A REAL-WORLD COMPARATIVE EFFECTIVENESS ANALYSIS OF PROTEASOME INHIBITOR-BASED REGIMENS IN RELAPSED/REFRACTORY MULTIPLE MYELOMA UTILIZING A NATIONWIDE DATABASE IN JAPAN
Author(s): ,
Hirokazu Tanaka
Affiliations:
Kindai University Faculty of Medicine,Sayama, Osaka,Japan
,
Kenshi Suzuki
Affiliations:
Japanese Red Cross Medical Center,Shibuya-ku, Tokyo,Japan
,
Saori Ito
Affiliations:
Takeda Pharmaceutical Company Limited,Chuo-ku, Tokyo,Japan
Junpei Soeda
Affiliations:
Takeda Pharmaceutical Company Limited,Chuo-ku, Tokyo,Japan
(Abstract release date: 05/14/20) EHA Library. Tanaka H. 06/12/20; 293539; EP1050
Dr. Hirokazu Tanaka
Dr. Hirokazu Tanaka
Contributions
Abstract

Abstract: EP1050

Type: e-Poster

Background
Proteasome inhibitors (PIs) are one of the most important class of agents for the treatment of relapse and /or refractory multiple myeloma (RRMM) and commonly used in routine care. Some studies have investigated clinical outcomes of PIs in real-world and reported shorter duration of treatment (DOT), compared to clinical trials. Although three PIs, bortezomib (Bor), carfilzomib (Car) and ixazomib (Ixa) have been approved in Japan, few real-world studies reported their effectiveness for Japanese RRMM patients. Effectiveness data for PIs treatments in clinical practice are complementary to clinical trials data and valuable for treatment choice.

Aims
To investigate the real-world effectiveness of Bor, Car and Ixa for RRMM patients in Japan.

Methods
This is a retrospective, observational study analyzing the large-scale, nationwide database from the Diagnosis Procedure Combination (DPC) system (a claims payment system in Japan) representing hospitals between April 2008 and December 2018. MM-diagnosed (ICD-10 code: C90.0) patients with the data of second and later line of therapies (LOTs≥2) including Bor, Car or Ixa were followed in this analysis, and then stratified by Bor-, Car- and Ixa-based treatments. LOT-specific patient demographics were described descriptively. DOT and time to next therapy (TTNT) in LOTs ≥2 were evaluated by Bor-, Car- and Ixa-based treatment cohorts using cox proportional hazard models, adjusting  for  propensity score of 17 covariates including age, gender, LOTs, prior regimens and comorbidities by Inverse Probability of Treatment Weights (IPTW). DOT and TTNT in respective LOTs (LOT=2,3,4 and ≥5) were additionally analyzed without adjustment because the number of each subset was small.  Using the Bor-based group as reference, DOT and TTNT of Car- and Ixa-based group were respectively compared with that of Bor.

Results
A total of 2,686 LOTs≥2patients were included in the analysis. Median age was 73 years; major comorbidities were bone fracture (64.9%), renal impairment (44.8%) and cardiac event (36.8%).  Bor, Car and Ixa-based treatments in the LOTs≥2 were used by 2,411, 414, and 311 patients, respectively. Median DOT and median TTNT in the LOTs≥2 were 115, 135, and 140 days and 170, 215, and 282 days for Bor-, Car- and Ixa-based treatments, respectively. The Car- and Ixa-based groups tended to have longer DOT (p=0.03 and 0.06, respectively) and TTNT (p=0.04 and 0.002, respectively) than the Bor-based group during LOTs≥2. Especially in second LOT, the Ixa-based group showed significantly longer DOT (p=0.04) and TTNT (p=0.02) than the Bor-based treatment group. The results of PIs-based regimens with lenalidomide and dexamethasone backbone will be also presented.

Conclusion
This study using a real-world large data suggested that in Japanese RRMM patients, Car- and Ixa-based treatments had longer DOT and TTNT than Bor-based treatments. This result is similar to previous studies comparing PI treatments for RRMM patients in the US, while the types of regimens analyzed in each study were not the same. Notably, the DOT and TTNT in second LOT was significantly longer in the Ixa-based group than Bor-based group, suggesting a benefit of Ixa-based treatments in early lines. This study has some limitations inherent to its retrospective design. Moreover, as the database used in this study covers only the data from the hospitals using DPC system, information in non-DPC hospitals cannot be captured. Further studies are needed to clarify the comparative effectiveness of PIs in the real-world.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Proteasome inhibitor

Abstract: EP1050

Type: e-Poster

Background
Proteasome inhibitors (PIs) are one of the most important class of agents for the treatment of relapse and /or refractory multiple myeloma (RRMM) and commonly used in routine care. Some studies have investigated clinical outcomes of PIs in real-world and reported shorter duration of treatment (DOT), compared to clinical trials. Although three PIs, bortezomib (Bor), carfilzomib (Car) and ixazomib (Ixa) have been approved in Japan, few real-world studies reported their effectiveness for Japanese RRMM patients. Effectiveness data for PIs treatments in clinical practice are complementary to clinical trials data and valuable for treatment choice.

Aims
To investigate the real-world effectiveness of Bor, Car and Ixa for RRMM patients in Japan.

Methods
This is a retrospective, observational study analyzing the large-scale, nationwide database from the Diagnosis Procedure Combination (DPC) system (a claims payment system in Japan) representing hospitals between April 2008 and December 2018. MM-diagnosed (ICD-10 code: C90.0) patients with the data of second and later line of therapies (LOTs≥2) including Bor, Car or Ixa were followed in this analysis, and then stratified by Bor-, Car- and Ixa-based treatments. LOT-specific patient demographics were described descriptively. DOT and time to next therapy (TTNT) in LOTs ≥2 were evaluated by Bor-, Car- and Ixa-based treatment cohorts using cox proportional hazard models, adjusting  for  propensity score of 17 covariates including age, gender, LOTs, prior regimens and comorbidities by Inverse Probability of Treatment Weights (IPTW). DOT and TTNT in respective LOTs (LOT=2,3,4 and ≥5) were additionally analyzed without adjustment because the number of each subset was small.  Using the Bor-based group as reference, DOT and TTNT of Car- and Ixa-based group were respectively compared with that of Bor.

Results
A total of 2,686 LOTs≥2patients were included in the analysis. Median age was 73 years; major comorbidities were bone fracture (64.9%), renal impairment (44.8%) and cardiac event (36.8%).  Bor, Car and Ixa-based treatments in the LOTs≥2 were used by 2,411, 414, and 311 patients, respectively. Median DOT and median TTNT in the LOTs≥2 were 115, 135, and 140 days and 170, 215, and 282 days for Bor-, Car- and Ixa-based treatments, respectively. The Car- and Ixa-based groups tended to have longer DOT (p=0.03 and 0.06, respectively) and TTNT (p=0.04 and 0.002, respectively) than the Bor-based group during LOTs≥2. Especially in second LOT, the Ixa-based group showed significantly longer DOT (p=0.04) and TTNT (p=0.02) than the Bor-based treatment group. The results of PIs-based regimens with lenalidomide and dexamethasone backbone will be also presented.

Conclusion
This study using a real-world large data suggested that in Japanese RRMM patients, Car- and Ixa-based treatments had longer DOT and TTNT than Bor-based treatments. This result is similar to previous studies comparing PI treatments for RRMM patients in the US, while the types of regimens analyzed in each study were not the same. Notably, the DOT and TTNT in second LOT was significantly longer in the Ixa-based group than Bor-based group, suggesting a benefit of Ixa-based treatments in early lines. This study has some limitations inherent to its retrospective design. Moreover, as the database used in this study covers only the data from the hospitals using DPC system, information in non-DPC hospitals cannot be captured. Further studies are needed to clarify the comparative effectiveness of PIs in the real-world.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple myeloma, Proteasome inhibitor

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