title: Randomized phase II study of two schedules of carboplatin and gemcitabine for stage IIIB and IV advanced non-small cell lung cancer (JACCRO LC-01 study).
abstract: BACKGROUND
  Gemcitabine combined with carboplatin (CG) is one of the regimens used widely for advanced non-small cell lung cancer. Improvement in its toxicity may result in good clinical outcomes.
  
  
  METHODS
  A new schedule of gemcitabine and carboplatin (CG8) was compared with the standard one (CG1). Both are 3-weekly regimens, but carboplatin is administered on day 1 in CG1 and on day 8 in CG8.
  
  
  RESULTS
  The response rate of CG1 was 29.2%, which was higher than that of CG8 (22.2%). Median survival times in CG1 and CG8 were 348 and 455.5 days, respectively. Grade ≥3 leukopenia, thrombocytopenia and anemia were observed in 56.0, 72.0 and 36.0% of patients with CG1 and in 33.3, 25.9 and 14.8% of patients with CG8, respectively. Whereas grade ≥3 elevation of asparatate aminotransferase, alanine aminotransferase and alkaline phosphatase was seen mainly in CG8, grade ≥3 non-hematologic toxicities such as febrile neutropenia, infection, appetite loss, diarrhea and eruption were observed only in CG1.
  
  
  CONCLUSIONS
  CG1 is superior in response rate, but CG8 shows improved toxicities and a tendency of prolonged survival.
authors.affiliation: Department of Thoracic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan. imamura-fu @ mc.pref.osaka.jp
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishio
authors.forename: Rintaro
authors.initials: R
authors.lastname: Noro
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuboi
authors.forename: Norihiko
authors.initials: N
authors.lastname: Ikeda
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Ohsaki
authors.forename: Yukio
authors.initials: Y
authors.lastname: Kimura
authors.forename: Kazumi
authors.initials: K
authors.lastname: Nishino
authors.forename: Junji
authors.initials: J
authors.lastname: Uchida
authors.forename: Takeshi
authors.initials: T
authors.lastname: Horai
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols; D001219:Aspartate Aminotransferases / Q000097:blood; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D000093542:Gemcitabine