Leone B, Vallejo C, Perez J, Cuevas M A, Machiavelli M, Lacava J, Focaccia G, Ferreyra R, Suttora G, Romero A, Castaldi J, Arroyo A, Rabinovich M
Grupo Oncologico Cooperativo del Sur (GOCS), Republica Argentina.
Am J Clin Oncol. 1996 Apr;19(2):132-5. doi: 10.1097/00000421-199604000-00008.
A phase II trial was performed to evaluate the efficacy and toxicity of a combination of cisplatin (CDDP) and ifosfamide (IFX) as neoadjuvant chemotherapy in advanced cervical carcinoma (ACC). Between August 1991 and September 1993, 57 untreated patients with stages IIB to IVA were entered into this study. Median age was 44 years (range, 25 to 74 years). The distribution by stages (International Federation of Gynecology and Obstetrics) was as follows: IIB, 31 patients; IIIB, 21 patients; and IVA, 5 patients. Therapy consisted of IFX 2000 mg/m(2) 1-h i.v. infusion days 1 to 3; mesna 400 mg/m(2) i.v. bolus at hours 0 and 4, and 800 mg p.o. at hour 8; and CDDP 100 mg/m(2) on day 3. Cycles were repeated every 28 days for a total of three courses. Both staging and response assessment were performed by a multidisciplinary team. An objective response was observed in 30 of 56 patients (54%; 95% confidence interval, 41 to 67%). Four patients (7%) had a complete response (CR) and 26(46%) had a partial response (PR). Patients with CR or operable PR underwent surgery, otherwise received definitive radiotherapy. Toxicity was mild to moderate. There were no toxicity related deaths. These results indicate that IFX/CDDP is an active combination for ACC with mild toxicity. The results of phase III studies that evaluate the real impact of neoadjuvant chemotherapy are awaited.
进行了一项II期试验，以评估顺铂（CDDP）与异环磷酰胺（IFX）联合作为晚期宫颈癌（ACC）新辅助化疗的疗效和毒性。1991年8月至1993年9月期间，57例未经治疗的IIB至IVA期患者进入本研究。中位年龄为44岁（范围25至74岁）。按分期（国际妇产科联合会）分布如下：IIB期31例；IIIB期21例；IVA期5例。治疗方案为：IFX 2000 mg/m²静脉滴注1小时，第1至3天；美司钠400 mg/m²静脉推注，在0小时和4小时，800 mg口服，在8小时；CDDP 100 mg/m²在第3天。每28天重复一个周期，共三个疗程。分期和疗效评估均由多学科团队进行。56例患者中有30例（54%；95%置信区间，41%至67%）观察到客观缓解。4例患者（7%）完全缓解（CR），26例（46%）部分缓解（PR）。CR或可手术PR的患者接受手术，否则接受根治性放疗。毒性为轻至中度。无毒性相关死亡。这些结果表明，IFX/CDDP是一种对ACC有效的联合方案，毒性轻微。期待评估新辅助化疗实际影响的III期研究结果。
