舒伐替尼加托瑞帕单抗联合依托泊苷和顺铂作为晚期小细胞肺癌患者的一线治疗:Ib/II期试验

IF 40.8 1区 医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Signal Transduction and Targeted Therapy Pub Date : 2024-09-27 DOI:10.1038/s41392-024-01974-2
Yaxiong Zhang, Yan Huang, Yunpeng Yang, Yuanyuan Zhao, Ting Zhou, Gang Chen, Shen Zhao, Huaqiang Zhou, Yuxiang Ma, Shaodong Hong, Hongyun Zhao, Li Zhang, Wenfeng Fang
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引用次数: 0

摘要

晚期小细胞肺癌(SCLC)的一线治疗仍有改进的余地。这项试验首先研究了抗血管生成疗法(索鲁法替尼)(200 毫克,每天三次,每次一粒)加抗 PD-1 疗法(托利帕单抗)(240 毫克,每天一次,每次点滴)联合依托泊苷(100 毫克/平方米,每天一次,每次三粒,每次点滴)和顺铂(25 毫克/平方米,每天一次,每次三粒,每次点滴)作为晚期小细胞肺癌一线治疗的有效性和安全性,该试验已在 ClinicalTrials.gov 上注册,标识符为 NCT04996771。四药治疗方案为4个周期的q3w治疗,同时使用舒伐替尼和托利帕利单抗进行维持治疗。主要终点是无进展生存期(PFS)。次要终点包括客观反应率(ORR)、疾病控制率(DCR)、总生存期(OS)和安全性。所有 38 名患者都被纳入了安全性分析,而只有 35 名患者被纳入了疗效分析,因为有 3 例患者在治疗后失去了疗效评估。中位随访 21.3 个月后,ORR 为 97.1%(34/35),DCR 和肿瘤缩小率均为 100%(35/35)。中位 PFS 为 6.9 个月(95% CI:4.6 个月-9.2 个月),中位 OS 为 21.1 个月(95% CI:12.1 个月-30.1 个月)。12个月、18个月和24个月的OS率分别为66.94%、51.39%和38.54%。≥3级治疗突发不良事件(TEAEs)发生率为63.2%(24/38),包括中性粒细胞计数减少(31.6%,12/38)、白细胞计数减少(23.7%,9/38)和血小板计数减少(10.5%,4/38)。未发生意外不良事件。这种新型四药方案(舒伐替尼、托利帕单抗、依托泊苷加顺铂)疗效显著,毒性可耐受。
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Surufatinib plus toripalimab combined with etoposide and cisplatin as first-line treatment in advanced small-cell lung cancer patients: a phase Ib/II trial

There is still room for improvement in first-line treatment of advanced small cell lung cancer (SCLC). This trial firstly investigated efficacy and safety of antiangiogenic therapy (surufatinib) (200 mg, qd, po) plus anti-PD-1 treatment (toripalimab) (240 mg, d1, ivdrip) combined with etoposide (100 mg/m², d1-d3, iv, drip) and cisplatin (25 mg/m², d1-d3, ivdrip) for advanced SCLC as first-line treatment, which has been registered on ClinicalTrials.gov under the identifier NCT04996771. The four-drug regimen was conducted q3w for 4 cycles with maintenance therapy of surufatinib and toripalimab. The primary endpoint was progression-free survival (PFS). The secondary end points included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. All of the 38 patients were enrolled for safety analysis, while only 35 patients were enrolled for efficacy analysis since loss of efficacy evaluation in 3 cases after treatment. After a median follow-up of 21.3 months, the ORR was 97.1% (34/35), and the DCR and the tumor shrinkage rate were both 100% (35/35). The median PFS was 6.9 months (95% CI: 4.6 m–9.2 m) and the median OS was 21.1 months (95% CI: 12.1 m–30.1 m). The 12-month, 18-month, and 24-month OS rates were 66.94%, 51.39% and 38.54%. The occurrence rate of grade ≥3 treatment-emergent adverse events (TEAEs) was 63.2% (24/38), including neutrophil count decreased (31.6%, 12/38), white blood cell count decreased (23.7%, 9/38) and platelet count decreased (10.5%, 4/38). No unexpected adverse events occurred. This novel four-drug regimen (surufatinib, toripalimab, etoposide plus cisplatin) revealed impressive therapeutic efficacy and tolerable toxicities.

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来源期刊
Signal Transduction and Targeted Therapy
Signal Transduction and Targeted Therapy Biochemistry, Genetics and Molecular Biology-Genetics
CiteScore
44.50
自引率
1.50%
发文量
384
审稿时长
5 weeks
期刊介绍: Signal Transduction and Targeted Therapy is an open access journal that focuses on timely publication of cutting-edge discoveries and advancements in basic science and clinical research related to signal transduction and targeted therapy. Scope: The journal covers research on major human diseases, including, but not limited to: Cancer,Cardiovascular diseases,Autoimmune diseases,Nervous system diseases.
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