- 期刊
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
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400mg/平方公尺劑量之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250mg/平方公尺之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500mg/平方公尺劑量之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爲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-freesurvival)分別爲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爲11.5%和8.8%；發生第三級皮膚過敏反應得比率分別爲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爲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，沒有病人因爲藥物毒性而死亡。 結論 我們的研究發現，對台灣發生轉移性結直腸癌病患之治療，雙週給予cetuximab合併FOLFIRI化療就如同單週給予cetuximab合併FOLFIRI化療一樣，都是相對安全且病患耐受性佳的處方，兩者也均可被接受作爲治療這類病患的第一線化療處方。
並列摘要
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/m^2 as a 120-min IV infusion at first week, then 250 mg/m^2 as a 60-min IV per week). In group B, 34 patients received intravenous (IV) cetuximab biweekly (500 mg/m^2 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 A and 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 A and 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.