Pharmacy
Contributions
Type: Publication Only
Background
The combination of bendamustine and rituximab (RB) has been shown to be an appropriate option for first line treatment or treatment for relapsed / refractory patients (pts) with indolent non-Hodgkin’s lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
Aims
The objective of this retrospective study was to compare the toxicities of RB between pts <65y and ≥ 65y among pts with indolent NHL or CLL in relapse.
Methods
Analysis was performed retrospectively on pts treated with RB between January 2009 and December 2013 in relapse. The treatment consisted of rituximab (375 mg/m2 D1) and bendamustine (90 mg/m2 D1-2) every 28 days. Fisher and Wilcoxon tests were used, and the probability of adverse event (AE) during cure was compared according to the age in generalized linear mixed models.
Results
Among the 76 pts included, 41 pts (54%) were <65y (median age= 57y, range 33-64), and 35 pts (46%) ≥65y (median age= 74y, range 65-80). In the cohort of pts <65y, 33 pts presented with indolent NHL (24 FL, 6 MZL, 2 SLL, 1 tricholeucocyte), 7 pts CLL, 1 MCL. In pts ≥65y, 26 pts presented with indolent NHL (15 FL, 7 MZL, 3 SLL, 1 Waldenström), 8 pts CLL and 1 MCL. The PS was ≥ 2 in 18% of pts <65y vs 32% of pts ≥ 65y, with high LDH in 29% vs 53% of pts. The median number of prior treatments was 4 in <65y and 6 for ≥65y. Fifty-seven (75%) pts received at least 4 cycles of RB and 34 (45%) pts at least 4 cycles, corresponding to 344 cycles overall (179 (52%) in pts <65y and 165 (48%) in pts ≥ 65y). Eighty-six percent of pts had at least one AE during their treatment, wich was G3/4 in 47% of the pts. The occurrence of G1/4 AE per cycle was 51% in the whole cohort without significant difference between age groups (53% and 49%, respectively in pts <65y and pts ≥65y, p=0.65). Among them, AE was noticed grade (G) 3/4 in 50 cycles corresponding to 28 (16%) cycles in pts <65y and 22 (13%) in pts ≥65y (p=0.64). Hematotoxicity was present in 29 pts (70%) <65y and 27 pts (77%) ≥65y. Probability of hematotoxicity per cycle was 20% for <65y and 18% for ≥ 65y (p=0.70). Thrombocytopenia and neutropenia were the most frequent G3/4 hematotoxicity, occurring in 12% and 17% of the pts <65y and pts ≥65y respectively. Nausea affected 34% of pts <65y vs 43% pts ≥65y. Twenty-seven percent of pts <65y and 31% pts ≥65y developed infections. Pulmonary toxicities G1/4 with bronchitis were rare (3% per cycle) but significantly more frequent in pts ≥65y, 5% per cycle compared to pts <65y, 1% per cycle (p <0.036). A dose adjustment was required for 10 pts (24%) <65y related to thrombocytopenia in 7 pts; the same happened to 12 pts (34%) ≥65y, because of thrombocytopenia, deep neutropenia, cutaneous rash G3, maculopapular rash, severe sepsis or digestive disorder. Treatment was discontinued in 13 (32%) pts <65y (4 pancytopenia, 2 thrombocytopenia, neutropenia G4, 1 severe sepsis and 1 pneumonitis) and in 11 (31%) pts ≥65y (4 fever infections (bronchitis), 2 febrile aplasia, 1 cutaneous rash G3, 1 pancytopenia, 1 thrombocytopenia, 1 mucositis G3 and 1 gastrointestinal intolerance) (p=1).
Summary
The toxicities of RB combination and their probabilities do not differ significantly with the age, except for respiratory disorders. Bronchitis G1/2 appears to occur more frequently in pts ≥ 65y. This has to be noticed in the perspective of association of BR with new agents such tyrosine Kinase inhibitors that may increase this risk of pulmonary toxicity in elderly patients.
Keyword(s): Age, Bendamustine, Rituximab, Toxicity
Session topic: Publication Only
Type: Publication Only
Background
The combination of bendamustine and rituximab (RB) has been shown to be an appropriate option for first line treatment or treatment for relapsed / refractory patients (pts) with indolent non-Hodgkin’s lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).
Aims
The objective of this retrospective study was to compare the toxicities of RB between pts <65y and ≥ 65y among pts with indolent NHL or CLL in relapse.
Methods
Analysis was performed retrospectively on pts treated with RB between January 2009 and December 2013 in relapse. The treatment consisted of rituximab (375 mg/m2 D1) and bendamustine (90 mg/m2 D1-2) every 28 days. Fisher and Wilcoxon tests were used, and the probability of adverse event (AE) during cure was compared according to the age in generalized linear mixed models.
Results
Among the 76 pts included, 41 pts (54%) were <65y (median age= 57y, range 33-64), and 35 pts (46%) ≥65y (median age= 74y, range 65-80). In the cohort of pts <65y, 33 pts presented with indolent NHL (24 FL, 6 MZL, 2 SLL, 1 tricholeucocyte), 7 pts CLL, 1 MCL. In pts ≥65y, 26 pts presented with indolent NHL (15 FL, 7 MZL, 3 SLL, 1 Waldenström), 8 pts CLL and 1 MCL. The PS was ≥ 2 in 18% of pts <65y vs 32% of pts ≥ 65y, with high LDH in 29% vs 53% of pts. The median number of prior treatments was 4 in <65y and 6 for ≥65y. Fifty-seven (75%) pts received at least 4 cycles of RB and 34 (45%) pts at least 4 cycles, corresponding to 344 cycles overall (179 (52%) in pts <65y and 165 (48%) in pts ≥ 65y). Eighty-six percent of pts had at least one AE during their treatment, wich was G3/4 in 47% of the pts. The occurrence of G1/4 AE per cycle was 51% in the whole cohort without significant difference between age groups (53% and 49%, respectively in pts <65y and pts ≥65y, p=0.65). Among them, AE was noticed grade (G) 3/4 in 50 cycles corresponding to 28 (16%) cycles in pts <65y and 22 (13%) in pts ≥65y (p=0.64). Hematotoxicity was present in 29 pts (70%) <65y and 27 pts (77%) ≥65y. Probability of hematotoxicity per cycle was 20% for <65y and 18% for ≥ 65y (p=0.70). Thrombocytopenia and neutropenia were the most frequent G3/4 hematotoxicity, occurring in 12% and 17% of the pts <65y and pts ≥65y respectively. Nausea affected 34% of pts <65y vs 43% pts ≥65y. Twenty-seven percent of pts <65y and 31% pts ≥65y developed infections. Pulmonary toxicities G1/4 with bronchitis were rare (3% per cycle) but significantly more frequent in pts ≥65y, 5% per cycle compared to pts <65y, 1% per cycle (p <0.036). A dose adjustment was required for 10 pts (24%) <65y related to thrombocytopenia in 7 pts; the same happened to 12 pts (34%) ≥65y, because of thrombocytopenia, deep neutropenia, cutaneous rash G3, maculopapular rash, severe sepsis or digestive disorder. Treatment was discontinued in 13 (32%) pts <65y (4 pancytopenia, 2 thrombocytopenia, neutropenia G4, 1 severe sepsis and 1 pneumonitis) and in 11 (31%) pts ≥65y (4 fever infections (bronchitis), 2 febrile aplasia, 1 cutaneous rash G3, 1 pancytopenia, 1 thrombocytopenia, 1 mucositis G3 and 1 gastrointestinal intolerance) (p=1).
Summary
The toxicities of RB combination and their probabilities do not differ significantly with the age, except for respiratory disorders. Bronchitis G1/2 appears to occur more frequently in pts ≥ 65y. This has to be noticed in the perspective of association of BR with new agents such tyrosine Kinase inhibitors that may increase this risk of pulmonary toxicity in elderly patients.
Keyword(s): Age, Bendamustine, Rituximab, Toxicity
Session topic: Publication Only