Real-World Outcomes Reveal Lower Survival for Vets Who Are Prescribed ICIs

The use of immune checkpoint inhibitors (ICIs) across tumor types in the Veterans Affairs (VA) health care system revealed lower real-world survival outcomes than those reported in pivotal clinical trials (PCTs), according to a study evaluating the electronic health records of 11,888 patients.¹ The study evaluated ICI outcomes across multiple tumor types in a real-world population in the VA versus historical controls reported in PCTs.

This diverse cohort included older patients, with a mean age at treatment initiation of 69 years and those with comorbidities who would likely be excluded from many ICI trials. In addition, a substantial numbers of African Americans and patients living in rural areas were included, 2 populations that are often underrepresented in PCTs. The majority of patients were treated for non–small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, head and neck squamous cell carcinoma, urothelial cancer, and hepatocellular carcinoma.

The investigators compared factors in the VA population that could affect overall survival (OS) versus sample populations examined in PCTs, which are more carefully controlled with inclusion and exclusion criteria.

Patients who were treated with frontline nivolumab (Opdivo) for melanoma had the longest OS of the study participants (25.5 months). Conversely, patients with urothelial cancer who were treated with second-line ICIs had the worst outcomes (6.7 months). Overall, patients in the VA who received ICIs appeared to have worse survival than those in corresponding PCTs, except for patients treated with frontline nivolumab for melanoma and second-line pembrolizumab (Keytruda) or nivolumab for NSCLC.

When OS results were stratified by frailty status, as defined by the VA frailty index, nonfrail patients had outcomes more closely correlating to those observed in PCTs, and the investigators noted better performance status and a lower degree of comorbidities for these patients. They recommended further research to determine how a factor such as frailty could be used to explain variation in prior non-VA studies of ICI real-world use.

This comprehensive approach to ICI therapy establishes a platform for additional analysis of ICI outcomes and optimization of usage in realworld practice, the investigators concluded.

_Reference

_{La J, Cheng D, Brophy MT, et al. Real-world outcomes for patients treated with immune checkpoint inhibitors in the Veterans Affairs system. JCO Clin Cancer Inform. 2020;4:918-928. doi:10.1200/CCI.20.00084}