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

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

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
Volume5
Issue number9
DOIs
Publication statusPublished - Sep 2010

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docetaxel
Platinum
Non-Small Cell Lung Carcinoma
Lung Neoplasms
Drug Therapy
Disease-Free Survival
Survival
Neutropenia
Safety
Recurrence

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

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

In: Journal of Thoracic Oncology, Vol. 5, No. 9, 09.2010, p. 1430-1434.

Research output: Contribution to journalArticle

Segawa, Yoshihiko ; Kiura, Katsuyuki ; Hotta, Katsuyuki ; Takigawa, Nagio ; Tabata, Masahiro ; Matsuo, Keitaro ; Yoshioka, Hiroshige ; Hayashi, Hidetoshi ; Kawai, Haruyuki ; Aoe, Keisuke ; Maeda, Tadashi ; Ueoka, Hiroshi ; Tanimoto, Mitsune. / 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. In: Journal of Thoracic Oncology. 2010 ; Vol. 5, No. 9. pp. 1430-1434.
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abstract = "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.",
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AU - Segawa, Yoshihiko

AU - Kiura, Katsuyuki

AU - Hotta, Katsuyuki

AU - Takigawa, Nagio

AU - Tabata, Masahiro

AU - Matsuo, Keitaro

AU - Yoshioka, Hiroshige

AU - Hayashi, Hidetoshi

AU - Kawai, Haruyuki

AU - Aoe, Keisuke

AU - Maeda, Tadashi

AU - Ueoka, Hiroshi

AU - Tanimoto, Mitsune

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N2 - 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.

AB - 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.

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