Background/Objectives: Cancer represents an important risk factor for acquiring severe acute respiratory syndrome by Coronavirus-2 (SARS-CoV-2) and subsequent hospitalization. The utility of early antiviral therapies, including their protective effect on long COVID outcomes, in cancer patients has not yet been clearly demonstrated. We conducted the CO.THER study (COVID-19 THErapies in patients with canceR) to address this knowledge gap. Methods: We designed an ambispective single-center cohort study. We collected clinical and oncological data from the hospital’s electronic patient records at the start of COVID-19 therapy (T0), seven days after T0 (T1), two weeks after T0 (T2), one month after T0 (T3), three months after T0 (T4), six months after T0 (T5), and twelve months after T0 (T6). The primary endpoint of this ambispective single-center cohort study was the rate of hospitalization for COVID-19 disease within 14 days in cancer patients using anti-SARS-CoV-2 early therapies. The proportion of hospitalizations within 14 days (primary endpoint) was computed together with its exact binomial 95% confidence interval (95%CI). Results: 131 patients’ records (53M [40.5%], 78F, [59.5%]; median age 62.45, interquartile range [IQR] 56–71) were enrolled. As shown by the Kaplan–Meier hospitalization-free estimate, only three patients (2.1%) were hospitalized for a COVID-19 related cause within 14 days of starting early treatment (95%CI 0.5–6.6%). The cumulative survival probability beyond 12 months in hospitalization-free patients was 98% (95%CI 93–99%). Twelve patients (9.2%) reported another COVID-19 infection during the follow-up and they were all retreated with Nirmatrelvir–Ritonavir. The cumulative reinfection-free survival was 90% at 12 months (95%CI 83–95%). Further, 15 patients of the 123 evaluable at 3 months (median age 51 years, IQR 40–68) reported long COVID symptoms (12.2%, 95%CI 7.0–19.3%). Conclusions: Our data demonstrate a low rate of hospitalization and reassuring data on safety in this cohort of high-risk subjects.
背景/目的：癌症是导致严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）感染及后续住院的重要风险因素。早期抗病毒治疗在癌症患者中的应用价值，包括其对长新冠结局的保护作用，尚未得到明确证实。为填补这一知识空白，我们开展了CO.THER研究（癌症患者中的COVID-19治疗研究）。方法：我们设计了一项双向性单中心队列研究。从医院电子病历系统中收集患者在接受COVID-19治疗起始时（T0）、T0后7天（T1）、T0后2周（T2）、T0后1个月（T3）、T0后3个月（T4）、T0后6个月（T5）及T0后12个月（T6）的临床与肿瘤学数据。本研究的主要终点是接受早期抗SARS-CoV-2治疗的癌症患者在14天内因COVID-19住院的发生率。计算14天内住院比例（主要终点）及其精确二项式95%置信区间（95%CI）。结果：共纳入131例患者病历（男性53例[40.5%]，女性78例[59.5%]；中位年龄62.45岁，四分位距[IQR] 56-71岁）。Kaplan-Meier无住院生存曲线显示，仅3例患者（2.1%）在开始早期治疗后14天内因COVID-19相关原因住院（95%CI 0.5-6.6%）。无住院患者超过12个月的累积生存概率为98%（95%CI 93-99%）。12例患者（9.2%）在随访期间报告再次感染COVID-19，均接受奈玛特韦-利托那韦复治。12个月时无再感染累积生存率为90%（95%CI 83-95%）。此外，在3个月时可评估的123例患者中（中位年龄51岁，IQR 40-68），15例报告长新冠症状（12.2%，95%CI 7.0-19.3%）。结论：本研究数据显示，在这组高风险人群中住院率较低，且安全性数据令人安心。
肿瘤(癌症)患者之家