For the next few days I'll look at a few of the studies presented at the ASH (American Society of Hematology) 2010 annual meeting from a caregiver's point of view. I'll try to boil the complicated findings about myeloma treatment down to a few key points.
What's really exciting is to be sitting in on the ASH panels, as Michael and I were, and hearing nuggets of hope. Case in point was when Dr. Michel Attal of the Hopital Purpan in Toulouse, France, lead investigator in a study of Revlimid maintenance after stem cell transplantation said, during a Q&A: "I'm convinced some of these patients will be cured."
Today, let's look at Revlimid in the maintenance setting and continuous treatment.
In the first study, 568 multiple myeloma patients under the age of 70 years were randomized to receive either Revlimid maintenance therapy or a placebo following autologous stem cell transplantation.
A preliminary data analysis from this study in 2009 showed such a significant improvement in the time to disease progression in the Revlimid maintenance arm that the study was unblinded, and patients in the placebo arm were allowed to switch over to the Revlimid maintenance arm.
The 18-month follow-up results were presented by lead investigator Dr. Philip McCarthy of the Roswell Park Cancer Institute in Buffalo, New York. The results showed that patients who received Revlimid exhibited a median time to disease progression of 42 months compared to 22 months for patients who received the placebo. Overall survival was similar for the two groups. Dr. McCarthy explained that this may be due to the significant percentage of placebo patients who switched over to Revlimid maintenance when the trial was unblinded in late 2009.
#2 Revlimid Maintenance After Stem Cell Transplantation (IFM Study)
One of the most exciting things to come out of this presentation was confirmation of what I wrote about in my first blog post: the importance to patients and caregivers of Quality of Life.
Here, 614 multiple myeloma patients under the age of 65 years who had recently undergone stem cell transplantation received consolidation therapy with Revlimid, and then were randomized to receive long-term Revlimid maintenance therapy or a placebo.
A preliminary data analysis in late 2009 showed that Revlimid maintenance significantly improved progression-free survival. Therefore, this trial was also unblinded in mid-2010, and patients who were originally in the placebo group began receiving the Revlimid treatment regimen.
Dr. Attal, lead investigator of the study, presented results based on data that was collected up until the unblinding of the study. The results showed that Revlimid consolidation therapy improved responses and progression-free survival compared to transplantation alone. Revlimid maintenance therapy, however, did not significantly increase the number of patients who achieved a complete response.
When the study was unblinded, it was estimated that four years after diagnosis 60% of patients who received Revlimid maintenance would still be alive without disease progression compared to 33% for patients who received the placebo.
This benefit was observed even if patients achieved a complete response after induction therapy, showing the importance of maintenance even if a patient achieves a good response after initial treatment.
Dr. Attal commented that a longer follow-up study was needed to appreciate the impact on overall survival. However, he said that the better progression free survival is a huge improvement in Quality of Life.
Dr. Antonio Palumbo from the University of Torino in Italy investigated the addition of Revlimid to melphalan and prednisone in elderly newly diagnosed myeloma patients.
The study included 459 patients ages 65 years and older who received one of three possible treatment regimens. One regimen consisted of nine 28-day cycles of melphalan and prednisone alone, followed by placebo (MP). The second regimen consisted of nine 28-day cycles of melphalan, prednisone, and Revlimid, also followed by placebo (MPR). The third regimen was the same as the second, but, instead of receiving placebo after the first nine cycles of treatment, patients received maintenance therapy with Revlimid (MPR-R).
Dr. Palumbo and his colleagues found that responses were more rapid and better with MPR-R than MP, with a median onset of response of 2 and 3 months, respectively, and overall response rates of 70% and 50%, respectively.
A comparison of the different regimens showed that the Revlimid maintenance regimen, MPR-R, had a longer progression-free survival than the other two regimens. Progression-free survival for MPR-R, MPR, and MP were 31, 14, and 13 months, respectively. These results show a clear benefit to Revlimid maintenance therapy but have caused some physicians to doubt the advantage of using Revlimid upfront in elderly patients.
Side effects of MPR-R were manageable, but a larger percentage of patients on that regimen discontinued therapy due to side effects as compared to patients on MP. The most common severe side effects were low blood cell counts that occurred during the MPR phase of treatment.
That's enough for today. Hope this info was helpful and interesting to you. Remember the IMF's motto, Knowledge is Power. The more we learn the better we'll be able to make treatment decisions along with our doctors.
I don't know about you, but I'm very excited with the results coming out of all of these trials and will certainly look forward to updated information to come.For further information, the full abstracts from ASH may be found at: http://bloodjournal.hematologylibrary.org/misc/ASH_Meeting_Abstracts_Info.dtl