尼妥珠单抗联合放化疗治疗不可切除局部晚期食管鳞癌（ESCC）：III 期临床试验的中期分析。
Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial.
机构信息
Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China.
Department of Radiation Oncology, Anyang Cancer Hospital, Anyang, China.
出版信息
Br J Cancer. 2023 Nov;129(11):1787-1792. doi: 10.1038/s41416-023-02388-7. Epub 2023 Oct 20.
BACKGROUND
This prospectively randomised, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial was conducted to assess the efficacy and safety profile of nimotuzumab (nimo) plus concurrent chemo-radiotherapy (CCRT) in patients with unresectable locally advanced ESCC.
METHODS
Patients were randomly assigned (1:1) to receive CCRT plus nimotuzumab or placebo. The primary endpoint was overall survival (OS). In addition, interim analysis for short-term response rate was pre-defined.
RESULTS
A total of 201 patients were randomised into two groups. Eighty patients in the nimo group and eighty-two in the placebo group were evaluable. Three to six months after treatment, 26 (32.5%) patients achieved complete response (CR) in the nimo group, and 10 (12.2%) in the placebo group (P = 0.002). The ORR of the nimo group was significantly higher than the placebo group (93.8% vs. 72.0%, P < 0.001). The two groups' grade 3-5 adverse drug reactions were 11.1% vs. 10.9% (P > 0.05).
CONCLUSIONS
Nimotuzumab, in combination with chemo-radiotherapy, increased the CRR and ORR with a good safety profile. The OS is needed to be followed and finally analysed.
CLINICAL TRIAL REGISTRATION
NCT02409186.
背景
本前瞻性随机、双盲、安慰剂对照、多中心 3 期临床试验旨在评估尼莫单抗（nimo）联合同期放化疗（CCRT）治疗不可切除局部晚期 ESCC 患者的疗效和安全性。
方法
患者按 1:1 随机分配接受 CCRT 加尼莫单抗或安慰剂。主要终点是总生存期（OS）。此外，还预先定义了短期反应率的中期分析。
结果
共有 201 例患者被随机分为两组。尼莫单抗组 80 例，安慰剂组 82 例。治疗后 3 至 6 个月，尼莫单抗组 26 例（32.5%）患者达到完全缓解（CR），安慰剂组 10 例（12.2%）（P=0.002）。尼莫单抗组的客观缓解率（ORR）明显高于安慰剂组（93.8%比 72.0%，P<0.001）。两组 3-5 级不良反应发生率分别为 11.1%和 10.9%（P>0.05）。
结论
尼莫单抗联合放化疗可提高 CRR 和 ORR，且安全性良好。需要进行随访和最终分析以评估 OS。
临床试验注册
NCT02409186。
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