JCO precision oncology
Sunitinib in Patients With Various Solid Tumors With FGFR1/2 Alterations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study
By Srkalovic G, Rothe M, Garrett-Mayer E and 22 others.
Abstract
Purpose
TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations. Results of two cohorts of patients with various solid tumors with FGFR1 or FGFR2 alterations treated with sunitinib are reported.
Methods
Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no remaining standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16 weeks duration (SD16+). Low accruing histology-specific cohorts with FGFR1 or FGFR2 alterations treated with sunitinib were collapsed into two histology-pooled cohorts for this analysis. The hypothesized null DC rate of 15% was evaluated by a 1-sided exact binomial test (alpha .10; 82% power) per cohort. Secondary end points included OR, progression-free survival, overall survival, duration of response, duration of SD, and safety.