TY - JOUR
T1 - Phase 2 Trial of Capecitabine, Gemcitabine, and Bevacizumab in Sarcomatoid Renal-Cell Carcinoma
AU - Maiti, Abhishek
AU - Nemati-Shafaee, Maryam
AU - Msaouel, Pavlos
AU - Pagliaro, Lance C.
AU - Jonasch, Eric
AU - Tannir, Nizar M.
AU - Shah, Amishi Y.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/2
Y1 - 2018/2
N2 - Patients with sarcomatoid renal-cell carcinomas (sRCC) have poor outcomes. We enrolled 34 patients onto a phase 2 trial of capecitabine, gemcitabine, and bevacizumab. Median progression-free survival was 5.5 months, median overall survival was 12 months, and objective response rate was 20%. This regimen is an option in sRCC; however, response rates are low. Novel therapies are needed. 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.
AB - Patients with sarcomatoid renal-cell carcinomas (sRCC) have poor outcomes. We enrolled 34 patients onto a phase 2 trial of capecitabine, gemcitabine, and bevacizumab. Median progression-free survival was 5.5 months, median overall survival was 12 months, and objective response rate was 20%. This regimen is an option in sRCC; however, response rates are low. Novel therapies are needed. 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.
KW - Cytoxic chemotherapy
KW - Metastatic renal-cell carcinoma
KW - Renal-cell carcinoma (RCC)
KW - Sarcomatoid
KW - Sarcomatoid RCC
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UR - http://www.scopus.com/inward/citedby.url?scp=85028593031&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2017.07.028
DO - 10.1016/j.clgc.2017.07.028
M3 - Article
AN - SCOPUS:85028593031
SN - 1558-7673
VL - 16
SP - e47-e57
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 1
ER -