CAJ | 학술논문

目的：观察索拉非尼治疗中国人群的疗效和安全性。方法选取2006年12月至2009年12月期间沈阳军区总医院收治的经病理确诊的晚期肾细胞癌（aRCC）患者101例，所有患者口服索拉非尼（400 mg，2次/d）直至疾病进展或出现不可耐受的毒性反应。根据 RECIST 1.0实体瘤评价标准联合影像学结果对患者进行疗效评估。应用 NCI-CTC-AE 3.0毒性评价标准进行安全性评估。结果中位随访时间为24个月，疗效评估显示：完全缓解（CR）5例，部分缓解（PR）32例，稳定（SD）50例和无效（PD）14例。总体客观有效率（ORR）、疾病控制率（DCR）和症状缓解率（SAR）分别为36.6%（37/101）、88.1%（89/101）和86.1%（87/101）。影像学分析发现：在早期治疗后，肺脏转移灶直径缩小且 CT 值降低。出现单纯肺脏转移患者的有效率明显高于其他脏器转移或多脏器转移的患者（P=0.001）。生存分析显示：32例患者在随访期间死亡，全组患者中位无进展生存期（PFS）为9个月，1年生存率为76.8%。最常见不良反应为乏力、手足综合征和腹泻。结论索拉非尼能够改善中国 aRCC 患者的 PFS 和1年总生存期（OS），且不良反应可耐受。出现单独肺脏转移或Ⅲ～Ⅳ度不良反应的 aRCC 患者接受索拉非尼治疗的疗效更佳。但上述结论还需大样本研究加以证实。
목적：관찰색랍비니치료중국인군적료효화안전성。방법선취2006년12월지2009년12월기간침양군구총의원수치적경병리학진적만기신세포암（aRCC）환자101례，소유환자구복색랍비니（400 mg，2차/d）직지질병진전혹출현불가내수적독성반응。근거 RECIST 1.0실체류평개표준연합영상학결과대환자진행료효평고。응용 NCI-CTC-AE 3.0독성평개표준진행안전성평고。결과중위수방시간위24개월，료효평고현시：완전완해（CR）5례，부분완해（PR）32례，은정（SD）50례화무효（PD）14례。총체객관유효솔（ORR）、질병공제솔（DCR）화증상완해솔（SAR）분별위36.6%（37/101）、88.1%（89/101）화86.1%（87/101）。영상학분석발현：재조기치료후，폐장전이조직경축소차 CT 치강저。출현단순폐장전이환자적유효솔명현고우기타장기전이혹다장기전이적환자（P=0.001）。생존분석현시：32례환자재수방기간사망，전조환자중위무진전생존기（PFS）위9개월，1년생존솔위76.8%。최상견불량반응위핍력、수족종합정화복사。결론색랍비니능구개선중국 aRCC 환자적 PFS 화1년총생존기（OS），차불량반응가내수。출현단독폐장전이혹Ⅲ～Ⅳ도불량반응적 aRCC 환자접수색랍비니치료적료효경가。단상술결론환수대양본연구가이증실。
Objective To observe the efficacy and toxicity of sorafenib in patients with advanced renal cell cancer. Methods From December 2006 to December 2009,we retrospectively analyzed the data from the General Hospital of Shenyang Military Region. 101 patients enrolled in this study and all cases were diagnosed as metastatic renal cell carcinoma(mRCC) histopathologically without exception. 400 mg sorafenib for patients was orally taken twice daily until the occurrence of PD or intolerable toxic reaction. We evaluated the clinical efficacy in patients according to RECIST 1.0 combined with imaging results,and NCI-CTC-AE 3.0 for safety assessment. Results The median follow-up periods were 24 months. Clinical efficacy assessment shows that CR 5 cases, PR 32 cases, SD 50 cases and PD 14 cases. We found that in the early days after treatment, the lung metastases narrow diameter and CT value reduced by imaging analysis . The prognosis of patients with lung metastasis had better than that of other organs metastasis. Survival analysis showed that 32 cases died during the follow-up period, all patients median PFS was 9 months, 1 year survival rate was 76.8%. The most common adverse reactions were fatigue, hand-and-foot syndrome and diarrhea. Conclusion Sorafenib has good effects on Chinese patients with mRCC and adverse reactions could be tolerated. Patients with lung metastasis alone or adverse reactions in Grade III~IV have better prognosis. Further studies need to be done sequentially.