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.
Gynecol Oncol
; 155(2): 186-191, 2019 11.
Article
in En
| MEDLINE
| ID: mdl-31519320
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 11 ratio to receive either 800â¯mg pazopanib once daily or placebo for up to 24â¯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 59.1â¯months in pazopanib and 64.0â¯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 14.5â¯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.Key words
Full text:
1
Collection:
01-internacional
Health context:
6_ODS3_enfermedades_notrasmisibles
Database:
MEDLINE
Main subject:
Ovarian Neoplasms
/
Pyrimidines
/
Sulfonamides
/
Angiogenesis Inhibitors
/
Carcinoma, Ovarian Epithelial
Type of study:
Clinical_trials
Aspects:
Patient_preference
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Middle aged
Language:
En
Journal:
Gynecol Oncol
Year:
2019
Document type:
Article