A Conconi1, G Martinelli2, A Lopez-Guillermo3, P L Zinzani4, A J M Ferreri5, L Rigacci6, L Devizzi7, U Vitolo8, S Luminari9, F Cavalli10, E Zucca10. 1. Department of Clinical and Experimental Medicine, Division of Hematology, AOU Maggiore della Carità, Amedeo Avogadro University of Eastern Piedmont, Novara. Electronic address: conconi@med.unipmn.it. 2. Division of Hematology-Oncology, European Institute of Oncology, Milan, Italy. 3. Department of Hematology, Hospital Clínic, Barcelona, Spain. 4. Institute of Hematology and Medical Oncology 'L. e A. Seràgnoli', University of Bologna, Bologna. 5. Unit of Lymphoid Malignancies, Medical Oncology Unit, Department of Oncology, San Raffaele H Scientific Institute, Milan. 6. Department of Hematology, Careggi Hospital and University of Florence, Florence. 7. Cristina Gandini Medical Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale Tumori, Milan. 8. SC Ematologia II, Azienda Ospedaliera e Universitaria San Giovanni Battista, Turin. 9. Department of Oncology and Hematology, University of Modena and Reggio Emilia, Modena, Italy. 10. IOSI-Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.
Abstract
BACKGROUND: The nuclear factor-kappa B activation in mucosa-associated lymphoid tissue (MALT) lymphoma pathogenesis provided the rationale for the evaluation of bortezomib in this malignancy. PATIENTS AND METHODS: Thirty-two patients with relapsed/refractory MALT lymphoma were enrolled. Thirty-one patients received bortezomib 1.3 mg/m(2) i.v., on days 1, 4, 8, and 11, for up to six 21-day cycles. RESULTS: Median age was 63 years (range, 37-82 years). Median number of prior therapies was 2 (range, 1-4). Nine patients had Ann Arbor stage I, 7 patients had stage II, and 16 patients had stage IV. Primary lymphoma localization was the stomach in 14 patients; multiple extranodal sites were present in 10 patients. Among the 29 patients assessable for response, the overall response rate was 48% [95% confidence interval (CI) 29% to 67%], with 9 complete and 5 partial responses. Nine patients experienced stable disease and six had disease progression during therapy. The most relevant adverse events were fatigue, thrombocytopenia, neutropenia, and peripheral neuropathy. After a median follow-up of 24 months, the median duration of response was not reached yet. Five deaths were reported, in two patients due to disease progression. CONCLUSION: Bortezomib is active in relapsed MALT lymphomas. Further investigations to identify optimal bortezomib dose, schedule, and combination regimens are needed since the frequent detection of dose-limiting peripheral neuropathy.
BACKGROUND: The nuclear factor-kappa B activation in mucosa-associated lymphoid tissue (MALT) lymphoma pathogenesis provided the rationale for the evaluation of bortezomib in this malignancy. PATIENTS AND METHODS: Thirty-two patients with relapsed/refractory MALT lymphoma were enrolled. Thirty-one patients received bortezomib 1.3 mg/m(2) i.v., on days 1, 4, 8, and 11, for up to six 21-day cycles. RESULTS: Median age was 63 years (range, 37-82 years). Median number of prior therapies was 2 (range, 1-4). Nine patients had Ann Arbor stage I, 7 patients had stage II, and 16 patients had stage IV. Primary lymphoma localization was the stomach in 14 patients; multiple extranodal sites were present in 10 patients. Among the 29 patients assessable for response, the overall response rate was 48% [95% confidence interval (CI) 29% to 67%], with 9 complete and 5 partial responses. Nine patients experienced stable disease and six had disease progression during therapy. The most relevant adverse events were fatigue, thrombocytopenia, neutropenia, and peripheral neuropathy. After a median follow-up of 24 months, the median duration of response was not reached yet. Five deaths were reported, in two patients due to disease progression. CONCLUSION:Bortezomib is active in relapsed MALT lymphomas. Further investigations to identify optimal bortezomib dose, schedule, and combination regimens are needed since the frequent detection of dose-limiting peripheral neuropathy.
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