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

Steven M. Devine, Kouros Owzar, William Blum, Flora Mulkey, Richard M. Stone, Jack W. Hsu, Richard E. Champlin, Yi Bin Chen, Ravi Vij, James L Slack, Robert J. Soiffer, Richard A. Larson, Thomas C. Shea, Vera Hars, Alexander B. Sibley, Sergio Giralt, Shelly Carter, Mary M. Horowitz, Charles Linker, Edwin P. Alyea

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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.

Original languageEnglish (US)
Pages (from-to)4167-4175
Number of pages9
JournalJournal of Clinical Oncology
Volume33
Issue number35
DOIs
StatePublished - Dec 10 2015

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Homologous Transplantation
Acute Myeloid Leukemia
Leukemia
Bone Marrow
Clinical Trials
Hematopoietic Stem Cell Transplantation
Transplants
Graft vs Host Disease
Neoplasms
Transplantation
Recurrence
Unrelated Donors
Disease-Free Survival
Survival
Mortality
Antilymphocyte Serum
Observational Studies
Survival Rate
Incidence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Devine, Steven M.; Owzar, Kouros; Blum, William; Mulkey, Flora; Stone, Richard M.; Hsu, Jack W.; Champlin, Richard E.; Chen, Yi Bin; Vij, Ravi; Slack, James L; Soiffer, Robert J.; Larson, Richard A.; Shea, Thomas C.; Hars, Vera; Sibley, Alexander B.; Giralt, Sergio; Carter, Shelly; Horowitz, Mary M.; Linker, Charles; Alyea, Edwin P.

In: Journal of Clinical Oncology, Vol. 33, No. 35, 10.12.2015, p. 4167-4175.

Research output: Contribution to journalArticle

Devine, Steven M. ; Owzar, Kouros ; Blum, William ; Mulkey, Flora ; Stone, Richard M. ; Hsu, Jack W. ; Champlin, Richard E. ; Chen, Yi Bin ; Vij, Ravi ; Slack, James L ; Soiffer, Robert J. ; Larson, Richard A. ; Shea, Thomas C. ; Hars, Vera ; Sibley, Alexander B. ; Giralt, Sergio ; Carter, Shelly ; Horowitz, Mary M. ; Linker, Charles ; Alyea, Edwin P. / 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. In: Journal of Clinical Oncology. 2015 ; Vol. 33, No. 35. pp. 4167-4175.
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title = "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",
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.",
author = "Devine, {Steven M.} and Kouros Owzar and William Blum and Flora Mulkey and Stone, {Richard M.} and Hsu, {Jack W.} and Champlin, {Richard E.} and Chen, {Yi Bin} and Ravi Vij and Slack, {James L} and Soiffer, {Robert J.} and Larson, {Richard A.} and Shea, {Thomas C.} and Vera Hars and Sibley, {Alexander B.} and Sergio Giralt and Shelly Carter and Horowitz, {Mary M.} and Charles Linker and Alyea, {Edwin P.}",
year = "2015",
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language = "English (US)",
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pages = "4167--4175",
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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

T2 - 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 L

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.

PY - 2015/12/10

Y1 - 2015/12/10

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.

AB - 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.

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