Abstract 502P
Background
Cytokine storm due to COVID-19 can cause high morbidity and mortality. Patients with cancer treated with immunotherapy (IO) and those with immunosuppression may have higher rates of cytokine storm due to immune dysregulation. We sought to evaluate the association of IO and immunosuppression with COVID-19 outcomes and cytokine storm occurrence among patients with cancer and COVID-19, based on data from the COVID-19 and Cancer Consortium (CCC19).
Methods
A registry-based retrospective cohort study was conducted on patients reported to the CCC19 registry from March 2020 to September 2021. The primary outcome was defined as an ordinal scale of COVID-19 severity. The secondary outcome was the occurrence of a cytokine storm using CCC19 variables, defined as biological and clinical evidence of severe inflammation, with end-organ dysfunction (Fajgenbaum D.C. et al., N Engl J Med., 2020). The association of IO or immunosuppression with the outcomes of interest were evaluated using a multivariable logistic regression balanced for covariate distributions through inverse probability of treatment weighting (IPTW).
Results
A total of 10,214 patients were included, among which 482 (4.7%) received IO, 3,715 (36.4%) received non-IO systemic therapies, and 6,017 (58.9%) were untreated in the 3 months prior to COVID-19 diagnosis. No difference in COVID-19 severity or the development of a cytokine storm was found in the IO group compared to the untreated group (aOR: 0.77; 95%CI:0.45-1.32, and aOR: 1.06; 95%CI:0.42-2.67, respectively). On multivariable analysis, baseline immunosuppression was associated with worse outcomes both in relation to COVID-19 severity (aOR: 1.89; 95%CI:1.51-2.35) and the presence of a cytokine storm (aOR: 1.75; 95%CI:1.30-2.35).
Conclusions
Administration of IO was not associated with severe outcomes in patients with cancer and COVID-19, whereas pre-existing baseline immunosuppression appears to be independently associated with worse clinical outcomes including cytokine storm.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
COVID-19 and Cancer Consortium (CCC19).
Funding
National Institutes of Health (NIH) National Cancer Institute (NCI).
Disclosure
Z. Bakouny: Non-Financial Interests, Institutional, Funding: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Genentech/ imCORE; Financial Interests, Personal, Writing Engagements: UpToDate. C. Labaki: Financial Interests, Institutional, Research Grant: Genentech/imCORE. S. Gulati: Financial Interests, Personal, Advisory Board: EMD Serono; Financial Interests, Personal, Invited Speaker, RCC advantage program (ASCO): ASCO; Financial Interests, Institutional, Invited Speaker, Funding to institution to conduct investigator inititated clinical trial: AstraZeneca; Financial Interests, Institutional, Invited Speaker: IsoRay. C. Hsu: Financial Interests, Personal, Other, Data analysis: Nashville Biosciences. M.A. Bilen: Financial Interests, Personal, Advisory Board: Exelixis, Bayer, BMS, Eisai, Pfizer, AstraZeneca, Janssen, Calithera Biosciences, Genomic Health, Nektar, EMD Serono, SeaGen, Sanofi; Financial Interests, Institutional, Research Grant: Merck, Xencor, Bayer, Bristol Myers Squibb, Genentech/Roche, SeaGen, Incyte, Nektar, AstraZeneca, Tricon Pharmaceuticals, Genome & Company, AAA, Peloton Therapeutics, Pfizer. C. Hwang: Financial Interests, Personal, Invited Speaker: OncLive; Financial Interests, Personal, Advisory Role: TEMPUS, Genzyme, EMD Sorono; Financial Interests, Personal, Stocks/Shares: Johnson and Johnson; Financial Interests, Institutional, Funding: Merck, Bayer, Genentech, AstraZeneca, Bausch Health; Financial Interests, Personal, Leadership Role: Wayne County Medical SocietyFoundation Board, Wayne County Medical Society of Southeast Michigan Board. H. Khan: Financial Interests, Personal, Advisory Board: Sanofi-Genzyme; Financial Interests, Personal, Principal Investigator: BMSF/AACR. R.R. McKay: Financial Interests, Personal, Advisory Board: Aveo, AstraZeneca, Bayer, Calithera, Dendreon, Exelixis, JNJ, Merck, Pfizer, Sanofi, Tempus; Financial Interests, Personal, Other, Molecular tumor board: Caris; Financial Interests, Personal, Other, Consultant: Dendreon, Myovant; Financial Interests, Personal, Invited Speaker: Exelixis, Merck, Novartis, Pfizer; Financial Interests, Invited Speaker: Aveo, JNJ, SeaGen, Bayer, AstraZeneca, Calibr, Poseida, Oncternal, Scholar Rock, Merck, Merck, Xencor, Genentech, Eli Lilly, Eli Lilly, BMS; Financial Interests, Institutional, Invited Speaker: Exelixis. E. Ruiz: Financial Interests, Personal, Advisory Board: Roche, Amgen, BMS, Bayer; Financial Interests, Personal, Invited Speaker: Roche, Merck. M.A. Thompson: Financial Interests, Personal, Advisory Board, Insight Myeloma Registry: Takeda; Financial Interests, Personal, Advisory Board, Registry: Adaptive; Financial Interests, Personal, Advisory Board: AbbVie, Epizyme, Janssen, Sanofi, GRAIL/Illumina; Financial Interests, Personal, Advisory Board, Co-chair of Myeloma, Lymphoma, ITP committees: Elsevier Clinical Path (prior: VIA Oncology); Financial Interests, Personal, Full or part-time Employment, VP of Clinical Partnerships: Tempus; Financial Interests, Personal, Stocks/Shares: Doximity; Financial Interests, Personal, Royalties, Myeloma Reviewer: UpToDate; Financial Interests, Institutional, Invited Speaker: AbbVie, Amgen, Denovo, GSK, Hoosier Research Network, Janssen, Lilly, LynxBio, Takeda, TG Therapeutics; Non-Financial Interests, Invited Speaker: ASCO; Non-Financial Interests, Advisory Role: Doximity; Non-Financial Interests, Advisory Role, Syapse Precision Medicine Council - 2018-2021: Syapse; Non-Financial Interests, Sponsor/Funding, ASCO PAC: ASCO. J. Warner: Financial Interests, Personal, Advisory Role: Westat, Roche, Melax Tech, Flatiron Health. Y. Shyr: Financial Interests, Personal, Invited Speaker: Roche. T.K. Choueiri: Financial Interests, Personal, Advisory Board, Advice on GU/RCC drugs: BMS, Pfizer, Merck, Exelixis, AstraZeneca; Financial Interests, Personal, Advisory Board, Advice on Onc drugs: Lilly, EMD Serono, Infinity; Financial Interests, Personal, Advisory Board, Advice on RCC drug: Calithera; Financial Interests, Personal, Invited Speaker, RCC drug: Ipsen; Financial Interests, Personal, Advisory Board, Advice on GU Onc drugs: Surface Oncology; Financial Interests, Personal, Other, Consultant on onc drugs: Analysis Group; Financial Interests, Personal, Invited Speaker, CME, ww2.peerview.com: Peerview; Financial Interests, Personal, Invited Speaker, CME, gotoper.com: PER; Financial Interests, Personal, Invited Speaker, CME, researchtopractice.com: ResearchToPractice; Financial Interests, Personal, Invited Speaker, National Association of Managed Care: NAMC; Financial Interests, Personal, Invited Speaker, ASCO-related event: ASCO-SITC; Financial Interests, Personal, Other, Grant review to Orien Network ($400): ORIEN; Financial Interests, Personal, Advisory Board, Advising oncology strategy: Aptitude Health; Financial Interests, Personal, Invited Speaker, Best of ASCO19 talk: Advent health; Financial Interests, Personal, Invited Speaker, Best of ESMO20 talk ($1000): UAE Society of Onc; Financial Interests, Personal, Invited Speaker, CME, mjhlifesciences.com (OncLive): MJH life sciences; Financial Interests, Personal, Invited Speaker, Grand Rounds: MDACC; Financial Interests, Personal, Invited Speaker, RCC webinar: Cancernet; Financial Interests, Personal, Invited Speaker, CME, Kidney Cancer Association ($1300): France Foundation; Financial Interests, Personal, Invited Speaker, CME, RCC: Springer, WebMed; Financial Interests, Personal, Invited Speaker, CME, ImmunoOncology in RCC: ASiM, CE; Financial Interests, Personal, Invited Speaker, CME, PodCast in RCC ($500.00): Caribou Publishing; Financial Interests, Personal, Invited Speaker, Reimbursement ($432.00): Kidney Cancer Association; Financial Interests, Personal, Other, member of the DSMB for clinical trial: Aravive; Financial Interests, Personal, Invited Speaker, unpaid https://www.accru.org/main/public/index.xhtml: ACCRU; Financial Interests, Personal, Invited Speaker, Unpaid https://kidneycan.org: KidneyCan; Financial Interests, Personal, Other, External Advisory Board Member: Gustave Roussy; Financial Interests, Personal, Stocks/Shares: Pionyr (not publicly traded), Tempest (publicly traded), Osel (not publicly traded), Nuscan ((not publicly traded)); Financial Interests, Personal, Royalties, For writing and updating chapters in GU Oncology: Up-To-Date online textbook; Financial Interests, Institutional, Funding, National Chair: BMS, Merck, Exelixis, AstraZeneca, Takeda, Tracon, Peloton; Financial Interests, Institutional, Invited Speaker: Roche, Surface Oncology, GSK; Financial Interests, Institutional, Funding, National co-chair: Pfizer, EMD-Serono; Financial Interests, Institutional, Funding, Chair of trial: Lilly; Financial Interests, Institutional, Funding, SC member: Eisai; Financial Interests, Institutional, Funding, National co-chair on 3 ongoing trials: Alliance Cooperative Group; Financial Interests, Institutional, Research Grant, for GU oncology translational research through IION program: BMS; Financial Interests, Institutional, Research Grant, for GU oncology translational research: Exelixis; Financial Interests, Institutional, Research Grant, For Health outcomes research: Roche; Financial Interests, Institutional, Invited Speaker, leads trials as PI: Nikang; Non-Financial Interests, Leadership Role, Co-Chair of the meeting, 2019-: Kidney Cancer Research Summit of KidneyCAN; Non-Financial Interests, Principal Investigator, Trial Global and National PI with GU Cancers, mostly Kidney Cancer: Multiple Academic and Industry entities; Non-Financial Interests, Personal, Other, Track Leader/Session chair/Speaker/Discussant: ASCO; Non-Financial Interests, Personal, Other, Speaker/Discussant/Track Leader: ESMO; Non-Financial Interests, Institutional, Other, Access to genomic database: Foundation Med, Guardant, Invitae; Non-Financial Interests, Personal, Other, Grants reviewers: AACR; Non-Financial Interests, Personal, Other, Reviewer of papers: Various journals (e.g. NEJM, Lancet, JCO); Non-Financial Interests, Personal, Other, Medical writing and editorial assistance support (e.g. ClinicalThinking, Envision Pharma Group, Fishawack Group of Companies, Health Interactions, Parexel, Oxford PharmaGenesis, pharmagenesis, and others). However, first draft frequently initiated by myself when I am 1st author: Medical Communication; Non-Financial Interests, Member: ASCO, AACR; Non-Financial Interests, Other, Political vote usually as “independent”, not a member of any political party. I am an issue voter: General US Politics; Other, Other, Employee at DFCI. Please see https://www.dana-farber.org/ for mission statement (non-profit hospital). I am also the past President of Medical Staff at DFCI 2015-2018: Dana-Farber Cancer Institute (DFCI); Other, Other, Professor at HMS, Please see https://hms.harvard.edu/ for mission statement (non-profit school): Harvard Medical School (HMS); Other, Other, No financial interest. Institutional.Filed patents related to biomarkers of immune checkpoint blockers, and circulating free methylated DNA. No money made and some patents were abandoned: Filed patents. T. Wise-draper: Financial Interests, Personal, Other, Consultant: Shattuck Labs; Financial Interests, Personal, Advisory Board: Exicure, Rakuten Medical, Merck & Co; Financial Interests, Personal, Invited Speaker: Physician Education Resource; Financial Interests, Personal, Other, Consultant for Molecular Tumor Board: Caris Life Sciences; Financial Interests, Personal, Ownership Interest: High Enroll; Financial Interests, Personal, Research Grant: BMS, Merck & Co, Tesaro/GSK, AstraZeneca, Janssen; Financial Interests, Personal and Institutional, Invited Speaker: BMS, EMD Serono, Replimune, AstraZeneca, Alkermes, Exicure, Shattuck Labs, Boston Medical, Debio Pharm, Eli Lilly, Epizyme, Iovance, Agenus, SQZbiotech, Triumvera, AdlaiNortye, Yingli, Vyriad, Ideaya. All other authors have declared no conflicts of interest.