Decreasing the steroid rapidly may help to improve the clinical outcomes of patients with intestinal steroid-refractory acute graft-versus-host disease receiving basiliximab treatment

Abstract

Intestinal steroid refractory acute graft-versus-host disease (SR-aGVHD) is the major cause of mortality in allogeneic hematopoietic stem cell transplantation (allo-HSCT). This retrospective cohort study aimed to identify the relationship between different steroid decreasing velocity and therapeutic response in patients with intestinal SR-aGVHD receiving basiliximab treatment, and also aimed to propose a reasonable steroid decreasing regimen for these patients. The median time for steroid dose decreasing to the 50% of initial dose and decreasing to the low-dose steroid for patients achieving ORR was 5 days and 12 days, respectively, which was both shorter than patients without achieving ORR. The ORR, NRM and survival in rapid and medium steroid decreasing group were all better than slow group. The cumulative incidence of ORR at any time was 90.4%, 78.1% and 62.3%, respectively, in rapid, medium, and slow group. The cumulative incidence of NRM at 1 year after basiliximab treatment was 18.7% (95% CI 11.3%-26.1%), 22.8% (95% CI 14.2%-31.4%) and 32.8% (95% CI 24.1%-41.5%), respectively, in rapid, medium, and slow group. The probability of OS at 1 year after basiliximab treatment was 76.9% (95% CI 68.9%-84.9%), 72.7% (95% CI 63.7%-81.7%), and 62.3% (95% CI 53.5%-71.1%), respectively, in rapid, medium, and slow group. Hence, it was helpful to decrease steroid to the 50% of initial dose ≤ 5 days and to the low-dose steroid ≤ 12 days after basiliximab treatment for intestinal SR-aGVHD patients, which may also be the reasonable steroid decrease protocol for these patients.

Keywords: acute graft-versus-host disease; basiliximab; hematopoietic stem cell transplantation; steroid decrease protocol; steroid refractory.

Figure 1

ROC analysis of steroid decrease time for ORR at day 28 and any time. The optimal cut-off point for steroid dose halving time (A) was 5 days according to the ORR at day 28 (AUC = 0.677, 95% CI 0.613-0.742, P < 0.001) and steroid dose reduction to low-dose steroid time (B) was 12 days according to the ORR at any time (AUC = 0.582, 95% CI 0.506-0.658, P = 0.033).

Figure 2

Overall response rate of steroid-refractory acute graft-versus-host disease (SR-aGVHD) patients after basiliximab treatment between steroid decreasing velocity subgroups. (A) At day 28, according to the optimal cut-off point for steroid dose halving time; (B) at any time, according to the optimal cut-off point for steroid dose halving time; (C) At day 28, according to the optimal cut-off point for steroid dose reduction to the low-dose steroid time; (D) at any time, according to the optimal cut-off point for steroid dose reduction to the low-dose steroid time; (E) At day 28, and (F) at any time, integrating between steroid decreasing velocity subgroups; The steroid decreasing velocity curve within 28 days in rapid, medium, and slow group (G).

Figure 3

The survival curve after basiliximab treatment. The OS (A) and DFS (B) in total population; The OS (C) and DFS (D) between steroid decreasing velocity subgroups.