title: Phase II study of bleomycin, vindesine, mitomycin C and cisplatin (BEMP) in recurrent or disseminated squamous cell carcinoma of the uterine cervix.
abstract: OBJECTIVE
  We carried out a phase II trial with BEMP [bleomycin, vindesine (Eldisine(R)), 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.
  
  
  METHODS
  Eligible patients received four cycles of E 3 mg/m(2), day 1 + 8; P 50 mg/m(2), day 1; B 15 mg/day (continuous infusion), day 2-4 and M 8 mg/m(2), 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/m(2), day 1 + 8, M 6 mg/m(2) (on alternate cycles) and P 50 mg/m(2), 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.
authors.affiliation: EORTC Datacenter, Brussels, Belgium.
authors.forename: I F
authors.initials: IF
authors.lastname: van Luijk
authors.forename: C
authors.initials: C
authors.lastname: Coens
authors.forename: M E L
authors.initials: ME
authors.lastname: van der Burg
authors.forename: A
authors.initials: A
authors.lastname: Kobierska
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: C
authors.initials: C
authors.lastname: Lhomme
authors.forename: P
authors.initials: P
authors.lastname: Zola
authors.forename: G
authors.initials: G
authors.lastname: Zanetta
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D016685:Mitomycin / Q000627:therapeutic use; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D015996:Survival Rate; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014751:Vindesine / Q000627:therapeutic use
chemical_list: D001761:Bleomycin; D016685:Mitomycin; D002945:Cisplatin; D014751:Vindesine