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Continuous treatment ‘essential’ for patients with newly diagnosed myeloma
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CHICAGO — Patients with newly diagnosed multiple myeloma who received continuous treatment experienced significantly longer PFS and OS than patients who received fixed-duration therapy, according to retrospective study results presented at the ASCO Annual Meeting.
“This discussion about treatment regimens has been ongoing for a few years. The majority of studies are showing [an OS] benefit, but some studies do not show a benefit,” Antonio Palumbo, MD, chief of the Myeloma Unit in the Division of Hematology at University of Torino in Italy, said during a presentation. “The question is, do we create chemotherapy resistance with continuous treatment? What we gain during first remission, are we going to lose during second remission? How can we evaluate the efficacy of our treatment?”
Palumbo and colleagues analyzed the results of two randomized phase 3 trials designed to compare continuous vs. fixed-duration therapy.
In one trial, patients assigned to continuous therapy received induction with lenalidomide (Revlimid, Celgene), consolidation and lenalidomide maintenance. Those assigned to fixed-duration therapy received lenalidomide-based induction and consolidation without maintenance.
In the other trial, patients in the continuous therapy arm received induction with bortezomib (Velcade, Millennium Pharmaceuticals) followed by maintenance. Those assigned to fixed-duration therapy received a bortezomib-based induction without maintenance.
In both trials, researchers assessed PFS1 (time from diagnosis to first relapse), PFS2 (time from diagnosis to second relapse) and OS.
The pooled analysis included 452 patients who received continuous therapy and 461 who received fixed-duration therapy. Median follow-up was 52 months.
Results showed patients assigned continuous therapy experienced significantly longer median PFS1 (35 months vs. 24 months; HR=0.58; P<.0001), PFS2 (63 months vs. 47 months; HR=0.69; P=.0001) and OS (not reached vs. 70 months; HR=.7; P=.0019).
The results of each individual study were similar to those observed in the pooled analysis, according to researchers.
“Prolongation of PFS2 suggests that the clinical benefit observed during first remission is not cancelled by a shorter second remission,” Palumbo and colleagues wrote. “PFS2 should be included in all continuous treatment vs. fixed-duration therapy studies to evaluate the risk of tumor resistance induced by continuous treatment.”
When patients experienced first relapse, researchers evaluated second PFS — defined as time from first relapse to second relapse — as well as the time from first relapse to death. Results of those analyses showed similar outcomes between those assigned continuous therapy and fixed-duration therapy.
“In the future, we are definitely going to see a shift in the treatment paradigm for multiple myeloma from the fixed period of time to continuous treatment,” Palumbo said. “The reason is very simple: In myeloma, we always have residual disease. Therefore, continuous treatment is essential, because otherwise the residual disease will grow very quickly.”
For more information:
Palumbo A. Abstract #8515. Presented at: ASCO Annual Meeting; May 30-June 3, 2014; Chicago.
Disclosure: The researchers report consultant/advisory roles with Byotest, Celgene, Italfarmaco, Janssen and Novartis; honoraria from Celgene, Janssen and Onyx; and research funding from Celgene and Janssen.