TY - JOUR
T1 - Overall survival results of AGO-OVAR16: A phase 3 study of maintenance pazopanib versus placebo in women who have not progressed after first-line chemotherapy for advanced ovarian cancer
AU - Vergote, I.
AU - du Bois, A.
AU - Floquet, A.
AU - Rau, J.
AU - Kim, J. W.
AU - del Campo, J. M.
AU - Friedlander, M.
AU - Pignata, S.
AU - Fujiwara, K.
AU - Colombo, N.
AU - Mirza, M. R.
AU - Monk, B. J.
AU - Tsibulak, I.
AU - Calvert, P. M.
AU - Herzog, T. J.
AU - Hanker, L. C.
AU - Meunier, J.
AU - Lee, J. Y.
AU - Bologna, A.
AU - Carrasco-Alfonso, M. J.
AU - Harter, P.
N1 - Publisher Copyright:
© 2019 The Authors
PY - 2019/11
Y1 - 2019/11
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85071963488&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2019.08.024
DO - 10.1016/j.ygyno.2019.08.024
M3 - Journal articles
C2 - 31519320
AN - SCOPUS:85071963488
SN - 0090-8258
VL - 155
SP - 186
EP - 191
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 2
ER -