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Randomized Phase II Trial of Embolization Therapy Versus Chemoembolization Therapy in Previously Treated Patients with Colorectal Carcinoma Metastatic to the Liver
- Source :
- Clinical Colorectal Cancer. 2:173-179
- Publication Year :
- 2002
- Publisher :
- Elsevier BV, 2002.
-
Abstract
- Locoregional therapies are useful in treating patients with colorectal cancer metastatic to the liver. A prospective randomized phase II trial of hepatic artery embolization 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 1 (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 11 months (95% confidence interval [CI], 8–15 months). Survival in patients with extrahepatic disease was 8 months (95% CI, 6- 10 months). Survival in patients with liver-only metastases was 15 months (95% CI, 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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Colorectal cancer
medicine.medical_treatment
Rectum
Adenocarcinoma
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Hepatic artery embolization
Prospective Studies
Embolization
Chemoembolization, Therapeutic
Aged
Aged, 80 and over
business.industry
Liver Neoplasms
Gastroenterology
Cancer
Middle Aged
medicine.disease
Embolization, Therapeutic
Surgery
Survival Rate
medicine.anatomical_structure
Oncology
Toxicity
Female
Polyvinyls
Fluorouracil
Interferons
Colorectal Neoplasms
business
Artery
Subjects
Details
- ISSN :
- 15330028
- Volume :
- 2
- Database :
- OpenAIRE
- Journal :
- Clinical Colorectal Cancer
- Accession number :
- edsair.doi.dedup.....5bc8c6d4074f69b7bf9296f3273a0613