CAJ | 학술논문

目的探讨索拉非尼治疗晚期肾癌的不良反应及其与疗效的相关性. 方法晚期肾癌患者51例,有可测病灶,其中T1Nx,0,1M1 26例、T2Nx,0 M112例、T3NxM1 8例、T4NxM1 5例,46例T1～T3患者原发灶已手术切除,5例T4NxM1患者原发灶未切除.51例患者均采用索拉非尼治疗,400 mg每日2次口服,不间断治疗.每2个月复查CT评效,根据疗效及不良反应调整索拉非尼用量.2例患者由于不良反应减量为200 mg每日2次,16例患者病情进展后予以增量治疗,其中12例患者增至600 mg每日2次,4例增至800 mg每日2次.详细记录患者治疗期间不良反应,并按照美国国立癌症研究所通用毒性标准3.0版进行分级,实体瘤评价标准进行疗效评价,观察客观反应率及无疾病进展生存期(PFS).应用统计学软件分析不良反应的发生率及其与疗效的相关性. 结果 51例患者发生手足皮肤反应35例(68.6%),腹泻20例(39.2%),皮疹13例(25.5%),黏膜炎12例(23.5 0A),高血压9例(17.6%),骨髓抑制7例(13.7%);发生3～4级不良反应患者的有效率33.3%(12/36),无3～4级不良反应患者12.0%(3/25).患者手足皮肤反应发生率高于其他不良反应(P<0.01),黏膜炎及皮疹发生与疗效具有相关性(P值分别为0.048及0.045),3～4级不良反应的发生与疗效具有相关性(P=0.008).中位PFS为15.0个月(95%CI 5.64～24.37个月),PFS与不良反应无相关性. 结论晚期肾癌患者接受索拉非尼治疗后出现相关不良反应可作为疗效的预测因素.
목적 탐토색랍비니치료만기신암적불량반응급기여료효적상관성. 방법 만기신암환자51례,유가측병조,기중T1Nx,0,1M1 26례、T2Nx,0 M112례、T3NxM1 8례、T4NxM1 5례,46례T1～T3환자원발조이수술절제,5례T4NxM1환자원발조미절제.51례환자균채용색랍비니치료,400 mg매일2차구복,불간단치료.매2개월복사CT평효,근거료효급불량반응조정색랍비니용량.2례환자유우불량반응감량위200 mg매일2차,16례환자병정진전후여이증량치료,기중12례환자증지600 mg매일2차,4례증지800 mg매일2차.상세기록환자치료기간불량반응,병안조미국국립암증연구소통용독성표준3.0판진행분급,실체류평개표준진행료효평개,관찰객관반응솔급무질병진전생존기(PFS).응용통계학연건분석불량반응적발생솔급기여료효적상관성. 결과 51례환자발생수족피부반응35례(68.6%),복사20례(39.2%),피진13례(25.5%),점막염12례(23.5 0A),고혈압9례(17.6%),골수억제7례(13.7%);발생3～4급불량반응환자적유효솔33.3%(12/36),무3～4급불량반응환자12.0%(3/25).환자수족피부반응발생솔고우기타불량반응(P<0.01),점막염급피진발생여료효구유상관성(P치분별위0.048급0.045),3～4급불량반응적발생여료효구유상관성(P=0.008).중위PFS위15.0개월(95%CI 5.64～24.37개월),PFS여불량반응무상관성. 결론 만기신암환자접수색랍비니치료후출현상관불량반응가작위료효적예측인소.
Objective To identify the relationship between sorafenib's efficacy and its side effects in treatment of advanced renal cell carcinoma patients. Methods Fifty-one patients having measurable diseases were diagnosed with advanced renal cell carcinoma. Of whom, 26 patients were in stage T1Nx,0,1M1, 12 patients in stage T2Nx,0 M1, 8 patients in stage T3NxM1, 5 patients in stage T4NxM1. These 46 patients of T1 -T3 had their primary diseases removed, but the 5 T~ patients didn"t have their primary diseases removed. These 51 patients received oral sorafenib 400 mg Bid continual-ly and they had CT scan every two months to evaluate the progression. The dosage of sorafenib wasmodified according to efficacy and toxicity. Two patients changed the dosage to 200 mg Bid due to se-vere side effects. Sixteen patients increased the dosage to 600 mg Bid or 800 mg Bid. The response ofSorafenib and toxicities as well as their severity were recorded. The toxicity severity was graded ac-cording to National Cancer Institute Common Toxicity Criteria version 3.0. The efficacy was deter-mined by RECIST criteria. The efficacy and progression free survival (PFS) were recorded. The sta-tistics analysis was conducted between sorafenib's side effects and efficacy as well as their severity by multi-faetor Logistic regression. Results The rates of adverse events in the patients receiving oral sorafenib were hand-foot skin reaetion 68. 6% (35/51), diarrhea 39. 2% (20/51), rash 25. 5% (13/ 51), mucositis 23.5% (12/51), hypertension 17.6% (9/51), and myelosuppression 13. 7%(7/51). The response rate in the patients who had toxicity of grade 3-4 was 33.3%(12/36), and that in the patients who had slight toxicity was 12.0%(3/25). The rate of hand-foot skin reaction was higher than that of diarrhea, rash, mucositis, hypertension and bone marrow suppression (P<0.01). Sor-afenib's efficacy was eorrelated to rash and mueositis (P=0.048, 0.045 respectively). More grade 3 4 side effects occurred in the patients who would have better response to sorafenib (P=0.008). The median PFS was 15.0 months and PFS was not related to the toxicity and its severity. Conclusions It may help to predict the response for sorafenib's side effects and efficacy in the treatment of the patients with advaneed renal cell earcinoma.