PURPOSE: This study aimed to determine activity and safety of weekly bortezomib and rituximab in patients with relapsed/refractory Waldenström macroglobulinemia (WM). PATIENTS AND METHODS: Patients who had at least one previous therapy were eligible. All patients received bortezomib intravenously weekly at 1.6 mg/m(2) on days 1, 8, and 15, every 28 days for six cycles and rituximab 375 mg/m(2) weekly on cycles 1 and 4. The primary end point was the percentage of patients with at least a minor response. RESULTS: Thirty-seven patients were treated. The majority of patients (78%) completed treatment per protocol. At least minimal response (MR) or better was observed in 81% (95% CI, 65% to 92%), with two patients (5%) in complete remission (CR)/near CR, 17 patients (46%) in partial response, and 11 patients (30%) in MR. The median time to progression was 16.4 months (95% CI, 11.4 to 21.1 months). Death occurred in one patient due to viral pneumonia. The most common grade 3 and 4 therapy-related adverse events included reversible neutropenia in 16%, anemia in 11%, and thrombocytopenia in 14%. Grade 3 peripheral neuropathy occurred in only two patients (5%). The median progression-free (PFS) is 15.6 months (95% CI, 11 to 21 months), with estimated 12-month and 18-month PFS of 57% (95% CI, 39% to 75%) and 45% (95% CI, 27% to 63%), respectively. The median overall survival has not been reached. CONCLUSION: The combination of weekly bortezomib and rituximab showed significant activity and minimal neurologic toxicity in patients with relapsed WM.
PURPOSE: This study aimed to determine activity and safety of weekly bortezomib and rituximab in patients with relapsed/refractory Waldenström macroglobulinemia (WM). PATIENTS AND METHODS: Patients who had at least one previous therapy were eligible. All patients received bortezomib intravenously weekly at 1.6 mg/m(2) on days 1, 8, and 15, every 28 days for six cycles and rituximab 375 mg/m(2) weekly on cycles 1 and 4. The primary end point was the percentage of patients with at least a minor response. RESULTS: Thirty-seven patients were treated. The majority of patients (78%) completed treatment per protocol. At least minimal response (MR) or better was observed in 81% (95% CI, 65% to 92%), with two patients (5%) in complete remission (CR)/near CR, 17 patients (46%) in partial response, and 11 patients (30%) in MR. The median time to progression was 16.4 months (95% CI, 11.4 to 21.1 months). Death occurred in one patient due to viral pneumonia. The most common grade 3 and 4 therapy-related adverse events included reversible neutropenia in 16%, anemia in 11%, and thrombocytopenia in 14%. Grade 3 peripheral neuropathy occurred in only two patients (5%). The median progression-free (PFS) is 15.6 months (95% CI, 11 to 21 months), with estimated 12-month and 18-month PFS of 57% (95% CI, 39% to 75%) and 45% (95% CI, 27% to 63%), respectively. The median overall survival has not been reached. CONCLUSION: The combination of weekly bortezomib and rituximab showed significant activity and minimal neurologic toxicity in patients with relapsed WM.
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Authors: Meletios A Dimopoulos; Efstathios Kastritis; Roger G Owen; Robert A Kyle; Ola Landgren; Enrica Morra; Xavier Leleu; Ramón García-Sanz; Nikhil Munshi; Kenneth C Anderson; Evangelos Terpos; Irene M Ghobrial; Pierre Morel; David Maloney; Mathias Rummel; Véronique Leblond; Ranjana H Advani; Morie A Gertz; Charalampia Kyriakou; Sheeba K Thomas; Bart Barlogie; Stephanie A Gregory; Eva Kimby; Giampaolo Merlini; Steven P Treon Journal: Blood Date: 2014-07-15 Impact factor: 22.113
Authors: I M Ghobrial; R Redd; P Armand; R Banwait; E Boswell; S Chuma; D Huynh; A Sacco; A M Roccaro; A Perilla-Glen; K Noonan; M MacNabb; H Leblebjian; D Warren; P Henrick; J J Castillo; P G Richardson; J Matous; E Weller; S P Treon Journal: Leukemia Date: 2015-07-03 Impact factor: 11.528