Efficacy of Dabrafenib Plus Trametinib Combination in Patients with BRAF V600E-Mutant NSCLC in Real-World Setting: GFPC 01-2019

Auliac, J.B.; Bayle, S.; Dô, Pascal; Garff, G. Le; Roa, M.; Falchero, L.; Huchot, É.; Quéré, Gilles; Jeannin, G.; Métivier, Anne-Cécile; Hobeika, Joelle; Guisier, Florian; Chouaïd, C.

doi:10.3390/cancers12123608

Cited by 12 publications

(6 citation statements)

References 11 publications

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“…Following treatment with dabrafenib plus trametinib, mPFS of 10.9 months was recorded in patients with previously untreated BRAF V600E mutant NSCLC 11 . Another retrospective multicentric study reported mPFS of 17.5 months in 40 BRAF V600E‐positive advanced NSCLC patients treated with dabrafenib plus trametinib 23 . Horn and colleagues demonstrated the efficacy of BRAFi/MEKi regimens as a later line of treatment in 20 BRAF V600E NSCLC patients and longer OS from metastatic onset relative to patients receiving usual care, highlighting the importance of targeted therapy in BRAF V600 mutant NSCLC cases 24 .…”

Section: Discussionmentioning

confidence: 99%

“…11 Another retrospective multicentric study reported mPFS of 17.5 months in 40 BRAF V600E-positive advanced NSCLC patients treated with dabrafenib plus trametinib. 23 Horn and colleagues demonstrated the efficacy of BRAFi/MEKi regimens as a later line of treatment in 20 BRAF V600E NSCLC patients and longer OS from metastatic onset relative to patients receiving usual care, highlighting the importance of targeted therapy in BRAF V600 mutant NSCLC cases. 24 In our study, mPFS in 13 patients receiving BRAF-TKIs was 7.0 months for all treatment lines.…”

Section: Survival Of Patients With Primary Braf Mutationsmentioning

confidence: 99%

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Treatment outcomes and prognosis of patients with primary and acquired BRAF‐mutated non‐small cell lung cancer: A multicenter retrospective study

Wang

et al. 2022

Genes Chromosomes & Cancer

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The incidence of primary and acquired BRAF mutations is low in non‐small cell lung cancer (NSCLC), with limited demographic and treatment outcome data available for this patient population. We evaluated lung cancer samples with programmed cell death ligand 1 (PD‐L1) information extracted from 12 051 cases (cohort A) of lung cancer from OncoPanscan™‐based sequencing of tissue (Genetron Health) and conducted retrospective multicenter data analysis using the database of Zhejiang Cancer Hospital and four other centers (cohort B, including 73 primary BRAF mutation and 14 acquired BRAF mutation cases) to compare treatment outcomes of patient groups with primary and acquired BRAF mutations. In cohort A, after propensity score analysis, 165 samples of NSCLC with BRAF mutations were screened along with 165 paired non‐BRAF mutation samples. We observed no significant differences in the proportion of samples with ≥1% PD‐L1 between BRAF and non‐BRAF mutant groups. The median progression‐free survival (mPFS) period in 13 patients with primary BRAF mutations receiving BRAF tyrosine kinase inhibitors (BRAF‐TKIs) was 7.0 months. The group with primary BRAF mutations receiving immune checkpoint inhibitor (ICI) combination chemotherapy had better PFS than those administered ICI monotherapy (14.77 months vs. 5.0 months, p = 0.025) and similar results were obtained for OS (unreached vs. 20.3 months, p = 0.013). For acquired BRAF mutations, mPFS of BRAF‐TKI, ICI‐based, and chemotherapy‐based regimens were 3.8, 1.5, and 1.9 months, respectively. Therefore, for patients with the primary BRAF V600E mutation, targeted therapy or immunochemotherapy could serve as effective treatment choices, while for those with acquired BRAF V600E, targeted drug therapy may remain the preferred solution in China.

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Section: Discussionmentioning

confidence: 99%

Section: Survival Of Patients With Primary Braf Mutationsmentioning

confidence: 99%

Treatment outcomes and prognosis of patients with primary and acquired BRAF‐mutated non‐small cell lung cancer: A multicenter retrospective study

Wang

et al. 2022

Genes Chromosomes & Cancer

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“…19 The panel deleted single-agent dabrafenib as a treatment option for patients with BRAF V600E mutation-positive metastatic NSCLC who cannot tolerate combination therapy with dabrafenib 1 trametinib; single-agent vemurafenib remains an option in this setting. 37,38 Although less toxic, dabrafenib monotherapy is less effective than combination therapy with dabrafenib 1 trametinib. 39 For the 2020 updates, the panel added selpercatinib and pralsetinib as preferred first-line therapy options for patients with RET rearrangement-positive metastatic NSCLC.…”

Section: Molecular Biomarkersmentioning

confidence: 99%

NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 2.2021

Ettinger

Wood

Aisner

et al. 2021

Journal of the National Comprehensive Cancer Network

760

606

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“…Among the nine patients receiving first-line therapy, median PFS and OS were 16.8 (95% CI: 6.1–23.2) and 21.8 months (95% CI: 1.0–not achieved), respectively. Median PFS and OS were 16.8 months (95% CI: 6.1–23.2) and 25.5 months (95% CI: 16.6 months–not met), respectively, in 31 patients receiving second-line therapy or above ( 22 ). In our study, 23.5% (12/51) and 39.1% (9/23) of the patients received BRAF/MEK-targeted therapy as first- and second-line therapies, respectively.…”

Section: Discussionmentioning

confidence: 99%

“…In Europe, a real-world study assessed the efficacy of combined dabrafenib and trametinib in treating BRAF V600E mutated advanced NSCLC. Across the entire cohort, median PFS and OS were 17.5 months (95% confidence interval [CI] 7.1–23.0 months) and 25.5 months (95% CI 16.6–not reached), respectively ( 22 ). Another study reported that the OS in BRAF-targeted therapy was longer (56.5 months) than that of conventionally treated patients (27.2 months), further emphasizing the importance of targeting treatments for BRAF V600E mutated NSCLC ( 23 ).…”

Section: Introductionmentioning

confidence: 99%

Clinical Characteristics, Co-Mutations, and Treatment Outcomes in Advanced Non-Small-Cell Lung Cancer Patients With the BRAF-V600E Mutation

Shen

et al. 2022

Front. Oncol.

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BackgroundLimited treatment outcome data is available for advanced non-small cell lung cancer (NSCLC) patients with BRAF V600E mutations. In this multicenter study, we describe therapeutic options and survival outcomes for patients with mutated BRAF V600E.MethodThis was a retrospective study in which BRAF V600E-mutated advanced NSCLC patients were retrospectively recruited between January 2015 and December 2021 and had their clinical characteristics, co-mutations, and treatment efficacy assessed.ResultsFifty-three patients with BRAF V600E-mutant advanced NSCLC were included in the study, of which 64.2% were non-smokers, and the BRAF V600E mutation was more prevalent in men (52.8%). In addition, 96.2% of the patients had adenocarcinoma, and most (96.2%) received first-line therapy (23.5% anti-BRAF), with a progression-free survival (PFS) and overall survival (OS) of 10.0 [95% confidence interval (CI): 1.5–36.0 months] and 24.0 months [95% CI: 3.0–53.0 months], respectively. Twenty-three patients (43.4%) received second-line treatment (39.1% anti-BRAF), and PFS and OS were 5.0 [95% CI: 1.0–21.0 months] and 13.0 months [95% CI: 1.5–26.0 months], respectively. BRAF and MEK-targeted therapy (dabrafenib plus trametinib) produced longer PFS compared with that of chemotherapy with or without bevacizumab as a first-line (NA vs. 4.0 months, P = 0.025) or second-line therapy (6.0 vs. 4.6 months, P = 0.017). NSCLC patients harboring driver oncogene mutations such as BRAF V600E, EGFR, or ALK should be treated using targeted therapies. Concurrent TP53 mutations were the most common, affecting 11.3% (n = 6) of the patients, followed by EGFR 19 Del (n = 5). Patients with concurrent mutations had shorter PFS (9.0 vs. 10.0 months, P = 0.875) and OS (14.0 vs. 15.0 months, P = 0.555) than those without these mutations.ConclusionThese results suggest that combined BRAF- and MEK-targeted therapy is effective in BRAF V600E-mutated advanced NSCLC patients. Dabrafenib and trametinib re-challenge is also an option for patients with BRAF V600E-mutated NSCLC.

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Efficacy of Dabrafenib Plus Trametinib Combination in Patients with BRAF V600E-Mutant NSCLC in Real-World Setting: GFPC 01-2019

Cited by 12 publications

References 11 publications

Treatment outcomes and prognosis of patients with primary and acquired BRAF‐mutated non‐small cell lung cancer: A multicenter retrospective study

Treatment outcomes and prognosis of patients with primary and acquired BRAF‐mutated non‐small cell lung cancer: A multicenter retrospective study

NCCN Guidelines Insights: Non–Small Cell Lung Cancer, Version 2.2021

Clinical Characteristics, Co-Mutations, and Treatment Outcomes in Advanced Non-Small-Cell Lung Cancer Patients With the BRAF-V600E Mutation

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