New evidence published in The Lancet Oncology shows that pediatric patients with hematological malignancies who receive allogeneic hemopoietic stem-cell transplantation (HSCT) from an unrelated donor have greater benefit from a 15 mg/kg vs a 30 mg/kg dose of rabbit anti-T-lymphocyte globulin (ATLG).1

ATLG is commonly used as preventative therapy for acute and chronic graft-versus-host disease (GVHD), a severe complication in patients who receive allogeneic HSCT. Prior studies demonstrated that ATLG can prevent acute and chronic GVHD, though the optimal dose was not previously determined.

This open-label phase 3 trial (ClinicalTrials.gov Identifier: NCT00934557) randomly assigned 172 pediatric patients who underwent HSCT 1:1 to receive intravenous 15 mg/kg or 30 mg/kg ATLG over 3 days.

Continue Reading

The 15 mg/kg ATLG arm had a 100-day cumulative incidence of grade 2 to 4 acute GVHD of 36% (95% CI, 28-48) vs 29% (95% CI, 20-40) in the 30 mg/kg arm (hazard ratio [HR], 0.74; 95% CI, 0.44-1.25; P = .26).

Non-relapse mortality in the 15 mg/kg group was 9% (95% CI, 5-18) vs 19% (95% CI, 12-30) in the 30 mg/kg group (HR, 2.08, 95% CI, 0.89-4.96; P = .092).

Five-year overall survival probability in the 15 mg/kg group was 78% (95% CI, 69-87) vs 62% (95% CI, 50-73) in the 30 mg/kg group (HR, 1.80; 95% CI, 1.01-3.20; P = .045).

Five-year event-free survival in the 15 mg/kg group was 77% vs 61% in the 30 mg/kg group (HR 1.87; 95% CI, 1.07-3.28; P = .028).

The study demonstrates that 15 mg/kg ATLG not only significantly improved survival probability, but also did not affect time to engraftment or increase the rate of acute and chronic GVHD vs 30 mg/kg.

RELATED: Third-line TKI Increases Non-relapse Mortality After Allo-HSCT in CML

The authors concluded that ATLG 15 mg/kg should be considered “the standard serotherapy regimen for unrelated donor allogeneic HSCT in this patient population.” 

Reference

  1. Locatelli F, Bernardo ME, Bertaina A, et al. Efficacy of two different doses of rabbit anti-T-lymphocyte globulin to prevent graft-versus-host disease in children with haemotological malignancies transplanted from an unrelated donor: a multicenre, randomized, open-label, phase 3 trial. Lancet Oncol. 2017 Jul 10. doi: 10.1016/S1470-2045(17)30417-5 [Epub ahead of print]

Topics:

Hematologic Cancers Pediatric Cancer