BACKGROUND: The combination of radiotherapy and cisplatin-based chemotherapy has proved to be an effective treatment for bladder carcinoma in many clinical studies. Intra-arterial approaches to chemotherapy have been developed to reduce systemic toxicities and improve response rates. This study was designed to determine the effectiveness of intra-arterial chemotherapy with cisplatin and doxorubicin combined with radiotherapy in the treatment of patients with invasive bladder carcinoma. The objectives were to evaluate the response rate, bladder preservation rate, toxicity, and survival rate. METHODS: Thirty-five patients with muscle-invasive bladder carcinoma at clinical stage T2-T4N0M0 were each treated with 2courses of intra-arterial cisplatin and doxorubicin at 3-week intervals, whereas radiotherapy was administered for 4 weeks (2 gray [Gy] given a total of 20 times, at 5 fractions per week). Patients with complete responses were given an additional course of chemotherapy (intra-arterial cisplatin and doxorubicin) and irradiation (20 Gy), and patients with residual tumor after the initial chemoradiotherapy underwent cystectomy. RESULTS: A clinical complete response was observed in 26 patients (74%; 95% confidence interval, 59-89%), and an incomplete response was observed in 9 (26%; 95% confidence interval, 11-41%). The bladder was preserved in all patients with a complete response, and it was tumor free in 19 of them (54% of all patients). The actuarial survival rate was 76.6% at 5 years. After a median follow-up interval of 45 months, 28 patients (80%) were alive and 7 (20%) had died due to disease progression. The regimen was well tolerated, with no severe systemic or local toxicities. CONCLUSIONS: The high rates of response, survival, and bladder preservation observed indicate that this combined intra-arterial chemotherapy and radiotherapy regimen would be useful in the management of invasive bladder carcinoma. This was a small Phase II trial; the results are preliminary, and the utility of this treatment modality in patient management remains to be proven.
BACKGROUND: The combination of radiotherapy and cisplatin-based chemotherapy has proved to be an effective treatment for bladder carcinoma in many clinical studies. Intra-arterial approaches to chemotherapy have been developed to reduce systemic toxicities and improve response rates. This study was designed to determine the effectiveness of intra-arterial chemotherapy with cisplatin and doxorubicin combined with radiotherapy in the treatment of patients with invasive bladder carcinoma. The objectives were to evaluate the response rate, bladder preservation rate, toxicity, and survival rate. METHODS: Thirty-five patients with muscle-invasive bladder carcinoma at clinical stage T2-T4N0M0 were each treated with 2courses of intra-arterial cisplatin and doxorubicin at 3-week intervals, whereas radiotherapy was administered for 4 weeks (2 gray [Gy] given a total of 20 times, at 5 fractions per week). Patients with complete responses were given an additional course of chemotherapy (intra-arterial cisplatin and doxorubicin) and irradiation (20 Gy), and patients with residual tumor after the initial chemoradiotherapy underwent cystectomy. RESULTS: A clinical complete response was observed in 26 patients (74%; 95% confidence interval, 59-89%), and an incomplete response was observed in 9 (26%; 95% confidence interval, 11-41%). The bladder was preserved in all patients with a complete response, and it was tumor free in 19 of them (54% of all patients). The actuarial survival rate was 76.6% at 5 years. After a median follow-up interval of 45 months, 28 patients (80%) were alive and 7 (20%) had died due to disease progression. The regimen was well tolerated, with no severe systemic or local toxicities. CONCLUSIONS: The high rates of response, survival, and bladder preservation observed indicate that this combined intra-arterial chemotherapy and radiotherapy regimen would be useful in the management of invasive bladder carcinoma. This was a small Phase II trial; the results are preliminary, and the utility of this treatment modality in patient management remains to be proven.