volume 03 | number 03
Assessing Lenalidomide Plus Rituximab for Patients With MALT Lymphoma
Patients with advanced mucosaassociated lymphoid tissue ( MALT ) lymphoma are often treated with chemotherapy-based regimens ; however , because of the indolent course of the disease , researchers are investigating immunomodulatory , chemotherapy-free strategies , including the combination of lenalidomide and rituximab . In a Letter to the Editor published in Blood , Barbara Kiesewetter , MD , of the Division of Oncology at the Medical University of Vienna in Austria , and authors reported interim results of the phase II AGMT MALT-2 trial , which was designed to assess the feasibility of this treatment combination in patients with MALT lymphoma .
The study enrolled patients with gastric and extragastric MALT lymphoma ( if they were Helicobacter pylori [ HP ] -negative or had successful elimination of HP ) who had adequate blood counts ( defined as an absolute neutrophil count of ≥1,000 / μL and a platelet count of ≥60x10 9 / L ).
Of 46 evaluable patients ( median age = 64 years ; range = 32-84 years ), most ( n = 28 ; 61 %) were female and had received the following prior treatments :
• systemic ( immunotherapy / chemotherapy ; n = 11 ; 24 %)
• rituximab-containing regimens ( n = 9 ; 20 %)
• prior lenalidomide ( n = 1 ; 2 %)
• > 2 prior lines of therapy ( n = 9 ; 20 %)
Patients received lenalidomide 20 mg administered orally on days one through 21 , followed by seven days of no treatment , and rituximab 375 mg / m 2 administered intravenously on day one of each 28-day cycle .
After three treatment courses , patients were assessed and were treated according to response :
• Patients who achieved stable disease ( SD ) or better received another 3 treatment cycles .
• Patients who achieved complete response ( CR ) after 6 cycles stopped treatment , whereas those who achieved partial response ( PR ) or SD received another 2 cycles for a maximum of 8 cycles .
Patients received an average of six treatment cycles ( range = 5 to 8 cycles ), with 54 percent ( n = 25 ) receiving six , 28 percent ( n = 13 ) receiving eight , and 17 percent ( n = 8 ) receiving five or fewer cycles .
After a median follow-up of 27 months ( range = 13.2-36.3 months ), the overall response rate was 80 percent ( n = 37 ; 95 % CI 69-92 ), with a median time to best response of 3.6 months ( range = 2.8-5.8 months ).
Twenty-five patients ( 54 %;
“ This combination appears to be feasible , safe , and active for treating patients with MALT lymphoma ..”
— BARBARA KIESEWETTER , MD
95 % CI 40-69 ) achieved CR , 12 ( 26 %; 95 % CI 13-39 ) achieved PR , and eight ( 17 %; 95 % CI 6-28 ) had SD . One patient with gastric MALT lymphoma demonstrated progressive disease ( PD ) at first restaging but “ was successfully salvaged with rituximab plus bendamustine and is an ongoing remission for > 18 months ,” the authors reported . “ Remarkably , two patients given only one cycle due to adverse events ( AEs ) showed durable PR , now ongoing for longer than 15 and 20 months .”
Eleven patients ( 24 %) converted to a better response between the first and second restaging , and an additional three patients ( 7 %) improved from cycle six to eight . Two patients whose initial best response was SD and PR had PD at final restaging after cycle eight .
CLINICAL NEWS
Though there was a trend toward worse response in patients with elevated lactate dehydrogenase at baseline ( p = 0.079 ) compared to those without , univariate analysis revealed no significant differences in response related to patient demographics ( including gender , localization , dissemination status , and prior treatment ).
Three patients relapsed during study follow-up ( occurring 5-8.8 months after response ), for a 91 percent progression-free survival rate . These data “ suggest durable responses in the majority of cases ,” Dr . Kiesewetter and authors wrote . In the safety analysis , which included data from 48 patients who received at least one dose of rituximab plus lenalidomide , 18 patients ( 38 %) experienced mild infusion reactions related to rituximab administration . AEs associated with lenalidomide included mild musculoskeletal pain ( 42 %), mild fatigue ( 33 %), cough / respiratory infections ( 33 %), diarrhea ( 23 %), and mild vertigo ( 23 %). Exanthema occurred in 46 percent of patients but was typically mild . Grade ≥3 hematologic AEs included neutropenia ( n = 9 ), leukopenia ( n = 2 ), and anemia ( n = 1 ).
“ Late remissions appear to be a common phenomenon in patients treated with immunomodulators [ like lenalidomide ] for MALT lymphoma , and long-term effects of rituximab [ plus ] lenalidomide might still be underestimated in [ our ] analysis ,” the authors concluded . Rituximab plus lenalidomide was “ equally effective ” for pretreated and non-treated patients , demonstrating that this combination appears to be “ feasible , safe , and active for treating patients with MALT lymphoma , irrespective of primary localization and pretreatment .”
The study is limited by its heterogeneous patient population and its short follow-up , along with the lack of a comparator group . ●
REFERENCE
Kiesewetter B , Willenbacher E , Willenbacher W , et al . A phase 2 study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma . Blood . 2017 ; 129:383-5 .
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