ILCA Guidance for patient vaccination

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ILCA & COVID-19

ILCA guidance for COVID-19 vaccination for patients with liver cancer

Updated 14 March 2021.
Drafted by Stephen L. Chan1, Changhoon Yoo2, Meyer Tim3.

Approval of vaccine for COVID-19

As of 14 Mar 2021, The U.S. FDA (Food and Drug Administration) or EMA (European Medicines Agency) have currently granted emergency use authorization (FDA) or conditional marketing authorization (EMA) to following vaccines with the following age and dosing interval parameters.[1, 2] There is no basis for the preferential recommendation of one vaccine over the other under any circumstance.

Manufacturer Technology Age Recommendation Interval between doses
Pfizer-BioNTech mRNA ≥16 years 21 days (2 doses)
Moderna mRNA ≥18 years 28 days (2 doses)
AstraZeneca vector vaccine
(simian adenovirus)
≥18 years 4-12 weeks (2 doses)
Johnson & Johnson vector vaccine
(adenovirus 26)
≥18 years Single dose

 

Roles of COVID-19 vaccine in patients with liver cancers

People with liver disease are at increased risk for complications and adverse outcomes of COVID-19 infection, including patients with cirrhosis, fatty liver diseases, hepatobiliary cancers and liver transplant. [3-11] Therefore, prevention of COVID-19 by community vaccination programs is anticipated to be beneficial to patients with liver cancers by reducing the incidence and severity of COVID-19 infection.

Clinical trials on COVID-19 vaccines have allowed an accrual of patients with chronic stable medical condition, including patients with hepatitis B or C infection.[12-14] Experience with other vaccines, including pneumococcal polysaccharide vaccine and influenza vaccine do not pose major concerns in patients with liver diseases and to date, there are no data suggesting those with chronic liver disease experience more adverse events from any of the currently approved COVID-19 vaccinations.[15] Therefore, chronic hepatitis viral infection, compensated cirrhosis or stably controlled liver cancers should not be considered a contraindication to COVID-19 vaccine.

Uncertainties of COVID-19 vaccine in patients with liver cancers

There is currently a lack of data of efficacy and immunogenicity data about COVID-19 vaccine in cancer populations.

Patients with moderate to severe immunocompromised condition or receiving immunosuppressive treatment were excluded from clinical trials on COVID-19 vaccine hence the benefit/risk ratio of COVID-19 in liver cancers undergoing immunomodulatory treatment (e.g., TACE, radiotherapy, immune checkpoint inhibitors) is uncertain.

Summary of international organizations on COVID-19 vaccination in patients with cancer
ESMO (16)

While acknowledging the need to generate data in the context of trials or registries, in order to refine the risk/benefit profile and prioritize subgroups of patients with cancer for anti-SARS-CoV-2 vaccination, we propose a four-step process:

  • Step 1: Consider the phase of malignant disease and therapy: active cancer on treatment, chronic disease after treatment or survivorship.
  • Step 2: Consider age, fitness/ performance status and medical comorbidities as general risk factors; specifically, obesity, diabetes mellitus, hypertension, respiratory, cardiac and renal disorders.
  • Step 3: Consider vaccine-related interactions on the tumour and on the treatment efficacy.
  • Step 4: Secure informed consent and improve shared decision making.
ASCO (17)
  • At this time, patients with cancer may be offered vaccination against COVID-19 as long as components of that vaccine are not contraindicated.
  • At this time, patients undergoing treatment may be offered vaccination against COVID-19 as long as any components of the vaccine are not contraindicated. Oncologists have experience providing other types of vaccines to patients receiving treatment for cancer, including chemotherapy, immunotherapy, radiation therapy or stem cell transplantation. Strategies such as providing the vaccine in between cycles of therapy and after appropriate waiting periods for patients receiving stem cell transplants and immune globulin treatment can be used to reduce the risks while maintaining the efficacy of vaccination.
  • Cancer survivors may be offered vaccination against COVID-19 as long as any components of the vaccine are not contraindicated.
NCCN (18)
  • Patients with active cancer and those on treatment should be prioritized for vaccination and should be immunized when any vaccine that has been authorized for use by the FDA is available to them.
  • Immunization is recommended for all patients receiving active therapy, with the understanding that there are limited safety and efficacy data in these patients.
EASL (19)

Prioritization for COVID-19 vaccine in:

  • patients with advanced liver disease (compensated or decompensated cirrhosis),
  • patients who have undergone a liver transplant,
  • patients who have hepatobiliary cancer,
  • patients with chronic liver disease and are immunosuppressed
AASLD (20)

Prioritizing for COVID-19 vaccine in patients with compensated or decompensated cirrhosis or liver cancers, patients receiving immunosuppression (e.g., solid organ transplant recipients and living liver donors)

ILCA recommendations for liver cancer patients

General

  • Benefits of COVID-19 vaccines are expected to out-weight risks in patients with liver cancers. Patients with liver cancers should be considered and assessed for COVID-19 vaccination as per local recommendation. Clinicians should keep themselves updated with the rapidly changing data regarding COVID-19 vaccination.
  • As there is still uncertainty around the extent to which immunocompromised patients with cancer will develop immunity in response to vaccination, vaccinated patients should continue to follow latest local guidance to protect themselves from exposure to COVID-19.
  • There are no preferences to the four FDA approved vaccines.

 Surgery (hepatic resection and transplant)

  • The specific timing of vaccines, including the first and second dose, in relation to surgery is less clear. To reduce the risk of vaccine-related complications (e.g., fever) or nosocomial infection, vaccination should be administered at least 1-2 weeks before There is some evidence that patient on immunosuppression for organ transplant mount less effective antibody response and patients on the transplant waiting list should also be considered as a priority for vaccination.[21]

Locoregional therapy and radiotherapy

  • As with surgery, vaccination should ideally be given at least 1-2 weeks before administration of locoregional therapy and radiotherapy.

Systemic therapy

  • For TKIs and ramucirumab, there is no guidance on the need of withholding drugs during COVID-19 vaccination. In general, TKIs and ramucirumab could be continued if there are no severe complications from COVID-19 vaccines.
  • For immune checkpoint inhibitors (ICIs) or its combinational regimens, because systemic immune side effects with the COVID-19 vaccine tend to occur within 2-3 days of the vaccine and may be more pronounced with the second dose, it is preferred to avoid concurrent administration of ICIs when the systemic immune complications of COVID-19 vaccination are expected.

Areas of research

  • The efficacy and immunogenicity of various COVID-19 vaccines in patients with liver cancers

Safety of COVID-19 vaccines in patients with liver cancers undergoing active treatment in particular patients undergoing ICIs.

References
  1. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines. 14 Mar 2021.
  2. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19. 14 Mar 2021
  3. Dhampalwar S, Saigal S, Choudhary N, Saraf N, Bhangui P, Rastogi A, Thiagrajan S, et al. Outcomes of Coronavirus Disease 2019 in Living Donor Liver Transplant Recipients. Liver Transpl 2020;26:1665-1666.
  4. Polak WG, Fondevila C, Karam V, Adam R, Baumann U, Germani G, Nadalin S, et al. Impact of COVID-19 on liver transplantation in Europe: alert from an early survey of European Liver and Intestine Transplantation Association and European Liver Transplant Registry. Transpl Int 2020;33:1244-1252.
  5. Bhoori S, Rossi RE, Citterio D, Mazzaferro V. COVID-19 in long-term liver transplant patients: preliminary experience from an Italian transplant centre in Lombardy. Lancet Gastroenterol Hepatol 2020;5:532-533.
  6. Belli LS, Duvoux C, Karam V, Adam R, Cuervas-Mons V, Pasulo L, Loinaz C, et al. COVID-19 in liver transplant recipients: preliminary data from the ELITA/ELTR registry. Lancet Gastroenterol Hepatol 2020;5:724-725.
  7. Iavarone M, Sangiovanni A, Carrafiello G, Rossi G, Lampertico P. Management of hepatocellular carcinoma in the time of COVID-19. Ann Oncol 2020.
  8. Munoz-Martinez S, Sapena V, Forner A, Nault JC, Sapisochin G, Rimassa L, Sangro B, et al. Assessing the impact of COVID-19 on liver cancer management (CERO-19). JHEP Rep 2021:100260.
  9. Amaddeo G, Brustia R, Allaire M, Lequoy M, Hollande C, Regnault H, Blaise L, et al. Impact of COVID-19 on the management of hepatocellular carcinoma in a high-prevalence area. JHEP Rep 2021;3:100199.
  10. Zhou YJ, Zheng KI, Wang XB, Yan HD, Sun QF, Pan KH, Wang TY, et al. Younger patients with MAFLD are at increased risk of severe COVID-19 illness: A multicenter preliminary analysis. J Hepatol 2020;73:719-721.
  11. Williamson EJ, Walker AJ, Bhaskaran K, Bacon S, Bates C, Morton CE, Curtis HJ, et al. Factors associated with COVID-19-related death using OpenSAFELY. Nature 2020;584:430-436.
  12. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383:2603-2615.
  13. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med 2021;384:403-416.
  14. Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet 2021;397:99-111.
  15. https://www.cdc.gov/vaccines/adults/rec-vac/health-conditions/liver-disease.html. 14 Mar 2021
  16. https://www.esmo.org/covid-19-and-cancer/covid-19-vaccination. 14 Mar 2021
  17. https://www.asco.org/asco-coronavirus-resources/covid-19-vaccines-patients-cancer. 14 Mar 2021
  18. https://www.nccn.org/covid-19/. 14 Mar 2021
  19. https://easl.eu/news/covid-19-vaccine-policy/. 14 Mar 2021
  20. https://www.aasld.org/sites/default/files/2021-02/AASLD-COVID19-VaccineDocument-February2021-FINAL.pdf. 14 Mar 2021
  21. Boyarsky BJ, Werbel WA, Avery RK, Tobian AAR, Massie AB, Segev DL, Garonzik-Wang JM. Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. JAMA 2021.

1Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China
2Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
3Royal Free Hospital and UCL Cancer Institute, London, United Kingdom

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