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 language | English |
|---|---|
| Pages (from-to) | 1430-1434 |
| Number of pages | 5 |
| Journal | Journal of Thoracic Oncology |
| Volume | 5 |
| Issue number | 9 |
| DOIs | |
| Publication status | Published - Sep 2010 |
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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 journal › Article
}
TY - JOUR
T1 - 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
T2 - Results of Okayama Lung Cancer Study Group (OLCSG) trial 0503
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
PY - 2010/9
Y1 - 2010/9
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.
KW - Docetaxel
KW - Non-small cell lung cancer
KW - S-1
KW - Second-line chemotherapy
UR - http://www.scopus.com/inward/record.url?scp=77956262817&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77956262817&partnerID=8YFLogxK
U2 - 10.1097/JTO.0b013e3181e3248e
DO - 10.1097/JTO.0b013e3181e3248e
M3 - Article
VL - 5
SP - 1430
EP - 1434
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
SN - 1556-0864
IS - 9
ER -