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 have limited survival. Thus, new chemotherapeutic agents and combinations are needed to improve patient outcome.


METHODS
Twenty-seven patients with Stage IV primary or recurrent carcinoma of the uterine cervix were assigned to chemotherapy treatment at 4-week intervals with methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC). The treatment was comprised of methotrexate, 30 mg/m2 administered intravenously (i.v.) on Days 1, 15, and 22; vinblastine, 3 mg/m2 i.v. on Days 2, 15, and 22; doxorubicin, 30 mg/m2 i.v. on Day 2; and cisplatin, 70 mg/m2 i.v. on Day 2. Granulocyte-colony stimulating factor (G-CSF) was given subcutaneously on Days 6-10 at a dose of 5 micrograms/kg.


RESULTS
After a median of 4 cycles (a maximum of 6 in responders), the authors observed objective responses in 14 patients (52%), including 3 complete responses (11%) and 11 partial responses (41%). Median overall survival was 11 months (range, 4-15+ months), and median progression free survival of the responders was 8 months (range, 6-15+ months). Toxicity was acceptable and included neutropenia, alopecia, vomiting, and stomatitis.


CONCLUSIONS
MVAC is an active regimen in the treatment of patients with advanced or recurrent carcinoma of the uterine cervix. It produced 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.
Papadimitriou
C A
CA
Department of Clinical Therapeutics, Alexandra Hospital, Athens University School of Medicine, Greece.
Dimopoulos
M A
MA
Giannakoulis
N
N
Sarris
K
K
Vassilakopoulos
G
G
Akrivos
T
T
Voulgaris
Z
Z
Vlahos
G
G
Diakomanolis
E
E
Michalas
S
S
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009367:Neoplasm Staging; D016019:Survival Analysis; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage
D014747:Vinblastine; D004317:Doxorubicin; D002945:Cisplatin; D008727:Methotrexate