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Clin Genitourin Cancer. 2017 Aug 10. pii: S1558-7673(17)30238-0. doi: 10.1016/j.clgc.2017.07.028. [Epub ahead of print]

Phase 2 Trial of Capecitabine, Gemcitabine, and Bevacizumab in Sarcomatoid Renal-Cell Carcinoma.

Author information

1
Department of Internal Medicine, The University of Texas Health Science Center at Houston, Houston, TX.
2
Department of Breast Medical Oncology, Baylor College of Medicine, Houston, TX.
3
Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
4
Department of Oncology, Mayo Clinic, Rochester, MN.
5
Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
6
Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: ayshah@mdanderson.org.

Abstract

BACKGROUND:

Patients with sarcomatoid renal-cell carcinomas (sRCC) have poor outcomes and limited treatment options. Preclinical and clinical data suggest susceptibility to cytotoxic agents and vascular endothelial growth factor-targeted therapies. We designed a phase 2 trial to evaluate the efficacy and safety of capecitabine, gemcitabine, and bevacizumab in sRCC.

PATIENTS AND METHODS:

Patients with metastatic or unresectable sRCC were eligible for inclusion. 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 (TTF). Secondary end points were safety, objective response rate, and overall survival.

RESULTS:

Thirty-four patients were enrolled onto the trial. One patient was excluded from survival analysis and 4 from response analysis as a result of missing data. Median progression-free survival was 5.5 months (95% confidence interval [CI], 3.4-7.7), median TTF 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. The most common reason for treatment discontinuation was progressive disease, which occurred in 24 patients (71%). The most common grade 3 toxicity was rash (including hand-foot syndrome) in 24% patients.

CONCLUSION:

The combination of capecitabine, gemcitabine, and bevacizumab is an option for patients with sRCC; however, response rates are low. Novel therapies are needed to improve outcomes in patients with sRCC.

KEYWORDS:

Cytoxic chemotherapy; Metastatic renal-cell carcinoma; Renal-cell carcinoma (RCC); Sarcomatoid; Sarcomatoid RCC

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