Abstract
Calcineurin inhibitor (CNI) and methotrexate are used as standard GVHD prophylaxis in HSCT. Trials using high dose post-transplant cyclophosphamide (PT-Cy) with or without immunosuppressive agents (IS) have shown success. Further studies are needed. To compare clinical outcomes of allo-HSCT using PT-Cy versus MTX as GVHD prophylaxis, we enrolled 80 patients (Pts) with acute leukaemia (53 males, 27 females) aged 18 to 60, who underwent matched and haplo allo-HSCT using reduced intensity chemotherapy at Maadi Armed Forces Hospital from 2014 to 2018. Median follow-up was 50 months after informed consent. Pts were randomized into 2 groups. The 1st group (40 patients) received MTX in the following doses: day +2 (15 mg), day +4 (10 mg), day +6 (10 mg) with cyclosporine (5 mg/kg) from day −3 till day +90 and mycophenolate (MMF) (2 −3gm/day) from day +1 till day +30. The 2nd group received PT-Cy (45 mg/kg/day) on days +3 and +4 with cyclosporine (5mg/kg) from day +5 till day +30 and MMF: (2-3 g/day) from day +5 till +30. At median 1-year post-allo, PT-Cy was associated with less incidence of chronic GVHD compared to MTX group (20%, 55%) respectively (P=0.002). Incidence of acute GVHD at day +100 was (40%, 32.5%) in group 1, 2 respectively (P=0.48). MTX group had higher incidence of renal & liver toxicity when compared to PT-Cy group (P=0.018, P=0.013) respectively. PT-Cy group had higher incidence of hemorrhagic cystitis when compared to MTX (P=0.006). In MTX group, renal toxicity caused mortality of 1 patient, hepatotoxicity caused mortality of 3 patients and HC caused mortality of 1 patient. In PT-Cy group, renal & hepatic toxicity caused no mortality while HC caused mortality of 3 patients. 87.5% of patients in group 1 and 90 % of patients in group 2 had full donor chimerism on day +30 (P=0.72). The cumulative incidence of relapse at 2 years post-allo was 17.5% for group 1 and 30% for group 2 (P >0.05). Cumulative 4 years disease free survival & overall survival (OS) in PT-Cy group was 45.7%, and 46.9%, respectively and for the MTX group, 43.4%, and 43.7%, respectively (P > 0.05). PT-Cy with addition of IS drugs has statistically significant difference in reducing the incidence of cGVHD compared with MTX based regimen without affecting engraftment, relapse, PFS & OS.
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