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 (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.