Contributions
Type: Publication Only
Background
The therapeutic approach of Multiple Myeloma (MM) has been marked by two great advances: the possibility of hematopoietic stem cell transplantation in eligible patients and the use of new active drugs, such as Talidomide, Bortezomib and Lenalidomide.
Aims
Analyze the follow-up of a group of patients with MM submitted to regimens including Bortezomib in the first line, evaluate the response to the treatment, analyze the overall survival (OS), duration of response (DOR) and time to progression (TTP).
Methods
Retrospective analyses of the clinical files of patients with MM, diagnosed between January 2009 and December 2014, undergoing treatment with protocols including Bortezomib in the first line. Response criteria after treatment according to the International Myeloma Working Group (IMWG). Statistic analyses using SPSS 22.
Results
Between January 2009 and December 2014, 65 patients were diagnosed with MM, 34 of which (52,3%) were treated with first line Bortezomib (CyBorDexa in 29; BorDexa in 3; VMP in 2). The median number of cycles administered was 8,5.
The median age at diagnosis was 65,6 years (min=42; max=79), 18 were females (52,9%) and 16 males (47,1%). The mean follow-up time was 1,9 years. At diagnosis 31 patients (91,2%) presented anemia, 24 bone disease (70,6%), 19 renal impairment (55,9%) and 11 hypercalcemia (32,4%). According to the ISS, 10 patients were low risk (ISS 1) (29,4%), 10 patients intermediate (ISS 2)(29,4%) and 14 high risk (ISS 3)(41,2%).
Six patients were eligible for transplant consolidation (17,6%). In 5 patients disease progression occurred during treatment (14,7%) and 3 are still under treatment. Response after treatment completion was accessed in 26 patients: PR=13 patients (50%), CR=9 (36,4%), VGPR=3 (11,5%) and sCR=1 (3,9%). Eleven patients progressed (42,3%) with a median TTP of 15,81 months and mean DOR of 9,09 months, 2 of them had reached VGPR and 9 PR. Five patients died. The 5-year overall survival was 85,3%.
Summary
The use of Bortezomib in the regimens CyBorDexa, BorDexa and VMP was effective in the majority of the patients, with response rates and overall survival mimicking the literature. In 58,8% of patients the ISS risk was low and intermediate; all the high risk patients presented renal impairment. Most of the patients completed treatment, 29/34 with CyBorDexa protocol, 86,4% reaching PR or CR. Among the responding patients, 15 (57,7%) have not progressed after a mean follow up time of 14 months.
Although being widely used for its good tolerance and low toxicity, in several studies the CyBorDexa protocol showed inferior results compared with other multiple-drug protocols, such as VTD (Bortezomib, Talidomide and Dexa) or VRD (Bortezomib, Lenalidomide and Dexa). Currently, ongoing clinical trials will hopefully define the new standard of care in Multiple Myeloma, namely for the transplant eligible patients.
Keyword(s): Bortezomib, Follow-up, Multiple myeloma, Treatment
Type: Publication Only
Background
The therapeutic approach of Multiple Myeloma (MM) has been marked by two great advances: the possibility of hematopoietic stem cell transplantation in eligible patients and the use of new active drugs, such as Talidomide, Bortezomib and Lenalidomide.
Aims
Analyze the follow-up of a group of patients with MM submitted to regimens including Bortezomib in the first line, evaluate the response to the treatment, analyze the overall survival (OS), duration of response (DOR) and time to progression (TTP).
Methods
Retrospective analyses of the clinical files of patients with MM, diagnosed between January 2009 and December 2014, undergoing treatment with protocols including Bortezomib in the first line. Response criteria after treatment according to the International Myeloma Working Group (IMWG). Statistic analyses using SPSS 22.
Results
Between January 2009 and December 2014, 65 patients were diagnosed with MM, 34 of which (52,3%) were treated with first line Bortezomib (CyBorDexa in 29; BorDexa in 3; VMP in 2). The median number of cycles administered was 8,5.
The median age at diagnosis was 65,6 years (min=42; max=79), 18 were females (52,9%) and 16 males (47,1%). The mean follow-up time was 1,9 years. At diagnosis 31 patients (91,2%) presented anemia, 24 bone disease (70,6%), 19 renal impairment (55,9%) and 11 hypercalcemia (32,4%). According to the ISS, 10 patients were low risk (ISS 1) (29,4%), 10 patients intermediate (ISS 2)(29,4%) and 14 high risk (ISS 3)(41,2%).
Six patients were eligible for transplant consolidation (17,6%). In 5 patients disease progression occurred during treatment (14,7%) and 3 are still under treatment. Response after treatment completion was accessed in 26 patients: PR=13 patients (50%), CR=9 (36,4%), VGPR=3 (11,5%) and sCR=1 (3,9%). Eleven patients progressed (42,3%) with a median TTP of 15,81 months and mean DOR of 9,09 months, 2 of them had reached VGPR and 9 PR. Five patients died. The 5-year overall survival was 85,3%.
Summary
The use of Bortezomib in the regimens CyBorDexa, BorDexa and VMP was effective in the majority of the patients, with response rates and overall survival mimicking the literature. In 58,8% of patients the ISS risk was low and intermediate; all the high risk patients presented renal impairment. Most of the patients completed treatment, 29/34 with CyBorDexa protocol, 86,4% reaching PR or CR. Among the responding patients, 15 (57,7%) have not progressed after a mean follow up time of 14 months.
Although being widely used for its good tolerance and low toxicity, in several studies the CyBorDexa protocol showed inferior results compared with other multiple-drug protocols, such as VTD (Bortezomib, Talidomide and Dexa) or VRD (Bortezomib, Lenalidomide and Dexa). Currently, ongoing clinical trials will hopefully define the new standard of care in Multiple Myeloma, namely for the transplant eligible patients.
Keyword(s): Bortezomib, Follow-up, Multiple myeloma, Treatment