Evidence map›Paper›PMID 31520559›Full record

ArticleCancer science2019

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 and 11 more

Registry-linked trialOpen access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01882868 (A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01882868 phase2completednot on this map

A Single-Arm Phase II Study in Japan to Assess the Efficacy and Safety of Aflibercept Administered Every Two Weeks in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Who Progressed During or Following an Oxaliplatin-Based Regimen

TypeinterventionalSponsorSanofiRan2013 to 2015Enrolled62ConditionsColorectal Cancer MetastaticArmsAflibercept, Levofolinate, Irinotecan, 5-FU
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
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  4. The Current Role of Antiangiogenics in Colorectal Cancer.International journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 20 institutions in 2 countries.

Tetsuya HamaguchiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Tadamichi DendaDepartment of Gastroenterology, Chiba Cancer Center, Chiba, Japan.ORCID https://orcid.org/0000-0003-2570-9692
Toshihiro KudoOsaka University Graduate School of Medicine, Suita, Japan.
Naotoshi SugimotoDepartment of Medical Oncology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan.
Takashi UraDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Kentaro YamazakiDepartment of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Hirofumi FujiiDepartment of Clinical Oncology, Jichi Medical University Hospital, Shimotsuke, Japan.
Takeshi KajiwaraDepartment of Gastrointestinal Medical Oncology, Shikoku Cancer Center, Matsuyama, Japan.
Takako Eguchi NakajimaDepartment of Medical Oncology, St. Marianna University School of Medicine Hospital, Kawasaki, Japan.
Shin TakahashiDepartment of Medical Oncology, Tohoku University Hospital, Sendai, Japan.
Satoshi OtsuDepartment of Medical Oncology, Oita University Hospital, Yufu, Japan.
Yoshito KomatsuDepartment of Cancer Center, Hokkaido University Hospital, Sapporo, Japan.
Fumio NagashimaDepartment of Medical Oncology, Kyorin University Hospital, Mitaka, Japan.
Toshikazu MoriwakiDepartment of Gastroenterology, University of Tsukuba Hospital, Tsukuba, Japan.ORCID https://orcid.org/0000-0001-7702-122X
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-9169-8453
Takeo SatoDepartment of Gastrointestinal Surgery, Kitasato University East Hospital, Sagamihara, Japan.
Michio ItabashiDepartment of Surgery 2, Tokyo Women's Medical University Hospital, Tokyo, Japan.
Eiji OkiDepartment of Gastrointestinal Surgery, Kyushu University Hospital, Fukuoka, Japan.
Toru SasakiResearch and development, Sanofi K. K., Tokyo, Japan.
Marielle ChironBiomarkers & Imaging Genomics, Sanofi, Alfortville, France.
Takayuki YoshinoDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
National Cancer Center Hospital East · JPAichi Cancer Center · JPChiba Cancer Center · JPHokkaido University · JPJichi Medical University · JPKitasato University Hospital · JPKyorin University · JPKyushu University Hospital · JPNational Kyushu Medical Center · JPOita University Hospital · JPOsaka International Cancer Institute · JPSanofi (France) · FRSanofi (Japan) · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPSt. Marianna University School of Medicine · JPThe University of Osaka · JPTohoku University Hospital · JPTokyo Women's Medical University Hospital · JPUniversity of Tsukuba Hospital · JP

Funding

Sanofi
6 · The paper itself

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.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAsian PeopleBiomarkers, TumorCamptothecinColonic NeoplasmsFluorouracilHumansInsulin-Like Growth Factor Binding Protein 1Interleukin-8JapanKallikreinsLeucovorinPlacenta Growth FactorPrognosisProgression-Free SurvivalProspective StudiesafliberceptBiomarkers, TumorCamptothecinFluorouracilIGFBP1 protein, humanInsulin-Like Growth Factor Binding Protein 1Interleukin-8KallikreinsKLK5 protein, humanLeucovorinPlacenta Growth FactorPulmonary Surfactant-Associated Protein DReceptor for Advanced Glycation End ProductsReceptors, Tumor Necrosis Factor, Type IIReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTenascinTIMP1 protein, humanTissue Inhibitor of Metalloproteinase-1TNC protein, humanVascular Endothelial Growth Factor Receptor-1afliberceptbiomarkercolorectal cancerFOLFIRImetastasis

Identifiers

PMID31520559
PMCPMC6825011
OpenAlexW2973100618

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.