Shearer R J, Chilvers C F, Bloom H J, Bliss J M, Horwich A, Babiker A
Department of Urology, Royal Marsden Hospital, London.
Br J Urol. 1988 Dec;62(6):558-64. doi: 10.1111/j.1464-410x.1988.tb04426.x.
We report the early results of a multi-centre, randomised prospective trial of neoadjuvant and maintenance chemotherapy with methotrexate (MTX) in 376 patients with advanced (T3) carcinoma of the bladder. In patients under 65 years of age, treatment consisted of radical radiotherapy (64 Gy) or, in some centres, pre-operative radiotherapy (44 Gy) and elective cystectomy. All patients over 65 had radical radiotherapy. MTX was administered to 188 patients. There was no increase in toxicity attributable to the MTX. MTX did not significantly increase the proportion of patients whose tumours responded to radiotherapy; 50% (70/141) responded to radiotherapy and 56% (76/136) to MTX radiotherapy. The development of metastases and survival was also similar in both groups (3-year survival: radiotherapy 37.3%, MTX + radiotherapy 38.6%). We report the logistic difficulties of the administration of prolonged courses of maintenance chemotherapy. Further controlled trials of neo-adjuvant chemotherapy in advanced bladder cancer are required, involving more active regimes.
我们报告了一项多中心随机前瞻性试验的早期结果，该试验对376例晚期（T3期）膀胱癌患者采用甲氨蝶呤（MTX）进行新辅助和维持化疗。对于65岁以下的患者，治疗包括根治性放疗（64 Gy），或在一些中心采用术前放疗（44 Gy）及选择性膀胱切除术。所有65岁以上的患者均接受根治性放疗。188例患者接受了MTX治疗。未发现因MTX导致的毒性增加。MTX并未显著提高肿瘤对放疗有反应的患者比例；50%（70/141）的患者对放疗有反应，56%（76/136）的患者对MTX放疗有反应。两组患者转移的发生情况和生存率也相似（3年生存率：放疗组为37.3%，MTX+放疗组为38.6%）。我们报告了进行长期维持化疗给药时的后勤困难。需要开展更多涉及更有效方案的晚期膀胱癌新辅助化疗对照试验。
