Annals of Oncology Advance Access published online on October 23, 2006
Annals of Oncology, doi:10.1093/annonc/mdl384
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1 EORTC Datacenter, Brussels, Belgium; Present address: Medical Center Haaglanden, Lijnbaan 32, 2512 VA Den Haag, The Netherlands
* To whom correspondence should be addressed. 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.
Received April 12, 2006
Revised August 12, 2006
Accepted September 11, 2006
original article
Phase II study of bleomycin, vindesine, mitomycin C and cisplatin (BEMP) in recurrent or disseminated squamous cell carcinoma of the uterine cervix
I. F. van Luijk 1, C. Coens 2, M. E. L. van der Burg 3, A. Kobierska 4, M. Namer 5, C. Lhomme 6, P. Zola 7, G. Zanetta 8, and J. B. Vermorken 9 *, For the Gynecological Cancer Group of the European Organization for Research and Treatment of Cancer
2 EORTC Datacenter, Brussels, Belgium
3 Erasmus MC, Rotterdam, The Netherlands
4 Medical University, Gdansk, Poland
5 Centre Antoine Laccasagne, Nice
6 Institut Gustave Roussy, Villejuif, France
7 Clinica Universita de Torino, Torino
8 Ospedale S. Gerardo, Monza, Italy
9 Department of Oncology, University Hospital Antwerp, Edegem, Belgium
J. B. Vermorken, E-mail: jan.b.vermorken{at}uza.be
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