Phase II trial of bleomycin, ifosfamide, and carboplatin in metastatic cervical cancer.

Abstract

PURPOSE A bleomycin, carboplatin, and ifosfamide (BIC) chemotherapy protocol was designed to evaluate tumor response and palliation in patients with advanced cervical cancer. PATIENTS AND METHODS Forty patients with stage IV primary or recurrent squamous cell carcinoma of the cervix (19 previously irradiated and 21 nonirradiated) were assigned to treatment with six cycles of BIC: bleomycin, 30 mg bolus on day 1; carboplatin, 200 mg/m2 bolus on day 1; and ifosfamide, 2g/m2 for 3 consecutive days, infused over 2 hours. Mesna was administered as a bolus 15 minutes, and 4 and 8 hours after ifosfamide at 20% (intravenous [IV]), and 40% (orally, at home) of the ifosfamide dose, respectively. RESULTS Thirty-five patients (27 stage IVA and eight stage IVB) were considered eligible for response and toxicity evaluation. After a median of four cycles (maximum of six in responders), we observed objective responses in 21 patients (60%), with eight complete responses (CRs; 23%), including two histologically documented by laparotomy, and 13 (37%) partial responses (PRs) (95% confidence limits, 44% to 76%, 9% to 37%, and 21% to 53%, respectively). Median overall survival duration was 11 months (range, 3 to 24+). Median overall survival duration in the nonirradiated group was 17 months versus 4 months in the previously irradiated group (P = .005). The median progression-free survival duration of the responders was 12 months, and the median disease-free survival duration of the complete responders was 14 months. Toxicity was acceptable and included manageable alopecia, vomiting, and neutropenia. There was one toxic death due to febrile neutropenia and sepsis. CONCLUSION BIC can be administered on an outpatient basis and seems to be effective in inducing tumor response and palliation in patients with disseminated squamous cell carcinoma of cervix, with a possible survival benefit for previously nonirradiated patients, with an acceptable toxicity profile.