多西他赛治疗晚期乳腺癌的临床研究

目的 观察国产多西他赛注射液对一线治疗后失败的晚期乳腺癌患者的临床疗效及毒副反应,并对安全性进行评估。方法 以国产多西他赛对44例既往治疗后进展的乳腺癌患者进行70mg／m^2静脉滴注,每3周1次,单药治疗。试验中不预防使用粒细胞集落刺激因子。用世界卫生组织（WHO）的疗效及抗肿瘤药急性及亚急性毒性反应分度标准评价疗效及毒性,用卡式评分评价身体状况变化。结果 在41例可评价疗效的患者中,4例达到完全缓解,14例部分缓解,有效率达43．9％,临床获益率85．4％。不良反应主要表现为Ⅲ、Ⅳ度白细胞下降（42．9％）、脱发（7．1％）和消化道反应（4．8％）。未出现水钠潴留。结论 使用多西他赛注射液治疗化疗后进展的晚期乳腺癌患者,疗效显著,耐受性良好,可作为该类患者的治疗选择。     

多西他赛联合顺铂治疗晚期乳腺癌32例疗效分析

目的 观察多西他赛联合顺铂治疗晚期乳腺癌疗效及毒副作用.方法 32例晚期乳腺癌采用多西他赛35 mg/m2,静脉滴注1小时,d1,d8,d15,化疗前一天给予地塞米松7.5 mg/次,2次/日,连用3天.顺铂20 mg/m2,静脉滴注d1-5.21天为1周期,至少应用2个周期后评价疗效,按照WHO标准进行评价.结果 晚期乳腺癌32例中完全缓解(CR)4例,部分缓解(PR)20例,稳定(SD)6例,进展(PD)2例.总有效率(PR+CR)为75%.初治疗效结果显示高于复治.结论 多西他赛联合顺铂治疗晚期乳腺癌疗效确切,毒副作用可以耐受,可广泛应用.     

国产多西他赛为主的联合化疗治疗转移性乳腺癌

 目的 观察国产多西他赛为主的联合化疗治疗转移性乳腺癌的疗效、毒副反应和临床受益反应（Clinical　benefit　response，CBR），并以进口多西他赛作对照。方法 A组30例转移性乳腺癌患者，既往未采用蒽环类药物治疗的14例采用国产多西他赛联合阿霉素治疗（A1组），既往蒽环类药物治疗失败的16例采用国产多西他赛联合卡培他滨治疗（A2组）；B组25例转移性乳腺癌患者作对照，其中未采用蒽环类药物治疗的11例采用进口多西他赛联合阿霉素治疗（BI组），既往蒽环类药物治疗失败的14例采用进口多西他赛联合卡培他滨治疗（B2组）；3周为1个周期，2周期评价疗效，记录毒副反应。结果 A组有效率（CR＋PR）66．7％，肿瘤控制率（CR＋PR＋SD）93．3％。毒副反应主要为骨髓抑制和脱发，可耐受，无治疗相关性死亡。CBR评价有效者73．3％；B组有效率68％，肿瘤控制率92％。毒副反应与A组相似。CBR评价有效者72％。结论 国产多西他赛为主的联合化疗治疗转移性乳腺癌有较好的疗效，毒副反应可耐受，临床受益反应良好，与进口多西他赛的疗效和不良反应相似。     

多西他赛联合洛铂治疗蒽环类耐药的晚期乳腺癌疗效分析

目的:观察多西他赛联合洛铂方案对蒽环类耐药的晚期乳腺癌患者的临床疗效及毒副作用。方法:采用多西他赛联合洛铂方案治疗晚期乳腺癌患者42例。多西他赛75mg/m2静脉滴注第1天,洛铂30mg/m2静脉滴注第1天。每21天重复,至少应用2个周期。结果:42例患者中,CR、PR分别为4、19例,总有效率为54.8%(23/42),1年生存率为64.3%(27/42),主要不良反应为骨髓抑制。结论:多西他赛联合洛铂方案治疗蒽环类耐药的晚期乳腺癌疗效好,不良反应轻,是治疗蒽环类耐药的晚期乳腺癌较好的方案。     

多西他赛联合洛铂治疗蒽环类耐药的晚期乳腺癌疗效分析

目的：观察多西他赛联合洛铂方案对蒽环类耐药的晚期乳腺癌患者的临床疗效及毒副作用。方法：采用多西他赛联合洛铂方案治疗晚期乳腺癌患者42例。多西他赛75mg/m2静脉滴注第1天,洛铂30mg/m2静脉滴注第1天。每21天重复,至少应用2个周期。结果：42例患者中,CR、PR分别为4、19例,总有效率为54.8%（23/42）,1年生存率为64.3%（27/42）,主要不良反应为骨髓抑制。结论：多西他赛联合洛铂方案治疗蒽环类耐药的晚期乳腺癌疗效好,不良反应轻,是治疗蒽环类耐药的晚期乳腺癌较好的方案。     

国产多西他赛联合卡培他滨治疗耐药性晚期乳腺癌临床观察

目的:观察国产多西他赛(TXT)联合小剂量卡培他滨(CAP)治疗蒽环类或紫杉醇化疗失败的转移性乳腺癌疗效和不良反应.方法:TXT 35ms/m2,静脉滴注,第1、8天;CAP 2000mg/天,分2次口服,第1-14天.21天为1个周期,治疗2个周期评价疗效.结果:31例患者中,完全缓解2例、部分缓解14例、稳定11例、进展4例,总有效率51.6%,疾病控制率87.1%,中位肿瘤进展时间6.4个月,1年生存率65.2%.不良反应主要为骨髓抑制、胃肠道反应、手足综合征、脱发和乏力等.结论:国产TXT联合小剂量CAP治疗蒽环类或紫杉醇化疗失败的转移性乳腺癌疗效满意,不良反应可以防治,病人耐受良好,值得临床推广使用.     

国产多西他赛联合卡培他滨治疗耐药性晚期乳腺癌临床观察

目的：观察国产多西他赛（TXT）联合小剂量卡培他滨（CAP）治疗蒽环类或紫杉醇化疗失败的转移性乳腺癌疗效和不良反应.方法：TXT 35ms/m2,静脉滴注,第1、8天;CAP 2000mg/天,分2次口服,第1-14天.21天为1个周期,治疗2个周期评价疗效.结果：31例患者中,完全缓解2例、部分缓解14例、稳定11例、进展4例,总有效率51.6%,疾病控制率87.1%,中位肿瘤进展时间6.4个月,1年生存率65.2%.不良反应主要为骨髓抑制、胃肠道反应、手足综合征、脱发和乏力等.结论：国产TXT联合小剂量CAP治疗蒽环类或紫杉醇化疗失败的转移性乳腺癌疗效满意,不良反应可以防治,病人耐受良好,值得临床推广使用.     

多西他赛联合顺铂治疗晚期食管癌近期疗效观察

目的:观察多西他赛(TXT)联合顺铂(DDP)治疗晚期食管癌的近期疗效及不良反应.方法:TXT 75mg/m2,d1;DDP 30mg/m2,d2-4.结果:23例患者中,1例CR,12例PR,有效率57%,主要不良反应为血小板、白细胞下降,轻中度消化道反应.无肝肾、心脏损害.结论:TXT +DDP治疗晚期食管癌安全有效,病人耐受性好.     

多西他赛联合顺铂治疗晚期恶性肿瘤近期疗效

多西他赛（艾素，多烯紫杉醇）是一种新型的植物紫杉类广谱抗肿瘤药物，临床研究发现其对非小细胞肺癌（NSCLC）、乳腺癌、卵巢癌等恶性肿瘤有较好疗效，且副作用低，耐受性好：我们近期采用多西他赛联合顺铂治疗晚期恶性肿瘤，取得满意疗效。     

多西紫杉醇为主的联合方案治疗晚期乳腺癌的临床观察

目的：观察多西紫杉醇联合顺铂或表阿霉素治疗晚期乳腺癌的疗效及不良反应。方法：晚期乳腺癌患者41例中,26例既往使用蒽环类治疗失败,予多西紫杉醇联合顺铂（TP方案）化疗;15例既往未曾采用葸环类治疗,予多西紫杉醇联合表阿霉索（TE方案）化疗。21天为1周期,2周期后评价疗效,有效者化疗4周期以上。结果：41例中CR5例,PR18例,SD11例,PD7例,总有效率为56．1％（23／41）。不良反应主要为骨髓抑制、脱发、消化道反应,但均可耐受,无化疗相关死亡。结论：多两紫杉醇为主的联合化疗方案治疗晚期乳腺癌疗效较好,不良反应可耐受。     

Capecitabine plus docetaxel combination chemotherapy for metastatic breast cancer

Doxifluridine(5'-DFUR)is converted to its metabolite 5-FU by the enzyme thymidine phosphorylase(TP). TP is expressed significantly higher in tumor tissue than in normal tissue. Capecitabine(N4-pentoxylcarbonyl -5'-deoxy-5-fluorocytidine)is a pro-drug of 5'-DFUR and a novel fluoropyrimidine carbamate that is converted to 5-FU preferentially in tumor tissue through a three-step enzymatic cascade. Expression of TP in tumor tissue may clinically predict efficacy of capecitabine. Induction of TP activity has brought about enhancement of capecitabine efficacy by taxanes in human cancer xenografts. In addition, a phase III study directly comparison docetaxel monotherapy and docetaxel plus capecitabine has been conducted for metastatic breast cancer patients who had received anthracyclines. The overall response rate of the combination group was 42%(n=255), and that of the monotherapy group was 30%(n=256)(p=0.006). The primary endpoints were time to disease progression, and time to treatment failure, and these parameters were superior in the combination arm than in the single arm, suggesting that capecitabine sensitization by docetaxel might be a new approach to breast cancer treatment.     

泰索帝联合顺铂治疗蒽环类药物耐药的晚期乳腺癌的临床研究

目的研究泰索帝联合顺铂治疗蒽环类药物耐药的晚期乳腺癌的疗效和安全性。方法28例蒽环类药物治疗失败的晚期乳腺癌患者均接受泰索帝联合顺铂方案治疗泰索帝75mg/m2静滴,第1天;顺铂80mg/m2静滴,第1天或分3天给予;每3周重复,完成3个周期化疗后评价疗效,有效病例4周后确认。结果28例患者均可评价疗效,CR3例,PR13例,SD11例,PD1例,总有效率(CR PR)57.1%(16/28)。主要不良反应为骨髓抑制。结论泰索帝联合顺铂是治疗蒽环类药物耐药的晚期乳腺癌的有效化疗方案,不良反应能够耐受。     

去甲长春花碱加表柔比星新辅助化疗方案治疗局部晚期乳腺癌的临床研究

目的：了解诺维本加表柔比星(表阿霉素)的联合新辅助化疗方案在局部晚期乳腺癌治疗中的疗效和毒性反应。方法：2001年9月～2003年2月，76例Ⅱb期至Ⅲb期的局部晚期乳腺癌病人入组本次临床试验。入组病例术前接受的新辅助化疗方案为：诺维本25mg／m^2，第1、8天；表阿霉素60mg/m^2，第1天，每三周为1个疗程，共3个疗程。分别观察新辅助化疗后肿瘤原发病灶和区域淋巴结的缓解情况，并观察新辅助化疗的毒性反应。结果：原发病灶临床有效率为84．2％，其中完全缓解(CR)19．7％，部分缓解(PR)64．5％，疾病稳定(SD)14．5％，疾病进展(PD)1．3％；病理完全缓解率为14．5％(11／76)。32例化疗前细针穿刺活检明确区域淋巴结转移阳性的病人中，9例(28．1％)术后病理腋淋巴结转移阴性。毒性反应主要为白细胞减少症、脱发和恶心／呕吐，共有39例(54．2％)病人发生了Ⅲ到Ⅳ度的白细胞减少症，但未有因此而发生的败血症和死亡病例。结论：诺维本加表阿霉素的新辅助化疗方案在局部晚期乳腺癌的治疗中疗效显著，耐受性良好。     

Paclitaxel-carboplatin combination chemotherapy in advanced breast cancer

Patients with metastatic breast cancer receive multiple lines of cytotoxic chemotherapy, with taxane and anthracycline-based regimens being the most active. Anthracyclines carry the risk of significant cardiotoxicity at high cumulative doses and when combined with trastuzumab, an anti-HER2 antibody. Carboplatin has shown promising single-agent activity in advanced breast cancer, is not a P-glycoprotein substrate, and is conveniently administered on an outpatient basis. Preclinical experiments demonstrated schedule-dependent synergistic cytotoxic effects of the paclitaxel first/carboplatin last (PC) combination. Pharmacokinetic parameters of paclitaxel and carboplatin were studied by Hellenic Cooperative Oncology Group (HECOG) and no significant interaction or correlation with clinical parameters were found. We assessed PC both as salvage as well as first-line treatment of advanced breast cancer patients in phase II studies which disclosed 40–60% response rates and median survival times of 12–20 mo with manageable toxicity. These results were confirmed by other groups and prompted us to the first randomized phase III trial comparing PC to the standard of epirubicin/paclitaxel (EP), a trial that showed equivalent efficacy and tolerable toxicity for PC. Registry retrospective analysis identified factors prognostic for improved outcome: good performance status, low tumor burden, lack of anthracycline exposure and of hormonal maintenance therapy. PC combinations with HER1 or HER2 modulators are being evaluated both by HECOG and by international groups. Paclitaxel coupled with carboplatin provides an alternative therapeutic option for anthracycline-exposed patients and warrants further clinical research in the direction of anthracycline-free management of metastatic breast cancer.     

Phase II study of vinorelbine (alternating intravenous and oral) in combination with docetaxel as first-line chemotherapy in metastatic breast cancer

Purpose  Combination of intravenous (i.v.) vinorelbine and docetaxel was shown to be feasible and effective in metastatic breast cancer (MBC). In an effort to improve patient convenience, we investigated in first-line treatment a regimen alternating i.v. and oral vinorelbine in combination with docetaxel. Patients and methods  Forty-nine patients (median age, 53 years) with MBC received a maximum of 6 cycles consisting of i.v. vinorelbine 20 mg/m2 plus docetaxel 60 mg/m2 given on day 1, and oral vinorelbine 60 mg/m2 on day 15 every 3 weeks in an open-label, multicentre phase II study (recommended dose established in phase I study [1]). Results  Sixty-three percent of the patient had received prior adjuvant chemotherapy and 78% presented visceral involvement. Twenty-four responses were documented and validated by an independent panel review, yielding response rates of 49% (95% CI: 34–64) in the 49 enrolled patients and 55.8% (95% CI: 40–71) in the 43 evaluable patients. Median duration of response was 9.4 months. Median progression-free survival and median overall survival were 5.5 and 33.2 months, respectively. Neutropenia was the main dose-limiting toxicity but complications were uncommon, four patients having experienced febrile neutropenia and one having developed neutropenic infection. Other frequently reported adverse events included alopecia, fatigue, stomatitis, constipation, diarrhoea and nausea, which were rarely severe. Conclusions  This regimen alternating oral and i.v. vinorelbine in combination with docetaxel is effective and manageable. Vinorelbine i.v. per oral day 1 per day 15-docetaxel day 1 every 3 weeks represents a convenient option to combine docetaxel and vinorelbine for the palliative treatment of MBC.     

多西他赛联合卡铂治疗晚期非小细胞肺癌的疗效

背景与目的 化疗是治疗晚期非小细胞肺癌的主要方法.本研究旨在分析多西他赛加卡铂治疗晚期非小细胞肺癌的疗效.方法 本组共治疗64例ⅢB、Ⅳ期非小细胞肺癌,采用多西他赛75 mg/m2静脉注射,第1天,卡铂AUC=5静脉注射,第2天.结果 全组总有效率CR PR为42.6%,临床获益率CR PR SD为68.9%,中位生存期14个月,1年生存率45.23%.初治病例1年生存率48.84%,中位生存期14个月;复治病例1年生存率37.89%,中位生存期12个月,两组之间差异有统计学意义(P=0.0233).ⅢB期病例1年生存率44.86%,中位生存期15个月;Ⅳ期病例1年生存率39.75%,中位生存期12个月,两组之间差异有统计学意义(P=0.0354).腺癌、鳞癌患者的疗效差异无统计学意义.主要毒副反应为粒细胞下降、乏力、恶心呕吐及脱发等.结论 多西他赛联合卡铂方案治疗晚期非小细胞肺癌疗效可靠,副反应轻微,可作为晚期非小细胞肺癌的一线和二线治疗方案.     

A phase II study of weekly docetaxel in patients with anthracycline pretreated metastatic breast cancer

Background: Docetaxel has significant activity in metastatic breast cancer and weekly schedules are associated with less myelosuppression than 3-weekly schedules. We evaluated the toxicity and the activity of weekly docetaxel in anthracycline-pretreated patients. Patients and methods: A total of 42 patients were studied. Treatment consisted of docetaxel 35 mg/m² weekly as a 30-min infusion for 6 weeks followed by a 2-week rest, with dexamethasone 8 mg i.v. pre-medication and 4 mg orally 12-hourly for 48 h following treatment. Results: The median age of the patients was 53 years (range 34–74). Twenty-six (62%) patients had received prior chemotherapy for advanced disease. Patients received a median 10 weeks of treatment (range 1–24). 11 had a partial response (ORR 26%; 95% CI 13–39%), five of whom had relapsed <12 months since the end of previous anthracycline-based chemotherapy. In addition six patients (14%) had stable disease for >16 weeks. Myelosuppression was rare with only 2 patients (5%) experiencing grade 3 neutropenia (no grade 4 neutropenia). Non-haematological grade III toxicities were as follows: fatigue 17%, neuropathy 0%, hyperlacrimation 5%, stomatitis 7%, diarrhoea 14%, and cutaneous toxicity 19%. Skin toxicity consisted of limb/palmar–plantar erythematous reactions, or fixed-plaque erythrodysaesthesia. Conclusions: Weekly docetaxel has moderate activity in women with anthracycline pre-treated breast cancer. Although the level of myelosuppression is lower than 3-weekly regimens, this weekly regimen cannot be recommended due to the significant non-haematological toxicities associated with the treatment.     

Combination chemotherapy in the treatment of advanced breast cancer

Seventy-two women with metastatic breast cancer were treated with multiple-agent chemotherapy. Fifty women were treated with 5 drugs in combination: 5-FU, methotrexate, vincristine, cytoxan, and prednisone; 22 were treated with the combination of 3 drugs: 5-FU, cytoxan, and prednisone. In 14 patients receiving 5 drugs and in 22 receiving 3 drugs, the multiple chemotherapy was the primary palliative treatment of extensive visceral metastases unsuitable for adrenalectomy. Results were similar with 6 responders in 14 (0.43) receiving 5 drugs, and 10 responders in 22 (0.45) receiving 3 drugs. The remaining 36 patients who were given 5-drug therapy all had previous adrenalectomy, and there were 16 responders (0.44). Toxicities from 3-drug treatment were substantially less severe than those from the 5-drug combination therapy. Whereas treatment-related death occurred in 6 of 50 patients receiving the 5-drug combination, no such incidence occurred in those receiving 3-drug combination therapy.     

多西紫杉醇为主的联合方案治疗转移性乳腺癌

目的:探讨多西紫杉醇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。方法:49例转移性乳腺癌患者中,22例既往使用蒽环类治疗失败,予多西紫杉醇联合顺铂或希罗达治疗;27例既往未曾采用蒽环类治疗,予多西紫杉醇联合阿霉素治疗。21天为1周期,2周期后评价疗效,有效者化疗4周期以上。结果:49例患者中,治疗后完全缓解(CR)11例,部分缓解(PR)23例,稳定(SD)8例,进展(PD)7例,有效率为69·3%(34/49)。中位疾病进展时间为8·5个月,中位生存时间为18·3个月。主要毒副反应为白细胞减少,其中Ⅲ~Ⅳ度占51·0%。结论:多西紫杉醇为主的联合化疗方案治疗转移性乳腺癌疗效确切,毒性反应可耐受。