中华肿瘤杂志
中華腫瘤雜誌
중화종류잡지
CHINESE JOURNAL OF ONCOLOGY
2011年
11期
854-859
,共6页
韩宝惠%修清玉%王慧敏%沈洁%顾爱琴%罗以%白春学%郭述良%刘文超%庄志祥%张阳%赵怡卓%姜丽岩%施春雷%金波%周建英%金先桥
韓寶惠%脩清玉%王慧敏%瀋潔%顧愛琴%囉以%白春學%郭述良%劉文超%莊誌祥%張暘%趙怡卓%薑麗巖%施春雷%金波%週建英%金先橋
한보혜%수청옥%왕혜민%침길%고애금%라이%백춘학%곽술량%류문초%장지상%장양%조이탁%강려암%시춘뢰%금파%주건영%금선교
癌,非小细胞肺%药物疗法,联合%治疗效果%恩度%紫杉醇%卡铂
癌,非小細胞肺%藥物療法,聯閤%治療效果%恩度%紫杉醇%卡鉑
암,비소세포폐%약물요법,연합%치료효과%은도%자삼순%잡박
Carcinoma,non-small cell lung%Drug therapy,combination%Treatment outcome%Endostar%Paclitaxel%Carboplatin
目的 比较泰素、卡铂(TC)联合重组人血管内皮抑制索注射液(商品名恩度(@))与TC 方案治疗晚期非小细胞肺癌(NSCLC)的疗效、生活质量及安全性.方法 采用前瞻性、多中心、随机、双肓、安慰剂对照临床研究.共126例晚期初治NSCLC患者入组,TC联合恩度治疗组63例,TC 对照组63例.所有入组患者在研究结束后继续随访至疾病进展和死亡.结果 恩度治疗组的客观缓解率(ORR)为39.3％,对照组的ORR为23.0％ (P =0.078).恩度治疗组和对照组24周的无进展生存率分别为78.3％和58.8％ (P =0.017),疾病进展风险比为0.35(95％置信区间0.13 ～0.90,P=0.030).恩度治疗组和对照组的中位疾病进展时间(TTP)分别为7.1个月和6.3个月(P＞0.05).恩度治疗组的中位生存期(mOS)为17.6个月(95％ CI为13.4～21.7个月),对照组为15.8个月(95％ CI为9.4～22.9个月),差异无统计学意义(P＞0.05).恩度治疗组治疗后生活质量评分(LCSS患者量表)有所改善,对照组患者在完成2个周期和3个周期治疗后,生活质量改善.恩度治疗组完成1个周期治疗后,其生活质昔评分与基线差异有统计学意义(P =0.028),对照组差异也有统计学意义(P =0.036),表明恩度治疗组在治疗初期更能改善患者的生活质量.恩度治疗组和对照组不良反应及严重不良反应发生率比较,差异无统计学意义(P＞0.05).结论 与单纯化疗相比,TC 联合恩度一线治疗晚期NSCLC可降低早期疾病进展风险比(24周),提高ORR(P =0.078).TC联合恩度方案具有较好的安全性及耐受性好,患者治疗前后生活质量有所改善,未增加严重不良反应发生率.
目的 比較泰素、卡鉑(TC)聯閤重組人血管內皮抑製索註射液(商品名恩度(@))與TC 方案治療晚期非小細胞肺癌(NSCLC)的療效、生活質量及安全性.方法 採用前瞻性、多中心、隨機、雙肓、安慰劑對照臨床研究.共126例晚期初治NSCLC患者入組,TC聯閤恩度治療組63例,TC 對照組63例.所有入組患者在研究結束後繼續隨訪至疾病進展和死亡.結果 恩度治療組的客觀緩解率(ORR)為39.3％,對照組的ORR為23.0％ (P =0.078).恩度治療組和對照組24週的無進展生存率分彆為78.3％和58.8％ (P =0.017),疾病進展風險比為0.35(95％置信區間0.13 ～0.90,P=0.030).恩度治療組和對照組的中位疾病進展時間(TTP)分彆為7.1箇月和6.3箇月(P＞0.05).恩度治療組的中位生存期(mOS)為17.6箇月(95％ CI為13.4～21.7箇月),對照組為15.8箇月(95％ CI為9.4～22.9箇月),差異無統計學意義(P＞0.05).恩度治療組治療後生活質量評分(LCSS患者量錶)有所改善,對照組患者在完成2箇週期和3箇週期治療後,生活質量改善.恩度治療組完成1箇週期治療後,其生活質昔評分與基線差異有統計學意義(P =0.028),對照組差異也有統計學意義(P =0.036),錶明恩度治療組在治療初期更能改善患者的生活質量.恩度治療組和對照組不良反應及嚴重不良反應髮生率比較,差異無統計學意義(P＞0.05).結論 與單純化療相比,TC 聯閤恩度一線治療晚期NSCLC可降低早期疾病進展風險比(24週),提高ORR(P =0.078).TC聯閤恩度方案具有較好的安全性及耐受性好,患者治療前後生活質量有所改善,未增加嚴重不良反應髮生率.
목적 비교태소、잡박(TC)연합중조인혈관내피억제색주사액(상품명은도(@))여TC 방안치료만기비소세포폐암(NSCLC)적료효、생활질량급안전성.방법 채용전첨성、다중심、수궤、쌍황、안위제대조림상연구.공126례만기초치NSCLC환자입조,TC연합은도치료조63례,TC 대조조63례.소유입조환자재연구결속후계속수방지질병진전화사망.결과 은도치료조적객관완해솔(ORR)위39.3％,대조조적ORR위23.0％ (P =0.078).은도치료조화대조조24주적무진전생존솔분별위78.3％화58.8％ (P =0.017),질병진전풍험비위0.35(95％치신구간0.13 ～0.90,P=0.030).은도치료조화대조조적중위질병진전시간(TTP)분별위7.1개월화6.3개월(P＞0.05).은도치료조적중위생존기(mOS)위17.6개월(95％ CI위13.4～21.7개월),대조조위15.8개월(95％ CI위9.4～22.9개월),차이무통계학의의(P＞0.05).은도치료조치료후생활질량평분(LCSS환자량표)유소개선,대조조환자재완성2개주기화3개주기치료후,생활질량개선.은도치료조완성1개주기치료후,기생활질석평분여기선차이유통계학의의(P =0.028),대조조차이야유통계학의의(P =0.036),표명은도치료조재치료초기경능개선환자적생활질량.은도치료조화대조조불량반응급엄중불량반응발생솔비교,차이무통계학의의(P＞0.05).결론 여단순화료상비,TC 연합은도일선치료만기NSCLC가강저조기질병진전풍험비(24주),제고ORR(P =0.078).TC연합은도방안구유교호적안전성급내수성호,환자치료전후생활질량유소개선,미증가엄중불량반응발생솔.
Objective To analyze the efficacy and quality of life and safety for paclitaxel and carboplatin (TC) and TC combined with endostar in the treatment of advanced non-small cell lung cancer (NSCLC).Methods This is a prospective,multicenter,randomized,double-blind,placebo-controlled clinical study.A total of 126 cases of untreated advanced NSCLC were enrolled in this study.There were 63 patients in the TC control arm and TC combined endostar arm,respectively.All enrolled patients were continuously followed-up for disease progression and death.Results The objective response rate (ORR) of TC combined with endostar arm was 39.3％,and that of TC control arm was 23.0％,P =0.078.The progression-free survival rates for TC combined with endostar arm and TC control arm were 78.3％ and 58.8％,respectively,in 24 weeks (P =0.017).The hazard ratio for the risk of disease progression was 0.35 (95％ CI 0.13 to 0.90,P =0.030).The median time to progression (TTP) of the TC combined with endostar arm was 7.1 months and TC arm 6.3 months ( P ＞ 0.05 ).The follow-up results showed that the median survival time (mOS) of the TC + Endostar arm was 17.6 months; (95％ CI 13.4 to 21.7 months),and the TC + placebo arm 15.8 months (95 ％ CI 9.4 to 22.9 months) ( P ＞ 0.05 ).The quality of life scores ( LCSS patient scale) after treatment of the TC combined with endostar arm was improved,and that of the TC group was improved after completion of two cycles and three cycles of treatment.The quality of life scores compared with baseline after the completion of one cycle treatment was significantly improved for both the TC combined with endostar arm (P =0.028 and),and TC arm (P =0.036).It Indicated that TC combined with endostar treatment improved the patient's quality of life in the early treatment.The difference of adverse and serious adverse event rates between the two groups was not significant ( P ＞ 0.05 ).Conclusions Compared with TC alone treatmrnt,TC combined with endostar treatment can reduce the risk of disease progression at early time (24 weeks),increase the ORR,and can be used as first-line treatment for advanced NSCLC.The TC combined with endostar treatment has good safety and tolerability,improves the quality of life,and not increases serious adverse effects and toxicity for patients with advanced NSCLC.
