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1.
Chest ; 162(4):A825, 2022.
Article in English | EMBASE | ID: covidwho-2060696

ABSTRACT

SESSION TITLE: COVID-19 Case Report Posters 2 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Coronavirus disease 2019 (COVID-19) is an enveloped positive stranded RNA virus that affects multiple organ systems in the body. COVID-19 venous and thromboembolic events are well documented;however, few reports of arterial thrombosis exist. Arterial embolism is reported to occur in one to five percent of patients. We present a case of a patient who experienced arterial thromboembolism. CASE PRESENTATION: A 38-year-old woman with a history of diabetes, hypertension, and recent COVID-19 pneumonia three weeks prior presented to the hospital for lower extremity weakness, paresthesias, and pain in her bilateral lower extremities. Upon examination, she was found to have bilateral cold feet, lack of sensation to toes or plantar aspect of feet, nondopplerable pedal or dorsalis pedis pulses bilaterally, dopplerable femoral pulses bilaterally. A CT angiogram of the abdomen with bilateral runoff revealed distal abdominal aortic and bilateral iliac artery thrombus, thrombus in bilateral runoff arteries. She was evaluated by vascular and started on a heparin drip. She underwent bilateral iliofemoral thromboembolectomy and bilateral iliac stents. Surgery recommended allowing demarcation in the outpatient setting, however, due to intractable pain vascular surgery determined that bilateral below the knee amputations were necessary. She underwent testing for possible hypercoagulable state and was found to have an elevated cardiolipin antibody and lupus anticoagulant (LA) screen positive which are reported in 50% of critically ill COVID-19 patients, though the clinical or pathological value of these results are unclear at this time. DISCUSSION: Several mechanisms for hypercoagulability in COVID-19 infection have been postulated. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) binds to host angiotensin converting enzyme 2 (ACE2) proteins. ACE2 receptors can be found throughout multiple organs and specifically on endothelial cells. ACE2 maintains the endothelial integrity of vessels. Coagulation testing in COVID-19 patients reveal increased prothrombin, activated partial thromboplastin time (aPTT), platelet counts, fibrinogen levels. Increased inflammation and cytokine release lead to a hypercoagulable state. Studies have shown that cardiolipin antibodies and LA positivity are higher in patients with COVID-19 which predispose patients to venous and arterial thrombosis. CONCLUSIONS: Venous thrombosis is often considered in patients with COVID-19 and clotting complications, however, due to the growing number of case reports regarding arterial thrombosis – arterial complications must be considered in the differential. Further research regarding the mechanism of arterial thrombosis are required to better understand the pathogenesis and develop targeted therapies to prevent occurrence of arterial thrombosis. Reference #1: Cheruiyot I, Kipkorir V, Ngure B, Misiani M, Munguti J, Ogeng'o J. Arterial Thrombosis in Coronavirus Disease 2019 Patients: A Rapid Systematic Review. Ann Vasc Surg. 2021;70:273-281. doi:10.1016/j.avsg.2020.08.087 Reference #2: Current and novel biomarkers of thrombotic risk in COVID-19: a Consensus Statement from the International COVID-19 Thrombosis Biomarkers Colloquium ;Nature Reviews Cardiology Reference #3: Taha, M., & Samavati, L. (2021). Antiphospholipid antibodies in COVID-19: a meta-analysis and systematic review. RMD open, 7(2), e001580. https://doi.org/10.1136/rmdopen-2021-001580 DISCLOSURES: No relevant relationships by Gretchen Grosch No relevant relationships by Stephanie Link No relevant relationships by Soophia Naydenov No relevant relationships by Tanner Wallen

2.
Chest ; 162(4):A663, 2022.
Article in English | EMBASE | ID: covidwho-2060662

ABSTRACT

SESSION TITLE: Challenging Cases of Hemophagocytic Lymphohistiocytosis SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/19/2022 12:45 pm - 1:45 pm INTRODUCTION: Worsening respiratory disease is the most common complication of severe COVID-19. However, when patients develop multi-organ dysfunction, clinicians must have a high index of suspicion for rare syndromes such as hemophagocytic lymphohistiocytosis (HLH). CASE PRESENTATION: A 39-year-old male smoker presented with 1 week of shortness of breath and malaise. Initial physical examination revealed T 37.3 C, pulse 85 min-1, respiratory rate 18 breaths min-1, SPO2 96% and clear breath sounds without labored respirations. Chest X-ray showed bilateral patchy airspace opacities in the mid and lower lung fields. A SARS-COV2 PCR test was positive. The patient was prescribed antibiotics and discharged home. Subsequently, the patient's symptoms worsened and he presented 1 week later with SPO2 90% (O2 10 L/min via nasal cannula). He was admitted to the hospital with COVID-19 pneumonia and began remdesivir, barcitinib, systemic steroids, albuterol and IV antibiotics. On admission his complete blood count and complete metabolic panel were unremarkable. After 3 weeks of hospitalization, he developed multi-organ failure with acute liver injury, acute kidney injury, shock, pancytopenia and worsening hypoxemia leading to endotracheal intubation and mechanical ventilation. CT chest imaging showed bilateral ground glass opacities in the lungs with superimposed consolidation (figure 1). Blood cultures remained sterile, HIV, hepatitis B and C viral serologies were negative. Serum viral polymerase chain reaction detected Herpes Simplex Virus-1 (HSV-1) and Epstein Barr Virus (EBV) infections. Trans-jugular liver biopsy confirmed HSV-1 hepatitis and showed sub-massive hemorrhagic necrosis of the liver (figure 2). Bone marrow biopsy demonstrated phagocytic histiocytes engulfing red blood cells and platelets consistent with HLH (figure 3). The patient began HLH targeted therapy with anakinra and high dose steroids. Despite this, the patient continued to deteriorate, developed refractory shock and subsequently expired. DISCUSSION: HLH is a rare disease of the immune system in which a genetic or infectious trigger causes uncontrolled T cell activation. T cell activation triggers macrophage activation, cytokine storm and macrophage phagocytosis of erythrocytes, leukocytes, platelets and precursors in the bone marrow and other tissues. If the syndrome is unrecognized, it can quickly lead to multi-organ failure and death. EBV is the most common infectious trigger of HLH;however, infection with HSV-1 and SARS-COV-2 viruses have been identified as rare and independent causes. CONCLUSIONS: This case illustrates the high index of suspicion providers should have for HLH in patients with severe COVID-19 who develop multi-organ injuries. Once HLH is suspected, prompt initiation of HLH-94 protocol with etoposide and dexamethasone may be lifesaving. For those patients with liver failure, other agents (e.g. anakinra) may be provided. Reference #1: Ramos-Casals M, Brito-Zerón P, López-Guillermo A, et al.: Adult haemophagocytic syndrome. Lancet 2014;383:1503–1516 Reference #2: Risma K, Jordan MB: Hemophagocytic lymphohistiocytosis: updates and evolving concepts. Curr Opin Pediatr 2012;24:9–15 Reference #3: Trottestam H, Horne A, Aricò M, et al.: Chemoimmunotherapy for hemophagocytic lymphohistiocytosis: long-term results of the HLH-94 treatment protocol. Blood 2011;118:4577–4584 DISCLOSURES: No relevant relationships by Erin Biringen No relevant relationships by Christine Brennan No relevant relationships by Joann Hutto No relevant relationships by Daniel Puebla Neira

3.
Chest ; 162(4):A479, 2022.
Article in English | EMBASE | ID: covidwho-2060604

ABSTRACT

SESSION TITLE: COVID-19: Other Considerations in Management SESSION TYPE: Original Investigations PRESENTED ON: 10/18/2022 02:45 pm - 03:45 pm PURPOSE: Patients who present with severe SARS CoV-2 2019 (COVID-19) infection frequently require invasive mechanical ventilation (MV) and subsequently are at increased risk of ventilator-associated pneumonia (VAP). We hypothesized that upfront empiric community acquired pneumonia (CAP) antimicrobial therapy is associated with reduced rates of VAP in patients with severe COVID-19 METHODS: After obtaining institutional review board approval, all patients admitted to the medical intensive care unit (ICU) at a tertiary care medical center with laboratory confirmed COVID-19 from March 2020- December 2020 were retrospectively identified. Exclusion criteria included outside hospital transfers, patients who underwent major surgery, were pregnant, < 18 years of age, and patients who did not require MV for at least 72 hours. Presence of VAP was defined as presence of positive sputum culture and worsening clinical and/or radiographic status requiring new antimicrobial treatment. Covid targeted therapies were defined as administration of either remdesivir, hydroxychloroquine, systemic steroids, or monoclonal antibodies. RESULTS: Overall, 113 patient’s met inclusion criteria with a median body mass index (BMI) of 32.9 kg/m2 (IQR 28.4-40.7) and age of 65 years (IQR 53-71). 65% (72/113) were male. High-dose corticosteroids were administered as part of institutional COVID-19 protocol in 44% (50/113). Median duration of MV was 16 days (IQR 11-24), 25% (28/113) of patients underwent tracheostomy, and 38% (43/113) expired during hospitalization. Empiric CAP antimicrobial therapy was started on hospital day 1 in 42% (47/113) of patients and primarily consisted of azithromycin in combination with ceftriaxone (97% [46/47]). On univariate analysis, duration of MV (p=0.003), absence of empiric antibiotic treatment of CAP (p=0.000), and male gender (p=0.045) were significantly associated with development of VAP. Neither medical comorbidities nor COVID-19 targeted therapy were associated with VAP. On multivariate logistic regression, lack of upfront empiric CAP antimicrobial therapy on admission was associated with development of VAP when adjusted for MV duration and gender (OR 0.23, 95% CI 0.09-0.54, p=0.001). CONCLUSIONS: Early empiric administration of CAP antimicrobial therapy in COVID-19 patients requiring MV was associated with reduced rates of VAP. CLINICAL IMPLICATIONS: Further prospective randomized studies are needed to better evaluate the potential risks and benefits of early empiric antibiotics to prevent hospital acquired infections in COVID-19 patients. DISCLOSURES: No relevant relationships by Robert Balk No relevant relationships by Rachel Geroux No relevant relationships by Seungjun Kim No relevant relationships by Christopher Seder No relevant relationships by Connor Wakefield

4.
Journal of Comprehensive Pediatrics ; 13(Supplement 1):32-33, 2022.
Article in English | EMBASE | ID: covidwho-2058676

ABSTRACT

Upper respiratory tract infection (URI) is one of the most frequent diseases observed at centers for pediatric care and results in significant morbidity worldwide. URI is the most common cause in children treated against acute respiratory infection. The difficulty found by clinicians in establishing the differential and etiologic diagnosis of URIs and the occasionally indiscriminate use of antimicrobial drugs. URIs range from the common, cold-typically a mild, self-limited, catarrhal syndrome of the nasopharynx to life-threatening illnesses such as epiglottitis. Viruses account for most URIs. Appropriate management in these cases may consist of reassurance, education, and instructions for symptomatic home treatment. Diagnostic tests for specific agents are helpful when targeted URI therapy depends on the results. Bacterial primary infection or superinfection may require targeted therapy. The upper respiratory tract includes the sinuses, nasal passages, pharynx, and larynx, gateways to the trachea, bronchi, and pulmonary alveolar spaces. Rhinitis, pharyngitis, sinusitis, epiglottitis, laryngitis, and tracheitis are specific manifestations of URIs. Most URIs are viral in origin. Typical viral agents that cause URIs include the Rhinoviruses, Coronaviruses, Adenoviruses, and Coxsackieviruses. In the emergency department, attention should be paid to the patient's vital signs, including temperature, heart rate, respiratory rate, blood pressure, and oxygen saturation (if obtained). Neonates are obligate nose breathers and may be at greater risk for respiratory distress;hence practitioners should auscultate the lungs for adequate aeration and assess breathing quality. The cardiovascular examination should assess adequate distal perfusion and an appropriate-for-age heart rate. Finally, dehydration can be a complication of any viral illness, and therefore, an assessment of hydration should be a part of the initial evaluation. Tests of nasopharyngeal specimens for specific pathogens are helpful when targeted therapy depends on the results (e.g., group A streptococcal infection, gonococcus, pertussis). Specific bacterial or viral testing is also warranted in other selected situations, such as when patients are immunocompromised, during inevitable outbreaks, or provide specific therapy to contacts. Symptombased therapy represents the mainstay of URI treatment in immunocompetent adults. Antimicrobial or antiviral therapy is appropriate in selected patients.

5.
Annals of Oncology ; 33:S1050, 2022.
Article in English | EMBASE | ID: covidwho-2041544

ABSTRACT

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.

6.
HemaSphere ; 6:1071-1072, 2022.
Article in English | EMBASE | ID: covidwho-2032136

ABSTRACT

Background: Patients with chronic lymphocytic leukemia (CLL) show high infection-related morbidity and mortality due to variable degree of humoral and cellular immune deficiency. High Covid-related mortality and reduced response to the SARS-Cov-2 vaccine have been reported in this patient population. Aims: We carried out a prospective multicenter study to define the rate of CLL patients with an appropriate immune response after the mRNA SARS-CoV2 vaccine (Pfizer-BioNTech;Moderna). Methods: Two-hundred patients with CLL received the first dose of the SARS-CoV-2 vaccine between February and August 2021. Centralized assessment of the anti-SARS-Cov-2 IgG levels (Sero Index, Kantaro Quantitative SARS-CoV-2 IgG Antibody, RUO-R&D System) was performed at the Istituto Superiore di Sanità of Rome, Italy. The median followup of this study is 10.7 months (range 1-12.9). Results: The median age of patients was 70 years, the median IgG level was 635 mg/dl, 61% of patients were IGHV unmutated, and 34% showed TP53 disruption. The majority of patients, 83.5%, were previously treated. Prior treatment included chemoimmunotherapy in 20 (10%) patients, ibrutinib-based therapy in 72 (36%;front-line, 21%;advanced line, 15%), venetoclax-based therapy in 75 (37.5%;front-line, 13.5%;advanced line, 24%). Overall, 135 (77.5%) patients had been previously treated with rituximab, 33 (16.5%) of them within 12 months before vaccination. We assessed the serologic response after the second dose of the SARS-CoV2 vaccine in 195 patients while five were excluded from the analysis (positive test before vaccination, 3 patients;lost to the follow-up, 1;Richter syndrome, 1). Adequate levels of anti-SARS-Cov-2 IgG were detected in 76/195 (39%) patients. Age (<70 vs.≥ 70 years;p <0.0001), CIRS value (<6 vs. ≥6;p=0.005), beta-2 microglobulin (<3.5 vs. ≥ 3.5mg/dl;p=0.04), IgG levels (<550 vs. ≤ 550 mg/dl;p <0.0001), prior treatment (p=0.0001), number of prior treatments (0+1 vs. ≥ 2;p=0.002) and the time between prior rituximab and vaccination (>12 vs. ≤12 month;p=0.001) showed a significant impact on the humoral response. In multivariate analysis only age (OR: 0.92 [95% CI: 0.92-0.97] p=0.0001), IgG levels (OR: 0.28 [95% CI: 0.13-0.58] p<0.001), and the time between prior rituximab and vaccination (OR: 0.10 [95% CI: 0.03-0.37] p=0.001), revealed a significant and independent impact on response. When the analysis was restricted to patients who received targeted therapy, in addition to the younger age (OR: 0.96 [95% CI: 0.92-0.99] p=0.04), higher IgG levels at baseline (OR: 0.31 [95% CI: 0.12-0.79] p=0.014), longer time between the start of ibrutinib or venetoclax-based therapy and vaccination (<18 vs.≥18 months;OR: 0.17 [95% CI: 0.06-0.44], p <0.0001) showed a favorable and independent impact on response. Ninety-three% (182/195) of patients received a third dose of the vaccine. A significant increase in the rate of serologic responses, 51.5% (85/165 evaluated patients, p=0.019), was observed after the booster dose. Moreover, a response was detected in 25% (26/103 evaluated patients) of previously seronegative patients. Summary/Conclusion: In this prospective, multicenter, centralized study, we recorded an effective immune response to the SARS-CoV-2 vaccine in about a third of patients with CLL. Younger age, higher IgG levels, no prior treatment, or stable disease after targeted therapy that suggest preserved immunocompetence were associated with a greater likelihood of achieving an effective immune response. A booster dose of the SARS-CoV-2 vaccine proved beneficial also in previously seronegative patients.

7.
Journal of Thoracic Oncology ; 17(9):S492, 2022.
Article in English | EMBASE | ID: covidwho-2031528

ABSTRACT

Introduction: Following initial response to TKI, advanced NSCLC patients with actionable mutations ultimately develop treatment resistance. In a proportion of patients (15-40%), initial, limited progression (≤5 lesions) is observed, termed oligoprogressive disease (OPD). SBRT offers hypofractionated, targeted radiotherapy treatment hypothesised to prolong clinical benefit from TKI prior to widespread disease development. With limited evidence to date, and poor clinical/biological selection criteria, the potential benefit offered by SBRT to ablate OPD sites prior to change in systemic therapy is an important question to address. Methods: HALT is a randomised, multi-centre, phase II/III international trial with seamless transition to phase III incorporated. Eligible patients (stage IV NSCLC, actionable mutation, TKI response prior to OPD) are randomised 2:1 to SBRT/continued TKI or continued TKI alone. Eligibility is confirmed by a virtual MDT (vMDT) comprising trial clinicians and radiologists (confirmation of OPD, SBRT suitability). Follow-up assessments are aligned with routine care at 3-monthly intervals until change in systemic therapy is clinically indicated, with imaging and toxicity assessment at each visit. Results: Recruitment commenced November 2017 with 25 centres (17 UK;8 non-UK) open to date. Following the COVID-19 pandemic, recruitment is recovering with 129 registered and 74 randomised patients. Over the last 4 years, little evidence has emerged to confirm any potential benefit of SBRT in this patient group and the impact on patient toxicity remains unknown. Therefore, with persisting questions around clinical equipoise, HALT remains highly relevant. With an 18-month extension and a recent amendment to the HALT inclusion criteria (≤5 OPD lesions, ≤7cm and OPD assessments by PET-avidity), the target of 110 randomised patients remains achievable. Conclusions: As the first randomised trial assessing SBRT benefit in this mutation-positive NSCLC patient population, HALT will provide valuable treatment efficacy and safety information, informing subsequent trial design and contribute to the development of international guidelines for the identification and clinical management of oligoprogression in mutation positive lung cancer. Keywords: Stereotactic body radiotherapy, NSCLC, Phase II

8.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009654

ABSTRACT

Background: Concerns about safety and treatment interference are known barriers to COVID-19 vaccination in cancer patients. Data on safety and tolerability in this population remain scarce. One of the objectives of this study is to describe COVID-19 vaccination safety in cancer patients. Methods: Patients diagnosed with a malignancy requiring systemic treatment in the last 12 months and undergoing COVID-19 vaccination were prospectively enrolled in this single-center study. Validated questionnaires to assess vaccine-related adverse events (VRAEs) were collected;chart review identified baseline characteristics and treatments received. Descriptive statistics and logistic regressions were performed. Results: 253 questionnaires were collected from 171 patients, enrolled between May and September 2021. 130 patients were survey-eligible after the 1st dose (D1) and 185 after 2nd dose (D2). 91 questionnaires were collected after D1 (Questionnaire 1: Q1) and 162 after D2 (Questionnaire 2: Q2). Surveys couldn't be collected due to interval > 1 month between D1 / enrollment, patients' unavailability, withdrawal of study or death. Median age was 55 (24-87) and 62.8% were female. 58.5% had solid tumors, treated with chemotherapy (49%) or checkpoint inhibitors only (9.5%);19.4% malignancies were treated with targeted therapies and 22.1% had hematological malignancies. Most frequent solid tumors were breast (31.3%), lung (15.9%) and gastro-intestinal (GI) (14.3%). Patients received 45.6% Pfizer/BioNTech, 52.8% Moderna and 1.6% Oxford/AstraZeneca. A combination of 2 different vaccines was administered to 11.9%. Interval between D1 and D2 was ≤30 days in 53.1%, 31-90 days in 42.6%, and 91-180 days in 4.3%. Among all patients, 84.1% developed VRAEs after a median of 2 days post-vaccine for a median of 4 days. 74.5% had local symptoms (Sx) (pain, sensitivity and/or redness at injection site and/or arm) and 65.8% had systemic Sx. Most frequent systemic Sx were fatigue, chills or myalgia (39.4%), GI (6.3%) and fever (2.9%). Most patients (90.7%) described their Sx as having no / minimal impact (Gr 1), 7.8% reported seeking medical consultation (Gr 2), and 1.5% lead to hospitalization (Gr 3) (1 cardiovascular event, 1 infection;causality with concurrent systemic treatment not excluded and 1 due to malignancy). Gr 2, but not Gr 3, VRAEs were more common after D2 (11.4% vs 2.5%, p = 0.03). 41.7% considered their Sx as a new health problem. On multivariate analysis, younger age and female sex were significantly associated with the development of any Sx (OR 1.08, p = 0.01;OR 2.92, p = 0.02, respectively) and local Sx (OR 1.04, p = 0.04;OR 2.19, p = 0.04), but not systemic Sx or new health problem. Conclusions: Patients experienced mostly minor and transient symptoms post-vaccination;few perceived these as a new health problem. COVID-19 vaccination is overall safe and well-tolerated among cancer patients.

9.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009647

ABSTRACT

Background: there are few reported series n women with breast cancer (BC) and COVID-19, a better prognosis has been observed, with a lower rate of hospitalization and mortality than other neoplasms. Methods: We conducted a restrospective, non-experimental, observational, single center, study with a sample of 69 patients with BC who had presented COVID-19, in the period between March 2020 to August 2021. Clinicopathological characteristics of patients with BC were compared between severe and non-severe covid 19 groups, as well as hospitalized and non-hospitalized patients. An analysis of possible risk factors associated with severe disease and hospitalization was performed. Results: 69 cases were reported, median age 52y, mean BMI 25.2, ECOG 0-1: 97%. Smoking history in 24%, diabetes and hypertension were the most frequent comorbidities. The most frequent histology was ductal carcinoma in 80.6%, 73.8% showed ER + and 69.3% PR +, HER2 was overexpressed in 9.2%. The early stages predominated, I 22 (31.3%), II 25 (37.3%), III in 12 (17.9%) and IV in 6 (9%). The most frequents symptoms of COVID-19 were fatigue 70.1%, fever 65.7%, cough 59.7%, headache 56.7%, hyposmia 47.8%, dysgeusia 38.8%. A total of 53 (76.8%) mild cases, 14 (20.3) severe cases and 2 (2.9%) critical cases were registered. The 89.9% (62 patients) were treated as an outpatient basis, while 7 (10.1%) required hospitalization. Active treatment (< 45 days) at the time of COVID-19 was hormonal therapy 36 (50.7%), chemotherapy 11 (16.4%), anti-HER2 in 3 (4.5%), immunotherapy in 1.5%, targeted treatment in 4 (6.0%), surgery in 7 (10.4%) and radiotherapy in 1 (1.5%) patient. When comparing the severe and non-severe groups, as well as hospitalized versus nonhospitalized, we observed no difference between the clinicopathological characteristics. Then, we serch for possible risk factors, in wich, surgery in a period of less than 3 months increases the risk of severity OR 1,297 (95% CI 1,112-1,514), the risk of hospitalization increased in the triple negative subgroup OR 1,143 (95% CI, 1,035- 1,262), surgery less than 3 months OR 1,116 (1,014-1,229) and chemotherapy less than 45 days OR 1,217 (95% CI, 1,024-1,447). Conclusions: In patients with BC, the prevalence of severe or critical COVID-19 was 23% and the hospitalizacion rate 10%. No patient died from this infection. The clinical and pathological characteristics of BC do not appear to increase the risk of severe COVID-19 or the rate of hospitalization. Surgery performed in a period of less than 3 months is marginally associated with an increased risk of severe disease. Chemotherapy, targeted therapy, and immunotherapy do not modify the risk of severe disease;however, higher Ki 67, triple negative subgroup, surgery and chemotherapy showed a slight increase in risk of hospitalization.

10.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009636

ABSTRACT

Background: Since cancer patients (pts) are at increased risk of severe morbidity and mortality due to COVID-19, SARS-CoV-2 vaccination is crucial to prevent severe disease course. The efficacy and longevity of vaccine protection, however, is still in question. Methods: In this prospective observational study we assessed immunogenicity of cancers patients on active treatment for solid cancers in two Slovenian Oncology Centres receiving SARS-CoV-2 vaccine by detection of anti-SARS-CoV-2 S1 IgG antibodies in serum;before, after first and second dose, 3 and 6 months (mo) after complete primary course of vaccination and 1 mo after the 3rd booster dose. Samples with ≥ 175 ng/ml were considered positive. Results: There were 125 pts included in the study, 112 completed the primary course of vaccination with 2 vaccine doses and 34 received the booster 3rd dose. Out of 34 pts receiving booster 3rd dose, the majority received mRNA based vaccines (88%) for the primary course of vaccination and all patients received mRNA based vaccines for the booster 3rd dose. Median time from 2nd to booster 3rd dose of vaccine was 6.75 mo, median age of pts was 66 yrs and 59% were male. Patients were receiving chemotherapy (ChT), immune checkpoint inhibitors (IO) or targeted therapy (TT) in 9%, 56% and 35%, respectively. They achieved seroconversion in 94% after the 2nd and in 97% after the 3rd booster dose. Overall, the median anti-SARS-CoV-2 S1 IgG titer was 11,191 ng/ml (mean 25,394;range 0 - 100,000) after complete primary course of vaccination and 1892 ng/ml (mean 6413;range 0 - 72,000) 6 mo after, P < 0.0001. However anti-SARS-CoV-2 S1 IgG antibodies increased significantly after the 3rd booster dose with median antibody value 51,310 ng/ml (mean 51,787;range 0 - 100,000), P < 0.001. Only one pt in this group got infected with SARS-CoV-2 and had a mild disease course. Conclusions: Cancer pts treated for solid malignancies achieve a high rate of seroconversion through the primary course of vaccination. However, significant waning of immunity against SARSCoV-2 is observed 6 months thereafter, which can be potentiated with additional 3rd booster dose of vaccine.

11.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009624

ABSTRACT

Background: Vaccination against COVID-19 decreases the risk of severe COVID 19 disease, hospitalization and death. Despite widespread recommendation from different cancer societies, vaccine hesitancy remains an issue in developing countries. Methods: Records of patients with cancer who received COVID-19 vaccination from March 1, 2021 and December 1, 2021, at Todua Clinic were analyzed retrospectively. Patient reported adverse effects (AE), vaccine related treatment interruptions, COVID -19 infection, and hospitalization rates were recorded. Results: A total of 1728 patients with cancer were treated at Todua Clinic during the study period. Of 177 (10%) patients who received Covid-19 vaccine, 63% were female and 34% were male. All patients were White. Mean age was 62 years. Majority of patients had solid cancer (93%) and only 7% had hematologic malignancies. A total of 76 (43%) patients had metastatic disease. Nearly half (47%) of patients were receiving cytotoxic chemotherapy, while others were receiving different treatment modalities (hormone therapy (33%), concurrent chemo-radiation (9%), chemo-immunotherapy (4%), targeted therapy (3%), immune therapy (2%), radiation therapy (2%)). Majority of the patients were vaccinated during the treatment process (61%), while 18% received covid-19 vaccine prior to treatment initiation and 21% patients received the vaccine after completion of treatment. A total of 124 patients (70%) were vaccinated with Pfizer-BioNTech, 33(19%) patients had received Sinopharm (Beijing), 14(8%) patients were vaccinated with The Oxford/ AstraZeneca and 6 (3%) patients with Sinovac/CoronaVac. Only 13 (7%) patients received a booster dose (BD). Injection site pain was main AE for all vaccines (AstraZeneca 50%, Pfizer 33%, Sinopharm 45%, Sinovac 50%). Fever was reported in 14% of patients vaccinated with AstraZeneca, and 2% of those who received Pfizer vaccine. There were isolated cases of lymphadenopathy, fatigue, loss of appetite, joint and muscle pain after Pfizer vaccine and one case of polyneuropathy after a booster dose (Pfizer). No treatment interruptions were attributed to vaccination. Only 23 patients (13%) had confirmed COVID-19 infection (post AstraZeneca 1, Pfizer 13, Sinopharm 8, Sinovac 1). Only 1 case of hospitalization was reported after Sinopharm vaccine. No death was reported due to COVID-19 infection. Majority of patients (80%) were vaccinated following recommendation from their treating oncologist. Conclusions: In our study, COVID-19 vaccination was found to be safe for patients with cancer, and performed well with only one COVID-19 related hospitalization and no deaths. Vaccination rates among cancer patients are marginal in Georgia, and institutional and national policies are needed.

12.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009616

ABSTRACT

Background: Immune checkpoint inhibitors (ICI) constitute the mainstay of treatment in several unresectable locally advanced and metastatic solid cancers. mRNA COVID-19 vaccines are immunogenic and can modulate intrinsic host immunostimulatory properties however the effect of COVID-19 mRNA vaccination on outcomes in patients receiving ICI is not well understood. This study examines the outcomes in cancer patients receiving ICI according to their vaccination status. Methods: From January 2021 to December 2021, we identified adult patients with locally advanced and metastatic solid tumors at the University of Illinois Hospital & Health Sciences System who had received at least one dose of ICI, either as monotherapy or in combination with chemotherapy or targeted therapy, in any line of cancer treatment. Patients were stratified by COVID-19 vaccination status and treatment type (monotherapy versus combined chemoimmunotherapy). Endpoints included immune-related adverse events (IRAEs), progression-free survival (PFS) from ICI initiation and overall survival (OS). Results: Among 89 patients meeting these inclusion criteria, the mean age at diagnosis was 66 years, patient sex was about equally split (female 50.5% to male 49.5%), most patients were minorities (including 58.4% African American), vaccinated (78.7%), had lung cancer (57.3%), were stage IV (71.1%), and had received ICI monotherapy (67.4%). There were no significant differences in the rate of IRAEs between vaccinated and non-vaccinated patients (p= 0.53). Patients who received ICI monotherapy had higher rates of IRAEs (p< 0.001). There was no difference in PFS between vaccinated and non-vaccinated patients (p= 0.7) and no difference in OS between vaccinated and non-vaccinated patients (p= 0.59). Conclusions: In this real-world sample of patients with advanced solid cancers who received ICI there were no significant differences in IRAEs, PFS or OS between vaccinated and non-vaccinated patients, which may be due to the relatively small sample size. Larger real-world datasets with long-term follow-up are needed to study the effect of mRNA COVID-19 vaccination on outcomes in advanced cancer patients receiving ICI.

13.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009596

ABSTRACT

Background: Cancer patients have a high risk of severe illness from COVID-19 infection, and the William Osler Health System oncology clinic (WOHS-OC) is in Brampton, ON, Canada, a COVID-19 hotspot with high community COVID-19 prevalence. As such, heightened symptom screening prior to entering the WOHS-OC, asymptomatic COVID-19 testing pre-chemotherapy, staff personal protective equipment (PPE) use, enhanced cleaning, and clinic capacity limits (including implementation of virtual visits) were employed in the outpatient WOHS-OC. This study examined patient's perspectives regarding the implemented containment and mitigation strategies in the WOHS-OC during the second wave of the COVID-19 pandemic. Methods: Consenting patients in the WOHS-OC from Dec 01 2020 to Feb 01 2021 were provided a written questionnaire regarding their care during the second wave of the COVID-19 pandemic. Questions about satisfaction with COVID-19 protocols were rated on an analogue scale from 1-5, with 1 being the worst and 5 being the best possible satisfaction. Patient demographics (age, sex, type of cancer, and treatment type) were obtained through electronic medical records. Patients also consented to a second survey should they contract COVID-19 regarding, symptoms and risk factors for contracting the virus. Results: Fifty-six patients with various solid and hematological malignancies consented to the study;median age 59.5, male (30%), type of treatment;chemotherapy (55%), immunotherapy (9%), targeted therapy (23%), biologic therapy (14%), endocrine therapy (11%). Patients felt safe coming to the oncology clinic (95% of respondents), and 100% of patients were screened for symptoms on entry. Prior to cancer treatment, 49% of participants were contacted to do a screening COVID-19 swab. In 57% of patients, at least one clinic visit was changed to virtual (telephone or video). Communication during virtual visits was felt to be adequate with 89% of patients rating communication 4 or 5. Rating of virtual visits compared to in-person visits was widely distributed (57% rated virtual 4 or 5 compared to in person). Infection control practices were rated highly (4 or 5;physical distancing 83%, enhanced cleaning 93%, staff screening 89%, and staff PPE 96%). No patients that consented to the survey contracted COVID-19 during the study period. Conclusions: COVID-19 mitigation strategies in the WOHS-OC made patients feel safe during the second wave of the pandemic. Additionally, despite high levels of community transmission, no patients responding to the survey tested positive for COVID-19 during the study period. Patients were satisfied with communication during virtual visits, however there was a wide distribution of follow-up preferences. Future interventions should be aimed at standardizing pre-treatment COVID-19 testing and delineating areas of virtual care that patients identify as needing improvement.

14.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009527

ABSTRACT

Background: Molecular profiling of tumor tissue is the gold standard for treatment decision making in advanced non-small cell lung cancer. Results may be delayed or unavailable due to insufficient tissue samples or prolonged wait times for biopsy, pathology assessment and testing. We piloted the use of plasma molecular testing as part of the initial diagnostic work-up for patients with suspected advanced lung cancer (NCT04863924). Methods: Patients with radiologic evidence of advanced lung cancer referred to the lung rapid diagnostic program underwent plasma circulating tumor DNA (ctDNA) testing using InVisionFirst-Lung, a next-generation sequencing (NGS) assay targeting 37 genes. Standard tissue testing was performed with comprehensive NGS (Oncomine). The primary endpoint was time to treatment in stage IV NSCLC patients compared to an historical pre-COVID-19 cohort (2018-9). Secondary endpoints included actionable targets identified in plasma, % of patients starting targeted therapy based on liquid biopsy and result turnaround time (TAT). Results: Between July 1 to December 31, 2021, 60 patients were enrolled. Median age was 70 years (range 33-91), 52% were female, 57% Caucasian, 48% never smokers. Of these, 73% had NSCLC, 12% small cell, 10% non-lung pathology and 5% declined tissue biopsy. Of 44 NSCLC patients, 5 (11%) had early-stage disease and underwent curative therapy. Most stage IV patients (79%) had systemic treatment. Median time to treatment initiation in the study cohort was 34 days (n = 31, range 10-90) versus 62 days (n = 101, range 13- 159) in the historical cohort (p<0.0001). Two thirds (N = 23) of stage IV NSCLC patients had actionable alterations identified, (30% in current/ex-smokers);18 started targeted therapy including 10 based on plasma results before tissue results were available. Median TAT was 7 days for plasma from blood draw to reporting (range 4-14) and 26 days for tissue molecular testing (range 11-42), p<0.0001. Concordance was high between plasma and tissue testing (70%). Liquid biopsy identified actionable alterations for 3 patients not identified by tissue NGS. In 4 cases, plasma testing failed to identify actionable alterations detected in tissue, due to undetectable plasma ctDNA. Conclusions: Liquid biopsy in the initial diagnostic workup of patients with suspected advanced NSCLC leads to faster molecular results and shortens time to treatment compared to tissue testing alone. Supplementing the current standard of tissue molecular testing with a plasma-first approach during the diagnostic work up of patients with suspected advanced lung cancer may increase access to precision medicine and improve patient outcomes. (Table Presented).

15.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009524

ABSTRACT

Background: Patients (pts) with cancer are at increased risk of severe COVID-19. Both underlying malignancy and anti-cancer treatments influence the immune system, potentially impacting the level of vaccine protection achieved. Methods: A systematic literature search of PubMed, Embase, CENTRAL and conference proceedings (ASCO annual meetings and ESMO congress) up to 28/09/21, was conducted to identify studies reporting anti-SARS-CoV-2 spike protein immunoglobulin G seroconversion rates (SR) at any time point after complete COVID-19 immunization (mRNA- or adenoviral-based vaccines) in cancer pts. Complete immunization was defined as 1 dose of JNJ-78436735 vaccine or 2 doses of BNT162b2, mRNA-1273 or ChAdOx1 nCoV-19 vaccines. Subgroup analyses were performed to examine the impact of cancer diagnosis, disease stage, and anticancer therapies on the SR. Overall effects were pooled using random-effects models and reported as pooled SR with 95% confidence intervals (CI). Results: Of 1,548 identified records, 64 studies were included in this analysis reporting data from 10,511 subjects. The Table shows the SR in the overall population and specific subgroups. In pts with solid malignancies (SM), disease stage and primary site did not significantly impact the SR. In pts with hematologic malignancies (HM), SR were significantly lower in pts with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) compared to acute lymphoblastic leukemia (ALL), Hodgkin lymphoma (HL), and multiple myeloma (MM). Concerning the impact of cancer therapies on SR, pts with SM undergoing chemotherapy had numerically lower SR (N = 1,234, SR 87%, CI 81-92) compared to those treated with immune checkpoint inhibitors (N = 574, SR 94%, CI 88-97) or endocrine therapy (N = 326, SR 94%, CI 86-97) with or without another targeted therapy. Pts with HM treated with anti-CD20 therapy (within the last 12 months: N = 360, SR 7%, CI 2-20;or more than 12m: N = 175, SR 59%, CI 35-80), immune-modulating agents (BTK or BCL2 inhibitors) (N = 462, SR 47%, CI 32-64%) or other immunotherapies (anti-CD19/CART or anti-CD38) (N = 293, SR 37%, CI 23-53) had lower SR compared to pts treated with autologous (N = 353, SR 77%, CI 67- 85) or allogenic stem cell transplantation (N = 509, SR 77%, CI 68-84). Conclusions: SR varies between cancer types and anticancer therapies with some cancer pts having low protection against COVID- 19 even after complete vaccination.

16.
Annals of the Rheumatic Diseases ; 81:42, 2022.
Article in English | EMBASE | ID: covidwho-2009151

ABSTRACT

Background: The ongoing coronavirus disease 2019 (COVID-19) pandemic and subsequent waves still represent a healthcare issue. Their impact on the treat-to-target (T2T) strategy in rheumatoid arthritis (RA) patients has been seldom investigated. Difficult access to rheumatology outpatient clinic, laboratory and imaging investigations as well as nationwide containment measures could potentially affect disease activity and tight-control strategy. Recently, we reported how a telephone-based tight control strategy ensured satisfactory management of RA treated with targeted therapies during the frst wave of the pandemic [1]. However, the performance of our different patterns of healthcare delivery across different pandemic waves has not been studied yet. Objectives: To analyze the impact of different patterns of healthcare delivery on remission of RA patients treated with targeted therapies during the frst wave (2020) and second/third waves (2021) of pandemic compared to the pre-pan-demic period (2019). Methods: In this observational real-life study, data of our cohort of RA patients treated with biologic or targeted synthetic drugs were extracted from a longitudinal registry. Clinical Disease Activity Index (CDAI) was analyzed in the same period from 22nd of February to 18th of May for three consecutive years: before the pandemic (2019), during the frst wave (2020), and during the second/third waves (2021). During the frst wave, patients could choose whether to receive home drug delivery or to maintain their face-to-face visits, in the other periods only in-person visits were delivered. A generalized linear model with the binomial error was ftted to evaluate the difference in the proportion of patients in CDAI remission. Quantile regression was used to compare the median of CDAI in difficult-to-treat (D2T) patients [2]. In both models, the correlation of different measurements on the same patient was considered. Results: In the pre-pandemic period (2019), 407 RA patients were included in this study. During the frst wave (2020) we analyzed 450 patients, of whom 359 patients chose in-person visits, while 91 patients home drug delivery and virtual visit. Finally, 540 patients were included in 2021 (second/third wave). The percentages of patients in CDAI remission were similar in the three periods (prevalence ratio 1.07, p-value 0.423 between 2020 and 2019, and 1.01, p-value 0.934 between 2021 and 2019). The CDAI remission rate was 40.55% (N=163), 43.18% (N=155) and 40.82% (N=220) in 2019, 2020 and 2021, respectively. The disease activity profile during the three periods is reported in detail in the Table 1 below. Among our cohort of D2T patients, the median value of CDAI before (2019), during the frst wave (2020), and during the second/third wave (2021) changed signifcantly (p= 0.053 between 2020 and 2019 and p=0.006 between 2021 and 2019). Conclusion: Although the pandemic has imposed changes in our healthcare delivery, these different strategies seem to be effective in ensuring satisfactory management of RA treated with targeted therapies. The approaches modulated in the context of the different periods have been a feasible compensation for ensuring disease control even in D2T patients.

17.
Annals of the Rheumatic Diseases ; 81:942-943, 2022.
Article in English | EMBASE | ID: covidwho-2008930

ABSTRACT

Background: Vaccination against SARS-CoV-2 is effective in preventing severe forms of COVID-19, but there remain concerns about a reduced vaccine response in patients suffering from infammatory arthritides who are treated by immunosuppressive therapies. Objectives: We analysed the impact of bDMARDs on the humoral anti-SARS-CoV-2 vaccine response of patients followed in day hospitals. Methods: We studied the vaccine response after a complete vaccine regimen followed in day hospital in 5 French hospitals and treated with an intravenous bDMARD between September 2019 and August 2021. After obtaining their informed consent, we included patients with an anti-SARS-CoV-2 serology. They were considered non-responders if the antibody level detected was inferior to the threshold of positivity of the kit used. Results: 205 patients were included (148 females/57 males). The median age was 64 years (Interquartile Range [IQR] 56-71). 25 were treated with tocilizumab (TCZ), 36 with abatacept (ABA), 53 with infiximab (IFX) and 91 with rituximab (RTX). When considering both patients after a complete vaccination schema (2 doses, or 1 dose in case of prior COVID-19) and those with 1 booster dose, 34 patients (16.6%) were non-responders (2 [5.9%] treated by IFX, none treated by TCZ, 9 [26.5%] treated by ABA and 23 [67.7%] treated by RTX). In multivariate analysis, the only characteristics that signifcantly and independently differed between respond-ers and non-responders were last bDMARD and corticosteroid therapy at the time of 1st vaccination (Table 1). In RTX-treated patients, the delay from last infusion to 1st vaccine dose was signifcantly shorter in non-responders (median 4.3 IQR [2.9-6.1] months in non-responders versus 8.4 IQR [5.7-14.5] in responders, p=0.0007). Median survival, I.e. achieving a vaccine response in 50% of RTX-treated subjects, was achieved after 277 days (95CI [209-310]) in patients vaccinated with 2 or 3 doses (Figure 1). In ABA-treated patients, the delay from last infusion to 1st vaccine dose was not different between non-responders and responders. Conclusion: ABA and RTX alter the anti-SARS-CoV-2 vaccine response and were associated with nearly all vaccine non-responses in the present study. Cor-ticosteroid therapy was associated with a lower vaccine response regardless of its indication or the concomitant use of bMARD.

18.
Journal of the ASEAN Federation of Endocrine Societies ; 37:50-51, 2022.
Article in English | EMBASE | ID: covidwho-2006562

ABSTRACT

Introduction Phaeochromocytoma and paraganglioma (PPGL) are rare tumors with up to 40% associated with inherited germline mutations. SHDB mutation is associated with an increased risk of metastasis. Case A 36-year-old male presented with hypertensive emergency. He was diagnosed to have a bladder paraganglioma at age 32 when he presented with hypertensive crisis. Ga-68 DOTANOC PET/CT scan then showed a localized 4.7 x 5.3 cm bladder paraganglioma and he underwent complete surgical resection with resolution of his symptoms. Genetic testing done showed SHDB, deletion (exon 1), heterogenous pathogenic variant. He remained asymptomatic and was lost to follow-up due to COVID-19 until his recent admission. During this admission, he had labile blood pressure with symptoms of palpitations and lethargy. He was found to have a 4.3x elevated urine normetanephrine (1639 ug/day, N<374.7). Metanephrine and 3-methoxytyramine levels were normal. His blood pressure was controlled with phenoxybenzamine 20 mg TDS (1 mg/kg), telmisartan 40 mg OM and carvedilol 25 mg BD with improvement in his symptoms. Subsequent anatomical imaging with CT and functional imaging with Ga-68 DOTATATE showed a small recurrence at the bladder wall with metastatic lesions at the left sacral ala measuring 4.5 x 5.1 cm, and multiple lytic lesions over the spine, ribs and also the left acetabulum with the highest uptake of Ga-68 DOTATATE at the C2 vertebra (SUV max 93). He is now planned for peptide receptor radionuclide therapy (PRRT). SHDB mutation is associated with a higher risk of metastatic disease which has remained unexplained. Treatment for metastatic disease include surgical resection where possible, targeted therapy such as PRRT, meta-iodobenzylguanidine (MIBG) therapy, radiotherapy and also systemic therapy such as chemotherapy and tyrosine kinase inhibitors. Conclusion Patients with PPGL, especially those with SHDB mutation, require monitoring at regular intervals to screen and detect metastasis to reduce mortality and morbidity.

19.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005713

ABSTRACT

Background: SARS-CoV-2 vaccines efficacy and safety have been tested in phase 3 studies which did not include cancer patients. Information is scarce regarding COVID-19 vaccines safety in this population. Methods: The objective of this study is to evaluate the safety profile of the mRNA-1273 vaccine across cancer patients and its relationship to patients' demographics. This cross sectional study included patients 18-years or older with solid malignancies receiving active treatment in Hospital Clínico San Carlos (Madrid, Spain) who had received the three dose schedule of the mRNA9 1273 vaccine. Patient electronic medical records were reviewed retrospectively to collect data between April 19, 2021 and December 31, 2021. Patients with documented previous infection by SARS-Cov-2 were excluded. Results: 93 patients met inclusion criteria. 31 patients (33%) were male and 62 patients (66%) were female. Mean age was 61 [SD 8]. 33% of the study population had metastatic disease. The majority of patients (60%) had ECOG 0 whereas 32% and 8% of the population had ECOG 1 and 2 respectively. Most common tumors were breast (33%) and gastrointestinal (17%). Treatment modalities included chemotherapy (37%), targeted therapy (23%), immunotherapy (12%) and combined therapy (28%). Local adverse effects at the site of injection and systemic adverse reactions had different trends, local adverse reactions were reported more frequently after the first and second dose than after the third (42%, 50% and 36% respectively), while systemic adverse reactions were reported less frequently after the first and second dose than after the third (16%, 35% and 53% respectively). Most common systemic adverse effect was fever followed by malaise and myalgia. No grade 4 or 5 adverse events were reported. We found a statistically significant association between sex and systemic adverse reactions after the third dose with a moderate correlation assessed by Cramer's V. Cochran-Armitage test showed a statistically significant linear trend, p = 0.012, with higher ECOG score associated with a lower proportion of patients suffering from systemic side effects. A logistic regression showed that females had 5.79 times higher odds to exhibit systemic adverse events after the third dose (p = 0.01) compared to males. Increasing age was associated with a decreased likelihood of exhibiting adverse events (p = 0.016). ECOG scores didn't show a statistically significant association. Conclusions: mRNA-1273 vaccine shows a tolerable safety profile, which is similar to the non-oncologic population. The likelihood of adverse reactions appears to be associated with gender and age. Its association with ECOG scores is less evident. Further studies are needed to elucidate the safety profile of COVID-19 vaccines in cancer patients.

20.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005676

ABSTRACT

Background: Data on safety of COVID-19 vaccination in malignancy patients, particularly those receiving cancer treatment, is lacking because they are excluded from vaccine trials. We aimed to evaluate vaccine-related adverse events (VRAEs) in actively treated cancer patients. Methods: This prospective, observational study of VRAEs following ChAdOx1-nCoV-19 vaccine among 399 solid malignancy patients on active cancer treatment was conducted in two Thai academic hospitals. Participants received the first dose between June 18 and July 27, 2021 and the second dose at 8-10 weeks later. Solicited and unsolicited VRAEs were collected using questionnaires. The primary endpoint was incidence of VRAEs among solid cancer patients, as compared to healthy controls. Results: 399 cancer patients received cancer treatments during the first dose of vaccine (43% chemotherapy, 34% targeted therapy, 8% immunotherapy, 4% hormonal therapy and 11% combination regimen) and 359 patients continuing the treatments during the second dose. Mean age of the cancer patients was significantly higher than the healthy volunteers (59 +/- 13 vs 48 +/- 13 years, P < 0.001). In overall population, incidence of VRAEs was significantly lower in cancer patients than in healthy controls (57% vs 80%, P < 0.001 in overall periods, 63% vs 93%, P < 0.001 after first dose;and 51% vs 66%, P 0.01 after second dose). In age-matched comparison including 76 cancer patients and 75 healthy volunteers, the incidence of VRAEs in cancer patients was significantly lower than healthy controls only after the first dose (82% vs 93%, P 0.03) but not after the second dose (64% vs 67%, P 0.77) and overall periods (74% vs 79%, P 0.32). There was no significant difference in severity of VRAEs between two groups following the first and second dose. In all patients of cancer cohort, the most common VRAEs were pain at injection site (first dose 39%, second dose 30%), fatigue (first dose 38%, second dose 27%) and myalgia (first dose 33%, second dose 23%). The most common grade 3 VRAEs was fatigue (1%) after the first dose and tenderness at injection site (2%) after the second dose. Fever was the only VRAEs led to interrupting the cancer treatment in two cases (0.5%). Among the cancer treatment types, patients who received a chemotherapy-containing regimen had a lower risk of VRAEs than those who received a non-chemotherapy regimen (odd ratio (OR) 0.2, P 0.001 after first dose and OR 0.4, P 0.001 after second dose). Conclusions: In age-matched comparison,the overall incidence of VRAEs in actively treated patients with solid malignancy following ChAdOx1-nCoV-19 vaccine was comparable to healthy controls. Most occurred VRAEs are mild severity and rarely interfered the cancer treatment. These findings assure that Covid-19 vaccination is safe in cancer patients undergoing treatment.

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