Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Department of Head and Neck Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Clin Cancer Res. 2022 Aug 2;28(15):3277-3286. doi: 10.1158/1078-0432.CCR-21-0985.
Limited long-term data are available on immune checkpoint inhibitor use in patients with advanced esophageal squamous cell carcinoma (ESCC). We report 3-year follow-up data from our study of nivolumab versus chemotherapy (paclitaxel or docetaxel) in patients with previously treated ESCC.
ATTRACTION-3 was a randomized, multicenter, open-label, phase III trial. Overall survival (OS), time from randomization to death from any cause, was the primary endpoint. An exploratory subanalysis assessed OS according to the best overall response (BOR) with and without landmark at 4 months.
Of the enrolled patients, 210 received nivolumab and 209 received chemotherapy. With a minimum follow-up of 36.0 months, OS was longer in the nivolumab versus the chemotherapy group (median, 10.9 vs. 8.5 months; HR, 0.79; P = 0.0264), with 3-year OS rates of 15.3% and 8.7%, respectively. The median OS was longer with nivolumab versus chemotherapy irrespective of the BOR (complete response/partial response: 19.9 vs. 15.4 months; stable disease: 17.4 vs. 8.8 months; and progressive disease: 7.6 vs. 4.2 months). Grade 3 or higher treatment-related adverse events were reported in 40 patients (19.1%) in the nivolumab group and 133 patients (63.9%) in the chemotherapy group.
Nivolumab as second-line therapy demonstrated clinically meaningful long-term improvement in OS compared with chemotherapy in previously treated patients with advanced ESCC. The OS was consistently improved in the nivolumab group compared with the chemotherapy group regardless of BOR. Nivolumab was well tolerated over the 3-year follow-up. See related commentary by Yoon et al., p. 3173.
关于晚期食管鳞状细胞癌（ESCC）患者使用免疫检查点抑制剂的数据有限。我们报告了 nivolumab 与化疗（紫杉醇或多西他赛）治疗既往治疗的 ESCC 患者的研究 3 年随访数据。
ATTRACTION-3 是一项随机、多中心、开放性、III 期试验。总生存期（OS），即从随机分组到任何原因死亡的时间，是主要终点。一项探索性亚分析根据最佳总体缓解（BOR）评估了 OS，有无 4 个月的里程碑。
在入组的患者中，210 例接受 nivolumab 治疗，209 例接受化疗。在至少随访 36.0 个月后，nivolumab 组的 OS 长于化疗组（中位 OS，10.9 个月 vs. 8.5 个月；HR，0.79；P = 0.0264），3 年 OS 率分别为 15.3%和 8.7%。无论 BOR 如何，nivolumab 组的中位 OS 均长于化疗组（完全缓解/部分缓解：19.9 个月 vs. 15.4 个月；稳定疾病：17.4 个月 vs. 8.8 个月；进展性疾病：7.6 个月 vs. 4.2 个月）。nivolumab 组有 40 例（19.1%）和化疗组有 133 例（63.9%）患者报告了 3 级或更高的治疗相关不良事件。
二线治疗 nivolumab 与化疗相比，在既往治疗的晚期 ESCC 患者中，OS 具有显著的临床意义的长期改善。无论 BOR 如何，nivolumab 组的 OS 均一致优于化疗组。在 3 年的随访中，nivolumab 的耐受性良好。详见 Yoon 等人的相关评论，第 3173 页。
