"This study demonstrates that hepatic arterial infusion therapy extends survival and improves quality of life in patients with colorectal cancer that has spread to the liver," said Nancy E. Kemeny, MD, an Attending Physician in the Department of Medicine at Memorial Sloan-Kettering Cancer Center and the study's lead author. "These positive findings are particularly important, given that metastasis to the liver occurs in 60% of patients with metastatic colorectal cancer, and most patients with these liver tumors eventually die of their disease."
Several smaller studies have previously compared outcomes of HAI with systemic chemotherapy, but this is the first large study that had no crossover between the groups, meaning that none of the patients in the systemic group received HAI therapy.
In the multi-institutional trial by researchers from the Cancer and Leukemia Group B and the Eastern Cooperative Oncology Group, 135 patients were assigned randomly to receive either HAI or systemic chemotherapy. All of the patients needed to undergo surgical removal (resection) of their primary tumors in the colon or rectum before initiating chemotherapy. Patients receiving HAI then underwent a surgical procedure to have a chemotherapy pump inserted into their abdomen. (This procedure can sometimes be done laparoscopically.)
Researchers found that patients receiving HAI lived longer than those receiving systemic chemotherapy, with a median survival of 24 versus 20 months. In addition, patients receiving HAI had better response rates (47% versus 24%), and longer time to disease progression in the liver (9.8 months versus 7.3 months).
While patients receiving systemic chemotherapy experienced the usual treatment-associated side effects such as diarrhea, decreased white blood cell counts, and hair loss, patients receiving HAI did not. However, because patients on the HAI regimen experienced mild toxicity to the liver, patients' liver functions were monitored closely throughout the duration of treatment to prevent the toxicity from becoming more severe.
For both methods of treatment, women fared better than men, with median survival in the HAI group of 29.4 and 20.1 months for women and men, respectively, and in the systemic group it was 22.0 and 18.3 months.
Because the research began in 1996, before chemotherapy drugs such as irinotecan and oxaliplatin were available, both sets of patients received fluorouracil and leucovorin. Both groups had access to the newer drugs as they became available. Dr. Kemeny noted that studies are currently underway using HAI therapy in combination with newer drugs, and response rates appear to be even higher. Furthermore, the addition of HAI therapy is also being investigated in patients with primary liver cancer.
"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)." Nancy E. Kemeny, Memorial Sloan-Kettering Cancer Center, New York, NY.
A consumer information piece on this study can be found on ASCO's patient website, People Living With Cancer.org, at www.plwc.org/CancerAdvances. For additional information on the diagnosis and treatment of colorectal and liver cancer including staging illustrations, visit www.plwc.org/colorectal and www.plwc.org/liver.
The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.
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