Key clinical point: In patients with sarcomatoid renal-cell carcinomas (sRCC), which are associated with poor outcomes and limited treatment options, a phase 2 trial to evaluate the efficacy and safety of capecitabine, gemcitabine, and bevacizumab found response rates are low.

Major finding: In 34 patients without metastatic or unresectable sRCC, median progression-free survival was 5.5 months (95% confidence interval [CI], 3.4-7.7), median time to treatment failure was 4.2 months (95% CI, 2.4-6.0), and median overall survival was 12 months (95% CI, 10.6-13.4). Objective response rate was 20% (5 partial responses, 1 complete response), and disease control rate was 73%. Thirty-one (91%) of the 34 patients discontinued treatment, mainly due to progressive disease (24 patients; 71%). The most common grade 3 toxicity was rash (including hand–foot syndrome) in 24% of patients.

Study details: Patients received oral capecitabine 800 mg/m² twice daily on days 1 to 21 of a 28-day cycle, intravenous gemcitabine 900 mg/m² on days 1 and 15, and intravenous bevacizumab 10 mg/kg on days 1 and 15. Primary end points were progression-free survival and time to treatment failure. Secondary end points were safety, objective response rate, and overall survival.

Disclosures: This original research was done in collaboration with Eli Lilly and Company. This study was supported in part by an MD Anderson Cancer Center Support grant. One of the authors had various relationships with drug companies; the other authors stated that they have no conflicts of interest.

Source: Maiti A et al. Clinical Genitourinary Cancer 2018 e47-e57 https://doi.org/10.1016/j.clgc.2017.07.028