Table 2.
Event | Number (%) Failures Among All Patients | Adjusted Hazard/Odds (Ratioa(95% Confidence Interval, p-value) | ||
---|---|---|---|---|
1993–97 (n=1418) | 2003–07 (n=1148) | All Patients | Patients who received myeloablative conditioning therapy | |
Outcomes | ||||
Day-200 non-relapse mortality | 419(30%) | 186(16%) | 0.40 (0.32–0.49, p<0.001) | 0.44 (0.36–0.54, p<0.001) |
Overall non-relapse mortality | 580(41%) | 297 (26%) | 0.48 (0.40–0.57, p<0.001) | 0.48 (0.40–0.58, p< 0.001) |
Relapse or progression | 379 (27%) | 302 (26%) | 0.79 (0.66–0.94, p=0.008) | 0.82 (0.68–0.99, p=0.04) |
Overall morality | 891 (63%) | 545 (47%) | 0.59 (0.52–0.67, p<0.001) | 0.61 (0.53–0.69, p<0.001) |
Liver dysfunction through day 100 | ||||
Peak total serum bilirubin ≥ 4 mg/dLb | 677 (48%) | 232 (20%) | 0.26 (0.21–0.32, p<0.001) | 0.28 (0.23–0.35, p<0.001) |
Peak total serum bilirubin ≥ 10 mg/dLb | 287 (20%) | 64 (6%) | 0.22 (0.16–0.30, p<0.001) | 0.24 (0.17–0.33, p<0.001) |
Stage 3–4 liver GVHDc | 165(12%) | 25 (2%) | 0.15 (0.09–0.24, p<0.001) | 0.18 (0.11–0.29, p<0.001) |
Stage 4 liver GVHDc | 78 (6%) | 2(<1%) | 0.03 (0.01–0.12, p<0.001) | 0.04 (0.01–0.17, p<0.001) |
Acute Kidney Injury through day 100 | ||||
Creatinine 2-times baseline | 710(50%) | 384 (33%) | 0.47 (0.39–0.56, p<0.001) | 0.46 (0.38–0.56, p<0.001) |
Creatinine 3-times baseline | 257(18%) | 115(10%) | 0.48 (0.37–0.64, p<0.001) | 0.51 (0.38–0.68, p<0.001) |
Dialysis | 112(7.9%) | 58 (5.0%) | 0.62 (0.42–0.90, p=0.01) | 0.72 (0.49–1.07, p=0.10) |
Pulmonary complications through day 100 | ||||
Bronchoscopy | 272(19%) | 242(21%) | 0.91 (0.75–1.12, p=0.38) | 0.90 (0.73–1.12, p=0.34) |
Respiratory Failure | 211 (15%) | 131(11%) | 0.64 (0.49–0.82, p=0.001) | 0.69 (0.53–0.90, p=0.007) |
Infections through day 100 | ||||
CMV infectiond | 420 (57%) | 419 (63%) | 1.02 (0.87–1.20, p=0.77) | 1.04 (0.88–1.23, p=0.63) |
CMV diseased | 62 (8%) | 33 (5%) | 0.52 (0.32–0.85, p=0.009) | 0.53 (0.31–0.89, p=0.02) |
Gram-negative bacteremia | 213 (15%) | 129 (11%) | 0.61 (0.48–0.79, p<0.001) | 0.57 (0.44–0.75, p<0.001)i |
Invasive mold infection | 125 (9%) | 80 (7%) | 0.49 (0.35–0.71, p<0.001) | 0.55 (0.38–0.78, p<0.001) |
Invasive Candida infection | 99 (7%) | 10 (1%) | 0.12 (0.06–0.25, p<0.001) | 0.15 (0.08–0.29, p<0.001) |
Acute GVHD | ||||
Grades 2–4 | 1076 (77%) | 815 (71%) | 0.61 (0.50–0.75, p<0.001) | 0.66 (0.53–0.82, p<0.001) |
Grades 3–4 | 421 (30%) | 161 (14%) | 0.33 (0.26–0.42, p<0.001) | 0.33 (0.26–0.42, p<0.001) |
Grade 4 | 102 (7%) | 27 (2%) | 0.31 (0.18–0.51, p<0.001) | 0.30 (0.18–0.53, p<0.001) |
Stage 2–4 gut GVHDe | 231 (17%) | 119 (10%) | 0.53 (0.40–0.70, p<0.001) | 0.52 (0.39–0.70, p<0.001) |
Stage 3–4 gut GVHDe | 141 (10%) | 73 (6%) | 0.53 (0.37–0.75, p<0.001) | 0.55 (0.38–0.79, p=0.001) |
Change over the decade is expressed as a hazard ratio (HR) or odds ratio (OR), as calculated by regression models adjusted for age, donor, disease severity, and baseline values for serum creatinine, ALT, FEV1, and DLCO (see Methods).
Conversion of total serum bilirubin to SI units: 1 mg/dL=17.1 μmol/L
Liver stage 1, total serum bilirubin 2–2.9 mg/dL; stage 2, 3–5.9 mg/dL; stage 3, 6–14.9 mg/dL; stage 4, ≥15 mg/dL (1 mg/dL=17.1 μmol/L).
Among CMV-seropositive patients.
Gut stage 1, diarrhea 500–999 mL/day or biopsy-proven upper gut involvement; stage 2, diarrhea 1000–1499 mL/day; stage 3, diarrhea 1500–1999 mL/day; stage 4, diarrhea > 2000 mL or severe abdominal pain with or without ileus.