Contributions
Abstract: S105
Type: Oral Presentation
Presentation during EHA22: On Friday, June 23, 2017 from 11:30 - 11:45
Location: Hall B
Background
Mantle cell lymphoma (MCL) is currently an incurable disease. In spite of high complete response rates (CR) after initial immunochemotherapy induction followed by autologous stem cell transplantation (ASCT), MCL patients experience iterative relapses.
Aims
We investigated whether or not rituximab maintenance (RM; 375mg/m2 every 2 months for 3 years) after ASCT prolongs response duration.
Methods
This phase III trial included 299 patients (<66y) at diagnosis, of whom 240 were randomly assigned to RM or observation after ASCT. The primary end point was event-free survival (EFS) (progression, relapse, death, severe infection during RM) after ASCT.
Results
After 4 courses of immunochemotherapy induction (R-DHAP; Rituximab, dexamethasone, cytarabine, platinium derivative), overall response and CR rates were 89.3% and 77.3%, respectively. ASCT was performed in 257 patients. Median follow-up from randomization after ASCT was 50.2 (46.4-54.2) months. Starting from randomization, 4-year EFS was 78.9% (95%CI; 69.5 to 85.6) for RM (n=120) versus 61.4% (95%CI; 51.3 to 69.9) for observation (n=120) (p=0.0012), 4-year progression-free survival (PFS) was 82.2% (95%CI; 73.2 to 88.4) for RM versus 64.6% (95%CI; 54.6 to 73) for observation (p=0.0005) and OS was 88.7% (95%CI; 80.7 to 93.5) for RM versus 81.4% (95%CI; 72.3 to 87.7) for observation (p=0.0413). The death rate was lower for patients in the RM arm were less likely to die (hazard ratio (HR)=0.5; 95%CI, 0.255 to 0.986) than for patients in the observation arm.
Conclusion
The LyMa trial demonstrates for the first time that RM after ASCT prolongs EFS, PFS and OS. Thus, 4 courses of R-DHAP plus ASCT (without TBI) followed by RM maintenance (one infusion every 2 month for 3 years) is a new standard of care for young MCL patients.
Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Mantle cell lymphoma, Maintenance
Abstract: S105
Type: Oral Presentation
Presentation during EHA22: On Friday, June 23, 2017 from 11:30 - 11:45
Location: Hall B
Background
Mantle cell lymphoma (MCL) is currently an incurable disease. In spite of high complete response rates (CR) after initial immunochemotherapy induction followed by autologous stem cell transplantation (ASCT), MCL patients experience iterative relapses.
Aims
We investigated whether or not rituximab maintenance (RM; 375mg/m2 every 2 months for 3 years) after ASCT prolongs response duration.
Methods
This phase III trial included 299 patients (<66y) at diagnosis, of whom 240 were randomly assigned to RM or observation after ASCT. The primary end point was event-free survival (EFS) (progression, relapse, death, severe infection during RM) after ASCT.
Results
After 4 courses of immunochemotherapy induction (R-DHAP; Rituximab, dexamethasone, cytarabine, platinium derivative), overall response and CR rates were 89.3% and 77.3%, respectively. ASCT was performed in 257 patients. Median follow-up from randomization after ASCT was 50.2 (46.4-54.2) months. Starting from randomization, 4-year EFS was 78.9% (95%CI; 69.5 to 85.6) for RM (n=120) versus 61.4% (95%CI; 51.3 to 69.9) for observation (n=120) (p=0.0012), 4-year progression-free survival (PFS) was 82.2% (95%CI; 73.2 to 88.4) for RM versus 64.6% (95%CI; 54.6 to 73) for observation (p=0.0005) and OS was 88.7% (95%CI; 80.7 to 93.5) for RM versus 81.4% (95%CI; 72.3 to 87.7) for observation (p=0.0413). The death rate was lower for patients in the RM arm were less likely to die (hazard ratio (HR)=0.5; 95%CI, 0.255 to 0.986) than for patients in the observation arm.
Conclusion
The LyMa trial demonstrates for the first time that RM after ASCT prolongs EFS, PFS and OS. Thus, 4 courses of R-DHAP plus ASCT (without TBI) followed by RM maintenance (one infusion every 2 month for 3 years) is a new standard of care for young MCL patients.
Session topic: 20. Aggressive Non-Hodgkin lymphoma - Clinical
Keyword(s): Mantle cell lymphoma, Maintenance