抄録
Background: This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment. Methods: Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade ≥3 neutropenia with fever over 38°C, grade ≥3 thrombocytopenia, or grade ≥3 major nonhematological toxicities. Results: Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose. Conclusion: The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m 2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
| 元の言語 | English |
|---|---|
| ページ（範囲） | 717-722 |
| ページ数 | 6 |
| ジャーナル | Cancer Chemotherapy and Pharmacology |
| 巻 | 67 |
| 発行部数 | 3 |
| DOI | |
| 出版物ステータス | Published - 2011 3 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
- Pharmacology
- Pharmacology (medical)
- Toxicology
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A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients. / Yoda, Satoshi; Soejima, Kenzo; Yasuda, Hiroyuki; Naoki, Katsuhiko; Kawada, Ichiro; Watanabe, Hideo; Nakachi, Ichiro; Satomi, Ryosuke; Nakayama, Sohei; Ikemura, Shinnosuke; Terai, Hideki; Sato, Takashi; Morosawa, Maiko; Asano, Koichiro.
：: Cancer Chemotherapy and Pharmacology, 巻 67, 番号 3, 03.2011, p. 717-722.研究成果: Article
}
TY - JOUR
T1 - A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients
AU - Yoda, Satoshi
AU - Soejima, Kenzo
AU - Yasuda, Hiroyuki
AU - Naoki, Katsuhiko
AU - Kawada, Ichiro
AU - Watanabe, Hideo
AU - Nakachi, Ichiro
AU - Satomi, Ryosuke
AU - Nakayama, Sohei
AU - Ikemura, Shinnosuke
AU - Terai, Hideki
AU - Sato, Takashi
AU - Morosawa, Maiko
AU - Asano, Koichiro
PY - 2011/3
Y1 - 2011/3
N2 - Background: This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment. Methods: Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade ≥3 neutropenia with fever over 38°C, grade ≥3 thrombocytopenia, or grade ≥3 major nonhematological toxicities. Results: Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose. Conclusion: The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m 2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
AB - Background: This phase I study was conducted to evaluate the feasibility and to determine the recommended doses of the combination therapy of S-1 and irinotecan (CPT-11) in patients with advanced non-small cell lung cancer (NSCLC) as second-line treatment. Methods: Patients with NSCLC who were previously treated with one chemotherapy regimen and had a performance status of 0 or 1 were eligible. CPT-11 was administered at 60 mg/m2 (level 1), 80 mg/m2 (level 2) on days 1 and 8, and oral S-1 was administered at 80 mg/day for body surface area (BSA) less than 1.25 m2, 100 mg/day for BSA 1.25-1.5 m2, and 120 mg/day for BSA more than 1.5 m2 on days 1-14 every 3 weeks. The dose-limiting toxicity (DLT) was defined as grade 4 leukocytopenia or neutropenia, grade ≥3 neutropenia with fever over 38°C, grade ≥3 thrombocytopenia, or grade ≥3 major nonhematological toxicities. Results: Nine patients were enrolled in the study. None of 3 patients enrolled in level 1 had any DLT. Of 6 patients in level 2, 2 patients had grade 3 diarrhea and one had grade 3 interstitial pneumonia. Level 1 was declared as the recommended dose. Conclusion: The feasibility of the combination therapy of S-1 and CPT-11 was shown in the second-line setting for the treatment of advanced NSCLC. The recommended dose of CPT-11 was 60 mg/m 2 combined with standard dose of S-1 for phase II trials of pretreated advanced NSCLC patients.
KW - Irinotecan
KW - Non-small cell lung cancer
KW - Phase I trial
KW - S-1
KW - Second line
UR - http://www.scopus.com/inward/record.url?scp=79953784420&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79953784420&partnerID=8YFLogxK
U2 - 10.1007/s00280-010-1539-y
DO - 10.1007/s00280-010-1539-y
M3 - Article
C2 - 21152917
AN - SCOPUS:79953784420
VL - 67
SP - 717
EP - 722
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 3
ER -