安罗替尼联合卡培他滨/替莫唑胺方案后线治疗 SCLC 脑转移患者的疗效和安全性研究. (Chinese)

Objective To evaluate the efficacy and safety of Anlotinib combined with Capecitabine/Temozolomide in the treatment of advanced SCLC brain metastasis after multi-line therapy.Methods A total of 23 SCLC patients who developed brain metastases after second-line chemotherapy in the First People′s Hospital of Longquanyi District Chengdu from August 2018 to August 2021 were included, and the posterior treatment regimen was given Anlotinib targeted therapy combined with CAPTEM antitumor therapy.The progression-free survival time(PFS), intracranial progression-free survival time(iPFS), objective response rate(ORR), disease control rate(DCR), and intracranial objective response rate(iORR) were observed, and univariate analysis was performed.The PFS and iPFS of the patients were included by COX multivariate regression analysis.Kaplan-Meier method was used for survival analysis of relevant data to evaluate the efficacy and safety of the combined regimen for the posterior line treatment of advanced SCLC brain metastases.Results Curative effect analysis: Among the 23 patients, 0 cases had complete remission, 10 cases had partial remission, 10 cases had stable disease, and three cases had disease progression.The ORR was 43.47% and the DCR was 86.95%.Brain metastasis evaluation: of the 23 patients, 0 were in complete remission, 11 were in partial remission, 10 were in stable condition, and two were in disease progression, with an iORR of 47.82%.The median PFS was 6.4(5.4, 7.0) months and iPFS was 6.5(5.5, 7.4) months.Univariate analysis: Smoking and other adverse lifestyle, physical status Easten Cooperative Oncology Group(ECOG) score and brain radiotherapy had some effects on PFS(P＜0.05), while physical status ECOG score and simultaneous intracranial metastatic radiotherapy were associated with iPFS(P＜0.05).Polyfactor analysis: physical status ECOG score of body dynamics had significant effects on PFS and iPFS of patients(P＜0.01).There were no grade four adverse events in 23 patients, and the common adverse reactions were hand-foot syndrome [30.43%(7/23)], oral mucositis [17.39%(4/23)], hypertension [26.08%(6/23)], gastrointestinal reactions [30.43%(7/23)], and loss of appetite [21.73%(5/23)], diarrhea [13.04%(3/23)], all of which were grade one to two; one patient developed grade three hypertensive adverse events, which were well controlled after prescribed hypertension drugs and responded well after dose adjustment.No severe adverse reactions such as hemoptysis and intracranial hemorrhage occurred in all patients.Conclusion Anlotinib combined with CAPTEM can benefit SCLC patients with brain metastases in the after-line treatment, and has a good safety. [ABSTRACT FROM AUTHOR]

目的 评价安罗替尼(Anlotinib)联合卡培他滨/替莫唑胺(CAPTEM)方案在晚期小细胞肺癌 (SCLC)脑转移患者后线治疗中的疗效及安全性。方法 纳入2018年8月至2021年8月在成都市龙泉驿区第 一人民医院二线化疗后进展脑转移的SCLC患者23例, 后线治疗方案予 Anlotinib靶向治疗联合 CAPTEM 方 案抗肿瘤治疗。观察患者的无进展生存时间(PFS)、颅内无进展生存时间(iPFS)、客观缓解率(ORR)、疾病控 制率(DCR)、颅内客观缓解率(iORR), 并进行单因素分析;采用 COX 多因素回归分析纳入患者的 PFS 和 iPFS;采用 Kaplan-Meier法进行相关数据的生存分析, 评估该联合方案对晚期SCLC脑转移患者后线治疗的疗 效及安全性。结果 疗效分析: 23例患者中完全缓解0例, 部分缓解10例, 病情稳定10例, 疾病进展3例; ORR为43.47%, DCR为86.95%。脑转移评估: 23例患者中完全缓解0例, 部分缓解11例, 病情稳定10例, 疾病进展2例, iORR为47.82%。患者中位PFS为6.4(5.4, 7.0)个月, iPFS为6.5(5.5, 7.4)个月。单因素分 析: 吸烟等不良生活方式、体力状况美国东部肿瘤协作组(ECOG)评分标准评分、同步颅内转移灶放疗对患者的 PFS有一定影响(P<0.05), 而体力状况 ECOG 评分、同步颅内转移灶放疗与患者的iPFS有关(P<0.05)。 多因素分析: 体力状况 ECOG 评分对患者的 PFS及iPFS均具有显著影响(P<0.01)。23例患者未出现4级 不良反应事件, 发 生 常 见 不 良 反 应 为 手 足 综 合 征 [30.43% (7/23)]、口 腔 黏 膜 炎 [17.39% (4/23)]、高 血 压 [26.08%(6/23)]、胃肠道反应[30.43%(7/23)]、食欲减退[21.73%(5/23)]、腹泻[13.04%(3/23)]等, 均为 1~2级;1例患者出现高血压3级不良事件, 予高血压药物后控制良好, 调整剂量后反应良好;所有患者无咯 血、颅内出血等严重不良反应发生。结论 Anlotinib联合 CAPTEM 方案使 SCLC脑转移患者在后线治疗中 的疗效获益, 同时具有较好的安全性。 [ABSTRACT FROM AUTHOR]

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