Among patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence. Atrial fibrillation and hypertension were more common with ibrutinib-rituximab, whereas infusion reactions and IgM flare were more common with placebo-rituximab. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397 .).
We analyzed prognostic factors of response, response duration, and possible impact on survival of epoetin ␣, epoetin , or darbepoetin ␣ (DAR) with or without granulocyte colony-stimulating factor in 403 myelodysplastic syndrome (MDS) patients. Sixty-two percent (40% major and 22% minor) and 50% erythroid responses were seen, and median response dura-
The FL2000 study was undertaken to evaluate the combination of the anti-CD20 monoclonal antibody rituximab with chemotherapy plus interferon in the first-line treatment of follicular lymphoma patients with a high tumor burden. Patients were randomly assigned to receive either 12 courses of the chemotherapy regimen CHVP (cyclophosphamide, adriamycin, etoposide, and prednisolone) plus interferon␣2a (CHVP؉I arm) over 18 months or 6 courses of the same chemotherapy regimen combined with 6 infusions of 375 mg/m 2 rituximab and interferon for the same time period (R-CHVP؉I arm). After a median follow-up of 5 years, event-free survival estimates were, respectively, 37% (95% confidence interval [CI], 29%-44%) and 53% (95% CI, 45%-60%) in the CHVP؉I and R-CHVP؉I arm (P ؍ .001). Five-year overall survival estimates were not statistically different in the CHVP؉I (79%; 95% CI, 72%-84%) and R-CHVP؉I (84%; 95% CI, 78%-84%) arms. In a multivariate regression analysis, eventfree survival was significantly influenced by both the Follicular Lymphoma International Prognostic Index score (hazard ratio ؍ 2.08; 95% CI, 1.6%-2.8%) and the treatment arm (hazard ratio ؍ 0.59; 95% CI, 0.44%-0.78%). With a 5-year follow-up, the combination of rituximab with CHVP؉I provides superior disease control in follicular lymphoma patients despite a shorter duration of chemotherapy.
Key Points
In this phase 1/2 study, obinutuzumab (GA101) monotherapy was active in patients with relapsed or refractory CLL. Best overall response was lower in phase 2 vs phase 1, possibly due to higher baseline tumor burden resulting in lower treatment exposure.
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