达非尼-曲美替尼（D-T）联合治疗BRAF v600e突变的转移性非小细胞肺癌（NSCLC）的实际疗效：来自IFCT-2004 BLaDE队列的结果

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2024-11-26 DOI:10.1016/j.lungcan.2024.108038

Aurélie Swalduz , Michèle Beau-Faller , David Planchard , Julien Mazieres , Sophie Bayle-Bleuez , Didier Debieuvre , Vincent Fallet , Margaux Geier , Alexis Cortot , Sébastien Couraud , Catherine Daniel , Charlotte Domblides , Eric Pichon , Elizabeth Fabre , Sébastien Larivé , Ulrike Lerolle , Pascale Tomasini , Marie Wislez , Pascale Missy , Franck Morin , Jean-Bernard Auliac

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引用次数: 0

摘要

braf V600E突变发生在2 - 5%的晚期非小细胞肺癌（NSCLC）患者中。在II期患者中，dabrafenib-trametinib （D-T）联合治疗与改善和持久的OS相关。这项研究（IFCT-2004 BLaDE研究）报道了D-T联合治疗在法国大型回顾性多中心晚期BRAF v600e突变的非小细胞肺癌患者中的疗效。方法纳入2016年1月1日至2019年12月31日期间诊断并接受D-T联合治疗的晚期BRAF v600e突变NSCLC患者，无论其治疗方案如何。主要终点是接受D-T作为二线或以上治疗的患者的12个月OS率（%）。结果共纳入163例患者：50.3%为女性，30.2%为从不吸烟者，95.1%为腺癌，78.2%的患者PDL1≥1%。中位年龄为68.3岁。在D-T开始时，80.8%的患者PS为0/1,78.6%为IV期疾病，20.9%为脑转移。截止时，中位随访时间为27.4个月。接受D + T作为二线或以上治疗的患者（n = 119）的12个月OS率为67.4%，中位无进展生存期（mPFS）为10.4个月。在接受D + T作为一线治疗的44例患者中，12个月的OS率为67.4%，mPFS为18.2个月。10.3%的患者因毒性停药。据我们所知，这是报道的brf突变患者中最大的回顾性队列。研究结果证实了D-T联合BRAF v600e突变的转移性NSCLC在治疗前和未治疗患者中的显著疗效。这些在真实世界条件下的结果与其他已登记的研究结果一致。

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Real-world efficacy of the dabrafenib-trametinib (D-T) combination in BRAF V600E-mutated metastatic non-small cell lung cancer (NSCLC): Results from the IFCT-2004 BLaDE cohort

Background

BRAF V600E mutations occur in 2–5 % of advanced non-small cell lung cancer (NSCLC) patients. The dabrafenib-trametinib (D-T) combination was associated with improved and durable OS in patients in phase II. This study (IFCT-2004 BLaDE study) reported the efficacy of D-T combination in a large retrospective French real-world multicenter cohort of patients with advanced BRAF V600E-mutated NSCLC.

Method

Patients with advanced BRAF V600E-mutated NSCLC diagnosed between 01.01.2016 and 31.12.2019 and treated with D-T in combination, regardless of the treatment line, were included. The primary endpoint was the 12-month OS rate (%) in patients receiving D-T as a second-line therapy or beyond.

Results

A total of 163 patients were included: 50.3 % were female, 30.2 % were never smokers, 95.1 % had adenocarcinoma, and 78.2 % had a PDL1 ≥ 1 %. The median age was 68.3 years. At D-T initiation, 80.8 % of patients had a PS of 0/1, 78.6 % had stage IV disease, and 20.9 % had brain metastasis. At the cutoff, the median follow-up was 27.4 months. The 12-month OS rate in patients receiving D + T as a second-line therapy or beyond (n = 119) was 67.4 %, with a median progression-free survival (mPFS) of 10.4 months. Among the 44 patients who received D + T as a first-line therapy, the 12-month OS rate was 67.4 %, with an mPFS of 18.2 months. D-T discontinuation for toxicity was reported in 10.3 % of patients.

Conclusions

To our knowledge, this is the largest retrospective cohort of BRAF-mutated patients reported. The findings confirmed the significant efficacy of D-T in combination with BRAF V600E-mutated metastatic NSCLC in pretreated and untreated patients. These results under real-world conditions are consistent with those of other registered studies.

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.