1. In patients with mantle-cell lymphoma who responded to induction therapy and autologous stem cell transplantation, rituximab maintenance therapy prolonged overall and progression-free survival compared to observation alone
2. Maintenance therapy with rituximab did not correlate with elevated rates of infection-related mortality.
Evidence Rating Level: 1
Study Rundown: The LYMA trial initially investigated the impact of rituximab maintenance therapy following induction therapy and autologous stem cell transplantation on event-free survival, progression-free survival, and overall survival in young patients with mantle cell lymphoma. In those receiving rituximab maintenance therapy, an increase in event-free and progression-free survival was observed. The present study extends the assessment, specifically looking at event-free survival at a prolonged follow-up time of 7.5 years. The LYMA trial was an unblinded, randomized controlled trial that assigned patients to either rituximab maintenance therapy every two months for three years, or observation alone. The trial included patients with mantle-cell lymphoma aged 18-65, without major comorbidities and an ECOG score of less than 3. The present trial overall supported that rituximab maintenance therapy improved overall survival and progression-free survival in comparison to observation alone. The study further noted that rituximab maintenance therapy was not associated with increases in infection-related morality. Strengths of this trial include its relatively large sample size (240 participants), and its long longitudinal follow-up time 7.5 years. The trial limited its population to individuals aged 18-65 which limits generalizability to other age groups. Some participants prematurely discontinued rituximab maintenance therapy, which may impact overall conclusions. Despite these limitations, this trial provides further evidence that rituximab maintenance therapy prolongs overall event-free survival at a longer follow-up time point of 7.5 years in comparison to observation alone.
In-Depth [randomized controlled trial]: This study provided evidence of improved event-free survival in young patients with mantle-cell lymphoma undergoing rituximab maintenance therapy in comparison to observation alone after induction therapy. It was an unblinded randomized controlled trial that enrolled 240 participants aged 18-65 with mantle-cell lymphoma. All patients must have been eligible for autologous stem-cell transplantation and be able to receive rituximab maintenance therapy every two months for three years. The study assessed the patients at 7.5 years of follow-up. Event-free survival was 76.2% in the rituximab maintenance group (95% CI, 67.4 to 82.9) in comparison to 46% in the observation group (95% CI 36.6 to 54.9). The study further noted that rituximab maintenance therapy was not associated with increases in infection-related morality. Overall survival did not demonstrate a statistically significant difference between the two groups. However, most deaths in the rituximab maintenance group occurred within three years, suggesting a potentially lower post-treatment mortality rate. The cause of death was most commonly lymphoma, with infection-related death being a small contributor. Overall, this study adds to previously established data suggesting that rituximab maintenance therapy is safe and efficacious at prolonging event-free survival at 7 years in young individuals with mantle-cell lymphoma.
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