Table 4.
Studies of allogeneic stem cell transplantation with melphalan containing preparative regimens in patients with acute myeloid leukemia/myelodysplastic syndrome (published 2000–2011)
| Author Publication year/type |
Diagnosis and disease status |
Median age (range) |
MRD/MUD/mismatch | Preparative regimen* | GVHD prophylaxis |
Primary graft failure (n) |
GVHD incidence (acute, chronic)† |
NRM ‡ | RI ‡ | PFS/OS‡ |
|---|---|---|---|---|---|---|---|---|---|---|
| de Lima, 2004/R (155) |
42 AML (10 in CR) 20 MDS |
54 (22–75) | 25/29/8 | FLU 100–150 mg/m2 + MEL 140–180 mg/m2 |
TCR/CSA + MTX |
2 | 39%, 39% | 100d: 26% 3yr: 39% |
NA | 3yr: 32% / NA |
| Malladi, 2004/R(156) |
12 AML (11 in CR) 4 MDS |
47 (27–66) | 16/0/0 | FLU 150 mg/m2 + MEL 140 mg/m2 |
CSA + MTX | 1 | 47% (II–III), 46% |
4yr: 13% | LFU: 1 pt |
4yr: 79% / 79% |
| van Besien, 2005/P(107) |
41 AML (13 in CR) MDS (11) |
52 (17–71) | 23/22/7 | FLU 150 mg/m2 + MEL 140 mg/m2 + ALE 100 mg/m2 |
TCR | 2 | 33%, 18% | 100d: 17% 2yr: 33% |
2yr: 40% |
2yr: 31% / 39% |
| Tauro, 2005/R(157) |
56 AML (42 in CR) MDS (20) |
52 (18–71) | 35/41/0 | FLU 150 mg/m2 + MEL 140 mg/m2 + ALE 50–100 mg/m2 |
CSA | 4 | None (III–IV), 8 pts |
100d: 9% 1yr: 19% |
LFU: 27 pts |
3yr: 37% / 41% |
| Nakamura, 2007/R(158) |
15 AML (8 in CR) MDS (28) |
(30–71) | 19/20/4 | FLU 125 mg/m2 + MEL 140 mg/m2 |
CSA + MMF (±MTX for MUDs) |
None | 63%, 23 pts | 100d: 27% 2yr: 35% |
2yr: 16% |
2yr: 51% / 54% |
| Oran, 2007/R(106) |
82 AML (30 in CR) MDS (30) |
55 (22–74) | 53/59/0 | FLU 100–150 mg/m2 + MEL 140–180 mg/m2 ± GO 2–4 mg/m2 (16) ± ATG (31 with MUD) |
TCR + MTX | 4 | 39%, 49% | LFU: 54% | 2yr: 25% |
2yr: NA / 44% |
| Small, 2007/P(159) § |
20 AML (1 in CR) (Total 43) |
46 (1–62) | 18/25/0 | BU (serum level of 600–900 ng/mL) + MEL135 mg/m2 ± ATG 30 mg/kg (MUDs) |
TCR + MTX | 2 | 24%, 11 pts | LFU: 28% | LFU: 10 pts (AML pts) |
3yr: 13% / NA (AML pts) |
| de Lima, 2008/P(160) |
48 AML (3 in CR) MDS (4) |
53 (13–72) | 31/19/2 | FLU 120 mg/m2 + MEL 140 mg/m2 ± GO 2–6 mg/m2 + ATG (MUDs) |
TCR + MTX | None | 42%, 52% | 100d: 13% 1yr: 29% |
NA | 2yr: NA / 38% |
| Marks, 2008/P(161) § |
58 AML (11 in CR) MDS (23) (Total 133) |
56 (24–74) | 68/59/6 | FLU 150 mg/m2 + BCNU 300–400 mg/m2 + MEL 110- 140 mg/m2 ± ATG (MUDs) |
CSA + MTX or MMF |
1 | 23%, 33% (ext) | 100d: 16% 5yr: 34% |
NA | 3yr: 40% / 47% (AML/MDS pts) |
| Kirschbaum, 2011/P(162) |
16 AML (9 in CR) | 63 (31–66) | 8/8/0 | CLO 150–200 mg/m2 + MEL 100–140 mg/m2 |
CSA + MMF or TCR + SRL |
None | 4 pts, 5 pts | 100d: 2pts | LFU: 2 pts |
LFU: 11 pts /12 pts |
Legend:
Cumulative doses shown;
Cumulative incidences of grade II–IV acute GVHD followed by limited & extensive chronic GVHD shown unless indicated. If incidence is not available, number of patients were shown;
Time points shown (d: day, yr: year) prior to incidence. If incidence not available, number of patients was shown;
Study including patients with diagnoses other than AML and MDS.
Information given is applicable to the whole cohort unless indicated; R indicates retrospective; P, prospective; AML, acute myeloid leukemia; MDS, myelodysplastic syndrome; CR, complete remission; MRD, matched related donor; MUD, matched unrelated donor; FLU, fludarabine; MEL, melphalan; ALE, alemtuzumab; GO, gemtuzumab ozogamicin; ATG, anti-thymocyte globulin; BU, busulfan; BCNU, carmustine; TCR, tacrolimus; CSA, cyclosporine A; MTX, methotrexate; MMF, mycophenolate mofetil; SRL, sirolimus; GVHD, graft-versus-host disease; NRM, non-relapse mortality; RI, relapse incidence; PFS, progression-free survival; OS, overall survival; LFU, last follow-up; ext, extensive chronic GVHD; pts, patients; NA, not available