Schutt A J, Hoth D, Moertel C G, Schein P S, Rubin J, O'Connell M J
Am J Clin Oncol. 1984 Oct;7(5):507-11. doi: 10.1097/00000421-198410000-00022.
Mayo clinic and georgetown university carried out a cooperative phase II study of chlorozotocin in measurable advanced large bowel carcinoma. Of 78 evaluable patients randomized, 39 received low-dose (120 mg/m2 if previously untreated, 100 mg/m2 if previously treated) and 39 high-dose (200 mg/m2 if previously untreated, 175 mg/m2 if previously treated) chlorozotocin intravenously at 6-week intervals. Both groups were comparable in regard to age, prior treatment, treating institution, site of metastases, and performance scores. Overall response rate was 8%, including 5% in low-dose patients and 10% in high-dose patients. Toxicity was mild to moderate, with gastrointestinal toxicity substantially, and hematologic toxicity somewhat less, than seen with other nitrosoureas. Time to progression and survival showed no significant difference between patients treated on the low- and high-dose schedules. As chlorozotocin produced less nausea and vomiting than other nitrosoureas, even in the high-dose regimen, it should be considered for evaluation in neoplasms where nitrosoureas have shown more activity than in colorectal carcinoma.
梅奥诊所和乔治敦大学开展了一项关于氯脲霉素治疗可测量的晚期大肠癌的合作性II期研究。在78例随机分组的可评估患者中，39例接受低剂量（若此前未接受过治疗则为120mg/m²，若此前接受过治疗则为100mg/m²）氯脲霉素，39例接受高剂量（若此前未接受过治疗则为200mg/m²，若此前接受过治疗则为175mg/m²）氯脲霉素，静脉给药，每6周一次。两组在年龄、既往治疗情况、治疗机构、转移部位及体能评分方面具有可比性。总体缓解率为8%，其中低剂量组患者为5%，高剂量组患者为10%。毒性为轻至中度，与其他亚硝基脲类药物相比，胃肠道毒性更显著，血液学毒性稍轻。低剂量和高剂量方案治疗的患者在疾病进展时间和生存期方面无显著差异。由于氯脲霉素产生的恶心和呕吐比其他亚硝基脲类药物少，即使在高剂量方案中也是如此，因此在亚硝基脲类药物比在结直肠癌中显示出更多活性的肿瘤中，应考虑对其进行评估。
