Final Overall Survival Results Show No Difference for Pazopanib vs Sunitinib in First-Line Treatment of Clear Cell Metastatic Renal Cell Carcinoma
A phase III trial reported in 2013 showed noninferiority of pazopanib (Votrient) vs sunitinib (Sutent) for progression-free survival in first-line treatment of clear cell metastatic renal cell carcinoma. In a letter to the editor in The New England Journal of Medicine, Motzer et al provided the final analysis of overall survival in the trial. As with the progression-free survival findings, overall survival results were similar in the two groups.
Overall survival was summarized by Kaplan-Meier curves and compared using a stratified log-rank test. The strata were baseline Karnofsky performance status (70 or 80 vs 90 or 100), lactate dehydrogenase level (> 1.5 vs ≤ 1.5 times upper limit of normal), and previous nephrectomy (yes vs no).
No Overall Survival Differences
As of the data cutoff on September 30, 2013, death had occurred in 334 (60%) of 557 pazopanib patients and 335 (61%) of 553 sunitinib patients (hazard ratio [HR] = 0.92, P = .24). Median overall survival was 28.3 vs 29.1 months.
Subgroup analysis according to Memorial Sloan Kettering Cancer Center risk criteria showed median overall survival of 42.5 months among 151 pazopanib patients vs 43.6 months among 152 sunitinib patients with favorable-risk disease (HR = 0.88, 95% confidence interval [CI] = 0.63–1.21), 26.9 months among 322 pazopanib patients vs 26.1 months among 328 sunitinib patients with intermediate-risk disease (HR = 0.90, 95% CI = 0.74–1.09), and 9.9 months among 67 pazopanib patients vs 7.7 months among 52 sunitinib patients with poor-risk disease (HR = 0.85, 95% CI = 0.56–1.28).
Totals of 34 pazopanib patients (6%) and 23 sunitinib patients (4%) continued study treatment. The median on-treatment period was 8.1 months for pazopanib patients and 7.6 months for sunitinib patients. The most common reasons for treatment discontinuation were disease progression (56% vs 60%) and adverse events (24% vs 20%). Safety results were consistent with those previously reported in the primary study analysis. Post-study treatment with antiangiogenesis agents or mTOR inhibitors was performed in 55% of pazopanib patients and 54% of sunitinib patients.
The investigators concluded, “[S]imilar overall survival outcomes support the findings of the primary analysis of progression-free survival, which showed the noninferiority of pazopanib versus sunitinib as first-line treatment for clear-cell renal-cell carcinoma.”
Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, is the corresponding author for The New England Journal of Medicine correspondence.
For full disclosures of the study authors, visit www.nejm.org.
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