title: Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers.
abstract: BACKGROUND
  Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM.
  
  
  METHODS
  A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials.gov identifier number NCT00594529). Patients were scheduled to receive 6 cycles of mFOLFOX6 therapy before liver surgery. The primary endpoint was the macroscopic curative resection rate.
  
  
  RESULTS
  A total of 30 patients were included in this study. Two patients who were diagnosed with hepatocellular and intrahepatic cholangiocellular carcinoma based on pathology were excluded from the analysis. More than half of the patients (57 %) had solitary liver metastasis. The completion rate of preoperative chemotherapy was 64.3 % and the response rate was 53.6 %. Two patients were unable to proceed to liver resections due to disease progression and severe postoperative complications following primary tumor resection. Macroscopic curative resection was obtained in 89.3 % of eligible patients. Postoperative mortality and severe complication (≥Gr. 3) rates were 0 and 11 %, respectively. The 3-year overall and progression-free survival rates were 81.9 and 47.4 %, respectively.
  
  
  CONCLUSIONS
  Our phase II study demonstrated the feasibility of liver resection combined with preoperative mFOLFOX6 therapy in patients with initially resectable CRLM. Further study is warranted to address the oncological effects of preoperative chemotherapy.
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan. nagayama@kuhp.kyoto-u.ac.jp.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Nagayama
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Suguru
authors.initials: S
authors.lastname: Hasegawa
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Koya
authors.initials: K
authors.lastname: Hida
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kawada
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Etsuro
authors.initials: E
authors.lastname: Hatano
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Kojiro
authors.initials: K
authors.lastname: Nakamura
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Satoru
authors.initials: S
authors.lastname: Seo
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Kojiro
authors.initials: K
authors.lastname: Taura
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Kentaro
authors.initials: K
authors.lastname: Yasuchika
authors.affiliation: Department of Surgery, Shiga Medical Center for Adults, 5-4-30 Moriyama, Moriyama City, Shiga, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsuo
authors.affiliation: Department of Surgery, Shiga Medical Center for Adults, 5-4-30 Moriyama, Moriyama City, Shiga, Japan.
authors.forename: Masazumi
authors.initials: M
authors.lastname: Zaima
authors.affiliation: Department of Surgery, Osaka Red Cross Hospital, 5-30 Fudegasaki-cho, Ten-noji-ku, Osaka, Japan.
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Kanazawa
authors.affiliation: Department of Surgery, Kitano Hospital, 2-4-20 Oogimachi, Kita-ku, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Terajima
authors.affiliation: Department of Surgery, Kitano Hospital, 2-4-20 Oogimachi, Kita-ku, Osaka, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Tada
authors.affiliation: Department of Surgery, Saiseikai Noe Hospital, 1-3-25 Furuichi, Joto-ku, Osaka, Japan.
authors.forename: Yukihito
authors.initials: Y
authors.lastname: Adachi
authors.affiliation: Department of Surgery, Kyoto Katsura Hospital, 17 Hirao-cho, Yamada, Nishikyo-ku, Kyoto, Japan.
authors.forename: Ryuta
authors.initials: R
authors.lastname: Nishitai
authors.affiliation: Department of Surgery, Kyoto Katsura Hospital, 17 Hirao-cho, Yamada, Nishikyo-ku, Kyoto, Japan.
authors.forename: Dai
authors.initials: D
authors.lastname: Manaka
authors.affiliation: Department of Surgery, Tenri Yorozu Hospital, 200 Mishima-cho, Tenri, Nara, Japan.
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Yoshimura
authors.affiliation: Department of Surgery, Fukui Red Cross Hospital, 2-4-1 Tsukimi, Fukui, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Doi
authors.affiliation: Department of Medical Oncology, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Horimatsu
authors.affiliation: Department of Surgery, Mitsubishi Kyoto Hospital, 1 Gosho-cho, Katsura, Sakyo-ku, Kyoto, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Mitsuyoshi
authors.affiliation: Translational Research Center, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Yoshimura
authors.affiliation: Translational Research Center, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Niimi
authors.affiliation: Department of Medical Oncology, Kyoto University Hospital, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, Japan.
authors.forename: Shigemi
authors.initials: S
authors.lastname: Matsumoto
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Yoshiharu
authors.initials: Y
authors.lastname: Sakai
authors.affiliation: Department of Surgery, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Sho-go-in, Sakyo-ku, Kyoto, 606-8507, Japan.
authors.forename: Shinji
authors.initials: S
authors.lastname: Uemoto
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006498:Hepatectomy; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000556:secondary / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: Colorectal liver metastasis; Liver resection; Preoperative mFOLFOX6 therapy