中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2009年
22期
1544-1548
,共5页
癌,非小细胞肺%抗肿瘤药%肿瘤治疗方案%治疗结果%多西他赛
癌,非小細胞肺%抗腫瘤藥%腫瘤治療方案%治療結果%多西他賽
암,비소세포폐%항종류약%종류치료방안%치료결과%다서타새
Carcinoma,non-small-cell lung%Antineoplastic agents%Antineoplastic protocols%Treatment outcome%Docetaxel
目的 比较晚期非小细胞肺癌(NSCLC)患者二线治疗中多西他赛单药与多西他赛联合铂类方案的疗效及毒副反应,为NSCLC的二线规范治疗提供依据.方法 回顾性分析2004年1月至2008年5月在上海交通大学附属胸科医院接受二线化疗的152例晚期NSCLC患者的临床资料.40例接受多西他赛单药治疗(单药组),其中Ⅲb期16例,Ⅳ期24例;治疗前体力状况(PS)评分0～1分32例,2分8例.112例接受多西他赛联合铂类治疗(联合组),其中Ⅲb期29例,Ⅳ期83例;治疗前PS评分0～1分98例,2分14例.主要研究终点为总生存期(OS),次要研究终点为疾病控制率(DCR)、无疾病进展时间(PFS)、1年生存率及药物毒副反应.应用Kaplan-Meire方法进行生存分析,并进行各影响因素与预后关系的单因素及多因素分析.结果 单药组中位PFS(3.0个月)短于联合组(4.2个月,P=0.048),中位OS(17.0个月)、DCR(61.1%)和1年生存率(84.6%)与联合组(18.8个月、69.1%、86.9%)比较,差异均无统计学意义(均P0.05).单药组Ⅲ～Ⅳ度白细胞减少和胃肠道反应发生率分别为32.5%和0,均明显低于联合组(56.2%,4.5%,均P=0.000).预后因素分析显示既往接受手术[危险比(HR)=0.428,95%可信区间(CI)为0.261～0.701]、治疗前PS评分(HR=1.919,95% CI为0.999～3.685)、肿瘤分期(HR=2.297,95% CI为1.427～3.696)以及二线治疗获益(HR=0.318,95% CI为0.177～0.571)是NSCLC的独立预后因素.结论 多西他赛联合铂类方案二线治疗与多西他赛单药方案相比有助于延长一般情况较好的晚期NSCLC患者的无疾病进展时间,但未显著增加患者的总生存期,并可给患者带来更大的血液学及胃肠道毒性.
目的 比較晚期非小細胞肺癌(NSCLC)患者二線治療中多西他賽單藥與多西他賽聯閤鉑類方案的療效及毒副反應,為NSCLC的二線規範治療提供依據.方法 迴顧性分析2004年1月至2008年5月在上海交通大學附屬胸科醫院接受二線化療的152例晚期NSCLC患者的臨床資料.40例接受多西他賽單藥治療(單藥組),其中Ⅲb期16例,Ⅳ期24例;治療前體力狀況(PS)評分0～1分32例,2分8例.112例接受多西他賽聯閤鉑類治療(聯閤組),其中Ⅲb期29例,Ⅳ期83例;治療前PS評分0～1分98例,2分14例.主要研究終點為總生存期(OS),次要研究終點為疾病控製率(DCR)、無疾病進展時間(PFS)、1年生存率及藥物毒副反應.應用Kaplan-Meire方法進行生存分析,併進行各影響因素與預後關繫的單因素及多因素分析.結果 單藥組中位PFS(3.0箇月)短于聯閤組(4.2箇月,P=0.048),中位OS(17.0箇月)、DCR(61.1%)和1年生存率(84.6%)與聯閤組(18.8箇月、69.1%、86.9%)比較,差異均無統計學意義(均P0.05).單藥組Ⅲ～Ⅳ度白細胞減少和胃腸道反應髮生率分彆為32.5%和0,均明顯低于聯閤組(56.2%,4.5%,均P=0.000).預後因素分析顯示既往接受手術[危險比(HR)=0.428,95%可信區間(CI)為0.261～0.701]、治療前PS評分(HR=1.919,95% CI為0.999～3.685)、腫瘤分期(HR=2.297,95% CI為1.427～3.696)以及二線治療穫益(HR=0.318,95% CI為0.177～0.571)是NSCLC的獨立預後因素.結論 多西他賽聯閤鉑類方案二線治療與多西他賽單藥方案相比有助于延長一般情況較好的晚期NSCLC患者的無疾病進展時間,但未顯著增加患者的總生存期,併可給患者帶來更大的血液學及胃腸道毒性.
목적 비교만기비소세포폐암(NSCLC)환자이선치료중다서타새단약여다서타새연합박류방안적료효급독부반응,위NSCLC적이선규범치료제공의거.방법 회고성분석2004년1월지2008년5월재상해교통대학부속흉과의원접수이선화료적152례만기NSCLC환자적림상자료.40례접수다서타새단약치료(단약조),기중Ⅲb기16례,Ⅳ기24례;치료전체력상황(PS)평분0～1분32례,2분8례.112례접수다서타새연합박류치료(연합조),기중Ⅲb기29례,Ⅳ기83례;치료전PS평분0～1분98례,2분14례.주요연구종점위총생존기(OS),차요연구종점위질병공제솔(DCR)、무질병진전시간(PFS)、1년생존솔급약물독부반응.응용Kaplan-Meire방법진행생존분석,병진행각영향인소여예후관계적단인소급다인소분석.결과 단약조중위PFS(3.0개월)단우연합조(4.2개월,P=0.048),중위OS(17.0개월)、DCR(61.1%)화1년생존솔(84.6%)여연합조(18.8개월、69.1%、86.9%)비교,차이균무통계학의의(균P0.05).단약조Ⅲ～Ⅳ도백세포감소화위장도반응발생솔분별위32.5%화0,균명현저우연합조(56.2%,4.5%,균P=0.000).예후인소분석현시기왕접수수술[위험비(HR)=0.428,95%가신구간(CI)위0.261～0.701]、치료전PS평분(HR=1.919,95% CI위0.999～3.685)、종류분기(HR=2.297,95% CI위1.427～3.696)이급이선치료획익(HR=0.318,95% CI위0.177～0.571)시NSCLC적독립예후인소.결론 다서타새연합박류방안이선치료여다서타새단약방안상비유조우연장일반정황교호적만기NSCLC환자적무질병진전시간,단미현저증가환자적총생존기,병가급환자대래경대적혈액학급위장도독성.
Objective To compare the therapeutic efficacies and toxicities of single-agent docetaxel or docetaxel plus platinum combination agent in patients with advanced non-small cell lung cancer (NSCLC) so as to provide rationales for standard second-line chemotherapy. Methods The clinical data from 152 patients with NSCLC who were admitted into Chest Hospital Affiliated to Shanghai Jiantong University, from January 2004 to May 2008 were retrospectively analyzed. Forty patients were treated with single-agent docetaxel (single-agent group, 16 and 24 patients with stages Ⅲb and Ⅳ disease respectively; 32 patients with PS score 0-1 before treatment and 8 patients with PS score 2 before treatment), and 112 patients were treated with docetaxel plus platinum combination agent (combination group, 29 and 83 patients with stage Ⅲ b and Ⅳ disease respectively; 98 patients with PS score 0 - 1 before treatment and 14 patients with PS score 2 before treatment). Primary end point was overall survival (OS) ,and secondary end point were progression-free survival time (PFS), disease control rate (DCR), one-year survival, and drug toxicity. Survival analysis was evaluated by Kaplan-Meier. Single factor analysis and Cox regression model were done to analyze the relationship between the influencing factors and the prognosis of disease. Results The median PFS of the single-agent group was 3.0 months, significantly shorter than that of the combination gtoup (4.2 months, P=0.048). However, no statistical differences were found in OS, DCR or one-year survival between the two groups (all P0.05). The most common grade 3 to 4 toxicities were leukopenia (32.5% for single-agent group, and 56.2% for combination group, P=0.000), and gastro-intestinal toxicity (0 for single-agent group, and 4.5% for combination group, P=0.000). Single factor analysis showed that the factors including radiotherapeutic history, operative history, PS score before treatment, clinical stage, and response to second-line treatment influenced the prognosis of NSCLC (all P<0.05). Cox regression analysis demonstrated operative history(HR=0.428, 95% CI: 0.261-0.701), PS score before treatment (HR=1.919, 95% CI: 0.999-3.685), clinical stage (HR=2.297, 95% CI: 1.427-3.696) and response to second-line treatment (HR=0. 318, 95% CI: 0.177-0.571) had effects on survival. Conclusions To those well-selected patients, docetaxel plus platinum combination agent as the second-line treatment of advanced NSCLC significantly prolongs the progression-free survival. But such a regimen is more toxic and does not improve the response rate and overall survival.
