Abstract:

Objective To evaluate the safety of ensartinib in the treatment of anaplastic lymphoma kinase （ALK）-positive non-small cell lung cancer （NSCLC） in the real-world clinical setting. Methods Clinical data of 2 221 patients with ALK-positive locally advanced or metastatic NSCLC who received ensartinib treatment （225 mg/d） from December 16， 2020 to December 16， 2021 were collected and analyzed to assess drug adverse reactions in all population including elderly patients （≥ 65 years old）. Results Among the total 2 221 patients， 511 patients （23.01%） experienced adverse events， including 8 patients （0.36%） who experienced serious adverse events. Adverse events led to dose modification in 67 patients （3.02%） and discontinuation in 18 patients （0.81%）. The common adverse events were rash （407/2 221， 18.33%）， pruritus （41/2 221， 1.85%）， constipation （41/2 221， 1.85%）， and facial edema （31/2 221，1.40%）. Thirty-six patients （1.62%） experienced ≥grade 3 adverse events. After symptomatic treatment of 511 patients with adverse reactions， 50 patients （9.78%） were healed， 271 patients （53.03%） were improved， 120 patients （23.48%） were persisted， and 70 patients （13.71%） were unknown due to loss of follow-up or other reasons. Forty-three patients （1.94%） reported 57 unintended adverse reactions. Among the 599 elderly patients， 116 patients （19.37%） experienced adverse events， including 1 patient （0.17%） who experienced serious adverse events. Adverse events led to dose modification in 25 patients （4.17%） and discontinuation in 5 patients （0.83%）. The common adverse events of elderly patients were rash （88/599， 14.69%）， constipation （14/599， 2.34%）， facial edema （12/599， 2.00%）， and pruritus （10/599， 1.67%）. Twelve patients （2.00%） experienced ≥grade 3 adverse events. Among the 116 elderly patients with adverse reactions following the symptomatic treatment， 11 patients （9.48%） were healed， 58 patients （50.00%） were improved， 28 patients （24.13%） were persisted， and 19 patients （16.39%） were unknown due to loss of follow-up or other reasons. During the treatment， 1 patient （0.05%） experienced grade 2 interstitial lung disease， and no patient died due to adverse events. Conclusion Ensartinib has a favorable safety profile in the real-world populations， with the most frequent adverse events being rash， mostly mild， and low incidence of ≥grade 3 adverse events. Overall， adverse reactions were tolerable and manageable.

Key words: Carcinoma, non-small-cell lung, Drug-related side effects and adverse reactions, Ensartinib