SAN FRANCISCO—Rituximab should be used as maintenance therapy following autologous stem cell transplantation for the treatment of young previously untreated patients with mantle cell lymphoma, interim analysis of the LyMa study presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition has shown.
For the prospective, phase 3 LyMa study, researchers from the LYSA group enrolled 299 patients with previously untreated mantle cell lymphoma between the ages of 27 and 65. All patients were enrolled at the time of diagnosis and received four courses of R-DHAP (rituximab, dexamethasone, cytarabine, and cisplatin) followed by autologous stem cell transplantation.
Patients who did not achieve at least a partial response after those four courses could then receive four additional courses of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
Patients then received R-BEAM (rituximab, carmustine, etoposide, cytarabin, and melphalan) conditioning for stem cell transplantation. Patients who achieved a partial or complete response following stem cell transplantation were then randomly assigned to receive rituximab 375 mg/m2 every 2 months as maintenance therapy for 3 years or wait and watch.
The 239 eligible patients were assigned 1:1 to rituximab or to wait and watch. The median follow-up from randomization is currently 34.3 months, said Steven Le Gouill, MD, PHD, from CHU Nantes in Nantes, France.
At the time of the interim analysis, the 4-year event-free survival was 80.4% (95% CI: 67.2-88.7) for rituximab and 61.8% (95% CI: 47.7-73.1; P=0.0057) for wait and watch, and the 4-year progression-free survival was 82% (95% CI: 69.2-89.9) for rituximab and 61.8% (95% CI: 47.7-73.1; P=0.0032) for wait and watch. Overall survival does not differ significantly between the treatment arms.
The 4-year overall survival rates from time of randomization was 83.4% (95% CI: 70.2-91.1) and 83.6% (95% CI: 72.8-90.5) for rituximab and wait and watch arms.
“The LyMa chemotherapy regimen provides high complete responses before and after autologous stem cell transplantation. In addition, it provides long-term disease control and long-term overall survival,” Dr. Le Gouill concluded. Dr. Le Gouill and colleagues plan to conduct the final analyses in the second quarter of 2016.
- Gouill, Steven Le, MD, PhD, et al. “146 Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study.” ASH 2014. Oral Presentation. December 7, 2014.