Scheulen M E, Niederle N, Bremer K, Schütte J, Seeber S
Cancer Treat Rev. 1983 Sep;10 Suppl A:93-101. doi: 10.1016/s0305-7372(83)80013-9.
In a clinical phase II study 151 patients with refractory malignant diseases were treated with ifosfamide (60 mg/kg/day i.v. days 1-5, q 21-28 days). Altogether, 490 courses of treatment were given, 92 with conventional prophylactic measures (continuous infusion of 3-4 litre physiological saline plus alkalinization of the urine) and 398 with mesna prophylaxis (12 mg/kg i.v., 0, 4 and 8 h after administration of ifosfamide). The overall response rate (min. 25% tumor reduction) was 67/151 (44%) including four complete remissions in a fairly unfavourable patient group with testicular teratoma (39/87), soft tissue sarcoma (10/16), malignant melanoma (2/7), osteogenic sarcoma (3/6), Ewing's sarcoma (2/6), lymphoma and acute leukemia (5/7) or other histologies (6/22). The response rate in patients pretreated by cyclophosphamide containing regimen was 7/19 (36%) including one complete remission and one partial remission. Mesna was highly effective in reducing the frequency of hemorrhagic cystitis from 25/92 (27%) to 16/398 (4%) ifosfamide courses. The antitumor activity of ifosfamide in testicular cancer was not reduced by mesna. In conclusion, ifosfamide with the potent uroprotector mesna appears to compare favourably with the most active agents in the treatment of malignant diseases.
在一项临床II期研究中，151例难治性恶性疾病患者接受了异环磷酰胺治疗（静脉注射，60mg/kg/天，第1 - 5天，每21 - 28天重复）。总共进行了490个疗程的治疗，其中92个疗程采用传统预防措施（持续输注3 - 4升生理盐水并碱化尿液），398个疗程采用美司钠预防（静脉注射12mg/kg，在异环磷酰胺给药后0、4和8小时）。总体缓解率（肿瘤缩小至少25%）为67/151（44%），包括在一组预后相当差的患者中出现4例完全缓解，这些患者分别患有睾丸畸胎瘤（39/87）、软组织肉瘤（10/16）、恶性黑色素瘤（2/7）、骨肉瘤（3/6）、尤因肉瘤（2/6）、淋巴瘤和急性白血病（5/7）或其他组织学类型（6/22）。接受过含环磷酰胺方案预处理的患者缓解率为7/19（36%），包括1例完全缓解和1例部分缓解。美司钠能有效降低出血性膀胱炎的发生率，从异环磷酰胺疗程的25/92（27%）降至16/398（4%）。美司钠未降低异环磷酰胺在睾丸癌中的抗肿瘤活性。总之，异环磷酰胺联合强效尿路保护剂美司钠在治疗恶性疾病方面似乎优于最有效的药物。
