Table 2.
IRM | NRM | Relapse | OS | PFS | ||||||
---|---|---|---|---|---|---|---|---|---|---|
UVA | MVA | UVA | MVA | UVA | MVA | UVA | MVA | UVA | MVA | |
Incidence % | (HR. 95% C.I.) | Incidence % | (HR. 95% C.I.) | Incidence % | (HR. 95% C.I.) | Probability % | (HR. 95% C.I.) | Probability % | (HR. 95% C.I.) | |
(95% CI) | (95% CI) | (95% CI) | (95% CI) | (95% CI) | ||||||
Disease status at transplant | ||||||||||
Complete remission (1st and 2nd)a | 20 (13–27) | NA | 27 (19–34) | NA | 11 (5–16) | 0.26 (0.14–0.5) | 61 (57–65) | 0.41 (0.28–0.6) | 59 (54–64) | 0.44 (0.3–0.63) |
Other status/responses | 18 (10–25) | 36 (26–46) | 35 (25–45) | 34 (29–39) | 31 (26–36) | |||||
p value | 0.1 | 0.7 | 0.07 | 0.05 | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 | 0.001 |
rDRI | ||||||||||
Low-intermediate* | 20 (13–26) | NA | 30 (23–38) | NA | 16 (10–22) | 0.44 (0.24–0.79) | 54 (50–58) | NA | 52 (48–56) | 0.64 (0.44–0.9) |
High-very high | 17 (8–25) | 30 (19–40) | 32 (21–42) | 40 (34–46) | 39 (33–45) | |||||
p value | 0.7 | 0.6 | 0.66 | 0.38 | 0.001 | 0.006 | 0.008 | 0.07 | 0.003 | 0.02 |
Prior alloSCT | ||||||||||
No* | 18 (11–23) | NA | 28 (22–34) | 0.55 (0.33–0.9) | 19 (14–25) | NA | 52 (48–56) | NA | 49 (45–53) | NA |
Yes | 26 (9–42) | 44 (26–63) | 26 (9–42) | 29 (21–38) | 29 (20–38) | |||||
p value | 0.3 | 0.3 | 0.02 | 0.02 | 0.3 | 0.8 | 0.001 | 0.117 | 0.001 | 0.09 |
Recipient years at transplant | ||||||||||
<50* | 13 (7–199 | 0.34 (0.17–0.64) | 25 (17–33) | 0.5 (0.3–0.83) | 21 (14–29) | NA | 54 (49–59) | 0.62 (0.43–0.9) | 52 (47–57) | 0.65 (0.45–0.9) |
≥50 | 26 (17–34) | 37 (28–46) | 20 (12–28) | 44 (39–49) | 42 (37–47) | |||||
p value | 0.02 | 0.002 | 0.06 | 0.008 | 0.7 | 0.35 | 0.13 | 0.02 | 0.2 | 0.023 |
Grade 3–4 acute GvHD | ||||||||||
No* | 17 (11–22) | 0.47 (0.23–0.9) | 26 (20–33) | 0.41 (0.24–0.72) | 21 (15–26) | NA | 53 (49–57) | 0.48 (0.29–0.78) | 50 (46–54) | NA |
Yes | 36 (18–53) | 58 (41–76) | 17 (3–31) | 28 (20–36) | 24 (16–32) | |||||
p value | 0.03 | 0.05 | 0.001 | 0.002 | 0.6 | 0.22 | 0.007 | 0.003 | 0.02 | 0.07 |
Underlying disease | ||||||||||
Myeloid* | 15 (9–22) | 0.49 (0.26–0.9) | 28 (20–36) | NA | 18 (11–25) | NA | 51 (46–56) | NA | 50 (45–55) | NA |
Lymphoid | 23 (15–31) | 33 (24–42) | 24 (16–33) | 49 (44–54) | 44 (39–49) | |||||
p value | 0.1 | 0.032 | 0.4 | 0.8 | 0.34 | 0.72 | 0.4 | 0.7 | 0.24 | 0.3 |
aReference variables in the MVA. In addition to the variables included in the table, other variables analyzed in the UVA and subsequently included in the MVA were: patient and donor sex, stem cell source, type of conditioning regimen (myeloablative vs. reduced-intensity), TBF conditioning vs. other, type of GvHD prophylaxis (tacrolimus vs. cyclosporine-MMF).