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Phase II study on hepatic arterial infusion chemotherapy using percutaneous catheter placement techniques for liver metastases from colorectal cancer (JFMC28 study)
Author(s) -
Arai Yasuaki,
Aoyama Toru,
Inaba Yoshitaka,
Okabe Haruumi,
Ihaya Takashi,
Kichikawa Kimihiko,
Ohashi Yasuo,
Sakamoto Junichi,
Oba Koji,
Saji Shigetoyo
Publication year - 2015
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12324
Subject(s) - medicine , clinical endpoint , colorectal cancer , metastasis , gastroenterology , adverse effect , percutaneous , chemotherapy , progressive disease , phases of clinical research , hepatic arterial infusion , catheter , fluorouracil , surgery , urology , cancer , randomized controlled trial
Aim 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/m 2 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). Conclusion 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 .