Randomized phase II trial of embolization therapy versus chemoembolization therapy in previously treated patients with colorectal carcinoma metastatic to the liver

Huda Shafic Salman, Jacov Cynamon, Marci Jagust, Curtis Bakal, Alla Rozenblit, Ron Kaleya, Abdissa Negassa, Scott Wadler

Research output: Contribution to journalArticle

47 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)173-179
Number of pages7
JournalClinical Colorectal Cancer
Volume2
Issue number3
DOIs
StatePublished - Jan 1 2002

Fingerprint

Colorectal Neoplasms
Liver
Therapeutics
Hepatic Artery
Survival
Neoplasm Metastasis
Liver Abscess
National Cancer Institute (U.S.)
Rectum
Fluorouracil
Interferons
Diarrhea
Colon
Adenocarcinoma
Confidence Intervals
Biopsy
Drug Therapy
Mortality
ivalon sponge

Keywords

  • 5-Fluorouracil
  • Hepatic artery emobolization
  • Interferon-αa
  • Locoregional therapy
  • Polyvinyl alcohol foam

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

Randomized phase II trial of embolization therapy versus chemoembolization therapy in previously treated patients with colorectal carcinoma metastatic to the liver. / Salman, Huda Shafic; Cynamon, Jacov; Jagust, Marci; Bakal, Curtis; Rozenblit, Alla; Kaleya, Ron; Negassa, Abdissa; Wadler, Scott.

In: Clinical Colorectal Cancer, Vol. 2, No. 3, 01.01.2002, p. 173-179.

Research output: Contribution to journalArticle

Salman, Huda Shafic ; Cynamon, Jacov ; Jagust, Marci ; Bakal, Curtis ; Rozenblit, Alla ; Kaleya, Ron ; Negassa, Abdissa ; Wadler, Scott. / Randomized phase II trial of embolization therapy versus chemoembolization therapy in previously treated patients with colorectal carcinoma metastatic to the liver. In: Clinical Colorectal Cancer. 2002 ; Vol. 2, No. 3. pp. 173-179.
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