长春瑞滨联合卡培他滨治疗转移性乳腺癌30例临床观察

目的观察长春瑞滨联合卡培他滨对蒽环类药物治疗后无效或复发的转移性乳腺癌的疗效.方法转移性乳腺癌患者30例,长春瑞滨20 mg/m2第1天和第8天静脉滴注,卡培他滨每天1 250 mg/m2,分早晚两次服用,连续服用2周,3周为一个周期.结果 CR 1例(33.3%),PR 7例(23.3%),MR 7例(23.3%),SD 7例(23.3%),PD 8例(26.7%),有效率达49.9%,中位缓解期4.6个月(2～13个月).常见的不良反应为骨髓抑制、胃肠道反应、手足综合征、神经毒性等.结论长春瑞滨联合卡培他滨对蒽环类药物治疗后失败的转移性乳腺癌有较好的疗效,毒性可以耐受.     

含卡培他滨方案治疗复发转移性乳腺癌的临床观察

目的观察含卡培他滨方案对蒽环类和(或)紫杉类药物治疗后复发转移性乳腺癌的疗效和不良反应。方法 70例蒽环类和(或)紫杉类药物治疗后复发转移性乳腺癌患者分为两组,卡培他滨联合长春瑞滨(NX组,36例),卡培他滨800～1000mg/m2,分早晚两次服用,第1～14天,长春瑞滨25mg/m2,第1天和第8天,静脉滴注,3周为1个周期。卡培他滨联合吉西他滨(GX组,34例),卡培他滨800～1000mg/m2,分早晚两次服用,第1～14天,吉西他滨1g/m2,静脉滴注,第1天和第8天,3周为1个周期。每两个周期评价疗效,均至少治疗2个周期以上。结果 NX组患者中,完全缓1例(2.8%),部分缓解20例(55.6%),疾病稳定11例(30.6%),疾病进展4例(11.1%),有效率为58.3%,中位疾病进展时间13.5个月;完全缓解1例(2.9%),部分缓解19例(55.9%),疾病稳定12例(35.3%),疾病进展2例(5.9%),有效率为58.8%,中位疾病进展时间13.8月。常见的不良反应主要为骨髓抑制、胃肠道反应、手足综合征等。结论含卡培他滨方案治疗蒽环类和(或)紫杉类药物治疗后复发转移乳腺癌疗效确切,毒性可耐受,是治疗复发转移性乳腺癌的较好方案。     

吉西他滨联合卡培他滨治疗晚期三阴性乳腺癌的临床观察

目的观察吉西他滨联合卡培他滨治疗ER、PR、HER-2均阴性（三阴性）晚期转移性乳腺癌的疗效与安全性。方法 2004年7月至2009年6月共14例经免疫组化证实ER、PR、HER-2均阴性的晚期转移性乳腺癌复治患者参与研究。患者接受吉西他滨联合卡培他滨方案治疗：吉西他滨800mg/m2,静脉滴注30min,d1、d8、d15;卡培他滨2500mg/m2口服,d1～14。28d重复。结果全组14例共完成58个周期的治疗,中位数4个周期,范围2～6个周期,均可评价疗效。完全缓解0例,部分缓解4例（28.6%）,病情稳定6例（42.9%）,病情进展4例（28.6%）,客观有效率为28.6%;中位疾病进展时间（mTTP）6个月（95%CI：2～10个月）,中位生存期（OS）16个月（95%CI：6～32个月）,1年生存率为64.4%,3年生存率为14.3%。毒副反应主要为Ⅰ～Ⅲ度骨髓抑制、胃肠道反应、手足综合征、末梢神经毒性、流感样症状、轻度肝功能损伤等。结论吉西他滨联合卡培他滨治疗晚期三阴性乳腺癌患者,初步观察有一定的疗效,其毒副作用患者可以耐受。     

58含长春瑞滨方案治疗(蒽环类/紫杉类治疗后)复发转移乳腺癌的临床观察

目的:观察含长春瑞滨方案对蒽环类/紫杉类药物治疗后复发转移性乳腺癌的有效性和安全性.方法:蒽环类,紫杉类药物治疗后复发转移性乳腺癌患者61例,其中58例可评价疗效;长春瑞滨联合顺铂(NP)41例,长春瑞滨25mg/m2,第1天和第8天.静脉滴注;顺铂75～80mg/m2,静脉滴注,分割为2～5天,3周为一周期;长春瑞滨联合卡培他滨或替加氟(NF)17例,长春瑞滨用法同NP组,卡培他滨800～1 000mg/m2,分早晚两次服用,第1～14天,或替加氟600mg/m2,第2～6天,3周为一周期.化疗过程中注意观察不良反应,根据不良反应的程度调整药物用量.每两周期评价疗效.结果:长春瑞滨联合顺铂(NP)组,CR 2例(4.9%),PR 23例(56.1%),SD 14例(34.1%),PD2例(4.9%),有效率为61.0%;长春瑞滨联合卡培他滨或替加氟(NF)组,CR 1例(5.9%),PR 8例(47.1%),SD 7例(41.2%).PD 1例(5.9%),有效率52.9%.常见的不良反应主要为骨髓抑制、胃肠道反应、手足综合症、神经毒性等.结论:含长春瑞滨方案治疗蒽环类,紫杉类药物治疗后复发转移乳腺癌疗效确切,毒性可耐受,是治疗复发转移性乳腺癌的较好方案.     

卡培他滨联合长春瑞滨治疗晚期乳腺癌临床观察

目的:观察卡培他滨联合长春瑞滨对耐药的晚期乳腺癌的疗效及毒性.方法:34 例耐药的晚期乳腺癌,均接受卡培他滨 2500 mg/m2,分早晚两次餐后30分钟温开水送服,第1-14天,间隔7天;长春瑞滨 25mg/m2 加入生理盐水100ml中静脉滴注15分钟,第1、8天,21天为1周期,化疗4个周期.结果:34例患者中,CR 5例(14.71%),PR 15例(44.12%),SD 8例(23.51%),PD 6例(17.65%),有效率为58.82%,疾病控制率为82.35%.结论:卡培他滨联合长春瑞滨治疗耐药的晚期乳腺癌有较好的疗效,不良反应轻,患者可耐受.     

吉西他滨联合卡培他滨治疗蒽环类和紫杉类药物耐药的转移性乳腺癌临床疗效分析

目的观察吉西他滨(Gemcitabine, GEM)联合卡培他滨(Capecitabine,CAP)治疗蒽环类和紫杉类药物耐药的转移性乳腺癌(anthracycline- and taxane-refractory metastatic breastcancer,ATRMBC)患者的疗效和不良反应。方法37例ATRMBC患者,采用吉西他滨联合卡培他滨方案化疗:吉西他滨1 000 mg/m² 静脉滴注,第1、8天;卡培他滨1 000 mg/m²口服,每日两次,第1～14天;每3周为1周期。结果37例患者共完成155周期化疗,中位化疗周期数为4周期。完全缓解1例(2.7%),部分缓解14例(37.9%),稳定13例(35.1%),进展9例(24.3%);客观有效率40.6%(95% CI 24.8～56.4);临床获益率64.9%(95% CI:49.5～80.3);平均随访14.8月,中位疾病进展时间7.3月(95% CI 6.2～8.4),中位生存期15.6月(95% CI 12.6～18.6)。结论吉西他滨联合卡培他滨是治疗蒽环类和紫杉类药物耐药的转移性乳腺癌的有效方案,其血液学和非血液学毒性能够耐受。     

含卡培他滨联合方案一线化疗后卡培他滨维持治疗转移性乳腺癌临床观察

目的:探讨转移性乳腺癌含卡培他滨联合方案一线化疗后继续卡培他滨维持化疗的疗效和毒副反应。方法:入组20例转移性乳腺癌患者,一线采用多西他赛/吉西他滨/长春瑞滨联合卡培他滨化疗6个周期,疗效评价无进展的患者采用卡培他滨维持化疗持续到疾病进展或出现不能耐受毒副反应为止。结果:一线治疗CR 1例,PR 7例,SD 12例,卡培他滨平均维持化疗周期为10个周期。中位PFS为12.2个月,中位TTP为7.7个月,中位OS为20.2个月。主要毒副反应为手足综合征、骨髓抑制、腹泻等,均可控制。结论:卡培他滨可作为转移性乳腺癌的维持治疗,可改善患者生存,毒副反应轻。     

长春瑞滨联合卡培他滨治疗28例转移性乳腺癌

目的：观察长春瑞滨联合卡培他滨治疗转移性乳腺癌的疗效及安全性。方法：28例有可测量病灶的转移性乳腺癌患者，中心静脉持续滴注(Civ)长春瑞滨：6mg／m^2，第1—5天，21天为一个周期，同时联合卡培他滨治疗2—4个周期。所有患者既往均接受过1种以上化疗方案的治疗，其中19例接受过蒽环类和(或)紫杉类治疗。结果：28例患者中13例接受了2个周期化疗，15例完成4个周期的化疗。CR 1例(3．57％)，PR 6例(21．43％)，MR7例(25．0％)，SD7例(25．0％)，PD7例(25．0％)，有效率达50．0％。最常见的不良反应为中性粒细胞减少、手足综合症、神经毒性、皮肤色素沉着、乏力等。结论：长春瑞滨联合卡培他滨作为二线方案治疗转移性乳腺癌的疗效确切，且不良反应可以耐受。有望成为转移性乳腺痛的理想二线化疗方案。     

吉西他滨联合长春瑞滨治疗转移性乳腺癌34例的疗效和毒副作用

背景与目的:化疗是治疗转移性乳腺癌的主要方法之一,蒽环类和紫杉类药物是乳腺癌化疗最有效的药物.但是很多患者在辅助治疗或者一线救援方案中已经用过这两类药物.长春瑞滨和吉西他滨也是乳腺癌化疗的有效药物之一.本研究目的是观察吉西他滨联合长春瑞滨治疗转移性乳腺癌的疗效与毒副作用.方法:34例接受过蒽环和/或紫杉类治疗的转移性乳腺癌患者,接受吉西他滨联合长春瑞滨方案治疗,吉西他滨1000 mg/m2静脉滴注30 min,d1、d8,长春瑞滨25 mg/m2静脉推注,d1、d8,每21天重复一次.结果:全组34例共完成109个周期的治疗,中位数3周期,范围1～6周期;均可评价疗效.没有完全缓解的病例,部分缓解9例,病情稳定19例,病情进展6例,客观有效率(完全缓解 部分缓解)26.47%;中位疾病进展时间5.4个月,中位生存期17.8个月;1年生存率68%(95%可信区间为50%～86%),2年生存率46%(95%可信区间为26%～66%).不良反应主要为Ⅰ～Ⅱ度骨髓抑制、末梢神经毒性及胃肠道反应,部分患者出现轻度的皮疹及肝功能损害.结论:吉西他滨联合长春瑞滨方案治疗转移性乳腺癌患者,初步观察有一定的疗效,其毒副作用患者可以耐受.     

吉西他滨联合卡培他滨治疗耐药转移性乳腺癌的临床观察

目的探讨吉西他滨和卡培他滨联合化疗治疗蒽环类和(或)紫杉类耐药的转移性乳腺癌的近期疗效和不良反应。方法 2008年3月至2011年3月应用吉西他滨联合卡培他滨治疗转移性乳腺癌38例,每3周为1个周期,所有患者均评估毒性,对至少用过2个周期化疗的患者评估疗效。结果 CR 3例,PR 13例,SD 14例,PD 8例,有效率(CR+PR)为42.1%(16/38),临床获益率(CR+PR+SD)为78.9%(30/38)。主要不良反应为骨髓抑制、手足综合征、胃肠道反应。Ⅲ～Ⅳ度的骨髓抑制发生率低,手足综合征及消化道反应以Ⅰ～Ⅱ度为主。结论吉西他滨联合卡培他滨对蒽环类和(或)紫杉类耐药的转移性乳腺癌有较好的治疗效果,且不良反应可以耐受。     

A Phase II study of capecitabine and vinorelbine in patients with metastatic breast cancer pretreated with anthracyclines and taxanes

PURPOSE: The aim of this study was to evaluate the efficacy and safety of capecitabine in combination with vinorelbine in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. PATIENTS AND METHODS: In this prospective, multicenter, open-label phase II trial, patients received capecitabine (2000 mg/m2 daily, taken in 2 oral doses) on days 1-14 and vinorelbine (25 mg/m2 intravenous infusion) on days 1 and 8. Cycles were repeated every 3 weeks up to a maximum of 6 cycles, unless disease progression or unacceptable toxicity occurred or patient consent was withdrawn. RESULTS: Thirty-one patients were included and received 152 cycles of chemotherapy, with a median of 3 cycles per patient. All patients were evaluated for efficacy and toxicity in an intent-to-treat analysis. The overall response rate was 49% (95% CI, 30%-67%), including 4 complete (13%) and 11 partial (36%) responses. With a median follow-up time of 9 months, the median time to disease progression was 7.6 months (95% CI, 5.7-9.8 months), and the median survival time was 27.2 months. The most frequent severe hematologic toxicities were neutropenia (48% of patients) and leukopenia (10% of patients). Vomiting (16% of patients) was the most common nonhematologic toxicity, while asthenia, bone pain, dyspnea, plantar-palmar erythrodysesthesia, nausea, and transaminase elevation were observed in 6%-10% of patients. There was 1 death from septic shock. CONCLUSION: Capecitabine in combination with vinorelbine is an effective and safe schedule for patients with MBC pretreated with anthracycline- and taxane-containing regimens.     

Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Background: Capecitabine and i.v. vinorelbine are both active in metastatic breast cancer with non‐overlapping toxicities. This study examined the efficacy and safety of the combination of these agents in patients with pretreated metastatic breast cancer. Methods: Patients previously treated for breast cancer, maximum of one prior metastatic regimen, received capecitabine 1000 mg/m² b.d. for days 1–14 and vinorelbine 25 mg/m² i.v. days 1 and 8 every 21 days. All patients had measurable disease and adequate baseline organ function. The primary endpoint was response and secondary endpoints time to progression, duration of response, survival and safety. Results: Twenty‐two patients (median age 56 years) received a median of six cycles. All patients had received anthracyclines and 64% taxanes. Objective responses were seen in 7/21 (33%, 95% confidence interval [CI] 18–57%), with two complete responses; stable disease was seen in 5/21 (24%, 95% CI 8–42%). Median duration of response was 6.9 months (95% CI 4.7–13.1), time to progression was 5.8 months (95% CI 2.8–6.8) and survival was 13.5 months (95% CI 6.9–19.9). The median dose intensity of vinorelbine was 75% of the intended dose and of capecitabine 85% of intended dose. The main toxicity was myelosuppression including 16 episodes of G3–4 neutropenia in 11 patients (50%). Other toxicities were generally mild to moderate. Conclusion: The combination of capecitabine and i.v. vinorelbine is active and well tolerated in patients with pretreated metastatic breast cancer. The recent availability of oral vinorelbine provides an opportunity to explore a fully oral combination.     

A phase II study of weekly vinorelbine and trastuzumab in patients with HER2-positive metastatic breast cancer

BACKGROUND: Trastuzumab combined with cytotoxic agents presents encouraging results in metastatic breast cancer (MBC), but cardiac toxicity limits some combinations. The synergism shown with trastuzumab and the favorable tolerability profile of vinorelbine provided the rationale for investigating this combination. PATIENTS AND METHODS: Patients with HER2-positive MBC who had received <2 lines of chemotherapy for metastatic disease were included. Vinorelbine (25 mg/m2 on day 2, then weekly on day 1) and trastuzumab (4 mg/kg on day 1, then 2 mg/kg weekly) were administered for a maximum of 6 cycles (1 cycle=3 weeks). RESULTS: A total of 52 patients were enrolled. The median age was 50 years (range, 26-79 years). Ninety percent of the patients had received adjuvant chemotherapy, 42% received a first line of chemotherapy for MBC, and 69% had disease at visceral sites. The overall response rate was 58% (95% CI, 43%-71%). The median time to progression and overall survival were 7 months (95% CI, 5-9 months) and 26 months (95% CI, 20-32 months), respectively. Grade 4 neutropenia was present in 3 courses; neutropenic fever was not reported. The main grade 3 nonhematologic toxicities were asthenia, neuropathy, diarrhea, alopecia, and nausea/vomiting. No patients experienced serious cardiac toxicity. CONCLUSION: These results confirm that weekly vinorelbine/trastuzumab is an active and safe regimen in patients with HER2-positive MBC with an unfavorable prognosis.     

Second-line bevacizumab-containing therapy in patients with triple-negative breast cancer: subgroup analysis of the RIBBON-2 trial

Patients with metastatic triple-negative breast cancer (TNBC) typically have a poor prognosis and limited treatment options. To determine the impact of combining bevacizumab with second-line chemotherapy in patients with metastatic TNBC, we performed an exploratory subgroup analysis of the randomized phase 3 RIBBON-2 trial. RIBBON-2 enrolled patients with metastatic breast cancer that had progressed on first-line non-bevacizumab-containing chemotherapy. After selection of chemotherapy (taxane, gemcitabine, capecitabine, or vinorelbine), patients were randomized 2:1 to receive chemotherapy with either bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) or placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and safety. Of 684 patients treated in RIBBON-2, 159 (23%) had TNBC. Baseline characteristics were reasonably balanced in the two treatment groups. The majority received taxane chemotherapy. The hazard ratio (HR) for PFS was 0.494 [95% confidence interval (CI) 0.33-0.74; P = 0.0006]. Median PFS was 6.0 months with bevacizumab-chemotherapy versus 2.7 months with chemotherapy alone. Median OS was 17.9 versus 12.6 months, respectively (HR 0.624, 95% CI 0.39-1.007; P = 0.0534). ORR was 41 versus 18%, respectively (P = 0.0078). The safety profile was consistent with the overall study population and previous phase 3 trials of bevacizumab. Patients with metastatic TNBC derived significant PFS and response benefits from the combination of bevacizumab with second-line chemotherapy. Despite the small sample size and immature data, there was a trend toward improved OS.     

Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer.

PURPOSE: To define the maximum-tolerated dose (MTD) and to evaluate the dose-limiting toxicities (DLT) of the combination of capecitabine and vinorelbine in patients with metastatic breast cancer who relapse after adjuvant and/or first-line treatment. In addition, we aimed to obtain data on efficacy and safety at the recommended dose. PATIENTS AND METHODS: Patients with measurable metastatic breast cancer after failure of prior chemotherapy (including anthracyclines and/or taxanes) were eligible. Capecitabine was administered with a fixed dose of 1000 mg/m(2) orally twice daily for 2 weeks followed by 1 week rest. One treatment cycle consisted of 6 weeks of treatment containing two treatment periods of capecitabine. Vinorelbine was given intravenously at escalated doses of 25 mg/m(2) (dose level 1) and 30 mg/m(2) (dose level 2) on days 1 and 8, and 22 and 29. RESULTS: Thirty-three patients received a total of 91 cycles of capecitabine and vinorelbine. The median number of administered cycles per patient was three (range one to six). Thirty-one patients were evaluable for toxicity. At dose level 2 four out of seven patients experienced DLTs (nausea/vomiting, febrile neutropenia, grade 4 neutropenia, infection and diarrhea); thus, the MTD was defined. In order to confirm the safety and efficacy, dose level 1 was extended to 24 patients. Two patients [8.3%; 95% confidence interval (CI) 1% to 27%] showed DLTs (hospitalization due to febrile neutropenia and prolonged neutropenia). The main toxicity was neutropenia, which was observed at National Cancer Institute Common Toxicity Criteria grade 3 and 4 in 39% of patients. The overall response rate for capecitabine and vinorelbine was 55% (95% CI 36% to 72.7%), including three patients with a complete remission. The median time to disease progression was 8 months (95% CI 4.3-11.7) with an overall survival of 19.2 months (95% CI 11.3-27.1) based on intention-to-treat analysis. CONCLUSIONS: The combination of capecitabine and vinorelbine can be administered with manageable toxicity and showed significant efficacy for patients with metastatic breast cancer even after failure of a anthracycline- and/or taxane-based therapy.     

Capecitabine plus docetaxel every 3 weeks in first- and second-line metastatic oesophageal cancer: final results of a phase II trial

Capecitabine and docetaxel have single-agent activity in upper gastrointestinal tumours, and have together demonstrated preclinical synergy and a survival benefit in breast cancer, and high response rates in first-line metastatic gastric cancer. This trial assessed the efficacy, safety and feasibility of capecitabine in combination with docetaxel in patients with metastatic oesophageal cancer. In all, 24 patients with advanced disease (17 squamous cell carcinoma and seven adenocarcinoma) received oral capecitabine (1000 mg m(-2) twice daily on days 1-14) plus intravenous docetaxel (75 mg m(-2) on day 1) every 3 weeks as first- (n = 16) or second-line (n = 8) therapy. Patients received a median of four cycles of treatment (range, 0-6). The median follow-up is 16.5 months (range, 7.9-21.4 months). Intent-to-treat efficacy analysis showed an overall response rate of 46%. Of the 11 responders (one complete and 10 partial), nine of 16 (56%) received first-line and two of eight (25%) received second-line therapy. The median time to progression was 6.1 months (95% confidence interval (CI), 4.5-7.7 months). The median survival was 15.8 months (95% CI, 7.8-23.9 months). Severe adverse events (grade 3/4) reported were: neutropenia (42%, including febrile neutropenia 8%), hand-foot syndrome (29%), diarrhoea (13%), sensory neuropathy (13%), anaemia (8%) and fatigue (8%). Capecitabine plus docetaxel has a manageable adverse event profile and very promising activity in metastatic oesophageal cancer, at least comparable to other doublet regimens. Therefore, the combination merits further investigation in this setting.     

多西他赛联合卡培他滨二线治疗晚期食管鳞状细胞癌的Ⅱ期研究

目的 研究多西他赛联合卡培他滨二线治疗晚期食管鳞状细胞癌的疗效、患者不良反应、至疾病进展时间（TTP）和总生存（OS）.方法 30例一线治疗失败的晚期食管鳞状细胞癌患者接受多西他赛60 mg/m2,第1天,静脉滴注1h;卡培他滨每天825 mg/m2,分2次口服,第1天至第14天;21d为1个周期,最多不超过6个周期.结果 30例患者接受中位2个周期（2～6个周期）化疗.中位随访时间15.4个月（3.0 ～ 31.5个月）.疗效评价为部分缓解7例（23.3％）,稳定13例（43.3％）.中位TTP为3.0个月（95％CI 1.929 ～ 4.071）,中位OS为8.3个月（95％CI 6.848 ～ 9.752）.严重（3/4级）不良反应为中性粒细胞减少10例,贫血5例,血小板减少3例,手足综合征4例和疲乏3例.结论 多西他赛联合卡培他滨对一线治疗失败的晚期食管鳞状细胞癌患者有效,不良反应可接受,可考虑作为治疗晚期食管鳞状细胞癌的二线化疗方案.     

TX方案治疗铂类治疗失败的进展期胃癌的临床疗效分析

目的：评价紫杉醇联合卡培他滨作为含铂类药物治疗失败的进展期胃癌二线治疗的疗效及安全性。方法：既往接受FP或者FOLFOX4方案化疗的进展期胃癌患者36例,采用TX方案化疗,紫杉醇145mg/m2静脉滴注3h,d1;卡培他滨2000mg/m2,分2次口服,d1-14,21天为一个周期,随访观察疗效,不良反应,进展时间和生存期。结果：36例患者共接受142个周期的化疗,中位化疗周期数4个。全组36例患者中有35例可评价疗效及不良反应,其中8例部分缓解,有效率为22.8%（95%CI：8.2%-37.5%）。中位进展时间和生存时间分别为4.8个月（95%CI：2.9-6.2）和8.1个月（95%CI：6.4-12.7）。Ⅲ/Ⅳ度不良反应主要为骨髓抑制、手足综合征及脱发。结论：紫杉醇联合卡培他滨方案二线治疗进展期胃癌疗效确切,不良反应小,尤其对老年患者耐受性好。     

吉西他滨联合顺铂一线或二线治疗晚期三阴性乳腺癌的临床观察

目的　观察吉西他滨联合顺铂一线或二线方案治疗晚期三阴性乳腺癌的近期疗效和毒副反应。方法　５４例晚期三阴性乳腺癌患者接受吉西他滨联合顺铂治疗,其中一线治疗４５例,二线９例,具体方案：吉西他滨１０００ｍｇ／ｍ^２ｄ_１、ｄ_８,顺铂２５ｍｇ／ｍ^２ｄ_１～ｄ_３,２１天为１周期。每２周期评价疗效,每周期进行安全性评估。结果　５４例患者中位治疗周期数为６周期（２～８周期）,获ＣＲ８例（１４.８％）,ＰＲ２４例（４４.４％）,ＳＤ１８例（３３.３％）,ＰＤ４例（７.４％）,总有效率（ＣＲ＋ＰＲ）为５９.２％。主要毒副反应为骨髓毒性和消化道反应,３～４级毒性分别为中性粒细胞减少４０.７％,血小板减少３５.２％,乏力１８.５％,食欲下降１４.８％,贫血１１.１％,恶心呕吐９.２％,外周神经毒性１.９％。结论　吉西他滨联合顺铂治疗晚期三阴性乳腺癌近期疗效好,毒副反应可以耐受,可推荐作为晚期三阴性乳腺癌的治疗选择。