Rituximab Maintenance Ups Survival in MCL After Transplant

Zosia Chustecka

December 04, 2016

SAN DIEGO — Younger patients with mantle cell lymphoma who have undergone an autologous stem cell transplantation should be given rituximab maintenance therapy (one injection every 2 weeks for 3 years), say French researchers who report a survival benefit with the regimen.

The new survival data come from the final results of the LyMa study, conducted in France and Belgium, and presented here at the American Society of Hematology 58th Annual Meeting (abstract 145) by Steven Le Gouill, MD, PhD, from the department of hematology, Nantes University Hospital in France.

Mantle cell lymphoma, which accounts for approximately 6% of non-Hodgkin's lymphoma in adults, commonly responds to initial therapy but inevitably patients relapse and response duration decreases from one salvage therapy to the next, Dr Le Gouill explained.

Rituximab maintenance therapy has already been shown to improve survival when used in elderly patients with mantle cell lymphoma (N Engl J Med 2012;367:520-531). In that trial, patients had induction therapy with R-CHOP (rituximab, cyclosporine, doxorubicin [hydroxydaunomycin], vincristine [Oncovin], and prednisolone).

The new results come from a trial in 229 younger patients (median age 57 years), which used a different induction therapy of R-DHAP (rituximab, dexamethasone, high-dose cytarabine [Ara-C], and platinum). The complete response (CR/Cru) rate after R-DHAP was 77.3%. Patients who did not respond to this regimen (n = 20) received additional courses of R-CHOP.

Patients then underwent autologous stem cell transplant, for which the conditioning regimen was R-BEAM (rituximab, carmustine [BiCNU], etoposide, cytarabine [Ara-C], and melphalan). In all, 257 patients (including 12 patients who received R-DHAP/R-CHOP) underwent transplant.

Patients who responded to the transplant (n = 240) were then randomized (1:1) to either be followed by observation or to receive rituximab maintenance (375 mg/m2, one infusion every 2 months for 3 years).

Final results from this study show that rituximab maintenance therapy reduced the risk of progression by 60% (HR, 0.4; 95% CI, 0.23 - 0.68; P = .0007) and the risk of death by 50% (HR, 0.5; 95% CI, 0.25 - 0.98; P = .0454).

The 4-year progression-free survival rate was 82.2% with rituximab vs 64.6% with observation (P = .0005), and the 4-year overall survival rate was 88.7% with rituximab vs 81.4% with observation (P = .0413).

Dr Le Gouill and colleagues concluded that rituximab maintenance (one infusion every 2 months for 3 years) is a new standard of care for young patients with mantle cell lymphoma.

Session chair Anca Prica, MD, from Princess Margaret Hospital, Toronto, Ontario, told Medscape Medical News that, for her, these data are confirmatory. "We already do this. We use rituximab maintenance routinely in our patients after transplant, having extrapolated the data from the non-transplant patients in other trials of indolent lymphoma that show rituximab improves progression-free survival."

The improvement in overall survival seen in this trial was impressive, several clinicians in the audience noted during the question and answer session. There was, however, some discussion over the use of R-DHAP as the treatment prior to transplantation — some clinicians said they use R-CHOP, and some, like Dr Prica, use an alternate schedule of R-DHAP and R-CHOP.

Dr Le Gouill reports receiving consultancy, honoraria, and/or research funding from Roche, Janssen-Cilag, and Celgene. Disclosures for the coauthors are listed in the abstract. Dr Prica reports receiving honoraria from Celgene and Janssen.

American Society of Hematology 58th Annual Meeting. Abstract 145. Presented December 3, 2016.

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