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HOME > Cancer Res Treat > Volume 56(3); 2024 > Article
Correspondence Bridging the Gap between Trial Adverse Events and Real-World Data
Sang Hyuk Kim1orcid, Hyun Lee2orcid, Dong Won Park2,orcid
Cancer Research and Treatment : Official Journal of Korean Cancer Association 2024;56(3):972-973.
DOI: https://doi.org/10.4143/crt.2024.019
Published online: January 10, 2024

1Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Internal Medicine, Dongguk University Gyeongju Hospital, Dongguk University College of Medicine, Gyeongju, Korea

2Division of Pulmonary Medicine and Allergy, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea

Correspondence: Dong Won Park, Division of Pulmonary Medicine and Allergy, Department of Internal Medicine, Hanyang University College of Medicine, 222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763, Korea
Tel: 82-2-2290-8114 Fax: 82-2-2298-9183 E-mail: dongwonpark@hanyang.ac.kr
*Sang Hyuk Kim and Hyun Lee contributed equally to this work.
• Received: January 5, 2024   • Accepted: January 7, 2024

Copyright © 2024 by the Korean Cancer Association

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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We congratulate Jeon et al. [1] for their thorough analysis comparing alectinib and brigatinib as first-line therapies for advanced non–small cell lung cancer (NSCLC) with anaplastic lymphoma receptor tyrosine kinase (ALK) rearrangement in a real-world context. This study provided valuable information that both drugs are highly effective and generally well tolerated with mild side effects. Nonetheless, further investigation into adverse events (AEs) associated with brigatinib is necessary to better understand the discrepancies between clinical trial data and real-world experiences in the treatment of ALK-positive NSCLC.
The study by Jeon et al. [1] predominantly focuses on AE profiles of alectinib with a limited exploration of those associated with brigatinib, such as hypertension, diarrhea and increased blood creatine phosphokinase, amylase, and lipase [2]. Although ALK inhibitors generally share similar safety concerns, the literature indicates that each may have a unique safety profile. The Phase III ALTA-3 study, which compared brigatinib and alectinib in patients with ALK-positive NSCLC that had progressed while being treated with crizotinib, demonstrated notable differences in the safety profiles of the two drugs [3]. In this study, hypertension was reported in 22% of patients treated with brigatinib, whereas it was considerably less common in those receiving alectinib (1%). Notably, compared with other laboratory findings, hypertension as an AE is often under-recognized in clinical practice.
The advent of newer generation ALK inhibitors has markedly improved the overall survival of patients with ALK-positive NSCLC [4], making the effective management of AEs critical for ensuring successful long-term survival. Most AEs associated with ALK inhibitors can be managed by adjusting dosage or temporarily interrupting treatment. Thus, prompt recognition of the specific toxicity patterns of each ALK inhibitor can help improve treatment-related outcomes. To this end, it is important to minimize the disparity between clinical trial findings and real-world patient experiences. A more detailed real-world study on AEs, particularly those noted in clinical trials, is essential. Such investigations will not only broaden our understanding of AEs associated with first-line ALK inhibitors but also lead to better strategies for managing AEs that may occur during treatment. While Jeon et al.’s research [1] significantly adds to our comprehension of ALK inhibitors in treating ALK-positive NSCLC, a pressing need remains for future research into the real-world AEs of these drugs, which may enable healthcare professionals to provide more effective patient care, ultimately leading to favorable treatment outcomes.

Author Contributions

Conceived and designed the analysis: Park DW.

Wrote the paper: Kim SH, Lee H.

Conflicts of Interest

Conflict of interest relevant to this article was not reported.

  • 1. Jeon Y, Park S, Jung HA, Sun JM, Lee SH, Ahn JS, et al. First-line alectinib vs. brigatinib in advanced non-small cell lung cancer with ALK rearrangement: real-world data. Cancer Res Treat. 2024;56:61–9. ArticlePubMedPMCPDF
  • 2. Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, et al. Brigatinib versus crizotinib in ALK inhibitor-naive advanced ALK-positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol. 2021;16:2091–108. PubMed
  • 3. Yang JC, Liu G, Lu S, He J, Burotto M, Ahn MJ, et al. Brigatinib versus alectinib in ALK-positive NSCLC after disease progression on crizotinib: results of phase 3 ALTA-3 trial. J Thorac Oncol. 2023;18:1743–55. ArticlePubMed
  • 4. Mok T, Camidge DR, Gadgeel SM, Rosell R, Dziadziuszko R, Kim DW, et al. Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol. 2020;31:1056–64. ArticlePubMed

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        Bridging the Gap between Trial Adverse Events and Real-World Data
        Cancer Res Treat. 2024;56(3):972-973.   Published online January 10, 2024
        DOI: https://doi.org/10.4143/crt.2024.019
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      Bridging the Gap between Trial Adverse Events and Real-World Data
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