紫杉醇脂质体与紫杉醇联合顺铂治疗晚期非小细胞肺癌对比研究

目的　探讨紫杉醇脂质体与紫杉醇联合顺铂治疗晚期非小细胞肺癌（ＮＳＣＬＣ）的临床疗效及不良反应。方法　晚期ＮＳＣＬＣ患者７２例,随机分为试验组与对照组,试验组采用紫杉醇脂质体１３５ｍｇ／ｍ^２,对照组采用紫杉醇１３５ｍｇ／ｍ^２化疗,两组均联合顺铂,２１天为１个周期,治疗２个周期后评价疗效。记录近期疗效与治疗期间毒副反应。结果　试验组有效率为４１.７％（１５／３６）,临床受益率为７７.７％（２８／３６）,对照组有效率为３８.９％（１４／３６）,临床受益率为７２.２％（２６／３６）,两组差异均无统计学意义（Ｐ＞０.０５）。白细胞减少和血小板减少的发生率两组差异无统计学意义（Ｐ＞０.０５）,脱发、腹泻、便秘及呼吸困难的发生率两组差异亦无统计学意义（Ｐ＞０.０５）,但试验组恶心、呕吐、皮疹、肌肉痛的发生率明显低于对照组（Ｐ＜０.０５）。结论　紫杉醇脂质体联合顺铂治疗晚期ＮＳＣＬＣ近期疗效确切有效,毒副反应较紫杉醇联合顺铂化疗为轻。     

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。     

局部晚期乳腺癌新辅助化疗每周方案与三周方案疗效分析

目的　探讨比较局部晚期乳腺癌采用剂量密集法和非剂量密集法行新辅助化疗的近期疗效。方法　４５例ⅢＡ期乳腺癌患者随机进入密集化疗组（Ａ组）和非密集化疗组（Ｂ组）。Ａ组：紫杉醇７０ｍｇ／ｍ^２,表阿霉素３０ｍｇ／ｍ^２,每周１次,连用３周,４周为１个周期。Ｂ组：紫杉醇１３５ｍｇ／ｍ２,第１天,表阿霉素８０ｍｇ／ｍ^２,第１天,３周为１个周期。如无疾病进展,共治疗３个周期。结果　Ａ组获ＣＲ７例（３１.８２％）,ＰＲ1２例（５４.５４％）,ＳＤ３例（１３.６４％）,ｐＣＲ５例（２２.７３％）,有效率（ＲＲ）为８６.３６％。Ｂ组获ＣＲ６例（２６.０９％）,ＰＲ１１例（５０％）,ＳＤ６例（２６.０９％）,ｐＣＲ３例（１３.０４％）,ＲＲ为７３.９１％。Ａ组的ＲＲ、ＣＲ、ｐＣＲ均优于Ｂ组,但无统计学意义。进一步分层分析,不同基因型乳腺癌新辅助化疗的疗效相当,无论Ａ组或Ｂ组,其ＩｕｍｉｎａｌＢ型、Ｂａｓａｌ-ｌｉｋｅ型和ＨＥＲ ２阳性型三者之间新辅助化疗的ＲＲ、ｃＣＲ、ＰＲ、ｐＣＲ的差别无统计学意义。两组３～４级毒副反应发生率除中性粒细胞减少外均相近。两组随访期间全部存活,ＯＳ正在进一步随访中。结论　紫杉类每周方案与标准的三周方案相比,可作用于不同增殖动力学的肿瘤细胞,剂量密度增加,更易于与其他化疗药物配伍,且每周方案较三周方案有更高的疗效,急性毒性无明显增加。     

紫杉醇脂质体治疗非小细胞肺癌３０例近期疗效及安全性分析

目的：比较国产紫杉醇脂质体与紫杉醇联合卡铂治疗非小细胞肺癌（ＮＳＣＬＣ）的疗效和安全性。方法：６２例晚期ＮＳＣＬＣ患者分为试验组（ｎ＝３０）和对照组（ｎ＝３2）,试验组每周期予以紫杉醇脂质体１３５ｍｇ／ｍ^２,对照组每周期予以紫杉醇１３５ｍｇ／ｍ^２,两组均联合卡铂３００ｍｇ／ｍ^２。２１天为１周期,２周期后评价疗效及安全性。结果：６２例患者中,６０例患者可评价疗效。试验组总有效率为２６.７％,对照组２3.3％,两组无显著性差异。两组血液学毒性发生率差异无显著性,周围神经炎及聚氧乙基代蓖麻油与无水乙醇的混合溶媒所产生的相关毒性方面,试验组发生率明显低于对照组,差异有显著性。结论：紫杉醇脂质体联合卡铂治疗晚期ＮＳＣＬＣ疗效与紫杉醇相当,但过敏反应和周围神经炎的发生率明显降低。     

紫杉醇脂质体联合顺铂、氟尿嘧啶一线治疗晚期胃癌的临床观察

目的：评价紫杉醇脂质体联合顺铂、氟尿嘧啶（ＰＣＦ方案）一线治疗晚期胃癌的临床疗效和毒副反应。方法：ＰＣＦ方案一线治疗４２例晚期胃癌的具体用法：紫杉醇脂质体１７５ｍｇ／ｍ^２,第１天静滴９０ｍｉｎ;顺铂７５ｍｇ／ｍ^２,第１天静滴;亚叶酸钙４００ｍｇ／ｍ^２,第１天滴注２ｈ;氟尿嘧啶２６ｇ／ｍ^２,亚叶酸钙滴注结束后立即持续泵入４６ｈ。２１天为１周期,每２周期按ＲＥ ＳＩＳＴ标准评价疗效,所有患者至少接受２周期化疗。结果：４２例患者共接受１９２个周期的化疗,所有患者均可评价疗效。完全缓解３例（７.１％）,部分缓解２０例（４７.６％）,稳定１２例（２８.６％）,进展７例,总有效率为５４.８％,中位进展时间（ＴＴＰ）６.５个月,中位生存时间（ＭＳＴ）１３.９个月。常见的不良反应为血液学毒性,胃肠反应、肌肉酸痛、外周神经毒性较轻,以Ⅰ、Ⅱ级为主。１０例（２３.８％）发生Ⅲ ～Ⅳ级粒细胞减少,伴发热１例（２.４％）;Ⅲ级恶心呕吐反应４例（９.５％）,Ⅲ级肌肉酸痛３例（７.１％）,Ⅲ级外周神经毒性２例（４.７％）,无化疗相关性死亡病例。结论：紫杉醇脂质体联合顺铂、氟尿嘧啶（ＰＣＦ方案）一线治疗晚期胃癌疗效确切,不良反应轻,值得临床推广应用。     

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。     

紫杉醇联合奈达铂和氟尿嘧啶治疗晚期食管癌的临床观察

目的　观察紫杉醇（ＰＴＸ）联合奈达铂（ＮＤＰ）和氟尿嘧啶（５-ＦＵ）治疗晚期食管癌的近期疗效和毒副反应。方法　晚期食管癌３０例,ＰＴＸ１３５～１７５ｍｇ／ｍ^２,静脉滴注,第１天;ＮＤＰ８０～１００ｍｇ／ｍ^２,静脉滴注,第２天;５-ＦＵ５００ｍｇ／ｍ^２,静脉滴注,第１～５天。２１天为１周期,连续２周期后评价疗效。结果　全组３０例均可评价疗效,完全缓解２例,部分缓解１７例,总有效率６３。３％（１９／３0）。主要毒副反应为血小板减少及白细胞减少,消化道反应较轻,未发现肝肾功能损害。结论　ＰＴＸ联合ＮＤＰ和５-ＦＵ治疗晚期食管癌近期疗效高,耐受性好,值得进一步观察应用。     

紫杉醇治疗食管癌疗效分析

目的 观察国产紫杉醇（紫素,ＴＡＸ）单药,与顺铂和５－氟尿嘧啶联合治疗食管癌的疗效。方法：用从我国红豆杉吕提取的ＴＡＸ治疗Ⅲ,Ⅳ期食管癌,单药治疗食管癌：ＴＡＸ１５０～１７５ｍｇ／ｍ＾２静滴３小时,每３周一次,共２周期。ＴＡＸ／ＤＤＰ／５－ＦＵ联合化疗：ＴＡＸ１３５ｍｇ／ｍ＾２,ｉｖ;ＤＤＰ每天２５ｍｇ／ｍ＾２第１～３天静滴,５－ＦＵ每天５００～７５０ｍｇ／ｍ＾２第１～５天静滴,联合化疗每２８天重     

肺耐药蛋白基因表达与紫杉醇脂质体联合顺铂治疗非小细胞肺癌疗效关系的探讨

目的　探讨肺耐药蛋白基因（ＬＲＰ）在非小细胞肺癌（ＮＳＣＬＣ）中的表达与化疗疗效之间的关系。方法　采用免疫组织化学Ｓ Ｐ法对４７例ＮＳＣＬＣ经气管镜活检组织进行ＬＲＰ表达水平的检测;采用ＴＰ方案化疗：紫杉醇脂质体１３５ｍｇ／ｍ^２,ｄ_１、ｄ_８,顺铂８０ｍｇ／ｍ^２,ｄ_１,３周为１周期,化疗２周期后评价疗效。结果　ＮＳＣＬＣ中ＬＲＰ的表达阳性率为６１.７０％,在肺腺癌和肺鳞癌中的表达阳性率分别为７６.９２％和４２.８６％（Ｐ＜０.０５）,ＬＲＰ表达水平与ＴＮＭ分期无关（Ｐ＞０.０５）。ＴＰ方案化疗２个周期后总有效率为４２.５５％,其中ＬＲＰ表达阳性和阴性的有效率分别为２７.５９％和６６.６７％（Ｐ＜０.０１）。结论　ＬＲＰ在ＮＳＣＬＣ中存在不同程度的表达,其表达在肺腺癌和肺鳞癌之间有差异,并与ＴＰ方案化疗的近期疗效相关。     

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。     

Clinical evaluation of effects from neo-adjuvant chemotherapy with epirubicin plus paclitaxel in cases of locally advanced breast cancer

Neo-adjuvant chemotherapy of epirubicin plus paclitaxel was administered to 23 patients with locally advanced breast cancer (including 13 cases of stage IIb, 6 of stage IIIa, and 4 of stage IIIb). All patients were female. They were treated with epirubicin 60 mg/m2, on day 1, by i.v. followed paclitaxel 150 mg/m2 by 3 hours continuous infusion on day 2 and every 3 weeks repeatedly. Premedication with dexamethasone, ondansetron, diphenhydramine and cimetidine were administered to prevent gastroenteric and allergic reactions before chemotherapy. Two to 4 cycles were used. Ten out of 23 patients had a complete response, 10 had partial response, and 3 had no change. The response rate was 87% (20/23). Six out of 23 patients underwent breast conserving surgery as tumor size had become smaller and downstaging was realized after neo-adjuvant chemotherapy. The major toxicities included neutropenia, myalgia, arthralgia, nephrotoxicity, gastroenteric reactions, alopecia and flushing to the face. However, these were well tolerated in these patients.     

Clinical evaluation of effects from neoadjuvant chemotherapy with epirubicin plus paclitaxel in cases of locally advanced breast cancer--comparative study of treatment with 2 and 4 cycles

Neoadjuvant chemotherapy of epirubicin plus paclitaxel was administered to 75 patients (including a 2-cycle group of 39 patients and a 4-cycle group of 36 patients) with locally advanced breast cancer (35 cases of stage IIb, 28 of stage IIIa, 12 of stage IIIb) to compare efficacy and toxicity of 2 cycle and 4 cycle regimens. All patients were female. They were treated with epirubicin 60 mg/m2, on day 1, by i.v., followed by paclitaxel 150 mg/m2, by 3 hour continuous infusion on day 2 repeated every 3 weeks. Premedication with dexamethasone, ondansetron, diphenhydramine and cimetidine were administered to prevent gastroenteritic and allergic reactions before chemotherapy. Thirty-nine patients were given 2 cycles and thirty-six were given 4 cycles of this regimen. One of 39 patients had complete response, 28 had partial response and 10 had no change in the 2-cycle group. In addition, 21 of 36 patients had complete response (including 9 who had pathologic complete response), 13 had partial response and 2 had no change. The response rates were 74% (29/39) in the 2-cycle group and 94% (34/36) in the 4-cycle group. There were no progressive disease in these 2 groups. However a higher proportion of PR was observed in stage II patients than in stage III patients. Twelve of 36 patients underwent breast conserving surgery, as tumor size had become smaller and down-staging was realized after neoadjuvant chemotherapy. In addition, axillary lymph nodes were palpable in all 75 patients before neoadjuvant chemotherapy with the ET regimen. But 46% (18/39) in the 2-cycle group and 75% (27/36) in the 4-cycle group became impalpable. Conversely, major toxicities (including leukopenia and gastroenteric reactions) were similar in both groups, but myalgia, arthralgia, neurotoxicity and alopecia were more severe in the 4-cycle group than in the 2-cycle group. In the present study, neoadjuvant chemotherapy with a 4-cycle ET regimen was more effective than with a 2-cycle regimen in down staging locally advanced breast cancer. Although major toxicities were more severe in the 4-cycle group than in the 2-cycle group, the regimen was tolerable and safe.     

Salvage treatment with epirubicin and/or paclitaxel in metastatic breast cancer patients relapsed after high-dose chemotherapy with peripheral blood progenitor cells

AIMS AND BACKGROUND: To evaluate feasibility and efficacy of paclitaxel as a single agent or in combination with epirubicin in breast cancer taxane-naive patients who have failed previous high-dose chemotherapy. METHODS: Since February 1995, we have treated 32 patients in first relapse or progression after high-dose chemotherapy. Nineteen patients had metastatic breast cancer, 12 more than 3 involved axillary lymph nodes, and 1 inflammatory breast cancer at inclusion to the program. The median time to relapse after high-dose chemotherapy was 12 months (range, 2-43). At relapse, 12 patients were treated with epirubicin (90 mg/m2) plus paclitaxel (175 mg/m2) administered on day 1 every 21 days. In 20 patients who had previously received more than 350 mg/m2 of a cumulative dose of epirubicin and in one patient pretreated with chemotherapy containing mitoxantrone, we employed paclitaxel (175 mg/m2) alone. A median number of five courses was administered (range, 2-10). RESULTS: The overall response rate after 3 courses (29 of 32 patients were assessable) was 55% and after 6 courses (21 of 32 patients were assessable) was 57%. The median time to progression was 7 months (95% CI, 5.7-9.2), and median survival was 27.5 months (95% CI, 17.8-37.0). Toxicity was recorded for 180 cycles (epirubicin + paclitaxel for 62 cycles and paclitaxel alone for 118 cycles). The main toxicity in both regimens was hematologic. We observed WHO grade 3-4 neutropenia (in 8 patients, 25%), for which G-CSF (5 microg/kg/day s.c.) was employed. WHO grade 3-4 thrombocytopenia occurred in 2 patients (6%) and WHO grade 3 anemia in 1 patient (3%). CONCLUSIONS: Our study showed that paclitaxel (alone or in combination with epirubicin) is feasible as salvage treatment in heavily pretreated patients.     

Frequency of febrile neutropenia in breast cancer patients receiving epirubicin and docetaxel/paclitaxel with colony-stimulating growth factors: a comparison of filgrastim or lenograstim with pegfilgrastim

OBJECTIVE: Recombinant granulocyte colony-stimulating factors (G-CSF) have been shown to be effective in reducing the risk of infections associated with antitumour chemotherapy. This report describes a single-centre experience of the efficacy of pegfilgrastim compared with filgrastim or lenograstim in reducing the incidence of febrile neutropenia in patients receiving combination chemotherapy with taxane and epirubicin in a neoadjuvant and adjuvant setting. METHODS: A total of 118 patients with breast cancer were treated with either epirubicin 75 mg/m(2) and docetaxel 75 mg/m(2) or epirubicin 90 mg/m(2) and paclitaxel 200 mg/m(2) every 3 weeks; 88 received G-CSF support with daily filgrastim or lenograstim and 30 with pegfilgrastim once per cycle. RESULTS: Eight patients (9.1%) with prophylactic filgrastim or lenograstim support developed febrile neutropenia, as well as 1 patient (3.3%) in the pegfilgrastim group (p = 0.445). Febrile neutropenia occurred in 13 (2.7%) of 476 filgrastim or lenograstim supported chemotherapy cycles and in 2 (1.2%) of 172 cycles with pegfilgrastim support (p = 0.376). The frequency of chemotherapy delays and dose reductions was not significantly different between the two G-CSF treatment groups. CONCLUSION: These data show a trend towards superiority of pegfilgrastim over filgrastim or lenograstim in reducing the frequency of febrile neutropenia in patients treated with taxane and epirubicin chemotherapy regimens for breast cancer.     

Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer.

PURPOSE: This randomized, noncomparative, parallel-group study was designed to evaluate the pathologic complete response (pCR) rate of combined doxorubicin plus paclitaxel (AP) and doxorubicin plus cyclophosphamide (AC) as neoadjuvant chemotherapy in patients with previously untreated breast cancer who were unsuitable for conservative surgery. PATIENTS AND METHODS: A total of 200 patients with T2-3, N0-1, M0 disease were randomly assigned in a 2:1 ratio to receive preoperative chemotherapy with either doxorubicin 60 mg/m(2) plus paclitaxel 200 mg/m(2) as a 3-hour infusion (AP) or doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) (AC) every 3 weeks for 4 courses followed by surgery. RESULTS: A pCR (eradication of invasive carcinoma in tumor and in axillary lymph nodes) was found in 16% and 10% of patients in the AP and AC arms, respectively, by study center pathologists, and in 8% and 6% of patients, respectively, by independent pathologists. Patients with pCRs tended to have unifocal disease, tumors with negative hormonal receptor status, and less differentiation (Scarff, Bloom, and Richardson scale grade 3). Breast-conserving surgery was performed in 58% and 45% of patients in the AP and AC arms, respectively. An objective clinical response was achieved in 89% of patients in the AP arm and 70% in the AC arm. At a median follow-up of 31 months, disease-free survival (DFS) was higher in patients who reached pCR versus those without pCR (91% v 70%). CONCLUSION: The encouraging pathologic and clinical responses of patients with breast cancer after neoadjuvant chemotherapy with doxorubicin plus paclitaxel warrant additional investigation of paclitaxel in the neoadjuvant setting of breast cancer management.     

三阴性乳腺癌白蛋白结合型紫杉醇与多西他赛新辅助化疗临床对照研究

目的：评价白蛋白结合型紫杉醇、表柔比星联合环磷酰胺对比多西他赛、表柔比星联合环磷酰胺新辅助化疗治疗三阴性乳腺癌的临床效果。方法：将东莞市人民医院2009—01—03—2012—01—31经病理学确诊的三阴性乳腺癌患者42例分为PEC组21例,给予白蛋白结合型紫杉醇260mg／m2,静脉滴入,表柔比星70mg／m2,静脉滴入,环磷酰胺500mg／m2,静脉滴入,3周重复,不做抗过敏预处理;TEC组21例,给予多西他赛75mg／m2,静脉滴入,表柔比星与环磷酰胺应用方法同PEC方案,3周重复,使用多西他赛前1d开始口服地塞米松片7．5mg,2次／d,连服3d。结果：两组患者均完成4个周期新辅助化疗。PEC组RR19例（90．5％）、CR8例（38．1％）、PR 11例（52．4％）、SD2例（9．5％）;TEC组RR18例（85．7％）、CR8例（38．1％）、PR10例（47．6％）和SD3例（14．3％）,两组差异均无统计学意义,P〉0．05;PEC组pCR为28．6％优于TEC组的19．1％,P=0．049。随访截止2013—04—01,中位随访时间25个月（12～48个月）,随访率为100．0％。毒副作用两组中性粒细胞下降、血小板减少、便秘、心脏毒性、肝功能异常、外周神经毒性、肝肾功能异常发生率相比差异均无统计学意义,P〉0．05。结论：白蛋白结合型紫杉醇、表柔比星联合环磷酰胺新辅助治疗局部晚期三阴性乳腺癌疗效显著,毒副作用可耐受,值得进一步研究。     

Feasibility of radiotherapy after high-dose dense chemotherapy with epirubicin, preceded by dexrazoxane, and paclitaxel for patients with high-risk Stage II-III breast cancer

PURPOSE: To verify the feasibility of, and quantify the risk of, pneumonitis from locoregional radiotherapy (RT) after high-dose dense chemotherapy with epirubicin and paclitaxel with peripheral blood progenitor cell support in patients with high-risk Stage II-III breast cancer. METHODS AND MATERIALS: Treatment consisted of a mobilizing course of epirubicin 150 mg/m2, preceded by dexrazoxane (Day 1), paclitaxel 175 mg/m2 (Day 2), and filgrastim; followed by three courses of epirubicin 150 mg/m2, preceded by dexrazoxane (Day 1), paclitaxel 400 mg/m2 (Day 2), and peripheral blood progenitor cell support and filgrastim, every 16-19 days. After chemotherapy, patients were treated with locoregional RT, which included the whole breast or the chest wall, axilla, and supraclavicular area. RESULTS: Overall, 64 of 69 patients were evaluable. The interval between the end of chemotherapy and the initiation of RT was at least 1.5-2 months (mean 2). No treatment-related death was reported. After a median follow-up of 27 months from RT (range 5-77 months), neither clinically relevant radiation pneumonitis nor congestive heart failure had been reported. Minor and transitory lung and cardiac toxicities were observed. CONCLUSION: Sequential high doses of epirubicin, preceded by dexrazoxane, and paclitaxel did not adversely affect the tolerability of locoregional RT in breast cancer patients. The risk of pneumonitis was not affected by the use of sequential paclitaxel with an interval of at least 1.5-2 months between the end of chemotherapy and the initiation of RT. Long-term follow-up is needed to define the risk of cardiotoxicity in these patients.     

紫杉醇联合表阿霉素剂量密集辅助化疗的安全性观察

目的 观察紫杉醇(PTX)联合表阿霉素(EPI)剂鼍密集化疗在高复发风险的乳腺癌辅助化疗中的安全性和耐受性.方法 2004年1月至2006年12月共收治101例乳腺癌术后患者,均具有高复发风险.采用FIX联合EPI的方案进行辅助化疗,随机分为密集组和常规组,计划每例患者接受6个周期的化疗.结果 全组有98例患者按计划完成化疗,中位随访24个月,中位无复发生存和总牛存时间均未达到.密集组和常规组的无复发率分别为89.8%和87.8%,2年生存率分别为100%和93.9%,其中高危患者的无复发率分别为86.8%和81.3%,2年生存率分别为100%和90.6%.全组101例患者均可评价不良反应,主要不良反应为粒细胞减少、恶心、呕吐和脱发.密集组和常规组的Ⅲ～Ⅳ度粒细胞减少发生率分别为16.0%和54.9%(P=0.000),凶不良反应而延迟化疗的发生率分别为2.4%和6.0%(P=0.027),两组间其他不良反应差异无统计学意义.结论 PTX联合EPI剂量密集方案用于高复发风险乳腺癌患者的辅助化疗,不良反应可以耐受,是一个安全的、有潜力的方案.     

Gemcitabine/epirubicin/paclitaxel as neoadjuvant chemotherapy in locally advanced breast cancer: a phase II trial of the NSABP Foundation Research Group

BACKGROUND: This phase II protocol of neoadjuvant chemotherapy with gemcitabine/epirubicin/paclitaxel (GET) was designed to determine the pathologic complete response (pCR) rate in the breast, clinical response rate, disease-free survival, and overall survival at 2 years as well as toxicity in patients with locally advanced breast cancer. This trial also evaluated the feasibility of tissue collection for gene-expression profiling. PATIENTS AND METHODS: Seventy-six women with stage IIB, IIIA, and IIIB breast cancer were entered into this trial. Patients received a maximum of 6 cycles of neoadjuvant GET chemotherapy every 21 days (gemcitabine 1000 mg/m2 intravenously [i.v.] on days 1 and 4, epirubicin 90 mg/m2 i.v. bolus on day 1, and paclitaxel 175 mg/m2 i.v. on day 1). After chemotherapy, patients underwent surgery and were assessed for pathologic response. RESULTS: The pCR rate among the 74 patients evaluable for efficacy was 23% (95% CI, 14%-34.2%). Adverse events among the 76 patients evaluable for toxicity included anemia requiring transfusion (14.5%), infection with grade 3/4 neutropenia (10.5%), febrile neutropenia (7.9%), and platelet transfusion (6.6%). Infectious complications occurred in 24 patients (31.6%), of whom 18.4% were in the setting of neutropenia. High-quality RNA and successful probe synthesis were obtained from all pretreatment core biopsy specimens that contained tumor cells (n=66; 88%). CONCLUSION: Neoadjuvant GET chemotherapy is an active regimen but with substantial toxicity. Tissue collection for gene-expression profiling is feasible in a multi-institutional setting.