The COVID-19 vaccine was safe and well tolerated in patients who received immune checkpoint inhibitors for renal cell carcinoma or melanoma.
The COVID-19 vaccine was safe and well tolerated in patients who received immune checkpoint inhibitors (ICIs) for renal cell carcinoma (RCC) or melanoma, according to findings from a retrospective chart review presented during the 2021 SITC Annual Meeting. Study co-author Hannah Dzimitrowicz, MD, noted that patients with cancer, particularly those receiving anticancer therapy, are especially susceptible to severe COVID-19 disease and mortality
“In a solid tumor population at high risk for severe COVID-19 infections, vaccination is important to mitigate this risk,” said Dzimitrowicz, a medical instructor in the department of medicine at the Duke University School of Medicine in Durham, North Carolina. “In a heterogeneous population of patients with RCC and melanoma receiving immune checkpoint inhibitor therapy, COVID-19 vaccination appears to be well tolerated and safe.”
Vaccines appeared to be effective in this patient population. Two patients in the ICI group (n = 74) developed COVID-19 infection after 1 vaccine dose and no patients developed COVID-19 infection after 2 doses.
Although patients receiving active cancer treatment were excluded from COVID-19 vaccine trials, major oncologic organizations including the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend vaccination.
To evaluate the safety and tolerability of COVID-19 vaccines in this population, Dzimitrowicz and her colleagues used electronic medical records to identify all patients who received at least 1 dose of an FDA-authorized COVID-19 vaccine from December 1, 2020, to April 1, 2021, had received ICI at the time of vaccination, and had at least 3 months of documented follow up at Duke Cancer Center.
They then compared safety results for those who received ICIs (n = 74) vs those who did not (n = 74). Safety outcomes measured included adverse events (AEs) attributed to vaccination, immune-related AEs (irAEs) following vaccination, and incidence of subsequent COVID-19 infections.
The proportion of patients with RCC (49%) and melanoma (51%) was the same in both cohorts.
The median age was 70 years (range, 33 to > 90) in the ICI cohort compared with 73 years (range, 35-88) in the control group. The experimental group was primarily male (70%) while the control group was more balanced (51%).
Most patients in the ICI group received the Pfizer vaccine (62%), followed by Moderna (35%) and Johnson & Johnson (3%). In the control group, those numbers were 83%, 16%, and 1%, respectively.
Half of patients received nivolumab (Opdivo), 16% received pembrolizumab (Keytruda), 15% received nivolumab plus cabozantinib (Cabometyx), 10% received nivolumab plus ipilimumab (Yervoy), 7% received pembrolizumab plus axitinib (Inlyta), and 1% received ipilimumab.
One patient in the control group reported fatigue and arm pain. Twenty percent of patients in the ICI group reported at least 1 AE including fevers (7%), chills (7%), myalgias (7%), arm pain (5%), headache (5%), fatigue (5%), diarrhea (3%), erythema at the injection site (3%), and nausea and vomiting (1%).
“It is important to note that all of these symptoms reported by patients were mild and none resulted in hospitalizations or treatment interruption,” Dzimitrowicz said.
Investigators also recorded AEs that patients or clinicians thought could be attributed to vaccination. One patient in the ICI group developed porokeratoses following the second vaccine dose. One patient in the control group developed a stye and 1 developed premature ventricular contractions.
Nine (12%) patients in the ICI cohort developed a new or worsening irAE that required a treatment hold, systemic steroids, and/or hospital admission. The most common irAE was colitis (n = 4). Two patients developed hepatitis and 1 patient each developed pancreatitis, gastritis, dermatitis, and adrenal insufficiently.
Dzimitrowicz pointed out that these data reflect the experience at a single institution, and physicians saw patients undergoing active therapy more frequently, so those patients had more opportunities to report AEs. She also pointed out that the study did not include to patients receiving concurrent cytotoxic chemotherapy, thus limiting applicability to that group
“It’s important to note that larger cohort studies of patients receiving immune checkpoint inhibitors are needed to fully assess the safety and efficacy of COVID-19 vaccination in this population,” she said. “Despite these limitations, this study provides valuable information regarding the safety of COVID-19 vaccination in patients receiving immune checkpoint inhibitors in real world practice.”