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纳武利尤单抗联合伊匹木单抗及化疗用于转移性非小细胞肺癌患者的多中心真实世界研究结果

Multi-Center Real-World Outcomes of Nivolumab Plus Ipilimumab and Chemotherapy in Patients with Metastatic Non-Small-Cell Lung Cancer.

作者信息

Shalata Walid, Yakobson Alexander, Dudnik Yulia, Swaid Forat, Ahmad Mohammad Sheikh, Abu Jama Ashraf, Cohen Ahron Yehonatan, Agbarya Abed

机构信息

The Legacy Heritage Cancer Center & Dr. Larry Norton Institute, Soroka Medical Center, Beer Sheva 84105, Israel.

Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva 84105, Israel.

出版信息

Biomedicines. 2023 Aug 31;11(9):2438. doi: 10.3390/biomedicines11092438.

Abstract

Immune checkpoint inhibitors have become the standard of care in the treatment of metastatic non-small-cell lung cancer (NSCLC). The combination of nivolumab plus ipilimumab and chemotherapy has been shown to improve outcomes in terms of overall survival (OS) and progression-free survival (PFS). The aim of this study was to evaluate the outcomes of metastatic NSCLC treated in routine practice on the treatment regimen of the CheckMate 9LA protocol. Medical records of 58 patients treated at Soroka and Bnai Zion Medical Centers between May 2020 and February 2022 were analyzed. All patients were treated with a regimen of platinum-based chemotherapy combined with immunotherapy of nivolumab every three weeks and ipilimumab every 6 weeks. The patients received 2-3 cycles of chemotherapy according to the physician's choice: platinum-based cisplatin or carboplatin with either pemetrexed or paclitaxel. The median PFS was 10.2 months, longer than that of the 9LA trial (6.7 months). Adenocarcinoma patients exhibited a higher median OS of 13.7 (range 5-33) months than squamous cell carcinoma (SCC) patients at 12.3 (5-20) months and PFS of 10.3 (4-33) months, while squamous cell carcinoma patients had a PFS of 9.2 (4-18) months. Patients whose programmed death ligand-1 (PD-L1) tumor expression level was ≥1% showed a higher median OS than those with PD-L1 expression of less than 1%. Treatment-related adverse events (TRAEs) were reported in 93.1% of patients, mostly grade 1 in severity. The first-line treatment of metastatic NSCLC patients in combination with nivolumab plus ipilimumab and chemotherapy can be given safely in routine clinical practice, with results comparable to those achieved in clinical trials of the regimen.

摘要

免疫检查点抑制剂已成为转移性非小细胞肺癌(NSCLC)治疗的标准疗法。纳武利尤单抗联合伊匹木单抗及化疗已被证明可改善总生存期(OS)和无进展生存期(PFS)。本研究旨在评估在常规临床实践中按照CheckMate 9LA方案治疗转移性NSCLC的疗效。分析了2020年5月至2022年2月期间在索罗卡医疗中心和贝纳伊锡安医疗中心接受治疗的58例患者的病历。所有患者均接受铂类化疗联合免疫治疗方案,每三周使用一次纳武利尤单抗,每六周使用一次伊匹木单抗。根据医生的选择,患者接受2 - 3个周期的化疗:铂类顺铂或卡铂联合培美曲塞或紫杉醇。中位PFS为10.2个月,长于9LA试验中的6.7个月。腺癌患者的中位OS为13.7(5 - 33)个月,高于鳞状细胞癌(SCC)患者的12.3(5 - 20)个月,腺癌患者的PFS为10.3(4 - 33)个月,而鳞状细胞癌患者的PFS为9.2(4 - 18)个月。程序性死亡配体-1(PD-L1)肿瘤表达水平≥1%的患者中位OS高于PD-L1表达低于1%的患者。93.1%的患者报告了治疗相关不良事件(TRAEs),大多数为1级严重程度。转移性NSCLC患者一线联合纳武利尤单抗、伊匹木单抗及化疗在常规临床实践中可安全给药,结果与该方案临床试验所取得的结果相当。

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