- 學位論文
第一線使用 bevacizumab合併 FOLFIRI 治療轉移性大腸直腸癌之觀察性研究
An Observational Study on Bevacizumab Combined with FOLFIRI as the First-line Treatment in Metastatic Colorectal Cancer
摘要
目的： 這項回溯性研究針對台灣地區轉移性大腸直腸癌病患，第一線使用Bevacizumab合併FOLFIRI（irinotecan/5-FU/LV）化療後，評估其毒性和療效。 方法： 52位在高雄醫學大學附設醫院之轉移性大腸直腸癌病患，在2008年1月至2009年12月期間，第一線使用Bevacizumab合併FOLFIRI化療，之後進行回溯性分析。病人在第1天化療，開始先以Bevacizumab 5 mg/kg（120分鐘靜脈滴注），之後irinotecan（180 mg/m2，120分鐘靜脈輸注），Leucovorin (LV) （400 mg/m2，靜脈滴注2小時以上）和5-Fluorouracil (5-FU)（先400 mg/m2靜脈推注，再以2400 mg/m2，連續靜脈注射輸液46小時），每2週重複治療一次。每一位接受化療病人的特點，化療後帶來的不利影響和腫瘤經治療後之反應率，均做記錄。 結果： 這些患者的腫瘤經治療後之整體反應率為59.6％，整體疾病控制率為82.7％。患者在接受化療後主要遭遇之3/4級不良事件有厭食（5.8％），腹瀉（7.7％），噁心（7.7％），嘔吐（3.8％），黏膜炎（1.9％），血液方面毒性（3.8％），蛋白尿（1.9％）。最後，我們比較Bevacizumab合併FOLFIRI化療後之3/4級毒性，在白種人，亞洲人，與我們的研究結果之差異。這些患者主要遇到的3/4級不良事件中有腹瀉（白種人0-15％，亞洲人4.2％和本研究7.7％），噁心/嘔吐（白種人0-6％/0-7％和本研究7.7％/3.8％），嗜中性白血球低下（白種人9.5-30％和本研究3.8％），高血壓（白種人0-26％和本研究0％），消化道出血（白種人0-4％和本研究0％）。 結論： 這項回溯性研究顯示針對轉移性大腸直腸癌病患，使用Bevacizumab合併FOLFIRI化療，具相當的療效和安全性，與前瞻性隨機對照臨床試驗的結果是一致的。在台灣地區之轉移性大腸直腸癌病患，Bevacizumab合併FOLFIRI化療，可被視為有效且耐受性良好之第一線治療方案。
並列摘要
Purpose This retrospective study was to evaluate the first-line treatment of bevacizumab combined with FOLFIRI regimen, and to compare the toxicities and the efficacy in Taiwanese patients with metastatic colorectal cancer (mCRC). Methods Fifty-two patients with mCRC receiving bevacizumab combined with FOLFIRI chemotherapy in Kaohsiung Medical University Hospital between January 2008 and December 2009 were analyzed retrospectively. The patients were initially treated with bevacizumab 5 mg/kg (a 120-min IV infusion) on day 1, followed by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (LV) (400mg/m2 IV infusion over 2 hours), and 5-Fluorouracil (5-FU) (400 mg/m2 as an IV bolus infusion followed by 2400 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. The characteristics of each patient, the adverse effects and responses after chemotherapy were recorded. Results The objective responses for treatment of patients were evaluated, and an overall response rate was 59.6% and the disease control rate was 82.7%. The major grade 3/4 adverse events encountered in these patients were asthenia (5.8%), diarrhea (7.7%), nausea (7.7%), vomiting (3.8%), mucositis (1.9%), hematological toxicity (3.8%), and proteinuria (1.9%). The most common grade 3/4 adverse events in our patients were diarrhea (0-15% in Caucasians, 4.2% in Asian, and 7.7% in the current study), nausea/vomiting (0-6%/0-7% in Caucasians and 7.7%/3.8% in the current study), neutropenia (9.5-30% in Caucasians and 3.8% in the current study), hypertension (0-26% in Caucasians and 0% in the current study), and gastrointestinal bleeding (0-4% in Caucasians and 0% in the current study). Conclusion The considerable efficacy and safety profile in this retrospective study showed that bevacizumab combined with FOLFIRI regimen is consistent with results in prospective randomized clinical trials. The combination of bevacizumab with FOLFIRI regimen for first-line treatment was effective and well-tolerated for Taiwan mCRC patients.