Ariel Jones

Urban Health Today

Second-line therapy comprising standard rituximab plus&nbsp;bendamustine&nbsp;and bortezomib was effective and well-tolerated as a salvage treatment option for patients with relapsed/refractory&nbsp;Waldenstr&ouml;m&nbsp;macroglobulinemia (WM), according to research presented by Giulia&nbsp;Benevolo, MD, of the University of Torino in Italy. Compared with historical controls, the combination therapy was associated with increases in progression-free survival (PFS) rate and measurable residual disease (MRD) negativity. These results were presented at the 2021 American Society of Hematology Annual Meeting.&nbsp;&nbsp;In this single-arm phase II study, researchers hypothesized that the 18-month PFS rate with this regimen would be at least 65%. Patients received intravenous (IV) rituximab 375 mg/m2&nbsp;on day 1, followed by IV&nbsp;bendamustine&nbsp;90 mg/m2&nbsp;on days 1 and 2 and subcutaneous bortezomib 1.3 mg/m2&nbsp;on days 1, 8, 15, and 22. Treatment lasted six months, with a total of six 28-day treatment cycles.&nbsp;At baseline (for mutational screening) and at the end of treatment (for MRD analysis), patients&rsquo; bone marrow, plasma, and peripheral blood samples were tested for MYD88L265P&nbsp;and CXCR4S338X&nbsp;mutations using droplet digital polymerase chain reaction.&nbsp;The median age of patients in the study was 66.8 years. Most patients had features of advanced disease, including cytopenia (anemia [71%], thrombocytopenia [20%]), systemic symptoms (40%), and symptomatic splenomegaly (24%). At least one comorbidity was present in 16 patients (42%), including cardiovascular disease (21%) or metabolic disorders (16%) such as diabetes mellitus.&nbsp;A total of 30 patients completed treatment. At the end of the six cycles, the overall response rate (ORR) was 82%. According to IWM response criteria, there were four (11%) complete responses, 15 (39%) very good partial responses, and 12 (32%) partial responses. The PFS rates at 18, 24, and 30 months were 84%, 81%, and 79%, respectively. Overall survival (OS) was 92% at 18 months in the entire study population.&nbsp;Seven patients discontinued therapy because of toxicity and one because of disease progression. Between 18 and 30 months of follow-up, no deaths were reported. Grade &ge;3 hematologic toxicities were observed in half of patients (n=19). Although nervous system disorders related to bortezomib were reported in six patients, these events did not result in discontinuation of treatment, the investigators reported.&nbsp;&nbsp;All 21 patients for whom mutational data was available scored MYD88L265P&nbsp;in bone marrow, 95% in plasma and 86% in peripheral blood, &ldquo;prospectively confirming the risk of false negative results when only peripheral blood of rituximab pretreated patients is analyzed,&rdquo; the authors wrote. CXCR4S338X&nbsp;was detected in one patient at baseline. After treatment, MRD negativity rates were 29% (n = 5/17) in bone marrow, 43% (n = 6/14) in plasma, and 75% (n = 12/1) in peripheral blood.&nbsp;&nbsp;&ldquo;Overall, a good concordance was observed between bone marrow and plasma, suggesting the possibility of avoiding bone marrow aspiration for mutational screening and MRD analysis,&rdquo; the authors wrote.&nbsp;

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Second-line therapy comprising standard rituximab plus bendamustine and bortezomib was effective and well-tolerated as ...