title: Phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer.
abstract: BACKGROUND
  To date, no phase II trial of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) has been published. The safety and efficacy of the combination of nedaplatin and weekly paclitaxel in patients with NSCLC was examined.
  
  
  METHODS
  Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0 to 2, were 75 years or younger and had adequate organ function. Patients were treated with nedaplatin (80 mg/m(2) on day 1) and weekly paclitaxel (90 mg/m(2) on days 1, 8 and 15).
  
  
  RESULTS
  From March 2005 through March 2008, 47 patients (31 men and 16 women; median age, 66 years; age range, 38 to 75 years) were enrolled. The overall response rate was 53.2% (95% confidence interval, 38.1% to 67.9%). The median survival time was 13 months (range, 1 to 36 months), the 1-year survival rate was 62% and the median time to disease progression was 5 months (range, 1 to 19 months). Grade 3 to 4 hematologic toxicities included neutropenia in 38.3% of patients, thrombocytopenia in 2.1% and anemia in 23.4% . Although frequent non-hematologic toxicities were nausea, hepatic dysfunction and peripheral neuropathy, all cases were of only mild to moderate severity. Although 1 patient had grade 3 pulmonary toxicity due to drug-induced pneumonia, this patient recovered after receiving steroid therapy.
  
  
  CONCLUSIONS
  This combination chemotherapy is effective and well tolerated and is an acceptable therapeutic option for patients with untreated advanced NSCLC.
authors.affiliation: Division of Respiratory and Allergy, Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan. thirose-shw@umin.ac.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Hirose
authors.forename: Tomohide
authors.initials: T
authors.lastname: Sugiyama
authors.forename: Sojiro
authors.initials: S
authors.lastname: Kusumoto
authors.forename: Takao
authors.initials: T
authors.lastname: Shirai
authors.forename: Masanao
authors.initials: M
authors.lastname: Nakashima
authors.forename: Toshimitsu
authors.initials: T
authors.lastname: Yamaoka
authors.forename: Kentaro
authors.initials: K
authors.lastname: Okuda
authors.forename: Keiichi
authors.initials: K
authors.lastname: Ogura
authors.forename: Tsukasa
authors.initials: T
authors.lastname: Ohnishi
authors.forename: Tohru
authors.initials: T
authors.lastname: Ohmori
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Adachi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage
chemical_list: D009944:Organoplatinum Compounds; C053989:nedaplatin; D017239:Paclitaxel