title: Phase I/II study of 3-week cycle cisplatin-gemcitabine in advanced non-small cell lung cancer.
abstract: BACKGROUND
  The combination of cisplatin and gemcitabine is one of the most active chemotherapy regimens against non-small cell lung cancer. However, the optimum schedule for this combination has not been determined. This study was performed to determine the maximum tolerated dose of gemcitabine combined with cisplatin in a 3-week cycle regimen and to observe safety and efficacy for Japanese patients with advanced non-small cell lung cancer.
  
  
  METHODS
  80 mg/m(2) of cisplatin on day 1 and escalated doses of gemcitabine on days 1 and 8 were administered every 3 weeks to patients with previously untreated, advanced non-small cell lung cancer. The initial dose of gemcitabine was 1000 mg/m(2) and was escalated in 250 mg/m(2) increments.
  
  
  RESULTS
  Twenty-four patients were enrolled between March and December 2000. In total, 64 courses were given. The main toxicities were neutropenia, thrombocytopenia and hepatotoxicity. The maximum tolerated dose was determined to be 1500 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin. Nine of 24 patients (37.5%) achieved a partial response.
  
  
  CONCLUSIONS
  This study demonstrates that the combination of cisplatin and gemcitabine repeated every three weeks is tolerable for Japanese patients with advanced non-small cell lung cancer. We determined 1250 mg/m(2) of gemcitabine combined with 80 mg/m(2 )of cisplatin to be the recommended dose.
authors.affiliation: Division of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kusaba
authors.forename: Tomohide
authors.initials: T
authors.lastname: Tamura
authors.forename: Tatsu
authors.initials: T
authors.lastname: Shimoyama
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nokihara
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ueda
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Akiyama
authors.forename: Noboru
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.forename: Hideo
authors.initials: H
authors.lastname: Kunitoh
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ohe
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kodama
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine