2023 中国多学科专家共识：赛沃替尼相关药物不良反应的管理（英

作者：中华医学网发布时间：2025-12-16 07:46浏览：次

该共识的英文全称为Chinese multidisciplinary expert consensus on the management of adverse drug reactions associated with savolitinib，于 2023 年 12 月 23 日发表在《Therapeutic Advances in Medical Oncology》杂志上，是全球首个针对赛沃替尼临床不良反应管理的共识，其核心英文内容及对应核心要点如下：

Basic Information and Theoretical Basis
- Drug Introduction：Savolitinib is a highly selective mesenchymal - epithelial transition (MET) tyrosine kinase inhibitor (TKI). It was approved for marketing in China on June 22, 2021, mainly for adult patients with locally advanced or metastatic non - small cell lung cancer who have MET exon 14 skipping mutations and whose disease progresses after platinum - containing chemotherapy or who cannot tolerate standard platinum - containing chemotherapy.
- Compilation Purpose：Based on two rounds of extensive national surveys, this consensus aims to guide clinicians to use savolitinib rationally, scientifically prevent and treat various adverse drug reactions, and improve patients' clinical benefits and quality of life. Notably, experts in Traditional Chinese Medicine also participated in formulating the consensus, which reflects the clinical treatment concept of integrating Traditional Chinese and Western medicines.
Key Safety Data

The safety data of savolitinib is derived from 5 clinical trials, involving a total of 345 tumor patients who received savolitinib monotherapy. Among patients receiving a dose of ≥ 400mg, the common adverse reactions (≥ 10%) are nausea (44.7%), edema (40.5%), fatigue or lassitude (31.1%), vomiting (31.1%), anorexia (21.0%), hypoalbuminemia (17.2%), anemia (16.6%), pyrexia (15.7%), diarrhea (13.6%) and abnormal liver function (11.8%). Most of these adverse reactions are grade 1 - 2, and their overall safety is controllable and manageable. No interstitial lung disease has been observed.

Standard Management Measures for Major Adverse Reactions

Adverse Reactions	Management Measures
Nausea and vomiting	These are common gastrointestinal adverse reactions. The consensus recommends symptomatic treatment such as antiemetic drugs when such reactions occur. Meanwhile, combining Traditional Chinese and Western medicine methods can also be adopted for intervention to relieve the patient's discomfort.
Peripheral edema	Before the occurrence of peripheral edema or when grade 1 - 2 peripheral edema occurs, lifestyle intervention or physical therapy can be used, such as a low - salt diet and wearing elastic stockings. For grade 3 peripheral edema, clinicians can conduct drug intervention based on clinical judgment. It is crucial to assess the patient's blood volume before diuretic therapy.
Liver - related adverse reactions	Multiple prevention strategies are proposed, including enhancing risk awareness, using drugs that may interact with savolitinib with caution, strengthening liver function monitoring, and adhering to standardized medication. For hepatocellular damage, the main focus is on protecting hepatocytes and stabilizing cell membranes; for biliary tract damage, it is necessary to strengthen choleretic treatment.
Pyrexia and allergic reactions	These are also the adverse reactions concerned in clinical practice. The consensus points out that these reactions are mostly mild to moderate. They can be alleviated through appropriate symptomatic supportive treatment. When necessary, the drug dose can be adjusted to avoid unnecessary dose reduction or premature drug withdrawal which may affect the therapeutic effect.