Contributions
Abstract: PB2241
Type: Publication Only
Background
The current report represents the interim results of clinical observation, estimating the efficiency and safety of Bortezomib based induction and maintenance therapy in transplant ineligible patients.
Aims
The aim of the current investigation includes assessment of progression free survival (PFS), treatment response rates, overall survival (OS) and adverse events.
Methods
The analysis includes 20 patients, 9 male and 11 female, who received treatment in the hematology clinics of the Military Medical Academy and UMPHAT "G.Stranski" -Pleven. Inclusion criteria: patients with multiple myeloma, who received Bortezomib-based first line treatment and Bortezomib maintenance for two years or till progression/toxicity; transplants ineligible; Exclusion criteria: polyneuropathy Grade > =2 or heavy comorbidity. Patients were assessed by laboratory exanimations, including FBC, biochemistry, β2-microglobulin, and serum and urine electrophoresis with immune fixation.
Patients’ diagnose, stage and response were evaluated according to the IMWC 2010 recommendations.
Bortezomib-induced hematology and non-hematology toxicity was graded according to the CTCAE v.4.03 criteria.
Methods of descriptive statistics were applied. The survival rate was assessed by the Kaplan-Meyer method. The survival in the individual groups was compared with the Log Rank test (Mantel-Cox) and the follow up time - by Kaplan-Meyer's inverted method. Results were accepted significant at p <0.05.
Results
After 27 months median follow up, the OS had not yet been reached, the PFS was 24 months. At 32 month, 61, 1 % of patients were still alive. The two year survival was 76%.
The majority of the patients were stage II-III ISS- 8 (80,0%) and Ig G type – 11(55%).
After a median follow- up time of 24 months, the PFS was 24 months.
The OS has not yet been reached. At 32-month, 61,1%of patients were still alive. The two-year survival was 76 %.
Median time to first response was 4 month (2-8), with predominant response rate (PR) in 75% of the patients.
Median time to best response was 2 months (2-31), with predominant response rate CR in 45% of the patients.
During the follow-up, 9 patients experienced loss of response. At the last visit, 11 patients continue their treatment.
In the course of treatment, the safety of the drug was also monitored. In 20% (n = 4) of patients, reversible Bortezomib-related toxicity was recorded and only one patient required dose reduction due to painful neuropathy . There were no serious CTCAE Grade 3-4 events, death or discontinuation of therapy due to Bortezomib.
Conclusion
Despite the small number of patients, the obtained results are comparable to those from the UPFRONT Phase 3 trial. Bortezomib (Velcade®) -based therapy, including induction and maintenance phase, in patients with multiple myeloma, unsuitable for transplantation, is an effective and safe therapeutic strategy.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): bortezomib, Elderly, Maintenance, Multiple Myeloma
Abstract: PB2241
Type: Publication Only
Background
The current report represents the interim results of clinical observation, estimating the efficiency and safety of Bortezomib based induction and maintenance therapy in transplant ineligible patients.
Aims
The aim of the current investigation includes assessment of progression free survival (PFS), treatment response rates, overall survival (OS) and adverse events.
Methods
The analysis includes 20 patients, 9 male and 11 female, who received treatment in the hematology clinics of the Military Medical Academy and UMPHAT "G.Stranski" -Pleven. Inclusion criteria: patients with multiple myeloma, who received Bortezomib-based first line treatment and Bortezomib maintenance for two years or till progression/toxicity; transplants ineligible; Exclusion criteria: polyneuropathy Grade > =2 or heavy comorbidity. Patients were assessed by laboratory exanimations, including FBC, biochemistry, β2-microglobulin, and serum and urine electrophoresis with immune fixation.
Patients’ diagnose, stage and response were evaluated according to the IMWC 2010 recommendations.
Bortezomib-induced hematology and non-hematology toxicity was graded according to the CTCAE v.4.03 criteria.
Methods of descriptive statistics were applied. The survival rate was assessed by the Kaplan-Meyer method. The survival in the individual groups was compared with the Log Rank test (Mantel-Cox) and the follow up time - by Kaplan-Meyer's inverted method. Results were accepted significant at p <0.05.
Results
After 27 months median follow up, the OS had not yet been reached, the PFS was 24 months. At 32 month, 61, 1 % of patients were still alive. The two year survival was 76%.
The majority of the patients were stage II-III ISS- 8 (80,0%) and Ig G type – 11(55%).
After a median follow- up time of 24 months, the PFS was 24 months.
The OS has not yet been reached. At 32-month, 61,1%of patients were still alive. The two-year survival was 76 %.
Median time to first response was 4 month (2-8), with predominant response rate (PR) in 75% of the patients.
Median time to best response was 2 months (2-31), with predominant response rate CR in 45% of the patients.
During the follow-up, 9 patients experienced loss of response. At the last visit, 11 patients continue their treatment.
In the course of treatment, the safety of the drug was also monitored. In 20% (n = 4) of patients, reversible Bortezomib-related toxicity was recorded and only one patient required dose reduction due to painful neuropathy . There were no serious CTCAE Grade 3-4 events, death or discontinuation of therapy due to Bortezomib.
Conclusion
Despite the small number of patients, the obtained results are comparable to those from the UPFRONT Phase 3 trial. Bortezomib (Velcade®) -based therapy, including induction and maintenance phase, in patients with multiple myeloma, unsuitable for transplantation, is an effective and safe therapeutic strategy.
Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical
Keyword(s): bortezomib, Elderly, Maintenance, Multiple Myeloma