中国医药
中國醫藥
중국의약
CHINA MEDICINE
2013年
5期
643-645
,共3页
朱琪伟%黄灿红%万志龙%蔡晶
硃琪偉%黃燦紅%萬誌龍%蔡晶
주기위%황찬홍%만지룡%채정
食管癌%奈达铂%同步放化疗%老年患者
食管癌%奈達鉑%同步放化療%老年患者
식관암%내체박%동보방화료%노년환자
Esophageal cancer%Nedaplatin%Concurrent chemoradiotherapy%Aged patients
目的 探讨奈达铂同步放化疗治疗老年食管癌的疗效.方法 以年龄65岁以上的食管癌患者为研究对象.第一阶段临床试验(12例)为剂量递增试验,奈达铂剂量20、25、30 mg/m2逐渐递增(每个剂量至少4例/量),30 mg/m2后不再增加剂量.依据第一阶段临床试验所得出的最大耐受剂量(30 mg/m2)进行第二阶段临床试验(31例).入组的62例患者按随机数字表法分为放化组和单放组,各31例.食管局部放疗采用6MVX线三维适形放疗,肿瘤吸收剂量(DT) 60 ～ 64 Gy.观察其近期疗效、不良反应及远期疗效.结果 第一阶段临床试验剂量递增至奈达铂30 mg/m2未出现限制性不良反应.第二阶段临床试验中22例患者完成6周期化疗,26例完成5周期化疗,29例完成4周期化疗,31例完成3周期化疗.患者均完成了DT 60～ 64 Gy放疗.放化组与单放组完全缓解率分别为64.5％ (20/31)、38.7％(12/31),差异有统计学意义(P＜0.05).放化组与单放组的1、2、3年生存率分别为74.0％ (23/31)、62.4％(19/31)、38.2％(12/31)和64.5％ (20/31)、34.5％(11/31) 、18.6％ (6/31),总生存率Log-rank检查差异有统计学意义(x2=4.675,P =0.031).结论 应用单药奈达铂同步放疗治疗老年食管癌,大多数患者能耐受30 mg/m2的同期化疗剂量,对体弱耐受性差的患者可适当减量,放疗同期使用奈达铂有放疗增敏作用.
目的 探討奈達鉑同步放化療治療老年食管癌的療效.方法 以年齡65歲以上的食管癌患者為研究對象.第一階段臨床試驗(12例)為劑量遞增試驗,奈達鉑劑量20、25、30 mg/m2逐漸遞增(每箇劑量至少4例/量),30 mg/m2後不再增加劑量.依據第一階段臨床試驗所得齣的最大耐受劑量(30 mg/m2)進行第二階段臨床試驗(31例).入組的62例患者按隨機數字錶法分為放化組和單放組,各31例.食管跼部放療採用6MVX線三維適形放療,腫瘤吸收劑量(DT) 60 ～ 64 Gy.觀察其近期療效、不良反應及遠期療效.結果 第一階段臨床試驗劑量遞增至奈達鉑30 mg/m2未齣現限製性不良反應.第二階段臨床試驗中22例患者完成6週期化療,26例完成5週期化療,29例完成4週期化療,31例完成3週期化療.患者均完成瞭DT 60～ 64 Gy放療.放化組與單放組完全緩解率分彆為64.5％ (20/31)、38.7％(12/31),差異有統計學意義(P＜0.05).放化組與單放組的1、2、3年生存率分彆為74.0％ (23/31)、62.4％(19/31)、38.2％(12/31)和64.5％ (20/31)、34.5％(11/31) 、18.6％ (6/31),總生存率Log-rank檢查差異有統計學意義(x2=4.675,P =0.031).結論 應用單藥奈達鉑同步放療治療老年食管癌,大多數患者能耐受30 mg/m2的同期化療劑量,對體弱耐受性差的患者可適噹減量,放療同期使用奈達鉑有放療增敏作用.
목적 탐토내체박동보방화료치료노년식관암적료효.방법 이년령65세이상적식관암환자위연구대상.제일계단림상시험(12례)위제량체증시험,내체박제량20、25、30 mg/m2축점체증(매개제량지소4례/량),30 mg/m2후불재증가제량.의거제일계단림상시험소득출적최대내수제량(30 mg/m2)진행제이계단림상시험(31례).입조적62례환자안수궤수자표법분위방화조화단방조,각31례.식관국부방료채용6MVX선삼유괄형방료,종류흡수제량(DT) 60 ～ 64 Gy.관찰기근기료효、불량반응급원기료효.결과 제일계단림상시험제량체증지내체박30 mg/m2미출현한제성불량반응.제이계단림상시험중22례환자완성6주기화료,26례완성5주기화료,29례완성4주기화료,31례완성3주기화료.환자균완성료DT 60～ 64 Gy방료.방화조여단방조완전완해솔분별위64.5％ (20/31)、38.7％(12/31),차이유통계학의의(P＜0.05).방화조여단방조적1、2、3년생존솔분별위74.0％ (23/31)、62.4％(19/31)、38.2％(12/31)화64.5％ (20/31)、34.5％(11/31) 、18.6％ (6/31),총생존솔Log-rank검사차이유통계학의의(x2=4.675,P =0.031).결론 응용단약내체박동보방료치료노년식관암,대다수환자능내수30 mg/m2적동기화료제량,대체약내수성차적환자가괄당감량,방료동기사용내체박유방료증민작용.
Objective To discuss the effect of weekly nedaplatin in aged patients with esophageal cancer.Methods Esophageal cancer patients older than 65 were eligible for the study.Phase Ⅰ study was dose-escalation trial with 12 patients.All patients received radiotherapy with three dimentional conformal radiotherapy technique.Concurrent nedaplatin started from the dose of 20 mg/m2 to 25 mg/m2,30 mg/m2 for the weekly schedule (≥4 patients per dose group),and the doses were steadily escalated to 30 mg/m2.According to the appropriate dose from phase Ⅰ study,we conduced phase Ⅱ clinical trial with 31 patients.Results In phase Ⅰ study,nedaplatin dose was escalated to 30 mg/m2 and DLT had not been reached.In phase Ⅱ study,22 patients completed 6 cycles of chemotherapy,26 patients completed 5 cycles and 29 patients completed 4 cycles.All patients completed radiotherapy.Complete remission rate in chemotherapy and radiotherapy group and simply radiotherapy group was 64.5％ (20/31) and 38.7％ (12/31) (P ＜0.05).1,2,3 year survival rates in chemotherapy,radiotherapy group and simply radiotherapy group were 74.0％ (23/31),62.4％ (19/31),38.2％ (12/31) and 64.5％ (20/31),34.5％(11/31),18.6％ (6/31),overall survival rate of Log-rank was statistically significant (x2 =4.675,P =0.031).Conclusions Weekly 30 mg/m2 nedaplatin concurrent with radiotherapy is well tolerated when given to aged patients with esophageal cancer.For patients with poor performance status,the nedaplatin dose needs to be reduced.
