Weekly Low Dose Irinotecan Combined with Oral Tegafur-uracil Plus Leucovorin as an Out-patient Treatment in Patients with Metastatic Colorectal Cancer (CRC)

背景　雖然irinotecan(CPT-11)與5-FU合併使用於治療晚期或轉移之大腸直腸癌已被廣泛接受，但是所建議使用的劑量常會造成嚴重腹瀉，甚至突然死亡的病例。目的　此一研究目的在於檢視門診病患接受低劑量irinotecan合併口服Tegafur-Uracil與leucovorin治療之效度與毒性。方法　從2002年5月到2003年1月總共有20位病患納入研究。以28天為一週期，病患在第1天，第8天，第15天在門診接受50mg/m2劑量之irinotecan，點滴注射90分鐘。其間每日口服Tegafur-Uracil 300mg與Leucovorin 30mg，分為早晚兩次，共計服用21天。結果　20位病患中，有18位可以評估治療效果與毒性。腫瘤完全消失的有兩位病患，另外有兩位病患達到部分消失的效果。對於第一線用藥病患的反應為37.5%。第二線為10%。對於第一線用藥與第二線用藥的中位數存活時間分別為16個月（範圍：6~24個月）與10個月（範圍：6~15個月）。中位數追蹤時間為21個月（範圍：6~24個月）。其間並無明顯的毒性反應除有一位病患有等級三的腹瀉情況。結論　此一研究發現，低劑量的irinotecan合併Tegafur/Uracil與leucovorin治療，除了有較低的毒性反應外，相較於之前的其他研究，效果是相當的。所以我們認為，此一治療療程可以提供給那些有高度危險的irinotecan毒性之病患，做為一個修正的治療方法。

關鍵字

化學治療； irinotecan ；低劑量療方；轉移性大腸直腸癌

並列摘要

Background. Although irinotecan combined with 5-FU is now accepted as standard treatment for advanced or metastatic colorectal cancer, it is toxic and recommended doses may cause sudden death. Aim. This study was thus to determine the efficacy and toxicity of low-dose irinotecan combined with oral Tegafur-Uracil/leucovorin as an out-patient treatment. Methods. From May 1, 2002 to January 31, 2003, 20 patients were enrolled in this study. Patients received irinotecan 50mg/m^2 as an intravenous 90-minute infusion on days 1, 8 and 15 and daily oral Tegafur-Uracil 300mg/m^2, and leucovorin 30mg in two divided doses for 21 days. Cycles were repeated every 28 days. Results. Eighteen of 20 patients were assessable for response and toxicity. Complete response was observed in two patients and partial response in two patients. The response rate was 37.5% for first line treatment group and 10% for second line treatment group, respectively. The median overall survival of first and second line patients were 14 months (range, 6-24 months) and 10 months (range, 6-15 months), respectively, with median follow-up duration of 21 months (range, 6-24). There was no severe toxicity except for one case of grade 3 diarrhea. Conclusions. The response rates obtained in this study are comparable to those observed in previous randomized studies, and this treatment scheme appears to have low toxicity. We therefore suggest that this treatment scheme should be considered as a modified first-line regime for some patients at high risk of severe irinotecan toxicity.

並列關鍵字

Chemotherapy ； Irinotecan ； Low-dose regimen ； Metastatic colorectal cancer

國際替代計量

Weekly Low Dose Irinotecan Combined with Oral Tegafur-uracil Plus Leucovorin as an Out-patient Treatment in Patients with Metastatic Colorectal Cancer (CRC)

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