Evidence map›Paper›PMID 40882248›Full record

Trial reportESMO open2025

A phase II study of intrapatient dose escalation of biweekly trifluridine/tipiracil plus bevacizumab for colorectal cancer (E-BiTS study).

M Wakabayashi, H Taniguchi, A Makiyama, Y Sunakawa, H Takeda, K Arimizu, Y Okumura, C Inagaki, S Mitani, T Kudo and 6 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

M WakabayashiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan; Department of Gastroenterology and Hepatology, Toho University Omori Medical Center, Tokyo, Japan.
H TaniguchiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. Electronic address: hiroya.taniguchi@aichi-cc.jp.
A MakiyamaCancer Center, Gifu University Hospital, Gifu, Japan.
Y SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
H TakedaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
K ArimizuDepartment of Gastrointestinal and Medical Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan.
Y OkumuraDepartment of Gastrointestinal and Medical Oncology, NHO Kyushu Cancer Center, Fukuoka, Japan.
C InagakiDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.
S MitaniDepartment of Medical Oncology, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.
T KudoDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.
S YukiDepartment of Gastroenterology and Hepatology, Hokkaido University Hospital, Sapporo, Japan.
N AkazawaDepartment of Gastroenterological Surgery, Sendai City Medical Center Sendai Open Hospital, Miyagi, Japan.
C KudoDepartment of Clinical Research, Aichi Cancer Center Hospital, Nagoya, Japan.
K MoriClinical Research Center, Shizuoka Cancer Center, Nagaizumi, Japan.
T MatsudaDepartment of Gastroenterology and Hepatology, Toho University Omori Medical Center, Tokyo, Japan.
K MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) remains a standard of care for refractory metastatic colorectal cancer (mCRC), though hematological toxicities remain a concern. Although a biweekly regimen has shown favorable tolerability, the optimal biweekly dosage has yet to be established. Thus, this study was conducted to evaluate the feasibility and clinical impact of intrapatient dose escalation of biweekly FTD/TPI plus BEV. MATERIALS AND

methodsThis multicenter, single-arm phase Ⅱ trial included patients with refractory mCRC who had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. Eligible patients received biweekly FTD/TPI (35 mg/m

resultsAmong the 36 enrolled patients, 34 were included in the full analysis set. The median age was 65 years (range 39-79 years); 76% had ECOG PS 0, 56% had RAS mutations, and 79% had two or more metastatic organs. Dose escalation was feasible in 91% of the patients. The disease control rate was 72.7% (80% confidence interval 60.4% to 82.8%), median PFS was 5.6 months, and median OS was 17.6 months, with a median follow-up duration of 18.0 months. Patients who experienced grade ≥2 neutropenia had significantly improved outcomes (PFS, 7.0 versus 2.3 months; OS, not reached versus 10.6 months). Hematologic toxicities were manageable, with no febrile neutropenia and only three treatment-related serious adverse events.

conclusionsIntrapatient dose escalation of biweekly FTD/TPI plus BEV was feasible and well tolerated and may enhance the efficacy of refractory mCRC treatment. Nonetheless, further studies are warranted to validate this individualized dosing strategy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsPyrrolidinesThymineTrifluridineAdultAgedDrug CombinationsFemaleHumansMaleMiddle AgedBevacizumabDrug CombinationsPyrrolidinesThymineTrifluridinetrifluridine tipiracil drug combinationbiweekly trifluridine/tipiracil plus bevacizumabcolorectal cancerintrapatient dose escalation strategy

Identifiers

PMID40882248
PMCPMC12414899

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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.