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真实世界中仑伐替尼治疗碘难治性分化型甲状腺癌的生存预测因素。

Survival Predictors of Radioiodine-refractory Differentiated Thyroid Cancer Treated With Lenvatinib in Real Life.

机构信息

UOC Clinica Endocrinologica e Diabetologica, AOU San Giovanni di Dio e Ruggi d'Aragona, 84131, Salerno, Italy.

Dipartimento di Medicina, Chirurgia e Odontoiatria, Università di Salerno, 84084, Salerno, Italy.

出版信息

J Clin Endocrinol Metab. 2024 Sep 16;109(10):2541-2552. doi: 10.1210/clinem/dgae181.

Abstract

CONTEXT

Lenvatinib is approved for the treatment of radioiodine-refractory differentiated thyroid cancer (RR-DTC). The definition of predictive factors of survival is incomplete.

OBJECTIVE

To identify pre- and posttreatment survival predictors in a real-life cohort of RR-DTC treated with lenvatinib.

DESIGN

Multicenter, retrospective, cohort study.

SETTING

3 Italian thyroid cancer referral centers.

PARTICIPANTS

55 RR-DTC treated with lenvatinib.

MAIN OUTCOME MEASURES

Progression-free survival (PFS) and overall survival (OS).

RESULTS

Lenvatinib was the first-line kinase-inhibitor in 96.4% of subjects. Median follow-up was 48 months. Median PFS and OS were 26 [95% confidence interval (CI) 19.06-32.93] and 70 months (95% CI 36-111.99), respectively. Pretreatment setting: Eastern Cooperative Oncology Group (ECOG) performance status was independently related to PFS [P < .001; hazard ratio (HR) 18.82; 95% CI 3.65-97.08: score 0-1 as reference] and OS (P = .001; HR 6.20; 95% CI 2.11-18.20; score 0-1 as reference); radioactive iodine (RAI) avidity was independently related to PFS (P = .047; HR 3.74; 95% CI 1.01-13.76; avid disease as reference). Patients with good ECOG status (0-1) and RAI-avid disease obtained objective response in 100% of cases and achieved a median PFS of 45 months without any death upon a median follow-up of 81 months. Posttreatment setting: the best radiological response independently predicted PFS (P = .001; HR 4.6; 95% CI 1.89-11.18; partial/complete response as reference) and OS (P = .013; HR 2.94; 95% CI 1.25-6.89; partial/complete response as reference).

CONCLUSION

RR-DTC with good performance status and RAI-avid disease obtains the highest clinical benefit from lenvatinib. After treatment initiation, objective response was the only independent survival predictor.

摘要

背景

仑伐替尼获批用于治疗放射性碘难治性分化型甲状腺癌(RR-DTC)。目前对生存预测因素的定义并不完整。

目的

在 RR-DTC 患者接受仑伐替尼治疗的真实队列中,确定治疗前和治疗后的生存预测因素。

设计

多中心、回顾性队列研究。

地点

意大利 3 家甲状腺癌转诊中心。

参与者

55 例 RR-DTC 患者接受仑伐替尼治疗。

主要观察指标

无进展生存期(PFS)和总生存期(OS)。

结果

96.4%的患者将仑伐替尼作为一线激酶抑制剂。中位随访时间为 48 个月。中位 PFS 和 OS 分别为 26 个月(95%CI 19.06-32.93)和 70 个月(95%CI 36-111.99)。治疗前情况:东部肿瘤协作组(ECOG)表现状态与 PFS 独立相关(P<0.001;风险比[HR]18.82;95%CI 3.65-97.08;以 0-1 分为参考)和 OS(P=0.001;HR 6.20;95%CI 2.11-18.20;以 0-1 分为参考);放射性碘(RAI)摄取与 PFS 独立相关(P=0.047;HR 3.74;95%CI 1.01-13.76;以摄取疾病为参考)。ECOG 状态良好(0-1)和 RAI 摄取活跃的患者在 100%的病例中获得了客观缓解,并在中位随访 81 个月时获得了中位无进展生存期 45 个月,无任何死亡。治疗后情况:最佳影像学反应独立预测 PFS(P=0.001;HR 4.6;95%CI 1.89-11.18;以部分/完全缓解为参考)和 OS(P=0.013;HR 2.94;95%CI 1.25-6.89;以部分/完全缓解为参考)。

结论

ECOG 状态良好且 RAI 摄取活跃的 RR-DTC 患者从仑伐替尼治疗中获得最大的临床获益。治疗开始后,客观缓解是唯一独立的生存预测因素。

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