Takeo Fujii, MD, MPH from MD Anderson Cancer Center speaks about the Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience.
Link to Study -
Immunotherapy is emerging as the cornerstone of treatment for patients with advanced cancer, but substantial toxicity (irAEs) associated with the unbridled activity of T cells remains a concern. Patients and Methods A retrospective review of the electronic medical records of 290 advanced cancer patients treated between February 2010 and September 2015 in an immunotherapy-based clinical trial at the Department of Investigative Cancer Therapeutics of the University of Texas MD Anderson Cancer Center was carried out. Clinical and laboratory parameters were obtained to assess the frequency of irAEs, risk factors, and their connection with treatment outcomes. Results Ninety-eight out of 290 patients (34%) experienced irAEs of any grade. Dermatitis and enterocolitis were the most common irAEs among the 15 (5.2 percent) patients with grade 3 irAEs. While systemic corticosteroids were required by 80% of patients with grade 3 irAEs, all 15 patients recovered from the irAEs. Four of the 5 patients who had received systemic corticosteroids for irAE continued to respond to re-challenge. No IrAE-related deaths have occurred. Importantly, compared with those without grade 3 irAEs, patients with grade 3 irAEs had an increased average response rate (25 vs. 6 percent; p = 0.039) and a longer median development period (30 weeks vs. 10 weeks; p = 0.0040). Conclusion The occurrence of irAEs with immunotherapy agents suggests an active immune status, suggesting the patient's future clinical gain. Further confirmation of this relationship is warranted in a broad prospective sample.