsun Chang; Peng-Hui Wang Journal: Int J Environ Res Public Health Date: 2020-03-26 Impact factor: 3.390
Authors: Min Cheng; Howard Hao Lee; Wen-Hsun Chang; Na-Rong Lee; Hsin-Yi Huang; Yi-Jen Chen; Huann-Cheng Horng; Wen-Ling Lee; Peng-Hui Wang Journal: Int J Environ Res Public Health Date: 2019-11-29 Impact factor: 3.390