A randomized controlled trial of surgery and postoperative modified FOLFOX6 versus surgery and perioperative modified FOLFOX6 plus cetuximab in patients ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2022-02-25

AUTHORS

Masaru Matsumura, Kiyoshi Hasegawa, Masaru Oba, Kensei Yamaguchi, Hiroyuki Uetake, Takayuki Yoshino, Satoshi Morita, Keiichi Takahashi, Michiaki Unno, Yasuhiro Shimada, Kei Muro, Nobuhisa Matsuhashi, Masaki Mori, Hideo Baba, Mitsuo Shimada, Yoshihiro Mise, Yoshikuni Kawaguchi, Tatsuo Kagimura, Kiyoshi Ishigure, Akio Saiura, Kenichi Sugihara, Norihiro Kokudo

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). More... »

PAGES

1345-1356

Journal

TITLE

Langenbeck's Archives of Surgery

ISSUE

4

VOLUME

407

Author Affiliations

  • Department of Surgery, Graduate School of Medicine, Hepato-Biliary-Pancreatic Surgery Division, the University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, 113-8655, Tokyo, Japan
  • Department of Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Ariake Hospital, Tokyo, Japan
  • Department of Clinical Research, National Disaster Medical Center, Tokyo, Japan
  • Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan
  • Department of Biomedical Statistics and Bioinformatics, Graduate School of Medicine, Kyoto University, Kyoto, Japan
  • Department of Surgery, Tokyo Metropolitan Health and Hospitals Corporation Ohkubo Hospital, Tokyo, Japan
  • Department of Surgery, Graduate School of Medicine, Tohoku University, Sendai, Japan
  • Department of Clinical Oncology, Kochi Health Sciences Center, Kochi, Japan
  • Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
  • Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan
  • Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, and School of Medicine, Tokai University, Isehara, Japan
  • Department of Gastroenterological Surgery, Graduate School of Medicine, Kumamoto University, Kumamoto, Japan
  • Department of Digestive and Pediatric Surgery, Graduate School of Medicine, Tokushima University, Tokushima, Japan
  • Department of Hepatobiliary-Pancreatic Surgery, Juntendo University Graduate School of Medicine, Tokyo, Japan
  • Translational Research Center for Medical Innovation, Foundation for Biomedical Research and Innovation at Kobe, Kobe, Japan
  • Department of Surgery, Konan Kosei Hospital, Nagoya, Japan
  • Tokyo Medical and Dental University, Tokyo, Japan
  • Department of Surgery, Center Hospital of the National Center for Global Health and Medicine, Tokyo, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s00423-022-02434-7

    DOI

    http://dx.doi.org/10.1007/s00423-022-02434-7

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1145819088

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/35211831


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