Contributions
Abstract: PB1877
Type: Publication Only
Background
Results from phase 3 'StiL' and BRIGHT trials demonstrated the effectiveness of the combination Bendamustine-Rituximab {BR} compared to R-CHOP/R-CVP regimens as frontline treatment for advanced Follicular Lymphoma {FL}, emphasizing BR as a standard strategy in this subset of patients. However, only a few studies investigated the efficacy and safety of R maintenance after frontline BR, indicating a global beneficial effect of R administration in term of PFS but not OS, in keeping with a good toxicity profile even over two years of tratment
Aims
In this study, we evaluated the role of maintenance therapy with R after induction with BR in previously untreated FL, and compared its efficacy and safety profile with recent publicly available results of 'StiL' trial.
Methods
FL patients [pts] were treated with a maximum of 6 cycles of B-R [Bendamustine 90 mg/m2 8days 1+2), Rituximab 375 mg/m2] every 28 days followed by 2 additional cycles of Rituximab monthly. Patients showing complete response [CR] or partial response [PR} were then allowed to receive R maintenance [375 mg/m2] administered every two months. To date 118 pts ( 65 women and 53 men) with FL have been recorded. Median age was 61 years ( range 28-86); 15 (13%), 41 (35%), 62 (52%) pts had respectively stage II, III and IV; median number of nodal areas was 4, bone marrow involvement was found in 56 (47%) pts, and median FLIPI was 3.
Results
Among the 118 pts, 94 were evaluable for response and safety. The overall response rate [ORR] was 89.2% with 83 pts achieving a remission after BR therapy. The CR rate was 84.4%, 7 pts had partial response, 5 pts (6.1%) had stable disease, whereas 3 (3.5%) showed no response to BR and had a progressive fatal disease. All of the pts achieving remission received the full planned 2 years Rituximab maintenance treatment and, among them, 24 pts (28.9%) were administered with R over the first two years. Primary adverse events recorded were of grade 3 anf 4 in 25% of cases. Infectious ( grade 3-4) and neutropenia (grade 3) were the most common adverse event, no additional unexpected toxicities were observed, whereas no occurrence of secondary malignancy was registered so far.
Conclusion
Our data, compared with recent reports about the role of Rituximab maintenance, support the efficacy of BR as backbone treatment of choice in previously untreated advanced FL. These results, moreover, are in line with those of other studies indicating that Rituximab standard maintenance and also over 2 years for FL appears safe and well tolerated, with no additional toxicities.
Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical
Keyword(s): Rituximab
Abstract: PB1877
Type: Publication Only
Background
Results from phase 3 'StiL' and BRIGHT trials demonstrated the effectiveness of the combination Bendamustine-Rituximab {BR} compared to R-CHOP/R-CVP regimens as frontline treatment for advanced Follicular Lymphoma {FL}, emphasizing BR as a standard strategy in this subset of patients. However, only a few studies investigated the efficacy and safety of R maintenance after frontline BR, indicating a global beneficial effect of R administration in term of PFS but not OS, in keeping with a good toxicity profile even over two years of tratment
Aims
In this study, we evaluated the role of maintenance therapy with R after induction with BR in previously untreated FL, and compared its efficacy and safety profile with recent publicly available results of 'StiL' trial.
Methods
FL patients [pts] were treated with a maximum of 6 cycles of B-R [Bendamustine 90 mg/m2 8days 1+2), Rituximab 375 mg/m2] every 28 days followed by 2 additional cycles of Rituximab monthly. Patients showing complete response [CR] or partial response [PR} were then allowed to receive R maintenance [375 mg/m2] administered every two months. To date 118 pts ( 65 women and 53 men) with FL have been recorded. Median age was 61 years ( range 28-86); 15 (13%), 41 (35%), 62 (52%) pts had respectively stage II, III and IV; median number of nodal areas was 4, bone marrow involvement was found in 56 (47%) pts, and median FLIPI was 3.
Results
Among the 118 pts, 94 were evaluable for response and safety. The overall response rate [ORR] was 89.2% with 83 pts achieving a remission after BR therapy. The CR rate was 84.4%, 7 pts had partial response, 5 pts (6.1%) had stable disease, whereas 3 (3.5%) showed no response to BR and had a progressive fatal disease. All of the pts achieving remission received the full planned 2 years Rituximab maintenance treatment and, among them, 24 pts (28.9%) were administered with R over the first two years. Primary adverse events recorded were of grade 3 anf 4 in 25% of cases. Infectious ( grade 3-4) and neutropenia (grade 3) were the most common adverse event, no additional unexpected toxicities were observed, whereas no occurrence of secondary malignancy was registered so far.
Conclusion
Our data, compared with recent reports about the role of Rituximab maintenance, support the efficacy of BR as backbone treatment of choice in previously untreated advanced FL. These results, moreover, are in line with those of other studies indicating that Rituximab standard maintenance and also over 2 years for FL appears safe and well tolerated, with no additional toxicities.
Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical
Keyword(s): Rituximab