安罗替尼一线维持治疗妇科肿瘤的疗效及安全性回顾性研究

Clinical observation of Anlotinib as first-line maintenance therapy for patients with gynecologic malignant tumor

目的探讨安罗替尼一线维持治疗妇科肿瘤的疗效和安全性。方法回顾性分析2020年3月—2022年3月青岛市市立医院收治的一线化疗后达缓解或稳定给予安罗替尼维持治疗的22例妇科恶性肿瘤患者的临床资料。患者治疗方案为安罗替尼8~12 mg口服,每日1次,d1~d14,21 d为1个周期。每3个周期评价疗效及随访患者生存状况,每周期评价不良反应,患者病情控制、不良反应能够耐受,则按时给药;患者不良反应评估为3/4级时,暂停给药,待不良反应恢复到2级以下,给药减量后继续服用,直至出现严重的不良反应或疾病进展,若2周仍未恢复,则停药,研究结束。结果22例患者均可评价疗效,其中部分缓解(PR)3例、病情稳定(SD)14例、疾病进展(PD)5例,客观缓解率(ORR)13.6%,疾病控制率(DCR)81.8%,中位无进展生存期(PFS)5.4个月。主要不良反应为乏力、厌食、高血压、腹泻、口腔黏膜炎、蛋白尿、眩晕、皮疹、手足综合征、血小板计数降低,无治疗相关性死亡。结论安罗替尼一线维持妇科肿瘤疗效较好,不良反应可耐受,安全性较好。

Objective To investigate the efficacy and safety of anlotinib as first-line maintenance therapy for patients with gynecologic malignant tumor.Methods The clinical data of 22 patients with gynecological malignant tumors who a-chieved remission or stability after first-line chemotherapy and received antirotinib maintenance treatment in our hospi-tal from March 2020 to March 2022 were retrospectively analyzed.The treatment regimen for patients was 8 to 12 mg of antirotinib orally,once a day,dl to d14,21 days for 1 cycle.The efficacy and survival status of patients were evaluated every 3 cycles,and adverse reactions were evaluated every cycle.If patients'disease was controlled and adverse reac-tions could be tolerated,drugs were administered on time;When the adverse reactions of patients were assessed as grade 3/4,the administration was suspended,and when the adverse reactions were restored to below grade 2,the administra-tion was continued after dose reduction until serious adverse reactions or disease progression occurred.If no recovery was achieved within two weeks,the administration was stopped and the study ended.Results All the patients completed the response evaluation.Three cases achieved partial response,fourteen cases had disease stable,and five cases had disease progressed.The objective response rate(ORR)was 13.6%,and the disease control rate(DCR)was 81.8%.The me-dian progression-free survival(PFS)was 5.4 months.The major adverse reactions included weak,anorexia,hyperten-sion,diarrhea,oralmucositis,proteinuria,dizziness,rash,handfoot syndrome,thrombocytopenaia.There was no treatment-related death.Conclusion Anlotinib as first-line maintenance therapy showed favorable efficacy and toler-ance for patients with gynecologic malignant tumor.