PURPOSE While there are studies under way to characterize the direct effects of the COVID-19 pandemic on the care of patients with cancer, there have been few quantitative reports of the impact that efforts to control the pandemic have had on the normal course of cancer diagnosis and treatment encounters. METHODS We used the TriNetX platform to analyze 20 health care institutions that have relevant, up-to-date encounter data. Using this COVID and Cancer Research Network (CCRN), we compared cancer cohorts identified by querying encounter data pre-COVID (January 2019-April 2019) and current (January 2020-April 2020). Cohorts were generated for all patients with neoplasms (malignant, benign, in situ, and of unspecified behavior), with new incidence neoplasms (first encounter), with exclusively malignant neoplasms, and with new incidence malignant neoplasms. Data from a UK institution were similarly analyzed. Additional analyses were performed on patients with selected cancers, as well as on those having had cancer screening. RESULTS Clear trends were identified that suggest a significant decline in all current cohorts explored, with April 2020 displaying the largest decrease in the number of patients with cancer having encounters. Of the cancer types analyzed, lung, colorectal, and hematologic cancer cohorts exhibited smaller decreases in size in April 2020 versus 2019 (−39.1%, −39.9%, −39.1%, respectively) compared with cohort size decreases for breast cancer, prostate cancer, and melanoma (−47.7%, −49.1%, −51.8%, respectively). In addition, cancer screenings declined drastically, with breast cancer screenings dropping by −89.2% and colorectal cancer screenings by −84.5%. CONCLUSION Trends seen in the CCRN clearly suggest a significant decrease in all cancer-related patient encounters as a result of the pandemic. The steep decreases in cancer screening and patients with a new incidence of cancer suggest the possibility of a future increase in patients with later-stage cancer being seen initially as well as an increased demand for cancer screening procedures as delayed tests are rescheduled.

TPS5090 Background: Responses to checkpoint inhibitor (CPI) monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) have been limited. This is in part attributed to low tumour mutational burden (TMB) and low tumour infiltrating lymphocytes (TILs). Previously ~20% patients with prostate cancer have demonstrated high TILs or TMB1. We hypothesize that patients with higher TMB due to mismatch repair deficiency (dMMR) or defective DNA damage response (dDDR) and patients with high TILs are more likely to respond to combination CPI with anti PD-1 and anti CTLA-4 therapy. Methods: NEPTUNES is a single arm phase II trial designed to assess the efficacy of nivolumab and ipilimumab in biomarker selected patients with mCRPC that have progressed following ≥1 line of therapy. The immunogenic signature (ImS) biomarker is defined by ≥1 of the following: 1) dMMR by immunohistochemistry (IHC); 2) dDDR detected by the UW-OncoPlex sequencing assay and; 3) high TILs on multiplexed IHC. The UW-OncoPlex assay detects mutations in >260 genes and provides an estimation of TMB. Assuming an ImS+ rate of 20%, we aim to pre-screen 175 patients in order to enrol 35 patients into the main study. The primary endpoint is composite response rate (CRR), achieved if ≥1 of the following criteria are satisfied: 1) radiological response by RECIST 1.1; 2) PSA response ≥50%; 3) conversion of circulating tumour cells (CTC) count from ≥5 cells at baseline to <5 cells at week 9. The treatment will be deemed ineffective if the CRR is <20%. Nivolumab (1 mg/kg) and ipilimumab (3 mg/kg) is dosed every three weeks for up to 4 times, followed by a 480mg flat dose of nivolumab every 4 weeks for up to one year. Baseline biopsies are mandated and paired biopsy at week 12 is encouraged. The secondary endpoints include safety, overall survival, and radiological and PSA progression free survival. Exploratory biological markers including TMB, mutational profiles, change in TILs and liquid biomarkers will be correlated with the primary clinical endpoint. Since opening in February 2018, 126 patients have been pre-screened with 25 ImS+. To date, 9/25 ImS+ patients have been enrolled into the main study. The trial is ongoing, with patient accrual expected to complete by late 2019. References: 1Linch, M., Goh, G., Hiley, C., Shanmugabavan, Y., McGranahan, N., Rowan, A., . . . Swanton, C. (2017). Intratumoural evolutionary landscape of high-risk prostate cancer: the PROGENY study of genomic and immune parameters. Ann Oncol, 28(10), 2472-2480. doi:10.1093/annonc/mdx355. Clinical trial information: NCT03061539.

The outbreak of COVID-19 has upended the health care industry and the world as a whole, with the full effects unlikely to be realized for years to come. Unfortunately, cancer patients are likely to be disproportionately impacted by the pandemic, and there are a number of key efforts under way to explore this, including the COVID-19 and Cancer Consortium (CCC19) and the ASCO Survey on COVID-19 in Oncology registries. However, there have been few studies to quantify the immediate impact COVID-19 has had on deviation from normal cancer care, as well as declines in screening efforts. Less screening may lead to delayed diagnoses and poorer future outcomes. We were able to leverage an existing health research network platform (TriNetX) to create a cohort of 20 different institutions across the US representing over 29 million patients. We initially focused on all patients with ICD-10 diagnostic codes for neoplasms (C00-D49). Key findings include a marked decrease in the number of patients having neoplasm-related encounters for March and April of 2020 when compared to the same months in 2019, with January and February remaining largely unchanged. Specifically, comparing April 2020 to April 2019, we observed roughly a -56.9% drop in the number of patients with a neoplasm-related encounter and a -74.0% drop in the number of patients seen for the first time (e.g., screening, initial diagnosis, second opinion, treatment initiation). Similar trends were observed when querying for patients with encounters related exclusively to malignant neoplasms (ICD-10 C00-C96). Site-specific malignancies were also analyzed, with melanoma, breast cancer, and prostate cancer displaying the largest decline in patients seen, and lung cancer, colorectal cancer, and hematologic cancers the smallest drop. Finally, changes in screening were investigated, with breast cancer screening falling by -89.2% and colorectal cancer screening by -84.5% in April of 2020 compared to 2019. Ultimately, these analyses validate the vital need to study and monitor the effect of COVID-19 on cancer patients moving forward, and provide the largest study to quantify the changes in cancer encounters due to the pandemic to date. Citation Format: Jack W. London, Elnara Fazio-Eynullayeva, Matvey Palchuk, Corinna Mossop, Peter Sankey, Christopher McNair. The Effects of the COVID-19 pandemic on cancer patient encounters [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-040.

This is a case report of a 67-year-old patient with castration resistant metastatic prostate cancer who developed an immune-mediated large vessel vasculitis following treatment with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1).