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Phase 2 Study of Modified Irinotecan and Bolus 5-Fluorouracil/l-Leucovorin in Japanese Metastatic Colorectal Cancer Patients

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Abstract

Introduction

Using the recommended doses obtained from our previous phase 1 trial of a modified Saltz chemotherapy regimen for metastatic colorectal cancer (weekly irinotecan and bolus 5-fluorouracil/l-leucovorin for 3 weeks every 28 days), we performed the present phase 2 trial to evaluate efficacy and toxicity.

Methods

A total of 29 patients with metastatic colorectal cancer were included. Our modified Saltz regimen was administered. The primary endpoint was overall response rate.

Results

Of the 29 patients, 11 had previous chemotherapy. A partial response occurred in 11 patients, stable disease in 16 patients, and progressive disease in two patients. Disease control rate was 93.1%. Response rates with and without previous treatment were 18.2% and 50%, respectively. Median progression-free survival was 17.3 months. The main hematologic toxicities were leukopenia (22.6%) and neutropenia (45.2%). No treatment-related deaths occurred.

Conclusion

Our modified Saltz regimen exhibited sufficient efficacy, feasibility, and manageable toxicity as a therapeutic option for selected colorectal cancer patients.

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Authors and Affiliations

  1. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, 812-8582, Japan

    Eishi Baba, Keita Uchino, Hitoshi Kusaba, Shuji Nakano & Koichi Akashi

  2. Department of Digestive Disease and Oncology, Kagoshima Medical Center Hospital, Kagoshima, Japan

    Hiromitsu Fujishima

  3. Department of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan

    Akitaka Makiyama & Taito Esaki

  4. Department of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan

    Risa Tanaka & Kenji Mitsugi

Authors
  1. Eishi Baba
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  2. Hiromitsu Fujishima
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  3. Akitaka Makiyama
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  4. Keita Uchino
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  5. Risa Tanaka
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  6. Taito Esaki
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  7. Hitoshi Kusaba
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  8. Kenji Mitsugi
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  9. Shuji Nakano
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  10. Koichi Akashi
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Correspondence to Eishi Baba.

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Baba, E., Fujishima, H., Makiyama, A. et al. Phase 2 Study of Modified Irinotecan and Bolus 5-Fluorouracil/l-Leucovorin in Japanese Metastatic Colorectal Cancer Patients. Adv Therapy 29, 287–296 (2012). https://doi.org/10.1007/s12325-012-0002-3

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  • DOI: https://doi.org/10.1007/s12325-012-0002-3

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