Background
Racial disparities among clinical trial participants present a challenge to assess whether trial results can be generalized into patients representing diverse races and ethnicities. The ...objective of this study was to evaluate the impact of race and ethnicity on treatment response in patients with advanced non‐small cell lung cancer (aNSCLC) treated with programmed cell death‐1 (PD‐1) or programmed cell death‐ligand 1 (PD‐L1) inhibitors through analysis of real‐world data (RWD).
Materials and Methods
A retrospective cohort study of 11,138 patients with lung cancer treated at hospitals within the Mount Sinai Health System was performed. Patients with confirmed aNSCLC who received anti‐PD‐1/PD‐L1 treatment were analyzed for clinical outcomes. Our cohort included 249 patients with aNSCLC who began nivolumab, pembrolizumab, or atezolizumab treatment between November 2014 and December 2018. Time‐to‐treatment discontinuation (TTD) and overall survival (OS) were the analyzed clinical endpoints.
Results
After a median follow‐up of 14.8 months, median TTD was 7.8 months (95% confidence interval, 5.4–not estimable NE) in 75 African American patients versus 4.6 (2.4–7.2) in 110 White patients (hazard ratio HR, 0.63). Median OS was not reached (18.4–NE) in African American patients versus 11.6 months (9.7–NE) in White patients (HR, 0.58). Multivariable Cox regression conducted with potential confounders confirmed longer TTD (adjusted HR, 0.65) and OS (adjusted HR, 0.60) in African American versus White patients. Similar real‐world response rate (42.6% vs. 43.5%) and disease control rate (59.6% vs. 56.5%) were observed in the African American and White patient populations. Further investigation revealed the African American patient group had lower incidence (14.7%) of putative hyperprogressive diseases (HPD) upon anti‐PD‐1/PD‐L1 treatment than the White patient group (24.5%).
Conclusion
Analysis of RWD showed longer TTD and OS in African American patients with aNSCLC treated with anti‐PD‐1/PD‐L1 inhibitors. Lower incidence of putative HPD is a possible reason for the favorable outcomes in this patient population.
Implications for Practice
There is a significant underrepresentation of minority patients in randomized clinical trials, and this study demonstrates that real‐world data can be used to investigate the impact of race and ethnicity on treatment response. In retrospective analysis of patients with advanced non‐small cell lung cancer treated with programmed cell death‐1 or programmed cell death‐ligand 1 inhibitors, African American patients had significantly longer time‐to‐treatment discontinuation and longer overall survival. Analysis of real‐world data can yield clinical insights and establish a more complete picture of medical interventions in routine clinical practice.
Racial disparities in clinical trials affect whether trial results can be generalized for diverse patient populations. This article evaluates real‐world data to assess the impact of race and ethnicity on treatment response in patients with advanced non‐small cell lung cancer treated with PD‐1 or PD‐L1 inhibitors.
More Sermon Nuggets contains ninety-five topics treated in hundreds of Fred R. Zimmerman's sermons delivered over the span of six decades to a wide-ranging number of Protestant congregations, mostly ...in Ohio.
Abstract only
e20642
Background: While optimal sequencing of systemic therapy in aNSCLC is critical to achieve maximal clinical benefit, it is practically challenging to study tx sequencing through ...clinical trials. RWD allow retrospective, observational studies to examine tx patterns and associated clinical outcomes. Methods: 1,609 aNSCLC patients who received systemic therapies at Mount Sinai hospitals were analyzed for the number of line of therapy (LOT), therapeutic modalities (chemotherapy, targeted therapy and immunotherapy), and the sequence in which treatments were given when LOT > 1. Time to tx discontinuation (TTD) was used as a surrogate clinical endpoint for outcomes. Results: 578 of the 1,609 (36%) patients received more than one LOT. 356 (22%) received tyrosine kinase inhibitors (TKIs), and 297 (16%) received immune checkpoint inhibitors (CPIs). Kaplan-Meier analysis revealed that among 297 patients who received CPIs, median TTD was longer in the 1
st
line setting (295 days, 95% CI 169 to 523; n=132) than when LOT > 1 (169 days, 95% CI 113 to 269; n=165), although the difference was not statistically significant (P=0.092, log-rank test). No difference of TTD on TKIs was observed between LOT = 1 and LOT > 1 (P=0.51). With respect to tx sequencing, when patients (n=94) received TKIs as the 1
st
LOT, 60%, 35%, and 5% of them received another TKI, chemotherapy, or a CPI-containing regimen, respectively, as the 2
nd
LOT. Among patients (n=370) who progressed on 1
st
line platinum-based chemotherapy, 52%, 32%, and 16% received another chemo regimen, a CPI-containing regimen, or a targeted therapy, respectively, as the 2
nd
LOT; these percentages shifted significantly toward more CPIs (24%, 66%, 10% for chemo, CPI, targeted, respectively) when only 2016-2018 data were examined. In the 2
nd
line setting after platinum therapy, TTD was significantly longer in the CPI group (332 days, 95% CI 169-484) compared to the chemo group (88 days, 95% CI 65-100; P<0.0001), consistent with results from pivotal clinical trials. Conclusions: As the tx algorithm of aNSCLC has been evolving rapidly, we observed diverse tx patterns in RWD. Various tx sequences may impact patient outcomes, and therefore warrant further investigation.
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