伊班膦酸钠联合化疗对乳腺癌骨转移的临床疗效

目的 观察伊班膦酸钠（艾本）联合化疗对乳腺癌骨转移的止痛效果和不良反应。方法 将65例晚期乳腺癌并骨转移患者随机分为A、B2个组，A组给予伊班膦酸钠4rng，静脉滴注，每4周1次，连用2～4次，并给长春瑞宾25mg／m^2，静脉注射，第1、8天；表阿霉素50-70mg／m^2，静脉注射，第2天；每21～28天为1个周期，连用2～4个周期。B组为单用伊班膦酸钠，剂量和用法同A组。结果 A、B2组止痛有效率分别为87．5％（28／32）和81.3％（26／32），经统计学分析，无显著性差异（P〉0．05）；A组不良反应较B组多，主要是化疗后骨髓抑制及消化道反应。结论 对乳腺癌骨转移性疼痛，采用伊班膦酸钠治疗，可获得较好的疗效，若再加化疗，并不能进一步提高近期镇痛效果。     

DE、NE方案治疗晚期乳腺癌的临床对比观察

目的观察多西紫杉醇联合表阿霉素（DE方案）与诺维本联合表阿霉素（NE方案）治疗晚期乳腺癌的疗效及不良反应。方法对64例晚期乳腺癌分别采用DE方案、NE方案治疗。DE方案组：多西紫杉醇75mg／m^2，静脉滴注，第1天；表阿霉素40-50mg／m^2，静脉注射，第2天。NE方案组：诺维本25mg／m^2，静脉滴注，第1、8天；表阿霉素用法同DE组。每21天为1个周期。结果DE方案组总有效率（61．8％，21／34）和复治有效率（57．9％，11／19）均分别高于NE方案组（40．0％，12／30；33．3％，6／18）；DE方案组中位疾病进展时间（9．2个月）长于NE方案组（7．2个月），P〈0．05；DE方案组和NE方案组中位生存期分别为18个月和17个月（P〉0．05）。不良反应以骨髓抑制、胃肠道反应和静脉炎为主。结论DE方案及NE方案对晚期乳腺癌均有较好的疗效，DE方案对复治患者疗效较好，可作为晚期乳腺癌一线化疗方案和复治晚期乳腺癌的解救方案。     

EPOCH方案和CHOP方案一线治疗非特殊性外周T细胞淋巴瘤回顾性临床对照研究

目的：比较EPOCH方案和CHOP方案一线治疗非特殊性外周T细胞淋巴瘤（FFCL—U）的疗效及不良反应。方法：A组：2008年1月至2010年4月,24例经病理确诊的PTCLU患者,采用EPOCH方案化疗：足叶已甙50mg/（m^2·d）,长春新碱04mg/（m^2·d）,表阿霉素15mg/（m^2·d）,上述三种药物持续静脉滴注96h,环磷酰胺750mg／m^2,静脉滴注,d0;强的松60mg/（m^2·d）,口服,d1-5。每3周为1周期。B组：2005年1月至2007年4月PTCL—U患者35例,采用CHOP方案化疗：环磷酰胺750mg/m^2,静脉滴注,d1,表阿霉素75mg/m^2,静脉滴注,d1,长春新碱14mg/m^2,静脉滴注,d1,强的松60mg/（m^2·d）,口服,d1-5,每3周为1周期。对两组的近期疗效、疾病进展时间、不良反应进行分析比较。结果：A组和B组的完全缓解效率分别为66.7％（16／24）和40.0％（14／35）,有显著性差异（P=0.0441）,有效率分别为79.2％（19／24）和65.7％（23／35）,无显著差异（P=0.2624）。A组和B组的中位疾病进展时间12.0月（1—27月）、10月（1—28月）（P=0.2045）。主要不良反应白细胞减少、神经毒性、脱发、心脏毒性等指标均无显著性差异（P〉0.05）。轻度口腔炎的发生率A组高于B组：24.8％：13％（P〈0.05）。结论：一线治疗PTCL—U,EPOCH方案近期疗效较CHOP方案具有一定的优势,不良反应相近,耐受性好。     

环磷酰胺、阿霉素、5-氟尿嘧啶方案与紫杉醇、顺铂方案治疗晚期乳腺癌的疗效比较

背景及目的：环磷酰胺、阿霉素、5－氟尿嘧啶方案（CAF方案）和紫杉醇、顺铂方案（TP方案）均是治疗晚期乳腺癌的有效方案,但TP方案给药复杂,我们对两组晚期乳腺癌病例进行回顾性分析。比较CAF方案及TP方案治疗晚期乳腺癌的客观疗效和不良反应。方法：经病理检查证实的晚期乳腺癌患者117例,按不同治疗方案分为CAF组和TP组,两组病例特征具可比性（P＞0．05）,CAF组（66例）：环磷酰胺600mg/m^2,静脉推注,第1天;5－氟尿嘧啶600mg/m^2,静脉滴注,第1、8天,阿霉素60mg/m^2,静脉推注,第1天,TP组（51例）,紫杉醇135mg/m^2,静脉滴注3h,第1天,顺铂60mg/m^2,静脉滴注,第2、3天,两组均以3周为1个疗程,至少接受2个疗程化疗。结果：CAF组初治病例有效率54．8％（17／31）,复治病例有效率31．4％（11／35）,总有效率42．4％（28／66）,TP组分别为62．5％（15／24）,59．3％（16／27）,60．8％（31／51）。两组初治病例有效率差异无统计学意义（P＞0．05,X2检测）,复治病例有效率及总有效率差异有统计学意义（P＜0．05,X2检验）,CAF组中位无进展时间7．8个月（95％可信区间（confidence interval,VI)为5．3－10．8个月）,中位生存时间17．8个月（95％CI为13．3－22．5个月）TP组分别为8．6个月（95％CI为6．5－12个月）和19个月,（95％CI为15－25．5个月）,两组差异均无统计学意义（P＞0．05,Log-rank检验）。腹泻的发生率在CAF组明显高于TP组,而肌痛,皮疹及周围神经毒性等不良反应的发生率在TP组则明显高于CAF组,差异均有统计学意义（P＜0．05）,秩和检验）,其余不良反应的发生率相近,所有不良反应均能耐受。结论：CAF方案疗效较好,可作为晚期乳腺癌首选治疗方案在临床应用。     

多西紫杉醇联合FOLFOX4方案治疗晚期胃癌50例

目的观察多西紫杉醇（TXT）联合FOLFOX4方案治疗晚期胃癌的临床疗效及患者不良反应。方法50例晚期胃癌患者随机分为治疗组及对照组。治疗组26例晚期胃癌采用r11）（T加FOLFOX4方案化疗。对照组24例采用FOLFOX4方案化疗。药物用法：TXT35mg／m^2第1天,静脉滴注;奥沙利铂（L—OHP）85mg／m^2第2天,静脉滴注;亚叶酸钙（CF）200mg／m^2第2、3天,静脉滴注;5-氟尿嘧啶（5-Fu）400mg／m^2第2、3天,静脉推注,5-Fu600mg／mz第2、3天,持续泵入22h。每2周重复,至少化疗2个周期后评价疗效。结果全组可评价病例50例,疗效按RECIST标准评定,以完全缓解（CR）＋部分缓解（PR）合计为有效,治疗组中CR2例,PR13例,有效率57．69％;对照组中CR0例,PR7例,有效率29．17％,两组间疗效差异有统计学意义（P〈0．05）,无进展生存期分别为7．3和4．3个月,中位生存期分别为13．1和6．8个月。治疗组主要不良反应为Ⅰ～Ⅱ度为主的白细胞减少、脱发和胃肠道反应。结论TXT联合FOLFOX4方案对于晚期胃癌患者有效率高,耐受性好。     

雷替曲塞联合奥沙利铂治疗术后复发晚期大肠癌的疗效观察

目的探讨雷替曲塞（Raltitrexed）联合奥沙利铂（L-OHP）治疗术后复发晚期大肠癌的疗效和安全性。方法84例术后复发晚期大肠癌患者分为3组：A组38例,奥沙利铂（L—OHP）130mg／m^2,d1,静脉滴注3h,甲酰四氢叶酸（LV）200mg／m^2,静脉滴注2h,续予5-氟尿嘧啶（5-Fu）400mg／m^2静脉滴注6～8h,连用5d。B组27例,伊利替康（CPT-11）180mg／m^2,d1,静脉滴注1．5h,甲酰四氢叶酸（LV）200mg／m^2,静脉滴注2h,续予5-Fu400mg／m2静脉滴注6～8h,连用5d。C组19例,奥沙利铂（L-OHP）130mg／m^2,dl,静脉滴注3h,雷替曲塞（Raltitrexed）3mg／m^2,d1,静脉注射15min。三组均每3周重复1次。结果A、B、C三组有效率（RR）分别为15．8％、18．5％和36．8％;A、B组分别与C组比较,两组RR比较差异均有统计学意义（P〈0．05）。三组的疾病控制率（DCR）分别为65．8％、70．4％和78．9％;A、B组与C组比较,两组DCR比较差异均无统计学意义（P〉0．05）。三组的中位疾病进展时间（TTP）分别为6．1个月、6．9个月和8．2个月。A组与C组比较,两组TTP差异有统计学意义（P〈0．05）;B组与C组比较,两组TTP差异无统计学意义。毒性反应方面,C组的黏膜炎发生率明显低于A和B组,具有显著差异;其肝功能异常发生率高于A和B组;其神经毒性与A组基本相同;其腹泻及脱发发生率明显低于B组。结论雷替曲塞联合L—OHP（TOMOX方案）在术后复发晚期结直肠癌的治疗上近期效果优于FOLFOX及FOLFIRI方案,且毒性反应低,患者耐受性好,尤其适合老年患者。     

去甲长春花碱联合顺铂治疗转移性乳腺癌

目的：观察去甲长春花碱（vinorelbine,NVB)联合顺铂（cisplatin,DDP)治疗转移性乳腺癌的疗效及不良反应,方法：采用NVB25mfg/m^2d1.8DDP30mg/m^2d1-3,每3周重复一次,共用2－4周期。结果：40例患者中有效率45％（18／40）,CR2．5％（1／40）,PR42．5％（17／40）,主要剂量限制不良反应是白细胞减少（Ⅲ、Ⅳ度27．5％）,结论：NVB联合DDP治疗转移性乳腺癌有较好的疗效,且阿霉素和／或泰素治疗失败的患者亦有较好的疗效,不良反应中耐受。     

吉西他滨联合顺铂二线治疗晚期乳腺癌的临床观察

目的：探讨吉西他滨联合顺铂二线治疗晚期乳腺癌的疗效和不良反应。方法：选择蒽环类和（或）紫杉类化疗后的转移性乳腺癌患者30例,采用吉西他滨1000mg／m^ 2,静脉滴注,第1、8天;顺铂25mg／m^2,静脉滴注,第1—3天,21d为1周期,至少2周期后评价疗效。结果：CR2例（6．7％）,PRl2例（40．0％）,总有效率为46．7％。中位生存期12．8个月,中位TTP5．6个月。主要不良反应为骨髓抑制及胃肠道反应。结论：吉西他滨联合顺铂二线治疗晚期乳腺癌的近期疗效较好,患者耐受性好,值得临床推广。     

单药周剂量与联合方案治疗老年晚期非小细胞肺癌的临床观察

目的：探讨单药周剂量与联合方案治疗老年晚期非小细胞肺癌的疗效、不良反应和对患者生活质量的改善 。方法：96例老年晚期非小细胞肺癌患者随机分为3组，进行静脉化疗。A组（P方案）30例，紫杉醇（PTX）60mg／m^2，d1，8，15。B组（PC方案）34例，紫杉醇（PTX）60mg／m^2，d1，8，15；顺铂（CDDP）30mg／m^2，d2～4。C组（PCb方案）32例，紫杉醇（PTX）60mg／m^2，d1，8，15；卡铂（CBP）按AUC（曲线下面积）=5计算剂量，d2。4周为1个周期，二个周期后评定疗效。结果：A组、B组和C组有效率分别为26．7％、55．9％和56．3％，1年生存率分别为39．7％、35．3％和47.2％．中位生存期分别为8个月、9个月和10个月。B组和C纽疗效显著高于A组（P〈0．05），而B组和C组疗效差异无统计学意义（P〉0．05），3组生存率差异无统计学意义（P〉0．05）。主要不良反应骨髓抑制、变态反应、脱发、口腔炎，3组相似，B组消化道反应发生率高（P〈0．05），C组生活质量改善显著高于A组和B组（P〈0．05），而A纽和B组间改善无统计学意义（P〉0．05）。结论：紫杉醇周剂量联合顺铂或卡铂方案治疗老年晚期非小细胞肺癌的疗效高于紫杉醇周剂量单药，不良反应可耐受，PCb方案改善患者生活质量优于P方案和PC方案。     

长春瑞滨联合表阿霉素治疗转移性乳腺癌的临床观察

目的观察长春瑞滨（NVB）和表阿霉素（EPI）联合化疗方案在转移性乳腺癌治疗中的疗效和毒副反应。方法采用NVB25mg／m^2,第1、8天,EPI60mg／m^2第1天,每21天为一周期,共用2-4周期,随访6—36个月。结果18例24处转移灶中,完全缓解（CR）37．50％（9／24）,部分缓解（PR）16．67％（4／24）,疾病稳定（SD）37．50％（9／24）,SD≥6个月者20．83％（5／24）,疾病进展（PD）8．33％（2／24）。总有效率（CR＋PR）54．17％,临床获益率（CR＋PR＋SD≥6个月）为75．00％,中他疾病进展时间TTP为6．5个月。对锁骨上淋巴结转移的有效率最高达87．50％。不良反应主要为白细胞减少、脱发和周围静脉炎。Ⅲ-Ⅳ度白细胞减少发生率为72．22％,Ⅲ～Ⅳ度静脉炎的发生率为11．11％。结论,长春瑞滨联合表阿霉素在转移性乳腺癌治疗中疗效显著,不良反应可耐受。     

国产多西他赛治疗乳腺癌和非小细胞肺癌的临床观察

目的:评价国产多西他赛(深圳万乐医药公司产品)单药以及多西他赛 顺铂联合化疗方案对乳腺癌和非小细胞肺癌的临床疗效和安全性,并以进口多西他赛(安万特公司) 顺铂联合化疗方案作对照.方法:1)单药治疗分为2组:多西他赛(万乐)75mg/m2第1天静脉滴注,21天为一周期,治疗乳腺癌(A组)和非小细胞肺癌(B组);2)联合治疗分为4组:乳腺癌患者随机分为多西他赛(万乐)70mg/m2 顺铂80mg/m2(C组),或泰索帝(进口)70mg/m2 顺铂80mg/m2(D组),21天为一周期;肺癌患者随机分为多西他赛(万乐) 顺铂(E组)或泰索帝(进口) 顺铂(F组),方案与乳腺癌相同.结果:147例患者中138例可评价疗效,141例可评价不良反应,单药有效率乳腺癌(A组)21.7%,单药非小细胞肺癌(B组)6.1%,联合治疗组有效率C组60.0%,D组35.0%,E组23.8%,F组28.6%.不良反应主要为骨髓抑制、恶心呕吐、脱发.联合治疗方案多西他赛(万乐)组与泰索帝(安万特)组比较,疗效和不良反应相似.结论:多西他赛(万乐)单药及联合顺铂方案治疗乳腺癌和非小细胞肺癌安全有效,耐受性好,与进口泰索帝疗效和不良反应相似.     

Phase II study of weekly docetaxel alone or in combination with trastuzumab in patients with metastatic breast cancer

This study was designed to determine the efficacy and toxicity of weekly docetaxel in metastatic breast cancer when given alone (for HER2/neu negative disease) or with trastuzumab (for HER2/neu overexpressing disease). Patients with metastatic breast carcinoma received docetaxel given on 2 different schedules (group 1A, 33 mg/m2 weekly [n = 21]; group 1B, 40 mg/m2 weekly for 3 weeks with 1 week off [n = 14]). Patients with HER2/neu overexpressing disease also received trastuzumab 4 mg/kg on day 1, then 2 mg/kg on days 8 and 15 of each 28-day cycle (group 2). Fifty-two patients were treated with docetaxel alone (group 1A/B, n = 35) or in combination with trastuzumab (group 2, n = 17). Prior taxane therapy given every 3 weeks had been used for metastatic disease in 19 of 35 patients (54%) in group 1A/B and in 2 of 17 patients (12%) in group 2. The mean delivered dose intensity of docetaxel was 29 mg/m2 per week. Partial response occurred in 7 of 35 patients (21%; 95% exact binomial confidence interval [CI], 9%-38%) treated with docetaxel alone, including 3 of 19 taxane-pretreated patients (16%) and 4 of 16 taxane-naive patients (25%). Partial response occurred in 10 of 17 patients (59%; 95% CI, 34%-82%) treated with docetaxel/trastuzumab. The most common grade 3/4 toxicities, occurring in more than or equal to 10% of patients, included neutropenia (21%), pulmonary toxicity (12%), and hyperglycemia (10%). The median times to disease progression were 4.5 months (95% CI, 2.5-6.5 months) in the docetaxel group and 8.5 months (95% CI, 4.5-12.5 months) in the docetaxel/trastuzumab group. Weekly docetaxel/trastuzumab is an effective regimen for patients with HER2/neu overexpressing metastatic breast cancer. Weekly docetaxel may be effective in as many as 20% of patients who had progressive disease after treatment with taxanes given every 3 weeks.     

Therapeutic Efficacy of a Novel Nanosomal Docetaxel Lipid Suspension Compared With Taxotere in Locally Advanced or Metastatic Breast Cancer Patients

BackgroundNanosomal docetaxel lipid suspension formulation was developed to eliminate ethanol and polysorbate 80 from the currently used docetaxel (Taxotere) drug for treatment of cancer patients. NDLS clinical safety and efficacy was evaluated and compared with Taxotere at 75 mg/m² in metastatic breast cancer patients.Patients and MethodsA total of 72 patients were randomized in a ratio of 2:1 (NDLS:Taxotere). Patients treated with NDLS were not premedicated with corticosteroids as required with solvent-based Taxotere. Disease status and tumor response was assessed after every 2 cycles of treatment using Response Evaluation Criteria in Solid Tumors 1.1 guidelines through cycle 6.ResultsOverall therapeutic response (complete + partial) rate in metastatic breast cancer patients treated with NDLS and Taxotere were 35.5% and 26.3%, respectively, indicating better response in patients treated with NDLS. Patients in the NDLS group were not premedicated but the safety results of NDLS were found to be comparable with Taxotere.ConclusionNDLS formulation with no premedication provides an alternative treatment option for breast cancer patients.     

Clinical data and pharmacokinetics of a docetaxel-vinorelbine combination in anthracycline resistant/ relapsed metastatic breast cancer

The aim of this study was to evaluate the pharmacokinetic parameters, efficacy and toxicity of a docetaxel and vinorelbine combination in metastatic breast cancer patients previously treated with anthracycline. A population of 40 patients was analyzed; 30 patients (75%) had visceral metastases as the dominant site of disease, including 20 patients (50%) with liver metastases. Three or more organs were involved in 43% of patients. All patients had received prior anthracycline therapy. Five patients (12%) had primary resistant disease, 10 patients (25%) secondary resistant disease and 25 patients (63%) had progressive metastatic breast cancer after first-line chemotherapy. Docetaxel and vinorelbine were given at 80 mg/m2 and 20 mg/m2 i.v., respectively, on day 1 every 3 weeks. After a median of 5 cycles, it was found that 5 patients had a complete remission (13%), 19 a partial remission (48%), 9 had stable disease (22%) and 7 had progressive disease (17%). Response rates in patients with visceral and liver metastases were 57% and 50%, respectively. After a median follow-up of 24 months (13-36), median time to progression was 8.5 months and median overall survival 17 months. Grade 4 neutropenia was observed in 78% of courses (febrile neutropenia in 9%). Possible pharmacokinetic interactions were studied in 23 patients by administering docetaxel immediately followed by vinorelbine (protocol A) or vinorelbine followed by docetaxel (protocol B). Patients in protocol B had significantly higher vinorelbine plasma levels and more pronounced neutropenia. Docetaxel plus vinorelbine is an effective combination in anthracycline resistant/relapsed metastatic breast cancer. The administration sequence docetaxel --> vinorelbine is safer than the reverse order.     

Docetaxel and pegylated liposomal doxorubicin combination as first-line therapy for metastatic breast cancer patients: results of the phase II GINECO trial CAPYTTOLE

BackgroundThis phase II study evaluated the clinical benefit of pegylated liposomal doxorubicin (PLD) and docetaxel (Taxotere) as first-line therapy for metastatic breast cancer (MBC).Patients and methodsMBC patients were enrolled to receive six cycles of PLD 35 mg/m² (day 1) and docetaxel 40 mg/m² (days 1 and 15), every 28 days (group A). Because of unacceptable toxic effects, doses were modified to PLD 30 mg/m² (day 1) and docetaxel 75 mg/m² (day 2), every 3 weeks (group B). The primary end point was clinical benefit.ResultsSixty-seven patients were included (group A, 53; group B, 14). In both groups, the median number of cycles delivered was 4 and the overall dose intensity was 82% for docetaxel and 71% for PLD. In group A, main toxic effects were hematologic, palmar–plantar erythrodysesthesia (PPE), and stomatitis. In group B, higher rates of grade 3–4 PPE, febrile neutropenia, and hematologic toxic effects were reported. The rate of clinical benefit was 47%. Among patients with a measurable disease, 49% achieved a partial response, 27% had a stable disease, and 13% progressed, according to RECIST criteria.ConclusionThe combination of PLD and docetaxel delivered at planned doses in this study yields unacceptable toxicity and should not be used routinely in patients with MBC.     

Combination of docetaxel and doxorubicin as first-line chemotherapy in metastatic breast cancer.

Docetaxel (Taxotere) and doxorubicin have previously demonstrated a significant antitumor activity in patients with metastatic breast cancer. Furthermore, a lack of cross resistance and overlapping toxicities between the two agents have been reported. In a prospective study, docetaxel (80 mg/m2, 1-hr iv infusion) and doxorubicin (60 mg/m2, 1-hr iv infusion) were administered as first-line chemotherapy in metastatic breast cancer patients to evaluate the clinical efficacy and toxicity of the combination. Forty-three patients were enrolled in the study. The median age was 47 years (range, 30-69). The docetaxel-doxorubicin combination was applied with 3-week intervals until progression. Complete response was achieved in 9 (21.4%) of 42 assessable patients and partial response in 24 (57.2%) patients, for an overall response rate of 78.6%. Median response duration was 8 months (3-18 months). Nausea and vomiting (76%), alopecia (64%), neutropenia (35.7%) and mucositis (33%) were the major side effects of the combination. There was one case of cardiac toxicity. In conclusion, the docetaxel-doxorubicin protocol can be considered as an active regimen for the treatment of patients with metastatic breast cancer with acceptable toxicity and a fairly high response rate.     

Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.

PURPOSE: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. PATIENTS AND METHODS: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m(2) or doxorubicin 75 mg/m(2) every 3 weeks for a maximum of seven treatment cycles. RESULTS: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P =.008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. CONCLUSION: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.     

Two special types of breast cancer presenting as progressive disease after neoadjuvant chemotherapy with docetaxel plus doxorubicin

Seventy-eight patients with primary breast cancer over 3 cm in diameter in stages II A, II B, III A and III B according to the UICC classification received neoadjuvant chemotherapy from August 1, 1998 to June 30, 2000 at the Breast Division of the National Cancer Center Hospital. Neoadjuvant chemotherapy consisted of doxorubicin (Adriamycin: ADM) 50 mg/m(2) and docetaxel (Taxotere: DOC) 60 mg/m(2) every three weeks. The overall clinical response to this regimen was 88% (69/78). Although neoadjuvant chemotherapy with this regimen achieved good responses in patients with breast cancer, 2 patients presented with progressive disease (PD) after treatment. One patient had inflammatory breast cancer (IBC) and the other had primary squamous cell carcinoma (SCC) of the breast. There were 4 cases of IBC and one case of SCC of the breast who received neoadjuvant chemotherapy in this series. Our observations suggest that this regimen might not be effective for these types of breast cancer.     

Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial.

PURPOSE: To evaluate the efficacy and toxicity of docetaxel administered weekly to elderly or poor-performance status patients with advanced breast cancer. PATIENTS AND METHODS: Forty-one patients with advanced breast cancer who were either over the age of 65 or considered to be poor candidates for combination chemotherapy received docetaxel 36 mg/m2 weekly for 6 consecutive weeks, followed by 2 weeks without treatment. The median age of patients in this trial was 74 years, and 73% of patients had one or more visceral sites of metastases. Seventy-five percent of patients received weekly docetaxel as first-line treatment for metastatic breast cancer, and the other 25% received it as second-line treatment. Thirty-six patients were assessable for efficacy, and all patients were assessed for toxicity. RESULTS: A total of 448 doses of weekly docetaxel were administered to 41 patients. Thirteen patients (36%) had objective responses to treatment, and an additional 13 patients (36%) had stable disease or minor response. Median time to progression for responding and stable patients was 7 months (range, 3 to 27 months). Median survival for the entire group was 13 months, with 1- and 2-year actuarial survival rates of 61% and 29%, respectively. Severe neutropenia occurred in only 0.4% of courses, and no other hematologic toxicity was observed. Grade 3/4 fatigue was the most common toxicity, occurring in 20% of patients. CONCLUSION: Weekly docetaxel therapy is active and well tolerated by elderly and/or poor-performance status patients with advanced breast cancer. This treatment can be administered with minimal myelosuppression. Weekly docetaxel provides an additional option for treatment in this difficult subgroup of patients with metastatic breast cancer. Well-tolerated combination regimens containing weekly docetaxel merit evaluation for this patient population.     

A phase II trial of docetaxel and carboplatin as first-line chemotherapy for metastatic breast cancer: NCCTG study N9932

OBJECTIVE: A phase II multi-institutional clinical trial conducted to evaluate the efficacy and tolerability of docetaxel and carboplatin as first-line therapy for women with metastatic breast cancer. METHODS: Patients had histologically confirmed metastatic breast cancer with at least one measurable lesion. Prior adjuvant chemotherapy was permitted, provided that at least 12 months had elapsed between any prior taxane and platinum therapy. Patients received docetaxel 75 mg/m(2) with carboplatin AUC 6 mg/ml.min every 21 days until disease progression or prohibitive toxicity. RESULTS: All 53 patients enrolled were evaluable for response and toxicity. Median number of cycles delivered was 6. Overall response rate was 60%, with 3 complete responses (6%) and 29 partial responses (54%). Median time to disease progression was 9.6 months. Median survival time was 20.4 months. Myelosuppression was the predominant toxicity, with grade 3 or 4 neutropenia occurring in 94% of patients and 15% of patients experiencing febrile neutropenia. The overall incidence (grades 1-3) of neurosensory toxicity was 57% and neuromotor toxicity was 25%, respectively, with grade 3 toxicity occurring in 4% of patients each. CONCLUSIONS: The combination of docetaxel and carboplatin is highly active in metastatic breast cancer. Prophylactic growth factor support is recommended in any further evaluation of this combination in the treatment of patients with breast cancer.