Skip to main content

Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes.

Publication ,  Journal Article
Scott, BL; Pasquini, MC; Logan, BR; Wu, J; Devine, SM; Porter, DL; Maziarz, RT; Warlick, ED; Fernandez, HF; Alyea, EP; Hamadani, M; Bashey, A ...
Published in: J Clin Oncol
April 10, 2017

Purpose The optimal regimen intensity before allogeneic hematopoietic cell transplantation (HCT) is unknown. We hypothesized that lower treatment-related mortality (TRM) with reduced-intensity conditioning (RIC) would result in improved overall survival (OS) compared with myeloablative conditioning (MAC). To test this hypothesis, we performed a phase III randomized trial comparing MAC with RIC in patients with acute myeloid leukemia or myelodysplastic syndromes. Patients and Methods Patients age 18 to 65 years with HCT comorbidity index ≤ 4 and < 5% marrow myeloblasts pre-HCT were randomly assigned to receive MAC (n = 135) or RIC (n = 137) followed by HCT from HLA-matched related or unrelated donors. The primary end point was OS 18 months post-random assignment based on an intent-to-treat analysis. Secondary end points included relapse-free survival (RFS) and TRM. Results Planned enrollment was 356 patients; accrual ceased at 272 because of high relapse incidence with RIC versus MAC (48.3%; 95% CI, 39.6% to 56.4% and 13.5%; 95% CI, 8.3% to 19.8%, respectively; P < .001). At 18 months, OS for patients in the RIC arm was 67.7% (95% CI, 59.1% to 74.9%) versus 77.5% (95% CI, 69.4% to 83.7%) for those in the MAC arm (difference, 9.8%; 95% CI, -0.8% to 20.3%; P = .07). TRM with RIC was 4.4% (95% CI, 1.8% to 8.9%) versus 15.8% (95% CI, 10.2% to 22.5%) with MAC ( P = .002). RFS with RIC was 47.3% (95% CI, 38.7% to 55.4%) versus 67.8% (95% CI, 59.1% to 75%) with MAC ( P < .01). Conclusion OS was higher with MAC, but this was not statistically significant. RIC resulted in lower TRM but higher relapse rates compared with MAC, with a statistically significant advantage in RFS with MAC. These data support the use of MAC as the standard of care for fit patients with acute myeloid leukemia or myelodysplastic syndromes.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 10, 2017

Volume

35

Issue

11

Start / End Page

1154 / 1161

Location

United States

Related Subject Headings

  • Young Adult
  • Whole-Body Irradiation
  • Vidarabine
  • Transplantation, Homologous
  • Transplantation Conditioning
  • Survival Rate
  • Recurrence
  • Oncology & Carcinogenesis
  • Myelodysplastic Syndromes
  • Middle Aged
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Scott, B. L., Pasquini, M. C., Logan, B. R., Wu, J., Devine, S. M., Porter, D. L., … Horwitz, M. E. (2017). Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol, 35(11), 1154–1161. https://doi.org/10.1200/JCO.2016.70.7091
Scott, Bart L., Marcelo C. Pasquini, Brent R. Logan, Juan Wu, Steven M. Devine, David L. Porter, Richard T. Maziarz, et al. “Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes.J Clin Oncol 35, no. 11 (April 10, 2017): 1154–61. https://doi.org/10.1200/JCO.2016.70.7091.
Scott BL, Pasquini MC, Logan BR, Wu J, Devine SM, Porter DL, et al. Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2017 Apr 10;35(11):1154–61.
Scott, Bart L., et al. “Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes.J Clin Oncol, vol. 35, no. 11, Apr. 2017, pp. 1154–61. Pubmed, doi:10.1200/JCO.2016.70.7091.
Scott BL, Pasquini MC, Logan BR, Wu J, Devine SM, Porter DL, Maziarz RT, Warlick ED, Fernandez HF, Alyea EP, Hamadani M, Bashey A, Giralt S, Geller NL, Leifer E, Le-Rademacher J, Mendizabal AM, Horowitz MM, Deeg HJ, Horwitz ME. Myeloablative Versus Reduced-Intensity Hematopoietic Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes. J Clin Oncol. 2017 Apr 10;35(11):1154–1161.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

April 10, 2017

Volume

35

Issue

11

Start / End Page

1154 / 1161

Location

United States

Related Subject Headings

  • Young Adult
  • Whole-Body Irradiation
  • Vidarabine
  • Transplantation, Homologous
  • Transplantation Conditioning
  • Survival Rate
  • Recurrence
  • Oncology & Carcinogenesis
  • Myelodysplastic Syndromes
  • Middle Aged