SAN DIEGO – Rituximab maintenance following autologous hematopoietic cell transplantation prolongs survival among younger patients with mantle cell lymphoma, according to a study presented at the American Society of Hematology (ASH) 58th Annual Meeting and Exposition.1
“The primary objective of the LyMa trial was to demonstrate the superiority in terms of 4-year event-free survival of rituximab maintenance compared to surveillance after autologous stem cell transplantation for mantle cell lymphoma patients aged 18 to 65 years,” said principal investigator Steven Le Gouill, MD, PhD, of the department of hematology, Nantes University Hospital, France.
Final results of the open-label, phase 3 LyMa trial (ClinicalTrials.gov Identifier: NCT00921414) demonstrated that rituximab maintenance therapy after autologous hematopoietic cell transplantation reduced the risk of an event by 54.3% (hazard ratio [HR], 0.457; 95% CI, 0.28-0.74; P = .0016), progression by 60% (HR, 0.4; 95% CI, 0.23-0.68; P = .0007), and death by 50% (HR, 0.5; 95% CI, 0.25-0.98; P = .0454), in contrast with no rituximab maintenance.
For the prospective, international study, investigators enrolled 299 treatment-naive patients younger than 66 years. All patients underwent induction chemoimmunotherapy consisting of 4 courses of R-DHAP (rituximab, dexamethasone, high-dose cytarabine, platinum) every 21 days followed by consolidation with autologous hematopoietic cell transplantation.
Twenty patients who were not in response after R-DHAP received 4 additional courses of R-CHOP-14 (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) before transplant. The conditioning regimen for autologous transplantation was R-BEAM (rituximab, carmustine, etoposide, cytarabine, melphalan).
A total of 240 patients in response after transplantation were then randomized 1:1 to receive rituximab maintenance or observation. Rituximab maintenance at 375 mg/m2 was administered every 2 months for 3 years.
With a median follow-up of 50.2 months, the 4-year event-free survival from randomization was 78.9% (95% CI, 69.6-85.6) in the rituximab maintenance arm, vs 61.4% (95% CI, 51.3-69.9) in the watch-and-wait arm (P = .0012); 4-year progression-free survival and 4-year overall survival were 82.2% (95% CI, 73.2-88.4) vs 64.6% (95% CI, 54.6-73; P = .0005) and 88.7% (95% CI, 80.7-93.5) vs 81.4% (95% CI, 72.3-87.7; P = .0413), respectively.
“The LyMa design provides high complete response/unconfirmed complete response before and after autologous stem cell transplantation, long-term disease control, and prolonged overall survival,” noted Dr Le Gouill.
Four courses of R-DHAP plus autologous hematopoietic cell transplantation followed by rituximab maintenance should be considered a new standard of care for younger patients with mantle cell lymphoma.
- Le Gouill S, Thieblemont C, Oberic L, et al. Rituximab maintenance after autologous stem cell transplantation prolongs survival in younger patients with mantle cell lymphoma: Final results of the randomized phase 3 LyMa trial of the Lysa/Goelams Group. Paper presented at: American Society of Hematology (ASH) 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.