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Table 3 Comparison of atorvastatin for the prophylaxis of aGVHD based on two representative studies

From: Management of dyslipidemia after allogeneic hematopoietic stem cell transplantation

 

Study 1 (Ref. 53)

Study 2 (Ref. 24)

First author

Yvonne A.Efebera

Mehdi Hamadani

Journal

Biology of Blood and Marrow Transplantation

Journal of Clinical Oncology

Study time

Mar 2012-Jan 2014

Sep 2010-Oct 2012

Publication year

2016

2013

Number of participants

50 patient-donor pairs

30 patient-donor pairs

Median age

Recipient

51

54.5

Donor

50

52.5

Control group

Historical control subjects (n = 96)

Historial data from the same institution

Conditioning regimen

Myeloablative conditioning

Fludarabine/busulfan (15%)

TBI/etoposide (10%)

TBI/cyclophosphamide (5%)

Busulfan/cyclophosphamide (6.6%)

Fludarabine/busulfan (36.6%)

Reduced-intensity conditioning

Fludarabine/busulfan (65%)

Fludarabine/melphalan (5%)

Fludarabine/busulfan (56.6%)

Diagnosis

AML (30%)

NHL + HL (36.6%)

MDS (10%)

PMF (6.6%)

Others (16.6%)

AML (33%)

NHL + HL (15%)

ALL (15%)

CML(8%)

MDS/CMML (18%)

Others (13%)

GVHD prophylaxis

Methotrexate and tacrolimus

Methotrexate and tacrolimus

Median CD34 + cell infused (× 106 /kg)

5.90

4.25

Median CD3 + cells infused (× 108 /kg)

2.65

3.30

Dose of atorvastatin

40 mg/day

40 mg/day

Timing of atorvastatin application (before stem cell collection)

14 days

Range from 14 to 28 days

Infection

CMV, EBV, BKV, fungal and bacterial infections did not differ significantly from the controls

Three patients (10%) developed CMV reactivation and BK-viral hemorrhagic cystitis

Immune reconstitution

NK and Treg cells were fewer than the control

No statistical significance

Cytokines

Elevation of RANTES

Elevation of IL-10

Grades 2–4 GVHD at + 100 and + 180 days (%)

30% and 40%, respectively

3.3% and 11.1%, respectively

Gades 2–4 GVHD in control group at + 100 days (%)

28%

Ranged from 30 to 35%

1 year NRM (%)

5.5%

9.8%

1 year PFS (%)

54%

65%

1 year OS (%)

82%

74%

Conclusion

Negative result

Positive result

  1. Abbreviations: AML Acute myelogenous leukemia, ALL Acute lymphocytic leukemia, CML Chronic myelogenous leukemia, HL Hodgkin lymphoma, NHL Non-Hodgkin lymphoma, MDS Myelodysplastic syndrome, CMV Cytomegalovirus, EBV Epstein-Barr virus, BKV BK virus, PMS Primary myelofibrosis, NRM Non relapse mortality, PFS Progression-free survival, OS Overall survival