中国实用医刊
中國實用醫刊
중국실용의간
CENTRAL PLAINS MEDICAL JOURNAL
2012年
20期
21-23
,共3页
务森%张宁%朱晓明%陈晓
務森%張寧%硃曉明%陳曉
무삼%장저%주효명%진효
小细胞肺癌%化疗%依托泊苷%伊立替康
小細胞肺癌%化療%依託泊苷%伊立替康
소세포폐암%화료%의탁박감%이립체강
Small cell lung cancer%Hemotherapy%Etoposide%Irinotecan
目的 本次研究主要比较伊立替康联合顺铂方案(IP)与依托泊苷联合顺铂方案一线治疗小细胞肺癌的近期疗效和不良反应.方法 61例符合入组条件的SCLC患者采用随机方法分为IP组和EP组,Ⅲ期38例(62.3％),Ⅳ期23例(37.7％).IP组方案:伊立替康80 mg/m2,第1、8天,顺铂25 mg/m2,第1～3天,21d为1个周期；EP组方案:依托泊苷100 mg/m2,第1～3天,顺铂25 mg/m2,第1～3天,21d为1周期.共4个周期,2个周期后评价为未获缓解的患者交换分组继续研究.结果 所有患者均完成预定的4周期化疗和疗效评价,客观有效率(ORR)为82.0％(50/61),IP组ORR为74.2％,EP组ORR为66.7％(x2=0.415,P=0.582),其中IP组完全缓解16例(51.6％),EP组完全缓解8例(26.7％)(x2 =5.056,P=0.033).交换组共18例患者,部分缓解7例(38.9％),IP+ EP 8例中部分缓解2例(25％),低于EP+IP 10例中部分缓解5例(50％)(x2=1.169,P=0.367).本研究无化疗相关死亡病例.IP组主要不良反应包括粒细胞减少75.6％、腹泻46.3％和呕吐41.5％.EP组主要不良反应包括呕吐71.1％、粒细胞减少68.4％和贫血28.9％.其中,IP组腹泻发生率与EP组比较差异有统计学意义(P＜0.01).G3以上不良反应发生率比较差异均无统计学意义(P＞0.05).结论 IP方案化疗具有更高的完全缓解率,腹泻发生率也明显高于EP方案,通过积极对症处理,可以耐受.
目的 本次研究主要比較伊立替康聯閤順鉑方案(IP)與依託泊苷聯閤順鉑方案一線治療小細胞肺癌的近期療效和不良反應.方法 61例符閤入組條件的SCLC患者採用隨機方法分為IP組和EP組,Ⅲ期38例(62.3％),Ⅳ期23例(37.7％).IP組方案:伊立替康80 mg/m2,第1、8天,順鉑25 mg/m2,第1～3天,21d為1箇週期；EP組方案:依託泊苷100 mg/m2,第1～3天,順鉑25 mg/m2,第1～3天,21d為1週期.共4箇週期,2箇週期後評價為未穫緩解的患者交換分組繼續研究.結果 所有患者均完成預定的4週期化療和療效評價,客觀有效率(ORR)為82.0％(50/61),IP組ORR為74.2％,EP組ORR為66.7％(x2=0.415,P=0.582),其中IP組完全緩解16例(51.6％),EP組完全緩解8例(26.7％)(x2 =5.056,P=0.033).交換組共18例患者,部分緩解7例(38.9％),IP+ EP 8例中部分緩解2例(25％),低于EP+IP 10例中部分緩解5例(50％)(x2=1.169,P=0.367).本研究無化療相關死亡病例.IP組主要不良反應包括粒細胞減少75.6％、腹瀉46.3％和嘔吐41.5％.EP組主要不良反應包括嘔吐71.1％、粒細胞減少68.4％和貧血28.9％.其中,IP組腹瀉髮生率與EP組比較差異有統計學意義(P＜0.01).G3以上不良反應髮生率比較差異均無統計學意義(P＞0.05).結論 IP方案化療具有更高的完全緩解率,腹瀉髮生率也明顯高于EP方案,通過積極對癥處理,可以耐受.
목적 본차연구주요비교이립체강연합순박방안(IP)여의탁박감연합순박방안일선치료소세포폐암적근기료효화불량반응.방법 61례부합입조조건적SCLC환자채용수궤방법분위IP조화EP조,Ⅲ기38례(62.3％),Ⅳ기23례(37.7％).IP조방안:이립체강80 mg/m2,제1、8천,순박25 mg/m2,제1～3천,21d위1개주기；EP조방안:의탁박감100 mg/m2,제1～3천,순박25 mg/m2,제1～3천,21d위1주기.공4개주기,2개주기후평개위미획완해적환자교환분조계속연구.결과 소유환자균완성예정적4주기화료화료효평개,객관유효솔(ORR)위82.0％(50/61),IP조ORR위74.2％,EP조ORR위66.7％(x2=0.415,P=0.582),기중IP조완전완해16례(51.6％),EP조완전완해8례(26.7％)(x2 =5.056,P=0.033).교환조공18례환자,부분완해7례(38.9％),IP+ EP 8례중부분완해2례(25％),저우EP+IP 10례중부분완해5례(50％)(x2=1.169,P=0.367).본연구무화료상관사망병례.IP조주요불량반응포괄립세포감소75.6％、복사46.3％화구토41.5％.EP조주요불량반응포괄구토71.1％、립세포감소68.4％화빈혈28.9％.기중,IP조복사발생솔여EP조비교차이유통계학의의(P＜0.01).G3이상불량반응발생솔비교차이균무통계학의의(P＞0.05).결론 IP방안화료구유경고적완전완해솔,복사발생솔야명현고우EP방안,통과적겁대증처리,가이내수.
Objective The purpose of this randomized trial is to compare the efficacy and toxicity of irinotecan plus cisplatin(IP) with EP as the first-line chemotherapy.Methods A total of 61 patients with SCLC were randomly divided into arm IP (irinotecan 80 mg/m2,d1,8 ; cisplatin 25 mg/m2,d1-3,21 d/cycle) and arm EP(etoposide 100 ng/m2,cisplatin 25 mg/m2,d1-3,21 d/cycle).38 patients(62.3％) were staged Ⅲ according to 7th UICC TNM staging,23 were staged Ⅳ.All patients completed 4 cycles chemotherapy,18 patients altered regimen while no response was found after 2 cycles.Results The total objective response rate (ORR) was 82.0％,74.2％ (IP) vs.66.7％ (EP)(P =0.582),the rate complete response(CR) with IP and EP was 51.6％ and 26.7％,respectively (P =0.033).7 patients(38.9％) experienced partial response after altered regimen,there was no difference between IP and EP(2/8 vs 5/10,P =0.367).The common adverse effects included neutropenia (75.6％),diarrhea (46.3％),and vomiting (41.5％) of IP,vomiting(71.1％),neutropenia (68.4％) and anemia(28.9％) of EP,the morbidity of diarrhea was higher of IP than EP(46.3％ vs.10.5％,P ＜ 0.01).Conclusions IP regimen cause a higher rate of CR than EP for SCLC,a higher morbidity of diarrhea too,the adverse effects can be tolerated by appropriate treatment.
