Bendamustine plus rituximab is an active combination in patients with relapsed indolent and mantle cell lymphoma.

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Despite the long history of bendamustineas treatment for indolent non-Hodgkin lymphoma (iNHL), long-term efficacy and toxicity data are minimal. We reviewed long-term data from three clinical trials to characterize toxicity and efficacy of patients receiving bendamustine. Data were available for 149 subjects at 21 sites. The median age was 60 years at the start of bendamustine (range 39-84), and patients had received a median of 3 prior therapies. The histologies included grade 1-2 follicular lymphoma (FL; n=73), grade 3 FL (n=23), small lymphocytic lymphoma (SLL; n=20), marginal zone lymphoma (MZL; n=15), mantle cell lymphoma (n=9), transformed lymphomas (n=5), lymphoplasmacytic lymphoma (n=2), and not reported (n=2). The median event-free survival was 14.1 months. Nine of 12 attempted stem cell collections were successful. With a median follow-up of 8.9 years, 23 patients developed 25 cancers, including 8 patients with myelodysplastic syndrome/acute myeloid leukemia. These data provide important information regarding the long-term toxicity of bendamustine in previously treated patients. A small but meaningful number of patients achieved durable remissions following bendamustine. These rigorously collected, patient-level, long-term follow-up data provide reassurance that bendamustine or bendamustine plus rituximab is associated with efficacy and safety for patients with relapsed or refractory iNHL.

SummaryThe North American Immune Tolerance Registry was initiated to study of immune tolerance (ITT) in Canada and the United States with respect to: 1) therapeutic regimens in use for haemophilia A (HA) and B (HB) inhibitor patients; 2) therapeutic outcomes; 3) potential predictors of successful outcome and 4) complications of therapy. Data on 188 ITT courses was collected by questionnaire from 60 haemophilia centers from 1993-99. Among the completed courses, the overall ITT success rate was 70% (115/164) for all HA and 31% (5/16) for all HB. Outcome parameters noted to be predictive of ITT success for all HA were 1) pre-ITT induction (p = 0.003), 2) ITT peak (p = 0.007) and 3) historical pre ITT peak (p = 0.04) inhibitor titres. An inverse correlation between total daily dose (units/kg/day) and success: (80% with under 50; 71% with 50-99; 73% with 100-199; and 41% with ≥ 200, p = 0.01) was found. Outcome predictors were not evaluable for HB, although adverse reactions to therapy, including nephrotic syndrome, and access complications were more common among failed courses. Infection most often complicated the use of access catheters. These results are discussed within the context of the international ITT registry and upcoming prospective ITT study.