Fang Caifu, Liu Tao, Liang Weiting, Feng Shiyin, Su Zhiqiang, Tang Hongmei, Huang Hongbing, Chen Zhuojia
Department of Pharmacy, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Department of Pharmacy, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Ann Transl Med. 2021 Sep;9(18):1488. doi: 10.21037/atm-21-3853.
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.
色瑞替尼和阿来替尼被推荐作为2019年中国临床肿瘤学会（CSCO）指南中一线治疗失败的间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌（NSCLC）患者的二线治疗药物，但尚未确定最佳二线治疗方案。2018年之前，美国和许多其他国家批准的色瑞替尼剂量为空腹750mg/d。在中国，批准剂量为进食时450mg/d，尽管临床实践中仍使用空腹750mg/d的剂量。在我们目前的病例中，一名临床药师参与了一名ALK阳性NSCLC患者靶向药物的选择和剂量调整。二线靶向药物的选择主要基于色瑞替尼和阿来替尼的临床试验结果和真实世界数据，同时综合分析医保政策、药物经济学和药物可及性。在二线治疗中，阿来替尼可能比色瑞替尼更有效。然而，在我们目前的病例中，患者在考虑药物价格和医保政策后最终选择了色瑞替尼。临床药师将色瑞替尼的剂量从空腹750mg/d优化为进食时450mg/d，这不仅提高了患者的用药依从性，还确保了药物的安全性和有效性；此外，它减轻了医保系统和患者的经济负担，为合理用药和降低医保费用提供了一个很好的范例。总之，在为ALK重排的NSCLC选择二线靶向治疗时，应考虑多种因素，包括临床疗效、不良反应、医保政策、药物价格和药物可及性，在真实世界中，色瑞替尼的剂量应优化为进食时450mg/d。
