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Does Interferon-α Prevent Recurrence of Malignant Tumors in Patients with Hepatitis C–Related Liver Cancer? FREE

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The summary below is from the full report titled “Effects of Long-Term Postoperative Interferon-α Therapy on Intrahepatic Recurrence after Resection of Hepatitis C Virus–Related Hepatocellular Carcinoma. A Randomized, Controlled Trial.” It is in the 15 May 2001 issue of Annals of Internal Medicine (volume 134, pages 963-967). The authors are S Kubo, S Nishiguchi, K Hirohashi, H Tanaka, T Shuto, O Yamazaki, S Shiomi, A Tamori, H Oka, S Igawa, T Kuroki, and H Kinoshita.


Ann Intern Med. 2001;134(10):S7. doi:10.7326/0003-4819-134-10-200105150-00006
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What is the problem and what is known about it so far?

Hepatitis C virus can infect the liver and, in some cases, leads to severe liver disease, including liver cancer (hepatocellular carcinoma). Interferon-α is a drug that decreases the chances of developing liver cancer when given to patients with hepatitis C virus infection who have not yet developed cancer. Once a person develops hepatitis C–associated liver cancer, surgery is often done to remove the cancer, but the cancer returns in 70% to 80% of patients within 5 years.

Why did the researchers do this particular study?

To find out whether use of interferon-α decreases the return of hepatitis C–associated liver cancer after surgical removal of the initial cancer.

Who was studied?

Thirty male patients in Japan with hepatitis C virus–associated liver cancer who had complete surgical removal of the initial cancer. In all patients, the initial cancer was a single tumor in the liver that had not spread to other locations.

How was the study done?

The researchers randomly assigned patients to receive either interferon-α injections (treatment group) or no additional treatment (controls). Beginning 5 to 15 weeks after the operation (except for one patient, who began 7 months after surgery), the patients assigned to the interferon-α group received daily injections for 2 weeks, then 3 times each week for the next 14 weeks, and then twice weekly for the remaining 88 weeks of the study. Patients had blood tests and special ultrasound or x-ray tests of the liver to look for return of the tumor within 2 months of surgery and every 3 months thereafter.

What did the researchers find?

Of the 30 study patients, 15 were assigned to interferon-α and 15 were assigned to receive no additional treatment after the operation. Of the patients assigned to the interferon-α group, 1 did not receive treatment because of an unrelated medical condition, and 7 had to stop use of the drug (because of complications [2 patients], cancer recurrence [4 patients], or a combination of complications plus cancer recurrence [1 patient]). At the end of the study, liver cancer returned in 5 of 15 patients assigned to interferon-α treatment and in 12 of the 15 controls. Statistical analysis suggests that not getting interferon-α was associated with a greater chance of return of the liver cancer.

What were the limitations of the study?

The number of patients studied was small, and some of the patients assigned to treatment with interferon-α did not actually get it. The apparent advantage to interferon-α therapy may not hold up in larger studies. The results may not apply to patients who have larger numerous initial tumors or who have cancer that has spread to other locations. In addition, the study followed patients for only 88 weeks. It is possible that the liver cancer could return after this time.

What are the implications of the study?

Interferon-α may be useful in preventing return of hepatitis C–associated liver cancer after surgical removal of initial cancer.

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