Patient characteristics and outcomes in the discovery (n = 110) and validation (n = 94) cohorts: discovery cohort
| . | . | 1-y overall survival . | 1-y relapse rate . | ||
|---|---|---|---|---|---|
| . | n . | Probability (%) . | HR (95%CI) (risk of death) . | Cumulative incidence (%) . | HR (95%CI) (risk of relapse) . |
| Age* | P = .08 | P = .74 | |||
| ≤40 y | 59 | 52.4 | 1 | 32.7 | 1 |
| >40 y | 51 | 35.6 | 1.57 (0.94-2.63) | 36.0 | 1.12 (0.56-2.22) |
| Sex | P = .23 | P = .24 | |||
| Male | 48 | 40.6 | 1 | 40.5 | 1 |
| Female | 62 | 47.9 | 0.73 (0.44-1.22) | 35.1 | 0.66 (0.23-1.61) |
| Diagnosis | P = .75 | P = .40 | |||
| AML | 44 | 41.5 | 1 | 41.0 | 1 |
| Acute lymphoblastic leukemia | 24 | 41.7 | 0.95 (0.49-1.84) | 23.1 | 0.51 (0.18-1.38) |
| Myelodysplastic syndromes | 19 | 40.6 | 1.00 (0.49-2.0) | 47.6 | 1.06 (0.45-2.48) |
| Lymphoproliferative disorder†I | 22 | 43.3 | 0.75 (0.28-1.51) | 30.3 | 0.44 (0.13-1.50) |
| Chronic myeloid leukemia | 1 | 100.0 | — | 0.0 | — |
| Disease status at transplant | P = .06 | P = .006 | |||
| Complete remission | 67 | 52.9 | 1 | 23.2 | 1 |
| Refractory/relapsed disease | 43 | 31.9 | 1.63 (0.97-2.73) | 51.3 | 2.55 (1.27-5.10) |
| Conditioning regimen | P = .20 | P = .55 | |||
| Myeloablative | 79 | 38.1 | 1 | 46.3 | 1 |
| Nonmyeloablative | 31 | 22.1 | 1.19 (0.67-2.09) | 40.9 | 0.56 (0.23-1.36) |
| Graft | P = .22 | P = .20 | |||
| Double cord | 105 | 45.9 | 1 | 32.6 | 1 |
| Single cord | 5 | 20.0 | 1.36 (0.82-2.27) | 0.60 | 1.51 (0.84-2.74) |
| CMV status‡ | P = .84 | P = .43 | |||
| Seronegative | 11 | 53.0 | 1 | 56.2 | 1 |
| Seropositive | 97 | 43.6 | 1.10 (0.44-2.75) | 32.0 | 0.66 (0.23-1.89) |
| HLA match between recipient and dominant CB unit§ | P = .50 | P = .34 | |||
| 7-8/8 | 16 | 61.4 | 1 | 25.1 | 1 |
| 5-6/8 | 46 | 47.1 | 1.41 (0.48-4.13) | 30.1 | 1.33 (0.42-6.01) |
| ≤4/8 | 38 | 40.8 | 1.80 (0.61-5.27) | 39.6 | 1.60 (0.61-4.81) |
| Total mononuclear cells infused|| | P = .90 | P = .99 | |||
| ≤4.1 × 108/kg | 56 | 46.1 | 1 | 34.2 | 1 |
| >4.1 × 108/kg | 54 | 42.6 | 1.035 (0.62-1.73) | 33.5 | 0.99 (0.50-1.96) |
| Patient HLA C group | P < .001 | P < .001 | |||
| C1/C1 | 31 | 59.9 | 1 | 27.3 | 1 |
| C1/C2 | 55 | 48.7 | 1.35 (0.68-2.67) | 24.9 | 0.92 (0.38-2.26) |
| C2/C2 | 24 | 15.0 | 4.33 (2.10-8.94) | 67.8 | 4.05 (1.66-9.87) |
| Patient HLA C group | P < .001 | P < .001 | |||
| C1/x | 86 | 52.9 | 1 | 26.0 | 1 |
| C2/C2 | 24 | 15.0 | 3.56 (2.05-6.18) | 67.8 | 4.25 (2.09-8.63) |
| Patients receiving CB grafts with the combined HLA-C1-KIR2DL2/L3/S2 genotype¶ | P = .002 | P = .009 | |||
| Yes | 67 | 64.6 | 1 | 46.9 | 1 |
| No | 37 | 34.3 | 2.65 (1.39-5.03) | 16.0 | 3.07 (1.26-7.47) |
| HLA-C1/x patients receiving CB grafts with the combined HLA-C1-KIR2DL2/L3/S2 genotype¶ | P = .003 | P = .002 | |||
| Yes | 31 | 74.2 | 1 | 6.7 | 1 |
| No | 49 | 41.3 | 3.31 (1.45-7.50) | 40.1 | 6.98 (1.61-30.25) |
| Patients receiving CB grafts with the combined HLA-C2-KIR2DL1/S1 genotype¶ | P = .17 | P = .72 | |||
| Yes | 47 | 51.9 | 1 | 35.2 | 1 |
| No | 57 | 39.1 | 1.45 (0.85-2.49) | 34.0 | 1.13 (0.56-2.27) |
| Number of CB units with haplotype B¶ | P = .45 | P = .30 | |||
| 2 CB units | 88 | 44.9 | 1 | 31.2 | 1 |
| 1 CB units | 14 | 42.9 | 0.961 (0.45-2.03) | 43.6 | 1.37 (0.18-10.15) |
| 0 CB units | 2 | 50.0 | 1.12 (0.09-16.27) | 50.0 | 2.12 (0.91-4.93) |
| . | . | 1-y overall survival . | 1-y relapse rate . | ||
|---|---|---|---|---|---|
| . | n . | Probability (%) . | HR (95%CI) (risk of death) . | Cumulative incidence (%) . | HR (95%CI) (risk of relapse) . |
| Age* | P = .08 | P = .74 | |||
| ≤40 y | 59 | 52.4 | 1 | 32.7 | 1 |
| >40 y | 51 | 35.6 | 1.57 (0.94-2.63) | 36.0 | 1.12 (0.56-2.22) |
| Sex | P = .23 | P = .24 | |||
| Male | 48 | 40.6 | 1 | 40.5 | 1 |
| Female | 62 | 47.9 | 0.73 (0.44-1.22) | 35.1 | 0.66 (0.23-1.61) |
| Diagnosis | P = .75 | P = .40 | |||
| AML | 44 | 41.5 | 1 | 41.0 | 1 |
| Acute lymphoblastic leukemia | 24 | 41.7 | 0.95 (0.49-1.84) | 23.1 | 0.51 (0.18-1.38) |
| Myelodysplastic syndromes | 19 | 40.6 | 1.00 (0.49-2.0) | 47.6 | 1.06 (0.45-2.48) |
| Lymphoproliferative disorder†I | 22 | 43.3 | 0.75 (0.28-1.51) | 30.3 | 0.44 (0.13-1.50) |
| Chronic myeloid leukemia | 1 | 100.0 | — | 0.0 | — |
| Disease status at transplant | P = .06 | P = .006 | |||
| Complete remission | 67 | 52.9 | 1 | 23.2 | 1 |
| Refractory/relapsed disease | 43 | 31.9 | 1.63 (0.97-2.73) | 51.3 | 2.55 (1.27-5.10) |
| Conditioning regimen | P = .20 | P = .55 | |||
| Myeloablative | 79 | 38.1 | 1 | 46.3 | 1 |
| Nonmyeloablative | 31 | 22.1 | 1.19 (0.67-2.09) | 40.9 | 0.56 (0.23-1.36) |
| Graft | P = .22 | P = .20 | |||
| Double cord | 105 | 45.9 | 1 | 32.6 | 1 |
| Single cord | 5 | 20.0 | 1.36 (0.82-2.27) | 0.60 | 1.51 (0.84-2.74) |
| CMV status‡ | P = .84 | P = .43 | |||
| Seronegative | 11 | 53.0 | 1 | 56.2 | 1 |
| Seropositive | 97 | 43.6 | 1.10 (0.44-2.75) | 32.0 | 0.66 (0.23-1.89) |
| HLA match between recipient and dominant CB unit§ | P = .50 | P = .34 | |||
| 7-8/8 | 16 | 61.4 | 1 | 25.1 | 1 |
| 5-6/8 | 46 | 47.1 | 1.41 (0.48-4.13) | 30.1 | 1.33 (0.42-6.01) |
| ≤4/8 | 38 | 40.8 | 1.80 (0.61-5.27) | 39.6 | 1.60 (0.61-4.81) |
| Total mononuclear cells infused|| | P = .90 | P = .99 | |||
| ≤4.1 × 108/kg | 56 | 46.1 | 1 | 34.2 | 1 |
| >4.1 × 108/kg | 54 | 42.6 | 1.035 (0.62-1.73) | 33.5 | 0.99 (0.50-1.96) |
| Patient HLA C group | P < .001 | P < .001 | |||
| C1/C1 | 31 | 59.9 | 1 | 27.3 | 1 |
| C1/C2 | 55 | 48.7 | 1.35 (0.68-2.67) | 24.9 | 0.92 (0.38-2.26) |
| C2/C2 | 24 | 15.0 | 4.33 (2.10-8.94) | 67.8 | 4.05 (1.66-9.87) |
| Patient HLA C group | P < .001 | P < .001 | |||
| C1/x | 86 | 52.9 | 1 | 26.0 | 1 |
| C2/C2 | 24 | 15.0 | 3.56 (2.05-6.18) | 67.8 | 4.25 (2.09-8.63) |
| Patients receiving CB grafts with the combined HLA-C1-KIR2DL2/L3/S2 genotype¶ | P = .002 | P = .009 | |||
| Yes | 67 | 64.6 | 1 | 46.9 | 1 |
| No | 37 | 34.3 | 2.65 (1.39-5.03) | 16.0 | 3.07 (1.26-7.47) |
| HLA-C1/x patients receiving CB grafts with the combined HLA-C1-KIR2DL2/L3/S2 genotype¶ | P = .003 | P = .002 | |||
| Yes | 31 | 74.2 | 1 | 6.7 | 1 |
| No | 49 | 41.3 | 3.31 (1.45-7.50) | 40.1 | 6.98 (1.61-30.25) |
| Patients receiving CB grafts with the combined HLA-C2-KIR2DL1/S1 genotype¶ | P = .17 | P = .72 | |||
| Yes | 47 | 51.9 | 1 | 35.2 | 1 |
| No | 57 | 39.1 | 1.45 (0.85-2.49) | 34.0 | 1.13 (0.56-2.27) |
| Number of CB units with haplotype B¶ | P = .45 | P = .30 | |||
| 2 CB units | 88 | 44.9 | 1 | 31.2 | 1 |
| 1 CB units | 14 | 42.9 | 0.961 (0.45-2.03) | 43.6 | 1.37 (0.18-10.15) |
| 0 CB units | 2 | 50.0 | 1.12 (0.09-16.27) | 50.0 | 2.12 (0.91-4.93) |
The median age was 38 y (range, 2-73).
Six patients had Hodgkin disease; 4 had chronic lymphocytic leukemia, and 12 had non-Hodgkin lymphoma.
Two patients had missing data.
The identity of the dominant CB unit could not be ascertained in 14 cases.
The median value for the total nucleated cells infused was 4.1 × 108/kg (range, 2.0 × 108/kg to 19.5 × 108/kg).
Six patients had missing data.