ABSTRACT
Introduction: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of their systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer undergoing systemic therapy. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021 patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients for vaccination was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of the 217 (51.1%) interviewed patients had received at least one shot of two-dose COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y). 68.7% had been diagnosed with breast and 25.1% with ovarian cancer;69% presented with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (Astra Zeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction in advance to increase the leukocyte count before vaccination). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for various reasons (e.g. until there is more information on side effects in cancer patients);5% refused vaccination. Conclusions: Breast and gynecologic cancer patients appear to tolerate COVID-19 vaccination under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the DGHO Congress.
ABSTRACT
Background: Cancer patients are at increased risk of developing severe COVID-19 disease. Possible side effects of systemic therapy and the lack of clinical data on safety and efficacy of COVID-19 vaccination in cancer patients cause uncertainty regarding the vaccination. Here, we evaluated attitude towards and effects of COVID-19 vaccination in patients with breast or gynecological cancer. The aim was to improve counseling of our patients in clinical routine. Methods: Since March 15th 2021, patients who received one of the approved COVID-19 vaccines were routinely interviewed about immediate (0-2 days) and late side effects (within two weeks after vaccination). Clinical parameters such as current therapy, time interval between therapy administration and vaccination, and changes in the therapy schedule due to the vaccination were documented. Furthermore, the willingness of non-vaccinated patients to be vaccinated was assessed. The collected data were anonymously analyzed as a part of routine quality assurance. Results: By May 10th 2021, 111 out of 217 (51.1%) interviewed patients had received at least one shot of COVID-19 vaccine and 21 patients both shots. More than half of the vaccinated patients were >55y (60.2%;mean: 60.7y, range 30-92y);69% with UICC/ FIGO stage III/IV cancer. 74.6% received Conmirnaty (BioNTech/ Pfizer), 18.9% Vaxzevria (AstraZeneca) and 6.5% Covid-19 Vaccine Moderna. After the first shot, 33.3% of the patients described no side effects, 49.1% reported a local reaction (swelling or pain), 23.4% flu-like symptoms, 10.8% headache and 3.6% nausea. 11 patients had symptoms that lasted longer than two days. In 11 cases, COVID-19 vaccination had an impact on delivery of the systemic therapy (n=10 postponements of therapy and n=1 dose reduction). 61.3% of the non-vaccinated patients (in total n=118) were already registered to get vaccinated;32.8% chose to postpone vaccination for personal reasons;5% refused vaccination. Conclusions: Breast and gynecological cancer patients appear to tolerate COVID-19 vaccination well under systemic therapy and only in few cases the vaccination interfered with the treatment schedule. Updated results will be presented at the ESMO Congress. Legal entity responsible for the study: LMU University Hospital. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.
ABSTRACT
Background: One of the major challenges with COVID-19 has been the changes to cancer services, including changes to the type of systemic anti-cancer treatment being delivered to patients. There needs to be a better understanding of which cancer patients are at the greatest amount of risk to make informed decisions on how cancer treatment can be altered to protect patients from COVID-19 infection. The CAPITOL (COVID-19 CAncer PatIenT Outcomes in North London) study investigated the outcomes of patients receiving systemic anti-cancer therapies (SACT) with regards to COVID-19 infection, as patients with cancer are hypothesised to be at higher risk. Methods: CAPITOL collected data from all patients receiving SACT at two cancer centres. The effect of clinical characteristics on the incidence and severity of COVID-19 infection in patients on SACT was the primary outcome, and we used univariable and multivariable models in our analysis, adjusting for age, gender and comorbidities. Results: 2871 patients were analysed from 2nd March to 31st May 2020, all of whom received SACT;during this time period 68 (2.4%) were diagnosed with COVID-19. Receiving SACT increased the risk of death when contracting COVID-19 (adjusted (adj.) OR 9.84;95% CI 5.73 - 16.9). The risk of contracting COVID-19 was increased by receiving chemotherapy (adj. OR 2.99;95% CI = 1.72 - 5.21), with the risk significantly increased by high dose chemotherapy (adj. OR 2.36, 95% CI 1.35 - 6.48). Patients with comorbidities (adjusted OR 2.29;95% CI 1.19 - 4.38), or with a respiratory or intrathoracic neoplasm (adj. OR 2.12;95% CI 1.04 - 4.36) were also at increased risk of contracting COVID-19. Cancer patients who received targeted treatment had a reduced risk of contracting COVID-19 (adj. OR 0.53;95% CI 0.30 - 0.95), while there was no significant change in risk caused by treatment intent (curative versus palliative), hormonal- or immunotherapy and solid versus haematological cancers. Conclusions: To the best of our knowledge, this is one of the first investigations into the risk of contracting COVID-19 in a cohort of all cancer patients on SACT. We found that patients on SACT are more likely to die if they contract COVID-19. The type of SACT received by cancer patients can affect their likelihood of contacting COVID-19, with chemotherapy increasing risk, targeted therapy decreasing risk and a potential protective effect for hormonal and immunotherapy.
ABSTRACT
INTRODUCTION: Esophagogastric varices are a common complication of portal hypertension and can present with life-threatening bleeding. Definitive endoscopic therapy is via band ligation or sclerotherapy. The former is preferred for esophageal varices, but efficacy is lower in gastric varices (GV). Sclerotherapy with cyanoacrylate (CA) has shown better efficacy and is now recommended as first line therapy for bleeding GV. Studies on long-term efficacy and complications remain limited. CASE DESCRIPTION/METHODS: A 62-year-old woman with NASH cirrhosis (MELD 11) presented with hematemesis. She denied any history of SBP, varices, or encephalopathy. She endorsed a previous history of COVID-19 and had reactive IgG but PCR probe for SARS-CoV-2 was negative. She underwent EGD and was found to have oozing GV along the lesser curvature, which were treated with 4cc of CA achieving hemostasis. The following night she had altered mentation and the blood lactate was increased to 7.2 mmol/L. AST and ALT were also increased. She received broad spectrum antibiotics, and a CT angiogram showed evidence of embolization of CA into the left lobe of the liver. On day 3 her level of consciousness declined and she was intubated for airway compromise. An MRCP confirmed the presence of CA within the left hepatic lobe with associated ischemia. The lactate increased to 20 mmol/L and the blood ammonia level to 700 mcg/dL, with MELD 45. Continuous hemodialysis was started for anuric renal failure. She underwent evaluation for liver transplantation, but cerebral edema and multiorgan failure with refractory acidosis occurred and she died on day 7. DISCUSSION: We present a case of GV treated with CA and the subsequent embolization of CA into the left lobe of the liver. This precipitated acute on chronic liver failure with features of fulminant hepatic failure (FHF) complicated by severe hyperammonemia, cerebral edema, multiorgan failure, and death. Although she had a recent diagnosis of COVID-19, the time course, relatively normal initial inflammatory markers, and imaging suggest that CA embolization was likely the injury that led to fulminant hepatic failure. Given the lack of case reports of CA embolization to the liver causing infarction and few cases to the brain or distant vessels, further research on its long-term safety is warranted. Another novel aspect to this case is the development of FHF in a patient with known cirrhosis.
ABSTRACT
Background: Patients with R/M SCC have low response rates to second line therapies, including PD-1 inhibitors nivolumab and pembrolizumab, representing an area of unmet clinical need. Cetuximab has modest activity as a single agent but potentiates the activity of radiotherapy in locally advanced head & neck SCC (HNSCC) and chemotherapy in R/M HNSCC. Cetuximab initiates Natural Killer cell antibody-dependent cell-mediated cytotoxicity, resulting in an anti-tumour immune response and the potential to augment the activity of PD-1/PD-L1 inhibition. Methods: Trial entry required histologically confirmed R/M SCC of any site, unselected by PD-L1 expression, considered incurable by local therapies and no previous treatment with cetuximab for recurrent/metastatic disease. Prior therapy with anti-PD-1, anti-PD-L1 or anti-PD-L2 was excluded. Patients had avelumab 10 mg/kg + cetuximab 500 mg/m2 intravenously every 2 weeks, for up to 1 year. Primary endpoint was occurrence of dose-limiting toxicity within 42 days of treatment starting, graded using CTCAE v5. Secondary endpoints were objective response (ORR) and disease control rate (DCR) at 6 and 12 months using iRECIST. Results: 16 patients, median age 58 years (range 34 – 88), were enrolled from 2 UK hospitals between July 2018 and October 2019. The trial stopped after completing the safety run-in. 5 patients remain on treatment, 9 stopped treatment early (7 disease progression, 1 patient choice, 1 due to risk of COVID-19). 2 patients died whilst on treatment (both unrelated to trial treatment). Grade 3 AEs were seen in 4 patients and grade 5 in 1 patient. None were related to trial treatment. No patients experienced dose-limiting toxicity. Of 10 patients evaluable for response by iRECIST 2 (20%) had complete response, 3 (30%) had partial response and 4 (40%) had stable disease as their best response, representing an ORR of 50%. One patient had confirmed disease progression. In 6 patients who remained on trial for >6 months, all 6 had disease control at 6 months (2 CR, 1 PR, 3 SD). Conclusions: Avelumab + cetuximab is safe and tolerable, and demonstrates promising efficacy in R/M SCC patients. Clinical trial identification: NCT03494322;20/03/2018;Sponsor reference: UCL/17/0560. Legal entity responsible for the study: University College London. Funding: Merck KGaA. Disclosure: M. Forster: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD;Advisory/Consultancy: Novartis;Advisory/Consultancy: PharmaMar;Advisory/Consultancy, Travel/Accommodation/Expenses: Roche;Advisory/Consultancy: Nanobiotix;Advisory/Consultancy, Travel/Accommodation/Expenses: Guardant Health;Advisory/Consultancy: Oxford VacMedix;Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca;Advisory/Consultancy: Takeda;Research grant/Funding (institution): Boehringer Ingelheim;Travel/Accommodation/Expenses: Celgene. J. Sacco: Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: BMS;Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD;Honoraria (self), Advisory/Consultancy: Amgen;Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Immunocore;Honoraria (self), Advisory/Consultancy: Delcath;Honoraria (self): Pierre Fabre;Research grant/Funding (institution): AstraZeneca. A. Kong: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Merck;Honoraria (self), Speaker Bureau/Expert testimony: BMS;Advisory/Consultancy: Centauri Therapeutics;Advisory/Consultancy: Amgen;Advisory/Consultancy, Research grant/Funding (institution): Puma Biotechnology;Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: MSD;Research grant/Funding (institution): AstraZeneca. G. Wheeler: Honoraria (self): AstraZeneca. J. Hartley: Full/Part-t me employment: AstraZeneca;Advisory/Consultancy, Shareholder/Stockholder/Stock options: ADC Therapeutics. All other authors have declared no conflicts of interest.