Novel agent-based continuous therapy significantly improved progression-free survival, both when measured from random assignment until first and second progression or death, and overall survival in patients with newly diagnosed multiple myeloma, a new study published in the Journal of Clinical Oncology has shown.
For the study, researchers in Italy pooled data from three phase 3 trials that randomly assigned 1,218 patients with newly diagnosed multiple myeloma to novel agent-based continuous therapy or fixed duration of therapy.
Primary endpoints were progression-free survival 1 (PFS1; time from random assignment until the first progression or death), PFS2 (time from random assignment until the second progression death), and overall survival.
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Results showed that during a median follow-up of 52 months, continuous therapy significantly improved PFS1 by a median of 16 months compared with fixed duration of therapy (32 versus 16 months; HR = 0.47; 95% CI, 0.40, 0.56; P<0.001).
Continuous therapy also significantly improved PFS2 by a median of 15 months (55 versus 40 months; HR = 0.61; 95% CI: 0.50, 0.75; P<0.001).
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The study demonstrated a 69% 4-year overall survival with continuous therapy compared with 60% with fixed duration of therapy (HR = 0.69; 95% CI, 0.54, 0.88; P=0.003).
The findings suggested that the benefit reported during first remission may not be negated by a shorter second remission. The authors also noted that that PFS2 is a valuable endpoint to evaluate long-term clinical benefit and should be used in future clinical trials.
Reference
- Palumbo A, Gay F, Cavallo F, et al. Continuous therapy versus fixed duration of therapy in patients with newly diagnosed multiple myeloma. J Clin Oncol. 2015. [epub ahead of print]. doi: 10.1200/JCO.2014.60.2466.
