Clinical characteristics of the 395 patients enrolled in the study and comparison between children and adolescents
| Characteristic . | Children . | Adolescents . | P . | ||
|---|---|---|---|---|---|
| n . | (%) . | n . | (%) . | ||
| No. of patients | 334 | (100) | 61 | (100) | |
| Sex | |||||
| Male | 212 | (63) | 44 | (72) | N.S. |
| Female | 122 | (37) | 17 | (28) | |
| Median age at diagnosis, y (range) | 4.9 | (1.1-13) | 13.3 | (5.6-16.9) | < .001 |
| Median WBC at diagnosis, × 109/L (range) | 14.5 | (0.1-430) | 8.1 | (0.3-311) | 0.01 |
| Immunophenotype | |||||
| B-lineage ALL | 215 | (64) | 35 | (57) | .08 |
| T-lineage ALL | 26 | (8) | 10 | (16) | |
| Missing/unknown | 93 | (28) | 16 | (26) | |
| Cytogenetic abnormalities | |||||
| t(9;22) | 12 | (4) | 3 | (5) | N.S. |
| Frontline chemotherapy protocol | |||||
| AIEOP LAL 82 | 6 | (2) | 0 | (0) | N.S. |
| AIEOP LAL 87 | 24 | (7) | 5 | (8) | |
| AIEOP LAL 88 | 20 | (6) | 2 | (3) | |
| AIEOP LAL 91 | 71 | (21) | 11 | (18) | |
| AIEOP LAL 95 | 116 | (34) | 17 | (28) | |
| AIEOP LAL 2000 | 87 | (27) | 21 | (35) | |
| Other | 10 | (3) | 5 | (8) | |
| Median interval between diagnosis and first relapse, mo (range) | 29 | (2-121) | 33 | (3-102) | N.S. |
| Relapse timing | |||||
| Very early relapse < 18 mo from diagnosis | 69 | (21) | 13 | (21) | N.S. |
| Early relapse 18-30 mo from diagnosis | 94 | (28) | 13 | (21) | |
| Late relapse > 30 mo from diagnosis | 159 | (48) | 32 | (53) | |
| Missing/unknown | 12 | (3) | 3 | (5) | |
| Site of first relapse | |||||
| BM | 232 | (69) | 40 | (65) | N.S. |
| Combined BM + extramedullary | 40 | (12) | 9 | (15) | |
| Isolated extramedullary | 40 | (12) | 6 | (10) | |
| Missing/unknown | 22 | (7) | 6 | (10) | |
| BFM class at relapse | |||||
| S1 | 9 | (3) | 0 | (0) | N.S. |
| S2 | 141 | (42) | 26 | (43) | |
| S3 | 38 | (11) | 2 | (3) | |
| S4 | 56 | (17) | 13 | (21) | |
| Missing/unknown | 90 | (27) | 20 | (33) | |
| Median age at HSCT, y (range) | 8.3 | (1.5-14) | 16 | (14-18) | < .001 |
| Median interval between diagnosis and HSCT, y (range) | 2.9 | (0.5-10) | 3.3 | (0.5-8.8) | N.S. |
| Donor | |||||
| MFD | 168 | (50) | 31 | (51) | N.S. |
| UD | 166 | (50) | 30 | (49) | |
| HLA typing resolution for UD | |||||
| High resolution | 113 | (68) | 21 | (70) | N.S. |
| Low resolution | 53 | (32) | 9 | (30) | |
| Stem cell source | |||||
| BM | 314 | (94) | 55 | (90) | N.S. |
| PB | 20 | (6) | 6 | (10) | |
| Infused cell dose | |||||
| BM, nucleated cells × 108/kg (range) | 4.2 | (1-11.1) | 3.1 | (1.3-5.9) | N.S. |
| PB, CD34+ cells × 106/kg (range) | 10.6 | (3.3-18.7) | 6.1 | (5.0-10.1) | N.S. |
| Conditioning regimen | |||||
| TBI | 301 | (90) | 56 | (92) | N.S. |
| Chemotherapy | 31 | (9) | 5 | (8) | |
| Missing/unknown | 2 | (1) | 0 | (0) | |
| GvHD prophylaxis | |||||
| MFD | |||||
| CsA ± PDN | 151 | (90) | 24 | (77) | N.S. |
| CsA + ATG | 4 | (2) | 0 | (0) | |
| CsA + MTX | 12 | (7) | 5 | (16) | |
| CsA + MTX + ATG | 1 | (1) | 2 | (7) | |
| UD | |||||
| CsA ± PDN | 3 | (1) | 0 | (0) | N.S. |
| CsA + ATG | 7 | (4) | 1 | (3) | |
| CsA + MTX | 29 | (18) | 3 | (10) | |
| CsA + MTX + ATG ± PDN | 127 | (77) | 26 | (87) | |
| Characteristic . | Children . | Adolescents . | P . | ||
|---|---|---|---|---|---|
| n . | (%) . | n . | (%) . | ||
| No. of patients | 334 | (100) | 61 | (100) | |
| Sex | |||||
| Male | 212 | (63) | 44 | (72) | N.S. |
| Female | 122 | (37) | 17 | (28) | |
| Median age at diagnosis, y (range) | 4.9 | (1.1-13) | 13.3 | (5.6-16.9) | < .001 |
| Median WBC at diagnosis, × 109/L (range) | 14.5 | (0.1-430) | 8.1 | (0.3-311) | 0.01 |
| Immunophenotype | |||||
| B-lineage ALL | 215 | (64) | 35 | (57) | .08 |
| T-lineage ALL | 26 | (8) | 10 | (16) | |
| Missing/unknown | 93 | (28) | 16 | (26) | |
| Cytogenetic abnormalities | |||||
| t(9;22) | 12 | (4) | 3 | (5) | N.S. |
| Frontline chemotherapy protocol | |||||
| AIEOP LAL 82 | 6 | (2) | 0 | (0) | N.S. |
| AIEOP LAL 87 | 24 | (7) | 5 | (8) | |
| AIEOP LAL 88 | 20 | (6) | 2 | (3) | |
| AIEOP LAL 91 | 71 | (21) | 11 | (18) | |
| AIEOP LAL 95 | 116 | (34) | 17 | (28) | |
| AIEOP LAL 2000 | 87 | (27) | 21 | (35) | |
| Other | 10 | (3) | 5 | (8) | |
| Median interval between diagnosis and first relapse, mo (range) | 29 | (2-121) | 33 | (3-102) | N.S. |
| Relapse timing | |||||
| Very early relapse < 18 mo from diagnosis | 69 | (21) | 13 | (21) | N.S. |
| Early relapse 18-30 mo from diagnosis | 94 | (28) | 13 | (21) | |
| Late relapse > 30 mo from diagnosis | 159 | (48) | 32 | (53) | |
| Missing/unknown | 12 | (3) | 3 | (5) | |
| Site of first relapse | |||||
| BM | 232 | (69) | 40 | (65) | N.S. |
| Combined BM + extramedullary | 40 | (12) | 9 | (15) | |
| Isolated extramedullary | 40 | (12) | 6 | (10) | |
| Missing/unknown | 22 | (7) | 6 | (10) | |
| BFM class at relapse | |||||
| S1 | 9 | (3) | 0 | (0) | N.S. |
| S2 | 141 | (42) | 26 | (43) | |
| S3 | 38 | (11) | 2 | (3) | |
| S4 | 56 | (17) | 13 | (21) | |
| Missing/unknown | 90 | (27) | 20 | (33) | |
| Median age at HSCT, y (range) | 8.3 | (1.5-14) | 16 | (14-18) | < .001 |
| Median interval between diagnosis and HSCT, y (range) | 2.9 | (0.5-10) | 3.3 | (0.5-8.8) | N.S. |
| Donor | |||||
| MFD | 168 | (50) | 31 | (51) | N.S. |
| UD | 166 | (50) | 30 | (49) | |
| HLA typing resolution for UD | |||||
| High resolution | 113 | (68) | 21 | (70) | N.S. |
| Low resolution | 53 | (32) | 9 | (30) | |
| Stem cell source | |||||
| BM | 314 | (94) | 55 | (90) | N.S. |
| PB | 20 | (6) | 6 | (10) | |
| Infused cell dose | |||||
| BM, nucleated cells × 108/kg (range) | 4.2 | (1-11.1) | 3.1 | (1.3-5.9) | N.S. |
| PB, CD34+ cells × 106/kg (range) | 10.6 | (3.3-18.7) | 6.1 | (5.0-10.1) | N.S. |
| Conditioning regimen | |||||
| TBI | 301 | (90) | 56 | (92) | N.S. |
| Chemotherapy | 31 | (9) | 5 | (8) | |
| Missing/unknown | 2 | (1) | 0 | (0) | |
| GvHD prophylaxis | |||||
| MFD | |||||
| CsA ± PDN | 151 | (90) | 24 | (77) | N.S. |
| CsA + ATG | 4 | (2) | 0 | (0) | |
| CsA + MTX | 12 | (7) | 5 | (16) | |
| CsA + MTX + ATG | 1 | (1) | 2 | (7) | |
| UD | |||||
| CsA ± PDN | 3 | (1) | 0 | (0) | N.S. |
| CsA + ATG | 7 | (4) | 1 | (3) | |
| CsA + MTX | 29 | (18) | 3 | (10) | |
| CsA + MTX + ATG ± PDN | 127 | (77) | 26 | (87) | |
WBC indicates white blood cell; PB, peripheral blood; TBI, total body irradiation; PDN, prednisone; ATG, anti-thymocyte globulin; MTX, methotrexate; and N.S., not significant.