The Effect of mRNA-Based COVID-19 Vaccination on Anti-Programmed Cell Death Protein 1 Blockade for Nasopharyngeal Cancer May Differ From a Virus-Inactivated Vaccine.

During the coronavirus disease 2019 (COVID-19) pandemic, a concern arises on the effects of COVID-19 vaccination on the efficacy of immune checkpoint inhibitors (ICIs) in patients with malignancies. Our results revealed no medical evidence stating that COVID-19 vaccination significantly improved the efficacy of the combination of immune cancer therapy with anti-programmed cell death protein 1 (anti-PD-1) antibody and chemotherapy in patients with advanced nasopharyngeal cancer (NPC). The cancer immunotherapy using anti-PD-1 antibody was effective in patients with NPC [1]. Its efficacy and safety were believed not to be affected by the timing of COVID-19 vaccination because of the long half-life of ICIs [1]. Therefore, COVID-19 vaccination is recommended for patients receiving cancer immunotherapy with ICIs. However, the details of the effect of COVID-19 vaccination on the therapeutic effect of ICIs in patients with cancer have not been reported for each cancer type [1]. Recent Chinese report reveals significantly improved antitumor efficacy of the combination of cancer immunotherapy with anti-PD-1 antibody and chemotherapy in patients with advanced NPC who received COVID-19 vaccination, but the incidence of severe immune-related adverse events was similar [2]. However, our study results differ from those of the clinical research conducted by the Chinese group. This study investigated the treatment of 2,651 patients (OncoGuideTM NCC oncopanel* test: 660 patients, Foundation One CDx** test: 1,991 patients) with cancer genomic medicine at national universities in Japan from December 2019 to November 2022. The treatment of 108 patients with advanced NPC was examined by cancer genomic medicine. The therapeutic efficacy of anti-PD-1 inhibitors in 106 patients with advanced NPC who had documented COVID-19 vaccination status was investigated. On March 24, 2017, the Ministry of Health, Labor, and Welfare in Japan approved the insurance coverage of nivolumab for patients with recurrent or distant metastatic head and neck cancer who had previously received platinum-containing chemotherapy [3]. The overall response rate (ORR) was 11.1% in 36 patients with advanced NPC, who received nivolumab alone and had not been vaccinated against COVID-19 (complete response (CR) in one (5.6%) patient, partial response (PR) in one (5.6%), stable disease (SD) in four (22.2%), and progressive disease (PD) in four (66.7%)) (Table 1). ORR with nivolumab was 11.1% in 54 patients with advanced NPC who received nivolumab alone and had been vaccinated against COVID-19 (CR in one (3.7%), PR in two (7.4%), SD in four (14.8%), and PD in 20 (74.1%) patients) (Table 1). Clinical study results revealed no medical evidence proving that COVID-19 vaccination significantly improved the efficacy of the combination of cancer immunotherapy with anti-PD-1 antibody and chemotherapy in patients with advanced NPC. The median age of participants in our clinical study was 65.8 years (range: 62 72). Therefore, Pfizer/BionTech’s BNT162b2 mRNA vaccine was inoculated in 60 participants, excluding six participants. Additionally, nivolumab monotherapy for human papillomavirus (HPV)-infected participants with advanced NPC has provided a long survival of 9.1 months compared with the survival time (7.5 months) by nivolumab administration alone to HPV-uninfected participants [3]. Our clinical research revealed a 40.6% HPV infection rate among participants (Tables 1-3). HPV tests for 15 (41.67%) participants were positive from the 36 patients with advanced NPC who received nivolumab alone and had not been vaccinated against COVID-19. Conversely, HPV tests were positive in 22 (40.74%) of 54 patients with advanced NPC who received nivolumab alone and had been vaccinated against COVID-19 (Tables 2, 3). No significant difference was found between the percentage of HPV-posManuscript submitted May 17, 2023, accepted July 3, 2023 Published online July 12, 2023