title: A randomized phase II study of a combination of docetaxel and S-1 versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy: results of Okayama Lung Cancer Study Group (OLCSG) Trial 0503.
abstract: BACKGROUND
  The survival impact of single-agent treatment with docetaxel, the standard regimen for relapsed patients with non-small cell lung cancer (NSCLC), remains modest. We conducted a randomized phase II study to evaluate the efficacy and safety of the combination of docetaxel and S-1 in the second-line setting.
  
  
  METHODS
  Patients with relapse of NSCLC after first-line platinum-based chemotherapy were randomly assigned to docetaxel alone (60 mg/m, day 1, q3 weeks; arm A) or a combination of docetaxel (40 mg/m, day 1, q3 weeks) and S-1 (80 mg/m, days 1-15; arm B). The primary end point was response rate, whereas secondary endpoints included overall survival, progression-free survival, and toxicity.
  
  
  RESULTS
  Between 2005 and 2008, a total of 60 patients were enrolled in the study. The objective response rates were 20.7% and 16.1% in arms A and B, respectively (p = 0.81). Progression-free survival was comparable in the two arms (median: 3.7 versus 3.4 months, p = 0.27), whereas overall survival time was longer in arm A (22.9 versus 8.7 months, p = 0.02). The major toxicity was myelosuppression with grade > or =3 neutropenia in 89.7% of patients versus 64.5% in arms A and B, respectively.
  
  
  CONCLUSIONS
  This study suggests that docetaxel monotherapy should continue to be considered the standard for second-line chemotherapy against NSCLC.
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Yamaguchi-Ube Medical Center, 685 Higashi-Kiwa, Ube, Yamaguchi, Japan. ysegawa1174@aol.com
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Segawa
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Keitaro
authors.initials: K
authors.lastname: Matsuo
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Hayashi
authors.forename: Haruyuki
authors.initials: H
authors.lastname: Kawai
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aoe
authors.forename: Tadashi
authors.initials: T
authors.lastname: Maeda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin