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. 2023 Jan 18;28(1):e1-e8.
doi: 10.1093/oncolo/oyac230.

SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy

David K Lau  1 , Maria Aresu  2 , Timothy Planche  3   4 , Amina Tran  2 , Retchel Lazaro-Alcausi  1 , Julie Duncan  1 , Shannon Kidd  1 , Susan Cromarty  1 , Ruwaida Begum  1 , Isma Rana  1 , Su Li  1 , Ali Abdulnabi Suwaidan  1 , Irene Monahan  3 , David J Clark  3 , Nicholas Eckersley  3 , Henry M Staines  3 , Elisabetta Groppelli  3 , Sanjeev Krishna  3   4   5   6 , Martin Mayora-Neto  7 , Nigel Temperton  7 , Charlotte Fribbens  1 , David Watkins  1 , Naureen Starling  1 , Ian Chau  1 , David Cunningham  1 , Sheela Rao  1
Affiliations

SARS-CoV-2 Vaccine Immunogenicity in Patients with Gastrointestinal Cancer Receiving Systemic Anti-Cancer Therapy

David K Lau et al. Oncologist. .

Abstract

Introduction: Patients with gastrointestinal (GI) cancers have an increased risk of serious complications and death from SARS-CoV-2 infection. The immunogenicity of vaccines in patients with GI cancers receiving anti-cancer therapies is unclear. We conducted a prospective study to evaluate the prevalence of neutralizing antibodies in a cohort of GI cancer patients receiving chemotherapy following SARS-CoV-2 vaccination.

Materials and methods: Between September 2020 and April 2021, patients with cancer undergoing chemotherapy were enrolled. At baseline (day 0), days 28, 56, and 84, we assessed serum antibodies to SARS-CoV-2 spike (anti-S) and anti-nucleocapsid (anti-NP) and concomitantly assessed virus neutralization using a pseudovirus neutralization assay. Patients received either the Pfizer/BioNTech BNT162b2, or the Oxford/AstraZeneca ChAdOx1 vaccine.

Results: All 152 patients enrolled had a prior diagnosis of cancer; colorectal (n = 80, 52.6%), oesophagogastric (n = 38, 25.0%), and hepato pancreatic biliary (n = 22, 12.5%). Nearly all were receiving systemic anti-cancer therapy (99.3%). Of the 51 patients who did not receive a vaccination prior to, or during the study, 5 patients had detectable anti-NP antibodies. Ninety-nine patients received at least one dose of vaccine prior to, or during the study. Within 19 days following the first dose of vaccine, 30.0% had anti-S detected in serum which increased to 70.2% at days 20-39. In the 19 days following a second dose, anti-S positivity was 84.2% (32/38). However, pseudovirus neutralization titers (pVNT80) decreased from days 20 to 39.

Conclusion: Despite the immunosuppressive effects of chemotherapy, 2 doses of SARS-CoV-2 vaccines are able to elicit a protective immune response in patients' ongoing treatment for gastrointestinal cancers. Decreases in pseudoviral neutralization were observed after 20-39 days, re-affirming the current recommendation for vaccine booster doses.

Clinical trial registration number: NCT04427280.

Keywords: COVID-19; SARS-CoV-2; anti-spike; chemotherapy; gastrointestinal cancer; immunity; pseudovirus; vaccines.

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Conflict of interest statement

David K. Lau is the recipient of the Australasian Gastro-Intestinal Trials Group/Merck Clinical Research Fellowship. Sanjeev Krishna is an advisor to and a shareholder in QuantuMDx, a molecular nucleic acid test-based diagnostic company, an advisor for Mologic, a developer of rapid diagnostic tests, and a member of the Scientific Advisory Committee for the Foundation for Innovative New Diagnostics (FIND), a not-for-profit organisation that produces global guidance on affordable diagnostics. Henry M. Staines is a shareholder in QuantuMDx, a molecular nucleic acid test-based diagnostic company, and advisor for Mologic, a developer of rapid diagnostic tests. David Cunningham has served in a consulting role or on the advisory boards for OVIBIO, has received institutional research funding from 4SC, Bayer, Celgene, Clovis Oncology, Leap Oncology, Lilly, MedImmune, Roche, and has ownership interests in OVIBIO. Naureen Starling has served in a consulting role or on the advisory boards for AstraZeneca, MSD, Pfizer, SERVIER, has received institutional research funding from AstraZeneca, BMS, Pfizer/ EMD Serono, has received honoraria from Amgen, GlaxoSmithKline, Lilly, Merck Serono, MSD Oncology, Pierre Fabre, SERVIER, and received travel accommodation expenses from AstraZeneca, BMS, Lilly, Merck, MSD Oncology, and Roche. Ian Chau has served in a consulting role or on the advisory boards for Eli Lilly, Bristol Meyers Squibb, MSD, Bayer, Roche, Merck Serono, Five Prime Therapeutics, Astra Zeneca, OncXerna, Pierre Fabre, Boehringer Ingelheim, Incyte, Astellas, GSK, Sotio, Eisai and Daiichi Sankyo, has received research funding from Eli-Lilly, Janssen-Cilag, and has received honoraria from Eli-Lilly, Eisai and Servier. Sheela Rao has served in a consulting role or on the advisory boards for Bayer, Boehringer Ingelheim, Hookipa Biotech, Incyte, and Merck Serono. The other authors indicated no financial relationships.

Figures

Figure 1.
Figure 1.
CONSORT diagram of the CARDS study. *Patients RM5287107, RF5287069 withdrew before blood samples were taken. Abbreviations: D0, baseline; D28, day 28; D56, day 56; D84, day 84.
Figure 2.
Figure 2.
Longitudinal analysis of SARS-CoV-2 vaccine immunogenicity relative to the 1st vaccine dose. Box plot of Anti-S index values (A) and pseudovirus neutralisation (titre 1/40) in all vaccinated patients (B) at time periods relative to the date of 1st vaccine dose. Each data point represents a serum sample. Solid horizontal lines denote the median and boxes represent the interquartile range. Samples from patients with positive nucleocapsid results are marked in red and negative in blue. Positivity thresholds are denoted by dotted lines (anti-S > 1.0, pVNT(1/40) > 0.5). Abbreviation: anti-S, anti-spike antibody.
Figure 3.
Figure 3.
Longitudinal analysis of SARS-CoV-2 vaccine immunogenicity following 2nd vaccine dose. Box plot of anti-S index values (A) and pseudovirus neutralisation (titre 1/40) in all vaccinated patients (B) at time periods relative to the date of 2nd SARS-CoV-2 vaccine dose. Each data point represents a serum sample. Solid lines denote the median and boxes represent the interquartile range. Samples from patients with positive nucleocapsid results are marked in red and negative in blue. Prespecified positivity thresholds are denoted by dotted lines (anti-S > 1.0, anti-S > 1.0, pVNT(1/40) > 0.5).
Figure 4.
Figure 4.
Box plots of pVNT80 neutralization titers after the 2nd dose of SARS-CoV-2 vaccine. A logarithmic scale was used for neutralization titre. Each data point represents a serum sample. Solid lines denote the median and boxes represent the interquartile range. Samples from patients with positive nucleocapsid results are marked in red and negative in blue.
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