Combination chemotherapy of biweekly irinotecan (CPT-11) plus tegafur/uracil (UFT) and leucovorin (LV) for patients with metastatic colorectal cancer

Phase I/II study in Japanese patients

Koji Okabayashi, Hirotoshi Hasegawa, Yoshiyuki Ishii, Takashi Endo, Hiroki Ochiai, Tetsuro Kubota, Yuukou Kitagawa

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: We aimed to evaluate the safety and efficacy of combination chemotherapy with biweekly irinotecan (CPT-11) plus oral tegafur/uracil (UFT) and leucovorin (LV) in patients with previously untreated metastatic colorectal adenocarcinoma in phase I/II setting. Patients and methods: We recruited 37 patients with histologically proven metastatic colorectal adenocarcinoma. UFT (300 mg/m2 per day) and LV (75 mg/day) were administered orally on days 1-21. CPT-11 was administered intravenously on day 1 and 15, at an initial dose of 60 mg/m2, stepping up to 150 mg/m2 in a traditional phase I fashion. The treatment was repeated every 4 weeks. After patients enrolled into a phase II portion, the efficacy and toxicity of this regimen were also assessed. Results: The recommended dose of CPT-11 was determined to be 150 mg/m2. Although one patient had a pulmonary embolism after 60 mg/m2 of CPT-11, the treatment was well tolerated in general. The overall objective response rate was 37.8% (14/37; 95% CI, 22.5-55.2) in all patients. Median progression-free survival was 226 days (95% CI, 133-276). Conclusions: Biweekly CPT-11 plus UFT and LV had a reasonable safety profile with manageable toxicity, and had a promising activity in patients with metastatic colorectal cancer. Further trials are indicated based on the promising results observed in this study.

Original languageEnglish
Pages (from-to)501-507
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume63
Issue number3
DOIs
Publication statusPublished - 2009 Feb

Fingerprint

irinotecan
Tegafur
Chemotherapy
Uracil
Leucovorin
Combination Drug Therapy
Colorectal Neoplasms
Toxicity
Adenocarcinoma
Safety
Pulmonary Embolism
Disease-Free Survival

Keywords

  • Chemotherapy
  • Irinotecan
  • Leucovorin
  • Metastatic colorectal cancer
  • UFT

ASJC Scopus subject areas

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

Cite this

Combination chemotherapy of biweekly irinotecan (CPT-11) plus tegafur/uracil (UFT) and leucovorin (LV) for patients with metastatic colorectal cancer : Phase I/II study in Japanese patients. / Okabayashi, Koji; Hasegawa, Hirotoshi; Ishii, Yoshiyuki; Endo, Takashi; Ochiai, Hiroki; Kubota, Tetsuro; Kitagawa, Yuukou.

In: Cancer Chemotherapy and Pharmacology, Vol. 63, No. 3, 02.2009, p. 501-507.

Research output: Contribution to journalArticle

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title = "Combination chemotherapy of biweekly irinotecan (CPT-11) plus tegafur/uracil (UFT) and leucovorin (LV) for patients with metastatic colorectal cancer: Phase I/II study in Japanese patients",
abstract = "Purpose: We aimed to evaluate the safety and efficacy of combination chemotherapy with biweekly irinotecan (CPT-11) plus oral tegafur/uracil (UFT) and leucovorin (LV) in patients with previously untreated metastatic colorectal adenocarcinoma in phase I/II setting. Patients and methods: We recruited 37 patients with histologically proven metastatic colorectal adenocarcinoma. UFT (300 mg/m2 per day) and LV (75 mg/day) were administered orally on days 1-21. CPT-11 was administered intravenously on day 1 and 15, at an initial dose of 60 mg/m2, stepping up to 150 mg/m2 in a traditional phase I fashion. The treatment was repeated every 4 weeks. After patients enrolled into a phase II portion, the efficacy and toxicity of this regimen were also assessed. Results: The recommended dose of CPT-11 was determined to be 150 mg/m2. Although one patient had a pulmonary embolism after 60 mg/m2 of CPT-11, the treatment was well tolerated in general. The overall objective response rate was 37.8{\%} (14/37; 95{\%} CI, 22.5-55.2) in all patients. Median progression-free survival was 226 days (95{\%} CI, 133-276). Conclusions: Biweekly CPT-11 plus UFT and LV had a reasonable safety profile with manageable toxicity, and had a promising activity in patients with metastatic colorectal cancer. Further trials are indicated based on the promising results observed in this study.",
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AU - Okabayashi, Koji

AU - Hasegawa, Hirotoshi

AU - Ishii, Yoshiyuki

AU - Endo, Takashi

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AU - Kubota, Tetsuro

AU - Kitagawa, Yuukou

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