Low doses of interferon don't prevent fatal recurrences of melanoma, according to a study by British researchers. Even though the interferon was given for 2 years, there were just as many deaths in the treatment group as in the comparison group, which received no treatment.

The study, which appeared in the Journal of Clinical Oncology (Vol. 22, No. 1: 53-61), may help melanoma patients and their doctors make decisions about how to proceed after surgery, said lead researcher Barry Hancock, MD, of the University of Sheffield.

"Our study found no clear advantage of low-dose interferon therapy following surgery in high-risk melanoma patients," he said in a statement. "Physicians and patients should be armed with all the facts so that they can make informed decisions regarding treatment."

Malignant melanoma is a cancer of the skin that often begins as a mole. It has been clearly related to sun-exposure, and is most common in fair-skinned people. Blacks have a very low chance of developing this disease.

Although melanoma is not a major cause of cancer-related deaths, the number of people diagnosed with this cancer has been steadily increasing. Some 55,000 Americans are expected to develop melanoma in 2004, and about 7,900 will die from it.

Melanoma can usually be cured with surgery if it is found early. Patients who have a high risk of dying from their melanoma usually are diagnosed after the melanoma has deeply invaded the skin or spread to nearby lymph nodes.

Doctors have had difficulty finding drugs that can prevent a recurrence in these patients, but early studies of interferon were very hopeful. High doses of the drug, given over the course of a year, clearly prevented the melanoma from coming back in some people. It may have even saved some lives, although many doctors aren't certain about its life-saving potential.

But treatment with interferon carries a high price. It is expensive and inconvenient because it must be given by injection, usually 3 times a week. Its side effects are even worse. Many patients develop extreme fatigue, fevers, headaches, nausea, weight loss and host of other problems. Some become depressed. Often, patients find the side effects unbearable and stop treatment.

To counter the side effects, many cancer specialists, especially in Europe, began using lower doses of the drug. But it wasn't clear if lower doses would also prevent the cancer from coming back, which led to the present study.

The British researchers enrolled 674 patients who had recently completed surgery for their melanoma and appeared to have a high risk of recurrence. Half the participants received injections of low doses of interferon 3 times a week for 2 years, while the rest of the patients had no treatment. Because of the low doses, toxicity was not a big problem and most patients were able to stick with their treatment.

But, there was no benefit from the drug. By 5 years, around 70% of the patients in each group had experienced a recurrence and around 42% to 45% of patients in each group had died.

The results leave doctors and patients with no clear answers about the best course of treatment for patients with high-risk melanoma, said Lynn Schuchter, MD, of the University of Pennsylvania Abramson Cancer Center, who wrote an editorial accompanying the study.

Although low doses appear ineffective, and high doses are toxic, interferon may still be "an appropriate option" for some patients, she wrote. More clinical trials are needed to determine how best to use the drug, she noted. Until then, doctors need to weigh all the evidence about the drug and use their best judgment, and patients must give "informed input," said Schuchter.

But, most importantly, as Schuchter points out, surgery can cure most melanomas if they are caught in time. Prevention and early detection are also key.

To help prevent skin cancer, the American Cancer Society recommends staying out of the sun, wearing protective clothing like hats, long sleeves, and sunglasses, and using sunscreen regularly. To find melanomas before they become deadly, ACS recommends self exams and regular checks by a doctor to look for suspicious moles.