CAJ | 학술논문

背景与目的:舒尼替尼治疗肾癌已取得显著疗效,本研究旨在初步探讨舒尼替尼治疗晚期肾癌的有效性及安全性.方法:晚期肾癌患者36例,其中单发转移16例,其余为全身多发转移病灶,均经穿刺病理证实为肾癌.采用标准4/2治疗方案:舒尼替尼50 mg,每天1次.口服,服药4周停药2周为1个周期,持续至患者疾病进展或出现不可耐受的不良反应,至少2个周期进行1次疗效评价.结果:随访截止至2012年7月,可评价疗效病例29例,疾病进展(progressive disease,PD)5例、部分缓解(partial response,PR)6例、完全缓解(complete response,CR)1例,疾病稳定(stable disease,SD)17例,疾病控制率(DCR=CR+PR+SD)为82.8%(24/29),客观反应率(ORR=CR+PR)为24.1%(7/29),因疾病进展死亡5例(17.2%),中位无进展生存期(progression-free survival,PFS)与总生存期(overall survival,OS)尚未达到.常见不良反应主要有乏力21例(58.3%)、皮肤黄染17例(47.2%)、手足皮肤反应18例(50%)、高血压16例(44.4%)、甲状腺功能减退8例(22.2%)、腹泻10例(27.8%)、贫血9例(25%)、中性粒细胞减少9例(25%)、血小板减少7例(19.4%),3、4级不良反应有手足皮肤反应2例(6%),高血压1例(3%),中性粒细胞减少3例(8%),血小板减少2例(6%).多数为轻度不良反应,经对症治疗后均可缓解.结论:舒尼替尼治疗晚期肾癌有效,严重不良反应较少,耐受性及安全性良好.
배경여목적:서니체니치료신암이취득현저료효,본연구지재초보탐토서니체니치료만기신암적유효성급안전성.방법:만기신암환자36례,기중단발전이16례,기여위전신다발전이병조,균경천자병리증실위신암.채용표준4/2치료방안:서니체니50 mg,매천1차.구복,복약4주정약2주위1개주기,지속지환자질병진전혹출현불가내수적불량반응,지소2개주기진행1차료효평개.결과:수방절지지2012년7월,가평개료효병례29례,질병진전(progressive disease,PD)5례、부분완해(partial response,PR)6례、완전완해(complete response,CR)1례,질병은정(stable disease,SD)17례,질병공제솔(DCR=CR+PR+SD)위82.8%(24/29),객관반응솔(ORR=CR+PR)위24.1%(7/29),인질병진전사망5례(17.2%),중위무진전생존기(progression-free survival,PFS)여총생존기(overall survival,OS)상미체도.상견불량반응주요유핍력21례(58.3%)、피부황염17례(47.2%)、수족피부반응18례(50%)、고혈압16례(44.4%)、갑상선공능감퇴8례(22.2%)、복사10례(27.8%)、빈혈9례(25%)、중성립세포감소9례(25%)、혈소판감소7례(19.4%),3、4급불량반응유수족피부반응2례(6%),고혈압1례(3%),중성립세포감소3례(8%),혈소판감소2례(6%).다수위경도불량반응,경대증치료후균가완해.결론:서니체니치료만기신암유효,엄중불량반응교소,내수성급안전성량호.
@@@@Background and purpose: There is significant efficacy in the treatment of renal cell carcinoma for sunitinib. This article aimed to investigate preliminarily the efficacy and safety of advanced renal cell carcinoma treated with sunitinib. Methods: A total number of 36 patients with advanced renal cell carcinoma were enrolled, including 16 cases of solitary metastases and the rest of systemic multiple metastases, all the patients were confirmed by biopsy. Sunitinib was administered in standard 4/2 regimens: 50 mg once a day orally, taking 4 weeks, stopping 2 weeks, 6 weeks per 1 cycle, and continued until disease progression or occurrence of intolerable adverse reactions, and had an efficacy evaluation at least 2 cycles. Results: The follow-up ended in Jul. 2012, 29 patients could be evaluated efficacy, 5(17.2%) patients dead, 5 patients developed progressive disease, 6 patients achieved partial remission, 1 patient achieved complete remission, 17 patients demonstrated stable disease, the disease control rate was 82.8%(24/29), objective response rate was 24.1% (7/29). The median progression-free survival and overall survival has not yet reached. The follow-up time was ranged from 3 to 28 months. Common adverse reactions were mainly fatigue, yellowish discoloration of skin, hand-foot skin reaction, hypertension, hypothyroidism, diarrhea, anemia, neutropenia, thrombocytopenia, 3-4 adverse events were hand-foot skin reaction (11.5%), hypertension, thrombocytopenia and neutropenia. Mostly mild adverse reactions after symptomatic treatment could be alleviated, did not affect the medication. Conclusion: Sunitinib was efficacious in the treatment of advanced kidney cancer, had fewer serious adverse reactions and good tolerability and safety.