ASCO 2017: Treatment After Nephrectomy in Patients With Renal Cell Carcinoma
For high-risk postnephrectomy patients with locally advanced renal cell carcinoma, adjuvant pazopanib (at 600 mg) demonstrated no survival benefit compared with placebo, but a reduced risk of recurrence was reported at the 800-mg dose, although this was a secondary objective of the study. These results of the phase III PROTECT trial were presented by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4507).
A total of 1538 patients with either resected pT2 (high grade) or ≥ pT3 clear cell renal cell carcinoma after nephrectomy were randomized to receive pazopanib or placebo for 1 year. Following treatment of 403 patients, the starting dose of 800 mg was lowered to 600 mg to improve tolerability. As a result, the primary endpoint was changed to disease-free survival with pazopanib at the lower dose in 1135 patients, which was not significantly different compared with placebo.
The results of the primary analysis were not significant, but secondary analysis of disease-free survival in the intent-to-treat population receiving the 800-mg dose and in the intent-to-treat population with all doses led to a 31% and a 20% reduced risk of recurrence, respectively.