Most patients with AML, myelodysplastic syndrome seropositive after two COVID vaccine doses
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A vast majority of patients with acute myeloid leukemia and myelodysplastic syndrome converted to seropositivity after two COVID-19 vaccine doses, according to a study presented at ASH Annual Meeting and Exposition.
Results of the single-site observational study — the largest to date among patients with AML and myelodysplastic syndrome with serial serologic data following two vaccine doses — should be substantiated in a larger cohort, according to researchers. However, their data showed the Moderna vaccine appeared to induce a strong humoral response among these patient populations.
“Patients with myeloid malignancies, including AML and myelodysplastic syndrome, are at a high risk for severe SARS-CoV-2 infection, including death,” Akriti G. Jain, MD, hematology and oncology fellow at Moffitt Cancer Center and Research Institute and University of South Florida, told Healio. “It is uncertain whether patients with AML and myelodysplastic syndrome, who frequently have quantitative or qualitative deficiencies of neutrophils and/or lymphocytes, will develop protective immunity from SARS-CoV-2 vaccines. Hence, we undertook this study with the primary aim to describe the immune response and safety profile to the mRNA-1273 [Moderna] vaccine among a cohort of patients with AML and myelodysplastic syndrome.”
The analysis included 46 patients (median age at vaccination, 68 years; range, 37-85; 58.7% men; 95.7% white) with AML (n = 30) and myelodysplastic syndrome (n = 16) enrolled at Moffitt Cancer Center and Research Institute from Jan. 12 to Jan. 25.
Researchers gathered information on baseline characteristics, cancer diagnoses, treatments received and disease status through chart reviews. Median time from diagnosis to the start of the vaccination series was 24.3 months (range, 4.5-105) and 15 patients (32.6%) were on active treatment for their disease during vaccination (13% with hypomethylating agents, 4.3% with an erythroid maturation agent, 2.2% with immunomodulatory drugs and 13% with targeted therapy).
Most patients (87%) were in remission at the time of vaccination, and more than two-thirds (69.6%) had undergone allogeneic stem cell transplantation.
The investigators collected blood specimens from patients prior to first and second vaccine doses (days 1 and 29) and about 4 weeks after the second dose (day 57) for antibody analyses. They used a two-step enzyme-linked immunosorbent assay to evaluate serostatus, measuring immunoglobulin G responses, and used the Fisher exact test or chi-squared test to compare COVID-19 antibody positivity rates. Additionally, they used the Kruskal-Wallis test to examine associations of the COVID-19 antibody titer and patient characteristics and a paired-T test to analyze differences of COVID-19 antibody titers from day 1 to after the first and second vaccinations.
Results showed that, among the total cohort, 69.6% of patients were seropositive at day 29 (after the first vaccine dose) and 95.7% were seropositive at day 57 (after two vaccine doses). Most patient characteristics — including age, sex, race, disease status, time to vaccination from disease diagnoses, therapy at time of vaccination, and whether on active treatment — did not significantly affect seropositivity rate.
Researchers found significantly higher antibody titer levels after the second vaccine dose compared with after the first dose (mean, 3,806.5 vs. 315; P < .0001), and reported that difference was seen across patient subsets. The most common adverse events after vaccination included mild injection site pain, fatigue, headache and arm swelling.
“In this observational study, the vast majority of patients with AML and myelodysplastic syndrome converted to seropositivity after two doses of the vaccine. Most clinical and laboratory variables (including neutropenia and lymphopenia) did not affect the seropositivity rate,” Jain told Healio. “More importantly, antibody titer levels increased dramatically following the second vaccine dose, indicating the potential utility of serial vaccination in poorly responsive patients.”
Perspective
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Douglas Tremblay, MD
This study is encouraging for clinicians and patients alike in that COVID-19 vaccination for patients with in MDS and AML produces a strong humoral immune response despite high rates of disease-related neutropenia and lymphopenia. In fact, almost all patients converted to seropositive after two doses.
Although we have always encouraged COVID-19 vaccination for our patients, this study provides further justification and can aid in counseling patients who are concerned how their AML or MDS may affect antibody responses to vaccination.
It is clear from prior studies that COVID-19 is disproportionally more severe in patients with MDS or AML. The outcomes in the era of vaccination are less clear, therefore longer follow-up to see if antibody response translates into improvements in disease severity and death will be important. In addition, the added benefit of the booster needs to be explored both from a serologic and clinical standpoint.
Icahn School of Medicine at Mount Sinai
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Jain AG, et al. Abstract 217. Presented at: ASH Annual Meeting and Exposition; Dec. 11-14, 2021; Atlanta.
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