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Original Investigation
December 12, 2019

Comparison of Patient Age Groups in Transplantation for Myelodysplastic Syndrome: The Medicare Coverage With Evidence Development Study

Author Affiliations
  • 1Division of Hematology & Oncology, Medical College of Wisconsin, Milwaukee
  • 2Division of Biostatistics, Department of Institute for Health and Equity, Medical College of Wisconsin, Milwaukee
  • 3Center for International Bone Marrow Transplant Research, Medical College of Wisconsin, Milwaukee
  • 4Dana-Farber Cancer Institute, Boston, Massachusetts
  • 5Fred Hutchinson Cancer Research Center, Seattle, Washington
  • 6Washington University School of Medicine in St Louis, St Louis, Missouri
  • 7Stem Cell Transplantation and Cellular Therapy, MD Anderson Cancer Center, Houston, Texas
  • 8Moffitt Cancer Center, University of South Florida, Tampa
  • 9National Marrow Donor Program, Minneapolis, Minnesota
  • 10Lu Daopei Hospitals, Beijing
  • 11Oregon Society of Medical Oncology, Portland
  • 12Stanford University School of Medicine, Stanford, California
  • 13University of Minnesota, Minneapolis
JAMA Oncol. 2020;6(4):486-493. doi:10.1001/jamaoncol.2019.5140
Key Points

Question  Is age associated with survival in the US Centers for Medicare & Medicaid Services (CMS) beneficiary population with myelodysplastic syndrome (MDS) who undergo allogeneic hematopoietic stem cell transplantation (HCT)?

Findings  In this prospective observational study that included 1280 patients with MDS undergoing HCT, age alone was not associated with survival.

Meaning  Based on these findings, we would recommend coverage of HCT for MDS by the CMS.

Abstract

Importance  In 2010, the US Centers for Medicare & Medicaid Services (CMS) indicated that data regarding efficacy of allogeneic hematopoietic stem cell transplantation (HCT) in the CMS beneficiary population with myelodysplastic syndrome (MDS) were currently insufficient, but that coverage would be provided for patients enrolled in a clinical study that met its criteria for Coverage with Evidence Development (CED).

Objective  The Center for International Bone Marrow Transplant Research (CIBMTR) submitted a study concept comparing the outcomes of patients aged 55 to 64 years vs aged 65 years or older who met those criteria, effectively providing coverage by CMS for HCT for MDS.

Design, Setting, and Participants  Data on patients aged 65 years or older were prospectively collected and their outcomes compared with patients aged 55 to 64 years. Patients were enrolled in the study from December 15, 2010, to May 14, 2014. The results reported herein were analyzed as of September 4, 2017, with a median follow-up of 47 months. The study was conducted by the CIBMTR. It comprises a voluntary working group of more than 420 centers worldwide that contribute detailed data on allogeneic and autologous HCT and cellular therapies.

Interventions  Patients with MDS received HCT according to institutional guidelines and preferences.

Main Outcomes and Measures  The primary outcome was overall survival (OS); secondary outcomes included nonrelapse mortality (NRM), relapse-free survival, and acute and chronic graft vs host disease.

Results  During the study period, 688 patients aged 65 years or older underwent HCT for MDS and were compared with 592 patients aged 55 to 64 years. Other than age, there were no differences in patient and disease characteristics between the groups. On univariate analysis, the 3-year NRM rate was 28% vs 25% for the 65 years or older group vs those aged 55 to 64 years, respectively. The 3-year OS was 37% vs 42% for the 65 years or older group vs the 55 to 64 years age group, respectively. On multivariable analysis after adjusting for excess risk of mortality in the older group, age group had no significant association with OS (HR, 1.09; 95% CI, 0.94-1.27; P = .23) or NRM (HR, 1.19; 95% CI, 0.93-1.52; P = .16).

Conclusions and Relevance  Older patients with MDS undergoing HCT have similar OS compared with younger patients. Based on current data, we would recommend coverage of HCT for MDS by the CMS.

Trial Registration  ClinicalTrials.gov identifier: NCT01166009

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