Characteristics of patients, disease, transplant, and transplant-related events
| Characteristic . | MAC group n = 449 (%) . | RIC group n = 127 (%) . | P . |
|---|---|---|---|
| Median recipient age, y (range) | 50 (45-68) | 56 (45-73) | < 10−4 |
| Median donor age, y (range) | 49 (1-69) | 55 (13-71) | < 10−4 |
| Recipient sex (male/female) | 241 (54)/208 (46) | 67 (53)/60 (47) | .86 |
| Female donor to a male recipient | 100 (22) | 39 (31) | .05 |
| Disease status at time of allo-SCT | |||
| First CR (CR1) | 391 (87) | 105 (83) | |
| Second CR (CR2) | 58 (13) | 22 (17) | .21 |
| Cytogenetics risk group | |||
| t(9;22) | 104 (51) | 41 (57) | |
| t(4;11) | 12 (6) | 0 | .10 |
| Other | 89 (43) | 31 (43) | |
| NA/failed | 244 | 55 | |
| Time from diagnosis to allo-SCT, d | |||
| CR1 | 159 (60-622) | 170 (55-606) | .053 |
| CR2 | 390 (126-2689) | 508 (120-1091) | .95 |
| Year of allo-SCT | 2004 (1997-2007) | 2005 (1997-2007) | .008 |
| Stem cell source | |||
| G-CSF–mobilized peripheral blood stem cells | 297 (66) | 115 (91) | |
| Bone marrow | 150 (34) | 12 (9) | < 10−4 |
| GVHD prophylaxis | |||
| CsA alone | 43 (16) | 23 (27) | |
| CsA and methotrexate | 212 (81) | 31 (37) | < 10−4 |
| CsA and mycophenolate mofetil | 7 (3) | 30 (36) | |
| NA | 183 | 43 | |
| Conditioning regimen* | |||
| High-dose TBI | 363 (81) | 0 | |
| Low-dose TBI | 0 | 40 (32) | < 10−4 |
| Acute GVHD | |||
| Grade 0 to 1 | 261 (62) | 83 (71) | |
| Grade 2 | 98 (23) | 21 (18) | |
| Grade 3 to 4 | 60 (14) | 13 (11) | .23 |
| Chronic GVHD (patients alive at day 90) | 136 (36) | 40 (38) | .58 |
| Causes of death | |||
| Relapse/disease progression | 88 (42) | 33 (58) | |
| Infection | 45 (21) | 8 (14) | .11 |
| GVHD | 40 (19) | 11 (19) | |
| Other transplant-related causes | 37 (18) | 5 (9) |
| Characteristic . | MAC group n = 449 (%) . | RIC group n = 127 (%) . | P . |
|---|---|---|---|
| Median recipient age, y (range) | 50 (45-68) | 56 (45-73) | < 10−4 |
| Median donor age, y (range) | 49 (1-69) | 55 (13-71) | < 10−4 |
| Recipient sex (male/female) | 241 (54)/208 (46) | 67 (53)/60 (47) | .86 |
| Female donor to a male recipient | 100 (22) | 39 (31) | .05 |
| Disease status at time of allo-SCT | |||
| First CR (CR1) | 391 (87) | 105 (83) | |
| Second CR (CR2) | 58 (13) | 22 (17) | .21 |
| Cytogenetics risk group | |||
| t(9;22) | 104 (51) | 41 (57) | |
| t(4;11) | 12 (6) | 0 | .10 |
| Other | 89 (43) | 31 (43) | |
| NA/failed | 244 | 55 | |
| Time from diagnosis to allo-SCT, d | |||
| CR1 | 159 (60-622) | 170 (55-606) | .053 |
| CR2 | 390 (126-2689) | 508 (120-1091) | .95 |
| Year of allo-SCT | 2004 (1997-2007) | 2005 (1997-2007) | .008 |
| Stem cell source | |||
| G-CSF–mobilized peripheral blood stem cells | 297 (66) | 115 (91) | |
| Bone marrow | 150 (34) | 12 (9) | < 10−4 |
| GVHD prophylaxis | |||
| CsA alone | 43 (16) | 23 (27) | |
| CsA and methotrexate | 212 (81) | 31 (37) | < 10−4 |
| CsA and mycophenolate mofetil | 7 (3) | 30 (36) | |
| NA | 183 | 43 | |
| Conditioning regimen* | |||
| High-dose TBI | 363 (81) | 0 | |
| Low-dose TBI | 0 | 40 (32) | < 10−4 |
| Acute GVHD | |||
| Grade 0 to 1 | 261 (62) | 83 (71) | |
| Grade 2 | 98 (23) | 21 (18) | |
| Grade 3 to 4 | 60 (14) | 13 (11) | .23 |
| Chronic GVHD (patients alive at day 90) | 136 (36) | 40 (38) | .58 |
| Causes of death | |||
| Relapse/disease progression | 88 (42) | 33 (58) | |
| Infection | 45 (21) | 8 (14) | .11 |
| GVHD | 40 (19) | 11 (19) | |
| Other transplant-related causes | 37 (18) | 5 (9) |
The MAC regimens included cyclophosphamide and high-dose TBI in 363 cases (81%) and high-dose chemotherapy alone in 86 cases (19%). The RIC regimens included low-dose TBI in 40 cases (32%) and chemotherapy alone in 87 cases (68%): fludarabine and busulfan in 23 cases, fludarabine and melphalan in 25 cases, fludarabine and other chemotherapy agents in 11 cases, and other regimens in 28 cases. Patients were eligible to receive a MAC regimen if they were aged under 50 or 55 years and did not have significant comorbidities that precluded the use of high-dose radio- or chemotherapy (n = 362). Eighty-seven patients (19%) who were aged > 55 years received a MAC regimen because they did not have significant comorbidities and were judged as “fit” to receive high-dose therapy. In the RIC group, 110 patients (87%) received a RIC regimen because of age ≥ 50 years (main reason) irrespective of the presence or absence of significant comorbidities. The remaining 17 patients (13%) who received a RIC regimen were aged < 50 years but had one or more comorbidities or specific reasons that precluded the use of high-dose therapy: 6 cases from centers where the age limit for a MAC regimen is set at 45 years as per centre policy, 3 cases with prior severe infections, 1 case with a history of CNS thrombosis, 1 case with a history of hepatitis, 1 case with heart left ventricular hypokinesia, 1 case with instable psychological status, 1 case of severe intolerance and toxicity to prior lines of chemotherapy, 1 case with concomitant Crohn disease, diabetes and pancreatitis, 1 case with unspecified different comorbidities, and 1 case according to patient choice.