ＤＣ和ＤＯ方案治疗晚期胃癌的临床观察

目的：观察比较多西紫杉醇联合卡培他滨（ＤＣ）方案和多西紫杉醇联合奥沙利铂（ＤＯ）方案治疗晚期胃癌的临床疗效和安全性。方法：我院２００５年１月～２００７年１２月收治８７例经病理证实的晚期胃癌患者,分为ＤＣ方案组４５例,ＤＯ方案组４２例。ＤＣ方案组：多西紫杉醇７５ｍｇ／ｍ２,ｄ１;卡培他滨２０００ｍｇ／ｍ２,分２次口服,ｄ１～ｄ１４,２１天为１周期。ＤＯ组：多西紫杉醇７５ｍｇ／ｍ２,ｄ１;奥沙利铂１３０ｍｇ／ｍ２,ｄ１,２１天为１周期,２周期后评价疗效。结果：ＤＣ组４５例患者,可评价３２例,总有效率（ＲＲ）为４６.９％;ＤＯ组４２例患者,可评价３１例,ＲＲ为４１.９％,两组疗效无统计学差异（Ｐ＞０.０５）。两组的主要毒副反应为骨髓抑制、胃肠道反应,多数为Ⅰ ～Ⅱ度,ＤＣ组的手足综合征发生率明显高于ＤＯ组,外周神经毒性ＤＯ组高于ＤＣ组。结论：ＤＣ和ＤＯ方案治疗晚期胃癌的疗效相近,毒副反应均可耐受,但ＤＣ方案用药更方便,是治疗晚期胃癌的较好方案之一。     

ＮＰ方案与ＤＰ方案同期放化疗治疗局部晚期非小细胞肺癌的比较

目的　比较ＮＰ方案和ＤＰ方案进行同期放化疗治疗局部晚期非小细胞肺癌（ＮＳＣＬＣ）的临床疗效和毒性反应。方法　８２例不能手术的ⅢＡ期及ⅢＢ期ＮＳＣＬＣ患者（ⅢＡ２６例,ⅢＢ５６例）根据入选标准随机分组,其中４０例进入ＮＰ组,４２例进入ＤＰ组。ＮＰ组：化疗方案：长春瑞滨（ＮＶＢ）１５～１８ｍｇ／ｍ^２ｄ_１,ｄ_８;顺铂（ＤＤＰ）７０ｍｇ／ｍ^２ｄ_１。放射治疗从第１天开始,６ＭＶ-Ｘ射线照射,三维适形照射ＤＴ４０Ｇｙ／４～４.５ｗ后缩野,追加剂量至ＤＴ６０～６５Ｇｙ／６～６.５ｗ。ＤＰ组：化疗方案：多西紫杉醇（ＤＯＣ）７０～７５ｍｇ／ｍ^２ ｄ_１,ＤＤＰ７０ｍｇ／ｍ^２ ｄ_１,放射治疗方案同ＮＰ组。结果　所有患者均顺利完成治疗。ＮＰ组获ＣＲ１０.０％,ＰＲ５２.５％,ＳＤ２５％,ＰＤ１９.１％;ＤＰ组获ＣＲ１１.９％,ＰＲ５.８％,ＳＤ２3.８％,ＰＤ９.５％,两组近期疗效差异无统计学意义（Ｐ＞０.０５）。两组患者的ＣＥＡ、ＣＹＦＲＡ２１ １和ＣＡ１９ ９治疗后均比治疗前有降低,但两组之间差异无统计学意义（Ｐ＞０.０５）。ＮＰ组和ＤＰ组的１年、２年和３年生存率分别为６５％、４２.５％、３７.５％和７６.２％、５７.１％、４５.２％。ＮＰ组和ＤＰ组的１年、２年和３年局部控制率分别为６８.９％、４８.９％、４２.２％和７９.１％、６５.１％、５１.２％。主要毒副反应为放射性食管炎和白细胞减少,两组患者的１～３级放射性食管炎和２～４级白细胞减少发生率均较高。结论　ＮＰ为化疗方案的同期放化疗和ＤＰ为化疗方案的同期放化疗疗效没有明显差异,毒副反应也相似。     

替吉奥联合顺铂治疗进展期胃癌的近期疗效观察

目的　观察国产替吉奥（Ｓ-１）联合顺铂一线治疗进展期胃癌的近期疗效及安全性。方法　４８例进展期胃癌患者分为治疗组和对照组,各２４例。治疗组方案为：Ｓ-１４０～６０ｍｇｂｉｄｄ１～ｄ２１;顺铂６０ｍｇ／ｍ２静滴,ｄ８,５周为１周期。对照组方案为：多西紫杉醇７５ｍｇ／ｍ２静滴,ｄ１;顺铂２０ｍｇ／ｍ２静滴,ｄ１～ｄ３;亚叶酸钙２０ｍｇ／ｍ２静滴,ｄ１ ～ｄ５;氟尿嘧啶３５０ｍｇ／ｍ２ 微量泵持续２４ｈ静滴,ｄ１～ｄ５,３周为１周期。３个周期后评价两组疗效及不良反应。结果　４８例患者均可评价疗效和不良反应,治疗组和对照组的有效率分别为５８.３％和５４.２％,差异无统计学意义（Ｐ＞０.０５）,但治疗组的临床获益率为８７.５％,优于对照组６２.５％,差异有统计学意义（Ｐ＜０.０５）;治疗组的不良反应及严重反应发生率均明显低于对照组。结论　Ｓ-１联合顺铂化疗方案一线治疗进展期胃癌的近期疗效较好,不良反应轻,值得临床进一步研究应用。     

乳腺癌ＣＯＸ-２表达与紫杉醇脂质体联合表柔比星新辅助化疗疗效关系的研究

目的　研究紫杉醇脂质体联合表柔比星新辅助化疗治疗乳腺癌前后ＣＯＸ-２表达的变化及其与新辅助化疗疗效的关系。方法　对４１例乳腺癌患者行新辅助化疗,方案为：表柔比星８０ｍｇ／ｍ^２,静脉注射,ｄ_１;紫杉醇脂质体１３５ｍｇ／ｍ^２,静脉滴注,３ｈ,ｄ_２,３周为１周期,共２～６个周期。免疫组织化学法检测新辅助化疗前后肿瘤组织ＣＯＸ-２的表达。结果　４１例乳腺癌患者新辅助化疗的有效率为７０.７％（２９／４１）。新辅助化疗前ＣＯＸ-２表达阳性率为６３.４％,化疗后为４３.９％ （Ｐ＜０.０５）。新辅助化疗前ＣＯＸ-２表达阳性者的有效率为６１.５％,ＣＯＸ-２表达阴性者有效率为８６.７％（Ｐ＜０.０５）。结论　ＣＯＸ-２有可能作为预测乳腺癌患者行紫杉醇脂质体联合表柔比星新辅助化疗疗效的分子生物学指标。     

MVP方案与CAP方案治疗晚期非小细胞肺癌的疗效比较

「目的」对比ＭＶＰ方案与ＣＡＰ方案治疗ＮＳＣＬＣ的疗效。「方法」７４例病人随机分为ＭＶＰ组和ＣＡＰ组。ＭＶＰ组：ＭＭＣ６ｍｇ／ｍ＾２，ｄ１，ＶＤＳ３ｍｇ／ｍ＾２，ｄ１，ｄ８，ＰＤＤ３０ｍｇ／ｍ＾２，ｄ１￣ｄ３。ＣＡＰ组：ＣＴＸ６００ｍｇ／ｍ＾２，ｄ１，ＡＤＭ（３０￣４０）ｍｇ／ｍ＾２，ｄ１，ＰＤＤ（２０￣３０）ｍｇ／ｍ＾２，ｄ１－３。两方案皆以２１天为一周期，使用二个周期后进行评价。「结果」ＭＶＰ     

伊立替康联合顺铂与吉西他滨联合顺铂一线治疗晚期非小细胞肺癌的随机对照研究

目的　探讨伊立替康（ＣＰＴ １１）联合顺铂（ＤＤＰ）方案（ＩＰ方案）与吉西他滨（ＧＥＭ）联合ＤＤＰ方案（ＧＰ方案）一线治疗非小细胞肺癌（ＮＳＣＬＣ）的近期疗效和毒副反应。方法　采用前瞻性、开放性、随机对照的临床研究设计,纳入经组织学或细胞学确诊的初治晚期ＮＳＣＬＣ患者８８例,按２∶１比例随机分入ＩＰ方案组和ＧＰ方案组,ＩＰ方案组６０例,ＧＰ方案组２８例。ＩＰ方案组：ＣＰＴ-11 １００ｍｇ／ｍ２,ｄ１、ｄ８;ＤＤＰ２５ｍｇ／ｍ２,ｄ１ ～ｄ３;２１天为１周期。ＧＰ方案组：ＧＥＭ １０００ｍｇ／ｍ２,ｄ１、ｄ８;ＤＤＰ２５ｍｇ／ｍ２,ｄ１～ｄ３;２１天为１周期。２个周期评价疗效和不良反应。结果　ＩＰ方案组获ＰＲ２７例,ＳＤ１６例,ＰＤ１２例,死亡１例,有效率按意向性治疗分析（ＩＴＴ）为４５.０％,按符合方案分析（ＰＰ）为４８.２％,中位生存时间为１１.２个月,１年生存率为４６.４％;ＧＰ方案组获ＰＲ１０例,ＳＤ９例,ＰＤ７例,有效率按ＩＴＴ为３５.７１％,按ＰＰ为３８.５％,中位生存时间为１１.８个月,１年生存率为４６.２％。两组主要不良反应为血液学毒性、消化道反应、疲乏和脱发,ＩＰ方案组腹泻、疲乏、脱发的发生率高于ＧＰ方案组,血小板减少发生率低于ＧＰ方案组（Ｐ＜０.０５）。结论　ＩＰ方案和ＧＰ方案治疗晚期ＮＳＣＬＣ的疗效确切且无显著差异,毒副反应均可耐受。     

改良ＤＣＦ方案治疗２７例晚期胃癌的临床观察

目的　研究改良的多西紫杉醇联合顺铂（ＤＤＰ）加亚叶酸钙（ＣＦ）和氟尿嘧啶（５ ＦＵ）方案（ｍＤＣＦ）治疗术后复发或不能手术的晚期胃癌的疗效及其毒副作用。方法　对入选的２７例晚期胃癌患者给予国产多西紫杉醇（艾素）５０ｍｇ／ｍ^２ｄ１、ＤＤＰ２５ｍｇ／ｍ２ｄ２～ｄ３、ＣＦ０２ｇ／ｍ^２ｄ２～ｄ３、５-ＦＵ２ｇ／ｍ^２持续静滴４６小时（ｄ２～ｄ３）双周方案全身化疗,观察其疗效及毒副作用。结果　２００６年５月至２００７年７月,２７例胃癌患者平均化疗４.５个周期,ＣＲ１例,ＰＲ１２例,总有效率（ＲＲ）为４８.１％（９５％ＣＩ：３２％ ～６４％）,对紫杉醇耐药者仍然３３.３％（２／６）有效,中位肿瘤进展时间（ＴＴＰ）为６.２个月,中位总生存时间（ＯＳ）１１.８个月。毒副反应主要为骨髓抑制,发生率达１００.０％,且４８.９％为３～４级（其中１６.３％为４级）,出现２例（７.４％）因骨髓抑制停止化疗;口腔黏膜炎、恶心呕吐、周围神经毒性、肝功能损害、腹泻、肾功能损害及心脏毒性发生率分别为５９.２％、５１.９％、４８.１％、４４.４％、２５.９％、１８.５％及１１.１％,大部分为１～２级。没有治疗相关死亡。结论　改良的多西紫杉醇联合ＤＤＰ加ＣＦ和５-ＦＵ双周方案（ｍＤＣＦ）治疗晚期胃癌疗效肯定,骨髓抑制等毒副反应仍然偏高,但有一定的治疗优势,与紫杉醇无完全交叉耐药,值得在临床中进一步改良和验证。     

奈达铂联合紫杉醇同期放化疗治疗局部晚期鼻咽癌

目的　评价奈达铂联合紫杉醇方案（ＴＮ）同期放化疗治疗Ⅲ、ⅣＡ期鼻咽癌的局控率、生存率和毒副反应。方法　将５０例Ⅲ、ⅣＡ期鼻咽癌患者分为ＴＮ组（ｎ＝２５）和ＰＦ组（ｎ＝２５）。ＴＮ组应用ＴＮ方案,具体为：紫杉醇１３５ｍｇ／ｍ２,ｄ１,奈达铂１００ｍｇ／ｍ２,ｄ１;ＰＦ组应用ＰＦ方案,具体为：顺铂３０ｍｇ／ｍ２,ｄ１～ｄ３,亚叶酸钙２００ｍｇ／ｍ２,ｄ１～ｄ５,氟尿嘧啶５００ｍｇ／ｍ２,ｄ１～ｄ５。两方案均从放疗的第１天开始化疗,２８天为１周期,均化疗２周期。两组的放疗方法相同。分别观察并比较两组的局控率、生存率和毒副反应。结果　ＣＲ率ＴＮ组为９２.０％,ＰＦ组为８４.０％,两组比较差异无统计学意义（Ｐ＞０.０５）。１年无复发生存率和１年无远处转移生存率ＴＮ组分别为９２.０％和９６.０％,ＰＦ组分别为８８.０％和９２.０％,两组比较差异无统计学意义（Ｐ＞０.０５）。ＴＮ组恶心呕吐低于ＰＦ组,尤其Ⅲ、Ⅳ级恶心呕吐明显降低（Ｐ＜０.０５）。Ⅲ、Ⅳ级皮肤、口腔黏膜炎ＴＮ组明显低于ＰＦ组,差异有统计学意义（Ｐ＜０.０５）。骨髓毒性ＴＮ组高于ＰＦ组,差异有统计学意义（Ｐ＜０.０５）。肝脏毒性及肾脏毒性两组比较差异无统计学意义（Ｐ＞０.０５）。结论　奈达铂联合紫杉醇方案同期放化疗治疗Ⅲ、ⅣＡ期鼻咽癌近期疗效确切,毒副反应较低,患者耐受性较好。     

后程适形放射治疗联合ＮＰ方案同步化疗治疗Ⅲ期非小细胞肺癌

目的　观察三维适形放射治疗联合长春瑞滨（ＮＶＢ）加顺铂（ＤＤＰ）同步化疗治疗Ⅲ期非小细胞肺癌（ＮＳＣＬＣ）的疗效及耐受性。方法　５０例Ⅲ期ＮＳＣＬＣ患者随机分为同步放化疗组和单放组,每组各２５例。单放组采用６ＭＶ或１５ＭＶＸ线常规外放疗ＤＴ４０Ｇｙ,后采用三维适形放疗２.５～３Ｇｙ／ｆ,１ｆ／ｄ,至ＤＴ７０～７５Ｇｙ,同步放化疗组在放疗的第１～３天联合ＮＰ方案化疗（ＮＶＢ２５ｍｇ／ｍ^２,ｄ_１、ｄ_８,ＤＤＰ３０ｍｇ／ｍ^２,ｄ_１～ｄ_３）,２１天为１周期,放疗后再采用该方案化疗３～６个周期。结果　同步放化疗组与单放组的有效率（ＣＲ＋ＰＲ）分别为８４.０％和６４.０％（Ｐ＞０.０５）;１、２年生存率分别为７６.０％、３６.０％和６８.０％、２４.０％（Ｐ均＞０.０５）。主要毒副反应表现为骨髓抑制和消化道反应。结论　后程三维适形放射治疗联合ＮＰ方案同步化疗治疗Ⅲ期ＮＳＣＬＣ近期疗效好,且毒性反应可以耐受。     

多西他赛联合卡培他滨治疗复发转移乳腺癌的疗效及相关因素研究

目的　探讨低剂量多西他赛联合卡培他滨治疗复发转移乳腺癌的疗效及其预测因素。方法　２００６年６月至２００９年１２月收治３８例复发转移乳腺癌女性患者给予多西他赛联合卡培他滨治疗,具体方案为：多西他赛６０ｍｇ／ｍ２静滴,ｄ１;卡培他滨９５０ｍｇ／ｍ２口服,每日２次,ｄ１～ｄ１４;２１天为１周期。２个周期评价疗效,并随访无进展生存时间（ＰＦＳ）。选取ＰＳ评分、绝经状态、ＥＲ、ＨＥＲ ２、转移数目、既往化疗共６个指标分别建立两分类Ｌｏｇｉｓｔｉｃ回归模型和Ｃｏｘ风险比例模型,分析上述指标对疗效的预测情况。结果　３８例患者均接受２～６个周期化疗,获ＣＲ３例,ＰＲ１８例,ＳＤ１０例,ＰＤ７例,有效率（ＲＲ）为５５.３％（２１／３８）;中位ＰＦＳ为７.１个月（９５％ＣＩ：４.８～９.６个月）。主要毒副反应为恶心呕吐、乏力、白细胞减少和手足综合征等,其中３～４级白细胞减少为１５.８％。６个指标中ＰＳ评分（Ｐ＝０.００３）、绝经状态（Ｐ＝０.０４３）和转移数目（Ｐ＝０.０２１）均与ＲＲ有关,仅ＰＳ评分为ＲＲ的独立预测因素（Ｐ＜０.０５）;Ｃｏｘ风险比例模型显示,ＰＳ评分是ＰＦＳ的独立预测因素（Ｐ＜０.０５）。结论　低剂量多西他赛联合卡培他滨治疗复发转移乳腺癌的疗效好,安全性高;ＰＳ评分可以作为该方案疗效预测的独立因素。     

多西紫杉醇联合卡培他滨治疗转移性乳腺癌的临床研究

背景与目的:对于既往使用过含蒽环、紫杉醇药物方案化疗失败的复发转移性乳腺癌,可用的药物不多.多西紫杉醇(docetaxel)联合卡培他滨(capecitabine)是近年来治疗转移性乳腺癌一个较新的方案,本研究初步探讨多西紫杉醇联合卡培他滨(DC)治疗转移性乳腺癌的近期疗效和安全性情况.方法:31例女性转移性乳腺癌患者接受多西紫杉醇联合卡培他滨方案化疗.卡培他滨2 500 mg·(m2·d)-1,第1～14天,分2次饭后30 min口服;多西紫杉醇75 mg/m2静滴1 h,第1天.方案21天重复循环.在多西紫杉醇用药前1天,开始口服地塞米松8 mg,每天2次,连用3天.结果:31例患者使用DC方案化疗共116疗程,中位疗程数为3.7个.总有效率(response rate,RR)为41.9%(13/31),完全缓解(complete remission,CR)3例(9.6%).主要不良反应为乏力、骨髓抑制、胃肠道反应、手足综合征、粘膜炎等.中位随访时间10.8个月(2～23个月),死亡2例(均死于肿瘤进展),中位无进展生存期(progression-free survival,PFS)5.7个月(2～12个月).结论:多西紫杉醇与卡培他滨联合治疗转移性乳腺癌,有效率高、疗效肯定、不良反应可以耐受,为治疗转移性乳腺癌的有效方案.     

Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer

BackgroundThe purpose of this study was to compare docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as front-line treatment in women with advanced breast cancer (ABC).Patients and MethodsPreviously untreated patients with ABC were randomly assigned to receive docetaxel 75 mg/m² plus epirubicin 75 mg/m² (DE) on day 1 or docetaxel 75 mg/m² on day 1 plus capecitabine 950 mg/m² orally twice daily on days 1–14 (DC) in 21-day cycles. Previous anthracycline-based (neo)-adjuvant chemotherapy was allowed if completed >1 year before enrollment. The primary objective of the study was to compare time to disease progression (TTP).ResultsOne hundred and thirty-six women were treated on each arm and median TTP was 10.6 versus 11.0 months (P = 0.7), for DE and DC, respectively. According to RECIST criteria we observed 15 (11%) versus 11 (8%) complete responses and 55 (40%) versus 61 (45%) partial responses (P = 0.8), with DE and DC, respectively. Severe toxicity included grade 3–4 neutropenia (57% versus 46%; P = 0.07), febrile neutropenia (11% versus 8%; P = 0.4), hand–foot syndrome (0% versus 4%; P = 0.02), grade 2–3 anemia (20% versus 7%; P = 0.001) and asthenia (12% versus 6%; P = 0.09) with DE and DC, respectively.ConclusionsThe DE and DC regimens have similar efficacy but different toxicity. Either regimen can be used as front-line treatment of ABC.     

多西他赛联合表阿霉素与多西他赛联合顺铂一线治疗晚期乳腺癌的临床研究

目的 评价多丙他赛联合表阿霉素(TE方案)与多西他赛联合顺铂(TP方案)一线治疗局部晚期或转移性乳腺癌患者的疗效和安全性.方法 88例患者按2:1随机进入TE组和TP组.TE组患者药物剂量为多西他赛75 mg/m2,表阿霉素60 mg/m2;TP组患者药物剂量为多西他赛75mg/m2,顺铂75 mg/m2. 21 d为1个周期,2个周期末评价近期疗效及安全性.结果 TE组可评价近期疗效者55例,其中CR 3例,PR 26例,SD 22例,PD 4例.TP组可评价近期疗效者27例,其中CR 1例,PR 16例,SD 9例,PD 1例.TE组和TP组近期有效率分别为48.3%和60.7%(P=0.2788),临床受益率分别为85.0%和92.9%(P=0.4899),中位肿瘤进展时间(TTP)分别为10个月和8个月(P=0.7119).Ⅲ、Ⅳ度不良反应主要为中性粒细胞减少,TE组和TP组发生率分别为66.7%和53.6%(P=0.2373);其次为脱发,TE和TP组分别为30.0%和10.7%(P=0.0508).结论 TE方案与TP方案一线治疗局部晚期或转移性乳腺癌的疗效和安全性相当.     

Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer.

PURPOSE: Capecitabine is an oral fluoropyrimidine with considerable activity and minimal myelosuppression and alopecia. This phase I study evaluated the addition of capecitabine to epirubicin/docetaxel combination therapy as first-line treatment for advanced breast cancer. PATIENTS AND METHODS: Twenty-three female patients with advanced breast cancer received capecitabine (765-1060 mg/m2 twice daily on days 1-14 of a 3-week treatment cycle) in combination with epirubicin and docetaxel (75 mg/m2 i.v. on day 1). RESULTS: The maximum tolerated dose of capecitabine was 985 mg/m2 and the principal dose-limiting toxicity was febrile neutropenia. No grade 3/4 anemia or thrombocytopenia occurred. There were no grade 4 non-hematological events and grade 3 events other than alopecia were rare. Alopecia occurred in all patients and treatment cycles, and asthenia occurred in all patients and in 84% of treatment cycles. Other frequent adverse events included nausea, vomiting, fever, paresthesia and elevated transaminase levels. An objective response to treatment was observed in 91% (95% confidence interval 72% to 99%) of patients. CONCLUSIONS: The addition of capecitabine to docetaxel/epirubicin combination therapy provides a well-tolerated and active first-line chemotherapy regimen in patients with advanced breast cancer, and merits phase II/III evaluation.     

Capecitabine in combination with docetaxel and epirubicin in patients with previously untreated,advanced breast carcinoma

BACKGROUND: The objective of this study was to evaluate the activity and safety of oral capecitabine in combination with docetaxel and epirubicin (TEX) as first-line treatment for patients with locally advanced/metastatic breast carcinoma. METHODS: This open-label, Phase II study was conducted at six Italian centers. Treatment consisted of epirubicin, 75 mg/m(2) (intravenous bolus), and docetaxel, 75 mg/m(2) (1-hour infusion), both administered on Day 1, plus oral capecitabine, 1000 mg/m(2) twice daily, on Days 1-14 of each 3-week treatment cycle. RESULTS: A total of 67 patients received 392 cycles of treatment, with a median of 6 cycles in patients with Stage III disease (n = 34 patients) and a median of 8 cycles in patients with Stage IV disease (n = 33 patients). The objective response rate was 82%, including complete responses in 21% of patients. A greater proportion of patients with Stage III disease achieved tumor responses compared with patients who had Stage IV disease (97% vs. 67%, respectively). Among 34 patients with Stage III disease, pathologic complete responses were confirmed in 10 patients (29%). TEX chemotherapy demonstrated an acceptable safety profile. There was a low incidence of Grade 3 adverse events, and Grade 4 adverse events were particularly rare (4%). The most common Grade 3-4 adverse event was febrile neutropenia, which occurred in 16% of patients. CONCLUSIONS: TEX combination therapy has important antitumor activity and an acceptable safety profile in this setting. A large, randomized, Phase III trial is ongoing to compare TEX chemotherapy with an epirubicin plus docetaxel regimen in patients with untreated, advanced breast carcinoma.     

A phase II study of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine and pegfilgrastim support as preoperative therapy for patients with stage II, IIIA breast cancer.

BACKGROUND: This phase II study was conducted to evaluate tumor response rate and safety profile of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine given preoperatively to patients with stage II or IIIA breast cancer. PATIENTS AND METHODS: Patients underwent four cycles of dose-dense cyclophosphamide 600 mg/m(2) and epirubicin 90 mg/m(2) every 2 weeks followed by two cycles of docetaxel 36 mg/m(2) on days 1, 8, and 15 plus capecitabine 1250 mg/m(2) on days 5-18 every 4 weeks, with prophylactic pegfilgrastim. The primary objective of the study was to determine the incidence of pathologic complete response defined as the absence of invasive or in situ cancer in the breast and the axillary nodes at definitive surgery. RESULTS: Forty-four patients were enrolled in the study and 41 (93%) were assessable for response to chemotherapy. An objective clinical response was observed in 38 (93%) patients. Seven patients (17.1%) exhibited a pathologic complete response. Breast-conserving surgery was carried out in 36 (88%) patients. Grade 3/4 neutropenia occurred in 4.3% of 252 administered chemotherapy cycles. No febrile neutropenia, cardiac toxicity, thrombocytopenia or other serious adverse event was registered. CONCLUSION: The sequential combination of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine is an effective and well-tolerated neo-adjuvant chemotherapy for stage II, IIIA breast cancer.     

多西紫杉醇联合表阿霉素治疗局部晚期乳腺癌的疗效观察

目的:了解多西紫杉醇加表阿霉素对局部晚期乳腺癌患者进行新辅助化疗的疗效及不良反应。方法:对我院治疗的63例均采用多西紫杉醇加表阿霉素(DE方案:多西紫杉醇75 mg/m2d1,表阿霉素75 mg/m2d1)化疗的局部晚期乳腺癌患进行回顾性分析,每位患者进行2-4疗程的化疗,结束后评估疗效及不良反应。结果:总有效率(CR+PR)为68.3%,完全缓解(CR)8例,部分缓解(PR)35例,无变化(SD)13例,进展(PD)7例。术后中位随访24个月,死亡6例,复发及转移13例,健在44例。结论:多西紫杉醇联合表阿霉素术前化疗可以使患者降期,使原发灶缩小,以增加手术机会,提高生存率。     

Capecitabine plus docetaxel combination therapy

BACKGROUND: For patients with anthracycline-pretreated metastatic breast carcinoma, capecitabine plus docetaxel significantly increased overall survival compared with docetaxel alone. The current study evaluated the cost-effectiveness of the capecitabine/docetaxel combination versus docetaxel monotherapy, comparing the gain in quality-adjusted survival with associated health care costs. METHODS: Patients were randomized to receive 21-day cycles of oral capecitabine 1250 mg/m2 twice daily, on Days 1-14, plus docetaxel 75 mg/m2 Day 1 (n = 255), or docetaxel 100 mg/m2 on Day 1 (n = 256). Health and cost outcomes in the two arms were compared, and cost-effectiveness was estimated. Data on survival time and medical care resource use were prospectively collected in the trial. Costs associated with medical care resource use and quality-of-life adjustments were obtained from the published literature. The incremental cost-effectiveness ratio was calculated as the cost per quality-adjusted life year (QALY) gained. RESULTS: Capecitabine/docetaxel increased the median overall survival by 3 months compared with docetaxel alone (14.5 vs. 11.5 months). The mean quality-adjusted survival was increased by 1.8 months in the capecitabine/docetaxel group. The total medical-resource utilization cost per patient was 8.9% higher with the combination: 24,475 dollars for combination therapy versus 22,477 dollars for single-agent docetaxel. The mean cost per QALY gained with combination therapy was 13,558 dollars (standard deviation, 6742 dollars). Cost savings due to reduced docetaxel dose and hospital use were the major cost offsets with the combination. Sensitivity analyses showed that varying the mean hospital cost per day from the 5th to the 95th percentile resulted in cost-utility ratios ranging from 20,326 dollars to as low as 6360 dollars. CONCLUSIONS: Capecitabine/docetaxel was a cost-effective treatment in patients with anthracycline-pretreated advanced breast carcinoma, and had an incremental cost-effectiveness ratio that compares very favorably with that of many other oncology therapies.     

多西紫杉醇联合卡培他滨治疗蒽环类耐药的转移性乳腺癌

目的 观察多西紫杉醇联合卡培他滨(DC方案)治疗蒽环类耐药的晚期乳腺癌的疗效和安全性.方法 选择32例葸环类耐药的转移性乳腺癌患者,给予DC方案化疗.根据WHO制定的实体瘤客观疗效评价标准和抗癌药物毒性分级(0～Ⅳ)标准评价疗效和不良反应.结果 32例患者共完成126个周期化疗,每例患者的化疗周期数为2～12个,中位化疗周期数4个.完全缓解(CR)1例,部分缓解(PR)14例,稳定(SD)11例,进展(PD)6例,总有效率为46.9%.14例肺转移患者中8例有效,13例肝转移患者中6例有效,7例皮肤软组织转移患者中3例有效,5例淋巴结转移患者中3例有效.32例患者的中位肿瘤进展时间(TTP)为5.6个月.1年生存率为56.3%.主要不良反应为骨髓抑制、手足综合征、恶心、呕吐、腹泻、口腔黏膜炎等,84.4%的患者出现中性粒细胞下降,2例达Ⅳ度骨髓抑制.结论 DC方案治疗转移性乳腺癌的有效率高,不良反应可以耐受,是治疗对蒽环类耐药转移性乳腺癌的有效方案.