Annals of Oncology 12:967-974, 2001
© 2001 European Society for Medical Oncology
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Randomized phase III trial of bleomycin, vindesine, mitomycin-C, and cisplatin (BEMP) versus cisplatin (P) in disseminated squamous-cell carcinoma of the uterine cervix: An EORTC Gynecological Cancer Cooperative Group study
1Department of Oncology, Academic Hospital Vrije Universiteit present address. Department of Oncologiy, Uni Ziekenhuis Antwerpen Amsterdam, The Netherlands Edegem. Belgium
2Department Obstetricae Ginecologica. Ospedale S. Gerardo Monza, Italy
3Servicio de Ginecologia, Hospitals da Universidade de Coimbra Coimbra, Portugal
4Department of Medical Oncology. Erasmus Universiteit/Dijkzigt Hospital Rotterdam, The Netherlands
5Department Oncologia Medica, Hospital General de Asturia Oviedo. Spain
6EORTC Data Center Brussels, Belgtum
7Istituto Europeo di Oncologia Milan, Italy
J. B.Vermorken, MD, PhD Department of Oncology Universitair Ziekenhuis Antwerpen Wilrijkstraat 10 2650 Edegem Belgium
Purpose: Three previous mitomycin-cisplatin-based chemotherapy trials conducted within the EORTC Gynecological Cancer Cooperative Group (GCCG) in patients with disseminated squamous-cell carcinoma of the uterine cervix (SCCUC) suggested that with such regimens a higher overall response rate and a higher complete response rate could be obtained compaied to what might have been expected from cisplatin alone. In that respect the combination of bleomycin, vindesine (Eldesine®), mitomycin C and cisplatin (BEMP) was the most piomising. In the present study BEMP has been compared with the best single agent, cisplatin (P) in the expectation that improved response rates might translate into a better survival.
Patients and methods: Eligible patients were those with SCCUC and disseminated measurable disease outside previously irradiated areas, aged 
75 years, with a WHO performance status 2 and adequate bone marrow, renal, hepatic and pulmonary function, who gave consent according to regulations followed in individual institutions. Patients were randomized to BEMP: E 3 mg/m2 day I, P 50 mg/m2 day 1, B 15 mg (24-hour infusion) day 2–4 and M 8 mg/m2 (at alternate cycles), or P 50 mg/m2 The first four cycles were given every 3 weeks (induction phase). Subsequent cycles were given every four weeks (maintenance phase), during which B was deleted from BEMP (MEP). Patients failing on P could be treated with BEM. Of the 287 patients entered, 235 were eligible and 201 evaluable for response.
Results: BEMP induced a significantly higher response rate than P (42% vs. 25Percnt;, P = 0.006). There was no difference in complete response rate (11% vs. 7%). BEMP was significantly more toxic than P (± BEM). both with respect to hematologic and nonhematologic toxicities. After a median follow-up of 6.1 years, survival curves were not significantly different. Median progression-free survival and overall survival were 5.3 and 10.1 months with BEMP and 4.5 and 9.3 months with P (± BEM). respectively. In a multivariate analysis of prognostic factors for survival, a lower age (P = 0.003), a lower performance status (P = 0.0001) and a short (< 1 year) interval since diagnosis (P = 0.0152) were all associated with an increased risk of dying. For progression-free survival, lower age, prior radiotherapy. locoregional involvement and no prior surgery were associated with a high risk. Treatment with BEMP or P had no significant impact on survival, but for progression-free survival there was a trend in favor of BEMP (P = 0.0893). Adjusting for prognostic factors did not change the effect of treatment.
Conclusions: Combination chemotherapy with BEMP produces more toxicity and more responses compared with cisplatin alone in patients with disseminated SCCUC. but this does not translate into a better survival. Therefore, in the palliative setting single-agent cisplatin should remain the standard therapy for these patients.
cervix cancer, cisplatin combination chemotherapy, single-agent cisplatin
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