Evidence map›Paper›PMID 35211831›Full record

Trial reportLangenbeck's archives of surgery2022

A randomized controlled trial of surgery and postoperative modified FOLFOX6 versus surgery and perioperative modified FOLFOX6 plus cetuximab in patients with KRAS wild-type resectable colorectal liver metastases: EXPERT study.

Masaru Matsumura, Kiyoshi Hasegawa, Masaru Oba, Kensei Yamaguchi, Hiroyuki Uetake, Takayuki Yoshino, Satoshi Morita, Keiichi Takahashi, Michiaki Unno, Yasuhiro Shimada and 12 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Langenbeck's archives of surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 33% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. 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

22 authors at 17 institutions in 1 country.

Masaru MatsumuraDepartment of Surgery, Graduate School of Medicine, Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Kiyoshi HasegawaDepartment of Surgery, Graduate School of Medicine, Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. kihase-tky@umin.ac.jp.ORCID http://orcid.org/0000-0001-8734-740X
Masaru ObaDepartment of Surgery, Graduate School of Medicine, Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Kensei YamaguchiDepartment of Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Ariake Hospital, Tokyo, Japan.
Hiroyuki UetakeDepartment of Clinical Research, National Disaster Medical Center, Tokyo, Japan.
Takayuki YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Keiichi TakahashiDepartment of Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ohkubo Hospital, Tokyo, Japan.
Michiaki UnnoDepartment of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan.
Yasuhiro ShimadaDepartment of Clinical Oncology, Kochi Health Sciences Center, Kochi, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Nobuhisa MatsuhashiDepartment of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.
Masaki MoriDepartment of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, and School of Medicine, Tokai University, Isehara, Japan.
Hideo BabaDepartment of Gastroenterological Surgery, Graduate School of Medicine, Kumamoto University, Kumamoto, Japan.
Mitsuo ShimadaDepartment of Digestive and Pediatric Surgery, Graduate School of Medicine, Tokushima University, Tokushima, Japan.
Yoshihiro MiseDepartment of Hepatobiliary-Pancreatic Surgery, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Yoshikuni KawaguchiDepartment of Surgery, Graduate School of Medicine, Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Tatsuo KagimuraTranslational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan.
Kiyoshi IshigureDepartment of Surgery, Konan Kosei Hospital, Nagoya, Japan.
Akio SaiuraDepartment of Hepatobiliary-Pancreatic Surgery, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Kenichi SugiharaTokyo Medical and Dental University, Tokyo, Japan.
Norihiro KokudoDepartment of Surgery, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan.
The University of Tokyo · JPJuntendo University · JPAichi Cancer Center · JPFoundation for Biomedical Research and Innovation · JPGifu University · JPJapanese Foundation For Cancer Research · JPKonan Kosei Hospital · JPKumamoto University · JPKyoto University · JPNational Cancer Center Hospital East · JPNational Center for Global Health and Medicine · JPNational Disaster Medical Center · JPOhkubo Hospital · JPTohoku University · JPTokai University · JPTokushima University · JPTokyo Medical and Dental University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo clarify the efficacy of perioperative chemotherapy for the patients with resectable colorectal liver metastases (CLM), we conducted a multicenter randomized phase III trial to compare surgery followed by postoperative FOLFOX regimen with perioperative FOLFOX regimen plus cetuximab in patients with KRAS wild-type resectable CLM.

methodsPatients who had KRAS wild-type resectable CLM having one to eight liver nodules without extrahepatic disease were randomly assigned to the postoperative chemotherapy group, wherein up-front hepatectomy was performed followed by 12 cycles of postoperative modified FOLFOX6, and the perioperative chemotherapy group (experimental), wherein six cycles of preoperative modified FOLFOX6 plus cetuximab were performed followed by hepatectomy and six cycles of postoperative modified FOLFOX6 plus cetuximab. The primary endpoint was progression-free survival (PFS).

resultsThere were 37 patients in postoperative chemotherapy group and 40 patients in the perioperative chemotherapy group who were analyzed. Baseline characteristics were well-balanced between groups. The PFS and overall survival (OS) showed no significant difference (PFS, hazard ratio 1.18 [95% confidence interval 0.69-2.01], P = 0.539: OS, 1.03 [0.46-2.29], P = 0.950). In the postoperative chemotherapy group, 35.1% had a 3-year PFS, and 86.5% had a 3-year OS. Meanwhile, in the perioperative chemotherapy group, 30.0% had a 3-year PFS, and 74.4% had a 3-year OS.

conclusionThere was no difference in survival found between the group of the perioperative chemotherapy plus cetuximab and that of the postoperative chemotherapy in the cohort of our study. The study was registered in the University Hospital Medical Information Network (UMIN000007787).

Indexed as

Colorectal NeoplasmsLiver NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease-Free SurvivalFluorouracilHepatectomyHumansLeucovorinProto-Oncogene Proteins p21(ras)CetuximabFluorouracilKRAS protein, humanLeucovorinProto-Oncogene Proteins p21(ras)a Multicenter-randomized controlled studyCetuximabPerioperative chemotherapyResectable colorectal liver metastases

Identifiers

PMID35211831
OpenAlexW4214638362

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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.