title: Phase II trial of methotrexate, vinblastine, doxorubicin, and cisplatin in advanced/recurrent carcinoma of the uterine cervix and vagina.
abstract: A phase II combination chemotherapy protocol combining methotrexate, vinblastine, doxorubicin, and cisplatin was designed to evaluate tumor response and survival in patients with advanced/recurrent cervix and vaginal cancer. Twenty-nine patients with advanced/recurrent cervix cancer and three patients with advanced vaginal cancer who had not previously received cytotoxic chemotherapy were assigned to chemotherapy treatment at 4-week intervals with methotrexate 30 mg/m2 i.v., Day 1, vinblastine 3 mg/m2 i.v., Days 2, 15, and 22, doxorubicin 30 mg/m2 i.v., Day 2, and cisplatin 70 mg/m2 i.v., Day 2. After a median of 4 cycles (maximum number 2 cycles beyond complete regression; 6 cycles with stable regression); we observed objective regressions in all 3 patients with vaginal cancer and 19 patients (66%, 95% CI = 46.82) with cervix cancer including complete regression in 6 patients (21%, 95% CI = 8.40) and partial regression in 13 patients (45%, 95% CI = 26.64). Median overall survival was 11.5 months (range 1.1-54+). Median survival of responders was 12.8 months (range 3.6-54+). Toxicity included neutropenia, alopecia, nausea, emesis, and stomatitis. Although grade 3 and 4 neutropenia was observed in over half of the patients, there were no treatment-related deaths. In conclusion, MVAC is a highly active outpatient chemotherapy regimen in patients with advanced/recurrent cervix cancer, achieving a high complete and partial response rate with moderate hematologic toxicity. These results need to be confirmed by phase III trial in advanced disease patients and MVAC may be a suitable regimen for investigation in neoadjuvant chemotherapy trials in poor prognosis, previously untreated patients.
authors.affiliation: Mayo Clinic, Rochester, Minnesota 55905, USA.
authors.forename: H J
authors.initials: HJ
authors.lastname: Long
authors.forename: W G
authors.initials: WG
authors.lastname: Cross
authors.forename: H S
authors.initials: HS
authors.lastname: Wieand
authors.forename: M J
authors.initials: MJ
authors.lastname: Webb
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: J W
authors.initials: JW
authors.lastname: Kugler
authors.forename: L K
authors.initials: LK
authors.lastname: Tschetter
authors.forename: C G
authors.initials: CG
authors.lastname: Kardinal
authors.forename: L P
authors.initials: LP
authors.lastname: Ebbert
authors.forename: S
authors.initials: S
authors.lastname: Rayson
mesh_terms: 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* / Q000401:mortality; D009367:Neoplasm Staging; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014625:Vaginal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D014747:Vinblastine; D004317:Doxorubicin; D002945:Cisplatin; D008727:Methotrexate