Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer

Tetsuya Hamaguchi, Tadamichi Denda, Toshihiro Kudo, Naotoshi Sugimoto, Takashi Ura, Kentaro Yamazaki, Hirofumi Fujii, Takeshi Kajiwara, Takako Eguchi Nakajima, Shin Takahashi, Satoshi Otsu, Yoshito Komatsu, Fumio Nagashima, Toshikazu Moriwaki, Taito Esaki, Takeo Sato, Michio Itabashi, Eiji Oki, Toru Sasaki, Marielle ChironTakayuki Yoshino

Research output: Contribution to journalArticle

Abstract

Aflibercept plus 5-fluorouracil/levofolinate/irinotecan (FOLFIRI) is a second-line treatment for metastatic colorectal cancer. This ancillary exploratory analysis of data in Japanese people was aimed at exploring the relationship between a set of potential prognostic biomarkers and efficacy endpoints following aflibercept plus FOLFIRI therapy. Sixty-two patients with metastatic colorectal cancer received aflibercept (4 mg/kg) plus FOLFIRI every 2 weeks. Seventy-eight potential protein biomarkers were chosen for analysis based on their roles in angiogenesis, tumor progression, and tumor-stroma interaction. Plasma levels of biomarkers at baseline and at pre-dose 3 (day 1 of treatment cycle 3) were measured in all patients by ELISA. Relationships between these levels and efficacy endpoints were assessed. Ten potential biomarkers had a ±30% change from baseline to pre-dose 3 (adjusted P <.001), with the greatest changes occurring in placental growth factor (median: +4716%) and vascular endothelial growth factor receptor 1 (+2171%). Baseline levels of eight potential biomarkers correlated with overall survival in a univariate Cox regression analysis: extracellular newly identified receptor for advanced glycation end-products binding protein, insulin-like growth factor-binding protein 1, interleukin-8, kallikrein 5, pulmonary surfactant-associated protein D, tissue inhibitor of metalloproteinases 1, tenascin-C, and tumor necrosis factor receptor 2. None correlated with progression-free survival or maximum tumor shrinkage. Pre-dose 3 levels did not correlate with any efficacy endpoints. Preliminary data show that these eight biomarkers could be associated with overall survival. ClinicalTrials.gov identifier: NCT01882868.

Original languageEnglish
Pages (from-to)3565-3572
Number of pages8
JournalCancer Science
Volume110
Issue number11
DOIs
Publication statusPublished - Nov 1 2019

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irinotecan
Fluorouracil
Colorectal Neoplasms
Biomarkers
Pulmonary Surfactant-Associated Protein D
Receptors, Tumor Necrosis Factor, Type II
Vascular Endothelial Growth Factor Receptor-1
Insulin-Like Growth Factor Binding Protein 1
Tenascin
Neoplasms
Kallikreins
Tissue Inhibitor of Metalloproteinase-1
Survival
Interleukin-8
Disease-Free Survival
aflibercept
Intercellular Signaling Peptides and Proteins
Carrier Proteins
Therapeutics
Enzyme-Linked Immunosorbent Assay

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Hamaguchi, T., Denda, T., Kudo, T., Sugimoto, N., Ura, T., Yamazaki, K., ... Yoshino, T. (2019). Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer. Cancer Science, 110(11), 3565-3572. https://doi.org/10.1111/cas.14198

Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer. / Hamaguchi, Tetsuya; Denda, Tadamichi; Kudo, Toshihiro; Sugimoto, Naotoshi; Ura, Takashi; Yamazaki, Kentaro; Fujii, Hirofumi; Kajiwara, Takeshi; Nakajima, Takako Eguchi; Takahashi, Shin; Otsu, Satoshi; Komatsu, Yoshito; Nagashima, Fumio; Moriwaki, Toshikazu; Esaki, Taito; Sato, Takeo; Itabashi, Michio; Oki, Eiji; Sasaki, Toru; Chiron, Marielle; Yoshino, Takayuki.

In: Cancer Science, Vol. 110, No. 11, 01.11.2019, p. 3565-3572.

Research output: Contribution to journalArticle

Hamaguchi, T, Denda, T, Kudo, T, Sugimoto, N, Ura, T, Yamazaki, K, Fujii, H, Kajiwara, T, Nakajima, TE, Takahashi, S, Otsu, S, Komatsu, Y, Nagashima, F, Moriwaki, T, Esaki, T, Sato, T, Itabashi, M, Oki, E, Sasaki, T, Chiron, M & Yoshino, T 2019, 'Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer', Cancer Science, vol. 110, no. 11, pp. 3565-3572. https://doi.org/10.1111/cas.14198
Hamaguchi, Tetsuya ; Denda, Tadamichi ; Kudo, Toshihiro ; Sugimoto, Naotoshi ; Ura, Takashi ; Yamazaki, Kentaro ; Fujii, Hirofumi ; Kajiwara, Takeshi ; Nakajima, Takako Eguchi ; Takahashi, Shin ; Otsu, Satoshi ; Komatsu, Yoshito ; Nagashima, Fumio ; Moriwaki, Toshikazu ; Esaki, Taito ; Sato, Takeo ; Itabashi, Michio ; Oki, Eiji ; Sasaki, Toru ; Chiron, Marielle ; Yoshino, Takayuki. / Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer. In: Cancer Science. 2019 ; Vol. 110, No. 11. pp. 3565-3572.
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abstract = "Aflibercept plus 5-fluorouracil/levofolinate/irinotecan (FOLFIRI) is a second-line treatment for metastatic colorectal cancer. This ancillary exploratory analysis of data in Japanese people was aimed at exploring the relationship between a set of potential prognostic biomarkers and efficacy endpoints following aflibercept plus FOLFIRI therapy. Sixty-two patients with metastatic colorectal cancer received aflibercept (4 mg/kg) plus FOLFIRI every 2 weeks. Seventy-eight potential protein biomarkers were chosen for analysis based on their roles in angiogenesis, tumor progression, and tumor-stroma interaction. Plasma levels of biomarkers at baseline and at pre-dose 3 (day 1 of treatment cycle 3) were measured in all patients by ELISA. Relationships between these levels and efficacy endpoints were assessed. Ten potential biomarkers had a ±30{\%} change from baseline to pre-dose 3 (adjusted P <.001), with the greatest changes occurring in placental growth factor (median: +4716{\%}) and vascular endothelial growth factor receptor 1 (+2171{\%}). Baseline levels of eight potential biomarkers correlated with overall survival in a univariate Cox regression analysis: extracellular newly identified receptor for advanced glycation end-products binding protein, insulin-like growth factor-binding protein 1, interleukin-8, kallikrein 5, pulmonary surfactant-associated protein D, tissue inhibitor of metalloproteinases 1, tenascin-C, and tumor necrosis factor receptor 2. None correlated with progression-free survival or maximum tumor shrinkage. Pre-dose 3 levels did not correlate with any efficacy endpoints. Preliminary data show that these eight biomarkers could be associated with overall survival. ClinicalTrials.gov identifier: NCT01882868.",
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AU - Ura, Takashi

AU - Yamazaki, Kentaro

AU - Fujii, Hirofumi

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AU - Nakajima, Takako Eguchi

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AU - Itabashi, Michio

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AU - Yoshino, Takayuki

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