Scalp Cooling in Preventing Persistent Chemotherapy-Induced Alopecia: A Randomized Controlled Trial
I guess scalp cooling does have some objective evidence that it works. Still the expense and time constraints will need to be considered.
Corticosteroids for Immune-Related Adverse Events and Checkpoint Inhibitor Efficacy: Analysis of Six Clinical Trials
Author(s): Rik J. Verheijden, MSc1,2; Jolien S. de Groot, MD, PhD3; Babs O. Fabriek, PhD3; Miki N. Hew, MD, PhD3; Anne M. May, PhD2; Karijn P.M. Suijkerbuijk, MD, PhD1
Source: https://doi.org/10.1200/JCO.24.00191
Dr. Anjan Patel's Thoughts
Pooled data of nearly 2000 patients across six trials in melanoma using IO therapy. It seems clear that high dose corticosteroid use was associated with worse outcomes, especially with high peak doses. What may be worth considering is if non-steroid based immunosuppression can be used as an adjunct to blunt this concerning effect.
PURPOSE
Retrospective studies suggest that immunosuppressive treatment of immune-related adverse events (irAEs) impairs survival in patients with melanoma who received immune checkpoint inhibitors. Here, we study this association across tumor types using data from six international phase II/III registrational trials.
METHODS
A post hoc analysis was performed on individual patient data from the anti–programmed cell death-1 (anti–PD-1) + anti–cytotoxic T lymphocyte–associated protein-4 (anti–CTLA-4) treatment arms of six clinical trials (CheckMate-067, -142, -214, -648, -743, and -9LA). Among patients who received systemic immunosuppression for treatment-related adverse events (trAEs), associations of peak and cumulative corticosteroid dose, and use of second-line immunosuppression with overall survival (OS) and progression-free survival (PFS) were assessed using multilevel Cox regression with adjustment for age and sex.
RESULTS
Of the 1,959 patients who received anti–PD-1 + anti–CTLA-4 therapy, 834 patients who were treated with immunosuppression for trAEs were included. Eight hundred and thirty-two patients (100%) received corticosteroids and 81 patients (10%) received second-line immunosuppressants. High corticosteroid peak dose was associated with worse PFS: adjusted hazard ratio (HRadj), 1.15 (95% CI, 1.02 to 1.29) for 1 versus 0.5 mg/kg prednisolone and HRadj, 1.43 (95% CI, 1.05 to 1.96) for 2 versus 0.5 mg/kg. Similar effects were observed for OS: HRadj, 1.21 (95% CI, 1.06 to 1.39) and HRadj, 1.66 (95% CI, 1.17 to 2.37) for 1 and 2 versus 0.5 mg/kg, respectively. Cumulative corticosteroid dose was not associated with survival. HRadj of use of second-line immunosuppression was 1.23 (95% CI, 0.90 to 1.68) for PFS and 1.25 (95% CI, 0.88 to 1.77) for OS.
CONCLUSION
Higher corticosteroid peak dose for trAEs is associated with worse survival across tumor types, while cumulative dose is not. Too few patients received second-line immunosuppressants to confirm or reject an association with survival. These data argue for a reconsideration of irAE management approaches, starting with lower corticosteroid dose whenever feasible.
Author Affiliations
1Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; 2Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands; 3Medicines Evaluation Board, Utrecht, the NetherlandsRelated Articles
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