9592 Background: We describe contemporary clinical patterns of guideline-mandated genomic testing in newly diagnosed US pts with aNSCLC. Methods: From the Flatiron Health electronic health record-derived de-identified database, we included pts with newly diagnosed advanced non-squamous cell carcinoma of the lung between 1.1.2018–6.30.2019 who had received first-line (1L) therapy. We defined inadequate testing as no successful test for at least one of four examined genes: ALK, BRAF, EGFR, and ROS1. We grouped pts according to testing received into users of next-generation sequencing (NGS) testing, including a subgroup using comprehensive genomic profiling (CGP, exemplified by Foundation Medicine, Inc.), users of non-NGS testing, and no testing. We describe the following aspects of genomic testing before the start of 1L therapy: occurrence of testing, patterns of use of testing technologies, occurrence of inadequate testing, test failures, percentage of pts with potentially missed targeted therapy with US Food and Drug Administration approval (no positive test and <4 successful tests), and recent trends in genomic testing. Results: Among 2971 included pts, 690 (23.2%) had no genomic testing before 1L treatment. Among pts who had a test (n=2281), 59.4% (n=1355) received NGS (CGP: 18.8%, n=429), while 40.6% (n=926) received non-NGS tests only. In the CGP user group, 79.7% of pts received no other type of test, compared with 29.8% of pts in the other NGS group. Inadequate testing was recorded in 13.4% of NGS-tested pts (CGP: 4.9%), compared with 52.5% of pts tested by non-NGS only. Test failures contributed to unsuccessful testing in 4.2% of pts tested by NGS (CGP: 1.2%) and in 6.8% of pts who received non-NGS tests. In the NGS group, 10.1% (CGP: 3.0%) of patients potentially missed a targeted therapy option, compared with 40.3% in the non-NGS group. EGFR and ALK testing were performed in ≥95% of pts, regardless of the testing group; however, only 83.6% and 55.7% of pts received tests for ROS1 and BRAF, respectively, in the non-NGS group. In the latter group, for the first 6 months of 2019, 88.4% and 58.2% of pts were tested for ROS1 and BRAF mutations, respectively. Conclusions: Not performing any, or performing only inadequate genomic testing in pts with newly diagnosed aNSCLC remains a concern in clinical practice. The use of NGS, particularly CGP, may help to avoid suboptimal testing, minimize test failures, and improve uptake of testing for newly introduced biomarkers, enabling individualized, targeted therapy.
Introduction Olfactory dysfunction has been included among the early symptoms of coronavirus disease (COVID-19). Evidence suggests that a relationship exists between the duration of olfaction disorders and the probability of developing severe COVID-19. Given the scope of the COVID-19 pandemic, this study aimed to determine the frequency of smell alteration and its association with the severity of COVID-19 in a referral hospital in Peru, which is one of the most affected countries in the Latin American region. Materials and Methods This study was an observational, prospective cohort study that included patients with COVID-19 who were treated at the Hospital Nacional Edgardo Rebagliati Martins from August to November 2020. To assess the association, the chi-square test of independence or Fisher’s exact test was performed. The outcome variable was COVID-19 severity, and the exposure variable was olfactory dysfunction. The first data collection was in the emergency department and the follow-up was via telephone. Results A total of 179 patients were included. The mean age was 61.6 ± 15.5 years, and 129 patients (72.1%) were male. Olfactory dysfunction was observed in 43 patients (24%). An inverse association was found between age and olfactory dysfunction ( P = .002). No significant association was found between COVID-19 severity level and olfactory alteration ( P = .056). However, a direct association was found between COVID-19 severity and age ( P = .003), cough ( P < .001), and respiratory distress ( P = .003). Conclusion This study did not find any association between the severity of COVID-19 and olfactory dysfunction. It showed a low incidence rate of smell alteration compared with studies from other regions. Moreover, smell alteration was associated with younger age.
548 Background: Real-world data (RWD) linking clinical outcomes with comprehensive genomic profiling (CGP) may enable identification of biomarkers to guide treatment selection and stratification in future trials. The primary objective was to characterize patients with metastatic urothelial carcinoma (mUC) included in a clinic-genomic database (CGDB), comprised of the electronic health record-derived Flatiron Health database with linked FoundationOne CGP results. As secondary objective, a novel Bladder Immune Prognostic Index (BIPI) was developed. Methods: A retrospective exploratory analysis was performed of de-identified RWD, retrieved from the CGDB. Data from mUC patients starting first-line single-agent immune checkpoint inhibitors (ICIs) and an unmatched group treated with front-line platinum-based chemotherapy (CHT) between Jan 1, 2011, and Sept 30, 2019, were analyzed and correlated with overall survival (OS). Known driver alterations, tumor mutational burden (TMB), and PD-L1 expression were described. A BIPI predicting outcome with ICIs was developed using a Cox-LASSO model and validated externally in a phase II trial (NCT02951767). Results: Of the 1021 patients with mUC identified in CGDB, 118 ICI-treated and 268 CHT-treated patients were included. Median follow-up duration was 9.4 and 14.5 months, respectively. Median OS was 5.4 months (95%CI, 3.3–9.2) with ICIs and 8.2 months (95%CI, 6.8–10.0) with CHT. In ICI-treated patients, low albumin and metastatic disease at initial presentation were associated with worse OS [HR (95%CI) 2.15 (1.18–3.90), p =.012; 2.58 (1.30–5.10), p =.007, respectively] whereas surgery for organ-confined disease and high TMB (≥10 mut/Mb) were associated with improved OS (HR (95%CI) 0.56 (0.36–0.88), p =.012; 0.58 [0.35–0.95]; p=.03), respectively. In CHT-treated patients, those with high APOBEC had worse OS (HR 1.43 [95% CI, 1.06–1.94]; p=.02). Neither PD-L1 (HR 0.96 [0.37-2.46]; p =.93), FGFR3 mutations (HR 0.98 [0.65-1.47]; p =.92) nor DNA damage-repair pathway alterations (HR 1.06 [0.73-1.52]; p =.77) were associated with OS. A novel BIPI for ICI-treated patients combining clinical and genomic variables (non-metastatic at initial diagnosis, normal albumin level, previous surgery for organ-confined disease, high TMB) was developed. Patients were categorized in 3 groups (low, intermediate, high risk) which correlated with OS. Median OS (95%CI) for low, intermediate and high risk was 11.7 (8.9−17.7), 4.1 (2.5–NE) and 2.4 months (1.0–4.0), (p <.001). Same results were observed in the validation cohort from an independent phase II immunotherapy trial in mUC (p <.001). Conclusions: This is the first time RWD including CGP were used to develop and validate a novel BIPI in mUC. This prognostic index may help patient selection in everyday practice and inform future trial design.
Supplementary Figure from Clinico-Genomic Characterization of Patients with Metastatic Urothelial Carcinoma in Real-World Practice Identifies a Novel Bladder Immune Performance Index (BIPI)
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