“My myeloma is stable. How long do I need to stay on maintenance therapy?”
This is the million dollar question for nearly all multiple myeloma patients at some time during their myeloma journey.
More and more articles like the one below nudge us toward the decision to stay on maintenance indefinitely. Give it a quick read and I’ll meet you on the other side:
Lenalidomide Maintenance After Stem-Cell Transplantation Benefits Patients With Multiple Myeloma
Jill SteinPublished Online: Friday, August 31, 2012
The immunomodulator lenalidomide (Revlimid) used continuously after autologous hematopoietic stem cell transplantation significantly prolonged the time to disease progression and overall survival in patients with multiple myeloma compared with placebo, according to the results of the phase III CALGB 100104 study.
Maintenance lenalidomide is, however, associated with increased toxicity and second primary cancers.
“This study suggests that lenalidomide maintenance therapy until disease progression is feasible for long-term use,” Philip L. McCarthy, MD, director of the Blood and Marrow Transplant Program at Roswell Park Cancer Institute in Buffalo, New York, and his co-authors wrote.
Investigators at 47 centers randomized 460 patients with stable disease or a marginal, partial, or complete response 100 days after undergoing a single stem-cell transplantation to maintenance lenalidomide (10 mg daily) or placebo until disease progression.
Multiple myeloma is largely incurable, and disease relapse/progression is the primary cause of treatment failure after high-dose autologous stem cell transplantation, the authors noted. Maintenance of a prolonged progression-free interval with minimal toxicity is an important objective in managing this disease.
The primary endpoint was time to disease progression, defined as time to progressive disease or death from any cause after transplantation.
The study was unblinded in 2009, after a median follow-up of 18 months, when 47 of 231 lenalidomide-treated patients (20%) had progressive disease or had died versus 101 of 229 placebo-treated patients (44%; P <.001). Of the remaining 128 patients who received placebo and did not have progressive disease, 86 crossed over to lenalidomide.
At a median follow-up of 34 months, 86 of 231 lenalidomide-treated patients (37%) and 132 of 229 placebo-treated patients (58%) had disease progression or had died. The median time to progression was 46 months and 27 months in the lenalidomide and placebo groups, respectively (P <.001). Overall, 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P = .03).
The lenalidomide group had a higher rate of grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events (P <.001 for both comparisons).
Of the 231 lenalidomide-treated patients, 8 (3.5%) developed new hematologic cancers and 10 (4.3%) developed solid-tumor cancers. Of the 229 placebo-treated patients, 1 (0.4%) developed new hematologic cancer and 5 (2.2%) developed solid-tumor cancers. The increase in second primary solid-tumor cancers in patients treated with the immunomodulator was not associated with a specific tumor type, and potential causes for the increase have not been clarified, the authors pointed out. They recommended close monitoring of blood counts and standard screening for cancers.
Finally, they said that future research is needed to determine whether combining other new agents with lenalidomide will further extend the time to disease progression and overall survival.
McCarthy PL, Owzar K, Hofmeister CC, et al. Lenalidomide after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1770-1781.
I didn’t see any overall survival (OS) statistics there, did you? Yes, fewer patients died while on maintenance:
Overall, 35 patients who received lenalidomide (15%) and 53 patients who received placebo (23%) died (P = .03).
That’s an 8% advantage for the maintenance patients. But did you notice that almost 8% of patients on maintenance developed a secondary cancer?Less than 3% of patients not using maintenance developed secondary cancers.
There is no discussion about quality of life issues, except that:
The lenalidomide group had a higher rate of grade 3 or 4 hematologic adverse events and grade 3 nonhematologic adverse events (P <.001 for both comparisons).
And what about the high cost of taking years one or more maintenance drug for years?
So as you can see, the answer to the question, “How long do I need to stay on maintenance therapy?” is a complicated one. A majority of hem/oncs would answer, “Indefinitely.” At least that’s what one needs to do in order to gain the significant time to disease progression benefit outlined in studies like the one above.
At this point, readers often ask: “How can using maintenance therapy keep my myeloma away for almost two extra years, yet in the end not help me live much longer?”
Great question! I will attempt to answer it tomorrow.
Feel good and keep smiling! Pat