EP1.01-62 The Safety Profile and Preliminary Efficacy of Ceritinib 450mg with Food in Chinese ALK/ROS-1 Positive NSCLC Patients

Tian, Ye; Yu, Ping; Yin, Xiaoyi; Wang, K.; Huang, Meijuan; Wang, Y.; Gong, Yuping; Li, J.

doi:10.1016/j.jtho.2019.08.2035

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“…The ASCEND-8 explored the administration pattern and dosage of ceritinib and found ceritinib 450 mg/d fed had similar pharmacokinetic profiles to 750 mg/d fed, but with significantly improved gastrointestinal events and better efficacy (9). Data from a real-world study (10) showed that ceritinib 450 mg/d fed demonstrated superior OR, disease control rate (DCR), and PFS in Chinese patients with brain metastases from ALK-positive NSCLC compared with a dose of 750 mg/d fasted, and therefore the approved dose for ceritinib in China is 450 mg/d.…”

Section: Dose Adjustment For Ceritinibmentioning

confidence: 99%

Clinical pharmacist participation in selecting and dosing targeted drugs for a patient with ALK-positive non-small cell lung cancer: a case report

Fang¹,

Liu²,

Liang³

et al. 2021

Ann Transl Med

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Ceritinib and alectinib are recommended as the second-line therapies in the 2019 Chinese Society of Clinical Oncology (CSCO) guidelines for patients with anaplastic lymphoma kinase (ALK) positive non-small-cell lung cancer (NSCLC) in whom the first-line therapy has failed, but no optimal second-line treatment has been identified. Before 2018, the approved dose of ceritinib in the United States and many other countries was 750 mg/d fasted. In China, the approved dose was 450 mg/d fed although the dose of 750 mg/d fasted is still used in clinical practices. In our current case, a clinical pharmacist was involved in the selection and dose adjustment of a targeted drug for an ALK-positive NSCLC patient. The selection of second-line targeted drugs is based mainly on the results of clinical trials and real-world data of ceritinib and aletinib, along with the comprehensive analysis of health insurance policy, pharmacoeconomics, and drug accessibility. Alectinib may be more efficacious than ceritinib is in second-line settings. However, in our current case, the patient finally chose ceritinib after considering the drug prices and the health insurance policy. The clinical pharmacist optimized the dosage of ceritinib from 750 mg/d fasted to 450 mg/d fed, which not only improved the patient's medication compliance but also ensured the safety and efficacy of the drug; in addition, it lowered the financial burden of both the health insurance system and the patient, offering a good example for rational drug use and health insurance cost reduction. In conclusion, in choosing second-line targeted therapy for ALK-rearranged NSCLC, a variety of factors should be considered, including clinical efficacy, adverse effects, health insurance policy, drug price, and drug accessibility, and the dosage of ceritinib should be optimized to 450 mg/d fed in real-world settings

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Section: Dose Adjustment For Ceritinibmentioning

confidence: 99%