Evidence map›Paper›PMID 39891883›Full record

Trial reportInternational journal of clinical oncology2025

A phase two trial evaluating FOLFIRI plus aflibercept after failure of FOLFOXIRI plus bevacizumab in patients with unresectable metastatic colorectal cancer.

Koji Ando, Hironaga Satake, Mototsugu Shimokawa, Hisateru Yasui, Yuji Negoro, Tatsuya Kinjo, Junya Kizaki, Kenji Baba, Hiroyuki Orita, Keiji Hirata and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Review
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

16 authors.

Koji AndoDepartment of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.ORCID http://orcid.org/0000-0002-0149-1505
Hironaga SatakeDepartment of Medical Oncology, Kochi Medical School, Cancer Treatment Centre, Kansai Medical University Hospital, Kochi, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Hisateru YasuiDepartment of Medical Oncology, Kobe City Medical Centre General Hospital, Kobe, Japan.
Yuji NegoroDepartment of Oncological Medicine, Kochi Health Sciences Centre, Kochi, Japan.
Tatsuya KinjoFaculty of Medicine, Department of Digestive and General Surgery, University of the Ryukyus, Nishihara, Japan.
Junya KizakiDepartment of Surgery, Social Insurance Tagawa Hospital, Tagawa, Japan.
Kenji BabaDepartment of Surgery, Imamura General Hospital, Kagoshima, Japan.
Hiroyuki OritaDepartment of Surgery, Nakatsu Municipal Hospital, Nakatsu, Japan.
Keiji HirataDepartment of Surgery 1, Hospital of the University of Occupational and Environmental Health, Kitakyushu, Japan.
Sanae SakamotoKyushu Study Group of Clinical Cancer, Fukuoka, Japan.
Akitaka MakiyamaCancer Centre, Gifu University Hospital, Gifu, Japan.
Hiroshi SaekiDepartment of General Surgical Science Graduate School of Medicine, Gunma University, Maebashi, Japan.
Akihito TsujiFaculty of Medicine, Department of Clinical Oncology, Kagawa University, Takamatsu, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan. oki.eiji.857@m.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0002-9763-9366

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFOLFOXIRI plus bevacizumab (BEV) is an option for first-line treatment of metastatic colorectal cancer (mCRC). However, there is no consensus on the optimal treatment strategy when disease progresses. The EFFORT open-label, multicenter, single-arm phase II study investigated whether FOLFIRI plus aflibercept retains activity after progression of FOLFOXIRI plus BEV treatment.

methodsThe patients with unresectable mCRC who failed first-line FOLFOXIRI plus BEV received FOLFIRI plus aflibercept. The primary endpoint was progression-free survival (PFS) in the full analysis set (FAS). Angiogenic biomarkers were measured before treatment initiation.

resultsFrom April 2019 to May 2021, 35 patients were enrolled and 34 were analysed in the FAS population (men, 18; median age, 63 years [range: 32-78]). The primary tumor was left-sided in most cases (23/34), 23 patients were RAS mutant, 3 patients had BRAF V600E mutation and 27 patients had liver metastases. The primary end-point was met with a median PFS of 4.3 months [80% confidence interval [CI] 3.7-5.1]. Median overall survival was 15.2 months [95% CI 8.9-22.7]. Per RECIST, there were 1 complete response, 4 partial responses, 21 stable diseases and 8 disease progressions. Overall response rate was 14.7% [95% CI 5.0-31.1], and disease control rate was 76.5% [95% CI 58.8-89.3]. Responses were more common in patients with high VEGF-C, low VEGF-D and low PlGF levels before treatment.

conclusionFOLFIRI plus aflibercept, administered after failure of FOLFOXIRI plus BEV, is effective and has a manageable safety profile. This regimen may be a useful second-line treatment option for these patients.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCamptothecinColorectal NeoplasmsRecombinant Fusion ProteinsAdultAgedBevacizumabFemaleFluorouracilHumansIrinotecanLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsafliberceptBevacizumabCamptothecinFluorouracilIrinotecanLeucovorinOrganoplatinum CompoundsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAfliberceptColorectal cancerFOLFIRIFOLFOXIRI plus bevacizumabIrinotecan reduced doseMetastatic

Identifiers

PMID39891883

What OpenQuestion holds

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Registered trials

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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.