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SALVAGE THERAPY WITH BORTEZOMIB AND DEXAMETHASONE IN VERY ELDERLY PATIENTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA.
Author(s): ,
Roberto Castelli
Affiliations:
Hematology,1 Department of Pathophysiology and Transplantation University of Milan, and Department of Haematology IRCCS Ca’ Granda Policlinico, Milan, Italy,Milan,Italy
,
Giuseppe Pantaleo
Affiliations:
2 UniSR-Social.Lab, Faculty of Psychology, Vita-Salute San Raffaele University of Milan, Italy,Milan,Italy
,
Paolo Gallipoli
Affiliations:
Department of Haematology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK,Cambridge,United Kingdom
,
Paolo Gallipoli
Affiliations:
Department of Haematology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK,Cambridge,United Kingdom
,
Massimo Arquati
Affiliations:
4Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Luigi Sacco Hospital Milan, Milan, Italy,University of Milan,Milan,Italy
,
Maddalena Alessandra Wu
Affiliations:
4Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Luigi Sacco Hospital Milan, Milan, Italy,University of Milan,Milan,Italy
,
Giorgio Lambertenghi Deliliers
Affiliations:
Fondazione Matarelli Milan,Fondazione Matarelli,Milan,Italy
Marco Cicardi
Affiliations:
4Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Luigi Sacco Hospital Milan, Milan, Italy,University of Milan,Milan,Italy
(Abstract release date: 05/21/15) EHA Library. Castelli R. 06/12/15; 102813; PB1875 Disclosure(s): University of Milan
Hematology
Roberto Castelli
Roberto Castelli
Contributions
Abstract
Abstract: PB1875

Type: Publication Only

Background
Despite recent advances in therapy, multiple myeloma (MM) patients eventually relapse and become refractory to treatment with a median survival ranging from 6 to 9 months. Over the last decade, the introduction of new front-line agents, such as the immunomodulatory drugs (IMIDs) thalidomide and lenalidomide and the proteasome inhibitor, have led to an increase in survival in MM by achieving deeper levels of responses and prolonging the duration of remission. Bortezomib (bort)–dexamethasone (dex) is an effective therapy for relapsed/refractory (R/R) MM, but few data are available for elderly patients. Although MM affects people of all ages, more than 60% of MM patients are older than 70 years of age (median age at diagnosis 70 years), and the number of new patients is expected to double worldwide by 2030

Aims
: to evaluate efficacy and toxicity of bort-dex treatment in elderly R/R MM patients.

Methods
From 2006 to 2015 we performed a retrospective, observational study to detect the efficacy and tolerability of bort-dex in a cohort of 81 elderly patients with R/R MM. Patients were treated with bortezomib at the dose of 1.3 mg⁄m2 on days 1, 4, 8, 11 every 3 weeks up to 6–8 cycles alone or in association with dexamethasone at the dose of 20 mg on the day of bortezomib administration and on the subsequent day. Responses were assessed according to the International Myeloma Working Group (IMWG) criteria

Results
Median age of study population was 73 years (range 65-89 years). Fifty-three (65. 4%) of patients achieved at least a partial response, including 8 patients (11%) with Complete Response (CR) and 9 patients (12.5%) with very good partial response (VGPR). The median number of prior lines of therapy was 2. The median number of cycles of bort-dex was 6 (range 1-11). Thirty-nine patients (48%) received bortezomib intravenously, 42 (52%) received bortezomib subcutaneously. Fifty patients (61.7%) had received immunomodulatory drugs. The median duration of response, time to next therapy and treatment free intervals were 8, 11 and 5 months. The duration of response was significantly longer for patients achieving CR⁄VGPR than for those achieving PR (7.3 vs. 3.8 months, p = 0.03). After a median follow up of 24 months, 78 patients showed disease progression and 70 patients died. Median Time to progression (TTP), progression free survival (PFS) and overall survival (OS) of the whole population were 8.9, 8.7 and 22 months respectively. The most relevant side effect was peripheral neuropathy (PN), occurring in 38 patients

Summary

The depth of response to bortezomib and clinical benefit are known to be strictly related in younger MM R/R patients. Our data highlight that bort-dex is highly effective and tolerable in fit elderly patients, thus justifying the efforts to obtain deeper responses to therapy also in this subset of patients.  However, awareness of the risk of short living haematological responses to bort-dex salvage therapy (both in young and in old patients) should lead to thorough evaluation about the need of a maintenance therapy with other agents such as lenalidomide or pomalidomide in order to achieve sustained responses.



Session topic: Publication Only
Abstract: PB1875

Type: Publication Only

Background
Despite recent advances in therapy, multiple myeloma (MM) patients eventually relapse and become refractory to treatment with a median survival ranging from 6 to 9 months. Over the last decade, the introduction of new front-line agents, such as the immunomodulatory drugs (IMIDs) thalidomide and lenalidomide and the proteasome inhibitor, have led to an increase in survival in MM by achieving deeper levels of responses and prolonging the duration of remission. Bortezomib (bort)–dexamethasone (dex) is an effective therapy for relapsed/refractory (R/R) MM, but few data are available for elderly patients. Although MM affects people of all ages, more than 60% of MM patients are older than 70 years of age (median age at diagnosis 70 years), and the number of new patients is expected to double worldwide by 2030

Aims
: to evaluate efficacy and toxicity of bort-dex treatment in elderly R/R MM patients.

Methods
From 2006 to 2015 we performed a retrospective, observational study to detect the efficacy and tolerability of bort-dex in a cohort of 81 elderly patients with R/R MM. Patients were treated with bortezomib at the dose of 1.3 mg⁄m2 on days 1, 4, 8, 11 every 3 weeks up to 6–8 cycles alone or in association with dexamethasone at the dose of 20 mg on the day of bortezomib administration and on the subsequent day. Responses were assessed according to the International Myeloma Working Group (IMWG) criteria

Results
Median age of study population was 73 years (range 65-89 years). Fifty-three (65. 4%) of patients achieved at least a partial response, including 8 patients (11%) with Complete Response (CR) and 9 patients (12.5%) with very good partial response (VGPR). The median number of prior lines of therapy was 2. The median number of cycles of bort-dex was 6 (range 1-11). Thirty-nine patients (48%) received bortezomib intravenously, 42 (52%) received bortezomib subcutaneously. Fifty patients (61.7%) had received immunomodulatory drugs. The median duration of response, time to next therapy and treatment free intervals were 8, 11 and 5 months. The duration of response was significantly longer for patients achieving CR⁄VGPR than for those achieving PR (7.3 vs. 3.8 months, p = 0.03). After a median follow up of 24 months, 78 patients showed disease progression and 70 patients died. Median Time to progression (TTP), progression free survival (PFS) and overall survival (OS) of the whole population were 8.9, 8.7 and 22 months respectively. The most relevant side effect was peripheral neuropathy (PN), occurring in 38 patients

Summary

The depth of response to bortezomib and clinical benefit are known to be strictly related in younger MM R/R patients. Our data highlight that bort-dex is highly effective and tolerable in fit elderly patients, thus justifying the efforts to obtain deeper responses to therapy also in this subset of patients.  However, awareness of the risk of short living haematological responses to bort-dex salvage therapy (both in young and in old patients) should lead to thorough evaluation about the need of a maintenance therapy with other agents such as lenalidomide or pomalidomide in order to achieve sustained responses.



Session topic: Publication Only

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