tetano
Editor, Senior Moderator
J Thorac Oncol
. 2022 Jun 4;S1556-0864(22)00295-7.
doi: 10.1016/j.jtho.2022.05.015. Online ahead of print.
Safety and immunogenicity of mRNA vaccines against SARS-CoV-2 in patients with lung cancer receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Makoto Hibino[SUP] 1 [/SUP], Kiyoaki Uryu[SUP] 2 [/SUP], Takayuki Takeda[SUP] 3 [/SUP], Yusuke Kunimatsu[SUP] 3 [/SUP], Shinsuke Shiotsu[SUP] 4 [/SUP], Junji Uchino[SUP] 5 [/SUP], Soichi Hirai[SUP] 5 [/SUP], Tadaaki Yamada[SUP] 5 [/SUP], Asuka Okada[SUP] 6 [/SUP], Yoshikazu Hasegawa[SUP] 7 [/SUP], Osamu Hiranuma[SUP] 8 [/SUP], Yusuke Chihara[SUP] 9 [/SUP], Riko Kamada[SUP] 10 [/SUP], Shunichi Tobe[SUP] 10 [/SUP], Maeda Kazunari[SUP] 10 [/SUP], Shigeto Horiuchi[SUP] 10 [/SUP], Tetsuri Kondo[SUP] 10 [/SUP], Koichi Takayama[SUP] 5 [/SUP]
Affiliations
Abstract
Introduction: Cancer patients have been prioritized for vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there are limited data regarding the safety, efficacy, and risk of developing immune-related adverse events (irAEs) associated with mRNA vaccines in patients with lung cancer, especially those being actively treated with immune checkpoint inhibitors (ICIs).
Methods: This multicenter prospective cohort study was conducted at nine hospitals in Japan. Patients with lung cancer (≥20 years) actively treated with ICIs between 4 weeks pre-first vaccination and 4 weeks post-second vaccination were enrolled. The primary endpoint was the incidence of irAEs of any grade based on an assumed incidence without vaccination rate of 35%. Immunogenicity was assessed by measuring anti-spike (S)-IgG antibody levels against SARS-CoV-2.
Results: A total of 126 patients with lung cancer (median age, 71 years; interquartile range, 65-74) were enrolled from May to November 2021 and followed up until December 2021. Twenty-six patients (20.6%, 95% CI: 13.9-28.8%) and seven patients (5.6%, 95% CI: 2.3-11.1%) developed irAEs of any grade pre- and post-vaccination, respectively, which was lower than the predicted incidence without vaccination. None of the patients experienced exacerbation of pre-existing irAEs post-vaccination. S-IgG antibodies were seroconverted in 96.7% and 100% of the patients with lung cancer and controls, respectively, but antibody levels were significantly lower in lung cancer patients (P<0.001).
Conclusions: Patients with lung cancer who were actively treated with ICIs were safely vaccinated without an increased incidence of irAEs; however, their vaccine immunogenicity was lower. This requires further evaluation.
Keywords: COVID-19; Immune checkpoint inhibitor; Immune-related adverse event; Immunoglobulin; SARS-CoV-2.
. 2022 Jun 4;S1556-0864(22)00295-7.
doi: 10.1016/j.jtho.2022.05.015. Online ahead of print.
Safety and immunogenicity of mRNA vaccines against SARS-CoV-2 in patients with lung cancer receiving immune checkpoint inhibitors: A multicenter observational study in Japan
Makoto Hibino[SUP] 1 [/SUP], Kiyoaki Uryu[SUP] 2 [/SUP], Takayuki Takeda[SUP] 3 [/SUP], Yusuke Kunimatsu[SUP] 3 [/SUP], Shinsuke Shiotsu[SUP] 4 [/SUP], Junji Uchino[SUP] 5 [/SUP], Soichi Hirai[SUP] 5 [/SUP], Tadaaki Yamada[SUP] 5 [/SUP], Asuka Okada[SUP] 6 [/SUP], Yoshikazu Hasegawa[SUP] 7 [/SUP], Osamu Hiranuma[SUP] 8 [/SUP], Yusuke Chihara[SUP] 9 [/SUP], Riko Kamada[SUP] 10 [/SUP], Shunichi Tobe[SUP] 10 [/SUP], Maeda Kazunari[SUP] 10 [/SUP], Shigeto Horiuchi[SUP] 10 [/SUP], Tetsuri Kondo[SUP] 10 [/SUP], Koichi Takayama[SUP] 5 [/SUP]
Affiliations
- PMID: 35752437
- PMCID: PMC9220466
- DOI: 10.1016/j.jtho.2022.05.015
Abstract
Introduction: Cancer patients have been prioritized for vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there are limited data regarding the safety, efficacy, and risk of developing immune-related adverse events (irAEs) associated with mRNA vaccines in patients with lung cancer, especially those being actively treated with immune checkpoint inhibitors (ICIs).
Methods: This multicenter prospective cohort study was conducted at nine hospitals in Japan. Patients with lung cancer (≥20 years) actively treated with ICIs between 4 weeks pre-first vaccination and 4 weeks post-second vaccination were enrolled. The primary endpoint was the incidence of irAEs of any grade based on an assumed incidence without vaccination rate of 35%. Immunogenicity was assessed by measuring anti-spike (S)-IgG antibody levels against SARS-CoV-2.
Results: A total of 126 patients with lung cancer (median age, 71 years; interquartile range, 65-74) were enrolled from May to November 2021 and followed up until December 2021. Twenty-six patients (20.6%, 95% CI: 13.9-28.8%) and seven patients (5.6%, 95% CI: 2.3-11.1%) developed irAEs of any grade pre- and post-vaccination, respectively, which was lower than the predicted incidence without vaccination. None of the patients experienced exacerbation of pre-existing irAEs post-vaccination. S-IgG antibodies were seroconverted in 96.7% and 100% of the patients with lung cancer and controls, respectively, but antibody levels were significantly lower in lung cancer patients (P<0.001).
Conclusions: Patients with lung cancer who were actively treated with ICIs were safely vaccinated without an increased incidence of irAEs; however, their vaccine immunogenicity was lower. This requires further evaluation.
Keywords: COVID-19; Immune checkpoint inhibitor; Immune-related adverse event; Immunoglobulin; SARS-CoV-2.