Wallace D M, Bloom H J
Br J Urol. 1976;48(7):587-94. doi: 10.1111/j.1464-410x.1976.tb06705.x.
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 T3 or B2C). 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 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 less than 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 T3 bladder cancers.
本文呈现了一项多中心合作随机试验的初步结果。该试验由伦敦泌尿外科研究所资助,旨在比较根治性放疗(6周内6000拉德)与术前放疗(4周内4000拉德)加根治性膀胱切除术治疗膀胱深部浸润癌(T3期或B2C期)的效果。1966年至1975年间纳入该试验的199例患者中,有189例符合研究条件。联合治疗的总体3年和5年生存率分别为41%和33%,而根治性放疗的相应生存率为28%和21%。手术死亡率为7.8%。两种治疗方法之间有利于联合治疗的差异尚未达到普遍认可的显著水平(P小于0.05),3年和5年结果的P值分别为0.064和0.077。在接受方案联合治疗的患者中,47%的病例手术标本中肿瘤分期降低。淋巴结转移的总体发生率为23%(与通常的40%-50%不同),如果原发肿瘤对放疗反应良好,发生率仅为8%。分期降低病例的3年和5年生存率分别为66%和55%,而手术标本中分期未降低的患者相应生存率为29%和22%。我们未来研究的目标是找到有效的放射增敏剂和细胞毒性药物,以尝试提高T3期膀胱癌综合治疗中术前放疗的肿瘤反应发生率和程度。