Comparison of Efficacy and Safety of Brigatinib in First-Line Treatments for Patients with Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Systematic Review and Indirect Treatment Comparison

Yang, Yu; Zhu, Fengsen; Zhang, Wenxin; Lü, Shun

doi:10.3390/jcm11112963

Cited by 5 publications

(5 citation statements)

References 29 publications

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“…Both studies demonstrated that brigatinib and alectinib had a comparable performance but authors emphasized the importance of performing a direct comparison via a randomized controlled study [ 19 , 20 ]. Further, Yu et al [ 21 ] preformed an indirect comparison by reviewing ALEX, J-ALEX, ALESIA, and ALTA-1L studies and found that brigatinib was superior to other ALK inhibitors like crizotinib and ceritinib, and its efficacy and safety profile had comparable performance when compared to second-generation ALK inhibitors.…”

Section: Discussionmentioning

confidence: 99%

First-Line Alectinib vs. Brigatinib in Advanced Non–Small Cell Lung Cancer with ALK Rearrangement: Real-World Data

et al. 2024

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Purpose Alectinib and brigatinib are second-generation anaplastic lymphoma receptor tyrosine kinases (ALKs) that are widely used as first-line therapy for treating ALK-positive advanced non–small cell lung cancer (NSCLC). Given the lack of a head-to-head comparison of these drugs as first-line therapies, this retrospective observational study aimed to compare the real-world efficacy and safety of alectinib and brigatinib.Materials and Methods Patients who received alectinib or brigatinib as the first-line treatment for ALK-positive advanced NSCLC were evaluated for clinical outcomes of objective response rate (ORR), intracranial ORR, time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety profiles.Results Of 208 patients who received either alectinib or brigatinib as a first-line treatment, 176 received alectinib and 32 received brigatinib. At the data cutoff point, the median follow-up duration was 16.5 months (95% confidence interval [CI], 14.7 to 18.3) in the brigatinib group and 27.5 months (95% CI, 24.6 to 30.4) in the alectinib group. The ORR was 92.5% with alectinib and 93.8% for brigatinib. The intracranial ORR rates were 92.7% (38/41) and 100% (10/10), respectively. The rate of PFS at 12 months was comparable between the alectinib group and the brigatinib groups (84.4% vs. 84.1%, p=0.64), and the median TTNT, PFS, and OS were not reached in either group. Treatment-related adverse events were usually mild, and treatment discontinuation due to adverse events was rare (alectinib 4.5% vs. brigatinib 6.25%).Conclusion Alectinib and brigatinib had similar clinical benefits when used as the first-line treatment of NSCLC patients with ALK rearrangement in the real world.

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Section: Discussionmentioning

confidence: 99%

First-Line Alectinib vs. Brigatinib in Advanced Non–Small Cell Lung Cancer with ALK Rearrangement: Real-World Data

et al. 2024

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“…Considering the long history of CNS disease, we decided to opt for this molecule, a second generation ALK inhibitor, instead of crizotinib, for its ability to penetrate through the blood-brain barrier, and its higher efficacy and lower risk of emerging resistance [14,37,38]. While there are no data on the use of brigatinib in pediatric ALK-positive tumours such as ALCL, IMT, neuroblastoma and glioma, data in adults affected by NSCLC showed superiority of brigatinib compared with crizotinib in terms of progression-free survival, response rate, intracranial tumor response rate, and death rate [37][38][39][40]. Given the refractoriness history of this patient and the difficulty to achieve clinical and molecular remission, we also decided to administer brigatinib for additional 12 months after allogeneic HSCT to prevent relapse.…”

Section: The Role Of Alk Inhibitors In the Treatment Of Patients With...mentioning

confidence: 99%

Refractory Anaplastic Large Cell Lymphoma Rescued by the Combination of the Second-Generation ALK Inhibitor Brigatinib, High-dose Chemotherapy and Allogeneic Stem Cell Transplantation: A Case Report and Review of the Literature

et al. 2023

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The treatment of pediatric patients with refractory or relapsed anaplastic large cell lymphoma (ALCL) is still a major challenge. In addition to conventional chemotherapy and stem cell transplantation, new therapeutic options such as anti-CD30 drugs and anaplastic lymphoma kinase (ALK) inhibitors have been recently introduced in this setting. Among ALK inhibitors, only the first-generation molecule crizotinib is approved for pediatric use, while second-generation molecules, such as brigatinib, are still under investigation. Here we report the case of a 13-year-old boy diagnosed with stage IV ALCL, refractory to first-line conventional chemotherapy and second-line therapy with the anti CD30 antibody–drug conjugate brentuximab-vedotin, who finally achieved remission after a combination of conventional high-dose chemotherapy and the second-generation ALK inhibitor brigatinib. The latter was chosen for its ability to penetrate through the blood–brain barrier, due to the persistent involvement of the patient’s cerebral nervous system. The remission was then consolidated with an allogeneic hematopoietic stem cell transplantation (HSCT) from an unrelated donor using myeloablative conditioning with total body irradiation. At 24 months after HSCT, the patient is in complete remission, alive and well. An updated review regarding the use of ALK inhibitors in ALCL patients is provided.

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“…Ethical considerations may also make a direct comparison impossible, as is often the case when developing treatments for life-threatening diseases. Moreover, direct comparison can be infeasible, such as for rare diseases where patient numbers can be very low [ 4 , 5 , 6 ]. Finally, if multiple comparators are of relevance to a particular indication, an RCT directly comparing all comparators of interest may be impractical.…”

Section: Introductionmentioning

confidence: 99%

Methods for Indirect Treatment Comparison: Results from a Systematic Literature Review

Macabeo,

Quenéchdu,

Aballéa

et al. 2024

JMAHP

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Introduction: Health technology assessment (HTA) agencies express a clear preference for randomized controlled trials when assessing the comparative efficacy of two or more treatments. However, an indirect treatment comparison (ITC) is often necessary where a direct comparison is unavailable or, in some cases, not possible. Numerous ITC techniques are described in the literature. A systematic literature review (SLR) was conducted to identify all the relevant literature on existing ITC techniques, provide a comprehensive description of each technique and evaluate their strengths and limitations from an HTA perspective in order to develop guidance on the most appropriate method to use in different scenarios. Methods: Electronic database searches of Embase and PubMed, as well as grey literature searches, were conducted on 15 November 2021. Eligible articles were peer-reviewed papers that specifically described the methods used for different ITC techniques and were written in English. The review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: A total of 73 articles were included in the SLR, reporting on seven different ITC techniques. All reported techniques were forms of adjusted ITC. Network meta-analysis (NMA) was the most frequently described technique (in 79.5% of the included articles), followed by matching-adjusted indirect comparison (MAIC) (30.1%), network meta-regression (24.7%), the Bucher method (23.3%), simulated treatment comparison (STC) (21.9%), propensity score matching (4.1%) and inverse probability of treatment weighting (4.1%). The appropriate choice of ITC technique is critical and should be based on the feasibility of a connected network, the evidence of heterogeneity between and within studies, the overall number of relevant studies and the availability of individual patient-level data (IPD). MAIC and STC were found to be common techniques in the case of single-arm studies, which are increasingly being conducted in oncology and rare diseases, whilst the Bucher method and NMA provide suitable options where no IPD is available. Conclusion: ITCs can provide alternative evidence where direct comparative evidence may be missing. ITCs are currently considered by HTA agencies on a case-by-case basis; however, their acceptability remains low. Clearer international consensus and guidance on the methods to use for different ITC techniques is needed to improve the quality of ITCs submitted to HTA agencies. ITC techniques continue to evolve quickly, and more efficient techniques may become available in the future.

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Comparison of Efficacy and Safety of Brigatinib in First-Line Treatments for Patients with Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Systematic Review and Indirect Treatment Comparison

Cited by 5 publications

References 29 publications

First-Line Alectinib vs. Brigatinib in Advanced Non–Small Cell Lung Cancer with ALK Rearrangement: Real-World Data

First-Line Alectinib vs. Brigatinib in Advanced Non–Small Cell Lung Cancer with ALK Rearrangement: Real-World Data

Refractory Anaplastic Large Cell Lymphoma Rescued by the Combination of the Second-Generation ALK Inhibitor Brigatinib, High-dose Chemotherapy and Allogeneic Stem Cell Transplantation: A Case Report and Review of the Literature

Methods for Indirect Treatment Comparison: Results from a Systematic Literature Review

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