Low-dose interferon fails to improve survival in high-risk melanoma patients

December 09, 2003

Alexandria, VA--A study examining the use of low-dose interferon following surgery in patients with high-risk melanoma showed no significant difference in recurrence-free or overall survival compared to patients receiving no further treatment. After more than a decade of conflicting studies on adjuvant interferon use, researchers stressed that patients and their physicians should know the facts about interferon before pursuing treatment options for high-risk melanoma. The results of this Phase III study will be reported December 9 online in the Journal of Clinical Oncology (JCO).

"Our study found no clear advantage of low-dose interferon therapy following surgery in high-risk melanoma patients," said Barry Hancock, MD, professor in the Academic Unit of Clinical Oncology at the University of Sheffield in the United Kingdom and lead author of the study.

According to Dr. Hancock, the trial was initiated after a series of studies on adjuvant interferon produced conflicting results and, in turn, conflicting interpretations of these results in both Europe and the United States. In Europe, prolonged duration of low-dose interferon is often considered standard therapy, while in the United States high-dose interferon is more commonly administered. However, despite studies showing high-dose interferon to be effective in extending disease-free survival, there has been widespread concern, even in the United States, among physicians and patients who believe the treatment to be ineffective or too toxic. As a result, researchers wanted to see whether prolonged, low doses of the drug would be effective in extending survival, without the harmful side effects of high-dose interferon.

Of the 674 patients enrolled in this trial, 338 received interferon following surgery, and 336 received no follow up treatment. After five years, 63% of patients in both groups experienced disease recurrence (211 IFN vs. 215 control), and 46% of patients in both groups died (151 IFN vs. 156 control). Five-year overall and recurrence-free survival was the same in both groups, estimated to be 44% and 32%, respectively.

In addition, the analysis found no clear difference in overall or recurrence-free survival when patients were compared by disease stage, age, and gender. As researchers expected, low-dose interferon was relatively well tolerated, with patients noting fatigue and mood disturbance as the primary side effects.

"The debate on adjuvant interferon in high-risk melanoma continues. After many years of clinical research, there is good evidence that high-dose interferon improves recurrence-free survival, but no clear evidence of the benefit to overall survival. Physicians and patients should be armed with all the facts so that they can make informed decisions regarding treatment," Dr. Hancock said.

In light of these findings, two accompanying editorials appearing in the JCO discuss the debate over adjuvant-interferon trials for patients with resected high-risk melanoma. The authors note that although the study did not find low-dose interferon to be a promising treatment for high-risk melanoma, it does provide insight into the available treatment options and implications for the design of future clinical trials.

"This study confirms that optimal care for patients with high-risk melanoma is still not clear. As a result, treatment decisions will require the integration of existing evidence, judgment of experienced clinicians, and informed input from patients, noted Lynn Schuchter, MD, Associate Professor of Medicine at the Abramson Cancer Center of the University of Pennsylvania and author of the accompanying editorial, Adjuvant Interferon Therapy For Melanoma: High-dose, Low-dose, No Dose, Which Dose? "Continued participation by physicians and patients in well-designed randomized clinical trials will facilitate continued progress in the treatment of melanoma.

"The challenge now is to go beyond these results - to develop more innovative and efficient clinical trials, and better identify those patients at risk of recurrence based upon the use of molecular genetic factors," Dr. Schuchter added.
-end-
"Adjuvant Low-dose Interferon In High-risk Melanoma." Barry Hancock, M.D. et al, University of Sheffield, United Kingdom.

The Journal of Clinical Oncology is the semi-monthly peer-reviewed journal of the American Society of Clinical Oncology (ASCO), the world's leading professional society representing physicians who treat people with cancer.

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