Evidence map›Paper›PMID 37605122›Full record

Trial reportBMC cancer2023

NEXUS trial: a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant colorectal oligometastases.

Shin Kobayashi, Hideaki Bando, Akinobu Taketomi, Takeshi Takamoto, Eiji Shinozaki, Manabu Shiozawa, Hiroki Hara, Kentaro Yamazaki, Koji Komori, Nobuhisa Matsuhashi and 8 more

Open access · goldAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2023. 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
1.6field-weighted citation impact, top 14% 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. Review
  5. Observational
  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

18 authors at 15 institutions in 1 country.

Shin Kobayashi *Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 2770882, Japan. shkobaya@east.ncc.go.jp.
Hideaki Bando *Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Akinobu TaketomiDepartment of Gastroenterological Surgery I, Hokkaido University Hospital, Sapporo, Japan.
Takeshi TakamotoDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, Japan.
Eiji ShinozakiGastrointestinal Oncology Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Manabu ShiozawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.
Hiroki HaraGastroenterological Department, Saitama Cancer Center, Ina, Japan.
Kentaro YamazakiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Koji KomoriDepartment of Gastroenterological Surgery Aichi Cancer Center Hospital, Nagoya, Japan.
Nobuhisa MatsuhashiDepartment of Gastroenterological Surgery, Pediatric Surgery, Gifu University Hospital, Gifu, Japan.
Takeshi KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Yoshinori KagawaDepartment of Gastroenterological Surgery, Osaka General Medical Center, Osaka, Japan.
Mitsuru YokotaDepartment of General Surgery, Kurashiki Central Hospital, Kurashiki, Japan.
Eiji OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Keigo KomineDepartment of Clinical Oncology, Tohoku University Hospital, Sendai, Japan.
Shinichiro TakahashiDepartment of Gastroenterological Surgery, Tokai University School of Medicine, Isehara, Japan.
Masashi WakabayashiDivision for the Promotion of Drug and Diagnostic Development, National Cancer Center Hospital East, Kashiwa, Japan.
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
National Cancer Center Hospital East · JPAichi Cancer Center · JPGifu University Hospital · JPHokkaido University Hospital · JPKanagawa Prefectural Hospital Organization · JPKurashiki Central Hospital · JPKyushu University · JPOsaka City General Hospital · JPOsaka National Hospital · JPSaitama Cancer Center · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JPTohoku University Hospital · JPTokai University · JPTokyo National Hospital · JP

Funding

Japan Agency for Medical Research and Development 21lk0201148h0001
6 · The paper itself

Abstract

backgroundThe optimal treatment strategy for resectable BRAF V600E mutant colorectal oligometastases (CRM) has not been established due to the rarity and rapid progression of the disease. Since the unresectable recurrence rate is high, development of novel perioperative therapies are warranted. On December 2020, the BEACON CRC triplet regimen of encorafenib, binimetinib, and cetuximab was approved for unresectable metastatic colorectal cancer in Japan.

methodsThe NEXUS trial is a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant CRM. The key inclusion criteria are as follows: histologically diagnosed with colorectal adeno/adenosquamous carcinoma; RAS wild-type and BRAF V600E mutation by tissue or blood; and previously untreated resectable distant metastases. The triplet regimen (encorafenib: 300 mg daily; binimetinib: 45 mg twice daily; cetuximab: 400 mg/m DISCUSSION: The use of the triplet regimen in the perioperative period is expected to be safe and effective in patients with resectable BRAF V600E mutant CRM.

trial registrationjRCT2031220025, April. 16, 2022.

Indexed as

Carcinoma, AdenosquamousColorectal NeoplasmsBenzimidazolesCarbamatesCetuximabHumansProto-Oncogene Proteins B-rafSulfonamidesBenzimidazolesbinimetinibBRAF protein, humanCarbamatesCetuximabencorafenibProto-Oncogene Proteins B-rafSulfonamidesBEACONBinimetinibBRAF V600ECetuximabColorectal cancerEncorafenibOligometastasesResectable

Identifiers

PMID37605122
PMCPMC10440878
OpenAlexW4386030349

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.