VALIDATION OF REVISED INTERNATIONAL STAGING SYSTEM (R-ISS) IN THE ERA OF NOVEL AGENTS: REAL-WORLD DATA ON 481 MYELOMA PATIENTS FROM A GREEK MYELOMA CENTER
(Abstract release date: 05/19/16)
EHA Library. Giannopoulou E. 06/09/16; 134844; PB1944
Dr. Evlambia Giannopoulou
Contributions
Contributions
Abstract
Abstract: PB1944
Type: Publication Only
Background
Risk stratification has a crucial role in the management of Multiple Myeloma (MM). International staging system (ISS) has been a powerful tool for risk stratification and prognosis in MM for many years. Recently, a revised ISS (R-ISS) has been validated in a large study that included patients enrolled in international randomized studies. This staging system combined ISS with two additional prognostic factors of overall survival (OS), that is abnormal lactate dehydrogenase (LDH) and high risk molecular cytogenetics i.e. del17p and/or t(4;14) and/or t(14;16). According to the aforementioned study, R-ISS represents a single powerful prognostic system that stratifies MM patients more effectively than conventional ISS with respect to the relative risk of their survival. Data regarding the prognostic value of R-ISS outside clinical trials, are limited.
Aims
Herein, we have presented real-world data regarding the prognostic value of R-ISS, in a large number of MM patients from a single Greek Myeloma Center.
Methods
We have reviewed the records of 481 consecutive symptomatic MM patients diagnosed and treated in our center between 2000-2015 (median age: 68 years, range: 29-90 years; M/F: 258/:223; IgG: 271, IgA: 124 Light chain: 66, non-secretory: 15, IgD: 4, IgM:1 ISS1: 153, ISS2: 148, ISS3: 180).
Results
R-ISS was available in 411 patients (M/F: 221/190; median age: 68 years, range: 29-90 years; IgG: 237, IgA: 103 Light chain: 53, non-secretory: 13, IgD: 4, IgM: 1; ISS1: 101, ISS2: 144 and ISS3: 165). Fifty-seven (13.8%) patients had R-ISS1, 286 patients had R-ISS2 (69.5%) and 68 patients had R-ISS3 (16%). High-risk molecular cytogenetics were present in 27% of patients while high LDH was present in 27% of patients. Overall, 280/481 patients (58%) were treated with novel agents (NA) combinations in first line (IMiD-based: 168, Vel-based: 110, conventional therapy: 194, missing data: 9). Second line therapy was administered in 230/481 patients; 78% was treated with NA (Lenalidomide-dexamethasone: 67, Vel-based: 44, Thal-based: 70, chemotherapy: 49). Autologous transplantation was offered in 68/190 (36%) eligible patients. After 1st line therapy, the objective response rate was 82%, while at least very good partial response (≥vgPR) was achieved by 58% of patients. After a median follow up of 8 years (95% CI: 80-114), 135/481 (28%) patients are alive. In the univariate analysis, age, creatinine, ISS, R-ISS, molecular cytogenetics, type of 1st and 2nd line treatment, achievement of ≥vgPR and autologous transplantation (ASCT) predicted for overall survival (OS). In the multivariate analysis, R-ISS and ≥vgPR were independent predictors for survival (p<0.001, HzR:0.4, 95% CI: 0.2-0.6 and p=0.03, HzR: 0.6, 95% CI: 0.4-0.9, respectively). Median OS for patients with R-ISS1, R-ISS2 and R-ISS3, was 92 months (95% CI: 55-129), 36 months (95% CI: 32-40) and 20 months (95% CI: 13-27), respectively (p<0.001). A subgroup analysis confirmed the prognostic role of R-ISS irrespective of age (<65 or ≥ 65), period of diagnosis (<2006 or ≥2006), type of treatment (bortezomib-based, IMiD-based or chemotherapy) and administration or not of ASCT.
Conclusion
Our results confirm that R-ISS is the most powerful prognostic factor for OS in an unselected MM population. Its predictive value is maintained across different groups of patients providing a simple and available tool for risk stratification of MM patients, which is essential for therapeutic decisions.
Session topic: E-poster
Keyword(s): Multiple myeloma, Prognosis
Type: Publication Only
Background
Risk stratification has a crucial role in the management of Multiple Myeloma (MM). International staging system (ISS) has been a powerful tool for risk stratification and prognosis in MM for many years. Recently, a revised ISS (R-ISS) has been validated in a large study that included patients enrolled in international randomized studies. This staging system combined ISS with two additional prognostic factors of overall survival (OS), that is abnormal lactate dehydrogenase (LDH) and high risk molecular cytogenetics i.e. del17p and/or t(4;14) and/or t(14;16). According to the aforementioned study, R-ISS represents a single powerful prognostic system that stratifies MM patients more effectively than conventional ISS with respect to the relative risk of their survival. Data regarding the prognostic value of R-ISS outside clinical trials, are limited.
Aims
Herein, we have presented real-world data regarding the prognostic value of R-ISS, in a large number of MM patients from a single Greek Myeloma Center.
Methods
We have reviewed the records of 481 consecutive symptomatic MM patients diagnosed and treated in our center between 2000-2015 (median age: 68 years, range: 29-90 years; M/F: 258/:223; IgG: 271, IgA: 124 Light chain: 66, non-secretory: 15, IgD: 4, IgM:1 ISS1: 153, ISS2: 148, ISS3: 180).
Results
R-ISS was available in 411 patients (M/F: 221/190; median age: 68 years, range: 29-90 years; IgG: 237, IgA: 103 Light chain: 53, non-secretory: 13, IgD: 4, IgM: 1; ISS1: 101, ISS2: 144 and ISS3: 165). Fifty-seven (13.8%) patients had R-ISS1, 286 patients had R-ISS2 (69.5%) and 68 patients had R-ISS3 (16%). High-risk molecular cytogenetics were present in 27% of patients while high LDH was present in 27% of patients. Overall, 280/481 patients (58%) were treated with novel agents (NA) combinations in first line (IMiD-based: 168, Vel-based: 110, conventional therapy: 194, missing data: 9). Second line therapy was administered in 230/481 patients; 78% was treated with NA (Lenalidomide-dexamethasone: 67, Vel-based: 44, Thal-based: 70, chemotherapy: 49). Autologous transplantation was offered in 68/190 (36%) eligible patients. After 1st line therapy, the objective response rate was 82%, while at least very good partial response (≥vgPR) was achieved by 58% of patients. After a median follow up of 8 years (95% CI: 80-114), 135/481 (28%) patients are alive. In the univariate analysis, age, creatinine, ISS, R-ISS, molecular cytogenetics, type of 1st and 2nd line treatment, achievement of ≥vgPR and autologous transplantation (ASCT) predicted for overall survival (OS). In the multivariate analysis, R-ISS and ≥vgPR were independent predictors for survival (p<0.001, HzR:0.4, 95% CI: 0.2-0.6 and p=0.03, HzR: 0.6, 95% CI: 0.4-0.9, respectively). Median OS for patients with R-ISS1, R-ISS2 and R-ISS3, was 92 months (95% CI: 55-129), 36 months (95% CI: 32-40) and 20 months (95% CI: 13-27), respectively (p<0.001). A subgroup analysis confirmed the prognostic role of R-ISS irrespective of age (<65 or ≥ 65), period of diagnosis (<2006 or ≥2006), type of treatment (bortezomib-based, IMiD-based or chemotherapy) and administration or not of ASCT.
Conclusion
Our results confirm that R-ISS is the most powerful prognostic factor for OS in an unselected MM population. Its predictive value is maintained across different groups of patients providing a simple and available tool for risk stratification of MM patients, which is essential for therapeutic decisions.
Session topic: E-poster
Keyword(s): Multiple myeloma, Prognosis
Abstract: PB1944
Type: Publication Only
Background
Risk stratification has a crucial role in the management of Multiple Myeloma (MM). International staging system (ISS) has been a powerful tool for risk stratification and prognosis in MM for many years. Recently, a revised ISS (R-ISS) has been validated in a large study that included patients enrolled in international randomized studies. This staging system combined ISS with two additional prognostic factors of overall survival (OS), that is abnormal lactate dehydrogenase (LDH) and high risk molecular cytogenetics i.e. del17p and/or t(4;14) and/or t(14;16). According to the aforementioned study, R-ISS represents a single powerful prognostic system that stratifies MM patients more effectively than conventional ISS with respect to the relative risk of their survival. Data regarding the prognostic value of R-ISS outside clinical trials, are limited.
Aims
Herein, we have presented real-world data regarding the prognostic value of R-ISS, in a large number of MM patients from a single Greek Myeloma Center.
Methods
We have reviewed the records of 481 consecutive symptomatic MM patients diagnosed and treated in our center between 2000-2015 (median age: 68 years, range: 29-90 years; M/F: 258/:223; IgG: 271, IgA: 124 Light chain: 66, non-secretory: 15, IgD: 4, IgM:1 ISS1: 153, ISS2: 148, ISS3: 180).
Results
R-ISS was available in 411 patients (M/F: 221/190; median age: 68 years, range: 29-90 years; IgG: 237, IgA: 103 Light chain: 53, non-secretory: 13, IgD: 4, IgM: 1; ISS1: 101, ISS2: 144 and ISS3: 165). Fifty-seven (13.8%) patients had R-ISS1, 286 patients had R-ISS2 (69.5%) and 68 patients had R-ISS3 (16%). High-risk molecular cytogenetics were present in 27% of patients while high LDH was present in 27% of patients. Overall, 280/481 patients (58%) were treated with novel agents (NA) combinations in first line (IMiD-based: 168, Vel-based: 110, conventional therapy: 194, missing data: 9). Second line therapy was administered in 230/481 patients; 78% was treated with NA (Lenalidomide-dexamethasone: 67, Vel-based: 44, Thal-based: 70, chemotherapy: 49). Autologous transplantation was offered in 68/190 (36%) eligible patients. After 1st line therapy, the objective response rate was 82%, while at least very good partial response (≥vgPR) was achieved by 58% of patients. After a median follow up of 8 years (95% CI: 80-114), 135/481 (28%) patients are alive. In the univariate analysis, age, creatinine, ISS, R-ISS, molecular cytogenetics, type of 1st and 2nd line treatment, achievement of ≥vgPR and autologous transplantation (ASCT) predicted for overall survival (OS). In the multivariate analysis, R-ISS and ≥vgPR were independent predictors for survival (p<0.001, HzR:0.4, 95% CI: 0.2-0.6 and p=0.03, HzR: 0.6, 95% CI: 0.4-0.9, respectively). Median OS for patients with R-ISS1, R-ISS2 and R-ISS3, was 92 months (95% CI: 55-129), 36 months (95% CI: 32-40) and 20 months (95% CI: 13-27), respectively (p<0.001). A subgroup analysis confirmed the prognostic role of R-ISS irrespective of age (<65 or ≥ 65), period of diagnosis (<2006 or ≥2006), type of treatment (bortezomib-based, IMiD-based or chemotherapy) and administration or not of ASCT.
Conclusion
Our results confirm that R-ISS is the most powerful prognostic factor for OS in an unselected MM population. Its predictive value is maintained across different groups of patients providing a simple and available tool for risk stratification of MM patients, which is essential for therapeutic decisions.
Session topic: E-poster
Keyword(s): Multiple myeloma, Prognosis
Type: Publication Only
Background
Risk stratification has a crucial role in the management of Multiple Myeloma (MM). International staging system (ISS) has been a powerful tool for risk stratification and prognosis in MM for many years. Recently, a revised ISS (R-ISS) has been validated in a large study that included patients enrolled in international randomized studies. This staging system combined ISS with two additional prognostic factors of overall survival (OS), that is abnormal lactate dehydrogenase (LDH) and high risk molecular cytogenetics i.e. del17p and/or t(4;14) and/or t(14;16). According to the aforementioned study, R-ISS represents a single powerful prognostic system that stratifies MM patients more effectively than conventional ISS with respect to the relative risk of their survival. Data regarding the prognostic value of R-ISS outside clinical trials, are limited.
Aims
Herein, we have presented real-world data regarding the prognostic value of R-ISS, in a large number of MM patients from a single Greek Myeloma Center.
Methods
We have reviewed the records of 481 consecutive symptomatic MM patients diagnosed and treated in our center between 2000-2015 (median age: 68 years, range: 29-90 years; M/F: 258/:223; IgG: 271, IgA: 124 Light chain: 66, non-secretory: 15, IgD: 4, IgM:1 ISS1: 153, ISS2: 148, ISS3: 180).
Results
R-ISS was available in 411 patients (M/F: 221/190; median age: 68 years, range: 29-90 years; IgG: 237, IgA: 103 Light chain: 53, non-secretory: 13, IgD: 4, IgM: 1; ISS1: 101, ISS2: 144 and ISS3: 165). Fifty-seven (13.8%) patients had R-ISS1, 286 patients had R-ISS2 (69.5%) and 68 patients had R-ISS3 (16%). High-risk molecular cytogenetics were present in 27% of patients while high LDH was present in 27% of patients. Overall, 280/481 patients (58%) were treated with novel agents (NA) combinations in first line (IMiD-based: 168, Vel-based: 110, conventional therapy: 194, missing data: 9). Second line therapy was administered in 230/481 patients; 78% was treated with NA (Lenalidomide-dexamethasone: 67, Vel-based: 44, Thal-based: 70, chemotherapy: 49). Autologous transplantation was offered in 68/190 (36%) eligible patients. After 1st line therapy, the objective response rate was 82%, while at least very good partial response (≥vgPR) was achieved by 58% of patients. After a median follow up of 8 years (95% CI: 80-114), 135/481 (28%) patients are alive. In the univariate analysis, age, creatinine, ISS, R-ISS, molecular cytogenetics, type of 1st and 2nd line treatment, achievement of ≥vgPR and autologous transplantation (ASCT) predicted for overall survival (OS). In the multivariate analysis, R-ISS and ≥vgPR were independent predictors for survival (p<0.001, HzR:0.4, 95% CI: 0.2-0.6 and p=0.03, HzR: 0.6, 95% CI: 0.4-0.9, respectively). Median OS for patients with R-ISS1, R-ISS2 and R-ISS3, was 92 months (95% CI: 55-129), 36 months (95% CI: 32-40) and 20 months (95% CI: 13-27), respectively (p<0.001). A subgroup analysis confirmed the prognostic role of R-ISS irrespective of age (<65 or ≥ 65), period of diagnosis (<2006 or ≥2006), type of treatment (bortezomib-based, IMiD-based or chemotherapy) and administration or not of ASCT.
Conclusion
Our results confirm that R-ISS is the most powerful prognostic factor for OS in an unselected MM population. Its predictive value is maintained across different groups of patients providing a simple and available tool for risk stratification of MM patients, which is essential for therapeutic decisions.
Session topic: E-poster
Keyword(s): Multiple myeloma, Prognosis
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