Henan Key Laboratory of Microbiome and Esophageal Cancer Prevention and Treatment, Henan Key Laboratory of Cancer Epigenetics, Cancer Hospital, The First Affiliated Hospital (College of Clinical Medicine) of Henan University of Science and Technology, Luoyang, China.
Department of Radiation Oncology, Anyang Tumor Hospital, The Affiliated Hospital, The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology, Henan Medical Key Laboratory of Precise Prevention and Treatment of Esophageal Cancer, Luoyang, China.
J Clin Oncol. 2024 Jul 10;42(20):2436-2445. doi: 10.1200/JCO.23.02009. Epub 2024 May 6.
This phase 3 trial aimed to compare the efficacy and safety of capecitabine or capecitabine plus oxaliplatin (XELOX) with those of fluorouracil plus cisplatin (PF) in definitive concurrent chemoradiotherapy (DCRT) for inoperable locally advanced esophageal squamous cell carcinoma (ESCC).
Patients were randomly assigned to receive two cycles of capecitabine, XELOX, or PF along with concurrent intensity-modulated radiation therapy. Patients in each arm were again randomly assigned to receive two cycles of consolidation chemotherapy or not. The primary end points were 2-year overall survival (OS) rate and incidence of grade ≥3 adverse events (AEs).
A total of 246 patients were randomly assigned into the capecitabine (n = 80), XELOX (n = 85), and PF (n = 81) arms. In capecitabine, XELOX, and PF arms, the 2-year OS rate was 75%, 66.7%, and 70.9% (capecitabine PF: hazard ratio [HR], 0.91 [95% CI, 0.61 to 1.35]; nominal = .637; XELOX PF: 0.86 [95% CI, 0.58 to 1.27]; = .444); the median OS was 40.9 (95% CI, 34.4 to 49.9), 41.9 (95% CI, 28.6 to 52.1), and 35.4 (95% CI, 30.4 to 45.4) months. The incidence of grade ≥3 AEs during the entire treatment was 28.8%, 36.5%, and 45.7%, respectively. Comparing the consolidation chemotherapy with the nonconsolidation chemotherapy groups, the median OS was 41.9 (95% CI, 34.6 to 52.8) versus 36.9 (95% CI, 28.5 to 44) months (HR, 0.71 [95% CI, 0.52 to 0.99]; nominal = .0403).
Capecitabine or XELOX did not significantly improve the 2-year OS rate over PF in DCRT for inoperable locally advanced ESCC. Capecitabine showed a lower incidence of grade ≥3 AEs than PF did.
本 3 期临床试验旨在比较卡培他滨或卡培他滨联合奥沙利铂（XELOX）与氟尿嘧啶联合顺铂（PF）在不可切除局部晚期食管鳞状细胞癌（ESCC）患者根治性同期放化疗（DCRT）中的疗效和安全性。
患者被随机分配接受两个周期的卡培他滨、XELOX 或 PF 联合强度调制放疗。每个治疗组的患者再次随机分配接受或不接受两个周期的巩固化疗。主要终点是 2 年总生存率（OS）率和≥3 级不良事件（AE）的发生率。
共 246 例患者被随机分配至卡培他滨（n = 80）、XELOX（n = 85）和 PF（n = 81）组。在卡培他滨、XELOX 和 PF 组中，2 年 OS 率分别为 75%、66.7%和 70.9%（卡培他滨-PF：风险比[HR]，0.91[95%CI，0.61 至 1.35]；名义值=.637；XELOX-PF：0.86[95%CI，0.58 至 1.27]；=.444）；中位 OS 分别为 40.9（95%CI，34.4 至 49.9）、41.9（95%CI，28.6 至 52.1）和 35.4（95%CI，30.4 至 45.4）个月。整个治疗过程中≥3 级 AE 的发生率分别为 28.8%、36.5%和 45.7%。与非巩固化疗组相比，巩固化疗组的中位 OS 为 41.9（95%CI，34.6 至 52.8）与 36.9（95%CI，28.5 至 44）个月（HR，0.71[95%CI，0.52 至 0.99]；名义值=.0403）。
卡培他滨或 XELOX 并未在不可切除局部晚期 ESCC 患者的 DCRT 中显著提高 2 年 OS 率。卡培他滨的不良反应发生率低于 PF。
