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Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481).

Publication ,  Journal Article
Kemeny, NE; Niedzwiecki, D; Hollis, DR; Lenz, H-J; Warren, RS; Naughton, MJ; Weeks, JC; Sigurdson, ER; Herndon, JE; Zhang, C; Mayer, RJ
Published in: J Clin Oncol
March 20, 2006

PURPOSE: Hepatic metastases derive most of their blood supply from the hepatic artery; therefore, for patients with hepatic metastases from colorectal cancer, hepatic arterial infusion (HAI) of chemotherapy may improve outcome. METHODS: In a multi-institutional trial, 135 patients were randomly assigned to receive HAI versus systemic bolus fluorouracil and leucovorin. The primary end point was survival; secondary end points were response, recurrence, toxicity, quality of life, cost, and the influence of molecular markers. RESULTS: Overall survival was significantly longer for HAI versus systemic treatment (median, 24.4 v 20 months; P = .0034), as were response rates (47% and 24%; P = .012) and time to hepatic progression (THP; 9.8 v 7.3 months; P = .034). Time to extrahepatic progression (7.7 v 14.8 months; P = .029) was significantly shorter in the HAI group. Quality-of-life measurements showed improved physical functioning in the HAI group at the 3- and 6-month follow-up assessments. Toxicity included grade > or = 3 neutropenia (2% and 45%; P < .01), stomatitis (0% and 24%; P < .01), and bilirubin elevation (18.6% and 0; P < .01) in the HAI and systemic treatment groups, respectively. A greater proportion of men versus women receiving HAI experienced biliary toxicity (37% and 15%, respectively; P = .05). For HAI patients with thymidylate synthase levels in tumor less than or > or = 4, the median survival was 24 and 14 months, respectively (P = .17). CONCLUSION: HAI therapy increased overall survival, response rate, THP, and was associated with better physical functioning compared with systemic therapy. Additional studies need to address the overall benefit and cost of new chemotherapy agents versus HAI alone or the combination of HAI with new agents.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2006

Volume

24

Issue

9

Start / End Page

1395 / 1403

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Quality of Life
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Leucovorin
  • Injections, Intravenous
  • Infusions, Intra-Arterial
 

Citation

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Kemeny, N. E., Niedzwiecki, D., Hollis, D. R., Lenz, H.-J., Warren, R. S., Naughton, M. J., … Mayer, R. J. (2006). Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481). J Clin Oncol, 24(9), 1395–1403. https://doi.org/10.1200/JCO.2005.03.8166
Kemeny, Nancy E., Donna Niedzwiecki, Donna R. Hollis, Heinz-Josef Lenz, Robert S. Warren, Michelle J. Naughton, Jane C. Weeks, et al. “Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481).J Clin Oncol 24, no. 9 (March 20, 2006): 1395–1403. https://doi.org/10.1200/JCO.2005.03.8166.
Kemeny NE, Niedzwiecki D, Hollis DR, Lenz H-J, Warren RS, Naughton MJ, et al. Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481). J Clin Oncol. 2006 Mar 20;24(9):1395–403.
Kemeny, Nancy E., et al. “Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481).J Clin Oncol, vol. 24, no. 9, Mar. 2006, pp. 1395–403. Pubmed, doi:10.1200/JCO.2005.03.8166.
Kemeny NE, Niedzwiecki D, Hollis DR, Lenz H-J, Warren RS, Naughton MJ, Weeks JC, Sigurdson ER, Herndon JE, Zhang C, Mayer RJ. Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481). J Clin Oncol. 2006 Mar 20;24(9):1395–1403.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

March 20, 2006

Volume

24

Issue

9

Start / End Page

1395 / 1403

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Quality of Life
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Leucovorin
  • Injections, Intravenous
  • Infusions, Intra-Arterial