Adjuvant Concurrent Uracil-Tegafur with Leucovorin and Radiotherapy for Locally Advanced Rectal Cancer

局部晚期直腸癌手術後放射治療併用Uracil-Tegafur及Leucovorin之療效初探

謝忱希(Chen-Hsi Hsieh) ； 許自齊(Tzu-Chi Hsu) ； 陳裕仁(Yu-Jen Chen) ； 許希賢(Hsi-Hsien Hsu) ； 劉建國(Chien-Kuo Liu) ； 洪世凱(Shih-Kai Hung) ； 賴允亮(Yuen-Liang Lai) ； 陳虹汶(Hong-Wen Chen) ； 張國華(Kou-Hwa Chang)

《放射治療與腫瘤學》 13卷2期 (2006/06) Pp. 117-125

https://doi.org/10.6316/TRO/200613(2)117

摘要

目的：本研究主要探討局部侵犯性直腸癌手術後併用Uracil-Tegafur (UFUR)，Leucovorin (LV)及同步放射線治療之療效、毒性及安全性。
材料與方法：自2001年2月至2004年11月，共17位接受同步性化學放射線治療併用UFUR與LV的直腸癌術後的患者。患者年齡中位數為54歲（從42至86歲）。手術的方式可分為APR與RP。在治療期間每天口服UFUR的劑量為200-250mg/m2/day；而LV為45-60 mg/day。放射線治療劑量為每日1.8Gy，共計照射28至33次。全骨盆照射共45Gy，之後再對腫瘤局部照射5.4Gy至14.4Gy。化學治療在放射治療後以同樣劑量持續使用一年以上或至復發為止。
結果：17位中，7位為男性，10位為女性。5位接受APR而12位接受RP。17位皆屬於腺癌。15位病理分級為中度分化，2位為分化不良。放射線治療的中位數劑量為59.4Gy(50.4Gy~59.4Gy)，平均劑量為57.7Gy。治療期間無人死亡。中位數生存月份為36個月。三年存活率68%。三年無病存活率為44%。4位(24%)發生局部復發及三年局部復發控制率為68%。5位(29%)發生遠處轉移而三年遠處轉移控制率為62%。本次研究中最常發生的副作用為噁心、嘔吐、疲倦、皮膚炎與貧血、白血球減少、血小板減少。沒有4級以上的毒性反應。3級以上的腹瀉佔18%；3級以上的疲倦佔6%；3級以上的嘔吐佔6%但都在可接受的程度。皮膚炎，最嚴重為2級的傷害。3級以上的貧血只佔6%。沒有3級以上的白血球減少，血小板減少的情形。
結論：局部侵犯性直腸癌手術後併用Uracil-Tegafur (UFUR)，LV及同步放射線治療可提供有效、安全方便而毒性少的治療。可再進行進一步的臨床隨機性試驗。

關鍵字

同步性化學放射線治療 ； UFUR ； 侵犯性直腸癌

並列摘要

Purpose: This prospective, nonrandomized study was conducted to test the efficacy and toxicity of adjuvant concurrent chemoradiation therapy (CCRT) using uracil-tegafur (UFUR) and leucovorin (LV) in patients with locally advanced rectal cancer.
Material and Methods: From February 2001 through November 2004, 17 patients with stage II or III rectal adenocarcinoma were enrolled in the study. All underwent curative resection followed by adjuvant CCRT at Mackay Memorial Hospital, Taipei. The median age was 54 (range, 42 to 86) years. The operative procedures were either abdominoperineal resection or a radical proctectomy. Radiotherapy (RT), delivered in 28 to 33 fractions, consisted of 45Gy of whole-pelvis irradiation followed by a 5.4 to 14.4Gy local boost to the tumor bed. A combination of oral UFUR at 200 to 250 mg/m2/day and LV 45 to 60 mg/day was given 7 days a week during the RT course and then for at least one year or until treatment failure, whichever came first.
Results: Of the 17 patients, 7 were male and 10 were female. Five had undergone APR and 12 RP. The adenocarcinoma was moderately differentiated in 15 poorly differentiated in 2. The median radiation dose was 59.4 (range, 50.4 to 59.4)Gy, with a mean 57.7Gy. None of the patients died during the CCRT course. The median survival for all 17 patients was 36 months, and the 3-year overall survival was 68%. The 3-year disease-free survival rate was 44%. Four patients developed local failure, yielding a 3-year local control rate of 68%. Five patients developed distant metastasis, for a 3-year metastasis-free rate of 62%. The most-common side effects were diarrhea and nausea or vomiting, dermatitis, fatigue, and hematological toxicity consisting of anemia, leucopenia, and thrombocytopenia. No grade 4 toxicity was observed. Three patients had grade 3 diarrhea, and 1 grade 3 fatigue and vomiting, but these were tolerable. None had greater than grade 2 skin toxicity. One patient had grade 3 anemia, but none had grade 3 leucopenia or thrombocytopenia.
Conclusions: Adjuvant CCRT that includes oral UFUR and LV provided acceptable survival and local control rates with acceptable toxicity in patients with locally advanced rectal cancer. A randomized trial of this combined treatment is warranted.

並列關鍵字

Concurrent chemoradiation therapy CCRT ； UFUR ； Advanced rectal cancer