A phase II trial of methotrexate, vinblastine, doxorubicin, and cisplatin in the treatment of metastatic carcinoma of the uterine cervix

Cancer. 1997 Jun 15;79(12):2391-5. doi: 10.1002/(sici)1097-0142(19970615)79:12<2391::aid-cncr14>3.0.co;2-m.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / administration & dosage
  • Doxorubicin / administration & dosage
  • Female
  • Humans
  • Methotrexate / administration & dosage
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Neoplasm Staging
  • Survival Analysis
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / pathology
  • Vinblastine / administration & dosage

Substances

  • Vinblastine
  • Doxorubicin
  • Cisplatin
  • Methotrexate

Supplementary concepts

  • M-VAC protocol