Sutton G P, Blessing J A, Adcock L, Webster K D, DeEulis T
Department of Obstetrics and Gynecology, Indiana University Medical School, Indianapolis.
Invest New Drugs. 1989 Nov;7(4):341-3. doi: 10.1007/BF00173765.
Thirty patients with advanced squamous carcinoma of the uterine cervix recurrent after radiotherapy or surgery and refractory to first-line chemotherapeutic agents were treated with ifosfamide in a dose of 1.2 grams/m2 IV daily for five days every four weeks and Mesna 300 mg/m2 IV every four hours for three doses daily for five days. One patient had an inadequate trial and two were inevaluable for response, leaving 27 patients evaluable for response. All but two patients had received prior radiotherapy and all but one prior cisplatin-based or cisplatin analog chemotherapy. Seventeen patients had prior surgery. All patients were Gynecologic Oncology Group performance status 0, 1, or 2. Partial responses were observed in three patients (11.1%), two with pelvic and one with extrapelvic disease. A 90% confidence interval for the true response rate is 4.5%-24.8%. Severe (grade 3 or 4) leukopenia and anemia were seen in nine and seven patients, respectively. Severe thrombocytopenia was not observed. Three patients had grade 3 or 4 neurotoxicity, and one had grade 3 renal impairment. Reversible alopecia was universal. This dose and schedule of ifosfamide and Mesna is active in patients with squamous carcinoma of the cervix failing platinum-based therapy. Phase II testing in untreated patients is currently underway.
30例子宫颈鳞状细胞癌患者在放疗或手术后复发，且对一线化疗药物耐药，接受异环磷酰胺治疗，剂量为1.2克/平方米，静脉滴注，每日1次，共5天，每4周重复；美司钠300毫克/平方米，静脉滴注，每4小时1次，每日3次，共5天。1例患者试验不充分，2例无法评估疗效，剩余27例可评估疗效。除2例患者外，其余均接受过放疗；除1例患者外，其余均接受过以顺铂为基础或顺铂类似物的化疗。17例患者接受过手术。所有患者的妇科肿瘤学组体能状态均为0、1或2级。3例患者（11.1%）出现部分缓解，2例为盆腔病变，1例为盆腔外病变。真实缓解率的90%置信区间为4.5%-24.8%。分别有9例和7例患者出现严重（3级或4级）白细胞减少和贫血。未观察到严重血小板减少。3例患者出现3级或4级神经毒性，1例出现3级肾功能损害。普遍出现可逆性脱发。这种异环磷酰胺和美司钠的剂量和给药方案对铂类治疗失败的子宫颈鳞状细胞癌患者有效。目前正在对未治疗的患者进行II期试验。
