LONG-TERM FOLLOW-UP OF A PHASE-III INTERGROUP STUDY OF CISPLATIN ALONE OR IN COMBINATION WITH METHOTREXATE, VINBLASTINE, AND DOXORUBICIN INPATIENTS WITH METASTATIC UROTHELIAL CARCINOMA - A COOPERATIVE GROUP-STUDY
Sb. Saxman et al., LONG-TERM FOLLOW-UP OF A PHASE-III INTERGROUP STUDY OF CISPLATIN ALONE OR IN COMBINATION WITH METHOTREXATE, VINBLASTINE, AND DOXORUBICIN INPATIENTS WITH METASTATIC UROTHELIAL CARCINOMA - A COOPERATIVE GROUP-STUDY, Journal of clinical oncology, 15(7), 1997, pp. 2564-2569
Purpose: A previously reported randomized intergroup trial demonstrate
d that combination chemotherapy with methotrexate, vinblastine, doxoru
bicin, and cisplatin (M-VAC) was superior to single-agent cisplatin in
patients with advanced urothelial carcinoma, We conducted a long-term
analysis of patients included in the intergroup trial to examine fact
ors associated with long-term survival, Patients and Methods: Two-hund
red fifty-five assessable patients with urothelial carcinoma were rand
omized to receive either single-agent cisplatin (70 mg/m(2) on day 1)
or combination chemotherapy with methotrexate (30 mg/m(2) on days 1, 1
5, and 22), vinblastine (3 mg/m(2) on days 2, 15, and 22), doxorubicin
(30 mg/m(2) on day 2), and cisplatin (70 mg/m(2) on day 2), Courses w
ere repeated every 28 days, The association between patient characteri
stics and survival was assessed using Cox proportional hazards models.
Results: With long-term follow-up evaluation, survival in the M-VAC a
rm continues to be superior to cisplatin (P = .00015, log-rank test),
Predictors of survival include performance status, histology, and the
presence of liver or bone metastasis. Only 3.7% of the patients random
ized to M-VAC are alive and continuously disease-free at 6 years, Conc
lusion: Long-term follow-up evaluation of the intergroup trial confirm
s that M-VAC is superior to single-agent cisplatin in patients with ad
vanced urothelial carcinoma; however, durable progression-free surviva
l is rare. Patients with non-transitional-cell histology, poor perform
ance status, and/or bone or visceral involvement fare poorly and are u
nlikely to benefit significantly from M-VAC chemotherapy. (C) 1997 by
American Society of Clinical Oncology.