Hj. Long et al., PHASE-II TRIAL OF METHOTREXATE, VINBLASTINE, DOXORUBICIN, AND CISPLATIN IN ADVANCED RECURRENT CARCINOMA OF THE UTERINE CERVIX AND VAGINA, Gynecologic oncology, 57(2), 1995, pp. 235-239
A phase II combination chemotherapy protocol combining methotrexate, v
inblastine, doxorubicin, and cisplatin was designed to evaluate tumor
response and survival in patients with advanced/recurrent recurrent ce
rvix 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 chemot
herapy treatment at 4-week intervals with methotrexate 30 mg/m2 iv, Da
y 1, vinblastine 3 mg/m(2) iv, Days 2, 15, and 22, doxorubicin 30 mg/m
2 iv, Day 2, and cisplatin 70 mg/m(2) iv, Day 2. After a median of 4 c
ycles (maximum number 2 cycles beyond complete regression; 6 cycles wi
th stable regression); we observed objective regressions in all 3 pati
ents with vaginal cancer and 19 patients (66%, 95% CI = 46,82) with ce
rvix cancer including complete regression in 6 patients (21%, 95% CI =
8,40) and partial regression in 13 patients (45%, 95% CI = 26,64). Me
dian overall survival was 11.5 months (range 1.1-54+). Median survival
of responders was 12.8 months (range 3.6-54+). Toxicity included neut
ropenia, alopecia, nausea, emesis, and stomatitis, Although grade 3 an
d 4 neutropenia was observed in over half of the patients, there were
no treatment-related deaths. In conclusion, MVAC is a highly active ou
tpatient chemotherapy regimen in patients with advanced/recurrent cerv
ix cancer, achieving a high complete and partial response rate with mo
derate hematologic toxicity, These results need to be confirmed by pha
se III trial in advanced disease patients and MVAC may be a suitable r
egimen for investigation in neoadjuvant chemotherapy trials in poor pr
ognosis, previously untreated patients. (C) 1995 Academic Press, Inc.