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.

Reference

  1. 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]