title: Randomized phase II trial of weekly paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin for elderly patients with advanced non-small-cell lung cancer.
abstract: BACKGROUND
  The optimal platinum doublet regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. We conducted a randomized phase II study to compare the efficacy and safety of weekly paclitaxel combined with carboplatin with those of the standard schedule.
  
  
  METHODS
  Elderly patients (age > or =70 years) with advanced NSCLC were randomly assigned to either the weekly arm {70 mg/m(2) paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m(2) paclitaxel and carboplatin (AUC = 6) on day 1]. The primary end point was the overall response rate (ORR).
  
  
  RESULTS
  Eighty-two patients were enrolled. The ORR and median progression-free survival were 55% and 6.0 months for the weekly arm and 53% and 5.6 months for the standard arm. Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively.
  
  
  CONCLUSIONS
  This is the first randomized study that compares the platinum doublet designed specifically for the elderly. Regarding the safety, the weekly regimen was less toxic than the standard regimen and seems to be preferable for elderly patients with advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Tohoku University Hospital. Electronic address: sakatomo@idac.tohoku.ac.jp.
authors.forename: T
authors.initials: T
authors.lastname: Sakakibara
authors.affiliation: Department of Respiratory Medicine, Tohoku University Hospital.
authors.forename: A
authors.initials: A
authors.lastname: Inoue
authors.affiliation: Department of Respiratory Medicine, Sendai Kousei Hospital, Sendai.
authors.forename: S
authors.initials: S
authors.lastname: Sugawara
authors.affiliation: Department of Respiratory Medicine, Miyagi Cancer Center, Natori.
authors.forename: M
authors.initials: M
authors.lastname: Maemondo
authors.affiliation: Department of Respiratory Medicine, Fukushima Medical University Hospital, Fukushima.
authors.forename: T
authors.initials: T
authors.lastname: Ishida
authors.affiliation: Department of Respiratory Medicine, Kanto Medical Center NTT EC, Shinagawa-ku, Tokyo.
authors.forename: K
authors.initials: K
authors.lastname: Usui
authors.affiliation: Department of Respiratory Medicine, Tohoku Kouseinenkin Hospital, Sendai.
authors.forename: T
authors.initials: T
authors.lastname: Abe
authors.affiliation: Department of Respiratory Medicine, Senseki Hospital, Higashimatsushima, Yamoto.
authors.forename: M
authors.initials: M
authors.lastname: Kanbe
authors.affiliation: Department of Respiratory Medicine, Saka General Hospital, Shiogama.
authors.forename: H
authors.initials: H
authors.lastname: Watanabe
authors.affiliation: Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Saijo
authors.affiliation: Department of Respiratory Medicine, Tohoku University Hospital.
authors.forename: T
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D004304:Dosage Forms / Q000592:standards; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000592:standards; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D004304:Dosage Forms; D016190:Carboplatin; D017239:Paclitaxel