title: Phase II trial of temozolomide and cisplatin followed by whole brain radiotherapy in non-small-cell lung cancer patients with brain metastases: a GLOT-GFPC study.
abstract: BACKGROUND
  Brain metastases (BM) considerably worsen the prognosis of non-small-cell lung cancer (NSCLC) patients. The usefulness and choice of chemotherapy remain uncertain in this indication since these patients are excluded from most clinical trials. We conducted a phase II study to determine the efficacy and tolerability of up-front chemotherapy with association of temozolomide and cisplatin in NSCLC patients with BM.
  
  
  METHODS
  Fifty NSCLC patients with BM received temozolomide (200 mg/m(2)/day for 5 days every 28 days) and cisplatin (75 mg/m(2) at day 1 of each cycle), up to six cycles, followed by whole brain radiotherapy (WBRT). An evaluation was carried out every two cycles and after WBRT. WBRT was performed earlier in case of progressive disease at any time or stable disease after cycle 4.
  
  
  RESULTS
  Eight objective responses were achieved (16%). Overall median survival was 5 months. Median time to progression was 2.3 months. Ten patients (20%) presented a grade 3/4 neutropenia and 11 patients (22%) presented a grade 3/4 thrombopenia.
  
  
  CONCLUSIONS
  This study demonstrates a lack of efficacy of up-front chemotherapy with association of temozolomide and cisplatin in these patients. Nevertheless, it supports the feasibility of chemotherapy before brain radiotherapy in NSCLC patients with BM.
authors.affiliation: Service de Pneumologie, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
authors.forename: A B
authors.initials: AB
authors.lastname: Cortot
authors.forename: L
authors.initials: L
authors.lastname: Gerinière
authors.forename: G
authors.initials: G
authors.lastname: Robinet
authors.forename: J-L
authors.initials: JL
authors.lastname: Breton
authors.forename: R
authors.initials: R
authors.lastname: Corre
authors.forename: L
authors.initials: L
authors.lastname: Falchero
authors.forename: H
authors.initials: H
authors.lastname: Berard
authors.forename: C
authors.initials: C
authors.lastname: Gimenez
authors.forename: J-M
authors.initials: JM
authors.lastname: Chavaillon
authors.forename: M
authors.initials: M
authors.lastname: Perol
authors.forename: P
authors.initials: P
authors.lastname: Bombaron
authors.forename: C
authors.initials: C
authors.lastname: Mercier
authors.forename: P-J
authors.initials: PJ
authors.lastname: Souquet
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000532:radiotherapy* / Q000556:secondary*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000077204:Temozolomide; D016896:Treatment Outcome
chemical_list: D003606:Dacarbazine; D002945:Cisplatin; D000077204:Temozolomide