I need to put details about my own story–and RVD “light,” on hold for a day to discuss some breaking news with you.
It wasn’t.
I should have jumped-on this story. I had the information–I just didn’t act on it.
Yep. The Myeloma Beacon scooped me on this one! Listen to this:
FDA Issues Extensive Update About Revlimid And Second Cancers
The Myeloma Beacon Staff – May 7, 2012
The U.S. Food and Drug Administration earlier today issued an extensive update regarding the risk of developing a second cancer while being treated with Revlimid.
The update comes on the heels of a change the Food and Drug Administration (FDA) made to the prescribing information for Revlimid (lenalidomide) in March of this year.
The change involved the addition of a warning that patients being treated with Revlimid have an increased risk of developing a second cancer (see related Beacon news).
Today’s update by the FDA includes more specific details of the agency’s analyses of Revlimid and second cancers.
In the update, the FDA says that it continues to recommend that physicians monitor patients being treated with Revlimid for the development of second cancers, and that physicians take into account both the potential benefit of the drug and the risk of second cancers when they consider treating a patient with Revlimid…
…Data from three ongoing clinical trials show so far that 7.9 percent of newly diagnosed patients receiving Revlimid maintenance have developed a second cancer, compared to 2.8 percent of patient who received a placebo. Patients receiving Revlimid were more likely to develop acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin’s lymphoma. The median time from start of Revlimid treatment till diagnosis of a second cancer was two years…
I don’t have any regrets about using Revlimid for five years. But nearly an 8% risk of developing a secondary cancer could give one pause.
But hold on a minute! I do have a secondary cancer–melanoma–caused by a compromised immune system, primarily from taking Revlimid. I doubt my case made the stats. I wonder what the number really is if you count melanoma or solid tumor cancers–yes, several myeloma specialists have shared with me that they have dealt with suspicious, post treatment solid tumor cancers. Did Revlimid cause these? Thalidomide? A combination of different anti-myeloma agents?
I have highlighted a few key points in BOLD.
For some reason, my system doesn’t like to link back to the Beacon site. But if you go to www.MyelomaBeacon.com, you can find this article. READ IT!
Wow! 7.9%. And note the median time to diagnosis of a second cancer was only two years. That means one half of the 7.9% to get a secondary cancer had it within two years. Very surprising that it would happen so fast.
Nothing like the close to 50% risk of using two or more years of melphalan and prednisone. Once a common anti-myeloma combination, this therapy is still commonly administered to patients too old to transplant.
We lost a senior member of one of my Minnesota based myeloma support group to a secondary blood cancer, most likely caused by this therapy combination.
They told him to expect to get it–but that it would be easier to treat than the myeloma. Unfortunately, but the time he reached that point his body was so worn-down that he was unable to withstand treatment.
It will be interesting to see how myeloma experts rationalize this. According to the Beacon, “European regulators concluded their review of Revlimid and second cancers last September by reporting that “the benefits of Revlimid, particularly improved survival, continue to outweigh the risks” (see related Beacon news).
Stay tuned. Feel good and keep smiling! Pat
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