In a Dutch study (VOICE) reported in The Lancet Oncology, Sjoukje F. Oosting, MD, and colleagues found that the mRNA-1273 (Moderna) COVID-19 vaccine produced adequate antibody responses in a majority of patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumors, with response rates being noninferior to the antibody response rate in participants without cancer.
Sjoukje F. Oosting, MD
Study Details
In the multicenter prospective noninferiority trial, 791 patients enrolled between February 17 and March 12, 2021, were to receive two doses of the vaccine 28 days apart. Among the participants, 247 did not have cancer (control cohort), 137 patients were receiving immunotherapy, 244 were receiving chemotherapy, and 163 were receiving chemoimmunotherapy.
The primary endpoint was SARS–CoV-2 spike S1–specific IgG serum antibody response at > 10 binding antibody units (BAU)/mL 28 days after the second vaccine dose among response-evaluable patients. The noninferiority margin was a 10% difference in response rate for patients with cancer vs the control group.
Key Findings
Median follow-up was 122 days (interquartile range = 118–128 days).
SARS–CoV-2-binding antibody response was achieved in 240 (100%, 95% confidence interval [CI] = 98%–100%) of 240 evaluable participants in the control cohort, 130 (99%, 95% CI = 96% to > 99%) of 131 patients in the immunotherapy cohort, 223 (97%, 95% CI = 94%–99%) of 229 patients in the chemotherapy cohort, and 143 (100%, 95% CI = 97%–100%) of 143 patients in the chemoimmunotherapy cohort, with noninferiority met in each of the patient cohorts.
Antibody response at > 300 BAU/mL was observed in 239 participants (> 99%, 95% CI = 98% to > 99%) in the control cohort, 122 patients (93%, 95% CI = 87%–97%) in the immunotherapy cohort, 192 patients (84%, 95% CI = 78%–88%) in the chemotherapy cohort, and 127 patients (89%, 95% CI = 82%–93%) in the chemoimmunotherapy cohort.
Grade ≥ 3 serious adverse events occurred in no participants in the control cohort, three patients (2%) in the immunotherapy cohort, six patients (2%) in the chemotherapy cohort, and one patient (1%) in the chemoimmunotherapy cohort. Of these, four events (fever in two patients and diarrhea and febrile neutropenia in one patient each) were considered potentially related to vaccination. Adverse events of special interest among patients with cancer included thromboembolic events in five patients, myocardial infarction in two, convulsion in one, and erythema multiforme that progressed to Stevens-Johnson syndrome in one. No vaccine-related deaths occurred.
The investigators concluded, “Most patients with cancer develop, while receiving chemotherapy, immunotherapy, or both for a solid tumour, an adequate antibody response to vaccination with the mRNA-1273 COVID-19 vaccine. The vaccine is also safe in these patients. The minority of patients with an inadequate response after two vaccinations might benefit from a third vaccination.”
Astrid A.M. van der Veldt, MD, of the Departments of Medical Oncology and Radiology and Nuclear Medicine, Erasmus Medical Centre Cancer Institute, Rotterdam, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by ZonMw, The Netherlands Organisation for Health Research and Development. For full disclosures of the study authors, visit thelancet.com.
