NEOADJUVANT CISPLATIN PLUS IFOSFAMIDE IN PATIENTS WITH STAGE IIB CERVICAL-CANCER - A SINGLE-CENTER PHASE-II STUDY

The objective of this study was to evaluate cisplatin plus ifosfamide as neoadjuvant chemotherapy with regard to toxicity and clinical respo nse in patients with stage IIB cervical cancer. Sixty-eight patients w ith previously untreated stage IIB cervical cancer were given two cycl es of chemotherapy: cisplatin 20 mg m(-2) on Days 1-5, infused over 1 h; ifosfamide 1.2 g m(-2) on Days 1-5 infused over 30 min. Mesna 120 m g m(-2) was administered as a bolus 15 min before ifosfamide, and a co ntinuous infusion, delivering Mesna 1.2 g m(-2), was given subsequentl y over the next 16 hours. The treatment cycle was repeated on day 21. Responders were then randomized to surgery or radiation therapy. All 6 8 patients were evaluable for toxicity. Toxicity was found to be accep table. One patient died at home one month after completion of the seco nd treatment cycle. There was one grade 4 thrombocytopenia. Grade 3 to xicities included anemia in four patients, leucopenia and nausea and v omiting in one patient each. Sixty-two patients were evaluable for res ponse. A clinical response was documented in 44 of the 55 evaluable pa tients (80%), with 17 complete responses (31%) and 27 partial response s (49%) (95% confidence limits 69%-91%, 19%-43%, and 36%-62% respectiv ely). The intent-to-treat response rate was 64.7%. Twenty-one patients were randomized to surgery and 23 patients to radiation therapy. Amon gst the eight patients with a complete clinical response, one patient had a complete pathological response and one patient had residual intr a-epithelial neoplasia. The drug combination of cisplatin plus ifosfam ide had acceptable toxicity and gave a clinical response rate of 80% i n previously untreated patients with stage IIB cervical cancer.