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Association Between Immune-Related Adverse Events and Clinical Outcomes to Programmed Cell Death Protein 1/Programmed
Biagio Ricciuti1, Abdul Rafeh Naqash2, Jarushka Naidoo3
1Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
Introduction:
The development of immune-related adverse events (irAEs) has been associated with improved efficacy of immune checkpoint inhibitors in patients with urothelial cancer, melanoma, and NSCLC. Whether this association exists in patients with SCLC is currently unknown.
Methods:
We conducted a multicenter retrospective study to evaluate the relationship between irAEs and immunotherapy efficacy in SCLC. To account for the lead-time bias resulting from the time-dependent nature of irAEs, the development of irAEs was considered as a time-varying covariate in univariate and multivariate Cox proportional hazard models.
Results:
Of the 183 patients treated with immunotherapy, 73 (39.9%) experienced at least one irAE. A total of 42 patients (22.9%) had grade 1 to 2 irAEs, whereas 31 patients (16.9%) had grade 3 to 4 irAEs. The median time of onset to the first irAE was 24 days (interquartile range: 14-55). The baseline clinicopathologic features were well-balanced between patients with and without irAEs. At a median follow-up of 24 months (95% confidence interval [CI]: 17.0-31.6), the median progression-free survival was significantly longer in the irAE group than the non-irAE group (3.8 versus 1.3 mo, p < 0.0001). The median overall survival was also significantly longer among patients with irAEs than patients without irAEs (13.8 versus 2.9 mo, p < 0.0001). When analyzed as a time-varying covariate, the development of irAEs was associated with a significant improvement in progression-free survival (hazard ratio: 0.44 [95% CI: 0.29-0.66], p < 0.001) and overall survival (hazard ratio: 0.47 [95% CI: 0.32-0.71], p < 0.001) in multivariate models.
Conclusions:
The development of irAEs is associated with improved clinical outcomes for immunotherapy in patients with advanced SCLC.
Insights
Immune-related adverse events (irAEs) are linked to better outcomes in small cell lung cancer (SCLC) patients receiving immunotherapy. Experiencing irAEs significantly improved progression-free and overall survival in this cohort.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Research
Background:
- Immune-related adverse events (irAEs) correlate with improved immune checkpoint inhibitor efficacy in urothelial cancer, melanoma, and NSCLC.
- The association between irAEs and immunotherapy efficacy in small cell lung cancer (SCLC) remains unestablished.
Purpose of the Study:
- To investigate the relationship between irAEs and immunotherapy efficacy in patients with SCLC.
- To determine if irAEs predict clinical outcomes in SCLC patients treated with immunotherapy.
Main Methods:
- A multicenter retrospective study was conducted.
- Immune-related adverse events (irAEs) were analyzed as a time-varying covariate using Cox proportional hazard models.
- Lead-time bias was addressed by incorporating irAE development as a time-dependent factor.
Main Results:
- Of 183 SCLC patients treated with immunotherapy, 39.9% experienced irAEs.
- Patients with irAEs demonstrated significantly longer median progression-free survival (3.8 vs. 1.3 months) and overall survival (13.8 vs. 2.9 months) compared to those without irAEs.
- Multivariate analysis confirmed that irAE development was associated with improved progression-free survival (HR: 0.44) and overall survival (HR: 0.47).
Conclusions:
- The occurrence of irAEs is associated with enhanced clinical outcomes in patients with advanced SCLC undergoing immunotherapy.
- irAEs may serve as a predictive biomarker for immunotherapy response in SCLC.
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