title: Clinical benefit for patients with non-small cell lung cancer enrolled in phase I trials.
abstract: OBJECTIVE
  To analyze the clinical features and outcomes of advanced non-small cell lung cancer (NSCLC) patients treated in phase I trials.
  
  
  METHODS
  The clinical characteristics, efficacy and toxicity data of 70 pretreated NSCLC patients enrolled in 17 phase I trials between January 2005 and June 2010 were analyzed at our institution.
  
  
  RESULTS
  The histological types were: adenocarcinoma (79%), squamous cell carcinoma (13%), and others. Patients received a median number of 3 prior lines of treatment before inclusion. 1 complete response (CR), 11 (16%) partial responses (PRs), and 29 (41%) stable diseases (SDs) were observed (according to Response Evaluation Criteria in Solid Tumors (RECIST)). The median overall survival (OS) time was 18 months and the median progression-free survival (PFS) time was 4.1 months. The median PFS of these patients within their prior therapy line before phase I inclusion was 4.3 months. A performance status score of 0 and the number of prior lines of treatment were significant for OS and PFS in multivariate analysis, respectively. Grade 3/4 toxicities were observed in 20 (27%) patients, and there was 1 treatment-related death.
  
  
  CONCLUSIONS
  Patients in good general condition and with limited pretreatment derived an improved benefit, suggesting that phase I studies may be a valid option for pretreated NSCLC patients.
authors.affiliation: SITEP (Service des Innovations Therapeutiques Precoces), Department of Medicine, Institut Gustave Roussy, Paris XI University, Villejuif, France.
authors.forename: Antonin
authors.initials: A
authors.lastname: Levy
authors.forename: Carlos
authors.initials: C
authors.lastname: Gomez-Roca
authors.forename: Christophe
authors.initials: C
authors.lastname: Massard
authors.forename: David
authors.initials: D
authors.lastname: Planchard
authors.forename: Laurence
authors.initials: L
authors.lastname: Albiges
authors.forename: Ratislav
authors.initials: R
authors.lastname: Bahleda
authors.forename: Céline
authors.initials: C
authors.lastname: Bourgier
authors.forename: Eric
authors.initials: E
authors.lastname: Deutsch
authors.forename: Jean Charles
authors.initials: JC
authors.lastname: Soria
authors.forename: Benjamin
authors.initials: B
authors.lastname: Besse
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality*; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000401:mortality*; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents