S-1 联合放化疗同步替莫唑胺治疗局部晚期食管鳞癌新辅助治疗失败患者：真实世界前瞻性研究。
S-1-based concurrent chemoradiotherapy plus nimotuzumab in patients with locally advanced esophageal squamous cell carcinoma who failed neoadjuvant therapy: a real-world prospective study.
机构信息
Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Department of Oncology, Beijing Changping Hospital, Beijing, China.
出版信息
Cancer Biol Ther. 2024 Dec 31;25(1):2417464. doi: 10.1080/15384047.2024.2417464. Epub 2024 Oct 27.
PURPOSE
This prospective study in a real-world setting investigated the feasibility and safety of S-1 plus nimotuzumab (S-1-Nimo) based concurrent chemoradiotherapy (CCRT) in locally advanced esophageal squamous cell carcinoma (LA-ESCC) patients who failed to neoadjuvant chemotherapy or chemoimmunotherapy.
METHODS
LA-ESCC patients who failed to converse to resectable disease after neoadjuvant chemotherapy or chemoimmunotherapy were enrolled to receive the 4-week S-1-Nimo regimen of radiotherapy (40 Gy in 20 fractions, 5 days per week), S-1 chemotherapy, and nimotuzumab. Then, after surgical assessments, patients evaluated as resectable disease received surgery; patients with unresectable disease continued to receive definitive radiotherapy (50-60 Gy in 25-30 fractions, 5 days per week) concurrently with S-1-Nimo. The primary endpoint was event-free survival (EFS).
RESULTS
Sixty-four patients were enrolled and evaluated. The median follow-up time was 23.2 months. Median EFS was 9.6 (95% confidence interval [CI], 7.1-14.0) months, with an estimated 2-year EFS rate of 24.2%. The median overall survival (OS) and the estimated OS rate at 2 years were 13.4 (95% CI, 10.3-17.5) months and 31.2%, respectively. Twelve underwent surgery, with a surgical conversion rate of 18.8% and an R0 resection rate of 100.0%. Subgroup analysis identified the significantly prolonged EFS and OS in patients who experienced radical surgery (median EFS, not reached vs. 8.7 months; = .0117. median OS, 24.9 vs. 10.6 months; = .0205) as compared to those treated with CCRT. Of 64 patients, grade 3 adverse events mainly included radiation esophagitis (4.7%), anemia (1.6%), and thrombocytopenia (1.6%).
CONCLUSION
The study demonstrated the reasonable efficacy and promising safety of the S-1-Nimo-based CCRT in LA-ESCC patients with failure to neoadjuvant chemotherapy or chemoimmunotherapy.
目的
本前瞻性研究在真实环境中调查了 S-1 联合尼妥珠单抗（S-1-Nimo）在新辅助化疗或化疗免疫治疗后无法转化为可切除疾病的局部晚期食管鳞状细胞癌（LA-ESCC）患者中同步放化疗（CCRT）的可行性和安全性。
方法
纳入新辅助化疗或化疗免疫治疗后无法转化为可切除疾病的 LA-ESCC 患者，接受 4 周 S-1-Nimo 放疗方案（40Gy，20 次，每周 5 天）、S-1 化疗和尼妥珠单抗治疗。然后，在进行手术评估后，将可切除疾病的患者进行手术治疗；不可切除疾病的患者继续接受根治性放疗（50-60Gy，25-30 次，每周 5 天），同时联合 S-1-Nimo。主要终点是无事件生存（EFS）。
结果
共纳入并评估了 64 例患者。中位随访时间为 23.2 个月。中位 EFS 为 9.6（95%置信区间[CI]，7.1-14.0）个月，估计 2 年 EFS 率为 24.2%。中位总生存期（OS）和估计 2 年 OS 率分别为 13.4（95%CI，10.3-17.5）个月和 31.2%。12 例患者接受了手术，手术转化率为 18.8%，R0 切除率为 100.0%。亚组分析发现，与接受 CCRT 治疗的患者相比，根治性手术患者的 EFS 和 OS 显著延长（中位 EFS，未达到 vs. 8.7 个月； = .0117. 中位 OS，24.9 vs. 10.6 个月； = .0205）。64 例患者中，3 级不良事件主要包括放射性食管炎（4.7%）、贫血（1.6%）和血小板减少症（1.6%）。
结论
该研究表明，S-1-Nimo 为基础的 CCRT 在新辅助化疗或化疗免疫治疗失败的 LA-ESCC 患者中具有合理的疗效和良好的安全性。
Zotero 插件