社團法人臺灣臨床藥學會

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【原著】Erlotinib用於肺腺癌EGFR野生型患者化學治療後之療效探討
Efficacy of Erlotinib in Post-Chemotherapy EGFR Wild-Type Lung Adenocarcinoma Patients
非小細胞肺癌、表皮生長因子接受器、表皮生長因子接受器野生型、Erlotinib、Non-Small Cell Lung Aancer, Epidermal Growth Factor Receptor, Epidermal Growth Factor Receptor Wild-Type, Erlotinib
劉錦鳳Chin-Feng Liu*1 、鄭幸宜Hsingi-I Cheng1 、李樂業Lo-Yeh Lee2
1高雄醫學大學附設中和紀念醫院藥劑部 、2高雄醫學大學附設中和紀念醫院影像醫學部
目的:近來研究酪胺酸激酶抑制劑 (tyrosine kinase inhibitors) 標靶藥品之一的erlotinib,用於表皮生長因子接受器 (epidermal growth factor receptor, EGFR) 野生型病人在治療效益上一直被探討;而臺灣多數的肺腺癌患者屬於突變型,相較之下沒有突變的族群在erlotinib 療效評估的文獻較少。因此本篇研究探討臺灣某醫學中心
EGFR 基因檢測為野生型的肺腺癌病人中,觀察使用erlotinib 療效與副作用情形。
方法:本篇以回溯方式蒐集2013 年10 月到2016 年5 月間合格病人條件:肺腺癌為第IIIB 期或第IV 期、曾接受手術治療又局部復發或遠端轉移,並以基因檢驗方法檢測出EGFR 基因為野生型,以及開始服用erlotinib 前有接受過全身性化學治療。
病人每日一錠erlotinib 150 mg 直到疾病出現進展或無法忍受的副作用而停止。
結果: 此研究共收案22 位病人, 年齡中位數為64 歲(35 ~ 81 歲)。22 位病人在overall response rate 和disease control rate 表現上分別為27% 和68.1%,progression-free survival 和 event-free survival 之中位數存活期為5.5 個月 (95% confidence interval [CI]: 0.00–12.2) 和6.1 個月 (95% CI: 0.4–11.7)。病人常發生的副作用以皮疹11 人 (50%) 和腹瀉10 人 (45%) 為最多,並且有2 位病人分別發生手足皮膚反應和瀰漫性頭皮結痂是erlotinib 較少被文獻描述到的不良反應。
結論:本篇以erlotinib 治療肺腺癌EGFR 野生型病人,發現部分病人在治療反應上呈現穩定狀態,推測erlotinib 的治療效益可能不侷限於EGFR 基因為突變型病人,但相關研究仍須進一步確認。

Objective: Recent studies show that erlotinib, a tyrosine kinase inhibitor targeted therapy, have been explored in the treatment of epidermal growth factor receptor (EGFR) wild-type. In Taiwan, most patients with lung adenocarcinoma belong to the EGFR mutation and documentation on erlotinib use in EGFR wild-type is sparse. Therefore, this study investigated the efficacy and adverse reactions of erlotinib used by such patients in a Taiwan medical center.
Methods: This study was conducted from October 2013 to May 2016 with the patients’ eligibility criteria: lung adenocarcinoma with stage IIIB/IV or postoperative recurrence, tumors with EGFR wild-type by EGFR gene detection methods. Patients were given systemic chemotherapy prior to taking erlotinib. Patients discontinued the erlotinib 150 mg daily tablet until the disease progressed or when the side effects could not be endured further.
Results: 22 patients were enrolled in the study. Median age was 64 years (35–81 years). Overall response rate and disease control rate for the patients were 27% and 68.1%, respectively. Median for progression-free survival and event-free survival were 5.5 months (95% confidence interval [CI]: 0.00–12.2) and 6.1 months (95% CI: 0.4–11.7). The most common side effects were skin rashes, in 11 patients (50%) and diarrhea, in 10 patients (45%). 2 patients developed hand-foot skin reactions and diffuse scalp crusting, rare adverse reactions mentioned in the documentation.
Conclusions: The study showed some patients were in stable condition following the erlotinib treatment. Thus, the effect of erlotinib may not be limited to EGFR mutationpatients only. However, relevant research need to be further confirmed.
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