安罗替尼一线治疗不耐受或拒绝化疗的驱动基因阴性的晚期NSCLC患者:一项多中心、前瞻性研究

Anlotinib as First-Line Treatment for Driver Gene-Negative Advanced NSCLC Patients Intolerant of or Rejecting Chemotherapy: A Multicenter and Prospective Study

目的:探索安罗替尼单药一线治疗不耐受或拒绝化疗且驱动基因阴性的晚期NSCLC患者的疗效与安全性。方法:纳入2018年12月至2021年1月就诊的不耐受或拒绝化疗的驱动基因阴性晚期NSCLC患者,予以安罗替尼,每次12 mg,一日1次,清晨空腹服用,21天为1个周期,若不耐受可下调剂量(下调至10 mg,仍不耐受则下调到8 mg),直至出现不能耐受的不良反应或病情进展。记录受试者无进展生存期、总生存期、客观缓解率、疾病控制率及不良反应发生率等情况,随访截止2021年9月。结果:共纳入27例受试者,其中男性19例,女性8例;中位年龄63岁(范围:47~85岁),年龄≥70岁者11例;腺癌19例,鳞癌及其他病例类型8例。整体人群客观有效率为56%,疾病控制率为70%,中位无进展生存期为4.0个月,中位总生存期为9.0个月,常见的不良反应为手足皮肤毒性(52%)、乏力(26%)和高血压(22%),多以1~2级为主。结论:安罗替尼一线治疗不耐受或拒绝化疗的驱动基因阴性晚期NSCLC患者具有一定疗效,不良反应可耐受,PS评分高的患者疗效相对较好。

Objective: To explore the efficacy and safety ofanlotinib in first-line treatment of driver gene-negative advanced NSCLC who reject or are intolerant of chemotherapy, and probe into the prognosis of its patients.Methods: FromDecember 2018 to January 2021, driver gene-negative advanced NSCLC patients who reject or were intolerant of chemothera-py were included in the study. They all received oral anlotinib(12 mg/d, q. a. m, pre-meal condition, 21 days per cycle, 8or 10 mg was acceptable if not tolerated) until the occurrence of intolerable adverse reactions or disease progression. Progres-sion free survival(PFS), objective remission rate(ORR), disease control rate(DCR) and adverse reactions were recor-ded.Results: 27 patients, including 19 males and 8 females, were included, with a median age of 63 years(47-85year), including 11 cases aged 70 years and over;among the 27 cases, 19 were adenocarcinoma, and 8 were squamous cellcarcinoma and other types. The ORR of anlotinib was 56%;its DCR was 70%;its median PFS was 4. 0 months;and itsmedian overall survival was 9. 0 months. Common side effects were hand-foot syndrome(52%), fatigue(26%) and hyper-tension(22%), most of which were in grade 1-2.Conclusion: Anlotinib, with controllable adverse reactions, is effectivefor the first-line treatment of driver gene-negative advanced NSCLC who refuse or are intolerant of chemotherapy. Patientswith higher PS scores may have better prognosis.