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1.
In Vivo ; 36(6): 2780-2789, 2022.
Article in English | MEDLINE | ID: covidwho-2100679

ABSTRACT

BACKGROUND/AIM: To prospectively evaluate the efficacy and safety of the BNT162b2 vaccine in solid cancer patients undergoing systemic chemotherapy (n=63). PATIENTS AND METHODS: COVID-19 anti-spike protein antibody levels were measured before the first BNT162b2 vaccination, just before the second BNT162b2 vaccination, one month after the second BNT162b2 vaccination, and 3 months after the second BNT162b2 vaccination. Anti-spike protein antibody seropositivity was set at ≥0.8 U/ml. RESULTS: Colorectal cancer was the most commonly observed primary disease (36.5%). ECOG-PS 0 was observed in the majority (52.4%) of patients. The overall response rate and the median (range) anti-spike protein antibody levels in the whole cohort at 3 months after the second BNT162b2 vaccination were 98.4% (62/63) and 206 (0.4-3,813) U/ml. None of the patients required postponement or discontinuation of systemic chemotherapy because of an adverse reaction. CONCLUSION: The BNT162b vaccine in solid cancer patients undergoing systemic chemotherapy is effective and safe.


Subject(s)
COVID-19 , Neoplasms , Vaccines , Humans , Prospective Studies , BNT162 Vaccine , COVID-19/prevention & control , Neoplasms/drug therapy , Vaccines/therapeutic use , Antibodies, Viral
2.
Journal of Clinical Oncology ; JOUR:186, 40(28 Supplement).
Article in English | EMBASE | ID: covidwho-2098611

ABSTRACT

Background: Completion of advance directives can help to ensure consistency with people's preferences at the end of life. However, disparities in access to advance care planning is common among Hispanic population and little is known about their end-of life wishes. Although in Mexico, advance directives were legalized in 2008, only 21% of people know about it. Objective(s): To describe end-of-life wishes among patients with advanced cancer planning in a third level hospital in Mexico City. Method(s): We conducted a cross-sectional analysis of advance directives planning from patients with advanced cancer included in a multidisciplinary patient navigator-led supportive care program in Mexico City (Te Acompanamos). Patients with a life expectancy of 6 months or less were invited to complete advance directives (AD). Life expectancy was calculated using the palliative performance scale (PPS). Descriptive statistics were used for this analysis. Result(s): From September 2017 to November 2021, a total of 238 patients were invited to complete AD and 55 (23.1%) completed it, 14.5% in 2017, 29% in 2018, 34.5% in 2019, 9% in 2020 and 12.7% in 2021. The mean age among those who completed AD was 65.8 years (range 38-91), 52.7% were women and 61.8% had gastrointestinal cancer. Fortythree (78.1%) patients stated their wish to die at home, 18.1% to have cardiopulmonary reanimation, 9% invasive mechanical ventilation, 24.4% tube feeding, 90.9% pain medications, 10.9% organ donation, 40% cremation, 38.1% a funeral and 50.9% a death ritual. At median follow up of 5 months (0-39), 43 (78.1%) patients have died, and their endo-of-life wishes were respected in 77.5 % of them concerning the place of death and in 96.7% regarding cardiopulmonary reanimation and invasive mechanical ventilation. Conclusion(s): In our patient navigator-led supportive program approximately a quarter of patients with advanced cancer and a life expectancy of 6 month or less completed AD and end-of-life wishes were respected in a significant proportion of them. Telemedicine methods used to invite patients during COVID-19 pandemic decreased the proportion of AD completion. Although, advanced care planning is associated with improved in quality of care at the end of life, several barriers and disparities exist among Hispanics and strategies to improve their completion are needed.

3.
Dissertation Abstracts International: Section B: The Sciences and Engineering ; 83(12-B):No Pagination Specified, 2022.
Article in English | APA PsycInfo | ID: covidwho-2072875

ABSTRACT

Background: Half of the population with cancer who are aged 20 to 54 years old will die from cancer with African Americans being 1.2 times more likely to die (NCI, 2019a;2021b). Parents with advanced cancer (PWAC) have concerns about their future and their remaining family's future, which causes suffering. Dying concerns are conscious/unconscious thoughts about death by a person facing a terminal illness or a family member coping with the impending death of a loved one (Arndt et al., 2006;Caparso et al., 2020;Kakuta et al., 2015). Purpose: Examine recruitment feasibility in PWAC and their co-parents.;and (2) Gain a shared understanding of the perspectives of the PWAC about the dying concerns family life before and after advanced cancer diagnosis and family resources to manage the crisis of advanced cancer for the co-parent following Gadamer's phenomenology and McCubbin and McCubbin's Family Resiliency Model.Methods: Four PWAC were recruited from Karmanos Cancer Center and Comprehensive Breast Care. Participants were diagnosed with advanced cancer, scored less than a 3 on the Eastern Cooperative Oncology Group (ECOG) scale, had at least one dependent child 18 years old or younger, identified a co-parent involved in care of the patient and children, and spoke English. Two semi-structured interviews were conducted, audio- video-recorded, and transcribed. The first interview was summarized and given to the participants for member-checking. Data analysis used the hermeneutic rule. All data was coded and verified between coders until consensus was reached.Results: Due to unforeseen circumstances and hospital restrictions of COVID-19, recruitment was challenging. Of 32 potential participants, 11 were approached and 4 consented. Completion of all study procedures for one participant took a little over a month. Completion of both interviews ranged about an hour and a half. Four themes regarding dying concerns emerged. Additional themes emerged which may have mediated the dying concern themes. Participants expressed co-parent concerns of "Uncertainty in End-of-Life Decisions", "Effectless Communication", "Parental Skepticism" and "Psychological Well-Being".Conclusions: PWAC have concerns for their co-parent in the event they die. Qualitatively understanding dying concerns from family members may improve communication between family members and healthcare providers. (PsycInfo Database Record (c) 2022 APA, all rights reserved)

4.
Otolaryngology - Head and Neck Surgery ; 167(1 Supplement):P201, 2022.
Article in English | EMBASE | ID: covidwho-2064416

ABSTRACT

Introduction: Access to specialty care is challenging in rural health environments, and this has been compounded by the COVID-19 pandemic. Routes to establishing care for head and neck cancer patients are especially important. We sought to quantify our referral patterns and processes to identify opportunities for optimization. Method(s): Retrospective review was performed of patients with initial head and neck tumor board presentation between January 1, 2020, through December 31, 2021. Assessed time points were date of referral, biopsy, pathological diagnosis, imaging order, imaging obtained, and initial presentation at head and neck tumor board. Result(s): A total of 429 patients were included. Squamous cell carcinoma (n=350, 81.6%) made up the majority, and most common primary sites were oropharynx (27.4%), oral cavity (20.3%), larynx (16.9%), and cutaneous (16.5%). At time of referral, 37.6% of patients had biopsy proven diagnosis. Average time to tumor board was 22 days, and significantly greater in those undiagnosed at referral (29 vs 14 days). Distance to provider did not correlate with time to tumor board. The period since the onset of the COVID crisis did not appear to affect access to care once in our system. However, there was evidence that patients presented with advanced locoregional disease during COVID-19. Conclusion(s): This study creates an approach to map access to care, evaluating critical time points and opportunities to expedite multiple steps that initiate therapy for head and neck cancer. There are both external (rural geography and the COVID-19 pandemic) and internal aspects that may pose barriers to access. Identification of these barriers allows for improved timely access to care in this susceptible population.

5.
Chest ; 162(4):A2362, 2022.
Article in English | EMBASE | ID: covidwho-2060940

ABSTRACT

SESSION TITLE: All About the CLOT: VTE SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: Patients diagnosed with intermediate high-risk pulmonary embolism (IHRPE) may develop early clinical decompensation requiring advanced reperfusion therapy. The clinical parameters and biomarkers which may prognosticate this progression to high risk acute PE are not clearly defined in the current clinical practice guidelines. There remains a critical knowledge gap regarding identifying the 5-17% of patients who will demonstrate decompensation within the first 72 hours after initial presentation. We measured serial acute PE biomarkers to better understand their patterns of evolution. METHODS: Single arm prospective observational pilot study measuring serial biomarkers in newly diagnosed and hospitalized IHRPE patients (age >18 years) meeting ESC 2019 criteria. Vital signs (HR, SBP, SI, SPO2/FiO2 index) were recorded at seven pre-specified times to assess clinical course during the first 72 hours. Blood biomarkers were evaluated during the same pre-specified time blocks. Cardiac biomarkers (NT Pro BNP, troponin) were measured every 8 hours for first 24 hours and then every 12 hours. Non-cardiac biomarkers (uric acid, lactate) were measured once every 24 hours. RESULTS: Total of 20 subjects (16M) were diagnosed via CT angiogram and enrolled after informed consent. Median age was 61.5 years (IQR 53, 72.5). Comorbidities included underlying malignancy (5), prior history of VTE (3) and Covid-19 (1). Radiographic embolus patterns included saddle (9), distal main PA/lobar (9) and segmental/sub-segmental (2). Lower extremity DVT were found in 14 subjects. Median admission vital signs (IQR) at time of presentation were: Heart rate 110 BPM (101,118), SBP 116 mmHg (100, 132);RR 21 per min (16, 23);Shock index 0.9 (0.8, 1.1);SPO2 85% (85, 96);and SPO2/FiO2 ratio 289 (246, 454). Subjects were admitted to the medical ward (13) and ICU (7). 16 remained clinically stable and 4 had clinical decompensation (2 respiratory failure, 2 shock) of whom 2 expired. At enrollment, troponin (TNT) was elevated in 20/20 subjects, NT proBNP in 18/20subjects, lactate in 8/20 subjects, and uric acid in 9/20 subjects;biomarkers normalized at different rates, with marked inter-individual variation. The median (IQR) peak values were: TNT, 0.05 (0.025, 0.078) ng/ml;NTproBNP, 2458 (1147, 5599) pg/ml;lactate, 1.8 (1.4, 3.4) mmol/L;and, uric acid, 6.2 (5.0, 7.4) mg/dl. 1/16 (6.3%) stable patients showed an 8-16 hr increase in TNT, compared with 2/4 (50%) of the decompensated patients, who required subsequent advanced PE interventions (p=0.088). CONCLUSIONS: Biomarkers in IHRPE patients evolve with variable time-courses. The potential of rising troponin at 16 hours to identify risk for circulatory or respiratory decompensation deserves further investigation. CLINICAL IMPLICATIONS: Abnormal biomarkers may aid clinical decision-making regarding advanced therapies in IHRPE patients. DISCLOSURES: No relevant relationships by Wendy Craig No relevant relationships by Ariel McKenna No relevant relationships by Victoria Molina No relevant relationships by Alexander Smith No relevant relationships by Hilamber Subba Advisory Committee Member relationship with ACI Clinical Please note: 2020-2022 Added 04/04/2022 by Joel Wirth, value=Salary

6.
Chest ; 162(4):A2338, 2022.
Article in English | EMBASE | ID: covidwho-2060935

ABSTRACT

SESSION TITLE: All About the CLOT: VTE SESSION TYPE: Original Investigations PRESENTED ON: 10/16/2022 10:30 am - 11:30 am PURPOSE: Pulmonary embolism (PE) is a disorder of coagulation that results in significant morbidity, mortality and emergency department visits. The usage of advanced imaging for the diagnosis of PE has increased greatly, almost 400% from 1998 to 2008. The Well’s Criteria for PE uses historical features, clinician gestalt, and heart rate to risk stratify patients for PE. The score ranges from 0-12.5 and is broken down into low risk 0-2, intermediate risk 3-6, and high risk 7+. The current American College of Emergency Physician guidelines advise that a patient suspected to be at risk for PE with a low or intermediate risk can undergo age adjusted D-Dimer testing. A further addition was the PERC rule. This rule applies 8 questions to the low risk PE patient and 8 negative responses mean the clinician can forgo D-Dimer testing. How well are we adhering to this guidance, and are deviations leading to unnecessary testing which could expose our patients to harm? METHODS: 280 sequential patients receiving diagnostic testing for PE were evaluated and 156 were excluded due to known, suspected, or history of COVID-19 infection. The work-up for the included patients was reviewed and Well’s criteria and the PERC rule were applied by retrospective review. Descriptive statistics were used to describe the proportion of patients evaluated with tests not suggested for their risk strata. RESULTS: Of the 124 patients evaluated, 31/124 (25%) had potentially unnecessary testing. 18 low risk patients underwent advanced imaging—17 CTAs and 1 VQ scan– without being tested by D-Dimer. 11 low risk, PERC rule negative patients still received D-Dimers–all negative, and 1 underwent CTA. One negative age-adjusted D-Dimer still lead to a CTA. One patient with a negative D-Dimer received CTA. These 18 CTAs and 1 VQ scan were all interpreted negative for PE. CONCLUSIONS: Patients undergoing evaluation in emergency departments in the United States may be undergoing unnecessary diagnostic testing based on current guidelines and the summation of the highest quality evidence available for directing the choice of how best to evaluate this patient population. CLINICAL IMPLICATIONS: The utilization of CTA for the diagnosis of PE is not without risk. Some estimate 20 additional breast cancers per 100,000 women undergoing the test. CTA studies for PE also pose the risk of unnecessary anticoagulation. A meta-analysis of imaging for PE showed an over diagnosis rate as high as 60% for subsegmental PE when these studies were re-reviewed by a panel of expert chest radiologists. This is quite high, but even more modest meta-analyses have shown a 10% false positive rate. Patients placed on anticoagulation have an annual bleeding risk attributed to anticoagulation of 7% and mortality attributed to anticoagulation of 0.4%. Creative strategies aimed at reducing unnecessary testing can help mitigate some of this risk and protect our patients. DISCLOSURES: No relevant relationships by Parth Gandhi research support relationship with Bristol Myers Squibb Please note: 2021-2022 Added 03/31/2022 by Jason Nomura, value=Grant/Research Consultant relationship with Philips Please note: 2020-2022 Added 03/31/2022 by Jason Nomura, value=Consulting fee No relevant relationships by Dustin Slagle

7.
Chest ; 162(4):A1866, 2022.
Article in English | EMBASE | ID: covidwho-2060877

ABSTRACT

SESSION TITLE: Drug-Induced and Associated Critical Care Cases Posters 1 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Interstitial pneumonitis (ILD) is inflammation of lung interstitium leading to scarring and pulmonary fibrosis. Various etiologies include idiopathic, connective tissue disorders, sarcoidosis and drug induced1. Many chemotherapy agents have been implicated in drug related ILD such as bleomycin, taxanes. However, newer chemotherapeutic drugs such as molecular agents such as anti-VEGF, anti-EGFR (panitumumab) could be causative of drug induced ILD. CASE PRESENTATION: A 75-year-old female with stage IV sigmoid colon cancer treated with surgery, adjuvant FOLFOX chemotherapy and Panitumumab. She presented to the emergency department with shortness of breath and hypoxia after known COVID-19 exposure. Initial imaging with chest radiography showed bilateral ground glass opacities. A chest CT pulmonary embolism protocol was negative for pulmonary embolism but showed bilateral ground glass opacities (GGOs) and some interstitial thickening (L>R) not typical of COVID-19 infection. She was treated with remdesivir and dexamethasone, however her oxygen requirements continued to rapidly escalate. A repeat CT chest without contrast showed bilateral asymmetric interstitial thickening and GGOs. Given persistence of CT chest abnormalities, workup for interstitial lung disease was initiated. The results include ANA titer 1:80, otherwise negative ANCA profile, rheumatoid factor, anti-CCP, Scl-70, Sjogren antibodies. Given clinical history and imaging findings, diagnosis of ILD was suspected, and she was started on solumedrol 1 mg/kg. Her oxygen requirements decreased significantly over the next 2 days, and she was discharged home on oral steroid taper and pneumocystis pneumonia prophylaxis. DISCUSSION: Panitumumab is a fully humanized monoclonal antibody against EGFR. Approved by the US Food and Drug Administration in 2006 for advanced or recurrent colorectal cancer exhibiting wild-type KRAS mutation.2 ILD is rarely reported with panitumumab monotherapy, but higher incidence when used as a combination treatment such as with FOLFOX or FOLFIRI. A Japanese post-marketing surveillance study from 2010-2015 showed an ILD incidence of 1.3% but mortality rates of 51.3%.2 EGFR is expressed on basal cells and non-cilia cells of the bronchioles and type II cells of the alveolus. EGFR mediated mechanisms are important in tissue repair.3 Therefore inhibition of this pathway has been postulated to play a role in development of ILD. Another mechanism was decreased surfactant production by type II cells in pre-clinical study.4,5 ILD secondary to Panitumumab can occur at any point during therapy and up to 1 year after administration of drug.6 The role of infectious processes, in this case, COVID-19 pneumonia, could synergistically worsen ILD presentation. CONCLUSIONS: Although the incidence of ILD is low, the mortality rate is high, therefore early recognition and treatment is associated with improved clinical outcomes. Reference #1: Mudawi D, Heyes K, Hastings R, Rivera-Ortega P, Chaudhuri N. An update on interstitial lung disease. Br J Hosp Med (Lond). Jul 2 2021;82(7):1-14. Reference #2: Osawa M, Kudoh S, Sakai F, et al. Clinical features and risk factors of panitumumab-induced interstitial lung disease: a postmarketing all-case surveillance study. Int J Clin Oncol. Dec 2015;20(6):1063-1071. Reference #3: The FASEB Journal - 2000 - Puddicombe - Involvement of the epidermal growth factor receptor in epithelial repair in asthma.pdf. DISCLOSURES: No relevant relationships by Navitha Ramesh No relevant relationships by Uba Udeh

8.
Chest ; 162(4):A1780, 2022.
Article in English | EMBASE | ID: covidwho-2060861

ABSTRACT

SESSION TITLE: Drug-Induced and Associated Critical Care Cases Posters 2 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Lung toxicity due to antineoplastic therapy is reported with both cytotoxic and molecularly targeted agents [1]. We present one such case of lung injury induced by capecitabine. CASE PRESENTATION: A 79-year-old female with history of triple negative infiltrating duct carcinoma of the right breast (status post mastectomy and adjuvant chemotherapy with docetaxel and cyclophosphamide 3 years prior) presented to the hospital with dyspnea on exertion following her fourth cycle of capecitabine therapy for breast cancer recurrence. Patient developed nausea, vomiting, and malaise with cycles 1, 2, and 3 of capecitabine therapy with onset of severe dyspnea on exertion, cough, and hypoxia following cycle 4. Computed tomography (CT) scan of the chest on admission showed consolidative opacities in the right upper, right middle, and anterior right lower lobe along with smaller opacities in the left lung apex and small subcentimeter nodules;no pulmonary embolism. Antibiotics were given for a short duration for suspected pneumonia without improvement. Capecitabine was held on discharge. She presented again to the emergency room with worsening shortness of breath, diarrhea, fatigue, and dizziness. COVID test was negative. Chest x-ray redemonstrated patchy airspace disease involving the right apical, lateral, mid lower lung field. Oral steroids were recommended for suspected organizing pneumonia, but the patient refused due to concerns about side effects. Her hospital course was complicated by Clostridium difficile infection (treated with oral vancomycin) and left lower extremity deep venous thrombosis (treated with anticoagulation). Subsequently she followed up with pulmonology outpatient. Repeat imaging showed evolving infiltrates in the same areas with elevated aspergillus IgG level (18.0 mcg/ml) and IgE (178 kU/L) but negative galactomannan and sputum bacterial/fungal/acid fast cultures. Oral steroids were initiated with clinical and symptomatic improvement. DISCUSSION: Capecitabine is a prodrug of fluorouracil (antimetabolite). It is used as a chemotherapy agent in multiple types of cancer including breast cancer. Respiratory side effects include cough (<7%) and bronchitis (<5%). Lung injury/pneumonitis is a rare complication with only a few cases reported to date [2,3]. The timing of symptoms with chemotherapy administration and the negative infectious work-up supports capecitabine as the inciting etiology of lung injury. Withholding chemotherapy and starting systemic steroids were effective treatments in this case of chemotherapy induced lung toxicity. CONCLUSIONS: Capecitabine induced lung injury is a rare but important entity and should always be kept in mind while evaluating dyspnea in cancer patients. Reference #1: Capri G, Chang J, et al. An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer. Ann Oncol. 2010;21(3):474. Epub 2009 Oct 8. DOI: 10.1093/annonc/mdp373 Reference #2: C. J. Benthin, G. Allada. Capecitabine-Induced Lung Injury. American Journal of Respiratory and Critical Care Medicine 2016;193:A1653. Reference #3: Andrew K Chan, Bok A Choo, John Glaholm. Pulmonary toxicity with oxaliplatin and capecitabine/5-Fluorouracil chemotherapy: a case report and review of the literature. Onkologie. 2011;34(8-9):443-6. doi: 10.1159/000331133. Epub 2011 Aug 19. DISCLOSURES: No relevant relationships by William Karkowsky No relevant relationships by Chahat Puri No relevant relationships by Sahib Singh

9.
Chest ; 162(4):A1764, 2022.
Article in English | EMBASE | ID: covidwho-2060857

ABSTRACT

SESSION TITLE: Pathologies of the Post-COVID-19 World SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 10:15 am - 11:10 am INTRODUCTION: COVID-19 Associated Pulmonary Aspergillosis (CAPA) is a subset of invasive pulmonary aspergillosis occurring in patients actively infected with or recovering from COVID-19. It has mostly been described in immunocompromised or severely ill patients requiring invasive mechanical ventilation[1-6]. The authors report a case of CAPA infection in an ambulatory and immunocompetent patient with prior lung resection. CASE PRESENTATION: A 20-year-old male presented to a Comprehensive Cancer Center for fever and hemoptysis. He carried a diagnosis of metastatic germ cell tumor to his lungs, status post left upper-lobe wedge resection. He had completed bleomycin, etoposide, and cisplatin (BEP) chemotherapy one year earlier. He was recently diagnosed with COVID-19 one month prior to admission and treated as an outpatient with monoclonal antibodies. He reported ongoing cough productive of clear sputum since his diagnosis, which had worsened over the previous two days and was now blood-tinged. He had been afebrile for weeks before noting new fevers over the same period. Physical examination was notable for fever to 38.6°C and lungs clear to auscultation. His labs were significant for a WBC of 14.5 K/mcl (82.5% neutrophils), Cr 2.1 mg/dL (baseline 1.5 mg/dL), and normal platelets and coagulation studies. Serum Aspergillus galactomannan was normal. Repeat SARS-CoV-2 PCR was negative. Chest x-ray was unchanged. V/Q scan showed no evidence of pulmonary embolism. Non-contrast CT chest performed on hospital day #4 revealed a partial opacification and increased wall thickness of patient's largest left upper lobe surgical cavitation (see Image 1). A bronchoscopy was performed day #6, with bronchoalveolar lavage (BAL) galactomannan >5.56 (normal <0.5)7;fungal culture was significant for septate hyphae. He was started on voriconazole with improvement in his symptoms and discharged day #9. DISCUSSION: Immunocompromised patients with prolonged neutropenia, solid-organ or stem cell transplants, and patients with advanced AIDS are at highest risk of contracting PA[8-9]. ARDS secondary to viral pneumonia is also a common precipitant in immunocompetent patients[1-6,10,11]. The exact mechanism of this association remains unknown, but it is postulated to occur due to multiple factors, including host immune dysregulation[1,2], widespread exposure to corticosteroids[1,2], concomitant lung disease[1], and viral-induced lymphopenia[2]. We report a case of an immunocompetent patient with prior lung resection recovering from COVID-19 who experienced a secondary worsening of symptoms ultimately found to have CAPA to further highlight the link between these conditions. CONCLUSIONS: While many of CAPA case reports describe patients with typical risk profiles for CAPA, this case suggests that clinicians should consider structural lung disease alone in an otherwise immunocompetent, ambulatory individual to be a potential risk factor. Reference #1: See Image 2 for full list of references. DISCLOSURES: No relevant relationships by Raphael Rabinowitz No relevant relationships by Matthew Velez

10.
Chest ; 162(4):A1612, 2022.
Article in English | EMBASE | ID: covidwho-2060849

ABSTRACT

SESSION TITLE: Unusual Cancer Cases SESSION TYPE: Case Reports PRESENTED ON: 10/19/2022 09:15 am - 10:15 am INTRODUCTION: Cutaneous lesions may present as a clue to an internal malignancy and provide an easily accessible site for tissue confirmation. We present a case of an eyelid metastatic lesion presenting as an initial sign of primary pulmonary malignancy. CASE PRESENTATION: A 67-year-old woman with past medical history of SARS-COVID-2 pneumonia six months ago and reformed smoker (26 pack year) who quit 27 years ago, presented to the primary care physician's office with a chief complaint of a small right upper eyelid margin (base of eyelashes) lesion (Figure 1A), and ongoing nonproductive cough and fatigue since diagnosis of SARS-COVID-2 pneumonia. The eyelid lesion appeared two weeks prior and had quickly grown in size. The lesion was associated with mild itching, but without any associated pain, discharge, or bleeding. She also complained of left elbow and foot pain but denied fever, chills, rigors, hemoptysis, pleurisy, and weight loss. Physical examination was negative for lymphadenopathy. Chest x-ray revealed a hazy left upper lobe opacity. Urine antigen for blastomycoses and histoplasma were negative. Rheumatoid factor, erythrocyte sedimentation rate, C reactive protein, QuantiFERON TB gold and anti-nuclear and cyclic citrullinated peptide antibodies were negative. Computed tomography of chest revealed a left upper lobe 3.7 x 5.4 x 5.6 cm mass, numerous bilateral ground glass opacities, and scattered (less than 5 mm) nodules (Figure 1B). Simultaneously, the patient was evaluated by an ophthalmologist for excision of the eyelid lesion. Histopathological evaluation revealed malignancy compatible with metastatic lung adenocarcinoma (Figure 1C) DISCUSSION: While an uncommon presentation, this case highlights the importance of a through history and examination in a patient presenting with pulmonary symptoms with risk factors for a lung malignancy. While she did have imaging that demonstrated lung masses, the diagnosis of lung cancer came not from invasive sampling of these masses, but rather from excision and histopathological evaluation of an eyelid soft tissue mass. Lung cancer is prone to metastasis, however cutaneous manifestations of lung cancer are relatively rare and are more common in the advanced stages of disease, making cutaneous metastasis a poor prognostic factor. In terms of cutaneous metastases, ocular metastases are one of the rarest locations making this a unique presentation. In a patient presenting with pulmonary masses, any concurrent development of new and/or growing skin lesions should be evaluated to rule out metastasis and potentially yield diagnosis. CONCLUSIONS: In patients presenting with concern for a malignant lung process, a skin exam should be completed, and suspicious skin lesions should be biopsied. Although rare, lung malignancies do metastasize to ocular cutaneous tissues and are a marker of more advanced stage of the malignancy. Reference #1: Hidaka T, Ishii Y, Kitamura S. Clinical features of skin metastasis from lung cancer. Intern Med. 1996;35:459-462. Reference #2: Marcoval J, Penin RM, Llatjos R, Martinez-Ballarin, I. Cutaneous metastasis from lung cancer: retrospective analysis of 30 patients. Australas J Dermatol. 2012;53(4):288-290. Reference #3: Abdeen Y, Amireh S, Patel A, Al-Halawani M, Shaaban H, Miller R. Cutaneous metastasis as a first presentation for lung adenocarcinoma. N Am J Med Sci. 2016;8(5): 222-225. DISCLOSURES: No relevant relationships by Gregory Griepentrog No relevant relationships by Chinmay Jani No relevant relationships by Bailey Ray No relevant relationships by Harpreet Singh No relevant relationships by Amit Taneja No relevant relationships by Kara Young

11.
Chest ; 162(4):A1585, 2022.
Article in English | EMBASE | ID: covidwho-2060845

ABSTRACT

SESSION TITLE: Using Imaging for Diagnosis Case Posters SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Immunotherapy is now a standard of care in solid-tumor oncology following the approvals of CTLA-4 and PD-1 inhibitors. Belzutifan, a small-molecule HIF-2a inhibitor, has recently gained FDA-approval for the treatment of advanced von Hippel-Lindau (VHL) associated renal cell carcinomas. CASE PRESENTATION: A 63-year-old female presented to our hospital with a one-day history of progressive dyspnea. Medical history is significant for metastatic renal cell carcinoma with pulmonary metastasis. Family and social history were noncontributory. Her cancer diagnosis was established in 2019 and had undergone cytoreductive nephrectomy and treatment with axitinib/pembrolizumab. As she had little improvement with immunotherapy, she was enrolled in a clinical trial at Memorial Sloan Kettering. Due to further disease progression, she was transitioned to lenvatinib/everolimus, though the treatment was discontinued due to anorexia and worsening pulmonary symptoms. Further work up revealed that she had ERG, MPL, VHL gene mutations. Thus, she was started on belzutifan two weeks prior to her presentation. Initial vitals were significant for hypoxia on room air that recovered with high flow nasal cannula (40L/80%). Physical examination was remarkable for severe respiratory distress with coarse breath sounds bilaterally. Laboratory studies revealed an acute leukocytosis with a neutrophilic prominence and a chronic metabolic alkalosis. COVID, flu PCR were negative. Chest x-ray demonstrated diffuse bilateral reticulonodular opacities. CTA revealed innumerable pulmonary nodules with areas of mass-like consolidation and a loculated left-sided pleural effusion. She was covered with azithromycin/ceftriaxone along with high-dose steroids and was admitted to the stepdown unit for further management. While in stepdown, she had a left PleurX catheter placed given her large effusion which was complicated by bloody output that required one unit of blood. Despite high-dose steroids, she had persistent hypoxia. As she remained unstable, goals of care discussions were held, which ultimately led to a change in code status to comfort measures. All aggressive measures were discontinued. She was started on comfort medications and ultimately passed away. DISCUSSION: Currently, neoplasms associated with VHL mutations are managed surgically to minimize the risk of metastatic disease. Nearly 70% of all patients with VHL mutations will develop renal cell carcinomas which means most patients undergo numerous surgical procedures. HIF-2a inhibition therefore offers an effective alternative that could reduce surgical burden and offer a new approach to management of VHL-associated disease. However due to its new approval, several adverse effects have yet to be documented. CONCLUSIONS: We report the only known case of Belzutifan-induced hypersensitivity pneumonitis and hope this case will become a useful contribution to the literature. Reference #1: Jonasch E, Donskov F, Iliopoulos O, Rathmell WK, Narayan VK, Maughan BL, Oudard S, Else T, Maranchie JK, Welsh SJ, Thamake S, Park EK, Perini RF, Linehan WM, Srinivasan R;MK-6482-004 Investigators. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 25;385(22):2036-2046. doi: 10.1056/NEJMoa2103425. PMID: 34818478. DISCLOSURES: No relevant relationships by Garrett Fiscus No relevant relationships by Niala Moallem No relevant relationships by Raj Parikh

12.
Chest ; 162(4):A390, 2022.
Article in English | EMBASE | ID: covidwho-2060580

ABSTRACT

SESSION TITLE: Complications of Thoracic Infections SESSION TYPE: Rapid Fire Case Reports PRESENTED ON: 10/18/2022 01:35 pm - 02:35 pm INTRODUCTION: Serratia marcescens is a gram negative bacteria known to colonize the human GI tract. While infections of urinary tract, respiratory tract, and CNS can occur, it is usually associated with immunocompromised hosts or patients who undergo invasive procedures or surgeries. Here, we present a 21-year-old immunocompetent male with Serratia marcescens cavitary pneumonia following COVID-19 infection. CASE PRESENTATION: A 21-year-old obese male with no past medical history presented with shortness of breath, cough and fevers for one week. In the emergency department (ED), he was febrile to 38.8°C, tachycardic, saturating 90% on room air. He was recently admitted to an outside hospital two weeks prior with COVID-19 pneumonia. He was treated with Remdesivir and decadron and discharged after five days. No invasive procedures were performed during his hospital stay and he never required advanced oxygen support other than simple nasal cannula. CTA of his chest in the ED showed thick walled bilateral lower lobe cavitary lesions and multifocal ground glass alveolar opacities. No pulmonary embolism was seen. Sputum cultures were collected but inadequate. Bronchoscopy with bronchoalveolar lavage (BAL) was performed and fluid studies showed white blood cell count of 70,029 cell/uL, with 94% neutrophils. BAL fluid cultures grew Serratia marcescens. He was originally placed on vancomycin and cefepime and discharged on oral Levaquin for four weeks based on sensitivities. HIV testing was negative. DISCUSSION: Serratia is a rod shaped gram negative bacteria found in soil, water, and human gut flora. It is known to be an opportunistic pathogen that can cause urinary, respiratory, CNS and blood stream infections in immunocompromised patients. Infections in immunocompetent are usually associated with invasive devices such as mechanical ventilation or central venous catheters. While superimposed bacterial infections in COVID-19 illness are well known, they are usually seen in patients with severe disease requiring mechanical ventilation and prolonged hospitalization. Those with underlying systemic illness, advanced age and impaired immune systems are particularly susceptible. Our patient was young, immunocompetent and only required minimal oxygen support while hospitalized for COVID-19. CONCLUSIONS: Serratia marcescens pneumonia is rarely seen in immunocompetent hosts, but should remain on the differential in patients with recent hospitalization and COVID-19 infection, regardless of severity of disease. Reference #1: Hidron, A., Quiceno, W., Cardeño, J. J., Roncancio, G., & García, C. (2021). Post-COVID-19 Necrotizing Pneumonia in Patients on Invasive Mechanical Ventilation. Infectious Disease Reports, 13(3), 835–842. https://doi.org/10.3390/idr13030075 Reference #2: Fazio, G., Galioto, F., Ferlito, A., Coronella, M., Palmucci, S., & Basile, A. (2021). Cavitated pulmonary nodules in a female patient with breast cancer: Keep in mind Serratia marcescens’ infections. Respiratory Medicine Case Reports, 33, 101441. https://doi.org/10.1016/j.rmcr.2021.101441 Reference #3: Jose, M., & Desai, K. (2020). Fatal Superimposed Bacterial Sepsis in a Healthy Coronavirus (COVID-19) Patient. Cureus. https://doi.org/10.7759/cureus.8350 DISCLOSURES: No relevant relationships by Lucy Checchio No relevant relationships by Syeda Hassan No relevant relationships by Jaclyn Rosenzweig No relevant relationships by Stephanie Tzarnas No relevant relationships by Laura Walters

13.
Journal of Global Trends in Pharmaceutical Sciences ; 13(3):9985-9989, 2022.
Article in English | EMBASE | ID: covidwho-2057926

ABSTRACT

Heparin is a sulphate polysaccharide of glycosaminoglycan that is made predominantly by mast cells of connective tissue. It is used in the management of thromboembolic problems in medicine. Heparin acts as a catalyst for antithrombin III, increasing its activity by thousand times. The larger heparin species catalyses the inactivation of activated factors II and X, in contrast LMWH inactivates the activated factor X. The final effect for both is systemic anti-coagulation. Heparin also produces platelet aggregating antibodies and causes coagulopathy in rare conditions. LMWH especially Enoxaparin (Inj Clexane) proved an effective treatment in patients with Covid -19 infection by preventing thromboembolism and pulmonary embolism thereby, helped in survival of the patients by reducing the risk of death due to coagulation and fibrosis. Hence, clinical trial reports and SOAP analysis of clinical case studies in random subjects and patients reported the over-view of advantages using LMWH heparins in disease management and emergency traumatic injuries produced a beneficial role of using LMWH over unfractioned heparins.

14.
European Journal of Molecular and Clinical Medicine ; 9(6):1075-1083, 2022.
Article in English | EMBASE | ID: covidwho-2058068

ABSTRACT

Introduction: The COVID-19 pandemic has been raging across the globe since early January 2020. Various geographical regions have been passing multiple swells of upsurge of cases which aren't matched temporally as well as in severity. The diapason of the complaint ranges from asymptomatic to severe life-hanging complaint. Advanced age and the presence of comorbidities similar as cardiovascular complaint, diabetes mellitus, hypertension, chronic lung complaint, chronic kidney complaint, cancer, and obesity are among the major threat factors for severe disease. Aims and objectives: Significance of lab parameter among Corona Patients. Materials and methods: The covid- 19 opinion was verified by reverse transcription- polymerase chain reaction (RT- PCR) assay of nasopharyngeal swab sample. Hematology blood samples were used to analyze by flow cytometry. Biochemical samples were used to analyze by completely auto analyzer diagnostic outfit. Serology tests were carried out the styles based on indirect ELISA technique, immune plates are coated with a admixture of purified viral antigen and probe using the patient serum. Results: It is found that there is statistically significant (p-value<0.05) mean difference within the lab parameters (IL-6, LDH and Ferritin) in Covid patients using the Post Hoc Analysis. It is also found that there statistically significant (p-value<0.05) mean difference between RBC, Hb level, Hematocrit, MCV, MCH, MCHC, Platelet, RDW, PCT and NL ratio while Age, WBC, MPV, M(Monocyte), E(Eosinophil), B(Basophil), D-dimer and PDW were found to be statistically insignificant (p-value>0.05) with respect to gender. Discussion: CBC, D- dimer, IL-6, LDH and Ferritin were analysed and found associated with adverse outcomes. There is significant association of age, gender, comorbidity. Conclusion: High NLR at admission associated with a higher mortality. Laboratory features (e.g., IL-6, LDH, Ferritin D-dimer etc.) were associated with poor outcomes.

15.
British Journal of Surgery ; 109:vi35-vi36, 2022.
Article in English | EMBASE | ID: covidwho-2042544

ABSTRACT

Introduction: We aim to establish if the first wave of COVID-19 has caused HNC patients to present later or with more advanced disease and if there have been delays in time to imaging, treatment or MDT discussion. Method: Patients were identified retrospectively from a database of cases discussed at head and neck MDT between June and October of 2019 and 2020. New HNC cases were included, and benign or recurrent disease excluded. Data was extracted from electronic patient records and statistical comparisons were performed using JASP. Results: Data was analysed from 216 patients (2019 n=98, 2020 n=118). No statistically significant differences were observed in age, ECOG, smoking and alcohol use. Significantly more patients presented with >6 weeks history of red flag symptoms in 2020 than 2019 with an odds ratio (OR) of 2.44 (95% CI, 1.38 to 4.23), (p=0.002). Patients in 2020 were also significantly more likely to present as an emergency, OR 5.94 (95% CI 1.31 to 27.02), (p=0.013). The OR of being in a higher AJCC stage in 2020 versus 2019 was 1.69 (95% CI, 1.00 to 2.84), (p=0.05). There were no significant differences in time to MDT discussion, first dedicated imaging, or time to initiation of treatment. Conclusion: This data supports concerns that COVID-19 has caused delays in patient presentation, evidenced by longer symptom duration, higher AJCC stage and more emergency presentations. The management was not impacted. HNC services are functioning well despite the pandemic and patients should be encouraged to present to facilitate earlier intervention.

16.
Annals of Oncology ; 33:S1427-S1428, 2022.
Article in English | EMBASE | ID: covidwho-2041570

ABSTRACT

Background: AAP or ENZ added to ADT improves outcomes for mHSPC. Any benefit of combining ENZ & AAP in this disease setting is uncertain. Methods: STAMPEDE is a multi-arm, multi-stage (MAMS), platform protocol conducted at 117 sites in the UK & Switzerland. 2 trials with no overlapping controls randomised mHSPC patients (pts) 1:1 to ADT +/- AAP (1000mg od AA + 5mg od P) or AAP + ENZ (160mg od). Treatment was continued to progression. From Jan 2016 docetaxel 75mg/m2 3-weekly with P 10mg od was permitted + ADT. Using meta-analysis methods, we tested for evidence of a difference in OS and secondary outcomes (as described previously: failure-free, metastatic progression-free, progression-free & prostate cancer specific survival) across the 2 trials using data frozen 3 Jul 2022. All confidence intervals (CI) 95%. Restricted mean survival times (RMST) restricted to 84 months (m). Results: Between Nov 2011 & Jan 2014, 1003 pts were randomised ADT +/- AAP & between Jul 2014 & Mar 2016, 916 pts were randomised ADT +/- AAP + ENZ. Randomised groups were well balanced across both trials. Pt cohort: age, median 68 years (yr), IQR 63, 72;PSA prior to ADT, median 95.7 ng/ml, IQR 26.5, 346;de novo 94%, relapsed after radical treatment, 6%. In AAP + ENZ trial, 9% had docetaxel + ADT. OS benefit in AAP + ENZ trial, HR 0.65 (CI 0.55‒0.77) p = 1.4×10-6;in AAP trial, HR 0.62 (0.53, 0.73) p = 1.6×10-9. No evidence of a difference in treatment effect (interaction HR 1.05 CI 0.83‒1.32, p = 0.71) or between-trial heterogeneity (I2 p = 0.70). Same for secondary end-points. % (CI) of pts reporting grade 3-5 toxicity in 1st 5 yr: AAP trial, ADT: 38.5 (34.2-42.8), + AAP: 54.4 (50.0-58.8);AAP + ENZ trial, ADT: 45.2 (40.6 – 49.8), + AAP + ENZ: 67.9 (63.5 – 72.2);most frequently increased with AAP or AAP + ENZ = liver derangement, hypertension. At 7 yr in AAP trial (median follow-up: 95.8m), % (CI) pts alive with ADT: 30 (26, 34) versus with ADT + AAP: 48 (43, 52);RMST: ADT: 50.4m, ADT + AAP: 60.6m, p = 6.6 x 10-9. Conclusions: ENZ + AAP need not be combined for mHSPC. Clinically important improvements in OS when adding AAP to ADT are maintained at 7 yr. Clinical trial identification: NCT00268476. Legal entity responsible for the study: Medical Research Council Clinical Trials Unit at University College London. Funding: Cancer Research UK, Medical Research Council, Janssen, Astellas. Disclosure: G. Attard: Financial Interests, Personal, Invited Speaker: Janssen, Astellas, AstraZeneca;Financial Interests, Personal, Advisory Board: Janssen, Astellas, Novartis, Bayer, AstraZeneca, Pfizer, Sanofi, Sapience, Orion;Financial Interests, Personal, Royalties, Included in list of rewards to discoverers of abiraterone: Institute of Cancer Research;Financial Interests, Institutional, Research Grant: Janssen, Astellas;Non-Financial Interests, Principal Investigator: Janssen, Astellas;Non-Financial Interests, Advisory Role: Janssen, AstraZeneca. W.R. Cross: Financial Interests, Personal, Invited Speaker, Speaker fee: Myriad Genetics, Janssen, Astellas;Financial Interests, Personal, Advisory Board, Advisory Board fee: Bayer;Financial Interests, Institutional, Research Grant, Research grant: Myriad Genetics. S. Gillessen: Financial Interests, Personal, Advisory Board, 2018: Sanofi, Roche;Financial Interests, Personal, Advisory Board, 2018, 2019: Orion;Financial Interests, Personal, Invited Speaker, 2019 Speaker's Bureau: Janssen Cilag;Financial Interests, Personal, Advisory Board, 2020: Amgen;Financial Interests, Personal, Invited Speaker, 2020: ESMO;Financial Interests, Personal, Other, Travel Grant 2020: ProteoMEdiX;Financial Interests, Institutional, Advisory Board, 2018, 2019, 2022: Bayer;Financial Interests, Institutional, Advisory Board, 2020: Janssen Cilag, Roche, MSD Merck Sharp & Dohme, Pfizer;Financial Interests, Institutional, Advisory Board, 2018: AAA International, Menarini Silicon Biosystems;Financial Interests, Institutional, Advisory Board, 2019, 2020: Astellas Pharma;Financial Interests, Institutional, Advisory B ard, 2019: Tolero Pharmaceuticals;Financial Interests, Personal, Invited Speaker, 2021, 2022: SAKK, DESO;Financial Interests, Institutional, Advisory Board, 2021: Telixpharma, BMS, AAA International, Novartis, Modra Pharmaceuticas Holding B.V.;Financial Interests, Institutional, Other, Steering Committee 2021: Amgen;Financial Interests, Institutional, Advisory Board, 2021, 2022: Orion, Bayer;Financial Interests, Personal, Invited Speaker, 2021: SAKK, SAKK, SAMO - IBCSG (Swiss Academy of Multidisciplinary oncology);Financial Interests, Personal, Advisory Board, 2021: MSD Merck Sharp & Dhome;Financial Interests, Personal, 2021: RSI (Televisione Svizzera Italiana);Financial Interests, Institutional, Invited Speaker, 2021: Silvio Grasso Consulting;Financial Interests, Institutional, Other, Faculty activity 2022: WebMD-Medscape;Financial Interests, Institutional, Advisory Board, 2022: Myriad genetics, AstraZeneca;Financial Interests, Institutional, Invited Speaker, 2022: TOLREMO;Financial Interests, Personal, Other, Travel support 2022: AstraZeneca;Financial Interests, Institutional, Funding, 2021, Unrestricted grant for a Covid related study as co-investigator: Astellas;Non-Financial Interests, Advisory Role, 2019: Menarini Silicon Biosystems, Aranda;Non-Financial Interests, Advisory Role, Continuing: ProteoMediX. C. Pezaro: Financial Interests, Personal, Advisory Board, Ad board Dec 2020: Advanced Accelerator Applications;Financial Interests, Personal, Advisory Board, Aug 2021: Astellas;Financial Interests, Personal, Advisory Board, Oct 2021: Bayer;Financial Interests, Personal, Invited Speaker, Sept-Oct 2020: AstraZeneca;Financial Interests, Personal, Invited Speaker, Oct 2020: Janssen;Financial Interests, Personal, Advisory Board, July-Sept 2022: Pfizer. Z. Malik: Financial Interests, Personal, Advisory Board, advisry board for new hormonal therapy for breast cancer: sanofi;Financial Interests, Institutional, Invited Speaker, research grant for CHROME study: sanofi;Other, Other, support to attend meetings or advisory boards in the past: Astellas,Jaansen,Bayer;Other, Other, Sponsorship to attend ASCO meeting 2022: Bayer. M.R. Sydes: Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training sessions for clinicians (no discussion of particular drugs): Janssen;Financial Interests, Personal, Invited Speaker, Speaker fees at clinical trial statistics training session for clinicians (no discussion of particular drugs): Eli Lilly;Financial Interests, Institutional, Research Grant, Educational grant and drug for STAMPEDE trial: Astellas, Janssen, Novartis, Pfizer, Sanofi;Financial Interests, Institutional, Research Grant, Educational grant and biomarker costs for STAMPEDE trial: Clovis Oncology. L.C. brown: Financial Interests, Institutional, Research Grant, £170k educational grant for the FOCUS4-C Trial from June 2017 to Dec 2021: AstraZeneca;Financial Interests, Institutional, Funding, Various grants awarded to my institution for work undertaken as part of the STAMPEDE Trial: janssen pharmaceuticals;Non-Financial Interests, Other, I am a member of the CRUK CERP funding advisory panel and my Institution also receive grant funding from CRUK for the STAMPEDE and FOCUS4 trials: Cancer Research UK. M.K. Parmar: Financial Interests, Institutional, Full or part-time Employment, Director at MRC Clinical Trials Unit at UCL: Medical Research Council Clinical Trials Unit at UCL;Financial Interests, Institutional, Research Grant: AstraZeneca, Astellas, Janssen, Clovis;Non-Financial Interests, Advisory Role, Euro Ewing Consortium: University College London;Non-Financial Interests, Advisory Role, rEECur: University of Birmingham;Non-Financial Interests, Advisory Role, CompARE Trial: University of Birmingham. N.D. James: Financial Interests, Personal, Advisory Board, Advice around PARP inhibitors: AstraZeneca;Financial Interests, Personal, Advisory Board, Prostate cancer therapies: Janssen, Clovis, Novartis;Financial Interests, Institutional, Expert Testimony, Assisted with submissions regarding licencing for abiraterone: Janssen;Financial Interests, Personal, Advisory Board, Docetaxel: Sanofi;Financial Interests, Institutional, Expert Testimony, Providing STAMPEDE trial data to facilitate licence extensions internationally for docetaxel: Sanofi;Financial Interests, Personal, Advisory Board, Bladder cancer therapy: Merck;Financial Interests, Personal, Advisory Board, Advice around novel hormone therapies for prostate cancer: Bayer;Financial Interests, Personal, Invited Speaker, Lecture tour in Brazil August 2022 - speaking on therapy for advanced prostate cancer: Merck Sharp & Dohme (UK) Limited;Financial Interests, Institutional, Invited Speaker, Funding for STAMPEDE trial: Janssen, Astellas;Financial Interests, Institutional, Invited Speaker, Funding for RADIO trial bladder cancer: AstraZeneca. All other authors have declared no conflicts of interest.

17.
Annals of Oncology ; 33:S1133, 2022.
Article in English | EMBASE | ID: covidwho-2041548

ABSTRACT

Background: Care in hospitals is generally focused on prolonging life and may not adequately address the needs of dying patients. The incidence of oncologic diseases is rising, and efforts should be made to guarantee a better quality of death and dying. Aim: to evaluate the end-of-life care in patients with cancer under gastroenterologist care. Methods: Cross-sectional study including all in-patients with cancer who deceased in a Gastroenterology department in Portugal between 2012-2021. Demographic characteristics, clinical attitudes, therapeutic interventions and symptom control up to 6 months prior to the patient’s death were assessed. Results: We included 120 patients, 73% male, mean age 71±12.5 years. The most common cancers were hepatocellular carcinoma (35%), gastric cancer (16%), pancreatic cancer (15%) and cholangiocarcinoma (14%). One third of the patients had ECOG of 0-1 at admission and 77% (n=92) had advanced disease (stage IV or Barcelona Clinic Liver Cancer C/D). The median number of emergency consultations and hospitalizations in the 6 months before death was 2 (IQR 1-4). In their last month of life, the median time of hospitalization was 21.5 (IQR 12-25) days. It was documented the presence of an available caregiver in 56%(n=68) and spiritual support in only 2% (n=2) of the cases. One quarter of the patients experienced not adequately controlled pain and 72% received opioids. Palliative care consultation occurred in 60% (n=72) with a median time between that and death of 12 (IQR 3-18) days. Invasive procedures (diagnostic and therapeutic endoscopy, ERCP and EUS) were performed in half of the patients, achieving technical and clinical success in 62% (n=38) and 32% (n=19) of the cases, respectively. The mean time between those interventions and death was 12±10 days. The prognosis was discussed with the patient and family in 35% and 68% of the cases, respectively. At least 73% of the patients had visits at the end of life, which was negatively affected by the COVID-19 pandemic (p=0.022). Conclusions: In our cohort, we found a high hospitalization length of stay in the last month of life and high percentage of invasive treatments until shortly before dying. Thus, it is urgent to define and implement metrics of quality of death to prevent futile/potentially inappropriate treatment. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

18.
Annals of Oncology ; 33:S1078, 2022.
Article in English | EMBASE | ID: covidwho-2041545

ABSTRACT

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

19.
Annals of Oncology ; 33:S1022-S1023, 2022.
Article in English | EMBASE | ID: covidwho-2041543

ABSTRACT

Background: OSE2101 (Tedopi) is an anticancer vaccine that increased overall survival (OS) (HR 0.59, p=0.017) versus Standard of Care Chemotherapy in the population of interest (PoI N=118) of patients with IO secondary resistance after sequential CT-IO (ESMO 2021 #47LBA). The Net Treatment Benefit (NTB) is an original method combining efficacy and safety endpoints to test the overall improvement in health outcome between 2 treatments (Buyse M. Stat Med 2010). NTB was assessed in the overall population (N=219) from whom OS improvement of OSE2101 (HR 0.86, p=0.35) was lower than in PoI. Methods: NTB was tested by comparing prioritized outcomes using Generalized Paired Wise Comparisons (GPC). The prioritized outcomes were OS, then time to worsening ECOG (threshold=2 months) followed by severe adverse events, progression free survival (shorter vs. longer than 2 months) and Quality of Life (threshold=5 points on Global Health Status of EORTC-QLQC30). Analysis was stratified using the 3 strata of the study (histology, best response to 1rst line, line of prior IO) and enrollment time (before vs during COVID-19). Sensitivity analyses used no stratification, different thresholds of clinical relevance and PoI. Results: In the primary analysis (1088 pairs), NTB was 19% and reached statistical significance in favor of OSE2101 (p=0.035). In unstratified analysis (11120 pairs), NTB was 11% (p=0.188). In the PoI (388 pairs), NTB was 22% (p stratified=0.074) and 28% (p=0.014) in unstratified analysis (3040 pairs). Although the primary analysis was statistically positive, results were not consistent in some sensitivity analyses due to the limited sample size and the impact of stratification factors. Conclusions: An overall improvement in health outcome was observed with OSE2101 in the overall population of advanced NSCLC after IO failure with a NTB of 19% over SoC. In PoI with IO secondary resistance after CT-IO, the NTB was 22%. Post-hoc analyses are ongoing intended to explain the variability of NTB and will be detailed. Clinical trial identification: EudraCT: 2015-003183-36;NCT02654587. Editorial acknowledgement: We thank Pierre Attali (Medical Expert, MD) for his support in the writing of the . Legal entity responsible for the study: Ose Immunotherapeutics. Funding: Ose Immunotherapeutics. Disclosure: M.E. Buyse: Financial Interests, Personal, Officer, Chief Scientific Officer: IDDI;Financial Interests, Personal, Invited Speaker, Board Member: CluePoints;Financial Interests, Personal, Stocks/Shares: IDDI, CluePoints. F. Montestruc: Financial Interests, Personal, Member of the Board of Directors, CEO of the Company: eXYSTAT SAS;Financial Interests, Institutional, Other, Statistician Consultant: AbbVie, Biocodex, Geneuro, Gensight, Guerbet, Imcheck, Ose Immunotherapeutics, Pfizer, Takeda;Non-Financial Interests, Personal, Other, Statistician Consultant and Training: Institut Pasteur. J. Chiem: Financial Interests, Personal, Full or part-time Employment: IDDI. V. Deltuvaite-Thomas: Financial Interests, Personal, Full or part-time Employment: IDDI. S. Salvaggio: Financial Interests, Personal, Full or part-time Employment, Working as a statistician: International Drug Development Institute. M.R. Garcia Campelo: Financial Interests, Personal, Advisory Role: Roche/Genentech, MSD Oncology, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, Janssen Oncology;Financial Interests, Personal, Speaker’s Bureau: Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Novartis, Takeda, Boehringer Ingelheim, MSD Oncology, Sanofi/Aventis, Janssen Oncology, Amgen;Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche/Genentech, MSD Oncology, Pfizer. F. Cappuzzo: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, PharmaMar, Mirati, Novocure, OSE, and MSD;Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, BMS, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, Mirati, PharmaMar, Novocure, OSE, Galecto and MS . S. Viteri Ramirez: Financial Interests, Personal, Advisory Board: Merck Healthcare KGAA Germany, Bristol Myers Squibb S.A. U, Puma Biotechnology;Financial Interests, Personal, Invited Speaker: Takeda Farmaceutica España SA, MSD de España SA, AstraZeneca Farmaceutica Spain, Roche Farma SA;Financial Interests, Personal, Expert Testimony: Reddy Pharma Iberia SAU. W. Schuette: Financial Interests, Personal, Other, Honoraria: Roche, MSD, Novartis;Financial Interests, Personal, Advisory Role: Roche, MSD, Novartis. A. Zer: Financial Interests, Personal, Invited Speaker: Roche, BMS, MSD, Takeda, Pfizer, Novartis;Financial Interests, Personal, Advisory Board: AstraZeneca, Steba, Oncohost;Financial Interests, Personal, Stocks/Shares: Nixio;Financial Interests, Institutional, Research Grant: BMS. S. Comis: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics. B. Vasseur: Financial Interests, Personal, Full or part-time Employment: Ose Immunotherapeutics;Financial Interests, Personal, Other, Actions: Ose Immunotherapeutics. R. Dziadziuszko: Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Seattle Genetics, Pfizer, Takeda, Regeneron, MSD, Bristol Myers-Squibb, PharmaMar, Bayer;Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim, Foundation Medicine;Financial Interests, Personal, Expert Testimony: Novartis;Financial Interests, Personal and Institutional, Invited Speaker: Roche, AstraZeneca, MSD, Amgen, Celon Pharma, Pfizer, Novartis, Brsitol Myers-Squibb, Eli Lilly, Loxo;Financial Interests, Invited Speaker: BeiGene, Ardigen, Ose Immunotherapeutics;Financial Interests, Personal and Institutional, Other, Subinvestigator and ad hoc Consultant: PDC* line Pharma;Non-Financial Interests, Institutional, Product Samples: Novartis, Pfizer, AstraZeneca, Roche;Other, Travel: Roche, Bristol Myers-Squibb, AstraZeneca. G. Giaccone: Financial Interests, Personal, Advisory Board: Novartis;Financial Interests, Institutional, Research Grant: Karyopharm. 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. E. Felip: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Glaxo Smith Kline, Janssen, Medical Trends, Merck Sharp & Dohme, Pfizer, Puma, Sanofi, Takeda, Merck Serono, Peptomyc, Regeneron, Syneos Health, F. Hoffmann-La Roche;Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Eli Lilly, Medscape, Merck Sharp & Dome, Peervoice, Pfizer, Springer, Touch Medical, Amgen, F. Hoffmann-La Roche, Janssen, Medical Trends, Merck Serono;Financial Interests, Personal, Invited Speaker, Independent member: Grifols;Financial Interests, Institutional, Invited Speaker, Clinical Trial: F. Hoffmann-La Roche Ltd, Merck Sharp & Dohme Corp, AstraZeneca AB, Daiichi Sankyo Inc, Exelixis Inc, Merck KGAA, Janssen Cilag International NV, GlaxoSmithKline Research & Development Limited, AbbVie Deutschland GmbH & Co KG, Novartis Farmaceutica SA, Bayer Consumer Care AG, Takeda Pharmaceuticals International, Boehringer Ingelheim International GmbH, Pfizer S.L.U., Amgen Inc, Bristol-Myers Squibb International Corporation (BMS), Mirati Therapeutics Inc;Non-Financial Interests, Leadership Role, President Elect (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica);Non-Financial Interests, Member, Member of ESMO Nominating Committee and Compliance Committee: ESMO;Non-Financial Interests, Leadership Role, Member of Board of Directors and the Executive Committee (2017-Sept 2021): IASLC (International Association for the Study of Lung Cancer);Non-Fina cial Interests, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform). All other authors have declared no conflicts of interest.

20.
Annals of Oncology ; 33:S1013-S1014, 2022.
Article in English | EMBASE | ID: covidwho-2041542

ABSTRACT

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

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