CAJ | 학술논문

目的探讨索拉非尼治疗晚期肾癌患者的疗效、耐受性与安全性.方法对2008年6月至2013年2月间在吉林省肿瘤医院住院的晚期肾癌患者63例进行随访观察,男45例,女18例,中位年龄57岁(15 ～82岁).48例行患肾切除术后复发或转移,其中36例在复发及转移前曾行细胞因子治疗;手术后发现复发或转移的间期＜1年者11例,≥1年者37例;肾原发病灶不能手术切除的患者15例,均行肾肿瘤穿刺活检.手术后及肾穿刺活检病理类型有49例为透明细胞癌,14例为乳头状癌.用药前患者体能状态按KPS(Karnofsky,卡氏功能状态评分标准)标准评分均在70分以上.均以索拉非尼作为一线药物,单一用药,口服索拉非尼400 mg,2次/d,持续使用至疾病进展或出现不可耐受的不良反应.结果随访截止2013年2月,中位随访时间20(6 ～42)个月,死亡患者24例.63例患者中完全缓解(CR)2例、部分缓解(PR)8例、疾病稳定(SD) 30例、疾病进展(PD)23例,客观反应率15.9％(10/63),疾病控制率为63.5％(40/63).手足综合征发生率70.0％、脱发62.5％、皮疹52.5％、腹泻37.5％、食欲减退32.5％、疲劳乏力27.5％,不良反应多于服药2～4周内出现,持续时间不等,经对症治疗后,均可缓解,未影响服药.结论索拉非尼用于晚期肾癌患者,具有较高的疾病控制率,所产生的不良反应类型与文献报道相似,程度一般较轻,具有良好的耐受性与安全性.
목적 탐토색랍비니치료만기신암환자적료효、내수성여안전성.방법 대2008년6월지2013년2월간재길림성종류의원주원적만기신암환자63례진행수방관찰,남45례,녀18례,중위년령57세(15 ～82세).48례행환신절제술후복발혹전이,기중36례재복발급전이전증행세포인자치료;수술후발현복발혹전이적간기＜1년자11례,≥1년자37례;신원발병조불능수술절제적환자15례,균행신종류천자활검.수술후급신천자활검병리류형유49례위투명세포암,14례위유두상암.용약전환자체능상태안KPS(Karnofsky,잡씨공능상태평분표준)표준평분균재70분이상.균이색랍비니작위일선약물,단일용약,구복색랍비니400 mg,2차/d,지속사용지질병진전혹출현불가내수적불량반응.결과 수방절지2013년2월,중위수방시간20(6 ～42)개월,사망환자24례.63례환자중완전완해(CR)2례、부분완해(PR)8례、질병은정(SD) 30례、질병진전(PD)23례,객관반응솔15.9％(10/63),질병공제솔위63.5％(40/63).수족종합정발생솔70.0％、탈발62.5％、피진52.5％、복사37.5％、식욕감퇴32.5％、피로핍력27.5％,불량반응다우복약2～4주내출현,지속시간불등,경대증치료후,균가완해,미영향복약.결론 색랍비니용우만기신암환자,구유교고적질병공제솔,소산생적불량반응류형여문헌보도상사,정도일반교경,구유량호적내수성여안전성.
Objective To explore the tolerability and safety of sorafenib for patients with advanced renal cell carcinoma.Methods Among 63 cases of advanced renal cell carcinoma,there were 45 males and 18 females with a median age of 57 years.And 48 patients had recurrence or metastasis after nephrectomy.And cytokine therapy was offered for 36 of them before recurrence or metastasis.Postoperative recurrence or metastasis occurred ＜ 1 year (n =11) and ≥ 1 year (n =37).And 15 cases of primary non-resectable renal lesions received biopsy.The pathological types were clear cell carcinoma (n =49) and papillary carcinoma (n =14).The pre-dosing Karnofsky performance scores were all ≥ 70 points.Sorafenib was used as a first-line single drug at 400 mg twice daily until disease progression or an onset of intolerable adverse reactions.Results Follow-ups ended in February 2013.The median follow-up period was 20 (6-42) months.Twenty-four patients died.The outcomes were complete remission (n =2),partial remission (n =8),stable disease (n =30) and disease progression (n =23).The overall objective response rate was 15.9％ (10/63)and disease control rate 63.5％ (40/63).Hand-foot skin reaction (70.0％),alopecia (62.5％),rash (52.5％),diarrhea (37.5％),loss of appetite (32.5％) and fatigue (27.5％) were noted.Most adverse reactions occurred at 2-4 weeks and subsided after symptomatic measures.And medication was not disrupted.Conclusion Sorafenib has a high disease control rate for advanced renal cell carcinoma.And its adverse reactions are generally mild and similar to those reported in the literature.It has excellent profiles of tolerability and safety.