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Gefitinib as First-Line Therapy for Advanced or Metastatic Non-Small Cell Lung Cancer Patients in Southern Taiwan

以Gefitinib為第一線藥物治療南台灣晚期非小細胞肺癌病患之經驗

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摘要


Gefitinib,為表皮生長激素受體酪胺酸激酶的專一抑制劑,是第一個當非小細胞肺癌病患在接受化學治療失敗之後,被核准可以使用的標靶治療藥物。過去曾有一些較小型的臨床試驗證實gefitinib對於未曾接受過化學治療的病患也有療效。本研究之目的在探討轉移與晚期非小細胞肺癌患者第一線即使用gefitinib這一標靶治療藥物時之反應率、病患整體存活率與其預測因子。本文以回溯性方式蒐集南台灣6家醫院所有在2004年5月至2006年4月接受gefitinib為第一線治療之轉移與晚期非小細胞肺癌患者,分析病患對藥物之反應率與病患存活率,及這二者與一些已知可預測因子之相關性。本研究共收納97位患者,對藥物之反應率為56%,疾病控制率為76%。在本研究中,只有病患之生活功能狀態與病患對於gefitinib是否產生反應有明顯相關。在本研究中,以gefitinib為第一線藥物治療轉移與晚期非小細胞肺癌患者,病患可以存活超過一年的機率為77%。我們認為第一線使用單一藥物gefitinib來治療特定族群之亞洲非小細胞肺癌病患是極具前景的。以控制隨機之臨床試驗進一步來驗證第一線gefitinib之療效是必須的。

並列摘要


Gefitinib, a selective epidermal growth factor receptor tyrosine kinase inhibitor, is effective in treating patients with non-small cell lung cancer (NSCLC) after unsuccessful chemotherapy. However, survival outcomes and predictors for its effectiveness in chemotherapy-naive NSCLC patients are still not clear. The goal of this study was to investigate the response and survival rates and identify the predictive factors for patients with advanced or metastatic disease receiving gefitinib as first-line therapy. We retrospectively analyzed the response and survival rates of patients with advanced or metastatic NSCLC who had received gefitinib as first-line therapy across six medical institutes in Southern Taiwan between May 2004 and April 2006. The relationship between the response and survival rates to the known predictive factors for gefitinib response and survival was also investigated. Atotal of 97 patients (65 females and 32 males) were enrolled in this study. Seventy-four patients (76%) had never smoked. Eighty-eight patients (91%) had adenocarcinoma or bronchioloalveolar cell carcinoma. The objective response rate was 56% and the disease control rate (partial response plus stable disease) was 76%. Only poor performance status (Eastern Cooperative Oncology Group score, 3-4) was statistically significantly associated with overall response in this study. The 1-year survival rate was 77%. We suggest that first-line gefitinib monotherapy is promising in some subgroups of Asian patients with NSCLC. Further randomized controlled studies are needed to validate the effectiveness of first-line gefitinib therapy.

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