Study of patients’ characteristics associated with osimertinib outcomes upfront or in following lines in EGFR-positive NSCLC

Background: In first line (L1) for EGFR-mutated (mEGFR) advanced NSCLC (aNSCLC), osimertinib (osi) has been the preferred option since 2018. First generation anti-EGFR TKI (1G) alone followed by osi, or 1G + anti-angiogenic or 1G + chemotherapy are other options. We aimed to assess the subgroups of patients (pts) that do not benefit from 1G alone compared with osimertinib L1 in mEGFR aNSCLC. Methods: Retrospective international study including pts with mEGFR aNSCLC treated with either osi or the sequence of 1G followed by osi (seq group). Primary endpoint was the PFS of the global strategy (PFSglob) defined as the time between L1 start and progression after L2 treatment or death. Subgroups analyses included pts with high tumour burden (high-TM;> 3 metastatic sites and/or central nervous system (CNS) involvement), poor performance status (PS), and T790M negative (seq subgroup only). Results: A total of 235 pts were included: 104 in the seq group, 118 in the osi L1 group. 15 had T790M negative at PD after 1G, they received osi as a therapeutic test. From these pts, 222 had an exon19 or 21 EGFR mut, 13 had uncommon mEGFR. Mean age was 65 years, 64% were female, and 60% never smokers. Pts from the osi L1 group had poorer PS (23% vs 10%), higher rate of co-mutations (23% vs 19%) and more CNS involvement (47% vs 19%). After a median (m) follow up of 30.6 months in the exon 19 and 21 population, mPFSglob was 27.4 mo (23.0-31.0) and mPFS L1 was 15.5mo (13.7-18.4) Table. The sequence was associated with shorter PFS L1 compared with osi L1 particularly in high-TM (10.5 mo vs 17.1 mo, p<0.0001);PFS was numerically shorter in poor PS (≥2) population (11.0 mo vs 15.6 mo, p=0.1). [Formula presented] Conclusions: 1G TKI followed by osi seemed to be detrimental compared with os L1 for pts with high-TM or poor PS mEGFR aNSCLC. In this population, the intensification of L1 treatment with osimertinib or a combination of 1G with anti-angiogenic or chemotherapy could be the better option in the first-line setting. Updated results will be presented at the congress. Legal entity responsible for the study: Institut Gustave Roussy. Funding: Has not received any funding Disclosure: E. Auclin: Financial Interests, Personal, Advisory Board: Sanofi, Amgen. N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi;Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin;Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen;Financial Interests, Institutional, Funding: BMS;Non-Financial Interests, Officer, International Thymic malignancy interest group, president: ITMIG;Other, Other, Family member is an employee: AstraZeneca. M.T. Moran Bueno: Financial Interests, Personal, Advisory Board, Advisory Role: AstraZeneca, Boehringer Ingelheim, BMS;Financial Interests, Personal, Advisory Board, Advisory role: Roche. B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals;Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, EISAI, Genzyme Corporation, Inivata, Ipsen, Turning Point Therapeutics. L. Mezquita: Financial Interests, Personal, Advisory Board: Takeda, AstraZeneca, Roche;Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Takeda;Financial Interests, Personal, Research Grant, SEOM Beca Retorno 2019: BI;Financial Interests, Personal, Research Grant, ESMO TR Research Fellowship 2019: BMS;Financial Interests, Institutional, Research Grant, COVID research Grant: Amgen;Financial Interests, Institutional, Invited Speaker: Inivata, Stilla. All other authors have declared no conflicts of interest.

HER2 copy number variation in non-small cell lung cancer (NSCLC)

Background: The value of increased HER2 gene copy number (GCN) in NSCLC is unclear. In this study we defined its frequency and characterized a cohort of patients harboring it. Methods: Patients with stage IIIB/IV NSCLC enrolled in the Gustave Roussy MSN study (NCT02105168) between Oct. 2009 and Feb. 2016 were screened by FISH (positivity defined as HER2 GCN to centromeres ratio ≥ 2) and tested for other molecular alterations. Descriptive analyses of clinical-pathological data were performed, progression-free survival (PFS) and overall survival (OS) were estimated by Kaplan-Meier method. Results: HER2 FISH tested positive in 22 of 250 screened patients (9%). Median age was 60 years (range 47-80), 68% (n=15) were male, 91% (n=20) were current or former tobacco smokers (median exposure 47 pack-year), 64% (n=14) had adenocarcinoma, 18% (n=4) squamous cell and 18% (n=4) large cell carcinoma. 91% (n=20) had an ECOG PS of 0 or 1. Stage IV with extra-thoracic involvement was the most common clinical presentation (64%, n=14). Overall, 95% of patients (n=21) had 1 or 2 metastatic sites at diagnosis (bone 32%, lung 27%, nodes 18%, liver 18%, brain 18%). In 9 patients (41%) 12 concurrent molecular alterations were detected: 5 KRAS mutation (3 G12C, 1 G12D, 1 G61H), 2 HER2 exon 20 insertion, 1 EGFR exon 19 deletion, 1 BRAF V600E mutation, 1 ALK rearrangement, 1 FGFR1 and 1 MET amplification. 18 patients received first-line platinum-based chemotherapy, with 33% (95% CI 16-56) objective response rate and 83% (95% CI 61-94) disease control rate. After a median follow-up of 28 months (95% CI 23-45), median PFS and OS were 5.9 (95% CI 3.4-11.0) and 15.3 (95% CI 10.3-NR) months, respectively. Median PFS was longer in patients with higher GCN. As further line of treatment, 5 patients received trastuzumab: 4 in combination with chemotherapy and 1 as monotherapy, with 1 stabilization of disease as best response. 3 patients received nivolumab (1 partial response and 1 stable disease) and 3 a targeted therapy (anti ALK, EGFR, BRAF). Conclusions: Increased HER2 GCN was found in 9% of patients with unresectable NSCLC, was not correlated to particular clinical characteristics, but frequently occurred with other molecular alterations. Its clinical actionability and the correlation with protein expression deserve further characterization. Clinical trial identification: NCT02105168. Legal entity responsible for the study: Gustave Roussy. Funding: Has not received any funding. Disclosure: M. Tagliamento: Other, Personal, Other, Travel grants: Roche, Bristol-Myers Squibb, AstraZeneca, Takeda, Eli Lilly;Other, Personal, Writing Engagements, Honoraria as medical writer: Novartis, Amgen. E. Auclin: Financial Interests, Personal, Advisory Board: Amgen, Sanofi. E. Rouleau: Financial Interests, Institutional, Advisory Board: AstraZeneca, Roche, Amgen, GSK;Financial Interests, Institutional, Invited Speaker: Clovis, BMS;Financial Interests, Institutional, Funding, Data base: AstraZeneca. A. Bayle: Non-Financial Interests, Institutional, Other, Principal/Sub-Investigator of Clinical Trials: AbbVie, Adaptimmune, Adlai Nortye USA Inc, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Astex Pharmaceuticals, AstraZeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, BeiGene, BicycleTx Ltd, Non-Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, Boehringer Ingelheim, GSK, INCA, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi;Financial Interests, Institutional, Other, drug supplied: AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GSK, MedImmune, Merck, NH TherAGuiX, Pfizer, Roche. F. Barlesi: Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Sanofi-Aventis, Seattle Genetics, Takeda;Non-Financial Interests, Principal Investigator: AstraZeneca, BMS, Merck, Pierre Fabre, F. Hoffmann-La Roche Ltd. D. Planchard: Financial I terests, Personal, Advisory Board: AstraZeneca, BMS, Merck, Novartis, Pfizer, Roche, Samsung, Celgene, AbbVie, Daiichi Sankyo, Janssen;Financial Interests, Personal, Invited Speaker: AstraZeneca, Novartis, Pfizer, priME Oncology, Peer CME, Samsung, AbbVie, Janssen;Non-Financial Interests, Principal Investigator, Institutional financial interests: AstraZeneca, BMS, Merck, Novartis, Pfizer, Roche, Daiichi Sankyo, Sanofi-Aventis, Pierre Fabre;Non-Financial Interests, Principal Investigator: AbbVie, Sanofi, Janssen. B. Besse: Financial Interests, Institutional, Funding: 4D Pharma, AbbVie, Amgen, Aptitude Health, AstraZeneca, BeiGene, Blueprint Medicines, Boehringer Ingelheim, Celgene, Cergentis, Cristal Therapeutics, Daiichi Sankyo, Eli Lilly, GSK, Janssen, Onxeo, Ose Immunotherapeutics, Pfizer, Roche-Genentech, Sanofi, Takeda, Tolero Pharmaceuticals;Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, EISAI, Genzyme Corporation, Inivata, Ipsen, Turning Point Therapeutics. L. Mezquita: Financial Interests, Personal, Advisory Board: Takeda, AstraZeneca, Roche;Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Takeda;Financial Interests, Personal, Research Grant, SEOM Beca Retorno 2019: BI;Financial Interests, Personal, Research Grant, ESMO TR Research Fellowship 2019: BMS;Financial Interests, Institutional, Research Grant, COVID research Grant: Amgen;Financial Interests, Institutional, Invited Speaker: Inivata, Stilla. All other authors have declared no conflicts of interest.

Mechanisms of primary and secondary resistance to RET inhibitors in patients with RET-positive advanced NSCLC

Background: RET fusions are found in 1-2% of patients (pts) with advanced non-small cell lung cancer (aNSCLC). Targeted therapy with RET inhibitors (RETi) significantly improved prognosis. Molecular mechanisms of resistance are still incompletely characterized. Methods: This multicentric retrospective study included 24 centres. Eligible pts had a RET+ aNSCLC, were treated with a RETi and had at least one molecular profile by next-generation sequencing (NGS), performed before and/or after RETi, on tissue and/or plasma samples. Primary resistance under RETi was defined as disease progression (PD) within 6 months of therapy. Results: 95 patients were included with 112 biopsies: 93 at baseline, 19 at PD. 17 patients had paired NGS (baseline and PD). Median age was 65 years (range 56-72);62% were female, 54% were never smokers, 17% had brain metastasis (BM) at diagnosis. 55 patients received pralsetinib, 36 selpercatinib, 4 other RETi. Overall, median PFS under RETi was 17.1 months (95%CI 12.6-28). Primary resistance to RETi occurred in 22 (23%) patients. Primary resistant versus durable responders to RETi had non-adenocarcinoma histology in 9% vs 46% (p=0.61), smoking history in 57% vs 40% (p=0.21), BM in 5% vs 21% (p=0.1), TP53 mutations in 37% vs 22% (p=0.23). KRAS G12V mutation and SMARCA4 alterations were found only in poor responders (4.5% vs 0%, p=0.2;and 25% vs 0%, p=0.04, respectively). Among biopsies at PD (N=19, 13 liquid and 6 tissue biopsies), 7/13 (54%) liquid biopsies failed due to insufficient ctDNA. In 12 evaluable pts, 3 (25%) acquired secondary RET mutations (2 G810S and 1 S904F), 3 (25%) had novel RET rearrangements (2 in intron 11, 1 RET-DOCK1, 1 RET-CSGALNACT2) and 3 (25%) pts had off-target alterations (2 MET and 1 MYC amplification). Three pts (25%) developed novel TP53 mutations, while 3 (25%) had no novel identifiable alterations at PD. Conclusions: SMARCA4 and KRAS co-mutations may have a role in primary resistance to RETi. Secondary RET mutations, novel RET rearrangements and MET/MYC amplifications were identified after treatment with RETi. More than half of pts had insufficient ctDNA at PD, making tissue biopsy essential to identify resistance mechanisms. Legal entity responsible for the study: Institut Gustave Roussy. Funding: Has not received any funding. Disclosure: V. Fallet: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Takeda, Roche, Pfizer, Sanofi, Sandoz, Jansen;Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Takeda, Pfizer, MSD;Financial Interests, Personal, Expert Testimony: GSK, Boehringer. C. Audigier-Valette: Financial Interests, Personal, Advisory Role: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Ipsen, Eli Lilly, Novartis, Pfizer, and Roche. A. Russo: Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, MSD, Novartis;Financial Interests, Personal, Writing Engagements: AstraZeneca, Novartis. A. Calles Blanco: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Pfizer, Roche, Lilly, Merck Sharp & Dohme, Novartis, Bristol-Myers Squibb, Takeda, Sanofi;Financial Interests, Personal, Other, Speaker honoraria: Bayer;Financial Interests, Institutional, Research Grant, Drug-only for Investigator-initiated trial: Merck Sharp & Dohme. P. Iranzo Gomez: Financial Interests, Personal, Advisory Role: Bristol-Myers Squibb Recipient, F. Hoffmann, La Roche AG, Merck Sharp & Dohme, Boehringer Ingelheim, MSD Oncology, Rovi, Yowa Kirin, Grunenthal Pharma S.A., Pfizer. M. Tagliamento: Financial Interests, Personal, Other, medical writer: Novartis, Amgen;Financial Interests, Personal, Invited Speaker, travel/accommodation: Roche, Bristol-Myers Squibb, AstraZeneca, Takeda. L. Mezquita: Financial Interests, Personal, Advisory Board: Takeda, AstraZeneca, Roche;Financial Interests, Personal, Invited Speaker: Roche, BMS, AstraZeneca, Takeda;Financial Interests, Personal, Research Grant, SEOM Beca Retorno 2019: BI;Financial Interests, Personal, Research Grant, ESMO TR Research Fellowship 2019: BMS;Financial Interests, Institutional, Research Grant, COVID research Grant: Amgen;Financial Interests, Institutional, Invited Speaker: Inivata, Stilla. C. Lindsay: Financial Interests, Institutional, Principal Investigator: Roche, Amgen, BI;Financial Interests, Personal, Advisory Role: CBPartners, Amgen. S. Ponce: Financial Interests, Institutional, Principal Investigator: Merck Sharp and Dohme, F. Hoffmann-La Roche, Foundation Medicine, PharmaMar. Personal fees: Merck Sharp and Dohme, Bristol-Myers Squibb, F. Hoffmann-La Roche, Foundation Medicine, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Pfizer, Amgen, Celgene.;Financial Interests, Personal, Advisory Board: Merck Sharp and Dohme, Bristol-Myers Squibb, F. Hoffmann-La Roche, Foundation Medicine, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Pfizer, Amgen, Celgene.;Non-Financial Interests, Personal, Other: Merck Sharp and Dohme, Bristol-Myers Squibb, F. Hoffmann-La Roche. M. Aldea: Financial Interests, Personal, Invited Speaker, travel/accommodation: Sandoz. All other authors have declared no conflicts of interest.

The FLARE score, circulating neutrophils, and association with COVID-19 outcomes in patients with solid tumors

Background: Inflammation and neutrophils play a central role in severe Covid-19 disease. In previous data, we showed that the FLARE score, combining both tumor and Covid-19-induced proinflammatory status (proinflamstatus), predicts early mortality in cancer patients (pts) with Covid-19 infection. We aimed to assess the impact of this score in a larger cohort and characterize the immunophenotype (IF) of circulating neutrophils. Methods: Multicenter retrospective cohort (RC) of pts with cancer and Covid-19 infection across 14 international centers. Circulating inflammatory markers were collected at two timepoints: baseline (-15 to -45d before Covid-19 diagnosis) and Covid-19 diagnosis. Tumor-induced proinflam-status was defined by high dNLR (neutrophils/(leucocytes-neutrophils)> 3) at baseline. Covid-19-induced proinflam-status was defined by +100% increase of dNLR between both timepoints. We built the FLARE score combining both Tumor and Infection-induced inflammation: T+/I+ (poor), if both proinflam-status;T+/I- (T-only), if inflammation only due to tumor;T-/I+ (I-only), if inflammation only due to Covid;T-/I- (favorable), if no proinflam-status. The IF of circulating neutrophils by flow cytometry was determined in a unicenter prospective cohort (PC) of pts with cancer during Covid-19 infection and in healthy volunteers (HV). Primary endpoint was 30-day mortality. Results: 524 pts were enrolled in the RC with a median follow- up of 84d (95%CI 78-90). Median age was 69 (range 35-98), 52% were male and 78% had baseline PS <1.Thoracic cancers were the most common (26%). 70% had active disease, 51% advanced stage and 57% were under systemic therapy. dNLR was high in 25% at baseline vs 55% at Covid-19 diagnosis. The median dNLR increase between both timepoints was +70% (IQR: 0-349%);42% had +100% increase of dNLR. Pts distribution and mortality across FLARE groups is resumed in the Table. Overall mortality rate was 26%. In multivariate analysis, including gender, stage and PS, the FLARE poor group was independently associated with 30-day mortality [OR 5.27;1.37-20.3]. 44 pts were enrolled in the PC. Median circulating neutrophils were higher in pts with cancer (n=10, 56.7% [IQR: 39-78.4%]) vs HV (n=6, 35.8% [IQR: 25.6-21%]), and particularly higher in pts with cancer and severe Covid-19 infection (n=7, 88.6% [IQR: 80.9-94%] (p=0.003). A more comprehensive characterization of the IF of circulating neutrophils, including Lox1/CD62/CD64, will be presented at ASCO. Conclusions: The FLARE score, combining tumor and Covid-19-induced proinflam-status, can identify the population at higher risk for mortality. A better characterization of circulating neutrophils may help improve the prediction of Covid-19 outcomes in pts with cancer. (Table Presented).

Mortality in adult patients with solid or hematological cancers and SARS-CoV-2 infection with a specific focus on lung and breast malignancies: A systematic review and meta-analysis

Background: Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection and a diagnosis of cancer are at high risk of severe symptomatic disease (COVID-19) and death. We performed a systematic review and meta-analysis of published studies, to estimate the case-fatality rate (CFR) of patients with solid or hematological tumors and SARS-CoV-2 infection. Methods: A systematic search of PubMed library up to 31 January, 2021, was performed in order to identify publications reporting the CFR among adult patients with solid or hematological tumors and SARS-CoV-2 infection. CFR was defined as the rate of deaths among SARS-CoV-2-positive cancer patients. Moreover, we separately assessed the CFR among patients with lung and breast cancer. Studies with at least 10 patients were included. The CFR was assessed through a random effect model, and 95% confidence intervals (CI) were calculated. The Higgins I2 index was computed to assess the heterogeneity between studies. Results: The systematic search of the literaturereturned 1,727studies. 1,551 were excluded on the basis of the title, 29 based on the abstract, and 3 were duplicates. A total of 144 studies were selected, including 35,725 patients with solid or hematological tumors and SARS-CoV-2 infection. In total, 46 and 32 studies reported the CFR among COVID-19 patients with lung (total N = 1,555) and breast (total N = 1.398) cancer, respectively. Overall, the CFR was 25.5% (95% CI 23.1%-28.1%, Egger test p < 0.001). A sensitivity analysis, after excluding studies with less than 100 patients, showed a CFR of 22.1% (95% CI 19.4%-25.2%). The CFR among patients with lung cancer and SARSCoV2 infection was 33.4% (95% CI 28.1%-39.6%) when including all studies and 26.3% (95% CI 17.6%-39.2%) at the sensitivity analysis after excluding studies with less than 100 patients. The CFR among patients with breast cancer and SARS-CoV2 infection was 13.7% (95% CI 9.1%-20.7%) when including all studies and 13.0% (95% CI 7.6%-22.1%) at the sensitivity analysis after excluding studies with less than 100 patients. Conclusions: One year after the outbreak of the pandemic, this large metaanalysis reports the impact of SARS-CoV-2 infection in patients with cancer. This population experienced a high probability of mortality, with a comparatively higher CFR in patients with lung cancer, and a comparatively lower CFR in patients with breast cancer. Patients with an underlying diagnosis of cancer require special attention with aggressive preventive measures that also include early access to COVID-19 vaccination.

Impact of COVID-19 on social media as perceived by the oncology community: results from a survey in collaboration with the European Society for Medical Oncology (ESMO) and the OncoAlert Network.

BACKGROUND: The COVID-19 pandemic has impacted all aspects of modern-day oncology, including how stakeholders communicate through social media. We surveyed oncology stakeholders in order to assess their attitudes pertaining to social media and how it has been affected during the pandemic. MATERIALS AND METHODS: A 40-item survey was distributed to stakeholders from 8 July to 22 July 2020 and was promoted through the European Society for Medical Oncology (ESMO) and the OncoAlert Network. RESULTS: One thousand and seventy-six physicians and stakeholders took part in the survey. In total, 57.3% of respondents were medical oncologists, 50.6% aged <40 years, 50.8% of female gender and mostly practicing in Europe (51.5%). More than 90% of respondents considered social media a useful tool for distributing scientific information and for education. Most used social media to stay up to date on cancer care in general (62.5%) and cancer care during COVID-19 (61%) given the constant flow of information. Respondents also used social media to interact with other oncologists (78.8%) and with patients (34.4%). Overall, 61.1% of respondents were satisfied with the role that social media was playing during the COVID-19 pandemic. On the other hand, 41.1% of respondents reported trouble in discriminating between credible and less credible information and 30% stated social networks were a source of stress. For this reason, one-third of respondents reduced its use during the COVID-19 pandemic. Regarding meeting attendance, a total of 59.1% of responding physicians preferred in-person meetings to virtual ones, and 51.8% agreed that virtual meetings and social distancing could hamper effective collaboration. CONCLUSION: Social media has a useful role in supporting cancer care and professional engagement in oncology. Although one-third of respondents reported reduced use of social media due to stress during the COVID-19 pandemic, the majority found social media useful to keep up to date and were satisfied with the role social media was playing during the pandemic.

Results of a national survey exploring the perception and attitudes of italian physicians towards the management of checkpoint inhibitors in oncology during covid-19 outbreak

Background: During the COVID-19 outbreak oncological care has been reorganized to face the emergency. Cancer patients have been reported to be at higher risk of severe events related to SARS-CoV-2. Moreover, there are concerns of a possible interference between immune checkpoint inhibitors (ICIs) and the pathogenesis of the infection. Material and Methods: A 22-item questionnaire was shared with Italian physicians managing ICIs, between May 6 and 16, 2020. This survey aimed at exploring the perception about SARS-CoV-2 related risks in cancer patients receiving ICIs, and whether the management of these patients has been modified during COVID-19 outbreak. Results: Respondents were 104, with a median age of 35.5 years, mainly females (58.7%), mainly working in Northern Italy (71.2%). 47.1% of respondents were afraid that a synergism could exist between ICIs mechanism of action and SARS-CoV-2 pathogenesis, leading to worse outcomes. 97.1% of respondents would not deny an ICI only for the possible occurrence of COVID-19. Measures for reducing hospital visits have been adopted by choosing the ICIs schedule with fewer administrations, adopting the highest labeled dose of each drug (55.8%) and/or choosing, among different ICIs for the same indication, the one with the longer interval between cycles (30.8%). 53.8% of respondents suggested the need to test for SARS-CoV-2 every cancer patient candidate to ICIs. Regarding the differential diagnosis between immune-related adverse events (irAEs) and COVID-19 manifestations, 71.2% of respondents declared to manage a patient with onset of dyspnea and cough like a COVID-19 patient until otherwise proven (ie, waiting for the result of SARS-CoV-2 test before doing other diagnostic or therapeutic procedures), while the same management has been applied only by the 28.8% of respondents when dealing with a patient with onset of diarrhea;however, 96.2% did not reduce the use of steroids to manage irAEs during the pandemic. No major impact of COVID-19 on physicians' attitudes towards the use of ICIs to manage specific clinical situations in different cancer types (ie, lung, breast, melanoma, urothelial) was observed. Conclusions: These results highlight the uncertainty of physicians dealing with ICIs in cancer patients during COVID-19 outbreak, supporting the need of dedicated studies on this regard.

Assessing the impact of covid-19 outbreak on the attitudes and practice of italian oncologists towards breast cancer care and related research activities

Background: Coronavirus disease 2019 (COVID-19) outbreak is changing the approach of medical oncologists to cancer management. However, the real impact on cancer care and its potential negative consequences are currently unknown. Methods: A 29-multiple choice question anonymous online survey was shared with members of the Italian Association of Medical Oncology and the Gruppo Italiano Mammella on April 3, 2020. The objectives of the survey were to investigate the attitudes and practice of Italian oncologists before and during COVID-19 outbreak on three relevant areas in breast cancer care: 1) (neo)adjuvant setting;2) metastatic setting;3) research activities. Results: The survey was completed by 165 oncologists, of whom 121 (73.3.%) worked in Breast Units. In the (neo) adjuvant setting, compared to before the emergency, a lower rate of oncologists adopted during COVID-19 outbreak weekly paclitaxel (68.5% vs. 93.9%, P<.001) and dose-dense schedule for anthracycline-based chemotherapy (43% vs. 58.8%, P<.001). In the metastatic setting, compared to before the emergency, a lower number of oncologists adopted during COVID-19 outbreak first-line weekly paclitaxel for HER2-positive disease (41.8% vs. 53.9%, P=.002) or CDK4/6 inhibitors for luminal tumors with less aggressive characteristics (55.8% vs. 80.0%, P<.001). A significant change was also observed in terms of delaying the timing for monitoring CDK4/6 inhibitors therapy, assessing treatment response with imaging and flushing central venous devices. Clinical research and scientific activities were reduced in 80.3% and 80.1% of respondents previously involved in these activities, respectively. Conclusions: Most of the changes in the attitudes and practice of Italian oncologists were reasonable responses to the current health emergency without expected major negative impact on patients' outcomes, although some potentially alarming signals of undertreatment were observed. These data invite developing cautious recommendations to help oncologists ensuring continuous effective and safe cancer care.

Perception and attitudes of Italian physicians towards the management of checkpoint inhibitors in oncology during COVID-19 outbreak: Results from a national survey

Background: During the COVID-19 outbreak oncological care has been reorganized to face the emergency. Cancer patients have been reported to be at higher risk of severe events related to SARS-CoV-2. Moreover, there are concerns of a possible interference between immune checkpoint inhibitors (ICIs) and the pathogenesis of the infection. Methods: A 22-item questionnaire was shared with Italian physicians managing ICIs, between May 6 and 16, 2020. This survey aimed at exploring the perception about SARS-CoV-2 related risks in cancer patients receiving ICIs, and whether the management of these patients has been modified during COVID-19 outbreak. Results: Respondents were 104, with a median age of 35.5 years, mainly females (58.7%), mainly working in Northern Italy (71%). 47.1% of respondents were afraid that a synergism could exist between ICIs mechanism of action and SARS-CoV-2 pathogenesis, leading to worse outcomes. 97.1% of respondents would not deny an ICI only for the possible occurrence of COVID-19. Measures for reducing hospital visits have been adopted by choosing the ICIs schedule with fewer administrations, adopting the highest labeled dose of each drug (55.8%) and/or choosing, among different ICIs for the same indication, the one with the longer interval between cycles (30.8%). 53.8% of respondents suggested the need to test for SARS-CoV-2 every cancer patient candidate to ICIs. Regarding differential diagnosis between immune-related adverse events (irAEs) and COVID-19 manifestations, 71.2% of respondents declared to manage a patient with onset of dyspnea and cough like a COVID-19 patient until otherwise proven (ie, waiting for the result of SARS-CoV-2 test before doing other diagnostic or therapeutic procedures);however, 96.2% did not reduce the use of steroids to manage irAEs during the pandemic. No major impact of COVID-19 on physicians’ attitudes towards the use of ICIs to manage specific clinical situations in different cancer types (ie, lung, breast, melanoma, urothelial) was observed. Conclusions: These results highlight the uncertainty of physicians dealing with ICIs in cancer patients during COVID-19 outbreak, supporting the need of dedicated studies on this regard. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: M. Tagliamento: Travel/Accommodation/Expenses: Roche, Bristol-Myers Squibb, Astra Zeneca, Takeda. F. Poggio: Travel/Accommodation/Expenses: Takeda, Ely Lilly;Honoraria (self): Merck Sharp & Dohme, Ely Lilly, Novartis. L. Del Mastro: Honoraria (self): Roche, Pfeizer, Ipsen, Eli Lilly, Novartis, Takeda, Merck Sharp & Dohme, Genomic Health, Seattle Genetics;Non-remunerated activity/ies: Celgene. M. Di Maio: Advisory/Consultancy: Eisai, Takeda, Janssen, Astellas, Pfizer, AstraZeneca. M. Lambertini: Advisory/Consultancy: Roche and Ely Lilly;Speaker Bureau/Expert testimony: Roche, Takeda and Theramex. All other authors have declared no conflicts of interest.

First results of the COCO study: COVID-19 outcomes in patients with cancer

Background: COVID-19 pandemic has drastically changed the management of patients with cancer;however, limited data exists regarding which pre-conditions affect the course of COVID-19 infection. Here, we sought to assess the clinical features and outcomes of COVID-19 infection in a large cohort of patients with cancer. Methods: We conducted a multicenter retrospective cohort study of patients with cancer diagnosed with SARS-CoV-2 infection by RT-PCR/Ag detection (n=274) or CT-scan (N=13) between 7/March and 30/April across 12 international centers. Clinical, pathological and biological data were collected. Primary endpoints were 30-day mortality rate and the rate of severe acute respiratory failure (SARF), defined by oxygen requirements >15 L/min. Descriptive statistics were used. Results: 287 patients were enrolled with a median follow-up of 23 days [95%CI 22-26]. Median age was 69 (range 35-98), 52% were male, 49% had hypertension and 23% had cardiovascular disease. As per cancer characteristics, 68% had active disease, 52% advanced stage and 79% had a baseline ECOG PS ≤1. Most frequent cancer-types were: 26% thoracic, 21% gastrointestinal, 19% breast and 15% genitourinary. Most patients (61%) were under systemic therapy, including chemotherapy (51%), endocrine therapy (23%) and immunotherapy (19%). At COVID-19 diagnosis, 44% of patients had moderate/severe symptoms such as fever (70%), cough (54%) and dyspnea (48%). The majority of patients (90%) required in-patient management and the median hospital stay duration was 10 days (range 1-52);8% of patients required intermediate or intensive care unit admission. Patients received treatment with: hydroxychloroquine (81%), azithromycin (61%), antiviral therapy (38%) and immunomodulatory drugs (14%). Finally, the overall mortality rate was 27% and the rate of SARF was 26%. In patients admitted to intermediate/intensive care units, the mortality and SARF rates were 45% and 73%, respectively. Mortality rate according to ECOG PS before COVID-19 was 20% in PS≤1 and 51% in PS>2 (p<0.0001). Conclusions: Patients with cancer are a susceptible population with a high likelihood of severe complications and high mortality from COVID-19 infection. Final results and treatment outcomes will be presented at the ESMO Congress. Legal entity responsible for the study: Aleix Prat. Funding: Has not received any funding. Disclosure: E. Auclin: Travel/Accommodation/Expenses: Mundipharma;Speaker Bureau/Expert testimony: Sanofi Genzymes. S. Pilotto: Speaker Bureau/Expert testimony: Astra-Zeneca;Eli-Lilly;BMS;Boehringer Ingelheim;MSD;Roche. L. Mezquita: Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb;Speaker Bureau/Expert testimony: Tecnofarma;Speaker Bureau/Expert testimony, Non-remunerated activity/ies: AstraZeneca;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Research grant/Funding (self): Boehringer Ingelheim. A. Prat: Honoraria (institution), Speaker Bureau/Expert testimony: Roche;Daiichi Sankyo;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Novartis;Amgen;Speaker Bureau/Expert testimony: BMS;Advisory/Consultancy: Puma;Oncolytics Biotech;MSD;Honoraria (institution), Advisory/Consultancy: Lilly;Honoraria (institution), Speaker Bureau/Expert testimony: Nanostring technologies;Officer/Board of Directors: Breast International Group;Officer/Board of Directors: Solti's Foundation;Leadership role: Actitud Frente al Cancer Foundation;Honoraria (institution): Boehringer;Honoraria (institution): Sysmex Europa GmbH;Honoraria (institution): Medica Scientia inno. Research;Honoraria (institution): Celgene;Honoraria (institution): Astellas Pharma. All other authors have declared no conflicts of interest.

Change of circulating pro-inflammatory markers between pre-COVID-19 condition and COVID-19 diagnosis predicts early death in cancer patients: The FLARE score

Background: Inflammation plays a central role in severe COVID-19 disease. Likewise, in cancer patients (pts), a circulating pro-inflammatory status (proinflam-status) is associated with poor outcomes. We aimed to assess if a proinflam-status induced by cancer can negatively impact on COVID-19 outcomes. Methods: Multicenter retrospective cohort of cancer pts with SARS-CoV-2 infection across 12 international centers. Circulating inflammatory markers were collected at two timepoints: pre-COVID condition (-15 to -45d before COVID-19 diagnosis) and COVID-19 diagnosis. Tumor-induced proinflam-status was defined by high derived neutrophil to lymphocyte ratio (dNLR>3) at pre-COVID condition. COVID-induced proinflam-status was defined by +100% increase of dNLR between both timepoints. We built the FLARE score, combining both Tumor and Infection-induced inflammation: T+/I+ (poor), if both proinflam-status;T+/I- (T-only), if inflammation only due to tumor;T-/I+ (I-only), if inflammation only due to COVID;and T-/I- (favorable), if no inflam-status. Primary endpoint was 30-day mortality. Results: 287 pts were enrolled with a median follow-up of 23d [95%CI 22-26]. Median age was 69 (range 35-98), 52% were male and 49% had hypertension. As per cancer characteristics: 68% had active disease, 52% advanced stage and 79% had a baseline PS≤1. Thoracic cancers were the most common (26%) and 61% of pts were under systemic therapy. The dNLR was high in 24% at pre-COVID condition vs. 55% at COVID-19 diagnosis. Median change between both timepoints was +67% (IQR: 0% to +153%);40% had +100% increase of dNLR. Pts distribution across FLARE groups were: 5% in poor (n=9), 20% in T-only (n=39), 35% in I-only (n=69) and 40% in favorable (n=80). Overall mortality rate was 27%. According to FLARE score: 67% mortality for poor vs. 35% for I-only vs. 33% for T-only vs. 19% in favorable group (p=0.008). The FLARE poor group was independently associated with 30-day mortality [OR 5.7;1.02-31.2]. Conclusions: Both tumor and infection-induced proinflam-status impact on COVID-19 outcomes in cancer pts. The FLARE score, based on simple dynamics between two timepoints, allows to identify the population at higher risk for early death. Legal entity responsible for the study: Aleix Prat. Funding: Has not received any funding. Disclosure: E. Auclin: Travel/Accommodation/Expenses: Mundipharma;Speaker Bureau/Expert testimony: Sanofi Genzymes. S. Pilotto: Speaker Bureau/Expert testimony: AstraZeneca;Eli-Lilly;BMS;Boehringer Ingelheim;MSD;Roche. A. Prat: Honoraria (institution), Speaker Bureau/Expert testimony: Roche;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Novartis;Amgen;Speaker Bureau/Expert testimony: BMS;Honoraria (institution), Speaker Bureau/Expert testimony: Daiichi Sankyo;Nanostring technologies;Advisory/Consultancy: Puma;Oncolytics Biotech;MSD;Honoraria (institution), Advisory/Consultancy: Lilly;Honoraria (institution): Boehringer;Sysmex Europa GmbH;Medica Scientia inno. Research;Celgene;Astellas Pharma;Officer/Board of Directors: Breast International Group;Solti's Foundation;Leadership role: Actitud Frente al Cancer Foundation. L. Mezquita: Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Myers Squibb;Speaker Bureau/Expert testimony: Tecnofarma;Speaker Bureau/Expert testimony, Non-remunerated activity/ies: AstraZeneca;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Research grant/Funding (self): Boehringer Ingelheim. All other authors have declared no conflicts of interest.

Assessing the impact of COVID-19 outbreak on the attitudes and practice of Italian oncologists towards breast cancer care and related research activities

Background: Coronavirus disease 2019 (COVID-19) outbreak is changing the approach of medical oncologists to cancer management. However, the real impact on cancer care and its potential negative consequences are currently unknown. Methods: A 29-multiple choice question anonymous online survey was shared with members of the Italian Association of Medical Oncology and the Italian Breast Cancer Study Group on April 3, 2020. The objectives of the survey were to investigate the attitudes and practice of Italian oncologists before and during COVID-19 outbreak on three relevant areas in breast cancer care: 1) (neo)adjuvant setting;2) metastatic setting;3) research activities. Results: The survey was completed by 165 oncologists, of whom 121 (73.3.%) worked in Breast Units. In the (neo)adjuvant setting, compared to before the emergency, a lower rate of oncologists adopted during COVID-19 outbreak weekly paclitaxel (68.5% vs. 93.9%, P<.001) and dose-dense schedule for anthracycline-based chemotherapy (43% vs. 58.8%, P<.001). In the metastatic setting, compared to before the emergency, a lower number of oncologists adopted during COVID-19 outbreak first-line weekly paclitaxel for HER2-positive disease (41.8% vs. 53.9%, P=.002) or CDK4/6 inhibitors for luminal tumors with less aggressive characteristics (55.8% vs. 80.0%, P<.001). A significant change was also observed in terms of delaying the timing for monitoring CDK4/6 inhibitors therapy, assessing treatment response with imaging and flushing central venous devices. Clinical research and scientific activities were reduced in 80.3% and 80.1% of respondents previously involved in these activities, respectively. Conclusions: Most of the changes in the attitudes and practice of Italian oncologists were reasonable responses to the current health emergency without expected major negative impact on patients’ outcomes, although some potentially alarming signals of undertreatment were observed. These data invite developing cautious recommendations to help oncologists ensuring continuous effective and safe cancer care. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: F. Poggio: Travel/Accommodation/Expenses: Takeda;Honoraria (self), Travel/Accommodation/Expenses: Ely Lilly;Honoraria (self): Merck Sharp & Dohme;Novartis. M. Tagliamento: Travel/Accommodation/Expenses: Roche;Bristol-Myers Squibb;AstraZeneca;Takeda;Honoraria (self): Novartis. M. Di Maio: Research grant/Funding (institution): Tesaro GSK;Honoraria (self), Advisory/Consultancy: AstraZeneca;Janssen;Astellas;Eisai;Pfizer;Merck Sharp & Dohme;Takeda. L. Del Mastro: Advisory/Consultancy: Roche;Novartis;Eisai;Pfizer;AstraZeneca;Ipsen;Eli Lilly;MSD;Seattle Genetics;Genomic Health. M. Lambertini: Advisory/Consultancy: Roche;Honoraria (self): Theramex, Eli Lilly. All other authors have declared no conflicts of interest.

Active smoking and severity of COVID-19 infection in cancer patients

Background: Smoking is the leading cause of cancer worldwide. Active smoking alters the inflammatory environment of the respiratory epithelium, increasing the production of potent pro-inflammatory cytokines that promote the recruitment of macrophages and neutrophils, leading to lung damage. We hypothesize that smoking-induced inflammation can impact on COVID-19 infection severity and mortality related to the proinflammatory cascade. Methods: Multicenter retrospective cohort of cancer patients (pts) with COVID-19 infection diagnosed by PCR/Ag detection (n=274) and CT-scan (N=13) in Mar-Apr/20r in 12 centers. Clinical and biological data were collected. Smoker was defined as active tobacco consumption and heavy smoker as >30 pack-year (PY). Primary endpoints were 30-day mortality rate and the rate of severe acute respiratory failure (SARF), defined by oxygen requirements >15 L/min. Results: A total of 287 pts were enrolled: 25 (9%) were active smokers, 127 (47%) were former and 116 (43%) never smoker. Among active smokers: 73% were heavy smokers, median age was 62y, 60% were male and median body mass index was 22. Regarding their comorbidities: 25% had hypertension, 8% cardiovascular disease, 28% chronic obstructive pulmonary disease and 24% diabetes. Thoracic tumors were the most common (52%), 72% had advanced disease and 56% were under systemic therapy. 92% of active smokers required hospitalization, 68% developed pneumonia and 58% required oxygen. Only 4% were escalated to the intensive care unit. Active smokers received treatment with hydroxychloroquine (91%), azithromycin (61%), antiviral therapy (33%) and steroids (29%). Only 4% received immunomodulatory drugs. SARF was the most common complication (25%) and no thromboembolic events were observed. A pro-inflammatory status was observed at COVID-19 diagnosis in active smokers, e.g. median of absolute neutrophil count was 6.35 (vs. 5.4), mean ferritin was 1269 (vs. 991) and D-Dimer was 2422 (vs. 1816);but with no significant differences. Overall mortality rate was 27%. Mortality rate was higher in active smokers (40% vs. 24% in non-smokers;p=0.08). Conclusions: Active smoking might be associated with severe COVID-19 infection and early death in cancer patients. Smoking induced-inflammation should be further explored. Legal entity responsible for the study: Aleix Prat. Funding: Has not received any funding. Disclosure: E. Auclin: Travel/Accommodation/Expenses: Mundifarma;Speaker Bureau/Expert testimony: Sanofi Genzime. S. Pilotto: Speaker Bureau/Expert testimony: Astra-Zeneca;Speaker Bureau/Expert testimony: Boehringer Ingelheim;Speaker Bureau/Expert testimony: Eli-Lilly;Speaker Bureau/Expert testimony: BMS. A. Prat: Honoraria (institution), Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Amgen;Speaker Bureau/Expert testimony: BMS;Honoraria (institution), Speaker Bureau/Expert testimony: Daiichi Sankyo;Nanostring;Advisory/Consultancy: Puma;Oncolytics Biotech;MSD;Honoraria (institution), Advisory/Consultancy: Lilly;Boehringer;Sysmex Europa GmbH;Medican Scientia inno. Research;Celgene;Astellas;Officer/Board of Directors: Breast International Group;Solti's Foundation;Actitud frente al cancer foundation. L. Mezquita: Speaker Bureau/Expert testimony, Research grant/Funding (self), Travel/Accommodation/Expenses: Bristol-Meyers Squibb;Speaker Bureau/Expert testimony: Tecnofarma;Honoraria (institution), Speaker Bureau/Expert testimony: Astrazeneca;Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Research grant/Funding (self): Boehringer Intelligence. All other authors have declared no conflicts of interest.

Expected medium and long term impact of the COVID-19 outbreak in oncology

Background: The ongoing SARS-CoV-2 pandemic and ensuing coronavirus disease (COVID-19) is challenging cancer care and services worldwide. Methods: A 95 items survey was distributed worldwide by 20 oncologists from 10 of the most affected countries in order to evaluate the impact on organization of oncological care. Results: 109 representatives from oncology centers in 18 countries (62.4% academic hospitals) filled out the survey (June 17 – July 14, 2020). A swab or gargle test is systematically performed before day care unit or overnight stay admissions in 27.5% and 58.7% of the centers, respectively. A local registry (64.2%) and systematic tracing (77.1%) of infected patients was organized in many centers. Treatment modalities mostly affected by the pandemic (cancellation/delay) were surgery (44.1%) and chemotherapy (25.7%). Earlier cessation of palliative treatment was observed in 32.1% of centers, and 64.2 % of participants agree that under-treatment is a major concern. At the pandemic peak, teleconsultations were performed for follow-up (94.5%), for oral therapy (92.7%), but also for patients receiving immunotherapy (57.8%) or chemotherapy (55%). Approximately 82% of participants estimate that they will continue to use telemedicine. Most participants reported more frequent use of virtual tumor boards (82%) and oncological team meetings (92%), but 45% disagree that virtual meetings are an acceptable alternative to live international meetings. Although 60.9% report reduced clinical activity during the pandemic peak, only 28.4% had an increased scientific activity. Only 18% of participants estimate that their well-being will not recover to previous levels by the end of the year;63% indicate easily accessible psychological support for caregivers, but only 10% used or planned to use it. All clinical trial activities are or will soon be reactivated in 72.5% of the centers. Major study protocol violations/deviations were observed in 27.5% and significant reductions of clinical trial activities are expected by 37% of centers this year. Conclusions: COVID-19 has a major impact on organization of patient care, well-being of caregivers, continued medical education and clinical trial activities in oncology. Legal entity responsible for the study: The authors. Funding: Fondation Léon Fredericq. Disclosure: G. Jerusalem: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen;Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca;Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: AbbVie;Travel/Accommodation/Expenses: MedImmune;Travel/Accommodation/Expenses: Merck KGaA. G. Curigliano: Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Seattle Genetics;Speaker Bureau/Expert testimony, Writing engagement: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy, Speaker Bureau/Expert testimony: Samsung;Advisory/Consultancy, Speaker Bureau/Expert testimony: Celltrion;Leadership role, Scientific Affairs Group: Ellipsis;Speaker Bureau/Expert testimony, Writing engagement: BMS;Speaker Bureau/Expert testimony: MSD;Advisory/Consultancy: Mylan. M. Campone: Honoraria (self), Advisory/Consultancy: GT1;Honoraria (institution), Advisory/Consultancy: Sanofi;Honoraria (institution), Advisory/Consultancy: Pierre-Favre;Honoraria (institution), Advisory/Consultancy: AstraZeneca;Honoraria (institution), Advisory/Consultancy: Servi r;Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Honoraria (institution), Advisory/Consultancy: AbbVie;Honoraria (institution), Advisory/Consultancy: Accord;Honoraria (institution), Advisory/Consultancy: Pfizer;Speaker Bureau/Expert testimony: Lilly. M. Martin: Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Puma;Advisory/Consultancy: AstraZeneca;Advisory/Consultancy: Amgen;Advisory/Consultancy: Taiho Oncology;Advisory/Consultancy: Daichii Sankyo;Advisory/Consultancy: PharmaMar;Advisory/Consultancy: Eli Lilly;Advisory/Consultancy: Pfizer. M. Cristofanilli: Advisory/Consultancy: CytoDyn;Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer;Advisory/Consultancy: Lilly;Advisory/Consultancy: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony: Foundation Medicine;Advisory/Consultancy: G1 Therapeutics;Advisory/Consultancy: Sermionexx;Advisory/Consultancy: Genentch. L. Pusztai: Honoraria (self), Research grant/Funding (institution), Clinical trial support: Merck;Honoraria (self), Research grant/Funding (institution), Clinical trial support: AstraZeneca;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Seattle Genetics;Honoraria (self): Novartis;Honoraria (self), Research grant/Funding (institution), Clinical trial support: Roche Genentech;Honoraria (self): Eisai;Honoraria (self): Daiichi;Honoraria (self): Syndax;Honoraria (self): Immunomedics. R. Bartsch: Advisory/Consultancy: Accord;Honoraria (self): AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution): Daiichi;Advisory/Consultancy, Travel/Accommodation/Expenses: Eli-Lilly;Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Advisory/Consultancy, Research grant/Funding (institution): Novartis;Advisory/Consultancy, Research grant/Funding (institution): Roche;Advisory/Consultancy: Puma;Advisory/Consultancy: Pierre-Favre;Advisory/Consultancy: Sandoz;Advisory/Consultancy: Eisai. M. Tagliamento: Travel/Accommodation/Expenses: Roche;Travel/Accommodation/Expenses: Bristol-Myers Squibb;Travel/Accommodation/Expenses: AstraZeneca;Travel/Accommodation/Expenses: Takeda;Travel/Accommodation/Expenses: Novartis;Travel/Accommodation/Expenses: Amgen. J. Cortés: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche;Honoraria (self), Advisory/Consultancy: Celgene;Advisory/Consultancy: Cellestia;Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca;Advisory/Consultancy: Biothera Pharmaceutical;Advisory/Consultancy: Merus;Advisory/Consultancy: Seattle Genetics;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Daiichi Sankyo;Advisory/Consultancy: Erytech;Advisory/Consultancy: Athenex + Polyphor;Advisory/Consultancy, Shareholder/Stockholder/Stock options: MedSIR;Honoraria (self), Advisory/Consultancy: Lilly;Advisory/Consultancy: Servier;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sharp Dome;Advisory/Consultancy: GSK;Advisory/Consultancy: Leuko;Advisory/Consultancy: Bioasis;Advisory/Consultancy: Clovis Oncology;Advisory/Consultancy: Boehringer Ingelheim;Honoraria (self), Travel/Accommodation/Expenses: Novartis;Honoraria (self), Travel/Accommodation/Expenses: Eisai;Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Honoraria (self): Samsung Bioepis;Research grant/Funding (institution): Ariad Pharmaceuticals;Research grant/Funding (institution): Baxalta GMBH/Servier Affaires;Research grant/Funding (institution): Bayer Healthcare;Research grant/Funding (institution): F. Hoffmann-La Roche;Research grant/Funding (institution): Guardanth Health;Research grant/Funding (institution): Piqur THerapeutics;Research grant/Funding (institution): Puma C;Research grant/ unding (institution): Queen Mary University of London. E.M. Ciruelos: Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Pfizer. H.S. Rugo: Research grant/Funding (institution): Eisai;Research grant/Funding (institution): Genentech;Research grant/Funding (institution): Lilly;Research grant/Funding (institution), Travel/Accommodation/Expenses: MacroGenics;Research grant/Funding (institution): Merck;Research grant/Funding (institution), Travel/Accommodation/Expenses: Novartis;Research grant/Funding (institution): Obi Pharma;Research grant/Funding (institution): Odonate Therapeutics;Research grant/Funding (institution): Immunomedics;Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi-Sankyo;Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer;Advisory/Consultancy: Samsung;Advisory/Consultancy: Celtrion;Travel/Accommodation/Expenses: Mylan;Travel/Accommodation/Expenses: AstraZeneca. All other authors have declared no conflicts of interest.

Expanding the role of medical oncologist in the management of COVID-19

Background: Cancer patients (pts) have been associated with severe SARS-CoV2 infection and higher mortality compared with the general population. This could be related to the limitation of therapeutic effort based on their prognosis and healthcare prioritization towards non-cancer pts. The oncologist’s role could be crucial for providing high-quality care. We aim to assess the impact of oncologists (ONC) on COVID-19 management. Methods: Multicentre retrospective analysis of cancer pts diagnosed with COVID-19 between Mar-Apr 2020. We classified pts according to an estimated life expectancy (based on tumor/stage/line) in 3 groups: favourable group (FG) mOS >5 years (y), intermediate (IG) 1-5y and poor (PG) <1y. We studied COVID-19 management based on oncologist’s involvement: mainly-ONC vs. mainly other specialists (Other). Primary endpoint: COVID-19 30-day mortality (early-M). Secondary outcomes: intensive care unit admission (ICUa), the incidence of acute respiratory distress syndrome (ARDS) and antiretroviral treatment (ARVt) and immunomodulatory drugs (ImD) administered. Results: 287 pts were enrolled, median age 69 (35-98), 52% male, 67% with an active tumor (of them 76% had advanced stage). Mostly thoracic tumors (26%), followed by gastrointestinal (21%) and breast (19%). Among 170 pts under treatment, 89 (52%) received chemotherapy (CHT). By prognostic group: 49% were included in FG (n=135), 40% in IG (n=113), and 11% in PG (n=30). Overall early-M rate was 27% (ONC 22% vs. Other 27%). Prognostic groups were associated with early-M: 19% (FG) vs. 31% (IG) vs. 37% (PG) (p=0.022). No significant differences regarding rate of ARDS (23% FG vs. 19% IG vs. 17% PG). The ONC-group (n=18) included 4 PG and 14 IG, 94% had an advanced stage disease, 83% receive CHT and 65% had PS≥2 (p=0.05 compared to Other group). In IG (ONC vs. Other): 7% vs. 2% ICUa, 100% vs. 34% ARVt and 57% vs. 7% ImD (all p<0.001). In PG (ONC vs. Other): 25% vs. 0% ICUa, 75% vs. 34% ARVt and 25% vs. 0% ImD (all p<0.001). Finally, FP managed only by Other: 13% ICUa;33% ARVt and 13% ImD. Conclusions: Oncologist mostly treated complex pts compared to other specialists. During COVID-19 crisis, setting prognostic groups helped to individualized therapeutic approaches, reflected by less mortality rate and no differences in terms of complications. Legal entity responsible for the study: Aleix Prat. Funding: Has not received any funding. Disclosure: L. Ghiglione: Licensing/Royalties: Hibor;Licensing/Royalties: Kyowa Kirin;Licensing/Royalties: Vifor Pharma. E. Auclin: Travel/Accommodation/Expenses: Mundipharma;Licensing/Royalties: Sanofi Genzymes. S. Pilotto: Licensing/Royalties: AstraZeneca;Eli-Lilly;BMS;: Boehringer Ingelheim;MSD;Roche. A. Prat: Research grant/Funding (institution), Licensing/Royalties: Roche;Advisory/Consultancy, Research grant/Funding (institution), Licensing/Royalties: Pfizer;Novartis;Amgen;Licensing/Royalties: BMS;Research grant/Funding (institution), Licensing/Royalties: Daiichi Sankyo;Advisory/Consultancy: Puma;Oncolytics Biotech;MSD;Advisory/Consultancy, Research grant/Funding (institution): Lilly;Research grant/Funding (institution), Licensing/Royalties: Nanostring technologies;Officer/Board of Directors: Beast International Group (BIG);Solti's Foundation;Actitud frente al cancer Foundation;Solti;Research grant/Funding (institution): Boehringer;Sysmex Europa GmbH;Medica Scientia inno. Research, SL;Celgene, SLU;Astellas Pharma. L. Mezquita: Research grant/Funding (self), Travel/Accommodation/Expenses, Licensing/Royalties: Bristol-Myers Squibb;Licensing/Royalties: Tecnofarma;Licensing/Royalties, International Mentorship Program: AstraZeneca;Advisory/Consultancy, Travel/Accommodation/Expenses, Licensing/Royalties: Roche;Advisory/Consultancy: Roche Diagnostics;Research grant/Funding (self): Boehringer Ingelheim. All other authors have declared no conflicts of interest.