Table 2.
Univariate analysis.
| cGVHD all Grade | cGVHD mod/sev | aGVHD G III-IV | aGVHD G II-IV | NRM | CIR | GRFS | PFS | OS | |
|---|---|---|---|---|---|---|---|---|---|
| p | p | p | p | p | p | p | p | p | |
| 2 y [95%CI] | 2 y [95%CI] | D100 [95%CI] | D100 [95%CI] | 2 y [95%CI] | 2 y [95%CI] | 2 y [95%CI] | 2 y [95%CI] | 2 y [95%CI] | |
| ATLG Dose | 0.21 | 0.045 | 0.70 | 0.20 | 0.11 | 0.64 | 0.10 | 0.40 | 0.20 |
| 15 mg/Kg | 73 [57–83] | 43 [31–55] | 13 [6–22] | 34 [23–45] | 13 [6–22] | 25 [15–37] | 24 [14–39] | 60 [49–75] | 72 (61–84) |
| 30 mg/Kg | 62 [50–72] | 28 [19–39] | 9 [4–16] | 18 [11–27] | 6 [2–13] | 28 [19–39] | 36 [27–49] | 65 [55–76] | 77 (68–87) |
| Patient Age | 0.21 | 0.87 | 0.31 | 0.09 | 0.02 | 0.68 | 0.02 | 0.04 | 0.01 |
| ≤58 Years | 74 [61–82] | 36 [26–47] | 8 [3–15] | 19 [12–28] | 3 [5–9] | 26 [17–37] | 36 [26–50] | 71 [61–82] | 82 [74–92] |
| >58 Years | 57 [43–68] | 33 [22–45] | 14 [7–23] | 32 [21–43] | 16 [8–26] | 28 [18–40] | 24 [16–38] | 53 [42–67] | 66 [55–79] |
| ECOG | 0.37 | 0.70 | 0.15 | 0.34 | 0.87 | 0.95 | 0.40 | 0.5 | 0.05 |
| 0 | 75 [57–86] | 37 [22–52] | 6 [1–16] | 21 [11–34] | 5 [1–16] | 28 [15–43] | 29 [18–49] | 66 [53–83] | 80 [69–94] |
| 1 | 63 [52–73] | 33 [24–43] | 13 [8–20] | 25 [18–34] | 10 [5–17] | 26 [18–37] | 33 [24–45] | 63 [54–74] | 75 [66–85] |
| 2 | NR | NR | 0 | 43 [7–76] | 14 [1–50] | 32 [3–70] | 14 [2–88] | 43 [18–100] | 43 [18–1] |
| Donor Age | 0.64 | 0.34 | 0.66 | 0.39 | 0.77 | 0.52 | 0.40 | 0.50 | 0.30 |
| ≤57 Years | 64 [52–73] | 30 [21–41] | 11 [6–19] | 30 [20–39] | 9 [4–16] | 25 [16–35] | 36 [27–49] | 65 [55–77] | 77 [69–87] |
| >57 Years | 69 [54–80] | 42 [29–54] | 10[4–18] | 19 [11–29] | 9 [4–18] | 31 [19–43] | 23 [14–39] | 60 [49–74] | 72 [61–84] |
| Patient CMV serology | 0.63 | 0.93 | 0.52 | 0.007 | 0.29 | 0.01 | 0.40 | 0.07 | 0.20 |
| Neg | 65 [51–76] | 35 [23–48] | 6 [2–14] | 12 [6–21] | 5 [1–13] | 37 [24–49] | 25 [15–40] | 57 [45–71] | 67 [56–81] |
| Pos | 66 [54–76] | 35 [25–45] | 14 [8–22] | 33 [24–43] | 12 [6–19] | 21 [13–31] | 36 [26–48] | 67 [58–79] | 80 [72–90] |
| Donor CMV Serology | 0.89 | 0.71 | 0.91 | 0.10 | 0.92 | 0.94 | 0.40 | 0.90 | 0.80 |
| Neg | 64 [51–75] | 37 [25–49] | 12 [6–21] | 23 [14–33] | 10 [4–18] | 24 [14–34] | 32 [23–46] | 66 [56–78] | 71 [62–83] |
| Pos | 67 [54–77] | 33 [23–44] | 9 [4–17] | 27 [18–37] | 8 [3–16] | 31 [20–42] | 31 [21–44] | 60 [50–73] | 78 [69–88] |
| Patient Sex | 0.81 | 0.61 | 0.73 | 0.71 | 0.56 | 0.91 | 0.50 | 0.90 | 0.60 |
| Male | 67 [55–77] | 33 [24–44] | 11 [5–18] | 24 [16–33] | 8 [4–16] | 29 [20–40] | 59 [22–44] | 61 [51–73] | 73 [63–83] |
| Female | 64 [50–75] | 37 [25–50] | 11 [5–19] | 26 [16–37] | 10 [4–19] | 24 [14–35] | 32 [22–48] | 66 [55–79] | 78 [68–90] |
| Donor Sex | 0.43 | 0.90 | 0.62 | 0.08 | 0.06 | 0.98 | 0.50 | 0.30 | 0.20 |
| Male | 65 [51–76] | 33 [22–43] | 11 [5–19] | 20 [12–29] | 6 [2–13] | 26 [17–37] | 36 [26–49] | 67 [57–79] | 79 [69–90] |
| Female | 67 [54–77] | 36 [25–48] | 10 [5–18] | 30 [21–41] | 12 [6–21] | 28 [18–39] | 28 [18–41] | 60 [49–72] | 71 [61–82] |
| ABO Incompatibility | 0.31 | 0.10 | 0.77 | 0.20 | 0.91 | 0.53 | 0.50 | 0.30 | 0.60 |
| Isogroup | 63 [52–72] | 33 [24–42] | 10 [5–16] | 23 [15–30] | 9 [5–16] | 28 [20–37] | 32 [24–43] | 62 [53–72] | 73 [65–83] |
| Minor | 75 [35–92] | 57 [24–81] | 15 [2–40] | 46 [18–71] | 8 [1–30] | 23 [5–49] | 19 [6–64] | 69 [48–99] | 69 [45–100] |
| Major | 76 [49–90] | 39 [19–59] | 13 [3–29] | 25 [10–44] | 9 [1–25] | 19 [5–39] | 31 [16–61] | 72 [55–94] | 82 [68–99] |
| Bidirectional | NR | 0 | 0 | 25 [1–71] | NR | NR | NR | NR | NR |
| Allo-SCT Year | 0.82 | 0.89 | 0.12 | 0.43 | 0.57 | 0.3 | 0.8 | 0.7 | 0.6 |
| ≤ 2019 | 35 [26–44] | 65 [54–73] | 8 [4–14] | 24 [16–32] | 8 [4–14] | 29 [21–38] | 32 [24–43] | 63 [54–73] | 74 [66–83] |
| > 2019 | 35 [19–50] | 74 [36–92] | 16 [7–29] | 28 [16–42] | 11 [3–24] | 25 [8–45] | 25 [10–61] | 62 [45–85] | 77 [63–95] |
| CD34 Dose | 0.83 | 0.29 | 0.23 | 0.40 | 0.89 | 0.31 | 0.10 | 0.40 | 0.30 |
| ≤5.7 ×106/kg | 68 [54–78] | 39 [28–51] | 13 [6–21] | 29 [20–39] | 10 [4–18] | 33 [22–45] | 22 [13–36] | 57 [46–71] | 71 [61–83] |
| >5.7 ×106/kg | 63 [50–74] | 31 [20–42] | 8 [3–15] | 20 [12–29] | 8 [3–16] | 22 [13–32] | 40 [30–53] | 68 [58–80] | 78 [69–89] |
| Conditioning intensity | 0.37 | 0.90 | 0.0006 | 0.18 | 0.38 | 0.91 | 0.02 | 0.40 | 0.99 |
| MAC | 71 [58–80] | 34 [24–44] | 4 [1–10] | 21 [13–30] | 6 [2–12] | 28 [18–39] | 37 [27–50] | 66 [56–78] | 77 [68–87] |
| RIC | 60 [46–72] | 35 [24–48] | 19 [10–29] | 30 [20–41] | 13 [6–23] | 26 [16–38] | 22 [14–38] | 59 [48–73] | 72 [61–85] |
| TBI | 0.59 | 0.71 | 0.52 | 0.47 | 0.57 | 0.005 | 0.10 | 0.001 | 0.0002 |
| TBI | 67 [58–75] | 35 [27–43] | 11 [7–17] | 25 [19–33] | 8 [4–14] | 24 [17–31] | 34 [26–43] | 67 [60–76] | 78 [71–86] |
| no TBI | 54 [22–77] | 31 [9–57] | 7 [1–28] | 21 [5–46] | 16 [2–41] | 64 [27–87] | 10 [2–58] | 20 [6–65] | 45 [24–84] |
| Disease status at SCT | 0.12 | 0.28 | 0.34 | 0.80 | 0.42 | 0.004 | 0.20 | 0.0003 | 0.0004 |
| CR | 73 [56–84] | 38 [24–52] | 6 [1–14] | 25 [14–37] | 4 [1–12] | 22 | 39 [27–58] | 71 [59–86] | 78 [67–91] |
| PR | 58 [27–80] | 36 [12–61] | 6 [1–25] | 31 [11–54] | 21 [5–45] | 21 [11–36] | 27 [12–63] | 58 [38–91] | 73 [53–99] |
| PD | 45 [26–61] | 19 [7–34] | 9 [2–22] | 19 [7–34] | 13 [4–27] | 55 [5–45] | 20 [9–41] | 32 [19–55] | 52 [37–73] |
| Untreated | 73 [57–84] | 43 [28–56] | 17 [9–28] | 27 [17–39] | 8 [3–19] | 17 [35–71] | 31 [19–48] | 75 [64–88] | 87 [77–97] |
| CR vs not CR | 0.76 | 0.42 | 0.07 | 0.87 | 0.28 | 0.49 | 0.10 | 0.30 | 0.50 |
| CR | 73 [56–84] | 38 [24–52] | 6 [1–14] | 25 [14–37] | 4 [1–12] | 23 [11–36] | 39 [27–58] | 71 [59–86] | 78 [67–91] |
| not CR | 62 [51–70] | 33 [24–42] | 13 [7–20] | 25 [17–34] | 11 [6–19] | 29 [21–39] | 27 [19–38] | 59 [50–70] | 73 [65–83] |
| DRSSS | 0.525 | <0.001 | 0.005 | <0.001 | 0.005 | ||||
| Standard | 0 [NA] | 16 [4–36] | 39 [21–76] | 81 [64–100] | 89 [75–100] | ||||
| Intermediate 1 | 9 [3–20] | 14 [6–26] | 40 [26–61] | 70 [56–88] | 79 [65–95] | ||||
| Intermediate 2 | 11 [4–20] | 21 [12–32] | 30 [19–47] | 64 [52–79] | 75 [63–88] | ||||
| High | 5 [0–21] | 15 [4–34] | 43 [26–72] | 72 [54–97] | 84 [69–100] | ||||
| Very High | 8 [1–23] | 60 [37–77] | 5 [1–33] | 28 [14–55] | 52 [35–78] |
cGVHD all Grade Chronic Graft-versus-Host Disease (all grades), cGVHD mod/sev Chronic Graft-versus-Host Disease (moderate/severe), aGVHD G III–IV Acute Graft-versus-Host Disease (Grade III–IV), aGVHD G II–IV Acute Graft-versus-Host Disease (Grade II–IV), NRM Non-Relapse Mortality, CIR Cumulative Incidence of Relapse, GRFS Graft-versus-Host Disease–Free, Relapse-Free Survival, PFS Progression-Free Survival, OS Overall Survival, 2 y 2-year outcome, D100 Day 100 outcome, [95% CI]: 95% Confidence Interval, ATLG Anti-T-Lymphocyte Globulin, ECOG Eastern Cooperative Oncology Group performance status, CMV cytomegalovirus, ABO ABO blood group, Allo-SCT Allogeneic Stem Cell Transplant, CD34 Dose Infused CD34⁺ cell dose (×10^6/kg), MAC Myeloablative Conditioning, RIC Reduced-Intensity Conditioning, TBI Total Body Irradiation, CR Complete Remission, PR Partial Remission, PD Progressive Disease, NR Not Reached (for survival estimates), p: p value.