title: Phase I study of the combination of nedaplatin and gemcitabine in previously untreated advanced squamous cell lung cancer.
abstract: OBJECTIVE
  The objectives of this phase I trial were to evaluate the toxicity of the nedaplatin/gemcitabine regimen, determine the maximum tolerated doses (MTDs) of these agents, and observe the anti-tumor effects of this regimen on advanced squamous cell lung cancer.
  
  
  METHODS
  Patients with previously untreated advanced squamous cell lung cancer were eligible if they had a performance status of 0 or 1 with adequate organ function. The doses of gemcitabine (days 1 and 8) and nedaplatin (day 8) studied were 800/70, 1,000/80, 1,000/90, and 1,000/100 (mg/m(2)), repeated every 3 weeks.
  
  
  RESULTS
  Toxicity and response could be assessed in all 13 patients enrolled. The patients included 12 men and one woman with a median age of 69 years (range 57-81 years). Three patients had stage IIIB disease and 10 patients had stage IV disease. The MTDs were reached at 1,000 mg/m(2) gemcitabine and 80 mg/m(2) nedaplatin. The most frequent toxic effects were thrombocytopenia and neutropenia; grade 3 or 4 thrombocytopenia was observed in 23% of patients, and grade 3 or 4 neutropenia was seen in 46% of patients. Non-hematologic toxicities were mild. Grade 3 fatigue, nausea/vomiting, and appetite loss occurred in two patients. The overall response rate was 62%.
  
  
  CONCLUSIONS
  We recommend doses of 800 mg/m(2) gemcitabine and 70 mg/m(2) nedaplatin for phase II study. This combination chemotherapeutic regimen is active and well tolerated.
authors.affiliation: Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, 54 Syogoin-Kawaracho, Sakyo-ku, Kyoto 606-8507, Japan. masago@kuhp.kyoto-u.ac.jp
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Masago
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.forename: Young Hak
authors.initials: YH
authors.lastname: Kim
authors.forename: Yukimasa
authors.initials: Y
authors.lastname: Hatachi
authors.forename: Akiko
authors.initials: A
authors.lastname: Fukuhara
authors.forename: Kaoru
authors.initials: K
authors.lastname: Irisa
authors.forename: Hiroki
authors.initials: H
authors.lastname: Nagai
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Sakamori
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Togashi
authors.forename: Tadashi
authors.initials: T
authors.lastname: Mio
authors.forename: Michiaki
authors.initials: M
authors.lastname: Mishima
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D018307:Neoplasms, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage*; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D003841:Deoxycytidine; C053989:nedaplatin; D000093542:Gemcitabine