TY - JOUR
T1 - Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance in untreated multiple myeloma patients
AU - Palumbo, Antonio
AU - Gay, Francesca
AU - Falco, Patrizia
AU - Crippa, Claudia
AU - Montefusco, Vittorio
AU - Patriarca, Francesca
AU - Rossini, Fausto
AU - Caltagirone, Simona
AU - Benevolo, Giulia
AU - Pescosta, Norbert
AU - Guglielmelli, Tommasina
AU - Bringhen, Sara
AU - Offidani, Massimo
AU - Giuliani, Nicola
AU - Petrucci, Maria Teresa
AU - Musto, Pellegrino
AU - Liberati, Anna Marina
AU - Rossi, Giuseppe
AU - Corradini, Paolo
AU - Boccadoro, Mario
PY - 2010/2/10
Y1 - 2010/2/10
N2 - Purpose: To evaluate the effect of bortezomib as induction therapy before autologous transplantation, followed by lenalidomide as consolidation- maintenance in myeloma patients. Patients and Methods: Newly diagnosed patients age 65 to 75 years were eligible. Induction (bortezomib, doxorubicin, and dexamethasone [PAD]) included four 21-day cycles of bortezomib (1.3 mg/m 2 on days 1, 4, 8, and 11), pegylated liposomal doxorubicin (30 mg/m2 on day 4), and dexamethasone (40 mg/d; cycle 1: days 1 to 4, 8 to 11, and 15 to 18; cycles 2 to 4: days 1 to 4). Autologous transplantation was tandem melphalan 100 mg/m2 (MEL100) and stem-cell support. Consolidation included four 28-day cycles of lenalidomide (25 mg/d on days 1 to 21 every 28 days) plus prednisone (50 mg every other day), followed by maintenance with lenalidomide (LP-L; 10 mg/d on days 1 to 21) until relapse. Primary end points were safety (incidence of grade 3 to 4 adverse events [AEs]) and efficacy (response rate). Results: A total of 102 patients were enrolled. In a per-protocol analysis, after PAD, 58% of patients had very good partial response (VGPR) or better, including 13% with complete response (CR); after MEL100, 82% of patients had at least VGPR and 38% had CR; and after LP-L, 86% of patients had at least VGPR and 66% had CR. After median follow-up time of 21 months, the 2-year progression-free survival rate was 69%, and the 2-year overall survival rate was 86%. During induction, treatment-related mortality was 3%; grade 3 to 4 AEs included thrombocytopenia (17%), neutropenia (10%), peripheral neuropathy (16%), and pneumonia (10%). During consolidation- maintenance, grade 3 to 4 AEs were neutropenia (16%), thrombocytopenia (6%), pneumonia (5%), and cutaneous rash (4%). Conclusion: Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance, is an effective regimen.
AB - Purpose: To evaluate the effect of bortezomib as induction therapy before autologous transplantation, followed by lenalidomide as consolidation- maintenance in myeloma patients. Patients and Methods: Newly diagnosed patients age 65 to 75 years were eligible. Induction (bortezomib, doxorubicin, and dexamethasone [PAD]) included four 21-day cycles of bortezomib (1.3 mg/m 2 on days 1, 4, 8, and 11), pegylated liposomal doxorubicin (30 mg/m2 on day 4), and dexamethasone (40 mg/d; cycle 1: days 1 to 4, 8 to 11, and 15 to 18; cycles 2 to 4: days 1 to 4). Autologous transplantation was tandem melphalan 100 mg/m2 (MEL100) and stem-cell support. Consolidation included four 28-day cycles of lenalidomide (25 mg/d on days 1 to 21 every 28 days) plus prednisone (50 mg every other day), followed by maintenance with lenalidomide (LP-L; 10 mg/d on days 1 to 21) until relapse. Primary end points were safety (incidence of grade 3 to 4 adverse events [AEs]) and efficacy (response rate). Results: A total of 102 patients were enrolled. In a per-protocol analysis, after PAD, 58% of patients had very good partial response (VGPR) or better, including 13% with complete response (CR); after MEL100, 82% of patients had at least VGPR and 38% had CR; and after LP-L, 86% of patients had at least VGPR and 66% had CR. After median follow-up time of 21 months, the 2-year progression-free survival rate was 69%, and the 2-year overall survival rate was 86%. During induction, treatment-related mortality was 3%; grade 3 to 4 AEs included thrombocytopenia (17%), neutropenia (10%), peripheral neuropathy (16%), and pneumonia (10%). During consolidation- maintenance, grade 3 to 4 AEs were neutropenia (16%), thrombocytopenia (6%), pneumonia (5%), and cutaneous rash (4%). Conclusion: Bortezomib as induction before autologous transplantation, followed by lenalidomide as consolidation-maintenance, is an effective regimen.
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U2 - 10.1200/JCO.2009.22.7561
DO - 10.1200/JCO.2009.22.7561
M3 - Article
C2 - 20048187
AN - SCOPUS:77649215631
VL - 28
SP - 800
EP - 807
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 5
ER -