Evidence map›Paper›PMID 30657223›Full record

Trial reportCancer science2019

Phase II trial of aflibercept with FOLFIRI as a second-line treatment for Japanese patients with metastatic colorectal cancer.

Tadamichi Denda, Daisuke Sakai, Tetsuya Hamaguchi, Naotoshi Sugimoto, Takashi Ura, Kentaro Yamazaki, Hirofumi Fujii, Takeshi Kajiwara, Takako Eguchi Nakajima, Shin Takahashi and 13 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. The Current Role of Antiangiogenics in Colorectal Cancer.International journal of molecular sciences · 2025
    Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Observational
  17. Review
  18. Article
  19. Review
  20. Article
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

23 authors.

Tadamichi DendaDepartment of Gastroenterology, Chiba Cancer Center, Chiba, Japan.ORCID http://orcid.org/0000-0003-2570-9692
Daisuke SakaiDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.ORCID http://orcid.org/0000-0002-9436-7553
Tetsuya HamaguchiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, 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 Medical 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 http://orcid.org/0000-0001-7702-122X
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.ORCID http://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 SasakiLocal Medical Operation, Sanofi K. K., Tokyo, Japan.
Yoshinori SunagaBiostatstics& Programming, Sanofi K. K., Tokyo, Japan.
Samira Ziti-LjajicPharmacokinetics, Sanofi Oncology, Alfortville, France.
Claire BrillacModeling& Simulation, Sanofi Oncology, Alfortville, France.
Takayuki YoshinoDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

Funding

Sanofi
6 · The paper itself

Abstract

Aflibercept targets vascular endothelial growth factor. The present study involved assessing the efficacy, safety and pharmacokinetics of aflibercept plus 5-fluorouracil/levofolinate/irinotecan (FOLFIRI) as a second-line treatment for metastatic colorectal cancer (mCRC) in Japanese patients. Aflibercept (4 mg/kg) plus FOLFIRI was administered every 2 weeks in 62 patients with mCRC until disease progression, unacceptable toxicity or patient withdrawal. Tumors were imaged every 6 weeks. The primary endpoint was objective response rate (ORR); secondary endpoints were progression-free survival, overall survival, safety, and pharmacokinetics of aflibercept, irinotecan and 5-fluorouracil. A total of 60 patients were evaluated for ORR; 50 had received prior bevacizumab. The ORR was 8.3% (95% confidence interval [CI]: 1.3%-15.3%), and the disease control rate (DCR) was 80.0% (69.9%-90.1%). The median progression-free survival was 5.42 months (4.14-6.70 months) and the median overall survival was 15.59 months (11.20-19.81 months). No treatment-related deaths were observed, and no significant drug-drug interactions were found. The most common treatment-emergent adverse events were neutropenia and decreased appetite. Free aflibercept had a mean maximum concentration (coefficient of variation) of 73.2 μg/mL (15%), clearance of 0.805 L/d (22%) and volume of distribution of 6.2 L (18%); aflibercept bound with vascular endothelial growth factor had a clearance of 0.162 L/d (9%) (N = 62). Aflibercept did not significantly affect the pharmacokinetics of irinotecan or 5-fluorouracil: The clearance was 11.1 L/h/m

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleCamptothecinColorectal NeoplasmsDisease-Free SurvivalFluorouracilHumansLeucovorinMaleProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AafliberceptCamptothecinFluorouracilLeucovorinReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor Aafliberceptangiogenesis inhibitorscolorectal neoplasmsneoplasm metastasisvascular endothelial growth factor A

Identifiers

PMID30657223
PMCPMC6398889

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.