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卡瑞利珠单抗联合化疗治疗晚期非鳞状非小细胞肺癌:疗效、生存模式和安全性。

Camrelizumab plus chemotherapy in advanced non-squamous non-small cell lung cancer: Treatment response, survival pattern, and safety.

机构信息

Department of Pulmonary and Critical Care Medicine, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

J Clin Pharm Ther. 2022 Nov;47(11):1775-1782. doi: 10.1111/jcpt.13732. Epub 2022 Jul 18.

DOI:10.1111/jcpt.13732
PMID:35851702
Abstract

WHAT IS KNOWN AND OBJECTIVE

Camrelizumab, a humanized monoclonal programmed cell death protein-1 antibody independently developed by China, is introduced as a treatment selection for non-small cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of camrelizumab plus chemotherapy in treating advanced non-squamous NSCLC patients.

METHODS

This study retrospectively analysed 31 driver-gene-negative advanced non-squamous NSCLC patients who received a 21-day therapy cycle for four cycles of camrelizumab (intravenous injection, 200 mg/cycle) plus carboplatin and pemetrexed (CP) chemotherapy, followed by maintenance therapy using camrelizumab or pemetrexed or camrelizumab plus pemetrexed. Another 40 patients who underwent CP chemotherapy were retrieved as control group.

RESULTS AND DISCUSSION

The objective response rate (ORR) was elevated in camrelizumab plus CP group compared to CP group (58.1% vs. 32.5%, p = 0.031), while disease control rate (DCR) was of no difference between those two groups (83.9% vs. 72.5%, p = 0.255). Camrelizumab plus CP achieved a prolonged PFS compared with CP alone (median: 11.0 (95% CI: 9.1-12.9) months versus 7.2 (95% CI: 5.1-9.3) months, p = 0.026), also realized an increasing OS trend (without statistical significance; 19.3 (95% CI: 15.4-23.2) months versus 15.1 (95% CI: 13.9-16.3) months, p = 0.093). Further multivariate Cox's regression analysis exhibited that camrelizumab plus CP (vs. CP) independently related to prolonged PFS (p < 0.001) and OS (p = 0.027). Moreover, the most common adverse events related to camrelizumab plus CP were fatigue (45.2%), peripheral neuropathy (35.5%), nausea and vomiting (35.5%); furthermore, most adverse events were controllable.

WHAT IS NEW AND CONCLUSION

Camrelizumab plus chemotherapy exhibits good efficacy and manageable adverse events in treating advanced non-squamous NSCLC patients.

摘要

已知和目的

Camrelizumab 是一种由中国自主开发的人源化单克隆程序性死亡蛋白-1 抗体,被引入用于治疗非小细胞肺癌(NSCLC)。本研究旨在评估 Camrelizumab 联合化疗治疗晚期非鳞状 NSCLC 患者的疗效和安全性。

方法

本研究回顾性分析了 31 例驱动基因阴性的晚期非鳞状 NSCLC 患者,他们接受了 21 天治疗周期的 4 个周期 Camrelizumab(静脉注射,200mg/周期)联合卡铂和培美曲塞(CP)化疗,随后使用 Camrelizumab 或培美曲塞或 Camrelizumab 联合培美曲塞进行维持治疗。另选取 40 例接受 CP 化疗的患者作为对照组。

结果和讨论

Camrelizumab 联合 CP 组的客观缓解率(ORR)高于 CP 组(58.1%比 32.5%,p=0.031),而两组的疾病控制率(DCR)无差异(83.9%比 72.5%,p=0.255)。Camrelizumab 联合 CP 组与 CP 单药组相比,无进展生存期(PFS)延长(中位数:11.0(95%CI:9.1-12.9)个月比 7.2(95%CI:5.1-9.3)个月,p=0.026),总生存期(OS)也呈现出延长的趋势(无统计学意义;19.3(95%CI:15.4-23.2)个月比 15.1(95%CI:13.9-16.3)个月,p=0.093)。进一步的多变量 Cox 回归分析表明,Camrelizumab 联合 CP(与 CP 相比)独立与延长 PFS(p<0.001)和 OS(p=0.027)相关。此外,Camrelizumab 联合 CP 最常见的相关不良反应是疲劳(45.2%)、周围神经病变(35.5%)、恶心和呕吐(35.5%);此外,大多数不良反应是可控的。

新发现和结论

Camrelizumab 联合化疗治疗晚期非鳞状 NSCLC 患者具有良好的疗效和可管理的不良反应。

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