FACULTY COMMENTS
DR LONIAL: SWOG-S0232 — the sister trial of ECOG-E4A03
— compared lenalidomide/high-dose dexamethasone (len/
HD) to dexamethasone alone (HD) for the treatment of newly
diagnosed myeloma.
It was a placebo-controlled Phase III trial, which was interrupted after enrollment of the first 25 or 30 patients because of a high incidence of deep vein thrombosis before prophylaxis was mandated. It was stopped early at 198 patients because of the E4A03 data — which I believe was somewhat premature — suggesting that it was unethical to use len/HD. So it’s not a truly finished trial in terms of accrual to its real power.
In this study, we saw the real CR rate of 22 percent for len/HD in the up-front setting. What I think is intriguing about this trial — and the follow-up is short — is that the 12-month overall survival was 93 percent, which is much better than the 12-month survival rate for len/HD in ECOG-E4A03.
The advantage of the SWOG trial is that it is easier to evaluate because it has a true control arm, and its data are consistent with what we have seen with len/dex in other trials.
The risk of infection was higher in the len/dex arm, but these were predominately Grade I/II, and neutropenia can be seen with lenalidomide. Thrombosis was the big surprise from this trial, and aspirin did not appear to reduce the risk. Practically speaking, len/dex has essentially replaced thal/dex because of the ECOG and SWOG data.
I believe that the responses are encouraging, but I also believe that we can do even better with combinations. Hence, RVD has become our standard, but I think len/HD or VD are reasonable up-front induction regimens.
DR JAKUBOWIAK: This presentation had the potential to be an
important study, but it addressed a question that was already
answered in the Weber and Dimopoulos studies, albeit not
in a front-line setting, which demonstrated that lenalidomide/
dexamethasone was superior to dexamethasone alone.
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