Abstract
Purpose: Initial findings in patients with cancer suggest a lower seroconversion to SARS-CoV-2 vaccination possibly related to myelo-immunosuppressive therapies. We conducted a prospective study to assess factors predicting poor seroconversion and adverse events following immunisation (AEFI) to the BNT162b2 vaccine in patients on active treatment.
Patients and methods: Cancer patients, candidates to two doses of BNT162b2 SARS-CoV-2 vaccination, were enrolled. Patients on active surveillance served as controls. The primary endpoint was poor seroconversion (anti S1/S2 IgG < 25 AU/mL) after 21 days from the second dose.
Results: Between March and July 2021, 320 subjects were recruited, and 291 were assessable. The lack of seroconversion at 21 days from the second dose was 1.6% (95% CI, 0.4-8.7) on active surveillance, 13.9% (8.2-21.6) on chemotherapy, 11.4% (5.1-21.3) on hormone therapy, 21.7% (7.5-43.7) on targeted therapy and 4.8% (0.12-23.8) on immune-checkpoint-inhibitors (ICI). Compared to controls, the risk of no IgG response was greater for chemotherapy (p = 0.033), targeted therapy (0.005) and hormonotherapy (p = 0.051). Lymphocyte count < 1 × 10 9 /L (p = 0.04) and older age (p = 0.03) also significantly predicted poor seroconversion. Overall, 43 patients (14.8%) complained of AEFI, mostly of mild grade. Risk of AEFI was greater in females (p = 0.001) and younger patients (p = 0.009).
Conclusion: Chemotherapy, targeted therapy, hormone therapy, lymphocyte count < 1 × 10 9 /L, and increasing age predict poor seroconversion after two doses of BNT162b2 in up to 20% of patients, indicating the need for a third dose and long-term serological testing in non-responders. AEFI occur much more frequently in women and younger subjects who may benefit from preventive medications. CLINICALTRIALS.
Gov identifier: NCT04932863 .
Keywords: Antibody responses to the BNT162b2 vaccine; COVID-19 vaccine in cancer patients; Cancer biological treatment; Cancer chemotherapy; Cancer hormone therapy; Cancer immunotherapy; Cancer target therapy; Immunogenicity; SARS-CoV-2 vaccine; SARS-CoV-2 vaccine adverse effects.
【저자키워드】 Cancer immunotherapy, immunogenicity, SARS-CoV-2 vaccine, cancer chemotherapy, Antibody responses to the BNT162b2 vaccine, COVID-19 vaccine in cancer patients, Cancer biological treatment, Cancer hormone therapy, Cancer target therapy, SARS-CoV-2 vaccine adverse effects., 【초록키워드】 Treatment, SARS-CoV-2, IgG, Cancer immunotherapy, BNT162b2 vaccine, COVID-19 vaccine, immunogenicity, therapy, Cancer, Antibody Response, Prospective Study, risk, medications, SARS-CoV-2 vaccine, Chemotherapy, BNT162b2, adverse effects, adverse events, Lymphocyte count, lymphocyte, Antibody responses, Seroconversion, Serological testing, non-responders, adverse event, female, Patient, Older age, Cancer patients, immunisation, Active surveillance, Mild, Hormone therapy, women, targeted therapy, patients, predict, Therapies, SARS-CoV-2 vaccination, primary endpoint, dose, active treatment, IgG response, Patients with cancer, Factor, 95% CI, subject, second dose, younger patients, S1/S2, ClinicalTrials, candidate, increasing age, responders, controls, benefit, younger subjects, greater, enrolled, predicted, lack, significantly, recruited, conducted, occur, of BNT162b2, younger patient, younger subject, 【제목키워드】 Treatment, SARS-CoV-2, mRNA BNT162b2 vaccine, adverse event, cancer patient,