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Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502.
J Clin Oncol. 2015 Dec 10; 33(35):4167-75.JC

Abstract

PURPOSE

Long-term survival rates for older patients with newly diagnosed acute myeloid leukemia (AML) are extremely low. Previous observational studies suggest that allogeneic hematopoietic stem-cell transplantation (HSCT) may improve overall survival (OS) because of lower rates of relapse. We sought to prospectively determine the value of HSCT for older patients with AML in first complete remission.

PATIENTS AND METHODS

We conducted a prospective multicenter phase II study to assess the efficacy of reduced-intensity conditioning HSCT for patients between the ages of 60 and 74 years with AML in first complete remission. The primary end point was disease-free survival at 2 years after HSCT. Secondary end points included nonrelapse mortality (NRM), graft-versus-host disease (GVHD), relapse, and OS.

RESULTS

In all, 114 patients with a median age of 65 years received transplantations. The majority (52%) received transplantations from unrelated donors and were given antithymocyte globulin for GVHD prophylaxis. Disease-free survival and OS at 2 years after transplantation were 42% (95% CI, 33% to 52%) and 48% (95% CI, 39% to 58%), respectively, for the entire group and 40% (95% CI, 29% to 55%) and 50% (95% CI, 38% to 64%) for the unrelated donor group. NRM at 2 years was 15% (95% CI, 8% to 21%). Grade 2 to 4 acute GVHD occurred in 9.6% (95% CI, 4% to 15%) of patients, and chronic GVHD occurred in 28% (95% CI, 19% to 36%) of patients. The cumulative incidence of relapse at 2 years was 44% (95% CI, 35% to 53%).

CONCLUSION

Reduced-intensity conditioning HSCT to maintain remission in selected older patients with AML is relatively well tolerated and appears to provide superior outcomes when compared with historical patients treated without HSCT. GVHD and NRM rates were lower than expected. Future transplantation studies in these patients should focus on further reducing the risk of relapse.

Authors+Show Affiliations

Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA. steven.devine@osumc.edu.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.Steven M. Devine and William Blum, Ohio State University, Columbus, OH; Kouros Owzar, Flora Mulkey, Vera Hars, and Alexander B. Sibley, Alliance Statistics and Data Center, Duke University, Durham; Thomas C. Shea, University of North Carolina, Chapel Hill, NC; Richard M. Stone, Robert J. Soiffer, and Edwin P. Alyea, Dana-Farber Cancer Institute; Yi-Bin Chen, Massachusetts General Hospital, Boston, MA; Jack W. Hsu, University of Florida, Gainesville, FL; Richard E. Champlin, MD Anderson Cancer Research Center, Houston, TX; Ravi Vij, Washington University, St. Louis, MO; James Slack, Mayo Clinic, Scottsdale, AZ; Richard A. Larson, University of Chicago, Chicago, IL; Sergio Giralt, Memorial Sloan Kettering Cancer Center, New York, NY; Shelly Carter, The EMMES Corporation, Bethesda, MD; Mary M. Horowitz, Medical College of Wisconsin, Milwaukee, WI; and Charles Linker, University of California at San Francisco, San Francisco, CA.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26527780

Citation

Devine, Steven M., et al. "Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 33, no. 35, 2015, pp. 4167-75.
Devine SM, Owzar K, Blum W, et al. Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. J Clin Oncol. 2015;33(35):4167-75.
Devine, S. M., Owzar, K., Blum, W., Mulkey, F., Stone, R. M., Hsu, J. W., Champlin, R. E., Chen, Y. B., Vij, R., Slack, J., Soiffer, R. J., Larson, R. A., Shea, T. C., Hars, V., Sibley, A. B., Giralt, S., Carter, S., Horowitz, M. M., Linker, C., & Alyea, E. P. (2015). Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 33(35), 4167-75. https://doi.org/10.1200/JCO.2015.62.7273
Devine SM, et al. Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. J Clin Oncol. 2015 Dec 10;33(35):4167-75. PubMed PMID: 26527780.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase II Study of Allogeneic Transplantation for Older Patients With Acute Myeloid Leukemia in First Complete Remission Using a Reduced-Intensity Conditioning Regimen: Results From Cancer and Leukemia Group B 100103 (Alliance for Clinical Trials in Oncology)/Blood and Marrow Transplant Clinical Trial Network 0502. AU - Devine,Steven M, AU - Owzar,Kouros, AU - Blum,William, AU - Mulkey,Flora, AU - Stone,Richard M, AU - Hsu,Jack W, AU - Champlin,Richard E, AU - Chen,Yi-Bin, AU - Vij,Ravi, AU - Slack,James, AU - Soiffer,Robert J, AU - Larson,Richard A, AU - Shea,Thomas C, AU - Hars,Vera, AU - Sibley,Alexander B, AU - Giralt,Sergio, AU - Carter,Shelly, AU - Horowitz,Mary M, AU - Linker,Charles, AU - Alyea,Edwin P, Y1 - 2015/11/02/ PY - 2015/11/4/entrez PY - 2015/11/4/pubmed PY - 2016/4/5/medline SP - 4167 EP - 75 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 33 IS - 35 N2 - PURPOSE: Long-term survival rates for older patients with newly diagnosed acute myeloid leukemia (AML) are extremely low. Previous observational studies suggest that allogeneic hematopoietic stem-cell transplantation (HSCT) may improve overall survival (OS) because of lower rates of relapse. We sought to prospectively determine the value of HSCT for older patients with AML in first complete remission. PATIENTS AND METHODS: We conducted a prospective multicenter phase II study to assess the efficacy of reduced-intensity conditioning HSCT for patients between the ages of 60 and 74 years with AML in first complete remission. The primary end point was disease-free survival at 2 years after HSCT. Secondary end points included nonrelapse mortality (NRM), graft-versus-host disease (GVHD), relapse, and OS. RESULTS: In all, 114 patients with a median age of 65 years received transplantations. The majority (52%) received transplantations from unrelated donors and were given antithymocyte globulin for GVHD prophylaxis. Disease-free survival and OS at 2 years after transplantation were 42% (95% CI, 33% to 52%) and 48% (95% CI, 39% to 58%), respectively, for the entire group and 40% (95% CI, 29% to 55%) and 50% (95% CI, 38% to 64%) for the unrelated donor group. NRM at 2 years was 15% (95% CI, 8% to 21%). Grade 2 to 4 acute GVHD occurred in 9.6% (95% CI, 4% to 15%) of patients, and chronic GVHD occurred in 28% (95% CI, 19% to 36%) of patients. The cumulative incidence of relapse at 2 years was 44% (95% CI, 35% to 53%). CONCLUSION: Reduced-intensity conditioning HSCT to maintain remission in selected older patients with AML is relatively well tolerated and appears to provide superior outcomes when compared with historical patients treated without HSCT. GVHD and NRM rates were lower than expected. Future transplantation studies in these patients should focus on further reducing the risk of relapse. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/26527780/Phase_II_Study_of_Allogeneic_Transplantation_for_Older_Patients_With_Acute_Myeloid_Leukemia_in_First_Complete_Remission_Using_a_Reduced_Intensity_Conditioning_Regimen:_Results_From_Cancer_and_Leukemia_Group_B_100103__Alliance_for_Clinical_Trials_in_Oncology_/Blood_and_Marrow_Transplant_Clinical_Trial_Network_0502_ L2 - https://ascopubs.org/doi/10.1200/JCO.2015.62.7273?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -