A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): Results of Southwest Oncology Group study 0312

Abstract

15562 Background: Previous reports have suggested benefit of GC in a modest number of patients with RCC but with concerns regarding toxicity. We subsequently evaluated an adjusted dose regimen in pts with advanced unresectable or metastatic RCC. Methods: Pts who had not received prior chemotherapy where treated with G at 900mg/m2 days 1,8,15 and C at 625mg/m2 BID day 1- 21 of a 28 day cycle. Pts must have had adequate performance status, organ function and may have received prior immunotherapy. The primary endpoint was probability of response, confirmed and unconfirmed complete (CR) and partial responses (PR). A one-stage design for accrual was used and regimen would not be considered of interest if the true probability of response was <=5%. Results: 43 patients were enrolled of which 1 was ineligible and 2 were not analyzable. Median follow-up was 11.2 months (range: 1.3 to 18.5). One confirmed complete response (CR) and three unconfirmed partial responses (PR) were observed, for an overall response probability of 10% (95% CI: 3% to 24%). Four of the eligible patients had inadequate disease assessment and were assumed to be non-responders. 19 pts (48%) had stable disease (SD). The 6-month probability of being free from treatment failure was 20% (95% CI: 8% to 32%). The probability of survival at 6 months was estimated to be 75% (95% CI: 62% to 88%). Median survival was estimated to be 13 months (lower limit of 95% CI is 7 months, upper limit not estimable). One patient each experienced Grade 4 neutropenia, fatigue, thrombocytopenia and hemolysis/renal failure. Most common Grade 3 toxicities were neutropenia (12 pts), fatigue (5 pts), and leucopenia (4 pts). Conclusions: GC at this dose and schedule benefits a small percentage of pts with RCC with an acceptable toxicity profile. Given the RR and SD, GC may serve as a base regimen for combination therapy with targeted agents. No significant financial relationships to disclose.