A PHASE-II TRIAL OF METHOTREXATE, VINBLASTINE, DOXORUBICIN, AND CISPLATIN IN THE TREATMENT OF METASTATIC CARCINOMA OF THE UTERINE CERVIX

BACKGROUND. Patients with metastatic carcinoma of the uterine cervix h ave limited survival. Thus, new chemotherapeutic agents and combinatio ns are needed to improve patient outcome. METHODS. Twenty-seven patien ts with Stage IV primary or recurrent carcinoma of the uterine cenix w ere assigned to chemotherapy treatment at 4-week intervals with methot rexate, vinblastine, doxorubicin, and cisplatin (MVAC). The treatment was comprised of methotrexate, 30 mg/m(2) administered intravenously ( i.v.) on Days 1, 15, and 22; vinblastine, 3 mg/m(2) i.v. on Days 2, 15 , and 22; doxorubicin, 30 mg/m(2) i.v. on Day 2; and cisplatin, 70 mg/ m(2) i.v. on Day 2. Granulocyte-colony stimulating factor (G-CSF) was given subcutaneously on Days 6-10 at a dose of 5 mu g/kg. RESULTS. Aft er a median of 4 cycles (a maximum of 6 in responders), the authors ob served objective responses in 14 patients (52%), including 3 complete responses (11%) and 11 partial responses (41%). Median overall surviva l was 11 months (range, 4-15+ months), and median progression free sur vival of the responders was 8 months (range, 6-15+ months). Toxicity w as acceptable and included neutropenia, alopecia, vomiting, and stomat itis. CONCLUSIONS. MVAC is an active regimen in the treatment of patie nts with advanced or recurrent carcinoma of the uterine cervix. It pro duced responses in one-half of the patients in this study, and it can be administered on an outpatient basis. The addition of G-CSF appears to reduce hematologic toxicity. (C) 1997 American Cancer Society.