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

Makoto Maemondo, Akira Inoue, Shunichi Sugawara, Toshiyuki Harada, Yuji Minegishi, Kazuhiro Usui, Koji Miwa, Naoto Morikawa, Mariko Kambe, Kenji Ube, Kana Watanabe, Osamu Ishimoto, Tomohiro Sakakibara, Akihiko Gemma, Toshihiro Nukiwa

Research output: Contribution to journalArticlepeer-review

19 Citations (Scopus)

Abstract

Background. Standard first-line chemotherapy for elderly non-small cell lung cancer (NSCLC) patients has been monotherapywith 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) (CPregimen) or to single-agentdocetaxel (60mg/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 CParm were generally moderate.One treatment-related death was observed in the docetaxel arm. Conclusion. 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.

Original languageEnglish
Pages (from-to)352-353
Number of pages2
JournalOncologist
Volume19
Issue number4
DOIs
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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