Freedman R S, Herson J, Wharton J T, Rutledge F N
Cancer Clin Trials. 1980;3(4):345-50.
A randomized study of 59 patients with recurrent squamous carcinoma of the cervix originally treated with radiotherapy is reported. Patients were randomized on recurrence to either Hexamethylmelamine, Adriamycin, or Cytoxan as first agent. When analysis was restricted to 37 patients with easily evaluable disease, Cytoxan had a significantly greater response rate (23.1%, 3/13) than Hexamethylmelamine (0%, 0/14) (p = 0.098). The response rate of Adriamycin was 20% (2/10). There was no evidence of a significant effect of first agent on survival time taken from the start of chemotherapy. The number of months from diagnosis to the start of chemotherapy (p = 0.04) and the patients' response status (p = 0.002) did however have significant effects on survival time. There was no evidence of a significant effect of first agent on survival time after treatment change but response to first agent did have a significant effect on survival (p = 0.05). Hexamethylmelamine had a greater frequency of severe toxicity (50%, 10/20) than Adriamycin (10.5%, 2/19) (p = 0.014) and Cytoxan (10%, 2/10) (p = 0.014).
本文报道了一项针对59例复发性宫颈鳞状细胞癌患者的随机研究,这些患者最初接受了放射治疗。复发时,患者被随机分配使用六甲蜜胺、阿霉素或环磷酰胺作为首选药物。当分析仅限于37例疾病易于评估的患者时,环磷酰胺的缓解率(23.1%,3/13)显著高于六甲蜜胺(0%,0/14)(p = 0.098)。阿霉素的缓解率为20%(2/10)。没有证据表明首选药物对化疗开始后的生存时间有显著影响。然而,从诊断到化疗开始的月数(p = 0.04)和患者的缓解状态(p = 0.002)确实对生存时间有显著影响。没有证据表明首选药物对治疗方案改变后的生存时间有显著影响,但对首选药物的反应确实对生存有显著影响(p = 0.05)。六甲蜜胺的严重毒性发生率(50%,10/20)高于阿霉素(10.5%,2/19)(p = 0.014)和环磷酰胺(10%,2/10)(p = 0.014)。