ASH is the American Society of Hematology, which has its annual meeting in early December each year, called the ASH Conference, or just ASH. I will be blogging on several topics, but this one, though it is “just” a poster talk and not an oral presentation, seems extremely important because it suggests a change in the standard of care for newly-diagnosed patients.
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.
Needless to say, this is a startling result, because the up-front ASCT preceded by Rev/Dex or some other induction is still thought by many doctors to be the standard of care. The authors are careful to downplay the obvious conclusions, however, saying that the study is small (47 patients total) and the follow-up short. They go so far as to say that the PFS and OS differences between the two arms are “not statistically significant,” presumably because of the small study size.
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.
My suggestion to any newly-diagnosed patient whose doctor is recommending a transplant: Ask your doctor if s/he has read this abstract, or better yet the full paper. If not, wait until s/he has read it. Then ask why the results do not apply in your case.
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.