Effective chemotherapy for advanced carcinoma of the cervix with bleomycin, cisplatin, vincristine, and methotrexate

Abstract

This study was designed as a Phase II clinical trial in advanced recurrent or metastatic squamous cell carcinoma of the cervix with a combination of bleomycin (B: 10 u/m²/d) and cisplatin (P: 20 mg/m²/d) administered for five consecutive days in intravenous infusion for 7 hours and vincristine (V: 1 mg/m²) and methotrexate (M: 40 mg/m²) administered only on day one of each cycle which was repeated every 28 days up to a maximum of 6 times. Over a period of 2 years, 15 evaluable patients with measurable disease received at least 3 courses of therapy. Six had recurrent disease and nine had distant metastases. All had previous radiation therapy. There were two dropouts after the first course due to nausea and vomiting which was practically universal. Other side effects included: mild paresthesias of the extremities (89%), stomatitis (41%), diarrhea (17%), moderate pancytopenia and hypomagnesemia which was reduced from 65% to 17% when magnesium sulfate 10% was administered with cisplatin. Sixty-six percent of the evaluable patients achieved remission (7 partial and 3 complete) usually before the fourth course of therapy. The disease-free interval was of 29.7 ± 15 weeks in all responders (40.6 ± 15.5 weeks in complete responders). The mean survival from the start of BPVM therapy was of 55.8 ± 33.3 weeks in responders and of only 14 ± 2.9 weeks in nonresponders (P < 0.01). It is concluded that BPVM is an effective combination chemotherapy in advanced squamous cell carcinoma of the cervix. These results should be confirmed in a Phase III trial. Cancer 52:2025-2030, 1983.