Background and objective: Afatinib is an irreversible ErbB-family blocker with a clinical activity in non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. The aim of this study is to assess the safety of afatinib in patients with advanced lung adenocarcinoma.
Methods: Patients with lung adenocarcinoma (stage IIIb or IV) with EGFR mutations were first-line treated with an oral administration of afatinib (40 mg/d) until disease progression. Adverse events, effects, and survival condition were observed.
Results: The most common adverse events were diarrhea (n=5, 100%), skin rash (n=4, 80%), and mucositis/stomatitis (n=4, 80%). Moderate toxicities not exceeding grade 3 were observed. Relatively, the most serious adverse reaction was mucositis/stomatitis. Mild diarrhea occurred in all patients. Three patients experienced temporary drug withdrawal and dose reduction because of adverse reaction. Among the four patients who were evaluated, partial response was observed in two patients (50%), one with stable disease (25%) and one with progressive disease (25%). Median progression-free survival was 9.7 months, whereas median overall survival was 18.4 months.
Conclusions: Afatinib was approved as first-line treatment for patients with advanced lung adenocarcinoma. The most common adverse events were diarrhea and skin rash. However, mucositis/stomatitis related to afatinib should also be considered. Considering the small number of cases, the conclusion requires more trials for confirmation.
背景与目的 阿法替尼是一种新型的低分子量人类表皮生长因子受体（human epidermal growth factor receptor, HER）家族抑制剂，它属于第二代表皮生长因子受体-酪氨酸激酶抑制剂（epidermal growth factor receptor-tyrosine kinase inhibitors, EGFR-TKIs），在临床前和临床研究中显示了该药对具有表皮生长因子受体（epidermal growth factor receptor, EGFR）活性突变的非小细胞肺癌（non-small cell lung cancer, NSCLC）的疗效。本研究关注阿法替尼治疗晚期肺腺癌患者的安全性。 方法 确诊为IIIb期或IV期肺腺癌、具有EGFR突变的患者，一线给予阿法替尼每日40 mg口服，直至疾病进展。观察不良反应、疗效及生存情况。结果 最常见不良反应为腹泻（n=5, 100%）、皮疹（n=4, 80%）、粘膜炎/口腔炎（n=4, 80%）。总体不良反应程度较轻，均≤III级，相对最严重的副反应为粘膜炎/口腔炎。腹泻虽发生于所有患者，但程度较轻。共有3例患者因不良反应暂停药、减量。在4例可评价疗效的患者中，部分缓解（partial response, PR）2例（50%），疾病稳定（stable disease, SD）1例（25%），疾病进展（progressive disease, PD）1例（25%）。中位无进展生存期（progression-free survival, PFS）9.7 个月，中位总生存期（overall survival, OS）18.4个月。结论 阿法替尼一线治疗晚期肺腺癌患者疗效确切，常见不良反应除腹泻、皮疹外，还应关注粘膜炎/口腔炎的发生。由于本研究入组人数较少，此结论尚需得到研究者的进一步关注。