The spectrum of treatment-related adverse events in patients treated with lorlatinib.
| AEs | Overall, n (%) | Grade 1–2, n (%) | Grade 3–4, n (%) |
|---|---|---|---|
| Hyperlipidemia | 46 (56.1) | 43 (52.4) | 3 (3.7) |
| Peripheral edema | 17 (20.7) | 17 (20.7) | - |
| Neurocognitive AEs | 7 (8.5) | 5 (6.1) | 2 (2.4) |
| Cognitive impairment | 3 (3.7) | 3 (3.7) | - |
| Mood events | 3 (3.7) | 2 (2.4) | 1 (1.2) |
| Psychotic events | 1 (1.2) | 0 (0.0) | 1 (1.2) |
| Weight gain | 6 (7.3) | 6 (7.3) | - |
| Peripheral neuropathy | 3 (3.7) | 3 (3.7) | - |
| Creatinine increased | 2 (2.4) | 2 (2.4) | - |
| AEs leading to dose reduction | 14 (17.1) | - | - |
| AEs leading to dose discontinuation | 0 (0.0) | - | - |
AEs: adverse events; -: not applicable.
SV Orlov: Validation, Writing—review & editing, Project administration, Supervision. KKL: Writing—review & editing, Project administration, Supervision. AAM: Conceptualization, Writing—original draft, Writing—review & editing, Data curation, Investigation, Visualization, Formal analysis, Validation. EVR, SV Odintsova, MAU, and VAK: Resources, Data curation, Investigation. VIT and AEL: Resources, Data curation. ENI: Writing—review & editing, Project administration, Supervision, Funding acquisition. All authors read and approved the final version of the manuscript.
Evgeny N. Imyanitov, who is the Editorial Board Member of Exploration of Targeted Anti-tumor Therapy, had no involvement in the decision-making or the review process of this manuscript. The other authors declare that they have no conflicts of interest.
The study was approved (approval no. 05/25) by the Ethics Committee of Pavlov First Saint Petersburg State Medical University, and was conducted in compliance with the Helsinki Declaration.
Informed consent to participate in the study was obtained from all participants.
Informed consent to publication was obtained from relevant participants.
The raw data supporting the conclusions of this manuscript will be made available by the corresponding author (a.musaelyan8@gmail.com), without undue reservation, to any qualified researcher.
This work has been supported by the Russian Science Foundation and St.-Petersburg Science Foundation grant [#24-45-10014]. The research was carried out at the <Primat> Shared Research Facilities using its equipment. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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