title: Quality-of-life evaluation for advanced non-small-cell lung cancer: a comparison between vinorelbine plus gemcitabine followed by docetaxel versus paclitaxel plus carboplatin regimens in a randomized trial: Japan Multinational Trial Organization LC00-03 (BRI LC03-01).
abstract: BACKGROUND
  A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) study initiated in the mid-course of this randomized trial.
  
  
  METHODS
  The patients themselves assessed the Functional Assessment of Cancer Therapy (FACT)-Lung (FACT-L), FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) QOL instruments at baseline and 6, 12 and 18 weeks after the treatment. The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups.
  
  
  RESULTS
  Sixty-eight patients from the trial (VGD, 34; PC, 34) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible. Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score (p = 0.004) between treatment regimens over time, but no difference was found in FACT-L score (p = 0.311) and FACIT-Sp score (p = 0.466) between the two groups.
  
  
  CONCLUSIONS
  The significant difference in slope of FACT-Taxane score favored the VGD regimen. These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer.
  
  
  BACKGROUND
  NCT00242983.
authors.affiliation: Otemae Hospital, 1-5-3 Otemae, Chuo-ku, Osaka, 540-0008, Japan. kawaharam@otemae.gr.jp
authors.forename: Masaaki
authors.initials: M
authors.lastname: Kawahara
authors.forename: Harue
authors.initials: H
authors.lastname: Tada
authors.forename: Akihiro
authors.initials: A
authors.lastname: Tokoro
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Hideki
authors.initials: H
authors.lastname: Origasa
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.forename: Tetsu
authors.initials: T
authors.lastname: Shinkai
authors.forename: Masanori
authors.initials: M
authors.lastname: Fukushima
authors.forename: Kiyoyuki
authors.initials: K
authors.lastname: Furuse
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D012647:Self-Assessment; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000008:administration & dosage; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine