中国肺癌杂志
中國肺癌雜誌
중국폐암잡지
CHINESE JOURNAL OF LUNG CANCER
2014年
4期
342-346
,共5页
陶虹%郭丽丽%唐俊舫%朱允中%徐丽艳%孟弃逸%武玮%李明智%吴卫华%仝丽%吴洪波%史亮%刘喆
陶虹%郭麗麗%唐俊舫%硃允中%徐麗豔%孟棄逸%武瑋%李明智%吳衛華%仝麗%吳洪波%史亮%劉喆
도홍%곽려려%당준방%주윤중%서려염%맹기일%무위%리명지%오위화%동려%오홍파%사량%류철
阿法替尼%表皮生长因子受体%酪氨酸激酶抑制剂%肺肿瘤%不良反应
阿法替尼%錶皮生長因子受體%酪氨痠激酶抑製劑%肺腫瘤%不良反應
아법체니%표피생장인자수체%락안산격매억제제%폐종류%불량반응
Afatinib%Epidermal growth factor receptor%Tyrosine kinase inhibitor%Lung neoplasms%Adverse event
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。
揹景與目的阿法替尼是一種新型的低分子量人類錶皮生長因子受體（human epidermal growth factor receptor, HER）傢族抑製劑，它屬于第二代錶皮生長因子受體-酪氨痠激酶抑製劑（epidermal growth factor receptor-tyrosine kinase inhibitors, EGFR-TKIs），在臨床前和臨床研究中顯示瞭該藥對具有錶皮生長因子受體（epidermal growth factor receptor, EGFR）活性突變的非小細胞肺癌（non-small cell lung cancer, NSCLC）的療效。本研究關註阿法替尼治療晚期肺腺癌患者的安全性。方法確診為IIIb期或IV期肺腺癌、具有EGFR突變的患者，一線給予阿法替尼每日40 mg口服，直至疾病進展。觀察不良反應、療效及生存情況。結果最常見不良反應為腹瀉（n=5,100%）、皮疹（n=4,80%）、粘膜炎/口腔炎（n=4,80%）。總體不良反應程度較輕，均≤III級，相對最嚴重的副反應為粘膜炎/口腔炎。腹瀉雖髮生于所有患者，但程度較輕。共有3例患者因不良反應暫停藥、減量。在4例可評價療效的患者中，部分緩解（partial response, PR）2例（50%），疾病穩定（stable disease, SD）1例（25%），疾病進展（progressive disease, PD）1例（25%）。中位無進展生存期（progression-free survival, PFS）9.7箇月，中位總生存期（overall survival, OS）18.4箇月。結論阿法替尼一線治療晚期肺腺癌患者療效確切，常見不良反應除腹瀉、皮疹外，還應關註粘膜炎/口腔炎的髮生。由于本研究入組人數較少，此結論尚需得到研究者的進一步關註。
배경여목적아법체니시일충신형적저분자량인류표피생장인자수체（human epidermal growth factor receptor, HER）가족억제제，타속우제이대표피생장인자수체-락안산격매억제제（epidermal growth factor receptor-tyrosine kinase inhibitors, EGFR-TKIs），재림상전화림상연구중현시료해약대구유표피생장인자수체（epidermal growth factor receptor, EGFR）활성돌변적비소세포폐암（non-small cell lung cancer, NSCLC）적료효。본연구관주아법체니치료만기폐선암환자적안전성。방법학진위IIIb기혹IV기폐선암、구유EGFR돌변적환자，일선급여아법체니매일40 mg구복，직지질병진전。관찰불량반응、료효급생존정황。결과최상견불량반응위복사（n=5,100%）、피진（n=4,80%）、점막염/구강염（n=4,80%）。총체불량반응정도교경，균≤III급，상대최엄중적부반응위점막염/구강염。복사수발생우소유환자，단정도교경。공유3례환자인불량반응잠정약、감량。재4례가평개료효적환자중，부분완해（partial response, PR）2례（50%），질병은정（stable disease, SD）1례（25%），질병진전（progressive disease, PD）1례（25%）。중위무진전생존기（progression-free survival, PFS）9.7개월，중위총생존기（overall survival, OS）18.4개월。결론아법체니일선치료만기폐선암환자료효학절，상견불량반응제복사、피진외，환응관주점막염/구강염적발생。유우본연구입조인수교소，차결론상수득도연구자적진일보관주。
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. hTe 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 ifrst-line treated with an oral administration of afatinib (40 mg/d) until disease progression. Adverse events, effects, and survival condition were observed. Results hTe 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. hTree 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. Conclusion Afa-tinib was approved as ifrst-line treatment for patients with advanced lung adenocarcinoma. hTe 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 conifrmation.
