Annals of Oncology Advance Access originally published online on October 23, 2006
Annals of Oncology 2007 18(2):275-281; doi:10.1093/annonc/mdl384
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© 2006 European Society for Medical Oncology
gynecologic tumors |
Phase II study of bleomycin, vindesine, mitomycin C and cisplatin (BEMP) in recurrent or disseminated squamous cell carcinoma of the uterine cervix
1 EORTC Datacenter, Brussels, Belgium
2 Erasmus MC, Rotterdam, The Netherlands
3 Medical University, Gdansk, Poland
4 Centre Antoine Laccasagne, Nice
5 Institut Gustave Roussy, Villejuif, France
6 Clinica Universita de Torino, Torino
7 Ospedale S. Gerardo, Monza, Italy
8 Department of Oncology, University Hospital Antwerp, Edegem, Belgium
* Correspondence to: Prof J. B. Vermorken, Department of Oncology, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium. Tel: +32-3-8213954; Fax: +32-3-8250564; E-mail: jan.b.vermorken{at}uza.be
Objective: We carried out a phase II trial with BEMP [bleomycin, vindesine (Eldisine®), mitomycin C and cisplatin] in patients with recurrent and/or metastatic squamous cell carcinoma of the uterine cervix with the specific aim to assess whether BEMP was of particular interest when certain disease sites were involved.
Patients and methods: Eligible patients received four cycles of E 3 mg/m2, day 1 + 8; P 50 mg/m2, day 1; B 15 mg/day (continuous infusion), day 2–4 and M 8 mg/m2, day 5 (on alternate cycles), every 3 weeks during an induction phase. Thereafter, those without progression continued with MEP every 4 weeks in a maintenance phase. MEP consisted of E 3 mg/m2, day 1 + 8, M 6 mg/m2 (on alternate cycles) and P 50 mg/m2, both on day 1. All drugs were given i.v. Both response evaluation and toxicity grading were assessed according to World Health Organization criteria.
Results: Of the 161 eligible patients, 143 were assessable for survival, 148 for toxicity and 131 for response. Overall response rate was 45% [complete (CR) 14.5%, partial response (PR) 30.5%]. Most responsive disease sites were lung, lymph nodes and skin metastases (>60% response, CR rate >25%). Median duration of response was 7.6 months. Survival was significantly better in patients with only distant metastases: 12.9 months versus 8.6 months in those with other disease sites involved (P = 0.002). In a multivariate analysis, patients with a good performance status yielded a better prognosis (P = 0.0017), as did the patients with only metastatic disease compared with those who had pelvic disease also or solely (P = 0.045). There were two toxic deaths and 21% of patients stopped treatment because of excessive toxicity.
Conclusions: Patients with a good performance status and only distant metastases seem optimal candidates to receive the BEMP regimen. This benefit should be balanced against the expected serious toxic effects.
Key words: BEMP, cervical cancer, chemotherapy, metastatic, recurrent
Present address: Medical Center Haaglanden, Lijnbaan 32, 2512 VA Den Haag, The Netherlands Received for publication April 12, 2006. Revision received August 12, 2006. Accepted for publication September 11, 2006.
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