中国癌症杂志
中國癌癥雜誌
중국암증잡지
CHINA ONCOLOGY
2014年
8期
615-621
,共7页
朱晓东%赵晓莹%彭伟%孙思%曹君%季冬梅%刘欣%王辰辰%于慧%李进%印季良
硃曉東%趙曉瑩%彭偉%孫思%曹君%季鼕梅%劉訢%王辰辰%于慧%李進%印季良
주효동%조효형%팽위%손사%조군%계동매%류흔%왕신신%우혜%리진%인계량
胃癌%联合化疗%表柔比星%奥沙利铂%氟尿嘧啶
胃癌%聯閤化療%錶柔比星%奧沙利鉑%氟尿嘧啶
위암%연합화료%표유비성%오사리박%불뇨밀정
Gastric cancer%Combination chemotherapy%Epirubicin%Oxaliplatin%5-fluorouracil
背景与目的：晚期胃癌治疗中，ECF(表柔比星、顺铂及5-FU持续滴注21 d)方案系经典一线方案，2004年起我们以奥沙利铂取代顺铂，以低剂量5-FU持续滴注120 h取代标准剂量持续滴注21 d，组成EOF5方案，以期提高疗效及依从性，先后开展了小样本探索性研究及扩大样本的Ⅱ期研究。方法：本研究回顾性分析了该两项Ⅱ期研究结果。患者均接受了表柔比星50 mg/m2，静脉推注，第1天；奥沙利铂130 mg/m2，静脉滴注2 h，第1天；每天5-FU的剂量为375~425 mg/m2，低剂量持续输注5 d共120 h；每3周重复，每6周评价疗效。治疗到进展、不能耐受或患者退出，对于6~8个疗程后稳定以上疗效的患者根据医师推荐及患者的意愿，选择氟尿嘧啶类药物维持治疗或观察。结果：178例晚期胃癌患者纳入本研究，170例可行疗效及不良反应评估，7例(3.9%)完全缓解(complete response，CR)，76例(42.7%)部分缓解(partial response，PR)，总有效率(overall response rate，ORR，CR+PR)为46.6%，69例(38.8%)疾病稳定(stable disease，SD)，18例(10.1%)疾病进展(progressive disease，PD)。中位无进展生存期(progress free survival，PFS)为6.0个月(95%CI：5.2~6.8)，中位总生存期(overall survival，OS)为12.6个月(95%CI：8.9~16.3)，1、2年生存率分别为50.9%和28.0%。3~4度以上不良反应主要有白细胞及中性粒细胞减少23.0%及38.8%、血红蛋白下降6.5%、血小板下降23.5%、恶心呕吐14.1%、手足麻木1.2%。接受二线治疗的75例患者，二线治疗中位生存时间8.0个月(95%CI：4.8~11.2)。结论：EOF5方案治疗晚期胃癌有效率高，PFS和OS同ECF及其改良方案类似，不良反应可控，是安全有效的晚期胃癌一线治疗方案。
揹景與目的：晚期胃癌治療中，ECF(錶柔比星、順鉑及5-FU持續滴註21 d)方案繫經典一線方案，2004年起我們以奧沙利鉑取代順鉑，以低劑量5-FU持續滴註120 h取代標準劑量持續滴註21 d，組成EOF5方案，以期提高療效及依從性，先後開展瞭小樣本探索性研究及擴大樣本的Ⅱ期研究。方法：本研究迴顧性分析瞭該兩項Ⅱ期研究結果。患者均接受瞭錶柔比星50 mg/m2，靜脈推註，第1天；奧沙利鉑130 mg/m2，靜脈滴註2 h，第1天；每天5-FU的劑量為375~425 mg/m2，低劑量持續輸註5 d共120 h；每3週重複，每6週評價療效。治療到進展、不能耐受或患者退齣，對于6~8箇療程後穩定以上療效的患者根據醫師推薦及患者的意願，選擇氟尿嘧啶類藥物維持治療或觀察。結果：178例晚期胃癌患者納入本研究，170例可行療效及不良反應評估，7例(3.9%)完全緩解(complete response，CR)，76例(42.7%)部分緩解(partial response，PR)，總有效率(overall response rate，ORR，CR+PR)為46.6%，69例(38.8%)疾病穩定(stable disease，SD)，18例(10.1%)疾病進展(progressive disease，PD)。中位無進展生存期(progress free survival，PFS)為6.0箇月(95%CI：5.2~6.8)，中位總生存期(overall survival，OS)為12.6箇月(95%CI：8.9~16.3)，1、2年生存率分彆為50.9%和28.0%。3~4度以上不良反應主要有白細胞及中性粒細胞減少23.0%及38.8%、血紅蛋白下降6.5%、血小闆下降23.5%、噁心嘔吐14.1%、手足痳木1.2%。接受二線治療的75例患者，二線治療中位生存時間8.0箇月(95%CI：4.8~11.2)。結論：EOF5方案治療晚期胃癌有效率高，PFS和OS同ECF及其改良方案類似，不良反應可控，是安全有效的晚期胃癌一線治療方案。
배경여목적：만기위암치료중，ECF(표유비성、순박급5-FU지속적주21 d)방안계경전일선방안，2004년기아문이오사리박취대순박，이저제량5-FU지속적주120 h취대표준제량지속적주21 d，조성EOF5방안，이기제고료효급의종성，선후개전료소양본탐색성연구급확대양본적Ⅱ기연구。방법：본연구회고성분석료해량항Ⅱ기연구결과。환자균접수료표유비성50 mg/m2，정맥추주，제1천；오사리박130 mg/m2，정맥적주2 h，제1천；매천5-FU적제량위375~425 mg/m2，저제량지속수주5 d공120 h；매3주중복，매6주평개료효。치료도진전、불능내수혹환자퇴출，대우6~8개료정후은정이상료효적환자근거의사추천급환자적의원，선택불뇨밀정류약물유지치료혹관찰。결과：178례만기위암환자납입본연구，170례가행료효급불량반응평고，7례(3.9%)완전완해(complete response，CR)，76례(42.7%)부분완해(partial response，PR)，총유효솔(overall response rate，ORR，CR+PR)위46.6%，69례(38.8%)질병은정(stable disease，SD)，18례(10.1%)질병진전(progressive disease，PD)。중위무진전생존기(progress free survival，PFS)위6.0개월(95%CI：5.2~6.8)，중위총생존기(overall survival，OS)위12.6개월(95%CI：8.9~16.3)，1、2년생존솔분별위50.9%화28.0%。3~4도이상불량반응주요유백세포급중성립세포감소23.0%급38.8%、혈홍단백하강6.5%、혈소판하강23.5%、악심구토14.1%、수족마목1.2%。접수이선치료적75례환자，이선치료중위생존시간8.0개월(95%CI：4.8~11.2)。결론：EOF5방안치료만기위암유효솔고，PFS화OS동ECF급기개량방안유사，불량반응가공，시안전유효적만기위암일선치료방안。
Background and purpose:Although there is still no standard ifrst line chemotherapy regimen for metastatic gastric cancer (MGC), the doublet and triplet regimens containing platinum and lfuorouracil were most popular worldwidely. The ECF regimen is the classical and one of the most popular treatment choices in this setting, while the marrow suppression, the renal toxicity and poor compliance inhibits its usage. In order to improve its efifcacy and tolerability, this study conducted 2 phaseⅡ trials by modified ECF regimen, the EOF5 regimen (substituting cisplatin with oxaliplatin, shortening the continuous infusion period to 120 h), to treat patients with MGC since 2004. This paper reported the comprehensive results of the 2 studies.Methods:All the patients who enrolled in our previous2 phaseⅡ trials and received EOF5 as ifrst line treatment entered this study. Each patient received the treatment of epirubicin 50 mg/m2 iv d1, oxaliplatin 130 mg/m2 iv gtt d1 and 5-FU 375-425 mg/m2·d-1 civ 120 h, and repeated every 3 weeks. Efifcacy was analyzed every 6 weeks.Results:A total number of 178 patients (all were metastatic patients but 2 advanced patients with unresectable lesions) were included into this study. One hundred and seventy patients were evaluable, and 7 patients (3.9%) achieved complete response (CR), 76 patients (42.7%) achieved partial response (PR), 46.6% patients achieved overall response rate (ORR, CR+PR), and the cases of stable disease (SD) and progressive disease (PD) were 69 (38.8%) and 18 (10.1%), respectively. The median progress free survival (PFS) and overall survival (OS) were 6.0 months (95%CI: 5.2-6.8) and 12.6 months (95%CI: 8.9-16.3), 1-year and 2-year survival rate were 50.9% and 28.0%, respectively. Grade 3, 4 toxicity including: leucopenia (23.0), neutropenia (38.8%), anemia (6.5%), thrombocytopenia (23.5%), nausea/vomiting (14.1%), and peripheral neuropathy toxicity (1.2%). Among 75 patients who received second line treatment, the median survival from second line treatment was 8.0 months (95%CI: 4.8-11.2).Conclusion:EOF5 regimen is a highly effective regimen with moderate and manageable toxicity, and it providesa suitable alternative for the ifrst-line treatment of MGC.
