ASCO--A randomized ECOG study of patients with high-risk melanoma showed significant gains in overall and recurrence free survival for adjuvant high-dose interferon alfa-2b(Drug information on interferon alfa-2b) (Intron), but also showed that the high-dose regimen has significant side effects. However, a new quality of life analysis suggests that, for most patients, the benefits of interferon clearly offset its toxicity, Bernard Cole, PhD, of Brown University, said at an ASCO scientific session.
The study evaluated the tradeoff between toxicity and improved clinical benefit by applying the Q-TWiST technique (Quality-Adjusted Time Without Symptoms or Toxicity) to the ECOG data.
The method examines the time spent in health states that may represent diminished quality of life, ie, time with treatment toxicity and time with disease relapse, as well as time with no symptoms or relapse (best possible health). These health states are then weighted to reflect possible patient preferences.
Results indicate that patients who received interferon compared to observation spent 3 additional months in a state of best possible health, and 2 fewer months in relapse. These gains came at a cost of spending 6 months on average with treatment toxicity.
The study found that regardless of the relative value placed on the health states, the interferon group had more quality-adjusted time than the observation group.
The gain was significant for patients who place a high relative value on toxicity (greater than 0.9) and a low relative value on relapse (less than 0.4). Such a patient would consider the side effects of interferon to be manageable and would be devastated by disease relapse, he said.
When the analysis was restricted to node-positive patients, who made up 90% of the study sample, the interferon benefit was significant for any case in which a patient places a higher value on time with toxicity than time with relapse.