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2.
Annals of Oncology ; 33:S657, 2022.
Article in English | EMBASE | ID: covidwho-2041523

ABSTRACT

Background: The poly(ADP-ribose) polymerase inhibitor niraparib showed clinical activity in advanced gBRCAm ovarian and breast cancers. LUZERN aims to assess the effectiveness of niraparib plus AI in HR+/HER2–, AI-resistant ABC with a pathogenic variant in homologous recombination-related genes. Here we report findings from the stage 1 interim analysis. Methods: This open-label, single-arm, Simon’s 2-stage, phase II trial is enrolling HR+/HER2– ABC patients (pts) with gBRCAm (cohort A;n=6 in stage 1, n=7 in stage 2) and gBRCA wild-type/HRd (cohort B;n=9 in stage 2). Pts had to have received ≤1 prior line of chemotherapy for ABC, 1–2 prior lines of endocrine therapy for early or ABC with secondary endocrine resistance to the last AI regimen. Pts receive niraparib (200/300mg daily orally) plus AI (same agent given with the prior regimen) on each 28-day cycle. Primary endpoint: clinical benefit rate (CBR) as per RECIST 1.1. Secondary endpoints: overall response rate, progression-free survival (PFS), and safety per CTCAE 5.0. If ≥1/6 pts experienced clinical benefit, the trial should proceed to stage 2. Results: Six pts were enrolled in stage 1. Median age was 46 years (range 32–76), 66.7% of pts had visceral disease, and 83.3% had received prior CDK4/6 inhibitor-containing regimen for ABC. At data cut-off, 50.0% of pts were ongoing and median duration of treatment was 4.6 months (range 2.4–5.7). One patient achieved complete response, meeting the criterion to proceed to stage 2. Median investigator-assessed PFS was 5.3 months (95%CI 3.9–NA). The most frequent adverse events (AEs) of any grade (G) were nausea (3 [50.0%]), neutropenia (2 [33.3%];16.7% G3), constipation (2 [33.3%]), and vomiting (1 [16.7%]). Serious AEs occurred in 3 pts (50.0%;G3 COVID-19 pneumonia;G3 pseudomonal bacteriemia;G2 sacral pain). No treatment-related discontinuations/deaths were reported. Conclusions: Niraparib plus AI showed preliminary activity with a tolerable safety profile in gBRCAm HR+/HER2– AI-resistant ABC pts. Based on the steering committee recommendation, enrolment in cohorts A and B is ongoing. Clinical trial identification: ClinicalTrials.gov identifier: NCT04240106. Legal entity responsible for the study: MEDSIR. Funding: GlaxoSmithKline. Disclosure: J.Á. García Saenz: Financial Interests, Personal, Advisory Board: Seagen, Gilead;Financial Interests, Personal, Invited Speaker: Novartis, Celgene, Eli Lilly, Eisai, AstraZeneca, Daiichi Sankyo, MSD, Exact Sciences;Financial Interests, Institutional, Funding: AstraZeneca. J. De la Haba Rodriguez: Financial Interests, Personal, Other, Consultant and Advisory Role, Research Funding and Speaking: Pfizer, Novartis, Roche, Lilly;Financial Interests, Personal, Other, grant support: Pfizer. J.E. Ales Martínez: Financial Interests, Personal, Other, travel grant: Pfizer;Financial Interests, Personal, Research Grant: MEDSIR. E. Alba Conejo: Financial Interests, Personal, Advisory Role: Roche, Novartis, Pfizer, Lilly, BMS, Astrazeneca, Pierre Fabre, Daiichi, Exact Sciences;Financial Interests, Personal, Research Grant: Pfizer. J. Balmaña: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer;Financial Interests, Institutional, Other, Steering committee member: AstraZeneca;Financial Interests, Institutional, Principal Investigator: Medsir, Pfizer. J.M. Perez Garcia: Financial Interests, Personal, Advisory Role: Lilly,Roche, Eisai, Daichii Sankyo, AstraZeneca, Seattle Genetics, Medsir;Financial Interests, Personal, Other, travel expenses: Roche. M. Sampayo-Cordero: Financial Interests, Personal, Other, honoraria: Medsir, Syntax for Science, Optimapharm, and Ability pharma;Financial Interests, Personal, Research Grant: Medsir;Financial Interests, Personal, Other, travel expenses: Medsir, Syntax for Science, Optimapharm, and Roche;Financial Interests, Personal, Other, consultant: Medsir, Syntax for Science, and Optimapharm;Financial Interests, Personal, Speaker’s Bureau: Medsir;Financial Interests, Personal, Full or part-time Employment: Me sir. A. Malfettone: Non-Financial Interests, Personal, Full or part-time Employment: MEDSIR. J. Cortés: Financial Interests, Personal, Advisory Role: Roche, Celgene, Cellestia, Astrazeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp&Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks;Financial Interests, Personal, Other, honoraria: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, Merck Sharp&Dohme, Daiichi Sankyo;Financial Interests, Institutional, Research Grant: Roche, Ariad pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, F.Hoffman-La Roche, Guardanth health, Merck Sharp&Dohme, Pfizer, Piqur Therapeutics, Puma C, Queen Mary University of London.;Financial Interests, Personal, Stocks/Shares: MEDSIR, Nektar Pharmaceuticals, Leuko (relative);Financial Interests, Personal, Other, travel, accomodation: Roche, Novartis, Eisai, pfizer, Daiichi Sankyo, Astrazeneca. A. Llombart Cussac: Financial Interests, Personal, Leadership Role: Eisai, Celgene, Lilly, Pfizer, Roche, Novartis, and MSD;Financial Interests, Personal, Stocks/Shares: MEDSIR and Initia-Research;Financial Interests, Personal, Advisory Role: Lilly, Roche, Pfizer, Novartis, Pierre-Fabre, GenomicHealth, GSK;Financial Interests, Personal, Speaker’s Bureau: Lilly, AstraZeneca, and MSD;Financial Interests, Personal, Research Grant: Roche, Foundation Medicine, Pierre-Fabre, and Agendia;Financial Interests, Personal, Other, travel compensation: Roche, Lilly, Novartis, Pfizer, and AstraZeneca. All other authors have declared no conflicts of interest.

3.
Annals of Oncology ; 33:S594-S595, 2022.
Article in English | EMBASE | ID: covidwho-2041518

ABSTRACT

Background: Many patients fail to achieve a clinical benefit from ICI. Several scores have been developed to improve ICI candidates selection but it is uncertain which one better predicts patients’ outcome. Here, we performed a direct comparison of the most successful scores. Methods: This is a sub-analysis of the immunoblood prospective observational study that enrolled patients diagnosed with advanced solid tumors treated with ICI. Main clinicopathological data were retrieved from medical records and responses assessed according to RECIST 1.1 criteria. LIPI, RMH, PMH, dNLR, NLR, PIPO and GRIm scores were calculated. Receiving operator characteristics (ROC) curves and their area under curve (AUC) were used to predict PFS and durable clinical benefit (DCB;stable disease≥6 months or better). Associations with PFS, OS and DCB, where assessed with Cox and logistic regressions. Scores’ correlation was assessed with Spearman rho. Significance was set at p<0.05. Results: We recruited 155 patients (65% male, mean age 63). NSCLC (28%), colorectal (20%) breast (9%) H&N (6%) cancer and melanoma (6%) were the most frequent tumor types. Frequency of the high risk/bad outcome group of each score were: LIPI 13%, RMH 36%, PMH 54%, GRIm 14%, PIPO 6%, NLR 32% and dNRL 27%. Fair accuracy in identifying patients at higher risk of progression or mild accuracy in predicting DCB were observed for the RMH (AUC PFS: 0.7, 95%CI: 0.6-0.8;AUC DCB: 0.6, 0.5-0.8) and LIPI (AUC PFS: 0.7, 95%CI: 0.6-0.8;AUC: 0.6, 0.5-0.7) scores. All other scores provided poor/no accuracy. No significant difference was observed between RMH and LIPI AUC for PFS and DCB (both p>0.05). Additionally, only LIPI and RMH were associated with PFS (p=0.001;p<0.001), OS (p<0.001;p=0.001) and DCB (p=0.034;p=0.010) at univariate analyses. At multivariate analyses RMH and LIPI remained significantly associated with PFS (p=0.030;p=0.021) and OS (p=0.012;p<0.001). A strong correlation between both scores (rho=0.72, p<0.001) was observed. Conclusions: RMH and LIPI scores were sufficiently reliable in assessing the prognosis of patients with advanced solid tumors treated with ICI. They were superior to other analyzed scores in our population and highly correlated. Legal entity responsible for the study: Hospital Clinic y Provincial de Barcelona, Medical Oncology Department. Funding: Has not received any funding. Disclosure: J. Garcia-Corbacho: Financial Interests, Personal, Advisory Board, FGFR inhibitors implementation in clinical practice: Johnson & Johnson Pharmaceutical;Financial Interests, Institutional, Invited Speaker, Participation in clinical trials of the company as PI: Johnson and Johnson Pharmaceutical, Boehringer Ingelheim, Astellas, Cytomx, Incyte, Lilly, Menarini, Merck, Bayer, AstraZeneca, Amgen, Daiichi Sankyo. 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. N. Baste Rotllan: Non-Financial Interests, Advisory Role: Eisai, MSD, Merck Serono, BioNTech, Roche, BMS, Exelixis. A. Prat: Financial Interests, Personal, Invited Speaker: Roche;Financial Interests, Personal, Invited Speaker, Lecture fees: Novartis, Daiichi Sankyo;Financial Interests, Personal, Advisory Board, Advisory role/consultancy: Novartis, Pfizer, BMS, Puma, Oncolytics Biotech, MSD, Guardant Health, Peptomyc;Financial Interests, Institutional, Invited Speaker, Clinical trials: Daiichi Sankyo;Financial Interests, Institutional, Other, Contracted research: Boehringer, Medica Scientia Inno. Research;Financial Interests, Personal, Advisory Board: AstraZeneca;Financial Interests, Personal, Invited Speaker, Leadership role: Reveal Genomics, SL.;Financial I terests, Personal, Stocks/Shares: Reveal Genomics, Oncolytics Biotech;Financial Interests, Personal, Royalties: Reveal Genomics;Financial Interests, Institutional, Invited Speaker: Roche, AstraZeneca, Novartis;Financial Interests, Personal and Institutional, Invited Speaker: Daiichi Sankyo;Non-Financial Interests, Institutional, Other, Leadership roles: Patronage committee: SOLTI Foundation, Actitud Frente al Cáncer Foundation. All other authors have declared no conflicts of interest.

5.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005653

ABSTRACT

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).

7.
Annals of Oncology ; 32:S1132, 2021.
Article in English | EMBASE | ID: covidwho-1432859

ABSTRACT

Background: Early reports from registry studies demonstrated high vulnerability of cancer patients from COVID-19, with case-fatality rates (CFR) >30% at the onset of the pandemic. With advances in disease management and increased testing capacity, the lethality of COVID-19 in cancer patients may have improved over time. Methods: The OnCovid registry lists European cancer patients consecutively diagnosed with COVID-19 in 35 centres from Jan 2020 to Feb 2021. We analysed clinical characteristics and outcomes stratified in 5 trimesters (Jan-Mar, Apr-Jun, Jul-Sep, Oct-Dec 2020 and Jan-Feb 2021) and studied predictors of mortality across 2 semesters (Jan-Jun 2020 and Jul 2020-Feb 2021). Results: At data cut-off, the 2634 eligible patients demonstrated significant time-dependant improvement in 14-days CFR with trimestral estimates of 29.8%, 20.3%, 12.5%, 17.2% and 14.5% (p<0.0001). Compared to the 2nd semester, patients diagnosed in the Jan-Jun 2020 time period were ≥65 (60.3% vs 56.1%, p=0.031) had ≥2 comorbidities (48.8% vs 42.4%, p=0.001) and non-advanced tumours (46.4% vs 56.1%, p<0.001). COVID-19 was more likely to be complicated in Jan-Jun 2020 (45.4% vs 33.9%, p<0.001), requiring hospitalization (59.8% vs 42.1%, p<0.001) and anti-COVID-19 therapy (61.7% vs 49.7%, p<0.001). The 14-days CFR for the 1st and 2nd semester was 25.6% vs 16.2% (p<0.0001), respectively. After adjusting for gender, age, comorbidities, tumour features, COVID-19 and anti-cancer therapy and COVID-19 complications, patients diagnosed in the 1st semester had an increased risk of death at 14 days (HR 1.68 [95%CI: 1.35-2.09]), but not at 3 months (HR 1.10 [95%CI: 0.94-1.29]) compared to those from the 2nd semester. Conclusions: We report a time-dependent improvement in the mortality from COVID-19 in European cancer patients. This may be explained by expanding testing capacity, improved healthcare resources and dynamic changes in community transmission over time. These findings are informative for clinical practice and policy making in the context of an unresolved pandemic. Clinical trial identification: NCT04393974. Legal entity responsible for the study: Imperial College London. Funding: Has not received any funding. Disclosure: D.J. Pinato: Financial Interests, Personal, Speaker’s Bureau: ViiV Healthcare;Financial Interests, Personal, Speaker’s Bureau: Bayer;Financial Interests, Personal, Advisory Board: EISAI;Financial Interests, Personal, Advisory Board: Roche;Financial Interests, Personal, Advisory Board: AstraZeneca. All other authors have declared no conflicts of interest.

9.
Annals of Oncology ; 31:S1366-S1366, 2020.
Article in English | PMC | ID: covidwho-1384958

ABSTRACT

Background: There is uncertainty as to the contribution of cancer patients' features on severity and mortality from Covid-19 and little guidance as to the role of anti-cancer and anti-Covid-19 therapy in this population. Method(s): OnCovid is a retrospective observational study conducted across 19 European centers that recruited cancer patients aged >18 and diagnosed with Covid-19 between 26/02 and 01/04/2020. Uni- and multivariable regression models were used to evaluate predictors of Covid-19 severity and mortality. Result(s): We identified 890 patients from UK (n=218, 24%), Italy (n=343, 37%), Spain (n=323, 36%) and Germany (n=6, 1%). Most patients were male (n=503, 56%) had a diagnosis of solid malignancy (n=753, 84%) and 556 (62%) had active disease. Mean (+/-SD) patient age was 68+/-13 years, and 670 (75%) had >1 co-morbidity, most commonly hypertension (n=386, 43%). Commonest presenting symptoms were fever (n=569, 63%) and cough (n=448, 50%), beginning 6.3 (+/-9.5 SD) days before diagnosis. Most patients (n=565, 63%) had >1 complication from Covid-19, including respiratory failure (n=527, 59%) and acute respiratory distress syndrome (n=127, 22%). In total, 110 patients (14%) were escalated to high-dependency or intensive care. At time of analysis, 299 patients had died (33%). Multi-variate logistic regression identified male gender, age>65 (p<0.0001) presence of >2 comorbidities (p=0.001) active malignancy (p=0.07) as predictors of complicated Covid-19. Mortality was associated with active malignancy (p<0.0001), age>65 and co-morbid burden (p=0.002). Provision of chemotherapy, targeted therapy or immunotherapy was not associated with higher mortality. Exposure to anti-malarials alone (chloroquine/hydroxychloroquine, n=182, p<0.001) or in combination with anti-virals (n=195, p<0.001) or tocilizumab (n=51, p=0.004) was associated with improved mortality compared to patients who did not receive any of these therapies (n=446) independent of patients' gender, age, tumour stage and severity of Covid-19. Conclusion(s): This study highlights the clinical utility of demographic factors for individualized risk-stratification of patients and supports further research into emerging anti Covid-19 therapeutics in SARS-Cov-2 infected cancer patients. Clinical trial identification: NCT04393974. Legal entity responsible for the study: Imperial College London. Funding(s): Has not received any funding. Disclosure: D.J. Pinato: Speaker Bureau/Expert testimony: ViiV Healthcare;Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer;Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Honoraria (self), Advisory/Consultancy: MiNa Therapeutics;Advisory/Consultancy: Eisai;Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy: AstraZeneca;Research grant/Funding (institution): MSD. All other authors have declared no conflicts of interest.Copyright © 2020 European Society for Medical Oncology

10.
Journal of Clinical Oncology ; 39(15 SUPPL), 2021.
Article in English | EMBASE | ID: covidwho-1339187

ABSTRACT

Background: Despite high contagiousness and rapid spread, SARS-Cov-2 has led to heterogeneous outcomes across affected nations. Within Europe, the United Kingdom is the most severely affected country, with a death toll in excess of 100.000 as of February 2021. We aimed to compare the national impact of Covid19 on the risk of death in UK cancer patients versus those in continental Europe (EU). Methods: We performed a retrospective analysis of the OnCovid study database, a European registry of cancer patients consecutively diagnosed with Covid-19 in 27 centres from February 27 to September 10, 2020. We analysed case fatality rates and risk of death at 30 days and 6 months stratified by region of origin (UK versus EU). We compared patient characteristics at baseline, oncological and Covid-19 specific therapy across cohorts and tested these in multivariable Cox regression models to identify predictors of adverse outcome in UK versus EU patients. Results: Compared to EU patients (n = 924), UK patients (n = 468) were characterised by higher case fatality rates (40.38% versus 26.5%, p < 0.0001), higher risk of death at 30 days (hazard ratio, HR 1.64 [95%CI 1.36-1.99]) and 6 months after Covid-19 diagnosis (47.64% versus 33.33%, p < 0.0001, HR 1.59 [95%CI 1.33-1.88]). UK patients were more often males, of older age and more co-morbid than EU counterparts (p < 0.01). Receipt of anti-cancer therapy was lower in UK versus EU patients (p < 0.001). Despite equal proportions of complicated Covid-19, rates of intensive care admission and use of mechanical ventilation, UK cancer patients were less likely to receive anti-Covid-19 therapies including corticosteroids, anti-virals and interleukin-6 antagonists (p < 0.0001). Multivariable analyses adjusted for imbalanced prognostic factors confirmed the UK cohort to be characterised by worse risk of death at 30 days and 6 months, independent of patient's age, gender, tumour stage and status, number of co-morbidities, Covid-19 severity, receipt of anti-cancer and anti-Covid-19 therapy. Rates of permanent cessation of anti-cancer therapy post Covid-19 were similar in UK versus EU. Conclusions: UK cancer patients have been more severely impacted by the unfolding of the Covid-19 pandemic despite societal risk mitigation factors and rapid deferral of anti-cancer therapy. The increased frailty of UK cancer patients highlights high-risk groups that should be prioritised for anti-SARS-Cov-2 vaccination. Continued evaluation of long-term outcomes is warranted.

15.
Journal of Thoracic Oncology ; 16(3):S141, 2021.
Article in English | EMBASE | ID: covidwho-1160568

ABSTRACT

Introduction: COVID-19 pandemic has drastically changed the management of patients with cancer. The prioritization of the healthcare towards COVID-19 patients could interfere with the initial diagnosis, resulting in delayed treatment and worse outcome. We aimed to study the incidence of lung cancer new diagnosis, severity and clinical outcomes during Covid-19-period (during-COVID) compared to the same period in 2019 (before-COVID). Methods: Bicenter retrospective cohort study of newly diagnosed non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) patients before (Jan-Jun/19) and during COVID-19 (Jan-Jun/20) in Spain. Clinical data were collected. We primarily assessed the difference on new lung cancer cases between both periods, and the disease severity considering: Performance status (PS), stage and any significant complication at diagnosis. Secondarily, we assessed the 30 days-mortality rate, progression-free survival (PFS) and overall survival (OS) by period. Results: 162 newly diagnosed lung cancer patients (68% NSCLC and 32% SCLC) were enrolled, with median age of 66 years, 70% were male, 33% smokers, 25% with PS ≥2. Advanced disease was diagnosed in 50% of NSCLC and 61% SCLC;13% of NSCLC harbored driver alterations. During-COVID, the number of new cases diagnosed decreased by 38% (43 NSCLC;19 SCLC), compared to before-COVID period (67 NSCLC;33 SCLC). More symptomatic cases were new diagnosed during vs. before-COVID. The Table 1 summarized clinical data and complications of new lung cancer cases by period and histology. In NSCLC population diagnosed during-COVID, we observed more respiratory symptoms at diagnosis (30% vs. 23% before-COVID) with mainly locally-advanced/advanced disease (82% vs. 76% before-COVID). Among the cases hospitalized, the mortality during-hospitalization was 44% (2/9) vs. 17% before-COVID. In SCLC population diagnosed during-COVID, respiratory symptoms were more common (32% vs. 24% before-COVID), but no more aggressive disease observed in terms of stage, complications and hospitalizations. Among the 4 cases hospitalized at diagnosis, none died during-hospitalization vs. 18% before-COVID (2/11). Overall, during-Covid the mOS was 6.7 months [95% CI, 5.4-not reached] vs. 7.9 months [95% CI, 4.7-12] before-COVID. In NSCLC, the 30-days mortality was 49% vs. 25% before-COVID;in SCLC, it was 32% vs. 18% before-COVID. Updated data and treatment outcomes will be presented in the meeting. [Formula presented] Conclusion: Lung cancer diagnosis has been affected during the COVID-19 pandemic with fewer cases diagnosed and more symptomatic disease compared to 2019, which seems to be associated with worse outcomes. This study is still ongoing. Keywords: NSCLC, SCLC, COVID-19

16.
Journal of Thoracic Oncology ; 16(3):S294-S295, 2021.
Article in English | EMBASE | ID: covidwho-1159484

ABSTRACT

Introduction: Covid-19 pandemic has drastically changed the management of patients with cancer;however, there is still limited data regarding the real impact of Covid-19 on patient’s outcomes due to delayed diagnosis and treatment of clinical complications. We aimed to assess the prevalence, severity and mortality of clinical complications and oncology emergencies in hospitalized patients in our institution during the Covid19 period vs. the same period of 2019. Methods: We conducted a retrospective study of patients with small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) who were admitted to the Department of Medical Oncology during Jan-Jun 2019 (before-Covid) and Jan-Jun 2020 (Covid-19 period). Clinical, pathological and biological data were collected. We assessed the clinical severity in both periods including: PS at admission, progression disease (PD), oncologic emergencies (%), start of a systemic therapy or switch to other therapy line. We also analyzed the differences on the 30-day mortality rate since hospitalization between both periods. Results: 229 admissions, 133 during and 93 before Covid-19 pandemic (N=180 patients) were enrolled;the median duration of the hospitalization was 9 days (4-16). Median age was 66 years, 35% were female, 88% with PS≥2, 27% were current smokers;83% had NSCLC histology. Most of them (82%) had advanced disease at admission;69% were under systemic therapy (chemotherapy 39%, immunotherapy 17%, targeted therapies 11%). Nine patients (4%) were active covid-19 cases (9 NSCLC, 0 SCLC). The table 1 summarized the most common clinical conditions by histology, in both periods. In NSCLC population, during-Covid, lower rate of admissions were observed (4 cases less per month), with no increase of oncologic emergencies. The PD during hospitalization was slightly higher during vs. before-Covid, but no differences were observed in 30-days mortality rate. In SCLC population, during-Covid, the rate of admissions was doubled (2 cases more per month), with more cases progressing during the hospitalization. (46% during vs. 34% before-Covid). In contrast to NSCLC, the 30-days mortality rate was higher during-Covid (38%) vs. before-Covid (20%). Updated data will be presented in the meeting. [Formula presented] Conclusion: We preliminary observed more aggressive disease with worse outcomes in patients with SCLC hospitalized during-Covid compared to the same period in 2019. No differences were observed in NSCLC. The final outcomes will be assessed in a larger and mature cohort still ongoing. Keywords: lung cancer, COVID-19, hospitalization

17.
Roeker, L. E.; Scarfo, L.; Chatzikonstantinou, T.; Abrisqueta, P.; Eyre, T. A.; Cordoba, R.; Prat, A. M.; Villacampa, G.; Leslie, L. A.; Koropsak, M.; Quaresmini, G.; Allan, J. N.; Furman, R. R.; Bhavsar, E. B.; Pagel, J. M.; Hernandez-Rivas, J. A.; Patel, K.; Motta, M.; Bailey, N.; Miras, F.; Lamanna, N.; Alonso, R.; Osorio-Prendes, S.; Vitale, C.; Kamdar, M.; Baltasar, P.; Osterborg, A.; Hanson, L.; Baile, M.; Rodriguez-Hernandez, I.; Valenciano, S.; Popov, V. M.; Garcia, A. B.; Alfayate, A.; Oliveira, A. C.; Eichhorst, B.; Quaglia, F. M.; Reda, G.; Jimenez, J. L.; Varettoni, M.; Marchetti, M.; Romero, P.; Grau, R. R.; Munir, T.; Zabalza, A.; Janssens, A.; Niemann, C. U.; Perini, G. F.; Delgado, J.; San Segundo, L. Y.; Roncero, M. I. G.; Wilson, M.; Patten, P.; Marasca, R.; Iyengar, S.; Seddon, A.; Torres, A.; Ferrari, A.; Cuellar-Garcia, C.; Wojenski, D.; El-Sharkawi, D.; Itchaki, G.; Parry, H.; Mateos-Mazon, J. J.; Martinez-Calle, N.; Ma, S.; Naya, D.; Van der Spek, E.; Seymour, E. K.; Vazquez, E. G.; Rigolin, G. M.; Mauro, F. R.; Walter, H. S.; Labrador, J.; De Paoli, L.; Laurenti, L.; Ruiz, E.; Levin, M. D.; Simkovic, M.; Spacek, M.; Andreu, R.; Walewska, R.; Perez-Gonzalez, S.; Sundaram, S.; Wiestner, A.; Cuesta, A.; Broom, A.; Kater, A. P.; Muina, B.; Velasquez, C. A.; Ujjani, C. S.; Seri, C.; Antic, D.; Bron, D.; Vandenberghe, E.; Chong, E. A.; Lista, E.; Garcia, F. C.; Del Poeta, G.; Ahn, I.; Pu, J. J.; Brown, J. R.; Campos, J. A. S.; Malerba, L.; Trentin, L.; Orsucci, L.; Farina, L.; Villalon, L.; Vidal, M. J.; Sanchez, M. J.; Terol, M. J.; De Paolis, M. R.; Gentile, M.; Davids, M. S.; Shadman, M.; Yassin, M. A.; Foglietta, M.; Jaksic, O.; Sportoletti, P.; Barr, P. M.; Ramos, R.; Santiago, R.; Ruchlemer, R.; Kersting, S.; Huntington, S. F.; Herold, T.; Herishanu, Y.; Thompson, M. C.; Lebowitz, S.; Ryan, C.; Jacobs, R. W.; Portell, C. A.; Isaac, K.; Rambaldi, A.; Nabhan, C.; Brander, D. M.; Montserrat, E.; Rossi, G.; Garcia-Marco, J. A.; Coscia, M.; Malakhov, N.; Fernandez-Escalada, N.; Skanland, S. S.; Coombs, C. C.; Ghione, P.; Schuster, S. J.; Foa, R.; Cuneo, A.; Bosch, F.; Stamatopoulos, K.; Ghia, P.; Mato, A. R.; Patel, M..
Blood ; 136:14, 2020.
Article in English | Web of Science | ID: covidwho-1088505
18.
Multiple Sclerosis Journal ; 26(3 SUPPL):555, 2020.
Article in English | EMBASE | ID: covidwho-1067121

ABSTRACT

Background: Neurological disability progression occurs across the spectrum of people living with multiple sclerosis (PwMS). Currently, no treatments exist that substantially modify the course of clinical progression in MS, one of the greatest unmet needs in clinical practice. Characterizing the determinants of clinical progression is essential for the development of novel therapeutic agents and treatment approaches that target progression in PwMS. Objectives: The overarching aim of CanProCo is to evaluate a wide spectrum of factors associated with the onset and rate of disease progression in MS, and to describe how these factors interact with one another to influence progression. Methods: CanProCo is a prospective, observational cohort study aiming to recruit 1000 individuals with radiologically-isolated syndrome (RIS), relapsing-remitting MS (RRMS), and primary-progressive MS (PPMS) within 10-15 years of disease onset, and 50 healthy controls (HCs) from five large academic MS centers in Canada. Participants undergo detailed clinical evaluations annually. A subset of participants enrolled within 5-10 years of disease onset (n=500) also have blood, cerebrospinal fluid, and MRIs collected facilitating study of biological measures (e.g. single-cell RNAsequencing[ scRNASeq]), MRI-based microstructural assessment, participant characteristics (self-reported, performance-based, clinician- assessed, health-system based), and environmental factors as determinants contributing to the differential progression in MS. Results: Recruitment commenced in April/May 2019 and n=536 patients have been recruited to date (RRMS=457, PPMS=35, RIS=25, HC=19). Baseline age, sex distribution, and Expanded Disability Status Scale (EDSS) scores (median, range) of each subgroup are: RRMS=38 years, 73% female, EDSS=1.5 (0-6.0);PPMS=52 years, 40% female, EDSS=4.0 (1.5-6.5);RIS=41 years, 68% female, EDSS=0 (0-3.0);HC=37 years, 63% female. Recruitment has surpassed the 50% target but has been paused due to the COVID-19 pandemic. scRNASeq on frozen blood samples has been validated. Conclusions: Halting the progression of MS is a fundamental clinical need to improve the lives of PwMS. Achieving this requires leveraging transdisciplinary approaches to better characterize mechanisms underlying clinical progression. CanProCo is the first prospective cohort study aiming to characterize these determinants to inform the development and implementation of efficacious and effective interventions.

19.
Multiple Sclerosis Journal ; 26(3 SUPPL):169-170, 2020.
Article in English | EMBASE | ID: covidwho-1067111

ABSTRACT

Background: Natalizumab (NZB) is a disease-modifying treatment (DMT) used in persons with MS (PwMS) with an active relapsing course, either as a first-line, or after previous treatments. The principal biological effect of NZB is thought to be the blockade of the molecular interaction between β4β1-integrin (also known as very late antigen-4) expressed by mononuclear inflammatory cells, and vascular cell adhesion molecule-1 (CAM-1) expressed by cerebral vascular endothelial cells. NZB is a potent DMT which must be monitored with caution, its use being hampered by the risk of opportunistic infections, mostly progressive multifocal leukoencephalopathy (PML). Objectives: To document the efficacy and safety of NZB for the treatment of RRMS in a population of persons with MS (PwMS) followed in a regular MS Clinic setting. Methods: We report our single-centre experience over a period of 13 years: from JAN 2007 through the end of May 2020. All PwMS treated with NZB were included, regardless of the treatment duration. The retainment of patients in our MS Clinic is 95%. We use the iMed database, an international MS registry. . Results: We report on 230 PwMS, 159 women, 71 men treated with NZB since 2007, up to 30 April 2020. We had no PML case. We had 2 PML 'clinical alerts', but CSF search for JC virus (JCV) was negative. There was no rebound of activity, nor IRIS, after NZB cessation, as we usually quickly switch to an alternative DMT. Median age at MS onset: 26.3 years. Median age at NZB initiation: 35 years. Median disease duration before treatment: 8.07 years. First line use: 94. Previous BRACE DMT: 136. Risk factors: previous immuno-suppression: 7;NZB duration > 24 months: 112;JCV index > 1: 81. Median treatment duration: 23 months;still active: 71 including 7 after > 6 years. ARR at NZB onset: 1.5;during NZB: 0.27;current: 0.89. Median EDSS at NZB start: 3.0. Current median EDSS: 2.8. EDSS stable: 65, worsened: 58;improved: 60. MRI: stable: 133 (58%) ;improved: 5 (2%);worsened: 35 (25%). Conversion to SPMS: 48 (20%) 29 W, 19 M. Reasons for NZB cessation: planned: 27;pregnancy: 3;loss of efficacy: 39;increased JCV index: 62. No blood toxicity (CBC, ALT). We had 9 pregnancies: 4 planned interruptions;5 full term, with normal babies. Treatment after NZB cessation: 48 fingolimod, glatiramer: 17;ocrelizumab: 16;others: 29;none: 32 (no rebound observed). One patient had COVID 1 year after NZB: complete recovery;needed only nasal O2 during 3 day hospital admission. Conclusions: NZB, when used with caution, is an effective and safe MS DMT during the RRMS phase, even after extended disease and treatment durations. NZB is most effective to reduce relapse frequency, less effective against progression, as 20% of PwMS transited to the secondary progressive phase. Gender, disease duration, and age do not influence outcomes. We encountered no significant toxicity, in particular no PML. Clinical, JCV index measures, and MRI monitoring are paramount to maintain safety.

20.
Annals of Oncology ; 31:S996, 2020.
Article in English | EMBASE | ID: covidwho-806073

ABSTRACT

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.

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