Evidence map›Paper›PMID 33097971›Full record

Trial reportInternational journal of clinical oncology2021

A phase II study of FOLFOXIRI plus bevacizumab as initial chemotherapy for patients with untreated metastatic colorectal cancer: TRICC1414 (BeTRI).

Katsunori Shinozaki, Takeshi Yamada, Junichiro Nasu, Toshihiko Matsumoto, Yasuhiro Yuasa, Takeshi Shiraishi, Hiroaki Nagano, Ichiro Moriyama, Toshiyoshi Fujiwara, Masashi Miguchi and 10 more

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

Trial report in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 38% 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, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Angiogenesis as a hallmark of solid tumors - clinical perspectives.Cellular oncology (Dordrecht, Netherlands) · 2021
    Review
  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

20 authors at 17 institutions in 1 country.

Katsunori ShinozakiDivision of Clinical Oncology, Hiroshima Prefectural Hospital, 1-5-54 Ujinakanda, Hiroshima, 734-8530, Japan. k-shinozaki@hph.pref.hiroshima.jp.ORCID http://orcid.org/0000-0003-0596-3423
Takeshi YamadaDivision of Gastroenterology, University of Tsukuba, Tsukuba, 305-8577, Japan.
Junichiro NasuDepartment of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, 700-8501, Japan.
Toshihiko MatsumotoDepartment of Internal Medicine, Himeji Red Cross Hospital, Himeji, 670-8540, Japan.
Yasuhiro YuasaDepartment of Surgery, Tokushima Red Cross Hospital, Tokushima, 773-8502, Japan.
Takeshi ShiraishiDepartment of Medical Oncology, Matsuyama Red Cross Hospital, Matsuyama, 790-8520, Japan.
Hiroaki NaganoDepartment of Gastroenterological Surgery, Yamaguchi University Graduate School of Medicine, Ube, 755-8505, Japan.
Ichiro MoriyamaInnovative Cancer Center, Shimane University Hospital, Izumo, 693-0021, Japan.
Toshiyoshi FujiwaraDepartment of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, 700-8530, Japan.
Masashi MiguchiDepartment of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, 731-0293, Japan.
Ryosuke YoshidaDepartment of Surgery, Okayama Rosai Hospital, Okayama, 702-8055, Japan.
Kimiyasu NozakaDepartment of Surgery, Sanin Rosai Hospital, Yonago, 683-8605, Japan.
Hiroaki TaniokaDepartment of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, 701-0192, Japan.
Takeshi NagasakaDepartment of Clinical Oncology, Kawasaki Medical School Hospital, Kurashiki, 701-0192, Japan.
Yasuro KurisuDepartment of Surgery, Hamada Medical Center, Hamada, 697-8511, Japan.
Michiya KobayashiCancer Treatment Center, Kochi Medical School Hospital, Nankoku, 783‑8505, Japan.
Kenji TsuchihashiDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, 812-8582, Japan.
Michio InukaiDepartment of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, 700-8501, Japan.
Takashi KikuchiFoundation for Biomedical Research and Innovation at Kobe for Medical Innovation, Kobe, 650-0047, Japan.
Tomohiro NishinaDepartment of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, 791-0280, Japan.
Kawasaki Medical School Hospital · JPOkayama Saiseikai General Hospital · JPFoundation for Biomedical Research and Innovation · JPHimeji Red Cross Hospital · JPHiroshima City Asa Citizens Hospital · JPHiroshima Prefectural Hospital · JPKochi Medical School Hospital · JPKyushu University Hospital · JPMatsuyama Red Cross Hospital · JPOkayama Rosai Hospital · JPOkayama University · JPSanin Rosai Hospital · JPShikoku Cancer Center · JPShimane University Hospital · JPTokushima Red Cross Hospital · JPUniversity of Tsukuba · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeFOLFOXIRI plus bevacizumab is regarded as a first-line therapeutic option for selected patients with metastatic colorectal cancer (mCRC). Our aim was to assess the efficacy and safety of induction treatment with FOLFOXIRI plus bevacizumab in patients with untreated mCRC harboring UGT1A1 wild (*1/*1), or single-hetero (*1/*6 or *1/*28) genotypes.

methodsTwelve cycles of FOLFOXIRI plus bevacizumab were administered to patients with untreated mCRC. The primary endpoint was the overall response rate (ORR) assessed by central independent reviewers. Secondary endpoints included time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), relative dose intensity (RDI), R0 resection rate, and safety. The exploratory objectives were early tumor shrinkage (ETS) and depth of response (DoR).

resultsOf the 47 patients enrolled, 46 and 44 patients were eligible for the safety and efficacy analysis, respectively. The primary endpoint was met. The ORR was 63.6% (95% CI 47.8-77.6). At a median follow-up of 25.4 months, median TTF, PFS, and OS was 8.1, 15.5, and 34.4 months, respectively. The median RDI of 5-fluorouracil, irinotecan, oxaliplatin, and bevacizumab was 72, 69, 62, and 71%, respectively. R0 resection rate was 22.7%. Grade 3 or higher adverse events (≥ 10%) included neutropenia (65.2%), febrile neutropenia (26.1%), leukopenia (23.9%), anorexia (10.9%), nausea (10.9%), and diarrhoea (10.9%). No treatment-related deaths were observed. ETS and DoR were 70.5 and 45.4%, respectively.

conclusionsFOLFOXIRI plus bevacizumab induction treatment of Japanese patients was shown to be beneficial and manageable, although caution is required since the treatment causes febrile neutropenia.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsAdultAgedBevacizumabCamptothecinDisease-Free SurvivalFemaleFluorouracilHumansLeucovorinMaleMiddle AgedOrganoplatinum CompoundsTreatment OutcomeBevacizumabCamptothecinFluorouracilLeucovorinOrganoplatinum CompoundsConversion surgeryEfficacyFOLFOXIRI plus bevacizumabMetastatic colorectal cancerSafety

Identifiers

PMID33097971
PMCPMC7819906
OpenAlexW3094400112

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.