The Management of Deeply Infiltrating (T ₃ ) Bladder Carcinoma: Controlled Trial of Radical Radiotherapy versus Preoperative Radiotherapy and Radical Cystectomy (First Report)

Abstract

Summary The preliminary results are presented of a multicentre, co‐operative randomised trial, sponsored by the Institute of Urology, London, in which radical irradiation (6,000 rads in 6 weeks) is compared with preoperative irradiation (4,000 rads in 4 weeks) plus radical cystectomy for deeply infiltrating carcinoma of the bladder (Stage T 3 or B 2 C). 189 of the 199 cases entered into the trial between 1966 and 1975 were eligible for study. The overall 3‐ and 5‐year survival rates for the combined treatment were 41% and 33%, respectively, compared with 28% and 21% for radical radiotherapy. The operative mortality was 7.8%. The difference between the two treatments in favour of the combined treatment has not yet reached the generally accepted level of significance ( P <0.05), the p factors for the 3‐ and 5‐year results being 0.064 and 0.077, respectively. Of patients receiving the protocol combined treatment, reduction in tumour stage was found in the surgical specimen in 47% of cases. The overall incidence of nodal metastases was 23% (against the usual figure of 40‐50%), and in the presence of a good response of the primary tumour to irradiation, only 8%. The 3‐ and 5‐year survival rates for the down‐staged cases were 66% and 55%, respectively, compared with 29% and 22% for patients showing no stage reduction in the surgical specimen. The aim of our future studies is to find effective radiosensitising and cytotoxic agents with which to try and increase the incidence and degree of tumour response to pre‐operative irradiation in the combined modality treatment of T 3 bladder cancers. We should like to acknowledge the considerable assistance given by Mr Brian Shepherd and Mr Alan Turner, past and present senior urological registrars at the Royal Marsden Hospital, and also our research assistants, Dr M. Hossain and Dr S. Morris in assembling and analysing the collective data from the 8 centres. Our gratitude is due to Mr Peter Payne, Director of the South Metropolitan Cancer Registry, for statistical advice and computer facilities.