Marcial V A, Amato D A, Brady L W, Johnson R J, Goodman R, Martz K L, Hanley J A
Am J Clin Oncol. 1985 Jun;8(3):185-99. doi: 10.1097/00000421-198506000-00001.
One hundred forty-eight patients with advanced carcinoma of the urinary bladder Stages C or D1 were randomized between continuous-course radiotherapy (6,000 cGy in 30 fractions of 200 cGy each, over 6 weeks) and split-course radiotherapy (2,750 cGy in 10 fractions of 275 cGy each, over 2 weeks; a rest period of 3 weeks; 2,750 cGy in 2 weeks); 139 are analyzed in this report. Ninety-four percent of the patients have been followed at least 5 years or until death. The patients ranged in age from 45 to 80 with a median of 69. Seventy-six percent of the patients were males and 58% had Stage C disease. In patients with information on the size of the tumor, in 66% the lesion measured 5 cm or larger; 26% had a diameter of 8 cm or larger. In general, the treatment groups were well balanced with respect to patient characteristics. Both treatment groups tolerated therapy well. Eighty-seven percent of the patients completed therapy, 66% as planned. Fifty-four percent experienced at least one severe reaction, with the most common types being diarrhea (28%), frequency of urination (24%), soreness or burning on urination (25%), and urgency of urination (19%). Late effects of therapy were minimal. Median survival times were 11.5 months and 9.4 months for continuous-course and split-course, respectively. The treatment differences were not significant (p = 0.88; Mantel-Haenszel stratified by stage and sex). Forty percent of the patients became free of all clinically detectable disease following radiotherapy either alone or in combination with additional surgery (40% for continuous-course, 4% cleared by surgery, and 39% for split-course, 3% cleared by surgery). When the tumor measured less than 5 cm, the clearance rate was 61% (20/33) vs. 33% (13/39) for 5-7.9 cm, and 24% (6/25) for 8 cm or larger (p less than 0.01; chi2 test for linear trend). For those who became disease free, median time disease free within the irradiated volume was 72 months for continuous-course and is currently undefined for split-course; median time disease free was 28 months and undefined, respectively. There were no significant treatment differences in tumor control for any of these endpoints. The ultimate long-term tumor control in the pelvis was 28% (19/68) for continuous- and 25% (18/71) for split-course therapy.(ABSTRACT TRUNCATED AT 400 WORDS)
148例C期或D1期晚期膀胱癌患者被随机分为连续疗程放疗组（6周内给予6000厘戈瑞，每次200厘戈瑞，共30次）和分割疗程放疗组（2周内给予2750厘戈瑞，每次275厘戈瑞，共10次；休息3周；再2周内给予2750厘戈瑞）；本报告分析了其中139例患者。94%的患者随访至少5年或直至死亡。患者年龄在45至80岁之间，中位年龄为69岁。76%的患者为男性，58%患有C期疾病。在有肿瘤大小信息的患者中，66%的病灶直径为5厘米或更大；26%的病灶直径为8厘米或更大。总体而言，治疗组在患者特征方面平衡良好。两个治疗组对治疗的耐受性都很好。87%的患者完成了治疗，66%按计划完成。54%的患者经历了至少一种严重反应，最常见的类型是腹泻（28%）、尿频（24%）、尿痛或烧灼感（25%）以及尿急（19%）。治疗的晚期效应最小。连续疗程和分割疗程的中位生存时间分别为11.5个月和9.4个月。治疗差异无统计学意义（p = 0.88；按分期和性别进行Mantel-Haenszel分层）。40%的患者在单纯放疗或联合额外手术治疗后所有临床可检测到的疾病消失（连续疗程组为40%，其中4%通过手术清除，分割疗程组为39%，其中3%通过手术清除）。当肿瘤直径小于5厘米时，清除率为61%（20/33），直径为5至7.9厘米时为33%（13/39），直径为8厘米或更大时为24%（6/25）（p<0.01；线性趋势卡方检验）。对于那些疾病消失的患者，连续疗程组照射野内无病的中位时间为72个月，分割疗程组目前未明确；无病的中位时间分别为28个月和未明确。在这些终点的肿瘤控制方面，治疗差异均无统计学意义。盆腔内最终的长期肿瘤控制率，连续疗程组为28%（19/68），分割疗程组为25%（18/71）。（摘要截取自400字）
