Assessment of Tolerability, Response and Complications of Concurrent Chemoradiation With Capecitabine and Cisplatin in Muscle-Invasive Bladder Cancer; A Single Arm Study

Radical cystectomy is the popular therapy for muscle-invasive bladder cancer. Concurrent chemoradiation is an accepted alternative. In his single-arm clinical trial, we sought the outcomes of patients treated with chemoradiotherapy using once daily radiation and concurrent cisplatin and capecitabine. Considering the promising response and compliance rates, the administration of our protocol warrants further attention in the context of MIBC treatment. Purpose : To evaluate the feasibility, tolerance and efficacy of cisplatin + capecitabine as a proposed combination in concurrent chemoradiotherapy for patients with muscle-invasive bladder cancer (MIBC). Methods : MIBC patients with stage T2-T4aN0M0 participated in this single-arm clinical trial. After maximal TURBT, 66Gy/33 daily fractions of radiation were administered with concurrent chemotherapy of cisplatin (35 mg/m 2 ) and capecitabine (625 mg/m 2 ). The primary endpoint was treatment tolerability, defined as receiving capecitabine + cisplatin combination for at least 5 weeks during radiation therapy. The secondary endpoints included complete response (CR) and acute toxicity rates. Results : This study included 19 MIBC patients from 2018 to 2019. Eighteen patients (94.7%, 95%CI: 75.4-99.0) completed the planned treatment course. Only one patient (5.26%, 95%CI: 0.9-24.6) discontinued the treatment due to grade-3 GI toxicity. Among those who completed the treatment, CR was seen in 12 patients (66.7%, 95% CI = 44.488.9) with no grade >= 3 toxicities. The most common grade-2 side effects during therapy were renal complications (57.9%), and the only grade-2 complication after therapy was urinary-related (11.1%). The median follow-up was 31 months and the median overall survival (OS) was 31 months. The 2-year OS was 78% (95% CI 58.4-97.6), Cystectomyfree survival was 61% (95% CI: 37.5-84.5), and the median OS after recurrence was 13 months. Distant metastases were the first type of recurrence in most patients with a recurrence, which occurred in 7 (36.8%) patients. Median metastasis-free survival (MFS) was 30 months, and 2-year MFS was 66% (95% CI:45-87). Conclusion : The promising tolerability rate seen with concurrent cisplatin + capecitabine in this study was comparable to the available literature. Thus, this combination concurrently with radiation warrants further studies in the context of chemoradiotherapy of MIBC.

Automated summary

This study evaluated the feasibility, tolerance, and efficacy of concurrent chemoradiotherapy using cisplatin and capecitabine in patients with muscle-invasive bladder cancer. The results showed good tolerability and promising efficacy. Further studies are warranted to investigate the use of this combination in the treatment of bladder cancer.