中国RET融合阳性非小细胞肺癌患者的诊断、治疗模式和疗效。

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2024-09-24 DOI:10.1007/s12325-024-02983-x

Shun Lu, Lan Shen, Qiming Wang, Haiyang Chen, Yi Zhao, Ying Li, Grace Segall, Manoj Khanal, Xue Zhang, Ding Ding, Jingxin Shao, Long Pang

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引用次数: 0

摘要

前言有关非小细胞肺癌（NSCLC）的流行病学研究指出，RET融合是一种致癌驱动因素。然而，中国有关 RET 生物标志物检测和治疗模式的实际数据仍然有限。本研究旨在研究RET融合阳性NSCLC患者的人口统计学、临床和分子特征、RET检测和治疗模式及结果：这项回顾性队列研究利用中国多中心肺癌精准医学注册中心的真实数据，重点关注2016年1月1日至2021年11月30日期间确诊为RET融合阳性NSCLC的中国患者。队列分为早期亚组和晚期亚组。对患者的人口统计学特征、临床和分子特征、接受的治疗以及包括实际无事件生存期（rwEFS）、实际无进展生存期（rwPFS）和总生存期（OS）在内的结果进行了评估：研究共纳入121例RET融合阳性NSCLC患者，其中包括80例早期患者和58例晚期患者。诊断时的生物标记物检测率很高（早期为75%，晚期为78%）。RET 检测通常通过组织样本（95.9%）和新一代测序（89.3%）进行。KIF5B（57.0%）和CCDC6（20.7%）是最常见的基因融合伙伴。最常见的致癌突变是TP53（15.7%）和表皮生长因子受体（6.6%）。铂类化疗是晚期患者最常见的一线治疗方法。接受一线化疗的晚期患者的中位rwPFS为9.22个月，所有晚期患者的中位OS为30.7个月。早期患者的2年rwEFS率为86.0%，中位OS为91.9个月：该研究观察到，中国早期和晚期RET融合阳性NSCLC患者初诊时的生物标志物检测率较高。晚期患者的治疗模式不尽相同，这表明需要更精确的循证治疗来指导临床决策。鉴于现有的治疗方案无法充分满足治疗需求，靶向治疗对改善预后至关重要。

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Diagnosis, Treatment Patterns, and Outcomes in Real-World Patients with RET Fusion-Positive Non-small Cell Lung Cancer in China

Introduction

Epidemiological studies on non-small cell lung cancer (NSCLC) have noted RET fusions as an oncogenic driver. However, real-world data on RET biomarker testing and treatment patterns in China remain limited. This study aimed to examine demographics, clinical and molecular features, and RET testing and treatment patterns and outcomes in patients with RET fusion-positive NSCLC.

Methods

Utilizing real-world data from the Chinese Multi-center Lung Cancer Precision Medicine Registry, this retrospective cohort study focused on Chinese patients diagnosed with RET fusion-positive NSCLC between January 1, 2016, and November 30, 2021. The cohort was divided into early-stage and advanced-stage subgroups. Demographics, clinical and molecular profiles, treatment received, and outcomes including real-world event free survival (rwEFS), real-world progression free survival (rwPFS), and overall survival (OS) were assessed.

Results

The study included 121 patients with RET fusion-positive NSCLC, comprising 80 early-stage and 58 advanced-stage patients. High biomarker testing rates were observed at diagnosis (75% for early-stage, 78% for advanced-stage). RET testing was often conducted via tissue samples (95.9%) and next-generation sequencing (89.3%). KIF5B (57.0%) and CCDC6 (20.7%) were the most common gene fusion partners. The most frequent oncogenic mutations were TP53 (15.7%) and EGFR (6.6%). Platinum-based chemotherapy was the most common first-line treatment among advanced-stage patients. Median rwPFS was 9.22 months for advanced-stage patients on first-line chemotherapy, and median OS was 30.7 months for all advanced-stage patients. The 2-year rwEFS rate for early-stage patients was 86.0%, with a median OS of 91.9 months.

Conclusions

The study observed high biomarker testing rates at initial diagnosis for early- and advanced-stage RET fusion-positive NSCLC patients in China. The heterogeneous treatment pattern of advanced patients suggests the need for more precise, evidence-based treatment to guide clinical decisions. Given the existing therapeutic regimens fall short of adequately addressing treatment needs, targeted therapies are essential to improve outcomes.

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.