多西紫杉醇联合卡培他滨治疗蒽环类耐药的晚期乳腺癌

目的:观察多西紫杉醇联合卡培他滨(DC)治疗蒽环类耐药晚期乳腺癌的疗效和安全性.方法:31例经病理证实的蒽环类耐药的转移性乳腺癌患者,采用多西紫杉醇联合卡培他滨化疗.剂量为多西紫杉醇75mg/m2,静滴,d1;希罗达2 500mg/m2,口服,d1～d14,21天为1个周期,化疗至疾病进展或不良反应无法耐受.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标准评价疗效和不良反应.结果:31例患者共完成118个周期化疗,每例患者化疗2个～8个周期,中位周期数4个.31例患者中,完全缓解1例(3.2%),部分缓解16例(51.6%),稳定10例(32.3%),进展4例(12.9%),总有效率为54.8%.中位肿瘤进展时间6.3个月,中位生存期13个月,1年生存率为58.8 %.主要不良反应为骨髓抑制、胃肠道反应和手足综合征,患者均可耐受.结论:多西紫杉醇联合卡培他滨治疗蒽环类耐药晚期乳腺癌的疗效较好,不良反应可以耐受,是治疗蒽环类耐药晚期乳腺癌的有效方案.     

多西紫杉醇联合卡培他滨治疗蒽环类耐药的晚期乳腺癌

目的:观察多西紫杉醇联合卡培他滨方案治疗对蒽环类耐药的晚期乳腺癌的疗效及毒副反应.方法:24例患者给予多西紫杉醇75mg/m2静滴d1,卡培他滨1650 mg/m2*d,口服,d1-d14.21天为1周期,至少用2个周期,中位化疗周期数3个(2-4周期).结果:总有效率41.7%,疾病控制率为83.3%,中位生存期16.5个月,主要毒副作用为骨髓抑制和脱发.结论:多西紫杉醇联合卡培他滨治疗对蒽环类耐药的晚期乳腺癌疗效好,毒副作用轻,是治疗对蒽环类耐药晚期乳腺癌较好的方案.     

含卡培他滨联合方案治疗转移性乳腺癌的临床观察

为了探讨卡培他滨为主的联合化疗方案治疗转移性乳腺癌的疗效及毒副反应,将52例转移性乳腺癌患者中的29例(既往使用蒽环类治疗失败)给予卡培他滨联合多西紫杉醇治疗.多西紫杉醇 75 mg/m2,静脉滴入,＞1 h,希罗达2 000 mg/m2,口服,2次/d,每21 d为1个周期;23例既往未曾采用蒽环类治疗,给予卡培他滨联合表柔比星治疗,化疗剂量为表柔比星60 mg/m2,静脉推注,希罗达2 000 mg/m2,口服,2次/d,每21 d为1个周期.2个周期后评价疗效,有效者化疗＞4个周期.52例患者中,治疗后CR 12例,PR 24例,SD 9例,PD 7例,有效率为69.23%(36/52).中位疾病进展时间(TTP)为8.6个月 ,中位生存时间(MST)为18.5个月.主要毒副反应为白细胞减少,其中Ⅲ～Ⅳ度占51.9%;手足综合征,其中Ⅱ～Ⅲ级占21.8%.初步研究结果提示,卡培他滨为主的联合化疗方案治疗转移性乳腺癌疗效确切,毒副反应可耐受.     

多西紫杉醇联合卡培他滨治疗转移性乳腺癌30例

 【摘要】　目的　观察多西紫杉醇联合卡培他滨方案治疗转移性乳腺癌的临床疗效及患者不良反应。方法　30例转移性乳腺癌患者应用多西紫杉醇35 mg／m2,第1、8天静脉滴注1 h,卡培他滨1000 mg／m2,口服,早晚 2次餐后服用,连用14 d,21 d为 1个周期,至少应用 2个周期后评价疗效。每周期化疗前后复查血常规及生化指标。结果　30例患者中完全缓解（CR）1例,部分缓解（PR）15例,疾病稳定（SD）11例,疾病进展（PD）3例,总有效（CR+PR）率53.3 %;中位生存时间14个月,疾病进展时间8.5个月;不良反应主要有骨髓抑制、胃肠道反应、手足综合征,均可耐受。结论　多西紫杉醇联合卡培他滨方案治疗转移性乳腺癌疗效确切,患者不良反应可以耐受。     

多西紫杉醇联合卡培他滨治疗蒽环类耐药的晚期乳腺癌

目的：观察多西紫杉醇联合卡培他滨方案治疗对蒽环类耐药的晚期乳腺癌的疗效及毒副反应。方法：24例患者给予多西紫杉醇75mg/m^2静滴d1,卡培他滨1650mg/m^2.d,口服,d1-d14。21天为1周期,至少用2个周期,中位化疗周期数3个（2-4周期）。结果：总有效率41.7%,疾病控制率为83.3%,中位生存期16.5个月,主要毒副作用为骨髓抑制和脱发。结论：多西紫杉醇联合卡培他滨治疗对蒽环类耐药的晚期乳腺癌疗效好,毒副作用轻,是治疗对蒽环类耐药晚期乳腺癌较好的方案。     

卡培他滨联合多西紫杉醇和奥沙利铂治疗晚期转移性食管癌的临床观察

目的 观察卡培他滨联合多西紫杉醇和奥沙利铂治疗晚期转移性食管癌的l临床疗效和毒副反应.方法 50例晚期转移性食管癌接受卡培他滨联合多西紫杉醇和奥沙利铂的联合方案化疗.应用卡培他滨(1 000 mg/m2,d1～14)+多两紫杉醇(30 mg/m2,d.)+奥沙利铂(50 mg/m2,d1),21 d为1周期,治疗后2个周期评价疗效和毒副反应.结果 全组50例中,无CR,PR 19例,SD 20例,PD 11例,总有效率为38%.中位肿瘤进展时间3.4个月.主要毒副反应为中性粒细胞减少(38%)、手足综合征(36%)、腹泻(44%),恶心呕吐(56%)、周围神经毒性(62%).结论 卡培他滨联合多西紫杉醇和奥沙利铂方案治疗晚期转移性食管癌疗效确切、毒副反应可耐受.     

多西紫杉醇联合卡培他滨治疗晚期乳腺癌的临床观察

目的 观察多西紫杉醇联合卡培他滨治疗蒽环类药物治疗失败复发转移性乳腺癌的近期疗效和不良反应,并与长春瑞滨(NVB)和顺铂(DDP)组成的NP方案进行比较.方法 蒽环类药治疗失败的复发转移性乳腺癌患者,选择匹配68例,分为A(治疗组)和B(对照组)两组. A组32例接受多西紫杉醇联合卡培他滨方案,多西紫杉醇75 mg/m2,静滴,第1天;卡培他滨950 mg/m2,每日2次口服,第1～14天.B组36例采用NP方案,NVB 25 mg/m2,第1、8天,静滴;DDP 80 mg/m2,分3 d(d1～3)静滴,每3周重复一次.治疗2个周期以上评价疗效.结果 68例患者均可行疗效和不良反应评价,A组和B组有效率分别为71.9%(23/32)和44.4%(16/36),两组差异有显著性(P＜0.05);中位肿瘤进展时间(TTP)A组和B组分别为5.7个月和3.8个月,差异有显著性(P＜0.01).两组主要不良反应均为中性粒细胞减少,A组和B组Ⅲ、Ⅳ度中性粒细胞减少发生率分别为53.1%和44.4%,差异无显著性(P＞0.05).A组主要不良反应还有手足综合征,多为Ⅰ～Ⅱ度.结论 多西紫杉醇联合卡培他滨是治疗蒽环类治疗失败复发转移性乳腺癌的有效方案,其有效率优于NP方案,不良反应可以耐受.     

多西紫杉醇联合卡培他滨治疗蒽环类耐药性晚期乳腺癌的疗效观察

目的 观察多西紫杉醇联合卡培他滨治疗蒽环类耐药性晚期乳腺癌的疗效和不良反应.方法 43例经病理证实的蒽环类耐药性晚期乳腺癌患者,采用多西紫杉醇联合卡培他滨方案化疗.多西紫杉醇75 mg/m<'2>、静脉滴注、dl,卡培他滨1600 mg/d、分2次口服、dl～14,21 d为1个周期,化疗周期数为3～6个周期,中位周期数4个,直至病情进展或不良反应无法耐受.结果 43例患者中,完全缓解9例(20.9%),部分缓解19例(44.2%),稳定9例(20.9%),疾病进展6例(14.0%),有效率为65.1%.中位肿瘤进展时间为7.5个月,中位生存期为15个月,1年生存率为62.8%,2年生存率为41.9%.不良反应主要为胃肠道反应、骨髓抑制和手足综合征,患者均可耐受.结论 多西紫杉醇联合卡培他滨治疗蒽环类耐药性晚期乳腺癌的疗效显著,不良反应可以耐受,可作为蒽环类耐药的晚期乳腺癌的有效解救治疗方案.     

卡培他滨联合多西紫杉醇治疗转移性乳腺癌的临床观察

为了探讨卡培他滨和多西紫杉醇联合方案治疗转移性乳腺癌的疗效及不良反应,29例转移性乳腺癌患者接受卡培他滨和多西紫杉联合方案化疗。卡培他滨2·0g/m2,d1~d14;多西紫杉醇35mg/m2,d1、d8、d15。21d重复,化疗2个周期以上。结果示29例患者入选,2例出组,27例可供评价疗效,29例可评价不良反应。有效率为51·9%(14/27),获益率为88·9%(24/27);主要不良反应为手足综合征、皮肤色素沉着、白细胞减少、血小板减少、血红蛋白降低、恶心呕吐、口腔炎、腹泻、肝功能损害、脱发、心脏毒性、末梢神经毒性、过敏反应等。初步研究结果提示,对蒽环类药物和(或)紫杉醇治疗失败的转移性乳腺癌,卡培他滨联合多西紫杉醇是一种新的选择方案。     

多西紫杉醇联合卡培他滨治疗转移性乳腺癌的疗效分析

目的探讨多西紫杉醇联合卡培他滨（DC方案）治疗转移性乳腺癌的临床疗效。方法选择79例转移性乳腺癌患者,均采用DC方案化疗,然后评价患者的临床疗效及不良反应。结果79例患者在本研究中共完成300个化疗周期,中位化疗周期数3．8个。总有效率为50．6％,其中CR3例（3．8％）。化疗主要不良反应有乏力、骨髓抑制、手足综合征、胃肠道反应、口腔黏膜炎等。65例患者出现中性粒细胞下降,其中5例达Ⅳ度骨髓抑制。中位随访时间为10．5个月,中位无进展生存期（progression—free survival,PFS）为5．8个月。结论多西紫杉醇联合卡培他滨方案治疗转移性乳腺癌的有效率高,疗效肯定,不良反应可以耐受,是治疗转移性乳腺癌的有效方案。     

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.     

DC方案与DE方案一线治疗转移性乳腺癌的对比研究

目的　比较多西紫杉醇联合卡培他滨（ＤＣ方案）与多西紫杉醇联合表柔比星（ＤＥ方案）一线治疗转移性乳腺癌的疗效及不良反应。方法　６５例转移性乳腺癌患者分别接受ＤＣ方案和ＤＥ方案治疗。ＤＣ方案组：多西紫杉醇７５ｍｇ／ｍ２静滴,ｄ１;卡培他滨２０００ｍｇ／（ｍ２·ｄ）,分两次口服,ｄ１～ｄ１４。ＤＥ方案组：多西紫杉醇７５ｍｇ／ｍ２静滴,ｄ１;表柔比星７５ｍｇ／ｍ２静推,ｄ１。两方案均以２１天为１个周期。结果　ＤＣ方案组有效率高于ＤＥ方案组（６０.６％ ｖｓ．４６.９％,Ｐ＞０.０５）,其中ＤＣ方案组完全缓解率高于ＤＥ方案组（２４.２％ ｖｓ．６.３％）,两组比较差异有统计学意义（Ｐ＜０.０５）。ＤＣ方案组的６个月后疾病无进展率（ＰＦＲ）优于ＤＥ方案组（７２.７％ ｖｓ．６２.５％,Ｐ＞０.０５）。中位无进展生存期（ＰＦＳ）ＤＣ方案组长于ＤＥ方案组（１１.４个月ｖｓ．７.６个月）,两组比较差异有统计学意义（Ｐ＜０.０５）。不良反应以骨髓抑制、胃肠道反应和脱发为主,３、４级手足综合征发生率ＤＣ方案组（２７.３％,９／３３）高于ＤＥ方案组（０）,差异有统计学意义（Ｐ＜０.０５）。结论　ＤＣ方案及ＤＥ方案一线治疗转移性乳腺癌均取得较好疗效,ＤＣ方案可以作为非蒽环类药物有效的一线治疗方案。     

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。     

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.     

多西紫杉醇联合希罗达治疗乳腺癌肺转移39例临床分析

目的 观察多西紫杉醇(紫杉特尔、Docetacel)联合希罗达治疗乳腺癌肺转移患者的临床疗效和不良反应,为临床治疗提供依据.方法 39例乳腺癌肺转移患者,用多西紫杉醇注射液75 mg/mz,第1天静脉滴注1小时,希罗达2 500 mg/m2,分早晚2次餐后半小时口服,第1-14天,21天为1个周期,连用4-6个周期.化疗前1天开始口服地塞米松8 mg,2次/天,连服3天,以防水钠潴留.每3周为1个周期,2个周期评价疗效.结果 39例患者完全缓解(CR)13例(33.3﹪),部分缓解(PR)14例(35.9﹪),总有效率(CR+PR)69.2﹪,稳定(SD)9例,进展(PD)3例.不良反应主要是骨髓抑制、胃肠道反应,对症治疗后均获得缓解,无化疗相关死亡.结论 多西紫杉醇联合希罗达治疗肺转移性乳腺癌有较好疗效,不良反应能耐受,是一种安全、有效的化疗方案.     

A pilot phase II study of capecitabine in advanced or recurrent breast cancer

BACKGROUND: A pilot phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent regimen of capecitabine (Xeloda) in patients with advanced or recurrent breast cancer. METHODS: A total of 23 patients who had received no more than one prior chemotherapy regimen received oral 828 mg/m2 capecitabine twice daily for 3 weeks followed by a 1-week rest period. The response to capecitabine was evaluated in 22 patients (one patient ineligible). RESULTS: The overall response rate was 45.5% (95% CI, 24.4-67.8%), including 1 complete response (4.5%) and 9 patients with partial response (40.9%). A further 7 patients (31.8%) had stable disease. The median duration of response was 7.2 months (range, 3.0-15.8 months) and the median time to progression was 6.4 months (95% CI, 4.1-15.1 months). Treatment-related adverse events >or= grade 3 were observed in 7 patients (30.1%). CONCLUSION: Intermittent capecitabine therapy (828 mg/m(2) twice daily for 3 weeks followed by a 1-week rest period) was shown to be effective and well tolerated as second-line treatment for advanced or recurrent breast cancer. The Japanese regimen is worthy of further study in larger numbers of patients in phase II / III clinical trials.     

Phase II study of docetaxel and capecitabine in patients with metastatic or recurrent gastric cancer

OBJECTIVES: A phase II study was conducted to evaluate the response rate and safety of a combination regimen of docetaxel plus capecitabine in patients with advanced gastric cancer. PATIENTS AND METHODS: Patients with previously untreated metastatic or recurrent measurable gastric cancer received i.v. docetaxel 75 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily from day 1 to 14 every 3-week cycle. RESULTS: Thirty-two patients were enrolled in the current study. Of these, 30 patients were assessable for efficacy and 31 assessable for toxicity. One complete response and 13 partial responses were confirmed, giving an overall response rate of 43.8% (95% CI; 25.6-61.9%). The median time to progression and median overall survival for all patients was 5.07 months and 8.4 months, respectively. Grade 3/4 neutropenia occurred in 3 patients (9.7%) and febrile neutropenia was observed in 2 patients (6.3%). Grade 1/2 nausea was observed in 45.2% of patients. Grade 2-3 hand-foot syndrome occurred in 4 patients (12.9%). CONCLUSIONS: The combination of docetaxel and capectabine was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer.     

Final results of a phase II clinical trial of weekly docetaxel in combination with capecitabine in anthracycline-pretreated metastatic breast cancer

The addition of capecitabine to docetaxel on a 3-week schedule resulted in superior response rate, increased time to progression (TTP), and improved overall survival in patients with anthracycline-pretreated metastatic breast cancer (MBC). Because the toxicity profile of weekly docetaxel differs from the standard 21-day docetaxel schedule, we performed a phase I/II trial to test the efficacy and safety of weekly docetaxel in combination with capecitabine given for 14 days every 21 days. The phase I study identified the doses of docetaxel (30 mg/m2 weekly) and capecitabine (900 mg/m2 twice daily on days 1-14 every 21 days) used in phase II. Twenty female patients with measurable or assessable MBC were enrolled. Eighteen patients had previously received anthracyclines; 2 had contraindications to anthracyclines. Patients remained on study for a maximum of eight 3-week cycles or until tumor progression or unacceptable toxicity occurred; response assessments were scheduled after cycle 2, 5, and 8. Seventeen patients were assessed after cycle 2; 3 subjects (18%) had a partial response (PR), 9 had stable disease (53%; SD), and 5 patients (29%) had progressive disease (PD). Ten patients were assessable after cycle 5. Two patients (20%) had a PR, 5 patients (50%) had SD, and 3 patients (30%) had PD. The most common grade 3 toxicities were nail loss (45%), asthenia (30%), and hand-foot syndrome (30%), and toxicities led to study discontinuation in 10 patients. The median time to treatment failure was 10 weeks and median TTP was 26 weeks. The median duration of response was 9 weeks and the median duration of SD was 16 weeks. The median overall survival was 82 weeks. This schedule of weekly docetaxel in combination with day 1-14 capecitabine has activity; however, toxicity discourages the use of this schedule in lieu of the standard docetaxel/capecitabine regimen.