Phase II study of vincristine, bleomycin, mitomycin C and cisplatin (VBMP) in disseminated squamous cell carcinoma of the uterine cervix.
The objective of this study was to study the antitumor activity of the vincristine, bleomycin, mitomycin C and cisplatin (VBMP) scheme in patients with disseminated squamous cell carcinoma of the uterine cervix and to document its toxicity. VBMP consisted of vincristine 1.4 mg/m2 (max. 2 mg) i.v. day 1, bleomycin 15 mg/day by continuous i.v. infusion on day 1 + 2, mitomycin C 6 mg/m2 i.v. day 3 and cisplatin 50 mg/m2 i.v. day 4, and was given every 4 weeks. Bleomycin was withdrawn from the schedule after a cumulative dose of 300 mg (210 mg in patients over 60). Thereafter VMP continued (V + M day 1, P day 2) with the same interval. A median number of 4.5 (range 2-13) treatment cycles was given to 50 fully evaluable patients, 26 with only distant metastases (group A) and 24 with pelvic disease also (23 previously irradiated) (group B). All patients were < 70 years old, had a Karnofsky index >/=60, and measurable metastatic lesions outside previously irradiated areas. They all had normal organ functions and gave informed consent. Response in group A was 54% (31% complete), in group B 25% (all partial), 40% in all. Median time to progression in group A was 20 weeks and in group B 15 weeks; median survival was 42 weeks in group A, 32 weeks in group B, 37 weeks for all patients. Hematologic toxicity was cumulative and the majority of patients needed blood transfusions. Nonhematologic toxicity was acceptable, but in one patient pulmonary toxicity might have contributed to death. Although it is active, it is unclear whether this regimen is superior to cisplatin alone.
Department of Medical Oncology, Academic Hospital of the Vrije Universiteit, Amsterdam, The Netherlands;Department of Gynecology, Ospedale San Gerardo, Monza, Italy;Department of Gynecology,Universita Di Brescia, Brescia, Italy;Department of Medical Oncology, University Hospital Rotterdam/Dijkzigt Hospital, Rotterdam, The Netherlands;Department of Medical Oncology, University Hospital, Leiden, The Netherlands;Antoni van Leeuwenhoekhuis, Amsterdam, The Netherlands; and EORTC Data Center, Brussels, Belgium.
J. B.
JB
Vermorken
C.
C
Mangioni
S.
S
Pecorelli
M. E. L.
ME
Van Der Burg
A. T.
AT
Van Oosterom
W. W.
WW
Ten Bokkel Huinink
N.
N
Rotmensz
O.
O
Dalesio