title: Second-line oral chemotherapy (lomustine, cyclophosphamide, etoposide) versus intravenous therapy (cyclophosphamide, doxorubicin, and vincristine) in patients with relapsed small cell lung cancer: a randomized phase II study of GFPC 0501.
abstract: BACKGROUND
  No reference second-line treatment of small-cell lung cancer is available. The aim of the present phase II randomized trial (Groupe Français de Pneumo-Cancérologie 0501) was to compare, in patients with progressive small-cell lung cancer after first-line platinum-based chemotherapy, oral multidrug chemotherapy (lomustine, cyclophosphamide, etoposide) and intravenous therapy with cyclophosphamide, doxorubicin, and vincristine (CAV) in terms of efficacy and tolerance. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, response rate, and tolerance.
  
  
  METHODS
  The study randomized 131 patients (76.7% male; median age, 61 ± 8.1 years, 85.5% with a performance status of 0-1), 65 to oral therapy and 66 to the CAV arm. No statistically significant differences were found in the baseline patient characteristics.
  
  
  RESULTS
  The OS and PFS was 6.1 and 3 months for the oral arm and 5.8 and 3.1 months for the CAV arm, respectively. The control disease rate was 61.6% and 45.5% in oral and CAV arms, respectively. No unexpected adverse events occurred, and no statistically significant difference was found between the 2 arms in terms of toxicity (grade 4 hematologic adverse events in 32.3% and 31.8% of patients in the oral and CAV arms, respectively).
  
  
  CONCLUSIONS
  Compared with CAV, oral therapy in this setting appears as feasible as, but not superior to, the efficacy in the CAV arm.
authors.affiliation: Services de Pneumologie, Centre régional de lutte contre le cancer François Baclesse, Caen, France.
authors.forename: Radj
authors.initials: R
authors.lastname: Gervais
authors.affiliation: Services de Pneumologie, Centre Hospialier de Draguignan, Draguignan, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Caer
authors.affiliation: Services de Pneumologie, Centre Hospialier de Créteil, Créteil, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Monnet
authors.affiliation: Services de Pneumologie, Centre Hospialier de Villefranche, Villefranche, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Falchero
authors.affiliation: Services de Pneumologie, Centre Hospialier de Angers, Angers, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Baize
authors.affiliation: Services de Pneumologie, Centre Hospialier de Longjumeau, Longjumeau, France.
authors.forename: Gerard
authors.initials: G
authors.lastname: Olivero
authors.affiliation: Services de Pneumologie, Centre Hospialier de Gap, Gap, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Thomas
authors.affiliation: Services de Pneumologie, Centre Hospialier de Toulon, Toulon, France.
authors.forename: Henri
authors.initials: H
authors.lastname: Berard
authors.affiliation: Services de Pneumologie, Centre Hospialier de Mantes la Jolie, Mantes la Jolie, France.
authors.forename: Jean Bernard
authors.initials: JB
authors.lastname: Auliac
authors.affiliation: Services de Pneumologie, Centre Hospialier de Créteil, Créteil, France. Electronic address: christos.chouaid@chicreteil.fr.
authors.forename: Christos
authors.initials: C
authors.lastname: Chouaid
mesh_terms: D061605:Administration, Intravenous; D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D005047:Etoposide; D008130:Lomustine; D004317:Doxorubicin; D003520:Cyclophosphamide
keywords: Chemotherapy; Lung outcomes; Lung treatment; Recurrent disease