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1.
ESMO Open ; 8(3): 101566, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2309806

ABSTRACT

BACKGROUND: COVID-19 has significantly affected patients with cancer and revealed unanticipated challenges in securing optimal cancer care across different disciplines. The European Society for Medical Oncology COVID-19 and CAncer REgistry (ESMO-CoCARE) is an international, real-world database, collecting data on the natural history, management, and outcomes of patients with cancer and SARS-CoV-2 infection. METHODS: This is the 2nd CoCARE analysis, jointly with Belgian (Belgian Society of Medical Oncology, BSMO) and Portuguese (Portuguese Society of Medical Oncology, PSMO) registries, with data from January 2020 to December 2021. The aim is to identify significant prognostic factors for COVID-19 hospitalization and mortality (primary outcomes), as well as intensive care unit admission and overall survival (OS) (secondary outcomes). Subgroup analyses by pandemic phase and vaccination status were carried out. RESULTS: The cohort includes 3294 patients (CoCARE: 2049; BSMO: 928, all hospitalized by eligibility criteria; PSMO: 317), diagnosed in four distinct pandemic phases (January to May 2020: 36%; June to September 2020: 9%; October 2020 to February 2021: 41%; March to December 2021: 12%). COVID-19 hospitalization rate was 54% (CoCARE/PSMO), ICU admission 14%, and COVID-19 mortality 22% (all data). At a 6-month median follow-up, 1013 deaths were recorded with 73% 3-month OS rate. No significant change was observed in COVID-19 mortality among hospitalized patients across the four pandemic phases (30%-33%). Hospitalizations and ICU admission decreased significantly (from 78% to 34% and 16% to 10%, respectively). Among 1522 patients with known vaccination status at COVID-19 diagnosis, 70% were non-vaccinated, 24% had incomplete vaccination, and 7% complete vaccination. Complete vaccination had a protective effect on hospitalization (odds ratio = 0.24; 95% confidence interval [0.14-0.38]), ICU admission (odds ratio = 0.29 [0.09-0.94]), and OS (hazard ratio = 0.39 [0.20-0.76]). In multivariable analyses, COVID-19 hospitalization was associated with patient/cancer characteristics, the first pandemic phase, the presence of COVID-19-related symptoms or inflammatory biomarkers, whereas COVID-19 mortality was significantly higher in symptomatic patients, males, older age, ethnicity other than Asian/Caucasian, Eastern Cooperative Oncology Group performance status ≥2, body mass index <25, hematological malignancy, progressive disease versus no evident disease, and advanced cancer stage. CONCLUSIONS: The updated CoCARE analysis, jointly with BSMO and PSMO, highlights factors that significantly affect COVID-19 outcomes, providing actionable clues for further reducing mortality.


Subject(s)
COVID-19 , Neoplasms , Male , Humans , SARS-CoV-2 , COVID-19 Testing , Risk Factors , Neoplasms/epidemiology , Neoplasms/therapy , Medical Oncology , Registries
2.
Immuno-Oncology and Technology ; Conference: ESMO Immuno-Oncology Congress 2022. Geneva Switzerland. 16(Supplement 1) (no pagination), 2022.
Article in English | EMBASE | ID: covidwho-2210535

ABSTRACT

Background: As management and prevention strategies against Coronavirus Disease-19 (COVID-19) evolve, it is still uncertain whether prior exposure to immune checkpoint inhibitors (ICIs) affects COVID-19 severity in patients (pts) with cancer. Method(s): In a joint analysis of ICI recipients from OnCovid (NCT04393974) and ESMO CoCARE registries, we assessed severity and mortality from SARS-CoV-2 in vaccinated and unvaccinated pts with cancer and explored whether prior immune-related adverse events (irAEs) influenced outcome from COVID-19. Result(s): The study population consisted of 240 pts diagnosed with COVID-19 between Jan 2020 and Feb 2022 exposed to ICI within 3 months prior to COVID-19 diagnosis, with a 30-day case fatality rate (CFR30) of 23.6% (95%CI: 17.8-30.7%). 42 (17.5%) were fully vaccinated prior to COVID-19 and experienced decreased CFR30 (4.8% vs 28.1%, p=0.001), hospitalization rate (27.5% vs 63.2%, p<0.001), requirement of oxygen therapy (15.8% vs 41.5%, p=0.003), COVID-19 complication rate (11.9% vs 34.6%, p=0.004), and COVID-19-specific therapy (26.3% vs 57.9%, p=0.001) compared with unvaccinated pts. IPTW-fitted multivariable analysis, following a clustered-robust correction for the data source (OnCovid vs ESMO CoCARE), confirmed that vaccinated pts experienced a decreased risk of death at 30 days (aOR 0.08, 95%CI: 0.01-0.69). 38 pts (15.8%) experienced at least 1 irAE of any grade at any time prior to COVID-19, at a median time of 3.2 months (0.13-48.7) from COVID-19 diagnosis. IrAEs occurred independently of baseline characteristics except for primary tumour (p=0.037) and were associated with a significantly decreased CFR30 (10.8% vs 26.0%, p=0.0462) additionally confirmed by the IPTW-fitted multivariable analysis (aOR: 0.47, 95%CI: 0.33-0.67). Pts who experienced irAEs also presented a higher median absolute lymphocyte count at COVID-19 (1.4 vs 0.8 109 cells/L, p=0.009). Conclusion(s): Anti-SARS-CoV-2 vaccination reduces morbidity and mortality from COVID-19 in ICI recipients. History of irAEs might identify pts with pre-existing protection from COVID-19, warranting further investigation of adaptive immune determinants of protection from SARS-CoV-2. Clinical trial identification: NCT04393974 OnCovid. Legal entity responsible for the study: Imperial College London & ESMO. Funding(s): Imperial Biomedical Research Centre ESMO. Disclosure: A. Cortellini: Financial Interests, Personal, Advisory Board: MSD, OncoC4;Financial Interests, Personal, Invited Speaker: Eisai, AstraZeneca;Financial Interests, Personal, Expert Testimony: Iqvia. D.J. Pinato: Financial Interests, Personal, Invited Speaker: ViiV Healthcare, Bayer, BMS, Roche, Eisai, Falk Foundation;Financial Interests, Personal, Advisory Board: Mina Therapuetics, Eisai, Roche, DaVolterra, AstraZeneca. All other authors have declared no conflicts of interest. Copyright © 2022 European Society for Medical Oncology

4.
Lung Cancer ; 165:S27, 2022.
Article in English | EMBASE | ID: covidwho-1996673

ABSTRACT

Introduction: There are limited options for the treatment of malignant mesothelioma (MM) following progression with pemetrexed-platinum chemotherapy. Recently, nivolumab showed a survival benefit over placebo in this setting. In the UK, since April 2020, nivolumab has been funded through the interim national COVID-19 cancer plan. We assessed the real-world efficacy and toxicity outcomes in MM patients treated with nivolumab at Guy’s Cancer Centre.Methods: We identified all chemotherapy-pre-treated patients administered single-agent nivolumab for MM. Baseline characteristics, treatment, response, survival and treatment-related adverse events (TRAEs) were assessed. Best responses – disease control or progression – were derived from radiologic and clinical documentation. Results: Twenty patients were identified. Median age was 72 years (range 45 – 85), 80% male and 95% had epithelioid (5% sarcomatoid) disease. Programmed death-ligand 1 (PD-L1) measurements were unavailable. Nineteen (95%) had pleural and one peritoneal MM. ECOG PS was 0, 1 or 2 in 1 (5%), 16 (80%) and 3 (15%) patients respectively. All were previously exposed to pemetrexed-platinum chemotherapy, and 4 (20%) had received rechallenge. Median time from prior treatment to commencement of nivolumab was 6 months. Median follow-up was 10.8 months. Median number of two-weekly 240mg equivalent cycles administered was twelve. Best response was disease control in 17 (85%) patients and progressive disease in 3 (15%). Median progression-free survival was 5.0 months (95% CI 3.7 – 6.2). Six patients (30%) had died by time of analysis, with median overall survival not reached. Twenty TRAEs were seen among 14 patients (70%), all except one graded 1/2 (Table 1). Conclusions: Nivolumab proved a safe and effective way to deliver non-myelosuppressive anticancer therapy at a favourable dosing schedule to a vulnerable population during the COVID-19 pandemic. These real-world outcomes corroborate findings from the CONFIRM trial, although limited by small sample size and retrospective nature.

5.
ESMO Open ; 7(3): 100499, 2022 06.
Article in English | MEDLINE | ID: covidwho-1821235

ABSTRACT

BACKGROUND: ESMO COVID-19 and CAncer REgistry (ESMO-CoCARE) is an international collaborative registry-based, cohort study gathering real-world data from Europe, Asia/Oceania and Africa on the natural history, management and outcomes of patients with cancer infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). PATIENTS AND METHODS: ESMO-CoCARE captures information on patients with solid/haematological malignancies, diagnosed with coronavirus disease 2019 (COVID-19). Data collected since June 2020 include demographics, comorbidities, laboratory measurements, cancer characteristics, COVID-19 clinical features, management and outcome. Parameters influencing COVID-19 severity/recovery were investigated as well as factors associated with overall survival (OS) upon SARS-CoV-2 infection. RESULTS: This analysis includes 1626 patients from 20 countries (87% from 24 European, 7% from 5 North African, 6% from 8 Asian/Oceanian centres), with COVID-19 diagnosis from January 2020 to May 2021. Median age was 64 years, with 52% of female, 57% of cancer stage III/IV and 65% receiving active cancer treatment. Nearly 64% patients required hospitalization due to COVID-19 diagnosis, with 11% receiving intensive care. In multivariable analysis, male sex, older age, Eastern Cooperative Oncology Group (ECOG) performance status ≥2, body mass index (BMI) <25 kg/m2, presence of comorbidities, symptomatic disease, as well as haematological malignancies, active/progressive cancer, neutrophil-to-lymphocyte ratio (NLR) ≥6 and OnCovid Inflammatory Score ≤40 were associated with COVID-19 severity (i.e. severe/moderate disease requiring hospitalization). About 98% of patients with mild COVID-19 recovered, as opposed to 71% with severe/moderate disease. Advanced cancer stage was an additional adverse prognostic factor for recovery. At data cut-off, and with median follow-up of 3 months, the COVID-19-related death rate was 24.5% (297/1212), with 380 deaths recorded in total. Almost all factors associated with COVID-19 severity, except for BMI and NLR, were also predictive of inferior OS, along with smoking and non-Asian ethnicity. CONCLUSIONS: Selected patient and cancer characteristics related to sex, ethnicity, poor fitness, comorbidities, inflammation and active malignancy predict for severe/moderate disease and adverse outcomes from COVID-19 in patients with cancer.


Subject(s)
COVID-19 , Hematologic Neoplasms , Neoplasms , COVID-19 Testing , Cohort Studies , Female , Humans , Male , Middle Aged , Neoplasms/epidemiology , Neoplasms/therapy , Registries , SARS-CoV-2
6.
Annals of Oncology ; 32:S1133, 2021.
Article in English | EMBASE | ID: covidwho-1432861

ABSTRACT

Background: At the height of the first wave of the SARS-COV-2 pandemic, ESMO mobilized to accelerate research for the understanding of COVID-19 in cancer patients (pts). ESMO CoCARE is an international collaborative registry-based, cohort study, gathering real-world data and information from healthcare professionals about the natural history, treatment and outcomes of COVID-19 in cancer pts. Methods: ESMO CoCARE captures information on pts with any solid or hematologic malignancy (including cancer survivors free of disease for ≥5 years) presenting with a COVID-19 diagnosis in any of the participating centers. Data collected since 06/2020 include demographics, cancer characteristics and status, co-morbidities, COVID-19 clinical features, course, management and outcome. Factors influencing COVID-19 severity (hospitalization +/- ICU support needed) and recovery are investigated using multivariable logistic regression with backward elimination method. The study is ongoing. Results: The current analysis includes 1551 registered pts (19 countries;87% pts from 23 European centers, 7% and 6% pts from 5 Northern African and 7 Asian centers), with COVID-19 diagnosis as of 11/03/2021. Median age was 64 years, with the majority female (52%), cancer stage III/IV (58%), and on active cancer treatment (60%). 65% had severe COVID-19 requiring hospitalization, with 11% receiving intensive care. In multivariable analysis, in addition to demographics (male gender, older age, other ethnicity than Caucasian, lower BMI), co-morbidities and symptomatic COVID-19, severe disease was associated to higher ECOG PS (Odds Ratio (OR)2 vs 0=5.9, OR1 vs 0=2.1), hematological malignancies (OR hemvs solid =2.0), and active/progressive cancer status (OR progressivevs no evidence of disease =1.6). 98% of pts with mild disease recovered, as opposed to only 70% of those with severe disease. Cancer stage was an additional prognostic factor for recovery (ORI/II vs IV =3.4). Conclusions: Demographic characteristics, type and status of cancer, and symptomatology of COVID-19 increase the probability of severe disease, while advanced cancer stage is also associated with the risk of death. Legal entity responsible for the study: Institut Curie, Paris, France. Funding: ESMO - European Society for Medical Oncology. Disclosure: E. Romano: Financial Interests, Institutional, Funding, Investigator-initiated trial: AstraZeneca;Financial Interests, Institutional, Funding, Investigator-initiated trial: BMS;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Merck;Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker: Pierre Fabre. R. Lee: Financial Interests, Personal, Invited Speaker: AstraZeneca;Financial Interests, Institutional, Funding: BMS. A. Croitoru: Financial Interests, Personal, Advisory Role: Ipsen;Financial Interests, Personal, Advisory Role: Astellas;Financial Interests, Personal and Institutional, Funding: Bristol-Myers Squibb;Financial Interests, Personal and Institutional, Funding: Merck;Financial Interests, Personal and Institutional, Funding: Astellas;Financial Interests, Personal and Institutional, Funding: Servier;Financial Interests, Personal and Institutional, Funding: Five Prime Therapeutics;Financial Interests, Personal and Institutional, Funding: Amgen;Financial Interests, Personal, Other, Travel funding: Merck;Financial Interests, Personal, Other, travel funding: Servier;Financial Interests, Personal, Other, travel funding: Roche. S. Susnjar: Financial Interests, Personal, Other, Honoraria and/or advisory fees: Roche;Financial Interests, Personal, Other, Honoraria and/or advisory fees: Pfizer;Financial Interests, Personal, Other, Honoraria and/or advisory fees: Novartis;Financial Interests, Personal, Other, Honoraria and/or advisory fees: AstraZeneca;Financial Interests, Personal, Other, Honoraria and/or advisory fees: Amicus. M. Rossi: Financial Interests, Personal, Other, travel and personal fees: Novartis;Financial terests, Personal, Other, travel and personal fees: Ipsen. O.A. Michielin: Financial Interests, Personal, Other, personal fees: Bristol-Myers Squibb;Financial Interests, Personal, Other, personal fees: MSD;Financial Interests, Personal, Other, personal fees: Novartis;Financial Interests, Personal, Other, personal fees: Roche;Financial Interests, Personal, Other, personal fees: Amgen;Financial Interests, Personal, Other, personal fees: NeraCare GmbH. G. Pentheroudakis: Financial Interests, Personal, Advisory Board: Amgen;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Advisory Board: Bristol Myers Squibb;Financial Interests, Personal, Advisory Board: Lilly;Financial Interests, Personal, Advisory Board: Merck;Financial Interests, Personal, Advisory Board: MSD;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Institutional, Principal Investigator: AbbVie;Financial Interests, Institutional, Research Grant: Amgen;Financial Interests, Institutional, Principal Investigator, Coordinating PI: Amgen;Financial Interests, Institutional, Research Grant: AstraZeneca;Financial Interests, Institutional, Principal Investigator: AstraZeneca;Financial Interests, Institutional, Research Grant: Boehringer Ingelheim;Financial Interests, Institutional, Funding: Boehringer Ingelheim;Financial Interests, Institutional, Funding: Bristol Myers Squibb;Financial Interests, Institutional, Principal Investigator: Bristol Myers Squibb;Financial Interests, Institutional, Principal Investigator: Debbiopharm;Financial Interests, Institutional, Funding: Enorasis;Financial Interests, Institutional, Funding: Genekor;Financial Interests, Institutional, Funding: Ipsen;Financial Interests, Institutional, Principal Investigator: Ipsen;Financial Interests, Institutional, Funding: Janssen;Financial Interests, Institutional, Principal Investigator: Lilly;Financial Interests, Institutional, Funding: Merck;Financial Interests, Institutional, Principal Investigator: Merck;Financial Interests, Institutional, Funding: MSD;Financial Interests, Institutional, Principal Investigator: MSD;Financial Interests, Institutional, Funding: Pfizer;Financial Interests, Institutional, Principal Investigator: Roche;Financial Interests, Institutional, Research Grant: Roche;Financial Interests, Institutional, Funding: Sanofi;Financial Interests, Institutional, Principal Investigator, Coodinating Pi: Servier;Financial Interests, Institutional, Funding: Servier. S. Peters: Consultation / Advisory role: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Biocartis, Bio Invent, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, Elsevier, F. Hoffmann-La Roche/Genentech, Foundation Medicine, Illumina, Incyte, IQVIA, Janssen, Medscape, Merck Sharp and Dohme, Merck Serono, Merrimack, Mirati, Novartis, PharmaMar, Phosplatin Therapeutics, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda, Vaccibody. Talk in a company’s organized public event: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, e-cancer, Eli Lilly, F. Hoffmann-La Roche/Genentech, Illumina, Medscape, Merck Sharp and Dohme, Novartis, PER, Pfizer, Prime, RTP, Sanofi, Takeda. Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, F. Hoffmann-La Roche/Genentech, GSK, Illumina, Lilly, Merck Sharp and Dohme, Merck Serono, Mirati, Novartis, and Pfizer, Phosplatin Therapeutics. All other authors have declared no conflicts of interest.

7.
Annals of Oncology ; 32:S64-S65, 2021.
Article in English | EMBASE | ID: covidwho-1333195

ABSTRACT

Background: CDK4-6 inhibitors are now considered the standard of care for advanced ER-positive HER2-negative advanced breast cancer (ABC) in combination with endocrine therapy (ET). During the first wave of the COVID-19 pandemic, clinicians were uncertain what impact CDK4-6 inhibitor-induced immunosuppression may have on the risk of contracting COVID-19 or the severity of infection. Some clinicians pre-emptively reduced doses, altered schedules, or even withheld treatment, continuing ET alone. There is currently no evidence that CDK4-6 inhibitors increase the risk or severity of COVID-19 infection, although there have reports of protracted illness. We describe our experience of 203 patients receiving CDK4-6 inhibitors during the first wave and demonstrate the safety of continuing treatment during this period. Methods: Epidemiological and clinical data were collected prospectively for patients at the Royal Marsden Hospital (RMH) and one network hospital with a ER-positive HER2-negative ABC that were receiving a CDK4-6 inhibitor between April 1st and June 30th 2020. Results: 200 patients received a CDK4-6 inhibitor in combination with ET, of which of 65/200 fulfilled local criteria to be screened with COVID-19 PCR testing and 6/65 were swab-positive. Two patients required hospital admission but there were no ICU admissions or COVID-19-associated deaths. Only 12 patients (6%) had treatment adjustments in the form of dose reduction (3/12), regime adjustment (2/12), or temporary interruption (7/12). In 9/12 cases this was a prophylactic measure due to additional risk factors;age (n=1), co-morbidities(n=3), patient choice (n=1) or overall concerns (n=4) to reduce the risk of contracting COVID-19. Results on dispensing >2 cycles at a time, telephone clinics, deferred CT scans and complications relating due to remote monitoring will also be reported. Conclusions: Based on this snapshot during the first wave of the COVID-19 pandemic, we conclude that continuation of CDK4-6 inhibitors appears safe. This project is helping to drive a UK-wide review of CDK4-6 inhibitor treatment continuation, adjustment during the pandemic, assessing the risk of acquiring clinically severe COVID-19 infection, and subsequent cancer-related outcomes for these patients. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: S.R.D. Johnston: Advisory/Consultancy: Eli Lilly;Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca;Advisory/Consultancy, Research grant/Funding (institution): Puma Biotechnology;Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Pfizer;Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis;Speaker Bureau/Expert testimony: Eisai;Research grant/Funding (institution), Clinical Trials: Roche/Genentech;Research grant/Funding (institution), Clinical Trials: Eli Lilly;Research grant/Funding (institution), Clinical Trials: Pfizer;Research grant/Funding (institution), Clinical Trials: AstraZeneca;Research grant/Funding (institution), Clinical Trials: Novartis;Research grant/Funding (institution), Laboratory studies: Pfizer;Research grant/Funding (institution), Laboratory studies: Puma Biotechnology. A. Okines: Research grant/Funding (self): Pfizer;Honoraria (self): Leo Pharma;Speaker Bureau/Expert testimony: Seagen;Advisory/Consultancy: Roche;Research grant/Funding (self): Roche;Honoraria (self): AstraZeneca;Advisory/Consultancy: Seagen. S. McGrath: Speaker Bureau/Expert testimony: Pfizer. All other authors have declared no conflicts of interest.

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