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.
