Ⅱ和Ⅲ期直肠癌术后卡培他滨±奥沙利铂同步放化疗急性副反应比较  

Comparison of acute toxicities between two postoperative concurrent chemoradiotherapy regimens of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer

作　　者：金晶[1] 李晔雄[1] 王维虎[1] 王凯[1] 宋永文[1] 王淑莲[1] 张世平[1] 刘跃平[1] 房辉[1] 曲媛[1] 刘新帆[1] 余子豪[1] 

机构地区：[1]中国医学科学院北京协和医学院肿瘤医院放疗科,北京100021

出　　处：《中华放射肿瘤学杂志》2009年第3期200-204,共5页Chinese Journal of Radiation Oncology

基　　金：卫生部吴阶平医学基金项目（WKJ2005-3-006）;北京希望马拉松专项基金资助（LC2007A17）

摘　　要：目的比较两个前瞻性非随机对照直肠癌术后同步放化疗临床Ⅱ期研究的急性毒副反应及耐受性。方法2005年3月至2007年11月分别进行卡培他滨术后同步放化疗（单药组，n=118）和奥沙利铂＋卡培他滨术后同步放化疗（双药组，n=90）的Ⅱ期临床研究。两组均予真骨盆放疗DT50Gy分25次5周完成，化疗药物予以连用2周停1周，放疗中共用2周期的方法。单药组卡培他滨每天2次1600mg/m^2；双药组奥沙利铂每周1次70mg/m^2，卡培他滨每天2次1300mg/m^2。结果双药组患者中断放疗（10．2％：6．7％，χ^2=0．80，P=0．460）或化疗的比率（9．3％：19．1％，χ^2=4．80，P=0．090）与单药组相似。双药组1～4级急性非血液学毒副反应发生率显著高于单药组，主要为恶心（χ^2=46．90，P=0．000），腹泻（χ^2=13．50，P=0．009），乏力（χ^2=18．90，P=0．000），手足综合症（χ^2=7．10，P=0．029）和食欲下降（χ^2=19．90，P=0．000）。全组发生3、4级以上严重副反应包括腹泻（24．0％、1．0％）、白细胞下降（4．3％、0．0％）、放射性皮炎（3．8％、0．O％）、腹痛（1．0％、0．0％）和乏力（0．5％、0．0％），但只有3、4级腹泻发生率双药组显著高于单药组（33．0％：18．6％，χ^2=5．90，P=0．023）。结论接受奥沙利铂＋卡培他滨双药同步放化疗患者3、4级腹泻发生率显著高于卡培他滨单药同步放化疗，但其他严重副反应发生率低且两组相似。Objective To compare the acute toxicities between two prospective, non-randomize phase Ⅱ trials on adjuvant radiochemotherapy of capecitabine with or without oxaliplatin in patients with stage Ⅱ and Ⅲ rectal cancer. Methods From March 2005 to November 2007,based on two fulfilled phase I studies, two phase Ⅱ trials were launched respectively to further observe the tolerance and toxicity. In one trial,118 patients were treated with concurrent eapeeitabine and radiotherapy（ Cap-CRT trial）, with radiotherapy of DT50 Gy/25 F/5 wks to the pelvis,and eapeeitabine at a dose of 1600 mg/m^2/d（dl -d14,3 weeks per cycle）. In the other trial ,90 patients received concurrent oxaliplatin, capecitabine and radiotherapy（ Cap-Oxa-CRT trial） ,with the same radiotherapy schedule ,while oxaliplatin at a dose of 70 mg/m^2 （ d1, d8） and eapecitabine of 1300 mg/m^2/d（ dl -d14,3 weeks per cycle）. Results There was no significant difference in the delay of radiotherapy（ 10.2% vs 6.7% ,χ^2 =0.80 ,P =0.460） or chemotherapy（9.3% vs 19.1% ,χ^2 =4.80,P =0. 090） between Cap-CRT and Cap-Oxa-CRT trials. Grade 1 - 4 leukopenia, diarrhea and nausea were the most common acute side-effects in the both trials, accounting for 70.2% ,65.9% and 42.3% ,respectively. When comparing with Cap-CRT trial, Cap-Oxa-CRT trial had significantly more grade 1 -4 non-hemotologieal toxicities,mainly in GI,including nausea（68.9% vs 22.0% ,χ^2=46.90 ,P = 0. 000） ,diarrhea（76.7% vs 57.6% ,χ^2 = 13.50,P =0.009） ,fatigue （47.8% vs 13.7% ,χ^2 = 18.90 ,P=0. 000） , hand-foot syndrome （ 14.4% vs 4.2% , χ^2 = 7.10, P = 0.029 ）, and inappetence （ 50.0% vs. 27.9% , χ^2= 25.70, P = 0. 000 ）, but not in hematological toxities of leukopenia, anemia or thrombocytopenia. Of all the patients, grade 3 and grade 4 toxicities were diarrhea（24.0% and 1.0% ）, leukopenia（4.3% and 0.0% ） ,radiation-induced dermatitis（3.8% and 0.0% ） ,cramping abdominal pain（ 1.0% and 0.0% ） and fatigue（0.5% and 0.0% ）. Only gra

关 键 词：直肠肿瘤/放化疗法 放化疗法 同步 奥沙利铂 卡培他滨 临床Ⅱ期研究 

分 类 号：R686[医药卫生—骨科学]