Rituximab maintenance prolonged EFS, PFS in young patients with mantle cell lymphoma

SAN FRANCISCO — Rituximab maintenance after autologous hematopoietic stem cell transplantation was associated with prolonged EFS and PFS compared with a watch-and-wait strategy among previously untreated young patients with mantle cell lymphoma, according to interim analysis results from the phase 3 LyMa trial presented at the ASH Annual Meeting and Exposition.

Perspective from Jonathon B. Cohen, MD

Steven Le Gouill, MD, PhD, of the department of hematology at CHU de Nantes in France, and colleagues evaluated data from 299 patients aged younger than 66 years (median age, 57 years; range, 27-65). About three-quarters (78.9%) of the patients were male.

More than half (53.2%) of patients had a low Mantle Cell Lymphoma International Prognostic Index score, whereas 27.4% had an intermediate score and 19.4% had a high score.

All patients received four courses of rituximab (Rituxan, Genentech/Biogen Idec), dexamethasone, cytarabine and cisplatin (R-DHAP), and 257 went on to undergo autologous HSCT. The confirmed and unconfirmed complete response rate increased from 81.4% before HSCT to 92% after HSCT.

The 238 patients who achieved a complete or partial response after transplantation were randomly assigned 1:1 to 3 years of maintenance therapy with 375 mg/m² rituximab every 2 months or to the watch-and-wait arm.

Median follow-up from randomization was 29.7 months.

The rates for 2-year EFS and PFS for both arms were each 87.5% (95% CI, 82.4-91.2). Median EFS and PFS had not yet been reached at the time of the analysis.

Significantly more patients in the rituximab maintenance arm achieved 2-year EFS than patients who underwent a watch-and-wait strategy (93.2% vs. 81.5%; HR=2.1; P=.015). Rituximab maintenance also was associated with significantly prolonged EFS compared with observation (P=.015).

However, 2-year OS did not statistically differ between the maintenance (93.4%; 95% CI, 86.6-96.9) and observation arms (93.9%; 95% CI, 86.7-97.3).

“This planned interim analysis of the LyMa trial shows that 3 years of rituximab maintenance after R-DHAP plus autologous HSCT as first-line treatment for young patients with mantle cell lymphoma significantly improves both EFS and PFS,” Le Gouill and colleagues concluded. “Thus, as reported in elderly mantle cell lymphoma, the LyMa trial demonstrates that rituximab should be used in maintenance therapy after autologous HSCT and provides the rationale for a new standard of care in mantle cell lymphoma.”

Disclosure: Le Gouill reports a consultant role with Janssen-Cilag and honoraria from Celgene, Janssen-Cilag, Mundipharma and Roche.

– by Alexandra Todak

Perspective

Jonathon B. Cohen, MD

This study, which looks at rituximab maintenance for patients who undergo a stem cell transplant for mantle cell lymphoma, is likely to change the way we approach treating this group of patients. Traditionally, we have not always used maintenance therapy for patients with mantle cell lymphoma who are treated very aggressively, but this study shows there may be a role for maintenance therapy, similar to what we see for multiple myeloma and some other malignancies.

Jonathon B. Cohen, MD

Winship Cancer Institute of Emory University

Disclosures: Cohen reports no relevant financial disclosures.