The 10-month mortality rate among older patients treated for digestive system cancer during the first wave of the COVID-19 pandemic: The CADIGCOVAGE multicentre cohort study.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has had a dramatic impact on cancer diagnosis and care pathways. Here, we assessed the mid-term impact of the COVID-19 pandemic on older adults with cancer before, during and after the lockdown period in 2020. MATERIALS AND METHODS: We performed a retrospective, observational, multicentre cohort study of prospectively collected electronic health records. All adults aged 65 or over and having been newly treated for a digestive system cancer in our institution between January 2018 until August 2020 were enrolled. RESULTS: Data on 7,881 patients were analyzed. Although the overall 10-month mortality rate was similar in 2020 vs. 2018-2019, the mortality rate among for patients newly treated in the 2020 post-lockdown period was (after four months of follow-up) significantly higher. A subgroup analysis revealed higher mortality rates for (i) patients diagnosed in the emergency department during the pre-lockdown period, (ii) patients with small intestine cancer newly treated during the post-lockdown period, and (iii) patients having undergone surgery with curative intent during the post-lockdown period. However, when considering individuals newly treated during the lockdown period, we observed lower mortality rates for (i) patients aged 80 and over, (ii) patients with a biliary or pancreatic cancer, and (iii) patients diagnosed in the emergency department. DISCUSSION: There was no overall increase in mortality among patients newly treated in 2020 vs. 2018-2019. Longer follow-up is needed to assess the consequences of the pandemic. A subgroup analysis revealed significant intergroup differences in mortality.

Capecitabine for advanced biliary tract cancers during COVID-19 pandemic

Background: Despite chemotherapy, metastatic gall bladder cancers (mGBC) have the worst prognosis. Many patients are unfit for the standard of care Cisplatin-based injectable chemotherapy. The study evaluates single-agent Capecitabine as an effective therapy option for frontline advanced GBC patients in a COVID pandemic affected hospital access. Methods: This is a retrospective analysis of mGBC patients treated at the PGIMER Medical Oncology Clinic between December 2019 and August 2021. Patients with an Eastern Cooperative Oncology Group performance rating of 0-2 were given Capecitabine 1,000 mg/m2 twice daily for 14 days. The primary goal was to measure progression-free survival (PFS). The secondary objectives were overall survival (OS), safety, and the need for biliary diversion. Results: A total of 72 patients were analyzed. With a median follow up of 12 months, the median PFS was 5.4 months (4.0-9.1), and the interim overall survival OS was 11.9 months (5.2-16). During treatment, 12% of patients required biliary diversion. The safety profile was consistent with previous capecitabine use, and no new safety signals were detected. There were 9.7 percent (7/72) of grade 3/4 adverse events (AEs) reported. Due to poor tolerability, one-third of patients (30.5%) required dose reduction/ interruption. Conclusions: In a COVID pandemic situation, Capecitabine is safe, effective, and comparable efficacy for patients with advanced mGBC. However, It needs to be evaluated in randomized clinical trials comparing the standard of care.

Liquid biopsy for diagnosis in patients with suspected pancreatic and biliary tract cancers: PREVAIL ctDNA pilot trial

Background: Most patients with pancreatic cancer (PC) and biliary tract cancer (BTC) present with advanced disease. In confirmed cases, circulating tumour DNA (ctDNA) may be detected through liquid biopsy in 80-90%. Obtaining a diagnostic biopsy can be technically challenging, require complex invasive procedures and may not be feasible due to comorbidity. Reduction in capacity of aerosol generating diagnostic procedures in many healthcare systems due to COVID19 has highlighted the unmet need for simple, noninvasive diagnostic tools. We piloted the use of ctDNA to support the diagnostic pathway in patients with suspected cancer across 6 tumour types, here we present its use in PC/BTC. Methods: This single centre prospective cohort pilot trial was conducted at the Royal Marsden from June 2020 to August 2021. 16 patients were planned each in the PC and BTC cohorts. Eligibility included radiologically suspicious PC/BTC without histological diagnosis, patients with prior non-diagnostic biopsy and inaccessible tumours. Liquid biopsy for ctDNA was collected for plasma based next generation sequencing, using a custom 59 gene panel of common variants in PC/BTC tumours, including analysis for somatic, copy number and structural variants. Clonal haematopoiesis of indeterminate potential (CHIP) and germline variants were identified and subtracted. A molecular tumour board (MTB) reviewed results for interpretation and clinical context. Primary outcome was the proportion of patients with a ctDNA result consistent with a diagnosis of malignancy following MTB discussion. Results: 32 patients with suspected PC (n= 16) and BTC (n=16) were recruited. Baseline characteristics are shown in table. ctDNA was detected in 69% off, 23 patients had a subsequent biopsy. The sensitivity and specificity of ctDNA as a diagnostic tool was 80% (90% CI 49.3-96.3) and 100% (90% CI 36.8-100) for PC respectively, and 100% (90% CI 60.7-100) and 75% (90% CI 24.9- 98.7) for BTC respectively. There were 2 false negatives in the PC cohort subsequently diagnosed with PC, and 1 false positive in the BTC cohort subsequently diagnosed with oesophageal cancer. Conclusions: ctDNA can be used to support a diagnosis of cancer in patients with radiologically suspected PC/BTC. A blood first, tissue second strategy in the diagnosis of PC/BTC could improve diagnostic efficiency, speed, and add resilience to the current diagnostic pathway.

IMPACT OF COVID-19 ON PANDEMIC MAJOR GASTROENTEROLOGY PROCEDURES, VISITS, AND NEW DIAGNOSIS OF GASTROINTESTINAL CANCERS

Introduction: The COVID-19 pandemic has caused an extraordinary burden on the healthcare system and has dramatically impacted the delivery of health care services including endoscopy procedures and routine gastroenterology inpatient and ambulatory care. This has led to significant concerns that major gastrointestinal cancer diagnosis can be delayed as a consequence of this pandemic. We aimed to quantify the impact of the COVID-19 pandemic on the diagnoses of major GI cancers. Methods: Search queries were performed on the TriNetX platform to estimate the number of patient encounters, procedures, and diagnoses of new GI cancers per 100,000 patients at participating HCOs in the US between March 15, 2020, and July 15, 2020, and March 15, 2019, to July 15, 2019. Differences in the number of encounters, procedure volume, and new diagnoses before and during the pandemic are compared and reported as a percentage increase or decrease. Results: During the pandemic, major declines were seen in both the inpatient (13,334.50 vs. 22,256.57;%change: -42.99% per HCO) and emergency department (21,933.06 vs.35,225.72;% change: -40.09% per HCO) in comparison to the same interval in 2019. A relatively smaller decline was seen in the ambulatory visits (130,245.84 vs. 159,996.81;% change -22.55% per HCO) during the pandemic compared to 2019. A large increase in virtual or telehealth visits (7,266 vs. 14,612.67;% change +4465.02%) was seen during the pandemic compared to 2019. The volume of the upper endoscopies per 100,000 patients had a decline of 71.84% (52.47 per 100,000 vs. 186.38 per 100,000) with 2019. Similarly, a decline of 84.66% (46.02 per 100,000 vs. 299.95 per 100,000) was seen in the volume of colonoscopies during the pandemic compared with 2019. The number of right upper quadrant abdominal ultrasounds (344.74 vs. 536.79;% change = -35.78%) decreased during the pandemic in comparison to the same duration in 2019. The new diagnoses of the liver and intrahepatic cancers declined to almost one-third (34.13%) during the pandemic while the diagnoses of colorectal cancers decreased by 30.91 % as compared to the similar duration in 2019. We also noticed a decline in the number of new diagnoses in the esophageal and gastric cancers (26.96%) followed by pancreato-biliary cancers (-22.81%). Conclusion: Our study showed that the health care encounters and major GI procedures declined during the pandemic leading to a reduction of new diagnoses GI cancer cases among the patients who had health care encounters during the pandemic that could have led to missed opportunities for a new diagnosis of cancers. Delay in diagnosis during the COVID-19 pandemic could lead to an increase in late-stage cancer cases and poor cancer outcomes. Urgent policy and practice interventions are needed to address the consequences of delays in the diagnosis of these can-cers.(Table Presented)Number of patient encounters, endoscopic procedures and new diagnoses of major GI cancers per 100,000 patients with a percentage change before and during the pandemic.