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題 名 | Efficacy and Safety of Weekly and Biweekly Cetuximab-Combined FOLFIRI Regimen as First-line Setting in Patients with Metastatic Colorectal Cancer: Experience in a Southern Taiwan Medical Center=轉移性結直腸癌病患以兩種不同的給藥頻率(每週以及雙週) 投與cetuximab 合併FOLFIRI化學治療處方做為第一線治療的有效性及安全性比較--單一南台灣醫學中心之經驗 |
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作 者 | 葉永松; 蔣政穎; 陳欽凡; 馬政仁; 陳芳銘; 陳漢文; 黃哲人; 謝建勳; 王照元; | 書刊名 | 中華民國大腸直腸外科醫學會雜誌 |
卷 期 | 21:2 2010.06[民99.06] |
頁 次 | 頁59-68 |
分類號 | 416.245 |
關鍵詞 | 雙週; 轉移性結直腸癌; 安全性; 有效性; Biweekly; Cetuximab; Metastatic colorectal cancer; Safety; Efficacy; |
語 文 | 英文(English) |
中文摘要 | 目的 此回溯性研究的目的主要是在比較兩種不同的給藥頻率 (每週以及雙週) 投與 cetuximab 合併FOLFIRI 化學治療處方,用於第一線治療南台灣轉移性之結直腸癌病患 的有效性及毒性。 方法 從2005 年1 月到2008 年12 月,我們針對共60 位在本院接受cetuximab 合併 FOLFIRI 化學治療之轉移性結直腸癌病患之病歷資料進行回溯性分析。依據所使用處方 的不同頻率,我們將病患分成兩組加以分析:在A 組中 (每週處方),總共有26 位病患 在第一個星期接受400 mg/m2 劑量之cetuximab,點滴注射120 分鐘,合併點滴注射之 標準FOLFIRI 化學治療,之後以每週的頻率施打250 mg/m2 之cetuximab,點滴注射120 分鐘,合併點滴注射之標準FOLFIRI 化學治療。在B 組中 (雙週處方),總共有34 位病 患以每兩個星期的頻率接受500 mg/m2 劑量之cetuximab,點滴注射120 分鐘,合併點 滴注射之標準FOLFIRI 化學治療。根據實體腫瘤反應評估標準 (response evaluation criteria in solid tumors) 我們記錄了每位病患的病史、特徵、接受化學治療後的反應及治 療過程中所遭遇的毒性。 結果 A 組及B 組的病患接受cetuximab 合併化療後的總疾病控制率分別為76.8% 和 82.4% (p = 0.602)。A 組及B 組病患在開始接受化療後的無疾病進展存活期 (progression- free survival) 分別為12 個月和13 個月 (p = 0.662)。在統計學上的分析比較上 兩組之間並無顯著的差異。在毒性分析方面,A 組及B 組的病患發生第三或第四級腹瀉 的比率為11.5% 和8.8%;發生第三級皮膚過敏反應得比率分別為11.5% 和14.7%;發 生第三級或更嚴重的嗜中性球缺乏症/貧血/血小板低下的比率分別為11.5%/7.7%/7.7%(A 組) 和14.7%/5.9%/5.9% (B 組)。這些毒性在統計學上的分析比較,在兩組之間均無 顯著的差異,並且在接受適當治療後均可以獲得顯著的改善。治療過程中,沒有病人因 為藥物毒性而死亡。 |
英文摘要 | Purpose. This retrospective study was designed to analyze the two different regimens of weekly and biweekly cetuximab-combination FOLFIRI chemotherapy, and determine the toxicities and the efficacy of these two different regimens administered in Taiwanese patients with metastatic colorectal cancer (mCRC). Methods. From January 2005 through December 2008, a total of sixty patients with metastatic colorectal cancer receiving target therapy of cetuximab- combination FOLFIRI chemotherapy were analyzed retrospectively. These patients were divided into two groups with different regimens of administration. In Group A, 26 patients received intravenous (IV) cetuximab weekly (400 mg/m2 as a 120-min IV infusion at first week, then 250 mg/m2 as a 60-min IV per week). In group B, 34 patients received intravenous (IV) cetuximab biweekly (500 mg/m2 as a 120-min IV infusion per two-week). According to the Response Evaluation Criteria in Solid Tumor (RECIST), characteristics of each patient, toxicities, efficacy or tumor response were regularly recorded. Results. The overall disease control rate (complete response + partial response + stable disease) was comparable of 76.8% (20/26) for group A and 82.4% (28/34) for group B respectively (p = 0.602). The progression- free survival was comparable between these two treatments (12 months in group A vs. 13 months in group B; p = 0.662). The efficacy of the every-2-weeks regimen was similar to the approved weekly dosing regimen. Among all recorded side effects, the incidence of grade 3 or 4 diarrhea was 11.5% (3/26) in group Aand 8.8% (3/34) in group B. Grade 3 skin rash was seen in 3 patients (11.5%) from group A and 5 patients (14.7%) from group B. The incidence of grade 3 or 4 neutropenia /anemia/ thrombocytopenia encounteredwas 11.5% (3/26)/7.7%(2/26)/7.7% (2/26) in group Aand 14.7% (5/34)/5.9%/ (2/34)/5.9% (2.34) in group B. There was no significant difference between these two different regimens of administration and all toxicities were easily controlled with standard therapies. No treatment-related deaths occurred in either group. Conclusions. Our results demonstrated similarities in terms of toxicity and efficacy to those obtained by weekly and biweekly administration of cetuximab with combined FOLFIRI chemotherapy in Taiwanese patients. |
本系統中英文摘要資訊取自各篇刊載內容。