BACKGROUND. The combination of radiotherapy and cisplatin-based chemot
herapy has proved to be an effective treatment for bladder carcinoma i
n many clinical studies. Intra-arterial approaches to chemotherapy hav
e been developed to reduce systemic toxicities and improve response ra
tes. This study was designed to determine the effectiveness of intra-a
rterial chemotherapy with cisplatin and doxorubicin combined with radi
otherapy in the treatment of patients with invasive bladder carcinoma.
The objectives were to evaluate the response rate, bladder preservati
on rate, toxicity, and survival rate. METHODS. Thirty-five patients wi
th muscle-invasive bladder carcinoma at clinical stage T2-T4NOMO were
each treated with 2 courses of intra-arterial cisplatin and doxorubici
n at S-week intervals, whereas radiotherapy was administered for 4 wee
ks (2 gray [Gy] given a total of 20 times, at 5 fractions per week). P
atients with complete responses were given an additional course of che
motherapy (intraarterial cisplatin and doxorubicin) and irradiation (2
0 Gy), and patients with residual tumor after the initial chemoradioth
erapy 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 res
ponse, 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 d
ied due to disease progression. The regimen was well tolerated, with n
o severe systemic or local toxicities. CONCLUSIONS. The high rates of
response, survival, and bladder preservation observed indicate that th
is 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. (
C) 1997 American Cnncer Society.