Division of Hematology-Oncology, Department of Internal Medicine, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, Korea.
Department of Hematology/Oncology, School of Medicine, Kyungpook National University, Daegu, Korea.
Cancer Res Treat. 2020 Jan;52(1):246-253. doi: 10.4143/crt.2019.189. Epub 2019 Jul 9.
Pneumococcal vaccination (13-valent pneumococcal conjugate vaccine [PCV13]) is recommended to cancer patients undergoing systemic chemotherapy. However, the optimal time interval between vaccine administration and initiation of chemotherapy has been little studied in adult patients with solid malignancies.
We conducted a prospective randomized controlled trial to evaluate whether administering PCV13 on the first day of chemotherapy is non-inferior to vaccinating 2 weeks prior to chemotherapy initiation. Patients were randomly assigned to two study arms, and serum samples were collected at baseline and 4 weeks after vaccination to analyze the serologic response against Streptococcus pneumoniae using a multiplexed opsonophagocytic killing assay.
Of the 92 patients who underwent randomization, 43 patients in arm A (vaccination 2 weeks before chemotherapy) and 44 patients in arm B (vaccination on the first day of chemotherapy) were analyzed. Immunogenicity was assessed by geometric mean and fold-increase of post-vaccination titers, seroprotection rates (percentage of patients with post-vaccination titers > 1:64), and seroconversion rates (percentage of patients with > 4-fold increase in post-vaccination titers). Serologic responses to PCV13 did not differ significantly between the two study arms according to all three types of assessments.
The overall antibody response to PCV13 is adequate in patients with gastric and colorectal cancer during adjuvant chemotherapy, and no significant difference was found when patients were vaccinated two weeks before or on the day of chemotherapy initiation.
肺炎球菌疫苗（13 价肺炎球菌结合疫苗[PCV13]）推荐给接受全身化疗的癌症患者。然而，在患有实体恶性肿瘤的成年患者中，疫苗接种与开始化疗之间的最佳时间间隔尚未得到充分研究。
我们进行了一项前瞻性随机对照试验，以评估在化疗的第一天接种 PCV13 是否不如在化疗开始前 2 周接种。患者被随机分配到两个研究臂，在基线和接种后 4 周采集血清样本，使用多重调理吞噬杀伤测定法分析针对肺炎链球菌的血清学反应。
在接受随机分组的 92 例患者中，43 例患者在臂 A（化疗前 2 周接种疫苗），44 例患者在臂 B（化疗第一天接种疫苗）进行了分析。免疫原性通过接种后滴度的几何均数和增加倍数、血清保护率（接种后滴度>1:64 的患者百分比）和血清转化率（接种后滴度增加>4 倍的患者百分比）进行评估。根据所有三种评估方法，两组研究臂之间 PCV13 的血清学反应没有显著差异。
在接受辅助化疗的胃癌和结直肠癌患者中，PCV13 的总体抗体反应是足够的，并且在化疗开始前 2 周或当天接种疫苗时没有发现显著差异。
