Paper 3180: Lenalidomide and Dexamethasone Alone Is Equivalent To Lenalidomide and Dexamethasone With Autologous Stem Cell Transplant In Newly Diagnosed Multiple Myeloma: Interim Study Results Of a Randomized Trial.
The authors are from Columbia University and two other major universities. Their small study has two arms: (1) Revlimid/dexamethasone (Rev/Dex), followed by autologous stem cell transplant (ASCT), then followed by Revlimid maintenance; and (2) The same Rev/Dex treatment and Rev maintenance, but without the transplant. Here are some of the results:
- More patients on the ASCT arm responded to treatment, 96% versus 77%. No surprise. Those who did not respond went off study and are not included in the statistics reported below.
- Patients on the ASCT arm had a median progression-free survival of 17.0 months, versus 25.2 months for the Rev/Dex-only arm. That's right - I don't have it backward.
- Similarly, patients in the ASCT arm have a median overall survival (OS) of 57.6 months, while the OS for the other arm has not been calculated yet because more than half are still alive.
I have other caveats:
- Previous studies have shown that more-aggressive treatment can benefit high-risk patients, and I do not see any effort in this study to identify those patients for separate evaluation or to remove their results from the overall calculations.
- This is a study of newly diagnosed patients, and the results may not be at all relevant to previously-treated patients, especially to patients looking toward a second transplant.
- Some of the numbers do not make sense to me. For example, the authors say that only four patients have died in the ASCT arm, out of 25, yet they have computed a median OS. I am missing something and did not have a chance to speak to the presenters.
- I invite comments! Perhaps someone can explain.
- Other studies have shown that other frontline treatments may be even more effective than Rev/Dex, such as Kyprolis/Rev/Dex, followed by Rev maintenance.
For that matter, I believe that a transplant recommendation always calls for a second opinion anyway. No matter what anyone says, a transplant is rough medicine with lifelong implications.