title: Randomized phase II trial comparing nitroglycerin plus vinorelbine and cisplatin with vinorelbine and cisplatin alone in previously untreated stage IIIB/IV non-small-cell lung cancer.
abstract: OBJECTIVE
  To investigate the efficacy and safety of nitroglycerin plus vinorelbine and cisplatin in patients with previously untreated stage IIIB/IV non-small-cell lung cancer (NSCLC) as the experimental arm for the next phase III trial.
  
  
  METHODS
  One hundred twenty patients with stage IIIB/IV NSCLC were randomly assigned to vinorelbine 25 mg/m2 on days 1 and 8 and cisplatin 80 mg/m2 on day 1, with transdermally applied nitroglycerin (25 mg/patient daily for 5 days; arm A) or with placebo patch (arm B) every 3 weeks for a maximum of four cycles in a double-blind and controlled trial. Primary efficacy end points were the best confirmed response rate and time to disease progression (TTP).
  
  
  RESULTS
  The response rate in arm A (72%; 43 of 60 patients) was significantly higher than that for patients in arm B (42%; 25 of 60 patients; P < .001). Median TTP in arm A was longer than that in arm B (327 v 185 days). No severe adverse effect was recognized for either arm. The rate of grade 1 to 2 headache in arm A (30%; 18 of 60 patients) was significantly higher than that in arm B (2%; one of 60 patients; P < .001, chi(2) test).
  
  
  CONCLUSIONS
  Use of nitroglycerin combined with vinorelbine and cisplatin may improve overall response and TTP in patients with stage IIIB/IV NSCLC. The arm A regimen is being evaluated in a large phase III trial.
authors.affiliation: Department of Geriatric and Respiratory Medicine, Tohoku University School of Medicine, Seiryo-machi, Aoba-ku, Sendai, Japan. yasuda@geriat.med.tohoku.ac.jp
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Yasuda
authors.forename: Mutsuo
authors.initials: M
authors.lastname: Yamaya
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Nakayama
authors.forename: Takahiko
authors.initials: T
authors.lastname: Sasaki
authors.forename: Satoru
authors.initials: S
authors.lastname: Ebihara
authors.forename: Akio
authors.initials: A
authors.lastname: Kanda
authors.forename: Masanori
authors.initials: M
authors.lastname: Asada
authors.forename: Daisuke
authors.initials: D
authors.lastname: Inoue
authors.forename: Tomoko
authors.initials: T
authors.lastname: Suzuki
authors.forename: Tatsuma
authors.initials: T
authors.lastname: Okazaki
authors.forename: Hidenori
authors.initials: H
authors.lastname: Takahashi
authors.forename: Motoki
authors.initials: M
authors.lastname: Yoshida
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Kaneta
authors.forename: Kota
authors.initials: K
authors.lastname: Ishizawa
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Yamanda
authors.forename: Naoki
authors.initials: N
authors.lastname: Tomita
authors.forename: Miyako
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Akiko
authors.initials: A
authors.lastname: Kikuchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kubo
authors.forename: Hidetada
authors.initials: H
authors.lastname: Sasaki
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D005996:Nitroglycerin / Q000008:administration & dosage; D016019:Survival Analysis; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000097:blood; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D042461:Vascular Endothelial Growth Factor A; D014747:Vinblastine; D005996:Nitroglycerin; D002945:Cisplatin; D000077235:Vinorelbine