ABSTRACT
Background: The COVID-19 pandemic required a rapid response and need for real-world data in cancer patients. The nationwide, real-time coordinated UKCCMP reporting network provided an immediate solution. Methods: The ability to set up an interdisciplinary multi-organisational team quickly, covering expert knowledge from clinical, legal, statistical, and computer science was essential. The technical infra-structure allows clinician-led anonymised data entry and rapid dissemination of results with a clinical (RedCap) database as core. However the development of a national cancer reporting network was crucial for the viability of the project. From its inception in March 2020 the reporting network was established via 4 iterative phases. Results: Within the first 4 weeks, >50 centres were involved with coverage throughout the UK. Expansion has continued with >70 centres within 6 weeks reporting over 1200 COVID positive cancer patients. This was achieved through a 4-phase approach: phase 1 - Outline: This involved project protocol development where key data and timelines were confirmed by a small project team followed by whole-team sign-off. phase 2 - Engagement: This involved identification and engagement of existing groups to establish an initial network. Professional body endorsement led to increased recognition and utilisation of their membership networks. Finally regional leads were identified. phase 3 - Invitation: The third phase involved the distribution of a formal invite letter via identified networks. Project specific email and standard mailing lists were created to enhance network identity and communication. phase 4 - Consolidation: Early development of an interactive project website and focus on communication via social media with varied content consolidated interest and led to further extension. Conclusions: Real-time reporting of real world data can be achieved with clearly defined project phases, standardised documentation and an iterative recruitment process. The COVID-19 pandemic necessitated a rapid response, proving that similar reporting networks can be set up quickly and robustly to react to the evidence-based needs of the oncology community in the drive for implementation of change. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: A.C. Olsson-Brown: Honoraria (self): Roche;Honoraria (institution): Roche;Honoraria (self): Bristol Myers Squibb;Research grant/Funding (institution): Bristol Myers Squibb;Research grant/Funding (institution): USB Pharma;Research grant/Funding (institution): Eli Lily;Research grant/Funding (institution): Novartis. D.J. Hughes: Honoraria (self): Novartis;Research grant/Funding (self): NanoMab Technology LtD. S. Sivakumar: Research grant/Funding (self): Celgene. All other authors have declared no conflicts of interest.
ABSTRACT
Background: Individuals with cancer, particularly those who are receiving systemic anti-cancer treatments, have been postulated to be at increased risk of mortality from SARS-CoV-2 related coronavirus disease (COVID-19). This conjecture has considerable impact on the treatment of cancer patients and large, multi-centre data to support this assumption is lacking due to the contingencies of the pandemic. Methods: The cancer community of the United Kingdom (UK) has launched the UK Coronavirus Cancer Monitoring Project (UKCCMP). The UKCCMP is the first COVID-19 clinical registry that enables near real-time reports to frontline doctors about the effect of COVID-19 on cancer patients. Results: An analysis of the first 800 cancer patients with symptomatic COVID-19 disease entered into the UKCCMP registry has been performed. Approximately half of these patients have a mild COVID-19 disease course (52%). Mortality was observed in 226 patients (28%) and risk of death was significantly associated with advancing patient age, sex (M>F) and the presence of other co-morbidities. Approximately one third had received cytotoxic chemotherapy within 4 weeks prior to testing positive for COVID-19. After adjusting for age, sex and comorbidities, recent receipt of chemotherapy had no significant effect on mortality from COVID-19 disease, when compared to cancer patients who had not received recent chemotherapy. No significant effect on mortality was also observed for patients with recent immunotherapy, hormonal therapy, targeted therapy or radiotherapy use. Conclusions: Mortality from COVID-19 in cancer patients appears to be principally driven by age, sex and co-morbidities. We are not able to identify evidence that cancer patients on cytotoxic chemotherapy or other anti-cancer treatment are at significantly increased risk of mortality from COVID-19 disease compared to those not on active treatment. Legal entity responsible for the study: Gary Middleton. Funding: University of Birmingham. Disclosure: All authors have declared no conflicts of interest.