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非小细胞肺癌PD-1抑制剂的新辅助治疗Neoadjuvant PD-1 inhibitor (Sintilimab) in Non-Small Cell Lung Cancer

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非小细胞肺癌PD-1抑制剂的新辅助治疗Neoadjuvant PD-1 inhibitor (Sintilimab) in Non-Small Cell Lung Cancer
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Abstract

Background

Programmed death receptor-1 (PD-1) inhibitors have shown efficacy in first line treatment of non-small cell lung cancer (NSCLC), however, evidence of PD-1 inhibitor as neoadjuvant treatment is limited. This is a phase 1b study to evaluate the safety and outcome of PD-1 inhibitor in neoadjuvant setting.

Methods

Treatment-naïve patients with resectable NSCLC (stage IA-IIIB) received two cycles of sintilimab (200 mg, intravenously, day 1/22). Surgery was performed between day 29-43. PET-CT was obtained at baseline and prior to surgery. Primary endpoint was safety. Efficacy endpoints included rate of major pathologic response (MPR) and objective response rate (ORR). PD-L1 expression was also evaluated. (Registration Number: ChiCTR-OIC-17013726).

Results

Forty patients enrolled, all of whom received 2 doses of sintilimab, and 37 underwent radical resection. Twenty-one (52.5%) patients experienced neoadjuvant treatment-related adverse events (TRAEs). Four (10.0%) patients experienced grade 3-4 neoadjuvant TRAEs, and one patient had grade 5 TRAE. Eight patients achieved radiological partial response, resulting in an ORR of 20.0%. Among 37 patients, 15 (40.5%) achieved MPR, including 6 (16.2%) with a pathologic complete response in primary tumor and 3 (8.1%) in lymph nodes as well. Squamouse cell NSCLC exhibited superior response compared to adenocarcinoma (MPR: 48.4% VS. 0%). Decrease of maximum standardized uptake values (SUVmax) after sintilimab treatment correlated with pathological remission (p<0.00001). Baseline PD-L1 expression of stromal cells instead of tumor cells was correlated with pathological regression (p=0.0471).

Conclusion

Neoadjuvant sintilimab was tolerable for NSCLC patients and 40.5% MPR rate is encouraging. The decrease of SUVmax after sintilimab might predict pathologic response.

背景

程序性死亡受体1(PD-1)抑制剂已在非小细胞肺癌(NSCLC)的一线治疗中显示出疗效,但是,PD-1抑制剂作为新辅助治疗的证据有限。这是一项1b期研究,旨在评估PD-1抑制剂在新辅助治疗中的安全性和疗效。

方法

初治的可切除NSCLC患者(IA-IIIB期)接受了两个周期的sintilimab(200 mg,静脉注射,第1/22天)。在第29-43天之间进行手术。PET-CT在基线和手术前获得。主要终点是安全性。疗效终点包括主要病理反应率(MPR)和客观反应率(ORR)。还评估了PD-L1表达。(注册号:ChiCTR-OIC-17013726)。

结果

入组40例患者,所有患者均接受2个周期的 sintilimab 治疗,其中37例接受了根治性切除。

21名患者(52.5%)经历了新辅助治疗相关的不良事件(TRAE)。4名(10.0%)患者经历了3-4级新辅助TRAE,而1名患者具有5级TRAE。8名患者实现了放射学部分缓解,ORR为20.0%。在37例患者中,有15例(40.5%)达到了MPR,其中6例(16.2%)在原发性肿瘤中实现了病理完全缓解,在淋巴结中也有3例(8.1%)。与腺癌相比,鳞状细胞NSCLC表现出更好的反应(MPR:48.4%VS. 0%)。sintilimab治疗后最大标准摄取值(SUVmax)的降低与病理缓解相关(p <0.00001)。

结论

NSCLC患者可耐受Sintilimab新辅助治疗,MPR率为40.5%令人鼓舞。Sintilimab后SUVmax的降低可能预示了病理反应。

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