Maintenance therapy with immunomodulatory drugs has shown to improve responses and delay relapse and progression in Multiple Myeloma (MM) patients after autologous stem cell transplantation (ASCT). Although maintenance therapy with Thalidomide (T) after ASCT increases progression free survival (PFS) in MM patients, it is associated with dose-limiting multiple toxicities. Lenalidomide (R), approved for relapsed and/or refractory MM, has been reported to be associated with lower rates of toxicities than T. We evaluated efficacy and safety of continuous maintenance therapy with alternate-day low dose R (LD-R, 10 mg/day), after high-dose melphalan (HD-MEL, 200 mg/mq) and ASCT, in 8 MM patients (6 male and 2 female) older than age 60 (median: 68 years, range 60-73), receiving pre-ASCT induction treatment with 4 cycles of conventional bortezomib, T and dexamethasone (VTD) regimen. Of these 8 MM patients, 2 and 6 patients were in complete remission (CR) and in very good partial remission (VgPR) after ASCT, respectively. After a median follow-up of 14 months (range 3-43) from the initiation of LD-R maintenance, patients in CR maintained their CR, and all patients in VgPR improved the depth of response except one who showed disease progression. In this LD-R group, PFS and overall survival (OS) at 24 months were 83% and 100%, respectively, and no significant specific R-related toxicity was encountered. LD-R maintenance therapy was retrospectively compared with a matched age, gender, disease stage cohort of 17 MM patients treated with low-dose T (LD-T) maintenance therapy (50 mg/day for 2 years) after HD-MEL ASCT. In this last cohort, after a median follow-up of 53 months (range 3-125), 8/17 (47%) patients relapsed, and median PFS and OS were 39 and 53 months, respectively. In LD-T group, grade I-III neurotoxicity was detected in 11/17 (65%) patients, increasing up to 80% after 2 years of therapy, leading to drug discontinuation in 4/17 (23%); in addition, grade I hematological toxicity was documented in 55% of patients. PFS and OS were not statistically significant between these two groups of patients. Our preliminary results provide evidence that continuous therapy with alternate-day LDR is a feasible and effective maintenance treatment after ASCT for MM patients enabling a long-lasting maintenance therapy. These results require further validation in prospective larger studies.

Continuous maintenance therapy with alternate-day low dose lenalidomide in multiple myeloma patients after autologous stem cell transplantation

Giudice V;SELLERI, Carmine
2013-01-01

Abstract

Maintenance therapy with immunomodulatory drugs has shown to improve responses and delay relapse and progression in Multiple Myeloma (MM) patients after autologous stem cell transplantation (ASCT). Although maintenance therapy with Thalidomide (T) after ASCT increases progression free survival (PFS) in MM patients, it is associated with dose-limiting multiple toxicities. Lenalidomide (R), approved for relapsed and/or refractory MM, has been reported to be associated with lower rates of toxicities than T. We evaluated efficacy and safety of continuous maintenance therapy with alternate-day low dose R (LD-R, 10 mg/day), after high-dose melphalan (HD-MEL, 200 mg/mq) and ASCT, in 8 MM patients (6 male and 2 female) older than age 60 (median: 68 years, range 60-73), receiving pre-ASCT induction treatment with 4 cycles of conventional bortezomib, T and dexamethasone (VTD) regimen. Of these 8 MM patients, 2 and 6 patients were in complete remission (CR) and in very good partial remission (VgPR) after ASCT, respectively. After a median follow-up of 14 months (range 3-43) from the initiation of LD-R maintenance, patients in CR maintained their CR, and all patients in VgPR improved the depth of response except one who showed disease progression. In this LD-R group, PFS and overall survival (OS) at 24 months were 83% and 100%, respectively, and no significant specific R-related toxicity was encountered. LD-R maintenance therapy was retrospectively compared with a matched age, gender, disease stage cohort of 17 MM patients treated with low-dose T (LD-T) maintenance therapy (50 mg/day for 2 years) after HD-MEL ASCT. In this last cohort, after a median follow-up of 53 months (range 3-125), 8/17 (47%) patients relapsed, and median PFS and OS were 39 and 53 months, respectively. In LD-T group, grade I-III neurotoxicity was detected in 11/17 (65%) patients, increasing up to 80% after 2 years of therapy, leading to drug discontinuation in 4/17 (23%); in addition, grade I hematological toxicity was documented in 55% of patients. PFS and OS were not statistically significant between these two groups of patients. Our preliminary results provide evidence that continuous therapy with alternate-day LDR is a feasible and effective maintenance treatment after ASCT for MM patients enabling a long-lasting maintenance therapy. These results require further validation in prospective larger studies.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11386/4238457
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