In a long-term analysis from the LYMA trial reported in the Journal of Clinical Oncology, Sarkozy et al found that rituximab maintenance following autologous stem cell transplantation (ASCT) continued to be of benefit vs observation in the first-line treatment of younger patients with mantle cell lymphoma.
Study Details and Key Findings
The analysis involved determination of long-term outcomes among 240 patients randomly assigned within 3 months after ASCT to receive rituximab maintenance (n = 120) or placebo (n = 120). Median follow-up from study inclusion was 7.5 years (95% confidence interval [CI] = 7.4–7.7 years).
In the total analysis population, 7-year progression-free survival was 55.5% (95% CI = 49.5%–61%) and 7-year overall survival was 69.5% (95% CI = 63.8%–74.5%). Event-free survival at 7 years was 76.2% in the rituximab group vs 46% in the observation group (hazard ratio [HR] = 0.39, 95% CI = 0.52–0.60, P < .0001). Progression-free survival rates at 7 years were 78.5% vs 47.4% (HR = 0.36, 95% CI = 0.23–0.56, P < .0001); overall survival at 7 years was 83.2% vs 72.2% (HR = 0.63, 95% CI = 0.37–1.08, P = .088).
Causes of death did not significantly differ between the two groups, with lymphoma being the most common. A very low rate of infection-related death was observed.
The investigators concluded, “Overall, the progression-free survival benefit of rituximab maintenance after [ASCT] remains after 7-year follow-up, and rituximab maintenance was not associated with an increase in infection-related mortality, making this strategy a safe standard of care with long-term follow-up.”
Steven Le Gouill, MD, PhD, of Institut Curie, Paris, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Roche. For full disclosures of the study authors, visit ascopubs.org.
