Davidoff Center, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
Department of Medicine E, Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.
JAMA Oncol. 2021 Aug 1;7(8):1133-1140. doi: 10.1001/jamaoncol.2021.2155.
Patients with cancer undergoing treatment are at high risk of COVID-19 following SARS-CoV-2 infection; however, their ability to produce an adequate antibody response to messenger RNA SARS-CoV-2 vaccines is unclear.
To evaluate rates of antispike (anti-S) antibody response to a BNT162b2 vaccine in patients with cancer who are undergoing systemic treatment vs healthy controls.
DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study included 102 adult patients with solid tumors undergoing active intravenous anticancer treatment and 78 controls who received the second dose of the BNT162b2 vaccine at least 12 days before enrollment. The controls were taken from a convenience sample of the patients' family/caregivers who accompanied them to treatment. The study was conducted between February 22, 2021, and March 15, 2021 at Davidoff Cancer Center at Beilinson Hospital (Petah Tikva, Israel).
Blood samples were drawn from the study participants. Serum samples were analyzed and the titers of the IgG antibodies against SARS-CoV-2 spike receptor-binding domain were determined using a commercially available immunoassay. Seropositivity was defined as 50 or greater AU/mL.
The primary outcome was the rate of seropositivity. Secondary outcomes included comparisons of IgG titers and identifying factors that were associated with seropositivity using univariate/multivariable analyses.
The analysis included 180 participants, which comprised 102 patients with cancer (median [interquartile range (IQR)] age, 66 [56-72] years; 58 men [57%]) and 78 healthy controls (median [IQR] age, 62 [49-70] years; 25 men [32%]). The most common tumor type was gastrointestinal (29 [28%]). In the patient group, 92 (90%) were seropositive for SARS-CoV 2 antispike IgG antibodies after the second vaccine dose, whereas in the control group, all were seropositive. The median IgG titer in the patients with cancer was significantly lower than that in the controls (1931 [IQR, 509-4386] AU/mL vs 7160 [IQR, 3129-11 241] AU/mL; P < .001). In a multivariable analysis, the only variable that was significantly associated with lower IgG titers was treatment with chemotherapy plus immunotherapy (β, -3.5; 95% CI, -5.6 to -1.5).
In this cohort study of patients with cancer who were receiving active systemic therapy, 90% of patients exhibited adequate antibody response to the BNT162b2 vaccine, although their antibody titers were significantly lower than those of healthy controls. Further research into the clinical relevance of lower titers and their durability is required. Nonetheless, the data support vaccinating patients with cancer as a high priority, even during therapy.
接受治疗的癌症患者在感染 SARS-CoV-2 后 COVID-19 的风险很高；然而，他们产生针对信使 RNA SARS-CoV-2 疫苗的充分抗体反应的能力尚不清楚。
评估正在接受全身治疗的癌症患者对 BNT162b2 疫苗的刺突（抗-S）抗体反应率与健康对照者相比。
设计、设置和参与者：这项前瞻性队列研究纳入了 102 名正在接受静脉内抗癌治疗的成年实体瘤患者和 78 名在入组前至少 12 天接受 BNT162b2 疫苗第二剂的对照者。对照组是从患者家属/照顾者的便利样本中选取的，他们陪同患者接受治疗。该研究于 2021 年 2 月 22 日至 2021 年 3 月 15 日在以色列佩塔提克瓦贝林森医院的大卫多夫癌症中心进行。
从研究参与者中抽取血样。使用商业上可获得的免疫测定法分析血清样本，并确定针对 SARS-CoV-2 刺突受体结合域的 IgG 抗体的滴度。血清阳性定义为 50 或更高的 AU/mL。
主要结局是血清阳性率。次要结局包括使用单变量/多变量分析比较 IgG 滴度和确定与血清阳性相关的因素。
分析纳入了 180 名参与者，其中包括 102 名癌症患者（中位数[四分位距（IQR）]年龄，66 [56-72] 岁；58 名男性[57%]）和 78 名健康对照者（中位数[IQR]年龄，62 [49-70] 岁；25 名男性[32%]）。最常见的肿瘤类型是胃肠道（29 [28%]）。在患者组中，92 名（90%）在接受第二剂疫苗后 SARS-CoV 2 抗刺突 IgG 抗体呈血清阳性，而对照组中所有人均呈血清阳性。癌症患者的 IgG 滴度中位数明显低于对照组（1931 [IQR，509-4386] AU/mL vs 7160 [IQR，3129-11241] AU/mL；P<0.001）。在多变量分析中，唯一与较低 IgG 滴度显著相关的变量是化疗加免疫治疗（β，-3.5；95%CI，-5.6 至-1.5）。
在这项正在接受积极全身治疗的癌症患者队列研究中，90%的患者对 BNT162b2 疫苗产生了充分的抗体反应，尽管他们的抗体滴度明显低于健康对照者。需要进一步研究较低滴度的临床意义及其持久性。尽管如此，数据支持将癌症患者作为高优先级进行疫苗接种，即使在治疗期间也是如此。
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