Jones Anna, Degregorio Paola, Sung Max W, Ramji Zahra, Ren Min, Baron Ari D
From Pacific Hematology Oncology Associates, San Francisco, California.
Mount Sinai Medical Center, New York, New York.
J Adv Pract Oncol. 2023 Nov;14(7):598-607. doi: 10.6004/jadpro.2023.14.7.4. Epub 2023 Nov 1.
Advanced practice providers (APPs) play a vital role in monitoring for and managing adverse reactions (ARs). As lenvatinib ARs can resemble cirrhosis (commonly presenting with hepatocellular carcinoma [HCC]), APP input is important for timely detection and management of ARs and to promote medication adherence.
The goal of this post-hoc analysis of the REFLECT trial was to characterize key ARs associated with lenvatinib, and to discuss management strategies.
In REFLECT, patients with unresectable HCC were randomized to either daily lenvatinib (12 mg/day for patients who weighed ≥ 60 kg or 8 mg/day for those < 60 kg) or sorafenib 400 mg twice daily. Adverse events in the lenvatinib arm were grouped into ARs (hypertension, fatigue, palmar-plantar erythrodysesthesia syndrome, proteinuria, and decreased appetite) per the United States Prescribing Information (USPI) for lenvatinib.
Key ARs in the lenvatinib arm ( = 476) generally occurred within months of starting lenvatinib. Some cases of proteinuria, decreased appetite, and diarrhea were first reported at about 2 years of treatment.
The onset of key ARs associated with lenvatinib treatment can be predicted and generally be managed (per the lenvatinib USPI and REFLECT) by withholding lenvatinib and resuming it at a reduced dose after the severity decreases. However, lenvatinib should generally be discontinued if the AR is life-threatening.
高级执业提供者（APPs）在监测和管理不良反应（ARs）中发挥着至关重要的作用。由于乐伐替尼的不良反应可能类似于肝硬化（通常表现为肝细胞癌[HCC]），APPs的参与对于及时发现和管理不良反应以及促进药物依从性非常重要。
这项对REFLECT试验的事后分析的目的是确定与乐伐替尼相关的关键不良反应，并讨论管理策略。
在REFLECT试验中，不可切除HCC患者被随机分为两组，一组每日服用乐伐替尼（体重≥60 kg的患者为12 mg/天，体重<60 kg的患者为8 mg/天），另一组每日两次服用索拉非尼400 mg。根据乐伐替尼的美国处方信息（USPI），将乐伐替尼组的不良事件分为不良反应（高血压、疲劳、手足皮肤反应综合征、蛋白尿和食欲减退）。
乐伐替尼组（n = 476）的关键不良反应通常在开始服用乐伐替尼后的数月内出现。一些蛋白尿、食欲减退和腹泻病例在治疗约2年后首次报告。
与乐伐替尼治疗相关的关键不良反应的发作可以预测，并且通常（根据乐伐替尼USPI和REFLECT）通过停用乐伐替尼并在严重程度降低后以较低剂量恢复服用进行管理。然而，如果不良反应危及生命，通常应停用乐伐替尼。
