A randomized phase II study of a combination of docetaxel and s-1 versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy: Results of Okayama Lung Cancer Study Group (OLCSG) trial 0503

Yoshihiko Segawa, Katsuyuki Kiura, Katsuyuki Hotta, Nagio Takigawa, Masahiro Tabata, Keitaro Matsuo, Hiroshige Yoshioka, Hidetoshi Hayashi, Haruyuki Kawai, Keisuke Aoe, Tadashi Maeda, Hiroshi Ueoka, Mitsune Tanimoto

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Background: The survival impact of single-agent treatment with docetaxel, the standard regimen for relapsed patients with non-small cell lung cancer (NSCLC), remains modest. We conducted a randomized phase II study to evaluate the efficacy and safety of the combination of docetaxel and S-1 in the second-line setting. Methods: Patients with relapse of NSCLC after first-line platinum-based chemotherapy were randomly assigned to docetaxel alone (60 mg/m2, day 1, q3 weeks; arm A) or a combination of docetaxel (40 mg/m2, day 1, q3 weeks) and S-1 (80 mg/m2, days 1-15; arm B). The primary end point was response rate, whereas secondary endpoints included overall survival, progression-free survival, and toxicity. Results: Between 2005 and 2008, a total of 60 patients were enrolled in the study. The objective response rates were 20.7% and 16.1% in arms A and B, respectively (p = 0.81). Progression-free survival was comparable in the two arms (median: 3.7 versus 3.4 months, p = 0.27), whereas overall survival time was longer in arm A (22.9 versus 8.7 months, p = 0.02). The major toxicity was myelosuppression with grade ≥3 neutropenia in 89.7% of patients versus 64.5% in arms A and B, respectively. Conclusions: This study suggests that docetaxel monotherapy should continue to be considered the standard for second-line chemotherapy against NSCLC.

Original languageEnglish
Pages (from-to)1430-1434
Number of pages5
JournalJournal of Thoracic Oncology
Issue number9
Publication statusPublished - Sep 2010



  • Docetaxel
  • Non-small cell lung cancer
  • S-1
  • Second-line chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

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