TY - JOUR
T1 - Randomized phase II trial of embolization therapy versus chemoembolization therapy in previously treated patients with colorectal carcinoma metastatic to the liver
AU - Salman, Huda S.
AU - Cynamon, Jacov
AU - Jagust, Marci
AU - Bakal, Curtis
AU - Rozenblit, Alla
AU - Kaleya, Ron
AU - Negassa, Abdissa
AU - Wadler, Scott
N1 - Funding Information:
This research was supported in part by Cancer Center Support Grant CA 13330 from the National Cancer Institute, National Institutes of Health.
PY - 2002/11
Y1 - 2002/11
N2 - Locoregional therapies are useful in treating patients with colorectal cancer metastatic to the liver. A prospective randomized phase II trial of hepatic artery embolizatin versus hepatic artery chemoembolization was conducted to evaluate the response rates and toxicities of these therapies in the second-line setting. Patients were required to have biopsy-proven adenocarcinoma of the colon or rectum metastatic to the liver, with the liver as the sole or predominant site of metastatic disease. All patients had measurable disease and had failed at least one prior systemic chemotherapy treatment for metastatic disease. Patients were randomized to receive either embolization therapy with polyvinyl alcohol foam (Ivalon®) administered as a single agent or chemoembolization using polyvinyl alcohol foam mixed with 750 mg/m2 of 5-fluorouracil and 9 million units of interferon. Drugs and embolic material were administered via the hepatic artery as a slurry with polyvinyl alcohol foam. Fifty eligible patients were enrolled. There were 24 patients in the chemoembolization arm and 26 in the embolization arm. Sixty-four percent of patients in both treatment arms had the liver as the sole metastatic site. The most common National Cancer Institute common toxicity criteria grade 3/4 toxicities were diarrhea (17%) and hepatic toxicity (8%). There was I (4%) treatment-related mortality due to a hepatic abscess. Four patients (15.4%) treated with embolization had a partial response (PR), and 5 patients (20.8%) treated with chemoembolization had a PR. The median survival for all patients was II months (95% confidence interval [CI], 8-15 months). Survival in patients with extrahepatic disease was 8 months (95% Cl, 6-10 months). Survival in patients with liver-only metastases was 15 months (95% Cl, 10-17 months). Embolization of the liver as second-line therapy in patients with liver-predominant metastases is safe and effective. Median survivals are comparable to other second-line therapies.
AB - Locoregional therapies are useful in treating patients with colorectal cancer metastatic to the liver. A prospective randomized phase II trial of hepatic artery embolizatin versus hepatic artery chemoembolization was conducted to evaluate the response rates and toxicities of these therapies in the second-line setting. Patients were required to have biopsy-proven adenocarcinoma of the colon or rectum metastatic to the liver, with the liver as the sole or predominant site of metastatic disease. All patients had measurable disease and had failed at least one prior systemic chemotherapy treatment for metastatic disease. Patients were randomized to receive either embolization therapy with polyvinyl alcohol foam (Ivalon®) administered as a single agent or chemoembolization using polyvinyl alcohol foam mixed with 750 mg/m2 of 5-fluorouracil and 9 million units of interferon. Drugs and embolic material were administered via the hepatic artery as a slurry with polyvinyl alcohol foam. Fifty eligible patients were enrolled. There were 24 patients in the chemoembolization arm and 26 in the embolization arm. Sixty-four percent of patients in both treatment arms had the liver as the sole metastatic site. The most common National Cancer Institute common toxicity criteria grade 3/4 toxicities were diarrhea (17%) and hepatic toxicity (8%). There was I (4%) treatment-related mortality due to a hepatic abscess. Four patients (15.4%) treated with embolization had a partial response (PR), and 5 patients (20.8%) treated with chemoembolization had a PR. The median survival for all patients was II months (95% confidence interval [CI], 8-15 months). Survival in patients with extrahepatic disease was 8 months (95% Cl, 6-10 months). Survival in patients with liver-only metastases was 15 months (95% Cl, 10-17 months). Embolization of the liver as second-line therapy in patients with liver-predominant metastases is safe and effective. Median survivals are comparable to other second-line therapies.
KW - 5-Fluorouracil
KW - Hepatic artery emobolization
KW - Interferon-αa
KW - Locoregional therapy
KW - Polyvinyl alcohol foam
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U2 - 10.3816/CCC.2002.n.022
DO - 10.3816/CCC.2002.n.022
M3 - Article
C2 - 12482334
AN - SCOPUS:0036864582
SN - 1533-0028
VL - 2
SP - 173
EP - 179
JO - Clinical colorectal cancer
JF - Clinical colorectal cancer
IS - 3
ER -