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Maintenance Pazopanib Does Not Yield OS Improvement in Advanced Ovarian Cancer
Findings from a phase 3 clinical trial show that although pazopanib extended progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer, the treatment was not tied to improved median overall survival (OS; Gynecol Oncol. 2019;155[2]:186-191).
The study was conducted by Ignace Vergote, MD, PhD, Department of Gynaecological Oncology, Belgian Gynaecological Oncology Group & University Hospitals Leuven, Belgium, and colleagues, who sought to evaluate the safety, efficacy, and tolerability of pazopanib maintenance therapy after first-line chemotherapy in this patient population.
A total of 940 patients with advanced ovarian cancer were included in the trial and randomized in a 1:1 ratio to receive pazopanib 800 mg once daily or matching placebo for up to 24 months, barring any disease progression, toxicity, withdrawal of consent, or death.
Because the primary end point of PFS has been previously reported by Dr Vergote et al, these findings reported here specifically refer to final analyses of OS.
“A third OS interim analysis showed futility and led to study closure and a final OS analysis after last patient last visit,” they explained.
As of the final OS analysis, only 494 (89.7%) of the 551 planned events had occurred, and there were no differences observed in OS between patients given pazopanib versus placebo (hazard ratio [HR]. 0.960; 95% CI, 0.805-1.145).
From randomization, the median OS was 59.1 months and 64.0 months in the pazopanib and placebo arms, respectively. Notably, a numerical negative trend was observed favoring placebo in East Asian patients (HR, 1.332; 95% CI, 0.863-2.054), a trend observed in the first 3 interim OS analyses.
A trend for a longer time to first subsequent anti-cancer therapy or death with was observed with pazopanib versus placebo in exploratory analyses (HR, 0.829; 95% CI, 0.713-0.965), with a median estimate of 19.0 and 14.5 months, respectively.
“Although pazopanib prolonged PFS, this was not associated with improvement in median OS,” Dr Vergote and co-investigators concluded.—Hina Porcelli
