Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, Tianjin Key Laboratory of Digestive Cancer, Tianjin, 300060, People's Republic of China.
Aerospace Center Hospital, Beijing, 100049, People's Republic of China.
Drug Des Devel Ther. 2024 Sep 16;18:4135-4151. doi: 10.2147/DDDT.S476457. eCollection 2024.
This study aimed to identify the effectiveness and safety of PD-1 blockades among elderly patients with metastatic esophageal squamous cell carcinoma (ESCC) clinically.
A total of 78 elderly patients with previously treated metastatic ESCC aged ≥65 years who received PD-1 blockades monotherapy were included retrospectively. Demographic characteristics, therapeutic effectiveness and adverse reactions of the elderly patients who underwent PD-1 blockade therapy were recorded. Regular follow-up was conducted for all patients. The analysis aimed to identify potential risk factors for OS by examining the correlation between prognosis and subgroups based on baseline characteristics.
The median age of the 78 elderly patients was 73 years, ranging from 65 to 87 years. Among the 78 patients, 18 cases showed partial response, 26 cases had stable disease, 29 cases experienced progressive disease and 5 cases were not assessable for response, yielding an ORR of 23.1%, a DCR of 56.4%. The prognostic outcomes indicated that among the 78 patients with metastatic ESCC who received PD-1 blockades, the median PFS was 3.1 months [95% confidence interval (CI): 1.64-4.56], and the median OS was 10.9 months (95% CI: 6.02-15.78), 24-month OS rate was 22.7% (95% CI: 12.8-34.2%). In terms of the safety profile, among the 78 patients with metastatic ESCC during PD-1 blockades single-agent treatment, a total of 61 patients (78.2%) experienced any grade adverse reactions and the incidence of grade ≥3 adverse reactions were 20.5%. Briefly, the common adverse reactions manifested as fatigue (32.1%), gastrointestinal reaction (24.4%), diarrhea (19.2%), anemia (17.9%) and rash (16.7%). Overall tolerability of PD-1 blockade monotherapy in elderly patients with metastatic ESCC was acceptable and manageable.
PD-1 blockades single agent demonstrated encouraging effectiveness and acceptable safety profile for elderly patients with previously treated metastatic ESCC in clinical practice. Prospective study should be performed to elucidate the conclusion in this study subsequently.
本研究旨在临床评估 PD-1 阻断剂在老年转移性食管鳞癌(ESCC)患者中的疗效和安全性。
回顾性纳入 78 例年龄≥65 岁、接受 PD-1 单药阻断治疗的既往治疗转移性 ESCC 的老年患者。记录患者的人口统计学特征、治疗效果和不良反应。所有患者均进行定期随访。分析旨在通过检查基于基线特征的预后与亚组之间的相关性,来确定 OS 的潜在危险因素。
78 例老年患者的中位年龄为 73 岁,年龄范围为 65-87 岁。78 例患者中,18 例部分缓解,26 例疾病稳定,29 例疾病进展,5 例无法评估反应,客观缓解率为 23.1%,疾病控制率为 56.4%。预后结果表明,在接受 PD-1 阻断治疗的 78 例转移性 ESCC 患者中,中位 PFS 为 3.1 个月[95%可信区间(CI):1.64-4.56],中位 OS 为 10.9 个月(95%CI:6.02-15.78),24 个月 OS 率为 22.7%(95%CI:12.8-34.2%)。在安全性方面,78 例转移性 ESCC 患者接受 PD-1 单药治疗期间,共有 61 例(78.2%)发生任何级别不良反应,≥3 级不良反应发生率为 20.5%。常见不良反应表现为乏力(32.1%)、胃肠道反应(24.4%)、腹泻(19.2%)、贫血(17.9%)和皮疹(16.7%)。PD-1 单药阻断治疗老年转移性 ESCC 的总体耐受性可接受且可管理。
PD-1 单药阻断剂在老年转移性 ESCC 患者中显示出令人鼓舞的疗效和可接受的安全性。应进行前瞻性研究以进一步阐明本研究的结论。