title: Phase II study on hepatic arterial infusion chemotherapy using percutaneous catheter placement techniques for liver metastases from colorectal cancer (JFMC28 study).
abstract: OBJECTIVE
  This prospective multicenter study aimed to evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC) using percutaneous catheter placement techniques for liver metastases from colorectal cancer (CRC).
  
  
  METHODS
  We administered 5-fluorouracil at 1000 mg/m2 over 5 h via hepatic arterial infusion on a weekly schedule. The primary endpoint was the overall response rate (RR). The secondary endpoints were the overall survival (OS), progression-free survival (PFS) and toxicities.
  
  
  RESULTS
  Between February 2000 and March 2002, seventy-seven eligible patients were enrolled in this study. After a median of 26 treatment cycles, 4 patients achieved a complete response, 29 achieved a partial response, 28 had stable disease, 15 had progressive disease and the status of one patient was unknown. The overall RR was 42.9% and the disease control rate (DCR) was 79.2%. The median PFS and OS times were 203 and 560 days, respectively. The most common grade 3 or 4 hematological and non-hematological toxicities were total bilirubin level elevation (10.4%) and gamma-glutamyl transferase level elevation (10.4%). With regard to the relationship between the background factors and treatment outcomes, the DCR, RR, PFS and OS were different between patients with and without extrahepatic lesions (DCR: 86.5% vs 64%, RR: 46.2% vs 36.0%, PFS: 233 days vs 99 days, OS: 587 days vs 558 days).
  
  
  CONCLUSIONS
  The primary endpoint of this study was not met. HAIC using percutaneous catheter placement techniques did not improve the RR for liver metastasis from CRC.
authors: National Cancer Center, Central Hospital, Tokyo, Japan.
authors: Yasuaki
authors: Y
authors: Arai
authors: Toru
authors: T
authors: Aoyama
authors: Yoshitaka
authors: Y
authors: Inaba
authors: Haruumi
authors: H
authors: Okabe
authors: Takashi
authors: T
authors: Ihaya
authors: Kimihiko
authors: K
authors: Kichikawa
authors: Yasuo
authors: Y
authors: Ohashi
authors: Junichi
authors: J
authors: Sakamoto
authors: Koji
authors: K
authors: Oba
authors: Shigetoyo
authors: S
authors: Saji
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002408:Catheters, Indwelling; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil
keywords: colorectal cancer; hepatic arterial infusion; liver metastases