Evidence map›Paper›PMID 38591098›Full record

Trial reportCancer medicine2024

Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild-type metastatic colorectal cancer: A phase II trial (HYBRID).

Hiroyuki Arai, Takashi Tsuda, Yu Sunakawa, Mototsugu Shimokawa, Kohei Akiyoshi, Shinya Tokunaga, Hirokazu Shoji, Kenji Kunieda, Masahito Kotaka, Toshihiko Matsumoto and 6 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 40% 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.

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

3 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. Review
  3. 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

16 authors at 11 institutions in 2 countries.

Hiroyuki AraiDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.ORCID 0000-0002-1886-7070
Takashi TsudaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Yu SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Kohei AkiyoshiDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Shinya TokunagaDepartment of Medical Oncology, Osaka City General Hospital, Osaka, Japan.
Hirokazu ShojiGastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-8922-5227
Kenji KuniedaDepartment of Medical Oncology, Saku Central Hospital Advanced Care Center, Saku, Japan.
Masahito KotakaDepartment of Gastrointestinal Cancer Center, Sano Hospital, Kobe, Japan.
Toshihiko MatsumotoDepartment of Internal Medicine, Himeji Red Cross Hospital, Himeji, Japan.
Yusuke NagataDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Takuro MizukamiDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Fumitaka MizukiCenter for Clinical Research, Yamaguchi University Hospital, Ube, Japan.
Kathleen D DanenbergLiquid Genomics, Inc., Torrance, California, USA.
Narikazu BokuDepartment of Oncology and General Medicine, Institute of Medical Science Hospital, University of Tokyo, Tokyo, Japan.
Takako Eguchi NakajimaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
St. Marianna University School of Medicine · JPOsaka City General Hospital · JPIchinomiya Municipal City Hospital · JPID Genomics (United States) · USJikei University School of Medicine · JPNational Cancer Center · USSaku Central Hospital · JPSanno Medical Center · JPTokyo Medical University Hospital · JPYamaguchi University · JPYamaguchi University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLong-term anti-EGFR antibody treatment increases the risk of severe dermatologic toxicities. This single-arm, phase II trial aimed to investigate the strategy of switching from cetuximab to bevacizumab in combination with FOLFIRI based on early tumor shrinkage (ETS) in patients with RAS wild-type metastatic colorectal cancer (mCRC).

methodsRadiologic assessment was performed to evaluate ETS, defined as ≥20% reduction in the sum of the largest diameters of target lesions 8 weeks after the introduction of FOLFIRI plus cetuximab. ETS-negative patients switched to FOLFIRI plus bevacizumab, whereas ETS-positive patients continued FOLFIRI plus cetuximab for eight more weeks, with a switch to FOLFIRI plus bevacizumab thereafter. The primary endpoint was progression-free survival.

resultsThis trial was prematurely terminated due to poor accrual after a total enrollment of 30 patients. In 29 eligible patients, 7 were ETS-negative and 22 were ETS-positive. Two ETS-negative patients and 17 ETS-positive patients switched to FOLFIRI plus bevacizumab 8 weeks and 16 weeks after initial FOLFIRI plus cetuximab, respectively. Median progression-free and overall survival durations were 13.4 and 34.7 months, respectively. Six (20%) patients experienced grade ≥3 paronychia, which improved to grade ≤2 by 18 weeks. Grade ≥3 acneiform rash, dry skin, and pruritus were not observed in any patients.

conclusionsOur novel treatment strategy delivered acceptable survival outcomes and reduced severe dermatologic toxicities.

Indexed as

Colonic NeoplasmsColorectal NeoplasmsRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinCetuximabFluorouracilHumansLeucovorinBevacizumabCamptothecinCetuximabFluorouracilLeucovorinbevacizumabcetuximabearly tumor shrinkagemetastatic colorectal cancer

Identifiers

PMID38591098
PMCPMC11002633
OpenAlexW4394619556

What OpenQuestion holds

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LicenceCC BY
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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.