Ca. Papadimitriou et al., A PHASE-II TRIAL OF METHOTREXATE, VINBLASTINE, DOXORUBICIN, AND CISPLATIN IN THE TREATMENT OF METASTATIC CARCINOMA OF THE UTERINE CERVIX, Cancer, 79(12), 1997, pp. 2391-2395
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.