Indian Journal of Urology
: 2006  |  Volume : 22  |  Issue : 1  |  Page : 85-

Neoadjuvant chemotherapy in invasive bladder tumor: Is it worth the trouble?

J Chandra Singh, Nitin S Kekre 
 Department of Urology, All India Institute of Medical Sciences, New Delhi, India

Correspondence Address:
J Chandra Singh
Department of Urology, All India Institute of Medical Sciences, New Delhi

How to cite this article:
Singh J C, Kekre NS. Neoadjuvant chemotherapy in invasive bladder tumor: Is it worth the trouble?.Indian J Urol 2006;22:85-85

How to cite this URL:
Singh J C, Kekre NS. Neoadjuvant chemotherapy in invasive bladder tumor: Is it worth the trouble?. Indian J Urol [serial online] 2006 [cited 2023 Feb 5 ];22:85-85
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The primary objective of this multicentric prospective randomized study[1] was to compare the survival among patients with clinical tumor-node-metastases (TNM) stage T2N0M0 to T4aN0M0 bladder cancer, treated either with cystectomy alone, or neoadjuvant Methotrexate, Vinblastine, Doxorubicin and Cisplatin (M-VAC), followed by cystectomy. A secondary objective was to quantify the effect of neoadjuvant M-VAC on the stage of the tumor ("tumor down-staging"). A sample size of 298 was arrived at, to detect a 50% or greater improvement in median survival between the combination-therapy group, with 80% power and type 1 error of 0.05. Two-sided P values were reported. 317 patients from 126 institutions were enrolled. Only those with adequate renal, hepatic and hematologic function and a SWOG performance status of 0 or 1 were recruited. Of those eligible, 154 and 153 were assigned to cystectomy alone and M-VAC, followed by cystectomy respectively, after stratifying according to age (65 years) and stage (superficial muscle invasion vs more extensive disease). The median survival was 46 months in the cystectomy group and 77 months in the combination group according to an intention-to-treat analysis. Five year survival was 57% and 43% in the combination-therapy group and cystectomy group, respectively (P=0.06). 38% cystectomy specimens were pathologically free of cancer following M-VAC at the time of cystectomy (including 22 who initially had stage T3 or T4a disease), but only 15% cystectomy specimens were free of tumor in the group which had cystectomy alone (P 70 years is under-represented in all these trials. Hence, the role of neoadjuvant chemotherapy in this elderly population remains to be studied. Though the incidence of toxicity was high in this study,[1] there were no deaths attributable to chemotherapy. If similar quality of care can be provided, neoadjuvant chemotherapy with M-VAC regimen is likely to downstage the tumor and be of survival benefit in younger patients with good performance status.


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