Women, younger patients more likely to select adjuvant interferon as tx for high-risk melanoma

October 1, 2007

A study published earlier this year found several patient characteristics to be predictive of the decision to choose adjuvant interferon in patients with high-risk melanoma. The study found women, younger patients, and those not prone to depression were more likely to opt for interferon therapy.

While this therapy is not effective in many patients with high-risk melanoma, adjuvant interferon results in relapse-free survival of up to 10 percent of patients who choose the therapy. Investigators retrospectively examined demographic information to find possible predictors of patients who chose interferon treatment.

"These patients are at a point where they have to make decisions about their care," says Tracy Bialy Bramlette, M.D., M.P.H., one of the investigators and a dermatologist at Emory University Hospital/Emory University School of Medicine.

The lifetime risk of developing melanoma for U.S.-born individuals in the year 2000 was 1 in 58 for men and 1 in 82 for women. Patients who have melanomas measuring 4 mm and more and/or sentinel lymph node (SLN) involvement have an elevated risk of tumor recurrence post-operatively, with the rate of recurrence ranging from 40 percent to 90 percent and disease-related mortality.

The only adjuvant treatment approved by the Food and Drug Administration (FDA) is high-dose interferon alfa-2b. However, a one-year course of interferon-alfa-2b is linked to hematologic and neurologic adverse events.

Moreover, results of clinical trials with interferon alfa-2b have been mixed, leading to effect on quality of life being a central part of the decision to take interferon alfa-2b therapy, Dr. Bialy Bramlette says.

Through a retrospective chart review and mining the Emory Melanoma Database review, investigators considered all patients who had undergone an SLN biopsy between 1996 and 2001. They included patients who had a positive biopsy or had a Breslow thickness of more than 4 mm, which represented 135 or 17.3 percent.

Oncologists counseled patients, informing them of a 50 percent or greater potential for recurrence and the threat of disease-related mortality. They were offered interferon-alfa-2b as an adjuvant treatment post-operatively, with information that the treatment offers up to an additional 10 percent survival benefit.

There were 91 surviving patients, a subset of which (66/91) completed a telephone survey analysis. A total of 60 patients (45 percent) decided to take interferon alfa-2b, whereas 75 of 135 (55 percent) declined treatment.

Researchers looked at patient traits such as age, gender, SLN status, mean Breslow thickness and presence of micro-ulceration. Their analysis found being female and having positive SLN status to be strongly associated with the choice to take adjuvant interferon.

In analyzing the subset of 66 patients, researchers found younger age (p= 0.04), diminished concern about developing depression (p< 0.01), more influenced by their oncologists, more understanding of the nature of the tumor (p< 0.01), not very affected by a drug's side effect profile (p<0.001) or the ability to endure an extended course of treatment, compared to patients who declined treatment.

Patients who chose to not take interferon therapy were influenced by the possibility of strained relationships with family (p=0.009) and disruptions in their social life (p=0.04).

"If you are going to target patients, we should more aggressively counsel patients who are more likely to tolerate the therapy and want to take it," Dr. Bialy Bramlette says.

"If patients thought there wasn't going to be a substantial improvement in survival, say 50 percent instead of 10 percent, they might have thought it wasn't worth it to undergo treatment if they were going to feel very sick while on interferon," Dr. Bialy Bramlette adds.