CISPLATIN, 5-FLUOROURACIL, AND IFOSFAMIDE IN THE TREATMENT OF RECURRENT OR ADVANCED CERVICAL-CANCER

We performed a prospective, phase II trial of cisplatin, 5-fluorouracil, and ifosfamide in the treatment of 30 women with recurrent or advanced cervical cancer. Median age was 47 years old. Twenty-one tumors were squamous and 83% of tumors were grade 2 or 3. Twenty-six patients (87%) received prior pelvic radiotherapy, and six patients (20%) received prior radiation sensitizing chemotherapy. Median time to recurrence was 6 months. In 11 patients (37%) tumor recurred in the pelvis. A combination of cisplatin 90 mg/m(2), 5-fluorouracil 1500 mg/m(2), and ifosfamide 3 g/m(2) was administered intravenously in divided doses over 3 consecutive days every 28 days. Sixteen patients (53%) responded to chemotherapy with a complete response occurring in 5 patients (17%) and a partial response in 11 patients (36%). One of 11 patients (7%) with a pelvic recurrence responded compared to 15 of 19 (79%) with extrapelvic recurrence (P = 0.001). Tumors recurring after 6 months had a higher response rate (73%) compared to those recurring before 6 months (33%) (P = 0.05). Three of the six patients (50%) treated with prior radiation sensitizing chemotherapy responded. Seven of nine patients (78%) with adenocarcinoma responded. Median survival is 12 months (3-36 months). In conclusion, cisplatin, 5-fluorouracil, and ifosfamide resulted in a favorable response rate (53%) and a median survival of 12 months. As expected, patients with extrapelvic recurrence and recurrence after 6 months had an improved response rate while, surprisingly, those receiving prior radiation sensitizing chemotherapy and those with adenocarcinoma did not exhibit a less favorable response rate. (C) 1995 Academic Press, Inc.