IFOSFAMIDE AND CISPLATIN AS NEOADJUVANT CHEMOTHERAPY FOR ADVANCED CERVICAL-CARCINOMA

A phase II trial was performed to evaluate the efficacy and toxicity o f a combination of cisplatin (CDDP) and ifosfamide (IFX) as neoadjuvan t chemotherapy in advanced cervical carcinoma (ACC). Between August 19 91 and September 1993, 57 untreated patients with stages IIB to IVA we re entered into this study. Median age was 44 years (range, 25 to 74 y ears). The distribution by stages (International Federation of Gynecol ogy and Obstetrics) was as follows: IIB, 31 patients; IIIB, 21 patient s; 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 obj ective 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 operabl e PR underwent surgery, otherwise received definitive radiotherapy. To xicity was mild to moderate. There were no toxicity related deaths. Th ese results indicate that IFX/CDDP is an active combination for ACC wi th mild toxicity. The results of phase III studies that evaluate the r eal impact of neoadjuvant chemotherapy are awaited.