Table 1.
Baseline Characteristics of the Patients
| Variable | Conventional-Intensity Conditioning
|
Reduced-Intensity Conditioning
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No Sirolimus (n = 25)
|
Sirolimus (n = 39)
|
P | No Sirolimus (n = 23)
|
Sirolimus (n = 103)
|
P | |||||
| No. | %* | No. | %* | No. | %* | No. | %* | |||
| GVHD prophylaxis | ||||||||||
| Tac/Siro/Mtx | 19 | 49 | 83 | 81 | ||||||
| Tac/Siro | 20 | 51 | 20 | 19 | ||||||
| CnI/Mtx | 25 | 100 | 23 | 100 | ||||||
| Age, years | NS | NS | ||||||||
| Median | 40 | 43 | 47 | 51 | ||||||
| Range | 21-56 | 22-58 | 20-67 | 18-67 | ||||||
| Disease | ||||||||||
| CLL/SLL | 2 | 8 | 8 | 21 | NS | 8 | 35 | 37 | 36 | NS |
| Low-grade B-cell NHL† | 5 | 20 | 9 | 23 | NS | 2 | 9 | 15 | 15 | NS |
| Aggressive B-cell NHL‡ | 13 | 52 | 11 | 28 | NS | 3 | 13 | 13 | 13 | NS |
| Mantle-cell lymphoma | 2 | 8 | 4 | 10 | NS | 1 | 4 | 9 | 9 | NS |
| T-cell lymphoma§ | 2 | 8 | 3 | 8 | NS | 0 | 0 | 3 | 3 | NS |
| Hodgkin's lymphoma | 1 | 4 | 2 | 5 | NS | 9 | 39 | 26 | 25 | NS |
| Disease status at HSCT | ||||||||||
| Sensitive | 22 | 88 | 28 | 72 | NS | 18 | 78 | 78 | 76 | NS |
| CR | 6 | 24 | 4 | 10 | NS | 2 | 9 | 25 | 24 | NS |
| PR | 16 | 64 | 24 | 62 | NS | 16 | 70 | 53 | 51 | NS |
| Refractory | 3 | 12 | 11 | 28 | NS | 4 | 17 | 25 | 24 | NS |
| SD | 1 | 4 | 2 | 5 | NS | 2 | 9 | 9 | 9 | NS |
| PD | 2 | 8 | 9 | 23 | NS | 2 | 9 | 16 | 16 | NS |
| Untreated relapse | 0 | 0 | 0 | 0 | 1 | 4 | 0 | 0 | NS | |
| No. of prior therapies | NS | NS | ||||||||
| Median | 3 | 3 | 4 | 4 | ||||||
| Range | 1-5 | 1-5 | 2-7 | 1-9 | ||||||
| Prior ASCT | 6 | 24 | 0 | 0 | .002 | 10 | 43 | 53 | 51 | NS |
| Months from ASCT to HSCT | NA | NS | ||||||||
| Median | 20 | NA | 21 | 20 | ||||||
| Range | 9-35 | NA | 12-67 | 2-170 | ||||||
| Donor HLA | ||||||||||
| Matched | ||||||||||
| MRD | 15 | 60 | 17 | 44 | NS | 9 | 39 | 35 | 34 | NS |
| MUD | 9 | 36 | 21 | 54 | NS | 14 | 61 | 53 | 51 | NS |
| Mismatched | 1 | 4 | 1 | 3 | NS | 0 | 0 | 15 | 15 | NS |
| MMRD | 1 | 4 | 0 | 0 | NS | 0 | 0 | 1 | 1 | NS |
| MMUD | 0 | 0 | 1 | 3 | NS | 0 | 0 | 14 | 14 | NS |
| Graft source | ||||||||||
| Bone marrow‖ | 6 | 24 | 4 | 10 | NS | 1 | 4 | 4 | 4 | NS |
| Peripheral blood | 19 | 76 | 35 | 90 | NS | 22 | 96 | 92 | 89 | NS |
| Umbilical cord blood | 0 | 0 | 7 | 7 | NS | |||||
| CMV seropositivity | ||||||||||
| Recipient | 4 | 16 | 16 | 41 | NS | 12 | 52 | 41 | 40 | NS |
| Donor¶ | 8 | 31 | 17 | 44 | NS | 21 | 34 | 38 | 37 | NS |
| Sex match: female to male | 5 | 20 | 9 | 23 | NS | 5 | 22 | 31 | 30 | NS |
| Year of HSCT | NS | < .001 | ||||||||
| Median | 2003 | 2003 | 2003 | 2004 | ||||||
| Range | 2000-2005 | 2000-2006 | 2002-2005 | 2002-2006 | ||||||
Abbreviations: GVHD, graft-versus-host disease; Tac, tacrolimus; Siro, sirolimus; Mtx, methotrexate; CnI, calcineurin inhibitor (cyclosporine or tacrolimus); NS, not significant; CLL, chronic lymphocytic leukemia; SLL, small lymphocytic lymphoma; NHL, non-Hodgkin's lymphoma; HSCT, hematopoietic stem-cell transplantation; CR, complete remission; PR, partial remission; SD, stable disease; PD, progressive disease; ASCT, autologous stem-cell transplantation; MRD, matched related donor; MUD, matched unrelated donor; MMRD, mismatched related donor; MMUD, mismatched unrelated donor; CMV, cytomegalovirus.
Percentages may not add to 100 because of rounding.
Including follicular lymphoma, marginal zone lymphoma, and lymphoplasmacytic lymphoma.
Including diffuse large B-cell lymphoma, mediastinal large-cell lymphoma, transformed low-grade lymphoma, Burkitt's lymphoma, and lymphoblastic lymphoma.
Excluding cutaneous T-cell lymphoma.
One patient received combined marrow and peripheral blood.
Data were not available for two patients.