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In patients who need a stem cell transplant but do not have a human leukocyte antigen (HLA) matched related or unrelated donor, a haploidentical donor transplantation can be considered. Complications such as graft-versus-host disease (GvHD) due to haploidentical hematopoietic stem cell transplant (haplo-HSCT), have recently been overcome with the successful use of posttransplant cyclophosphamide (PTCy), making it increasingly popular. However, hitherto studies of haplo-HSCT using PTCy have been retrospective with multiple different regimes and cell sources, limiting the interpretation of data.
During the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, John Moore, St Vincent’s Hospital Sydney, AU, presented the preliminary results of a prospective multicenter cohort study (ANZHIT-1; ACTRN12617000151336) that assessed the use of PTCy in patients who had received a predefined conditioning regimen and were undergoing haplo-HSCT 1.
Figure 1. RIC and MAC regimens1
CNI, calcineurin inhibitor; d, day; GvHD, graft-versus-host disease; MAC, myeloablative conditioning; MMF, mycophenolate mofetil; PTCy, posttransplant cyclophosphamide; RIC, reduced intensity conditioning; TBI, total body irradiation; TDS, thrice daily.
Table 1. Patient baseline characteristics1
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; DRI, disease risk index; HCT-CI, hematopoietic cell transplantation comorbidity index; HL, Hodgkin lymphoma; MAC, myeloablative conditioning; MDS, myelodysplastic syndromes; NHL, non-Hodgkin lymphoma; RIC, reduced intensity conditioning. |
||
Characteristic |
MAC (n = 32) |
RIC (n = 46) |
---|---|---|
Age, Median, years (range) |
38 (18–56) |
59 (20–69) |
Age, > 50 MAC, < 50 RIC, n |
6 (all were HCT 1–2) |
6 (4 HL) |
HCT-CI, n (range) |
1 (0–1) |
1 (0–5) |
High DRI, n |
3 |
7 |
Intermediate DRI, n |
18 |
23 |
Disease |
||
AML, n (%) |
14 (43.7) |
25 (54.3) |
ALL, n (%) |
9 (28.1) |
3 (6.5) |
MDS, n (%) |
2 (6.25) |
2 (4.3) |
NHL, n (%) |
3 (9.3) |
7 (15.2) |
HL, n (%) |
0 (0) |
4 (8.7) |
Other, n (%) |
5 (15.6) |
5 (10.9) |
Table 2. Primary and secondary outcomes1
DFS, disease-free survival; OS, overall survival; GvDH, graft-versus-host disease; MAC, myeloablative conditioning; RIC, reduced intensity conditioning; TRM, transplant-related mortality. |
||
Outcome |
MAC (n = 32) |
RIC (n = 46) |
---|---|---|
Follow-up, median (range) |
369 (28–397) |
440 (39–1,259) |
Primary OS at 1 year, % (95% CI) |
74.1 (52.9–86.8) |
77.8 (61.6–87.8) |
Secondary |
||
Neutrophil engraftment, median (range) |
19 (13–92) |
18 (16–40) |
Platelet engraftment, median (range) |
30 (13–92) |
38 (24–98) |
Relapse rate, % |
6.3 |
17.4 |
TRM Day 100, % |
6.3 |
2.2 |
TRM 1 year, % |
18.8 |
8.7 |
Acute II–IV GvHD, % |
21.9 |
43.5 |
Acute III–IV GvHD, % |
3.1 |
21.7 |
Chronic GvHD 1 year, % |
31.2 |
43.5 |
Severe chronic GvHD (NIH), % |
6.3 |
6.5 |
The study shows encouraging overall survival rates in patients at 1 year irrespective of conditioning regimen. However, early relapse in RIC patients is a concern, while TRM and toxicity profile were significantly higher in patients who received MAC. GvHD rates in both groups are high but majority are mild to moderate acute or chronic GvHD. While relapse seemed to be very well controlled in the MAC arm, a longer follow-up is required to assess relapse rates in both groups. The authors perceived a need for further refinement of the conditioning and GvHD prophylaxis regimen, which they have incorporated in their follow-up phase II multicenter (Australia and New Zealand) ANZHIT-2 study.
References
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