December 8, 2013
MMRF Newsflash from ASH 2013 - Volume 2
Breaking News from the Plenary Session!
The penultimate honor at a meeting like ASH is to present at a plenary session. Multiple myeloma does not have a slot every year, so it was a rare honor for the FIRST study to be presented to be presented by Dr. Thierry Facon in front of thousands of attendees. The study consisted of 1,623 patients from 246 centers from 18 countries on four continents, and compared continuous Revlimid-dex (until disease progression) vs 18 cycles of Revlimid-dex vs melphalan-prednisone-thalidomide (a regimen not used in the US but still occasionally in some countries worldwide) in patients ineligible for high-dose chemotherapy and stem cell transplant.
The primary endpoint was measuring progression free survival (the amount of time patients were alive with their disease worsening). The group who received continuous Rev-dex had a PFS of 25.5 months vs. 20.7 and 21.2 for the other groups. There are 121 patients still receiving Revlimid-dex today. PFS was superior in this group regardless of factors like age, sex, and stage of disease. The toxicity profile for the Rev-dex arms was superior with fewer Grade 3-4 (serious) toxicities, with infection being most commonly reported. Importantly, there was no increased risk of second cancers, which has been seen in other Revlimid maintenance studies; it seems that this slightly elevated risk may be due to the combination of Revlimid with an alkylating agent like melphalan.
Both Dr. Facon and Dr. San Miguel who had introduced the abstract stated that continuous Revlimid-dex represents a new standard of care in this population. It is important to note that the study did not include comparisons with other regimens commonly used today in the US (Velcade-dex and Revlimid-Velcade-dex) or outside the US (Velcade-melphalan-prednisone and Velcade-thalidomide-dex), but nonetheless, the results are certainly encouraging, particularly when considering other trials showing a PFS benefit for prolonged or continuous Revlimid early in the disease course.
To see the full MMRF coverage from ASH with ongoing updates, please visit: www.themmrf.org/ash2013.