Evidence map›Paper›PMID 37148491›Full record

Trial reportTargeted oncology2023

A Phase II Trial of Trifluridine/Tipiracil in Combination with Cetuximab Rechallenge in Patients with RAS Wild-Type mCRC Refractory to Prior Anti-EGFR Antibodies: WJOG8916G Trial.

Naoki Izawa, Toshiki Masuishi, Naoki Takahashi, Hirokazu Shoji, Yoshiyuki Yamamoto, Toshihiko Matsumoto, Keiji Sugiyama, Takeshi Kajiwara, Kentaro Kawakami, Naoki Aomatsu and 13 more

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

Trial report in Targeted oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 12% 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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Article
  7. 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

23 authors at 14 institutions in 1 country.

Naoki IzawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Toshiki MasuishiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Naoki TakahashiDepartment of Gastroenterology, Saitama Cancer Center Hospital, Kita-Adachi, Japan.
Hirokazu ShojiDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Yoshiyuki YamamotoDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Toshihiko MatsumotoDepartment of Internal Medicine, Himeji Red Cross Hospital, Himeji, Japan.
Keiji SugiyamaDepartment of Medical Oncology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Takeshi KajiwaraDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Kentaro KawakamiDepartment of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.
Naoki AomatsuDepartment of Surgery, Aomatsu memorial hospital, Izumisano, Japan.
Chihiro KondohDepartment of Medical Oncology, Toranomon Hospital, Tokyo, Japan.
Hisato KawakamiDepartment of Medical Oncology Faculty of Medicine, Kindai University, Osakasayama, Japan.
Naoki TakegawaDepartment of Gastroenterology, Hyogo Cancer Center Hospital, Akashi, Japan.
Taito EsakiDepartment of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Ube, Japan.
Kazuto NishioDepartment of Genome Biology, Faculty of Medicine, Kindai University, Higashi-Osaka, Japan.
Yukiya NaritaDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center Hospital, Kita-Adachi, Japan.
Yu SunakawaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.
Narikazu BokuDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Toshikazu MoriwakiDepartment of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Takako Eguchi NakajimaDepartment of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan. tnakajima@kuhp.kyoto-u.ac.jp.ORCID 0000-0002-4589-2335
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Aichi Cancer Center · JPSt. Marianna University School of Medicine · JPKindai University · JPNational Cancer Center Hospital East · JPSaitama Cancer Center · JPUniversity of Tsukuba · JPHimeji Red Cross Hospital · JPHyogo Prefectural Cancer Center · JPKeiyukai Sapporo Hospital · JPNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPShikoku Cancer Center · JPToranomon Hospital · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTrifluridine/tipiracil (FTD/TPI) improved the overall survival in patients with metastatic colorectal cancer (mCRC) who had previously received standard chemotherapies; however, the clinical outcomes remain poor.

objectiveA multicenter phase II study aimed to assess the efficacy and safety of FTD/TPI plus cetuximab rechallenge. PATIENTS AND

methodsPatients with histologically confirmed RAS wild-type mCRC refractory to prior anti-epidermal growth factor receptor (anti-EGFR) antibody were enrolled and treated with FTD/TPI (35 mg/m

resultsA total of 56 patients (median age 60 years; left-sided tumors 91%; objective partial or complete response during the prior anti-EGFR therapy 61%) were enrolled. The DCR was 54% (80% confidence interval [CI] 44-63; P = 0.12), with a partial response rate of 3.6%. Median progression-free survival (PFS) was 2.4 months (95% CI 2.1-3.7). In the circulating tumor DNA analysis, patients without any alterations of the six genes (n = 20) demonstrated higher DCR (75% vs. 39%; P = 0.02) and longer PFS (median 4.7 vs. 2.1 months; P < 0.01) than those with any gene alterations (n = 33). The most common grade 3/4 hematologic adverse event was neutropenia (55%). No treatment-related deaths occurred.

conclusionsFTD/TPI plus cetuximab rechallenge did not demonstrate clinically meaningful efficacy in all mCRC patients, but might be beneficial for the molecularly selected population.

Indexed as

Circulating Tumor DNAColonic NeoplasmsColorectal NeoplasmsFrontotemporal DementiaAntineoplastic Combined Chemotherapy ProtocolsCetuximabHumansMiddle AgedPyrrolidinesThymineTrifluridineCetuximabCirculating Tumor DNAPyrrolidinesThyminetipiracilTrifluridine

Identifiers

PMID37148491
OpenAlexW4372355469

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.