Article Figures & Data
Figures
- Fig. 1
A, Kaplan-Meier estimates of OS of patients achieving an ALC-15 ≥ 500 cells/μL versus patients achieving an ALC-15 < 500 cells/μL post-ASCT in amyloidosis. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were only three events in the ALC-15 ≥ 500 cells/μL group versus 25 events in the ALC-15 < 500 cells/μL group. The median OS was not reached in the group of patients with an ALC-15 ≥ 500 cells/μL and 53 months in the group of patients with an ALC- 15 < 500 cells/μL. The OS rates at 5 years were 93% and 59%, respectively (χ2 = 13.06, P < 0.0003). B, Kaplan-Meier estimates of PFS of patients achieving an ALC-15 ≥ 500 cells/μL versus patients achieving an ALC-15 < 500 cells/μl post-ASCT in amyloidosis. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were nine events in the ALC-15 ≥ 500 cells/μL group versus 40 events in the ALC-15 < 500 cells/μL group. The median PFS was not reached in the group of patients with an ALC-15 ≥ 500 cells/μL and 27 months in the group of patients with an ALC- 15 < 500 cells/μL. The PFS rates at 5 years were 77% and 32%, respectively (χ2 = 14.83, P < 0.0001).
- Fig. 2
A, Kaplan-Meier estimates of OS of patients infused with an A-ALC ≥ 0.5 × 109 lymphocytes/kg versus patients infused with an A-ALC < 0.5 × 109 lymphocytes/kg post-ASCT in AL. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were six events in the A-ALC ≥ 0.5 × 109 lymphocytes/kg group versus 22 events in the A-ALC < 0.5 × 109 lymphocytes/kg. The median OS was not reached in the group of patients infused with an A-ALC ≥ 0.5 × 109 lymphocytes/kg and 53 months in the group of patients infused with an A-ALC < 0.5 × 109 lymphocytes/kg. The OS rates at 5 years were 88% and 40%, respectively (χ2 = 12.59, P < 0.0004). B, Kaplan-Meier estimates of PFS of patients infused with an A-ALC ≥ 0.5 × 109 lymphocytes/kg versus patients infused with an A-ALC < 0.5 × 109 lymphocytes/kg post-ASCT in amyloidosis. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were 14 events in the A-ALC ≥ 0.5 × 109 lymphocytes/kg group versus 35 events in the A-ALC < 0.5 × 109 lymphocytes/kg. The median PFS was not reached in the group of patients infused with an A-ALC ≥ 0.5 × 109 lymphocytes/kg and 26 months in the group of patients infused with an A-ALC < 0.5 × 109 lymphocytes/kg. The PFS rates at 5 years were 77% and 32%, respectively (χ2 = 15.47, P < 0.0001).
- Fig. 3
A, Kaplan-Meier estimates of OS of patients with the variables of A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by amyloidosis versus patients with an A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by amyloidosis. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were three events in the A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by AL group versus 25 events inpatients with an A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by amyloidosis group. The median OS was not reached in the group of patients infused with A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by amyloidosis and 53 months in the group of patients with A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by amyloidosis. The OS rates at 5 years were 92% and 40%, respectively (χ2 = 16.14, P < 0.0001). B, Kaplan-Meier estimates of PFS of patients with the variables of A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by AL versus patients with an A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by amyloidosis. Dots above horizontal line, censored data; dots below horizontal line, uncensored data. There were eight events in the A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by amyloidosis group versus 45 events inpatients with an A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by amyloidosis group. The median PFS was not reached in the group of patients infused with A-ALC ≥ 0.5 × 109 lymphocytes/kg and <3 organs involved by amyloidosis and 26 months in the group of patients with A-ALC < 0.5 × 109 lymphocytes/kg and ≥3 organs involved by AL. The PFS rates at 5 years were 81% and 26%, respectively (χ2 = 22.98, P < 0.0001).
Tables
- Table 1
Baseline characteristics of patients according to the absolute lymphocyte count at day 15 (ALC-15) after ASCT
Characteristics ALC-15 < 500 cells/μL (n = 86) ALC-15 ≥ 500 cells/μL (n = 59) P Age (y) Median (range) 55 (35-69) 55 (31-71) 0.88 Sex Females 32 27 0.50 Males 52 32 Prognostic factors for amyloidosis Age (y) ≥50 63 40 0.58 <50 23 19 Albumin (g/dl) ≥3.5 20 10 0.41 <3.5 66 49 Alkaline (units/L) phosphatase >375 17 7 0.26 ≤375 69 52 β-2 microglobulin (mg/L) ≥2.7 29 15 0.36 <2.7 57 44 Bone marrow plasma cells (%) >20 15 5 0.15 ≤20 71 54 Circulating plasma cells (%) >1 3 2 0.97 ≤1 83 57 C-reactive protein (mg/L) >0.8 12 8 0.95 ≤0.8 74 51 Creatinine (mg/L) >2.0 9 1 0.05 ≤2.0 77 58 Ejection fraction (%) ≥60 66 48 0.54 <60 26 11 Interventricular septal thickness (mm) ≥15 26 14 0.45 <15 60 45 LDH Elevated 23 6 0.02 Normal for age/sex 63 53 No. organs involved >2 15 11 0.85 ≤2 71 48 Plasma cell labeling index (%) ≥1 5 2 0.70 <1 81 57 Serum light chain by immunofixation λ 46 31 0.79 κ 13 11 None 27 16 Serum M spike (g/dl) >1.0 18 6 0.11 ≤1.0 68 53 24 h urine protein (g) >3.0 48 34 0.87 ≤3.0 38 25 Troponin T* (μg/L) ≥0.035 12 4 0.20 <0.035 50 36 Urine light chain by immunofixation λ 57 41 0.79 κ 20 11 None 9 7 Urine M protein (g/d) >0.25 31 23 0.73 ≤0.25 55 36 Free κ light chain before ASCT† (g/L) >0.026 24 18 0.80 ≤0.026 15 9 >0.019 14 7 0.43 ≤0.019 25 20 No. prior therapies 0 58 38 0.59 1 23 16 2 5 4 3 0 1 Stem cell mobilization regimens Cytoxan/GM-CSF 16 14 0.46 G-CSF 70 45 Conditioning regimens Melphalan/TBI 6 9 0.05 Melphalan 200 46 38 Melphalan 160 0 1 Melphalan 140 28 9 Melphalan 100 6 2 - Table 2
Univariate analysis for OS and PFS for all patients in the cohort
OS PFS Prognostic factors at transplantation RR (95% confidence interval) P RR (95% confidence interval) P ALC-15 ≥ 0.5 × 109 lymphocyte/kg 0.459 (0.267-0.710) 0.0002 0.527 (0.355-0.741) 0.0001 β-2 Microglobulin ≥ 2.7 mg/L 1.482 (1.039-2.085) 0.031 1.475 (1.093-1.967) 0.012 Circulating plasma cells >1% 2.601 (1.255-4.501) 0.014 2.491 (1.351-4.000) 0.006 Conditioning regimen: melphalan/total body irradiation versus melphalan alone 0.638 (0.407-1.106) 0.102 0.716 (0.494-1.119) 0.132 C-reactive protein ≥ 0.8 mg/L 1.375 (0.870-2.030) 0.160 Creatinine > 2.0 mg/L 1.475 (0.910-2.177) 0.107 Interventricular septal thickness ≥ 15 mm 1.523 (1.069-2.141) 0.021 1.424 (1.045-1.908) 0.026 LDH > normal 1.477 (0.933-2.183) 0.091 1.526 (1.045-2.127) 0.030 No. organs involved > 2 1.876 (1.289-2.671) 0.0015 1.796 (1.300-2.429) 0.0007 No. prior therapies to ASCT ≥ 1 1.316 (0.984-1.743) 0.06 Stem cell mobilization regimen: G-CSF versus Cytoxan/GM-CSF 0.666 (0.456-1.002) 0.051 0.766 (0.570-1.054) 0.100 Troponin T ≥ 0.035* 2.278 (1.413-3.593) 0.0012 2.177 (1.492-3.111) 0.0001 Urine M protein > 0.25 g/d 1.319 (0.907-1.919) 0.146 1.412 (1.066-1.876) 0.016 ↵* Only available data in 102 patients.
- Table 3
Multivariate analysis for OS and PFS
OS PFS Prognostic factors at transplantation RR (95% confidence interval) P RR (95% confidence interval) P ALC- 15 ≥ 0.5 × 109 lymphocyte/kg 0.388 (0.189-0.660) <0.0001 0.417 (0.252-0.653) <0.0001 Circulating plasma cells > 1% 3.066 (1.271-6.895) <0.0151 2.806 (1.328-5.505) <0.0088 No. organs involved > 2 2.191 (1.410-3.381) <0.0007 1.750 (1.202-2.503) <0.0042 Likelihood ratio, P < 0.0001 NOTE. Statistical significance declared at P < 0.0026.
Volume 11, Issue 3
