title: Randomized phase II trial comparing carboplatin plus weekly paclitaxel and docetaxel alone in elderly patients with advanced non-small cell lung cancer: north japan lung cancer group trial 0801.
abstract: BACKGROUND
  Standard first-line chemotherapy for elderly non-small cell lung cancer (NSCLC) patients has been monotherapy with vinorelbine or gemcitabine. Docetaxel has also been considered as an alternative option for the elderly population in Japan. We have previously demonstrated the high efficacy of carboplatin plus weekly paclitaxel for elderly NSCLC patients. Consequently, we conducted a randomized phase II study to select the proper regimen for a future phase III trial.
  
  
  METHODS
  Eligible patients were aged 70 years or older with newly diagnosed advanced NSCLC. Patients were randomly assigned either to a combination of carboplatin (area under the curve: 6 mg/mL per minute) with weekly paclitaxel (70 mg/m²) (CP regimen) or to single-agent docetaxel (60 mg/m²). The primary endpoint of this study was objective response rate. Secondary endpoints were progression-free survival, overall survival, and toxicity profile.
  
  
  RESULTS
  Among 83 eligible patients (41 to CP, 42 to docetaxel), the objective response rates were 54% (95% confidence interval: 39%-69%) and 24% (95% confidence interval: 11%-37%) and median progression-free survival was 6.6 months and 3.5 months in the CP arm and the docetaxel arm, respectively. Severe neutropenia, febrile neutropenia, and nausea were significantly frequent in the docetaxel arm, whereas toxicities in the CP arm were generally moderate. One treatment-related death was observed in the docetaxel arm.
  
  
  CONCLUSIONS
  The CP regimen achieved higher activity with less toxicity than single-agent docetaxel. Considering the results of this phase II trial and the IFCT-0501 trial, we have selected the CP regimen for a future phase III trial in elderly patients with advanced NSCLC.
authors.affiliation: Miyagi Cancer Center, Natori, Japan;
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sugawara
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Harada
authors.forename: Yuji
authors.initials: Y
authors.lastname: Minegishi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Usui
authors.forename: Koji
authors.initials: K
authors.lastname: Miwa
authors.forename: Naoto
authors.initials: N
authors.lastname: Morikawa
authors.forename: Mariko
authors.initials: M
authors.lastname: Kambe
authors.forename: Kenji
authors.initials: K
authors.lastname: Ube
authors.forename: Kana
authors.initials: K
authors.lastname: Watanabe
authors.forename: Osamu
authors.initials: O
authors.lastname: Ishimoto
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Sakakibara
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D006801:Humans; D007564:Japan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel