Pooled Analysis Shows Improved Outcomes With Continuous vs Fixed-Duration Therapy in Newly Diagnosed Multiple Myeloma
In a pooled analysis of trials assessing novel agent-based continuous therapy vs fixed duration of therapy reported in the Journal of Clinical Oncology, Palumbo et al found that continuous therapy prolonged progression-free survival, progression-free survival-2 (time to second progression or death), and overall survival in patients with newly diagnosed multiple myeloma.
Study Details
The analysis included patients from three phase III trials (Italian Group for Hematologic Diseases in Adults [GIMEMA]-MM-03-05, RV-MM-PI-209, and CC-5013-MM-015) coordinated by the same principal investigator. Patients were randomly assigned to continuous therapy or fixed-duration therapy with novel agents (thalidomide [Thalomid], lenalidomide [Revlimid], or bortezomib [Velcade]). Fixed duration of therapy was defined as up-front therapy (induction/consolidation) for ≤ 1 year; continuous therapy was defined as upfront therapy followed by maintenance lasting ≥ 2 years.
Patients eligible for the current analysis were those eligible for continuous therapy—ie, those who were alive and progression-free at 1 year from randomization. In the pooled populations, 604 patients were randomly assigned to continuous therapy and 614 to fixed duration of therapy in the intent-to-treat population; of these, 417 and 410 were included in the current analysis.
Continuous Therapy Benefit
Median follow-up was 52 months. Continuous therapy was associated with significantly better median progression-free survival (32 vs 16 months, hazard ratio [HR] = 0.47, P < .001), median progression-free survival-2 (55 vs 40 months, HR = 0.61, P < .001), and 4-year overall survival (69% vs 60%, HR = 0.69, P = .003).
The investigators concluded: “In this pooled analysis, [continuous therapy] significantly improved [progression-free survival-1, progression-free survival-2, and overall survival]. The improvement in [progression-free survival-2] suggests that the benefit reported during first remission is not cancelled by a shorter second remission. [Progression-free survival-2] is a valuable endpoint to estimate long-term clinical benefit and should be included in future trials.”
Antonio Palumbo, MD, of Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, is the corresponding author for the Journal of Clinical Oncology article.
For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
