首页|安罗替尼对进展性碘难治性分化型甲状腺癌疗效及生存时间的影响

安罗替尼对进展性碘难治性分化型甲状腺癌疗效及生存时间的影响

Efficacy of anlotinib in treatment of progressive iodine-refractory differentiated thyroid cancer and its effect on patient's survival time

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目的 评估安罗替尼对进展性碘难治性分化型甲状腺癌(RAIR-DTC)疗效及生存时间的影响.方法 采取前瞻性研究方法,选取2018年1月至2023年12月于甘肃省肿瘤医院进行安罗替尼治疗的82例进展RAIR-DTC患者作为观察组,另选同期进行索拉非尼治疗的进展性RAIR-DTC患者78例作为对照组.对患者进行随访调查(随访至2023年12月).治疗3、6、16周后,比较两组患者的血清甲状腺球蛋白(Tg)下降率.比较两组患者的随访6、12个月靶病灶体积缩小率,采用Kaplan-Meier法比较两组患者的无进展生存期及总生存期.结果 治疗后,观察组患者客观缓解率(ORR)(89.02%)高于对照组(74.36%)(χ2=5.794,P<0.05);观察组和对照组的治疗后Tg水平和靶病灶的体积[分别为(44.25±5.31)μg·L-1,(93.63±28.35)mm3;(42.00±5.82)μg·L-1,(132.78±27.72)mm3]较治疗前[分别为(151.87±25.21)μg·L-1,(702.94±105.64)mm3,(152.62±25.62)μg·L-1,(703.26±106.84)mm3]均下降(t=37.827、50.445,t=37.186、45.647,均P<0.05).两组患者血清Tg下降率差异无统计学意义(t=1.616,P>0.05).治疗6个月后,两组患者靶病灶体积缩小率差异无统计学意义(t=1.272,P>0.05).治疗12个月后,观察组靶病灶体积缩小率高于对照组(t=1.661,P<0.05).观察组1年总生存率(98.78%)与对照组(98.72%)差异无统计学意义(χ2=0.001,P>0.05).观察组中位无进展生存期及中位总生存时间(分别为21、34个月)与对照组(分别为22、36个月)比较差异无统计学意义(χ2=0.748,0.001,均P>0.05).观察组不良反应总发生率(56.10%)低于对照组(77.79%)(χ2=4.262,P<0.05),且观察组手足皮肤反应(12.20%)、腹泻(12.20%)和乏力(12.20%)的发生率低于对照组(分别为26.92%、29.49%、26.92%)(χ2=5.551,7.301,7.301,均P<0.05).结论 安罗替尼对RAIR-DTC患者具有显著的疗效及安全性,可作为进展性RAIR-DTC患者治疗方案的新选择.
Objective To evaluate the efficacy of anlotinib in treatment of progressive iodine-refractory differentiated thyroid cancer(RAIR-DTC)and its effect on patient's survival time.Methods Conducting a prospective study,we selected 82 patients with RAIR-DTC treated with anlotinib in Gansu Provincial Tumor Hospital between January 2018 and December 2023 for the observation group.Another 78 patients with progressive RAIR-DTC receiving sorafenib during the identical period were enrolled for the control group.A follow-up investigation was conducted on the patients(follow-up until December 2023).After 3,6 and 16 weeks of treatment,the serum thyroglobulin(Tg)decline rate was compared between the two groups.The volume reduction rates of target lesions in the two groups of patients were compared for 6 months and 12 months of follow-up,and Kaplan-Meier was used to compare the progression-free survival and overall survival between the two groups.Results Following treatment,the overall response rate(ORR)in the observation group was notably higher(89.02%)as compared with the control(74.36%)(χ2=5.794,P<0.05).Both the Tg levels and target lesions in the observation were found to be significantly elevated as compared with those in the control(74.36%).The volume measurements((44.25±5.31)μg·L-1,(93.63±28.35)mm3,(42.00±5.82)μg·L-1,(132.78±27.72)mm3)decreased substantially from pretreatment values((151.87±25.21)μg·L-1,(702.94±105.64)mm3,(152.62±25.62)μg·L-1,(703.26±106.84)mm3)(t=37.827,50.445,t=37.186,45.647,all P<0.05).There was no notable difference in the decline rate of serum Tg between the two groups(t=1.616,P>0.05).Moreover,6 months after treatment,there was no significant variance in the volume reduction rate of target lesions between the two groups(t=1.272,P>0.05).After 12 months of treatment,the observation group exhibited a significantly higher reduction rate of target lesion volumes as compared with the control(t=1.661,P<0.05).The 1-year overall survival rate showed no statistically significant difference between the observation group(98.78%)and the control(98.72%)(χ2=0.001,P>0.05).Similarly,the median progression-free survival time and overall survival time did not significantly differ between the two groups(21 months,34 months vs 22 months,36 months,χ2=0.748,0.001,both P>0.05).In terms of adverse reactions,the observation group experienced a significantly lower incidence(56.10%)than the control(77.79%)(χ2=4.262,P<0.05).Meanwhile,the observation group had lower rates of hand and foot skin reactions(12.20%),diarrhea(12.20%)and fatigue(12.20%)as compared with the control(26.92%,29.49%,26.92%)(χ2=5.551,7.301,7.301,all P<0.05).Conclusion Anlotinib has significant efficacy and safety in treatment of patients with RAIR-DTC and can be used as a new treatment option for these patients.

AnlotinibThyroid cancerTherapeutic efficacySurvival timeSafety

满国栋、王健力

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甘肃省肿瘤医院头颈外科,兰州 730050

安罗替尼 甲状腺癌 疗效 生存时间 安全性

甘肃省科技计划项目

22JR5RA646

2024

中国药物应用与监测
中国人民解放军总医院

中国药物应用与监测

CSTPCD
影响因子:1.983
ISSN:1672-8157
年,卷(期):2024.21(4)