Study protocol of the B-CAST study: A multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

Megumi Ishiguro, Kenjiro Kotake, Genichi Nishimura, Naohiro Tomita, Wataru Ichikawa, Keiichi Takahashi, Toshiaki Watanabe, Tomohisa Furuhata, Ken Kondo, Masaki Mori, Yoshihiro Kakeji, Akiyoshi Kanazawa, Michiya Kobayashi, Masazumi Okajima, Ichinosuke Hyodo, Keiko Miyakoda, Kenichi Sugihara

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Abstract

Background: Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. Methods/design: The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients' clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. Discussion: A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results of the study will identify the predictors of benefit from each 5-FU derivative, and will contribute to establish the "personalized therapy" in adjuvant chemotherapy for colon cancer. Trial registration: ClinicalTrials.gov: NCT00918827, UMIN Clinical Trials Registry (UMIN-CTR) UMIN000002013.

Original languageEnglish
Article number149
JournalBMC Cancer
Volume13
DOIs
Publication statusPublished - Mar 25 2013

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Adjuvant Chemotherapy
Tumor Biomarkers
Fluorouracil
Colonic Neoplasms
Multicenter Studies
Cohort Studies
Prospective Studies
Dihydrouracil Dehydrogenase (NADP)
Thymidine Phosphorylase
Disease-Free Survival
Thymidylate Synthase
Messenger RNA
Enzyme Activation
Translational Medical Research
Survival
Therapeutics
Transferases
Epidermal Growth Factor Receptor
Pharmaceutical Preparations
Vascular Endothelial Growth Factor A

All Science Journal Classification (ASJC) codes

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Study protocol of the B-CAST study : A multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. / Ishiguro, Megumi; Kotake, Kenjiro; Nishimura, Genichi; Tomita, Naohiro; Ichikawa, Wataru; Takahashi, Keiichi; Watanabe, Toshiaki; Furuhata, Tomohisa; Kondo, Ken; Mori, Masaki; Kakeji, Yoshihiro; Kanazawa, Akiyoshi; Kobayashi, Michiya; Okajima, Masazumi; Hyodo, Ichinosuke; Miyakoda, Keiko; Sugihara, Kenichi.

In: BMC Cancer, Vol. 13, 149, 25.03.2013.

Research output: Contribution to journalArticle

Ishiguro, M, Kotake, K, Nishimura, G, Tomita, N, Ichikawa, W, Takahashi, K, Watanabe, T, Furuhata, T, Kondo, K, Mori, M, Kakeji, Y, Kanazawa, A, Kobayashi, M, Okajima, M, Hyodo, I, Miyakoda, K & Sugihara, K 2013, 'Study protocol of the B-CAST study: A multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer', BMC Cancer, vol. 13, 149. https://doi.org/10.1186/1471-2407-13-149
Ishiguro, Megumi ; Kotake, Kenjiro ; Nishimura, Genichi ; Tomita, Naohiro ; Ichikawa, Wataru ; Takahashi, Keiichi ; Watanabe, Toshiaki ; Furuhata, Tomohisa ; Kondo, Ken ; Mori, Masaki ; Kakeji, Yoshihiro ; Kanazawa, Akiyoshi ; Kobayashi, Michiya ; Okajima, Masazumi ; Hyodo, Ichinosuke ; Miyakoda, Keiko ; Sugihara, Kenichi. / Study protocol of the B-CAST study : A multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer. In: BMC Cancer. 2013 ; Vol. 13.
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AU - Ishiguro, Megumi

AU - Kotake, Kenjiro

AU - Nishimura, Genichi

AU - Tomita, Naohiro

AU - Ichikawa, Wataru

AU - Takahashi, Keiichi

AU - Watanabe, Toshiaki

AU - Furuhata, Tomohisa

AU - Kondo, Ken

AU - Mori, Masaki

AU - Kakeji, Yoshihiro

AU - Kanazawa, Akiyoshi

AU - Kobayashi, Michiya

AU - Okajima, Masazumi

AU - Hyodo, Ichinosuke

AU - Miyakoda, Keiko

AU - Sugihara, Kenichi

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