A phase II/III randomized, multicenter trial of prednisone/sirolimus versus prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft- versus -host disease: BMT CTN 0801

Initial therapy of chronic graft- -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone...

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Published inHaematologica (Roma) Vol. 103; no. 11; pp. 1915 - 1924
Main Authors Carpenter, Paul A., Logan, Brent R., Lee, Stephanie J., Weisdorf, Daniel J., Johnston, Laura, Costa, Luciano J., Kitko, Carrie L., Bolaños-Meade, Javier, Sarantopoulos, Stefanie, Alousi, Amin M., Abhyankar, Sunil, Waller, Edmund K., Mendizabal, Adam, Zhu, Jiaxi, O’Brien, Kelly A., Lazaryan, Aleksandr, Wu, Juan, Nemecek, Eneida R., Pavletic, Steven Z., Cutler, Corey S., Horowitz, Mary M., Arora, Mukta
Format Journal Article
LanguageEnglish
Published Italy Ferrata Storti Foundation 01.11.2018
Subjects
Aged
Calcineurin Inhibitors - administration & dosage
Chronic Disease
Disease-Free Survival
Female
Graft vs Host Disease - mortality
Graft vs Host Disease - therapy
Humans
Male
Middle Aged
Photopheresis
Prednisolone - administration & dosage
Sirolimus - administration & dosage
Survival Rate
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Abstract Initial therapy of chronic graft- -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft- -host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% 50.0%, =0.87), or 2-year complete response (14.7% 15.5%, =0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% 11.7%, =0.025) and 6 months (7.8% 24.0%, =0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months ( =0.02 and =0.04, respectively) and 6 months ( =0.007 and =0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% 46.2%, =0.78; 81.5% 74%, =0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft- -host disease, being easier to administer and better tolerated.
AbstractList Initial therapy of chronic graft- versus -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft- versus -host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug versus three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% versus 50.0%, P =0.87), or 2-year complete response (14.7% versus 15.5%, P =0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% versus 11.7%, P =0.025) and 6 months (7.8% versus 24.0%, P =0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months ( P =0.02 and P =0.04, respectively) and 6 months ( P =0.007 and P =0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% versus 46.2%, P =0.78; 81.5% versus 74%, P =0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft- versus -host disease, being easier to administer and better tolerated. Clinicaltrials.gov identifier: NCT01106833.
Initial therapy of chronic graft- -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft- -host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% 50.0%, =0.87), or 2-year complete response (14.7% 15.5%, =0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% 11.7%, =0.025) and 6 months (7.8% 24.0%, =0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months ( =0.02 and =0.04, respectively) and 6 months ( =0.007 and =0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% 46.2%, =0.78; 81.5% 74%, =0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft- -host disease, being easier to administer and better tolerated.
Initial therapy of chronic graft-versus-host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft-versus-host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug versus three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% versus 50.0%, P=0.87), or 2-year complete response (14.7% versus 15.5%, P=0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% versus 11.7%, P=0.025) and 6 months (7.8% versus 24.0%, P=0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months (P=0.02 and P=0.04, respectively) and 6 months (P=0.007 and P=0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% versus 46.2%, P=0.78; 81.5% versus 74%, P=0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft-versus-host disease, being easier to administer and better tolerated. Clinicaltrials.gov identifier: NCT01106833.
Initial therapy of chronic graft-versus-host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft-versus-host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug versus three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% versus 50.0%, P=0.87), or 2-year complete response (14.7% versus 15.5%, P=0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% versus 11.7%, P=0.025) and 6 months (7.8% versus 24.0%, P=0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months (P=0.02 and P=0.04, respectively) and 6 months (P=0.007 and P=0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% versus 46.2%, P=0.78; 81.5% versus 74%, P=0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft-versus-host disease, being easier to administer and better tolerated. Clinicaltrials.gov identifier: NCT01106833.Initial therapy of chronic graft-versus-host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating chronic graft-versus-host disease in treatment-naïve or early inadequate responders. Primary endpoints of this study were proportions of subjects alive without relapse or secondary therapy with 6-month complete or partial response in phase II, or with 2-year complete response in phase III. The prednisone/sirolimus/photopheresis arm closed prematurely because of slow accrual and the remaining two-drug versus three-drug study ended in phase II due to statistical futility with 138 evaluable subjects. The two-drug and three-drug arms did not differ in rates of 6-month complete or partial response (48.6% versus 50.0%, P=0.87), or 2-year complete response (14.7% versus 15.5%, P=0.90). Serum creatinine values >1.5 times baseline were less frequent in the calcineurin-inhibitor-free arm at 2 months (1.5% versus 11.7%, P=0.025) and 6 months (7.8% versus 24.0%, P=0.016). Higher adjusted Short Form-36 Physical Component Summary and Physical Functioning scores were seen in the two-drug arm at both 2 months (P=0.02 and P=0.04, respectively) and 6 months (P=0.007 and P=0.001, respectively). Failure-free survival and overall survival rates at 2 years were similar for patients in the the two-drug and three-drug arms (48.6% versus 46.2%, P=0.78; 81.5% versus 74%, P=0.28). Based on similar long-term outcomes, prednisone/sirolimus is a therapeutic alternative to prednisone/sirolimus/calcineurin-inhibitor for chronic graft-versus-host disease, being easier to administer and better tolerated. Clinicaltrials.gov identifier: NCT01106833.
Author Zhu, Jiaxi
Horowitz, Mary M.
Waller, Edmund K.
Carpenter, Paul A.
Cutler, Corey S.
Sarantopoulos, Stefanie
Alousi, Amin M.
Lee, Stephanie J.
Wu, Juan
Johnston, Laura
Pavletic, Steven Z.
Mendizabal, Adam
Arora, Mukta
O’Brien, Kelly A.
Weisdorf, Daniel J.
Kitko, Carrie L.
Bolaños-Meade, Javier
Lazaryan, Aleksandr
Logan, Brent R.
Abhyankar, Sunil
Nemecek, Eneida R.
Costa, Luciano J.
AuthorAffiliation 12 The Emmes Corporation, Rockville, MD
13 Oregon Health and Sciences University, Portland, OR
7 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
14 Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD
2 Medical College of Wisconsin, Milwaukee, WI
4 Stanford Hospital and Clinics, Stanford, CA
8 Duke University Medical Center, Durham, NC
10 The University of Kansas Medical Center, Kansas City, KS
1 Fred Hutchinson Cancer Research Center, Seattle, WA
15 Dana Farber Cancer Institute, Boston, MA, USA
6 Vanderbilt University School of Medicine, Nashville, TN
9 University of Texas MD Anderson Cancer Center, Houston, TX
3 University of Minnesota, Minneapolis, MN
5 University of Alabama at Birmingham, AL
11 Emory University School of Medicine, Atlanta, GA
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Snippet Initial therapy of chronic graft- -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized, adaptive,...
Initial therapy of chronic graft-versus-host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized,...
Initial therapy of chronic graft- versus -host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In a randomized,...
SourceID doaj
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SubjectTerms Aged
Calcineurin Inhibitors - administration & dosage
Chronic Disease
Disease-Free Survival
Female
Graft vs Host Disease - mortality
Graft vs Host Disease - therapy
Humans
Male
Middle Aged
Photopheresis
Prednisolone - administration & dosage
Sirolimus - administration & dosage
Survival Rate
Title A phase II/III randomized, multicenter trial of prednisone/sirolimus versus prednisone/ sirolimus/calcineurin inhibitor for the treatment of chronic graft- versus -host disease: BMT CTN 0801
URI https://www.ncbi.nlm.nih.gov/pubmed/29954931
https://www.proquest.com/docview/2062833550
https://pubmed.ncbi.nlm.nih.gov/PMC6278959
https://doaj.org/article/9059324d5be3405fab10b729d5956a8e
Volume 103
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