Fukui I, Sekine H, Kihara K, Yamada T, Kawai T, Washizuka M, Ishiwata D, Oka K, Hosoda K, Ikegami S
Department of Urology, Tokyo Medical and Dental University Hospital, Japan.
Cancer Chemother Pharmacol. 1987;20 Suppl:S52-5. doi: 10.1007/BF00262486.
From October 1983 to September 1985, 84 patients with superficial bladder tumor (Ta, Tl, Tis) were treated with sequential instillation of mitomycin C (MMC) and adriamycin (ADM). Doses of 20 mg MMC on day 1 and 40 mg ADM on day 2 were instilled into the bladder and retained for at least 2 h; this was repeated once a week for 5 consecutive weeks. Patients who achieved complete response (CR), were randomized and underwent prophylactic treatment taking the form of either intermittent instillation of MMC or daily oral administration of 5-fluorouracil. Of 79 evaluable patients, 72 (91%) had received prior treatment for superficial bladder tumors, 69 (87%) had high-grade tumors, and 18 (23%) had non-papillary Tis. The overall response rate was 68%, made up of CR in 43 patients (54%) and partial response (PR) in 11 (14%). Patients with either five or more tumors or tumors larger than 1 cm showed a significantly lower response rate than those with fewer than five tumors and tumors smaller than 1 cm, respectively. There was no correlation between tumor growth pattern, tumor grade and response rate, though non-papillary Tis appeared to respond better than papillary tumors. A history of prior instillation therapy or of toxicity to this treatment had no significant influence on the response rate. Although no systemic toxicity was observed, 62 patients (74%) experienced cystitis and the treatment had to be discontinued within 4 weeks in 13 of 33 cases with severe symptoms. The preliminary conclusion of prophylactic treatment was that intermittent instillation of MMC was superior to 5-FU medication in reducing the recurrence rate for at least 2 years after the treatment.
1983年10月至1985年9月，84例浅表性膀胱肿瘤（Ta、T1、Tis）患者接受了丝裂霉素C（MMC）和阿霉素（ADM）序贯膀胱灌注治疗。第1天给予20mg MMC，第2天给予40mg ADM膀胱灌注，并保留至少2小时；每周重复1次，连续5周。达到完全缓解（CR）的患者被随机分组，接受MMC间歇性膀胱灌注或5-氟尿嘧啶每日口服形式的预防性治疗。在79例可评估患者中，72例（91%）曾接受过浅表性膀胱肿瘤的治疗，69例（87%）为高级别肿瘤，18例（23%）为非乳头状Tis。总缓解率为68%，其中43例（54%）为CR，11例（14%）为部分缓解（PR）。肿瘤数量为5个或更多或肿瘤大于1cm的患者，其缓解率分别显著低于肿瘤数量少于5个和肿瘤小于1cm的患者。肿瘤生长方式、肿瘤分级与缓解率之间无相关性，尽管非乳头状Tis似乎比乳头状肿瘤反应更好。既往膀胱灌注治疗史或对该治疗的毒性反应对缓解率无显著影响。虽然未观察到全身毒性，但62例患者（74%）出现膀胱炎，33例症状严重的患者中有13例在4周内不得不停止治疗。预防性治疗的初步结论是，MMC间歇性膀胱灌注在降低治疗后至少2年的复发率方面优于5-氟尿嘧啶药物治疗。
