There is one last study that was presented as a poster summary on Sunday at ASH that is worth mentioning. It concerns the Italian study that is one of the first to ask the question: Does it make sense to give patients a stem cell transplant early in their treatment, or is it better just to treat them longer with a regimen including one of the novel agents.
In the Italian trial, all 402 newly diagnosed patients in the trial received four cycles of Revlimid and low-dose dexamethasone. Patients were then split randomly into two groups.
One group received an autologous stem cell transplant preceded by high-dose melphalan conditioning therapy. This group is designated the MEL200 group in articles and abstracts about the study.
The second group received no stem cell transplant and, instead, received six 28-day cycles of melphalan, prednison, and Revlimid (MPR).
What were the key results of the trial?
The transplant group had better progression free survival and overall survival.
Progression free survival was 73 percent for the MEL200 (transplant) group at 24 months, versus 54 percent for the MPR group. This is a statistically significant difference.
Overall survival was 90 percent for the MEL200 group at 24 months, versus 87 percent for the MPR group. This difference is not yet statistically significant.
The authors of the study acknowledge, however, that the MPR group experienced a noticeably lower level of side effects than was experienced by the transplant group.
http://ash.confex.com/ash/2011/webprogram/Paper36073.html
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