title: Influence of altering administration sequence of docetaxel, gemcitabine and cisplatin in patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  A phase II study of a triplet chemotherapy with the administration sequence of gemcitabine (GEM), docetaxel (DCT) and cisplatin (CDDP) (OLCSG9908) was previously conducted in patients with advanced non-small cell lung cancer (NSCLC). The objective response rate was 34% and the median survival time (MST) and 1-year survival rate were 11.7 months and 49%, respectively. In an in vitro study of different sequence exposures to GEM and DCT, it was reported that the synergistic effect was more prominent using the administration sequence of DCT followed by GEM compared with the reverse sequence. In order to estimate the effects of the administration sequence, a phase II study of the same triplet chemotherapy was conducted with the administration sequence of DCT, CDDP and GEM.
  
  
  METHODS
  Patients with unresectable stage IIIB/IV NSCLC were eligible. All drugs were given intravenously on days 1 and 8, and repeated every 4 weeks for up to 4 cycles. DCT (30 mg/m2) was given first, followed by CDDP (40 mg/m2) and GEM (800 mg/m2).
  
  
  RESULTS
  Thirty-four patients were enrolled on this study (OLCSG0101). The objective response rate was 38% (95% CI: 22-56%). As grade 3/4 hematological toxicities, neutropenia, thrombocytopenia and anemia were observed in 70%, 41% and 21%, respectively, and febrile neutropenia was observed in 12%. As grade 3/4 non-hematological toxicities, vomiting and liver dysfunction were observed in 15% and 18%, respectively. These toxicities were manageable by conventional therapy. The MST and 1-year survival rate were 13.3 months (95% CI: 7.8-18.7 months) and 55% (95% CI: 38-73%), respectively. These results were similar to those of OLCSG9908.
  
  
  CONCLUSIONS
  This triplet chemotherapy is well tolerated and effective in patients with advanced NSCLC, however, the treatment outcome was not significantly influenced by the administration sequence of DCT and GEM.
authors.affiliation: Department of Internal Medicine, Chugoku Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuyama, Japan. harita-shingo@kouritu-cch.jp
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.forename: Youichi
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.forename: Shoichi
authors.initials: S
authors.lastname: Kuyama
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.forename: Haruhito
authors.initials: H
authors.lastname: Kamei
authors.forename: Atsuhiko
authors.initials: A
authors.lastname: Tada
authors.forename: Niro
authors.initials: N
authors.lastname: Okimoto
authors.forename: Kenichi
authors.initials: K
authors.lastname: Genba
authors.forename: Shinichi
authors.initials: S
authors.lastname: Tada
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.forename: Shunkichi
authors.initials: S
authors.lastname: Hiraki
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine