A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients

Satoshi Yoda, Kenzo Soejima, Hiroyuki Yasuda, Katsuhiko Naoki, Ichiro Kawada, Hideo Watanabe, Ichiro Nakachi, Ryosuke Satomi, Sohei Nakayama, Shinnosuke Ikemura, Hideki Terai, Takashi Sato, Maiko Morosawa, Koichiro Asano

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)717-722
Number of pages6
JournalCancer Chemotherapy and Pharmacology
Volume67
Issue number3
DOIs
Publication statusPublished - 2011 Mar

Fingerprint

irinotecan
Non-Small Cell Lung Carcinoma
Cells
Toxicity
Body Surface Area
Neutropenia
Therapeutics
Chemotherapy
Interstitial Lung Diseases
Leukopenia
S 1 (combination)
S Phase

Keywords

  • Irinotecan
  • Non-small cell lung cancer
  • Phase I trial
  • S-1
  • Second line

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

Cite this

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.

In: Cancer Chemotherapy and Pharmacology, Vol. 67, No. 3, 03.2011, p. 717-722.

Research output: Contribution to journalArticle

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. / A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients. In: Cancer Chemotherapy and Pharmacology. 2011 ; Vol. 67, No. 3. pp. 717-722.
@article{10d59188ff6446848d479b86b79b5ebe,
title = "A phase i study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients",
abstract = "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.",
keywords = "Irinotecan, Non-small cell lung cancer, Phase I trial, S-1, Second line",
author = "Satoshi Yoda and Kenzo Soejima and Hiroyuki Yasuda and Katsuhiko Naoki and Ichiro Kawada and Hideo Watanabe and Ichiro Nakachi and Ryosuke Satomi and Sohei Nakayama and Shinnosuke Ikemura and Hideki Terai and Takashi Sato and Maiko Morosawa and Koichiro Asano",
year = "2011",
month = "3",
doi = "10.1007/s00280-010-1539-y",
language = "English",
volume = "67",
pages = "717--722",
journal = "Cancer Chemotherapy and Pharmacology",
issn = "0344-5704",
publisher = "Springer Verlag",
number = "3",

}

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

VL - 67

SP - 717

EP - 722

JO - Cancer Chemotherapy and Pharmacology

JF - Cancer Chemotherapy and Pharmacology

SN - 0344-5704

IS - 3

ER -