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Cancer Chemotherapy and Pharmacology

Erschienen in:

01.10.2010 | Clinical Trial Report

A phase II study of combination therapy with irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer

verfasst von: Manabu Shiozawa, Makoto Akaike, Nobuhiro Sugano, Kazuhito Tsuchida, Naoto Yamamoto, Soichiro Morinaga

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 5/2010

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Abstract

Purpose

A combination of irinotecan with continuous infusional 5-fluorouracil (5-FU) is the standard treatment for advanced colorectal cancer. The aim of this study was to determine the efficacy and safety of combining irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer.

Methods

Irinotecan was administered as an intravenous infusion at a dose of 120 mg/m² on day 1 and 15. And S-1 was administered orally on days 1–14 of a 28-day cycle. S-1 was given orally at a dose that did not exceed 40 mg/m² based BSA: BSA < 1.25 m², 40 mg twice daily; 1.25–1.5 m², 50 mg twice daily, and BSA > 1.5 m², 60 mg twice daily, for 14 consecutive days.

Results

A total of 38 patients were enrolled. An intent-to-treat analysis showed a complete response and partial response to occur in 13.2% and 50.0%, respectively. The disease control rate was 84.2%. The median progression-free survival and overall survival were 10.0 months and 29.1 months, respectively. The rates of grade 3/4 toxicity over 4 cycles were the following: neutropenia, 15.8%; leucopenia, 7.9%; anorexia, 15.8%; diarrhea, 10.5%. Conclusion: IRIS is an effective, well tolerated and convenient treatment regimen for patients with advanced colorectal cancer.

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Titel: A phase II study of combination therapy with irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer
verfasst von: Manabu Shiozawa
Makoto Akaike
Nobuhiro Sugano
Kazuhito Tsuchida
Naoto Yamamoto
Soichiro Morinaga
Publikationsdatum: 01.10.2010
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 5/2010
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-010-1278-0

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A phase II study of combination therapy with irinotecan and S-1 (IRIS) in patients with advanced colorectal cancer