title: Randomised multicenter phase II study of two schedules of docetaxel and gemcitabine or cisplatin/gemcitabine followed by docetaxel as first line treatment for advanced non-small cell lung cancer.
abstract: BACKGROUND
  In the attempt to optimize the efficacy of chemotherapy in advanced non-small cell lung cancer (NSCLC) several strategies need to be investigated including the use of non-platinum combinations and the sequential use of different agents.
  
  
  METHODS
  In a phase II randomised study 165 patients with stage IIIB or IV NSCLC were assigned to receive docetaxel 40 mg/m(2) days 1 and 8 plus gemcitabine 1200 mg/m(2) days 1 and 8 every 21 days (arm A, N=54) or docetaxel 50 mg/m(2) days 1 and 15 plus gemcitabine 1600 mg/m(2) days 1 and 15 every 28 days (arm B, N=57) or gemcitabine 1200 mg/m(2) days 1 and 8 plus cisplatin 100mg/m(2) day 2 every 21 days for 3 cycles followed by docetaxel 75 mg/m(2) day 1 every 21 days for 3 cycles (arm C, N=54). The primary endpoint of the trial was overall response rate. Secondary end points included safety, progression-free and overall survival.
  
  
  RESULTS
  Response rate was 22.2%, 23.2% and 33.3% after 3 cycles, whereas at the end of treatment was 24.1%, 12.5% and 27.8% in arm A-C, respectively. Median time to progression was similar in all the 3 arms: 6.7 months in arm A (95% CI: 4.8-9.7), 5.6 in arm B (5.0-7.9) and 6.6 in arm C (5.7-9.1). The median survival time was 10.7 months in arm A (95% CI: 6.8-15.6), 8.9 in arm B (7.4-12.5) and 14.6 in arm C (8.0-22.4) and 1-year survival rate was 46.3%, 37.9% and 53.9%, respectively. Grade 3-4 haematological toxicities were more frequent in arm C while non-haematological were more common in the gemcitabine and docetaxel arms.
  
  
  CONCLUSIONS
  The results of this phase II randomised clinical trial do not indicate a clear superior efficacy of one of the tested combinations according to the planned statistical design and none of these regimens is sufficiently active or less toxic to warrant further investigation in a phase III study.
authors.affiliation: Department of Clinical & Biological Sciences, Thoracic Oncology Unit, University of Turin, Italy. silvia.novello@unito.it
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
authors.forename: Alfredo
authors.initials: A
authors.lastname: Falcone
authors.forename: Lucio
authors.initials: L
authors.lastname: Crinò
authors.forename: Massimo
authors.initials: M
authors.lastname: Rinaldi
authors.forename: Mario
authors.initials: M
authors.lastname: Nardi
authors.forename: Filippo
authors.initials: F
authors.lastname: De Marinis
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tonato
authors.forename: Carmelo
authors.initials: C
authors.lastname: Tibaldi
authors.forename: Angelo
authors.initials: A
authors.lastname: Tinazzi
authors.forename: Francesca
authors.initials: F
authors.lastname: Russo
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Grassivaro
authors.forename: Giorgio Vittorio
authors.initials: GV
authors.lastname: Scagliotti