P09.18 COVID-19 Outcomes in Patients With Thoracic Malignancies According to Gender and Ethnicity (TERAVOLT)

Introduction: Previously reported data on patients with thoracic malignancies who develop COVID-19 have suggested a higher mortality rate compared to the general population and to other cancer types, particularly in patients over 65 years of age or suffering from active or progressive disease. Preliminary data from other studies have suggested that gender and ethnicity may also impact patient outcomes. Methods: TERAVOLT is a multi-center, international observational study composed of a cross-sectional component and a longitudinal cohort component. Eligibility criteria include the presence of any thoracic cancer and a COVID-19 diagnosis confirmed in the laboratory with RT-PCR/serology, highly suspicious radiological and clinical findings, or suspected with symptoms and known contact with a positive person. The overarching goals of this consortium are to provide data for guidance to oncology professionals on managing patients with thoracic malignancies while understanding the risk factors for morbidity and mortality from this novel virus. Clinical outcomes including hospitalization, ICU admission, oxygen requirement and mortality were collected. The association between demographic/clinical characteristics and outcomes were measured with odds ratio with 95% confidence intervals using a logistic regression model. Results: As of August 20, 2020, a total of 1,053 patients with COVID-19 and thoracic cancers from 19 countries and 130 centers have been identified, including 42% females and 84% White, 9.3% African American, 25% Hispanic. The median age of male patients was 69 compared to 66 years of age for females. While ECOG PS was similar between treatment groups, 77% of males were admitted to hospital with a mortality rate of 37% compared to 66% of females with a mortality rate of 28%. The median age of African American patients was 66 years of age compared to 68 and 69 years of age for white and Hispanic patients, respectively;26% of African American and 25% White patients had an ECOG PS ≥2 compared to 19% of Hispanics. A similar percentage of patients were admitted to the hospital and ICU, while the mortality rate for Hispanics was 36% compared to 34% for whites and 26% for African Americans. Conclusion: Similar to the general population, the mortality rate of males with thoracic cancer is higher than females. Regarding ethnicity, there is a difference in the median age of African American patients compared to Whites and Hispanics. Although the severity of COVID-19 disease, as defined by hospital admission, is similar between ethnic groups, the mortality rate in Hispanics is higher. We will present a multivariate analysis of these data according to gender and ethnicity, including the impact of cancer stage, prior cancer therapy, and COVID-19 therapy on outcomes. Keywords: TERAVOLT, international COVID-19 registry, thoracic malignancies

Defining COVID-19 outcomes in thoracic cancer patients: TERAVOLT (Thoracic cancERs international coVid 19 cOLlaboraTion)

Background: Patients with thoracic malignancies may have increased risk for COVID-19 mortality. This risk may be attributable to age, comorbidities, smoking history, pulmonary disease burden and cancer-directed therapies. Methods: TERAVOLT is a global consortium examining outcomes and assessing risk factors associated with mortality of patients with thoracic malignancies and COVID-19 infection. Results: As of July 15, 2020, 1012 patients from 20 countries have been entered;median age was 68 with 58 % male, 80% current/former smokers, most common comorbidities of HTN (49%) & COPD (26%);82% NSCLC, 68 % patients with stage IV disease at COVID diagnosis, 65% on treatment (38% chemotherapy, 26% immune checkpoint inhibitor (ICI), 16 % targeted tyrosine kinase inhibitor (TKI). Of these, 72% were hospitalized;56% of patients developed complications, most frequently pneumonia (40%) and 47% who did not have prior oxygen therapy required it. 32% of patients died during their COVID-19 infection. Only 33 % of patients continued their oncology treatment after infection. Patients presenting with pneumonia (OR 2.7 2-3.5), consolidation (OR 2 CI 1,5-2,8), bilateral lung abnormalities (OR 2,8 CI 2-3,9) and pleural effusion (OR 2,7 CI 1,8-4) were at increased risk of mortality. In multivariate analysis age ≥ 65 (OR 1,53 CI 1,11-2,1), active smoking (OR 2 CI 1,3-3), higher stage of cancer (OR 1,9 CI 1,3-2,7), ECOG PS ≥2 (OR 3,7 CI 2,7-5), steroids prior to COVID diagnosis (OR 1,8 CI 1,2-2,7), were associated with increased risk of death, while chemotherapy and TKI therapy use were not and interestingly patients on immunotherapy appeared to be at decreased risk for mortality (OR 0,6 CI 0,5-0,97). Conclusions: Facing this ongoing global pandemic, TERAVOLT is the largest thoracic malignancy database confirming the high risk for COVID-19 mortality in this specific patient group. Physicians need to evaluate the risk of mortality from COVID-19 based on age, smoking status, stage of cancer, performance status, need for steroids and specific therapy in order to determine the appropriateness for cancer therapy and tailor patient care taking into account patients’ wishes and status of pandemic in the country. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: J. Baena Espinar: Advisory/Consultancy: AstraZeneca;Honoraria (self), Travel/Accommodation/Expenses: Angelini. F.R. Hirsch: Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: BMS;Advisory/Consultancy: Merck;Advisory/Consultancy: Daiichi;Advisory/Consultancy: Genentech/Roche;Advisory/Consultancy: Lilly/Loxo;Advisory/Consultancy: Boehringer-Ingelheim. M. Tiseo: Honoraria (self), Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution): Boehringer Ingelheim;Advisory/Consultancy: Novartis;Advisory/Consultancy: MSD;Advisory/Consultancy: BMS;Advisory/Consultancy: Takeda. E. Felip: Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: AbbVie;Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: AstraZeneca;Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Blue Print Medicines;Advisory/Consultancy, Advisory role or speaker's bureau: Boehringer Ingelheim;Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Bristol-Myers Squibb;Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: GSK;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Eli Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Guardant Health;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Janssen;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Medscape;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Merck KGaA;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Spea er's bureau: Merck Sharp and Dohme;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: prIME Oncology;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Samsung;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Springer;Advisory/Consultancy, Speaker Bureau/Expert testimony, Advisory role or Speaker's bureau: Takeda;Advisory/Consultancy, Advisory role or Speaker's bureau: Touchime;Research grant/Funding (self), Research Funding: Fundacion Merck Salud;Research grant/Funding (institution), Research Funding: Grant for Oncology Innovation;Full/Part-time employment, Board (Independent Member: Grifols Boards. H.A. Wakelee: Research grant/Funding (institution), Clinical Research grant: Gilead;Honoraria (self), Advisory/ Consultancy, advisor or consultant honoraria: AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution), advisor or consultant, research: Xcovery;Advisory/Consultancy, advisor or consultant: Jassen;Advisory/Consultancy, advisor or consultant: Daiichi Sankyo, INC;Advisory/Consultancy, advisor or consultant: Helsinn;Advisory/Consultancy, advisor or consultant: Mirati;Advisory/Consultancy, advisor or consultant (not: Takeda;Advisory/Consultancy, advisor or consultant (not: Cellworks;Advisory/Consultancy, Research grant/Funding (institution), advisor or consultant (not: Genentech/Roche;Advisory/Consultancy, Research grant/Funding (institution), advisor or consultant (not: Merck;Travel/Accommodation/Expenses, CME presentation (travel funding): Clinical care options oncology, LLC;Travel/Accommodation/Expenses, CME presentation (travel funding): Fishawack facilitate LTD;Travel/Accommodation/Expenses, CME presentation (travel funding): Medscape;Travel/Accommodation/Expenses, CME presentation (travel funding): Onclive/intellisphere LLC;Travel/Accommodation/Expenses, CME presentation (travel funding): Philips Gillmore Oncology 2018;Travel/Accommodation/Expenses, CME presentation (travel funding): Physician education resource, LLC/MJH;Travel/Accommodation/Expenses, CME presentation (travel funding): Potomac center for medical education;Travel/Accommodation/Expenses, CME presentation (travel funding): Prime Oncology LLC (2018);Travel/Accommodation/Expenses, CME presentation (travel funding): Primo (2018);Travel/Accommodation/Expenses, CME presentation (travel funding): Research to practice;Travel/Accommodation/Expenses, CME presentation (travel funding): UpToDate;Travel/Accommodation/Expenses, CME presentation (travel funding): WebMdHealth;Honoraria (self), Research grant/Funding (institution), honoraria, research funding to: Novartis;Travel/Accommodation/Expenses, International professional society: RGCON- Rajiv gand conference;Travel/Accommodation/Expenses, International professional society: JLCS - japanese lung cancer society;Travel/Accommodation/Expenses, International professional society: KSMO - korean society of medical oncology;Full/Part-time employment, professor of medicine: Stanford university;Travel/Accommodation/Expenses, Scientific advisory committe - travel: ITMIG;Research grant/Funding (institution), research funding to institution: ACEA biosciences. M.C. Garassino: Honoraria (self): Boehringer Ingelheim;Honoraria (self), Local PI, Enrollment in clinical Trials in: Otsuka Pharma;Honoraria (self), Research grant/Funding (institution), PI, Enrollment and Steering: AstraZeneca;Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinical Trials in: Novartis;Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinical Trials in: BMS;Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinic l Trials in: Roche;Honoraria (self), Research grant/Funding (institution), PI, MISP in Thimic malignancies: Pfizer;Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinical Trials in: Celgene;Research grant/Funding (institution): Incyte;Research grant/Funding (institution): Inivata;Research grant/Funding (self): Takeda;Honoraria (self), PI, Enrollment in clinical Trials Thimic: Tiziana Sciences;Honoraria (self), PI, Enrollment in clinical Trials in: Clovis;Honoraria (self), PI, Enrollment in clinical Trials in: Merck Serono;Honoraria (self), Research grant/Funding (self), PI, Enrollment in clinical Trials in: Bayer;Honoraria (self), Research grant/Funding (institution), PI, Enrollment in clinical Trials in: MSD;Honoraria (self), Local PI, Enrollment and Steering: GlaxoSmithKline S.p.A.;Research grant/Funding (institution): Sanofi-Aventis;Honoraria (self), PI, Enrollment in clinical Trials: Spectrum Pharmaceutcials;Honoraria (self), PI, Enrollment in clinical Trials: Blueprint Medicine;Research grant/Funding (institution): Seattle Genetics;Research grant/Funding (institution): Daiichi Sankyo;Honoraria (self), PI, MISP in Thimic malignancies: Eli Lilly. S. Peters: Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: AbbVie;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: Amgen;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: AstraZeneca;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: Bayer;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: Biocartis;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: Boehringer-Ingelheim;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium: Bistrol-Myers Squibb;Honoraria (self), Advisory/Consultancy, Advisory board + honorarium:Clovis;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Daiichi Sankyo;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Debiopharm;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Eli Lilly;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: F. Hoffmann-La Roche;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Foundation Medicine;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Illumina;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Janssen;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Merck Sharp and Dohme;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Merck Serono;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Merrimack;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Novartis;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Pharma Mar;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Pfizer;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Regeneron;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Sanofi;Honoraria (self), Advisory/Consultancy, Advisory Board + honorarium: Seattle Genetics and Takeda;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: AstraZeneca;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: Boehringer-Ingelheim;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: Bristol-Myers Squibb;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: Eli Lilly;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: F. Hoffmann-La Roche;Honoraria (self), Speaker Bureau/Expert testimony, Talk + honorarium: Merck Sharp and Dohme. L. Horn: Advisory/Consultancy, Consulting: AstraZeneca;Advisory/Consultancy, Consulting: Genentech-Roche;Advisory/Consultancy, Consulting: Incyte;Advisory/Consultancy, Consulting: Merck;Advisory/Consultancy, Consulting: Pfizer;Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses, Consulting and travel to meeting: Xcovery;dvisory/Consultancy, Consulting: EMD Serono;Advisory/Consultancy, Consulting: Tesaro;Advisory/Consultancy, Consulting: AbbVie;Research grant/Funding (self): Boehringer Ingelheim;Research grant/Funding (self), Travel/Accommodation/Expenses, Honorarium: BMS;Honoraria (self), Honorarium: Medscape;Honoraria (self), Honorarium: PER;Honoraria (self), Honorarium: Research to Practice;Honoraria (self), Honorarium: OncLive;Advisory/Consultancy, Consulting: Amgen;Advisory/Consultancy, Consulting: Bayer. All other authors have declared no conflicts of interest.