Post-transplant cyclophosphamide for graft-versus-host disease prophylaxis in HLA matched sibling or matched unrelated donor transplant for patients with acute leukemia, on behalf of ALWP-EBMT

Ruggeri, Annalisa; Labopin, Myriam; Bacigalupo, Andrea; Afanasyev, Boris; Cornelissen, Jan J.; Elmaagacli, Ahmet; Itälä-Remes, Maija; Blaise, Didier; Meijer, Ellen; Koc, Yener; Milpied, Noel; Schouten, Harry C.; Kroeger, Nicolaus; Mohty, Mohamad; Nagler, Arnon

doi:10.1186/s13045-018-0586-4

Table 2 Multivariate analysis

From: Post-transplant cyclophosphamide for graft-versus-host disease prophylaxis in HLA matched sibling or matched unrelated donor transplant for patients with acute leukemia, on behalf of ALWP-EBMT

	HR	95% CI	p value
OS
PTCy alone	Reference
PT-Cy + 1 drug	0.72	0.40–1.30	0.27
PT-Cy + 2 drugs	0.49	0.26–0.93	0.03
Age (per 10 years)	1.11	0.97–1.28	0.18
AML vs. ALL	0.60	0.39–0.91	0.02
Year of Tx	0.99	0.88–1.12	0.90
UD vs. MSD	0.95	0.66–1.36	0.77
Disease status
CR1	Reference
CR2/C3	1.7	1.07–2.70	0.02
Active disease	2.48	1.71–3.59	< 0.001
RIC vs. MAC	1.20	0.83–1.74	0.34
PB vs. BM	1.13	0.69–1.83	0.63
In vivo TCD	1.07	0.72–1.60	0.73
Patient positive CMV serology	1.07	0.73–1.58	0.73
Donor positive CMV serology	1.17	0.81–1.71	0.40
Center (frailty)			0.25
GRFS
PTCy alone	Reference
PT-Cy + 1 drug	0.72	0.45–1.16	0.18
PT-Cy + 2 drugs	0.51	0.31–0.84	0.007
Age (per 10 years)	0.96	0.87–1.07	0.48
AML vs. ALL	0.89	0.62–1.26	0.50
Year of Tx	0.97	0.88–1.08	0.60
UD vs. MSD	1.04	0.78–1.40	0.77
Disease status
CR1	Reference
CR2/C3	1.27	0.85–1.89	0.24
Active disease	2.18	1.61–2.95	< 0.001
RIC vs. MAC	1.32	0.98–1.77	0.07
PB vs. BM	1.30	0.87–1.94	0.20
In vivo TCD	0.83	0.60–1.16	0.27
Patient positive CMV serology	0.95	0.69–1.31	0.77
Donor positive CMV serology	1.20	0.88–1.63	0.26
Center (frailty)			0.91
LFS
PTCy alone	Reference
PT-Cy + 1 drug	0.97	0.57–1.63	0.90
PT-Cy + 2 drugs	0.65	0.37–1.12	0.12
Age (per 10 years)	1.09	0.97–1.23	0.17
AML vs. ALL	0.68	0.46–0.99	0.04
Year of Tx	1	0.89–1.11	0.94
UD vs. MSD	0.92	0.659–1.27	0.60
Disease status
CR1	Reference
CR2/C3	1.64	1.07–2.51	0.02
Active disease	2.49	1.78–3.47	< 0.001
RIC vs. MAC	1.255	0.9–1.75	0.18
PB vs. BM	0.94	0.61–1.45	0.78
In vivo TCD	1.07	0.75–1.54	0.70
Patient positive CMV serology	0.98	0.69–1.39	0.93
Donor positive CMV serology	1.24	0.89–1.74	0.21
Center (frailty)			0.91
Acute GvHD II-IV
PTCy alone	Reference
PT-Cy + 1 drug	0.62	0.29–1.36	0.23
PT-Cy + 2 drugs	1.40	0.65–3.01	0.38
Age (per 10 years)	1.01	0.87–1.18	0.90
AML vs. ALL	0.53	0.33–0.85	0.008
Year of Tx	0.91	0.80–1.04	0.16
UD vs. MSD	1.66	1.06–2.60	0.03
Disease status
CR1	Reference
CR2/C3	0.62	0.32–1.19	0.15
Active disease	1.14	0.71–1.84	0.59
RIC vs. MAC	1.72	1.10–2.70	0.02
PB vs. BM	1.59	0.83–3.02	0.16
In vivo TCD	1.18	0.74–1.89	0.48
Patient positive CMV serology	0.74	0.47–1.15	0.18
Donor positive CMV serology	1.78	1.13–2.79	0.01
Center (frailty)			0.23
Chronic GvHD
PTCy alone	Reference
PT-Cy + 1 drug	0.60	0.27–1.37	0.23
PT-Cy + 2 drugs	0.52	0.22–1.23	0.14
Age (per 10 years)	0.90	0.76–1.05	0.18
AML vs. ALL	1.01	0.58–1.75	0.97
Year of Tx	0.97	0.82–1.14	0.69
UD vs. MSD	0.99	0.64–1.54	0.96
Disease status
CR1	Reference
CR2/C3	0.52	0.24–1.09	0.08
Active disease	0.84	0.47–1.48	0.54
RIC vs. MAC	1.01	0.63–1.62	0.96
PB vs. BM	2.41	1.19–4.89	0.01
In vivo TCD	0.59	0.37–0.96	0.03
Patient positive CMV serology	0.88	0.55–1.43	0.61
Donor positive CMV serology	0.86	0.53–1.39	0.53
Center (frailty)			0.93
Extensive chronic GvHD
PTCy alone	Reference
PT-Cy + 1 drug	0.57	0.21–1.56	0.27
PT-Cy + 2 drugs	0.25	0.08–0.84	0.02
Age (per 10 years)	0.76	0.63–0.96	0.02
AML vs. ALL	1.64	0.65–4.16	0.30
Year of Tx	1	0.79–1.26	0.98
UD vs. MSD	1.26	0.68–2.33	0.47
Disease status
CR1	Reference
CR2/C3	0.56	0.19–1.63	0.29
Active disease	1.24	0.57–2.68	0.59
RIC vs. MAC	1.43	0.72–2.84	0.30
PB vs. BM	4.57	1.61–12.99	0.004
In vivo TCD	0.23	0.01–0.54	< 0.001
Patient positive CMV serology	0.92	0.46–1.80	0.80
Donor positive CMV serology	0.76	0.38–1.55	0.45
Center (frailty)			0.94
Relapse
PTCy alone	Reference
PT-Cy + 1 drug	1.12	0.59–2.13	0.73
PT-Cy + 2 drugs	0.82	0.42–1.61	0.57
Age (per 10 years)	1.03	0.89–1.19	0.69
AML vs. ALL	0.97	0.59–1.6	0.91
Year of Tx	1.03	0.90–1.18	0.64
UD vs. MSD	0.87	0.58–1.30	0.50
Disease status
CR1	Reference
CR2/C3	1.64	0.97–2.80	0.07
Active disease	2.42	1.60–3.66	< 0.001
RIC vs. MAC	1.18	0.78–1.77	0.44
PB vs. BM	0.83	0.50–1.38	0.47
In vivo TCD	0.89	0.57–1.39	0.61
Patient positive CMV serology	0.71	0.46–1.08	0.11
Donor positive CMV serology	1.34	0.88–2.04	0.17
Center (frailty)			0.92
NRM
PTCy alone	Reference
PT-Cy + 1 drug	0.69	0.27–1.73	0.42
PT-Cy + 2 drugs	0.358	0.13–0.99	0.05
Age (per 10 years)	1.195	0.96–1.48	0.11
AML vs. ALL	0.353	0.19–0.67	0.001
Year of Tx	0.95	0.78–1.15	0.60
UD vs. MSD	1.022	0.58–1.81	0.94
Disease status
CR1	Reference
CR2/C3	1.63	0.78–3.38	0.19
Active disease	2.949	1.65–5.27	< 0.001
RIC vs. MAC	1.339	0.74–2.42	0.33
PB vs. BM	1.247	0.56–2.78	0.59
In vivo TCD	1.47	0.78–2.75	0.23
Patient positive CMV serology	2.042	1.03–4.04	0.04
Donor positive CMV serology	1.038	0.58–1.87	0.90
Center (frailty)			0.29

HR hazard ratio, CI confidence interval, aGVHD acute graft-versus-host disease, cGVHD chronic GVHD, NRM non-relapse mortality, OS overall survival, LFS leukemia-free survival, GRFS GvHD-free relapse-free survival, MAC myeloablative, RIC reduced intensity conditioning regimen, PTCy post-transplant cyclophosphamide, AML acute myeloid leukemia, ALL acute lymphoblastic leukemia, Tx transplant, UD unrelated donor, MSD matched sibling donor, CR complete remission, PB peripheral blood, BM bone marrow, TCD T cell depletion, CMV cytomegalovirus

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