Maintenance therapy with the monoclonal antibody, rituximab, may improve progression-free survival for patients with chronic lymphocytic leukemia (CLL) who achieved at least a partial response with chemotherapy, according to a study published in The Lancet Haematology.1
For this randomized 1:1 phase 3 clinical trial, researchers enrolled 263 patients with CLL who, after treatment with rituximab-containing chemotherapy, had achieved either a complete response, a complete response with only partial bone marrow recovery, or a partial response.
Patients were assigned to receive either intravenous rituximab 375 mg/m2 every 3 months, or to observation only, for 2 years. Progression-free survival was significantly longer for the 134 patients assigned to rituximab, in contrast with the 129 under observation (47.0 versus 35.5 months, hazard ratio, .50; P = .00077).
The rate of infection contraction was, however, much more common in the rituximab group; 66% of these patients, versus 50% of patients on observation, contracted an infection of any grade. These infections did not increase mortality rates.
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The authors concluded that progression-free survival is improved in patients who receive rituximab maintenance therapy after achieving a partial response or better with rituximab plus chemotherapy. Adverse events, including neutropenia, respiratory tract infection, pneumonia, thrombopenia, neoplasms, and eye disorders, were similar in both cohorts.
- Greil R, Obrtlikova P, Smolej L, et al. Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial. Lancet Haematol. doi: 10.1016/S2352-3026(16)30045-X [Epub ahead of print]