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安罗替尼联合铂类-依托泊苷化疗作为广泛期小细胞肺癌一线治疗的疗效和安全性:一项中国多中心真实世界研究

The efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy as first-line treatment for extensive-stage small cell lung cancer: A Chinese multicenter real-world study.

作者信息

Zheng Hao-Ran, Jiang Ai-Min, Gao Huan, Liu Na, Zheng Xiao-Qiang, Fu Xiao, Ruan Zhi-Ping, Tian Tao, Liang Xuan, Yao Yu

机构信息

Department of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.

Department of Medical Oncology, Xi'an No.3 Hospital, Xi'an, China.

出版信息

Front Oncol. 2022 Sep 20;12:894835. doi: 10.3389/fonc.2022.894835. eCollection 2022.

Abstract

BACKGROUND

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have high recurrence rates and bleak prognosis. This multicenter real-world study aimed to explore the efficacy and safety of anlotinib combined with platinum-etoposide chemotherapy as the first-line treatment of ES-SCLC.

METHODS

Pathologically confirmed ES-SCLC patients receiving anlotinib plus platinum-etoposide chemotherapy as the first-line treatment were enrolled in this retrospective study. The primary endpoint of this study was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and adverse reactions. The Cox regression analyses were employed to investigate the independent prognostic factors for OS and PFS of these individuals.

RESULTS

In total, 58 patients were included in this study. The median PFS was 6.0 months [95% confidence interval (CI): 3.5-8.5], and the median OS was 10.5 months (95%CI 8.7-12.3). Thirty-four patients achieved partial response (PR), 18 patients achieved stable disease (SD), and 6 patients achieved progressive disease (PD). The ORR and DCR were 58.6% and 89.6%. The main treatment-related adverse reactions were generally tolerated. Myelosuppression (44.8%) was the most common adverse reaction, followed by hypertension (41.4%), fatigue (34.5%), gastrointestinal reaction (32.7%), and hand-foot syndrome (24.1%). Multivariate analysis showed that post-medication hand-foot syndrome [PFS 8.5 5.5 months, Hazards Ratio (HR)=0.23, 95%CI 0.07-0.72, =0.012] was the independent predictor of PFS, and hypertension (OS 15.9 8.3 months, HR=0.18, 95%CI 0.05-0.58, =0.005) was the independent predictor of OS.

CONCLUSION

Anlotinib combined with platinum-etoposide chemotherapy as the first-line treatment for ES-SCLC appears to be effective and well-tolerated in the real-world. Well-designed large-scale prospective studies are urgently needed in the future to verify our findings.

摘要

背景

广泛期小细胞肺癌(ES-SCLC)患者复发率高,预后不佳。这项多中心真实世界研究旨在探讨安罗替尼联合铂类-依托泊苷化疗作为ES-SCLC一线治疗的疗效和安全性。

方法

本回顾性研究纳入了经病理确诊、接受安罗替尼联合铂类-依托泊苷化疗作为一线治疗的ES-SCLC患者。本研究的主要终点是无进展生存期(PFS),次要终点包括总生存期(OS)、客观缓解率(ORR)、疾病控制率(DCR)和不良反应。采用Cox回归分析来研究这些患者OS和PFS的独立预后因素。

结果

本研究共纳入58例患者。中位PFS为6.0个月[95%置信区间(CI):3.5 - 8.5],中位OS为10.5个月(95%CI 8.7 - 12.3)。34例患者达到部分缓解(PR),18例患者疾病稳定(SD),6例患者疾病进展(PD)。ORR和DCR分别为58.6%和89.6%。主要的治疗相关不良反应一般可耐受。骨髓抑制(44.8%)是最常见的不良反应,其次是高血压(41.4%)、疲劳(34.5%)、胃肠道反应(32.7%)和手足综合征(24.1%)。多因素分析显示,用药后手足综合征[PFS 8.5对5.5个月,风险比(HR)=0.23,95%CI 0.07 - 0.72,P =0.012]是PFS的独立预测因素,高血压(OS 15.9对8.3个月,HR=0.18,95%CI 0.05 - 0.58,P =0.005)是OS的独立预测因素。

结论

在真实世界中,安罗替尼联合铂类-依托泊苷化疗作为ES-SCLC的一线治疗似乎有效且耐受性良好。未来迫切需要设计良好的大规模前瞻性研究来验证我们的发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6adb/9531009/5ec1814139e9/fonc-12-894835-g001.jpg

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