卡培他滨维持治疗转移性乳腺癌的临床观察

目的观察应用卡培他滨维持治疗转移性乳腺癌患者的疗效及不良反应。方法对一线化疗疾病获得控制的晚期转移性乳腺癌患者,给予卡培他滨单药维持化疗直至疾病进展,具体给药方案:1000 mg/m2口服,每天2次,第1~14天持续给药,每3周重复。结果 30例转移性乳腺癌患者共完成维持化疗124个周期,中位无进展生存时间(MPFS)为6.8个月(2.9~19.0个月)。主要不良反应为手足综合征和白细胞减少,但均可耐受。结论转移性乳腺癌患者给予卡培他滨维持治疗,可明显延长患者的无进展生存期,同时不良反应均可耐受。     

卡培他滨治疗蒽环类耐药的转移性乳腺癌

目的 研究卡倍他滨治疗既往蒽环类药物治疗失败的转移性乳腺癌患者的疗效和安全性。方法 17例具有可测量病灶的转移性乳腺癌患者接受卡培他滨（2510mg^2/天，口服14天，休息7天为一疗程）单药治疗2-6个疗程。结果 17例患者中CR1例，PR4例，SD4例和PD8例，有效率为29.3%。至疾病进展中位时间5个月（范围2-10^ 个月）。最常见的不良反应为手足综合征（64.7%)，皮肤色素沉着（58.8%)、白细胞减少（41.2%）和恶心呕吐消化道反应（17.6%），一般程度较轻，可耐受，Ⅲ度毒性反应为1例手足综合征，无IV度不良反应。应用Vitb6治疗能减轻手足综合征的症状。结论 卡培他滨治疗蒽环类药物治疗失败的转移性乳腺癌患者疗效好，不良反应少，且口服方便，对于晚期乳腺癌患者门诊治疗是一理想选择。     

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。     

卡培他滨维持治疗晚期乳腺癌的临床观察

背景与目的：卡培他滨是晚期乳腺癌一线治疗方案用药,但在晚期乳腺癌的维持治疗中的研究较少。本文旨在探讨卡培他滨维持治疗晚期乳腺癌的疗效及不良反应。方法：将一线化疗后处于完全缓解(complete response,CR)、部分缓解(partial response,PR)或疾病稳定(stable disease,SD)的62例患者分为2组,卡培他滨治疗组(31例)患者予以单药口服卡培他滨维持治疗,对照组(31例)患者予以定期随访观察。每2个化疗周期后评价疗效。结果：卡培他滨治疗组中位疾病进展时间(time to progression,TTP)为12(2～24)个月,明显高于对照组的7(1～18)个月,且2组差异有统计学意义(P<0.05)。在亚组分析中,未绝经组、激素受体阳性组、HER-2阳性组、有内脏转移组、有肺转移组及既往未接受过卡培他滨化疗组的患者中,卡培他滨治疗组患者的TTP均显著高于对照组患者。卡培他滨治疗组总有效率(CR+PR)为19.4%(6/31),肿瘤控制率(CR+PR+SD)为74.2%(23/31)。主要不良反应为手足综合征及血液学不良反应,其次为胃肠道不良反应,但均可以耐受。卡培他滨治疗组的生活质量评分较对照组明显提高。结论：卡培他滨用于晚期乳腺癌一线治疗后的维持治疗可以延缓疾病进展,提高生活质量。     

吉西他滨联合卡培他滨治疗复发转移性乳腺癌的临床观察

在我国,乳腺癌近年来发病率呈明显上升趋势,并已成为导致妇女死亡的主要肿瘤,含有蒽环类的联合化疗方案广泛用于乳腺癌的一线治疗或辅助治疗。此外,活性较高的紫杉类药物现已逐渐用于早期的辅助治疗,但对于紫杉类药物治疗后出现复发的病例,目前尚无公认的替代治疗方案。针对晚期复发转移性乳腺癌,给予正确的化疗、内分泌治疗、放疗等综合手段治疗可达到姑息性治疗的目的,提高患者的生活质量。其中化疗方案的选择是整个治疗中一个重要的环节。[第一段]     

含卡培他滨联合化疗方案序贯卡培他滨维持治疗转移性乳腺癌患者的疗效观察

目的探讨含卡培他滨联合化疗方案治疗晚期转移性乳腺癌(MBC)后继续予卡培他滨单药维持治疗的疗效和安全性。方法选取2012年6月至2016年6月间湖南省肿瘤医院收治的158例MBC患者,分别接受3种不同的含卡培他滨联合化疗方案治疗后,将疗效评价为缓解或稳定的139例患者分为维持治疗组(73例)和未维持组(66例)。维持治疗组患者予以口服卡培他滨单药维持治疗,未维持组患者予以定期随访观察。评价所有患者的疗效和不良反应。结果维持治疗组患者中位无进展生存时间(PFS)明显长于未维持组患者,差异有统计学意义(P<0.05)。158例患者联合治疗近期客观有效率(ORR)为48.1%,疾病控制率(DCR)为88.0%。年龄>45岁的患者有较高的ORR(P<0.05)。维持治疗组患者维持阶段ORR为16.4%,DCR为68.5%。在亚组分析中,联合化疗采用GX方案的患者中位PFS较TX或NX联合化疗有延长的趋势,转移灶≥3处患者的中位PFS较转移灶数目为1~2处有缩短的趋势,转移后2线及以上治疗患者的中位PFS较转移后1线治疗的患者也有缩短的趋势,但差异均无统计学意义(均P>0.05)。主要不良反应为血液学不良反应、手足综合征和胃肠道不良反应,患者均可以耐受。结论卡培他滨是MBC维持治疗的有效药物,能够延缓患者的疾病进展,且具有较轻的不良反应。     

卡培他滨治疗蒽环类及紫杉类耐药的复发转移性乳腺癌的临床观察

目的:观察卡培他滨对蒽环类、紫杉类耐药的复发转移性乳腺癌的作用。方法:40例复发转移性乳腺癌患者,均经过蒽环类及紫杉类治疗后出现疾病进展。给予卡培他滨2510mg/(m2·d),分2次口服,连服2周,3周为1个周期。至少2个周期后评价疗效。结果:本组化疗均数为4个周期。CR1例,PR8例,SD23例,PD7例,有效率23.1%,疾病控制率(CR PR SD)为82.0%(32/39);TTP3.4个月;中位生存时间11.2个月。常见不良反应为手足综合征(70.0%)、皮肤色素沉着(60.0%)、恶心呕吐(52.5%)、腹泻(42.5%),2例出现3～4级严重腹泻而住院治疗。结论:卡培他滨对蒽环类、紫杉类耐药的复发转移性乳腺癌仍有一定的疗效,耐受性较好。     

卡培他滨长期维持治疗三阴性乳腺癌1例

三阴性乳腺癌（triple negative breast carcinoma, TNBC）指雌激素受体（ER）、孕激素受体（PR）和人表皮生长因子受体2（HER－2）均为阴性的乳腺癌。 TNBC 在乳腺癌中的比例达17％～20％［1］,中位复发时间为30．2个月,2年内复发患者的比例占36．3％,2～3年内复发患者比例达27．8％［2］。TNBC 具有易复发转移、生存率低、预后差的特点,是目前乳腺癌研究的热点和难点。现将我院收治的1例反复未控TNBC 应用卡培他滨治疗获长期生存的病例报告如下。     

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。     

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。     

Clinical observation of capecitabine monotherapy in elderly patients with advanced breast cancer

Objective The aim of the study was to evaluate the safety and efficacy of capecitabine mono-chemotherapy in elderly patients with advanced breast cancer. Methods The data from 36 cases of capecitabine monotherapy in elderly patients with advanced breast cancer were retrospectively analyzed. Oral administration of capecitabine 2000 mg/m2 twice daily(D1–14) for 21 days constituted a cycle. The effect of the disease and main adverse reactions were evaluated every 2 cycles. Results The data from 36 elderly patients were studied. The median number of chemotherapy cycles was 4. The total effective rate was 30.6%(11/36) and the disease control rate was 72.2%(26/36). The number of patients with clinical complete remission was 2, clinical partial response was 9, stable disease was 15, and progressive disease was 10. Where treatment was effective, the median time to progression was 6 months and the median overall survival was 9.5 months. The main adverse events were gastrointestinal reactions, bone marrow suppression, and oral mucositis; most of the reactions were grade 1 to 2. Grade 3 to 4 adverse reactions included granulocytopenia in 2 patients(12.5%) and hand-foot syndrome in 1 patient(6.7%).Conclusion Capecitabine monotherapy was effective in controlling disease progression, and adverse reactions were tolerated by elderly patients with advanced breast cancer.     

Efficacy of capecitabine-based combination therapy and single-agent capecitabine maintenance therapy in patients with metastatic breast cancer

Objective

The purpose of this study was to observe the efficacy and toxicities of capecitabine-based chemotherapy and capecitabine monotherapy as maintenance therapy in the treatment of metastatic breast cancer (MBC).

Patients and methods

A total of 98 MBC patients were treated with capecitabine combined with vinorelbine (NX).

Results

The median number of treatment was 6 cycles (1-7 cycles). There were two cases of complete remission (CR), 58 partial remission, 27 stable disease (SD), 11 progression disease. The overall response rate (ORR) (CR + PR) was 61.2%. The clinical benefit rate (CBR) was 75.5%. Fifty of effective patients received with capecitabine monotherapy as maintenance therapy. The ORR (CR + PR) was 4%. The CBR was 48%. The median progression-free survival (PFS) was 12 months. In maintenance therapy or not, the median post metastasis survival rate (MSR) was 63 and 28 months, respectively. In the combination therapy group, the major grade 3/4 toxicities included hand-foot syndrome (3.1%), skin pigmentation (2.0%), diarrhoea and abdominal distension (5.1%), stomatitis (1.0%), and leukopenia (20.4%).

Conclusions

Capecitabine-based combination therapy and single-agent capecitabine maintenance therapy were well tolerated and effective to MBC.     

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2500mg／m^2,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／m^2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,CR5例（14．71％）,PR15例（44．12％）,SD8例（23．51％）,PD6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。     

Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer

BACKGROUND:

Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7—7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first‐line and second‐line settings.

METHODS:

Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7—7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression‐free survival (PFS).

RESULTS:

Forty‐one patients were treated. After a median of 7 cycles (range, 1‐32 cycles), partial responses were observed in 20% of patients, and stable disease for ≥6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment‐related toxicities were hand‐foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2‐4), and vomiting (0% grade 2‐4) were rare.

CONCLUSIONS:

Capecitabine administered for 7 days followed by a 7‐day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal. Cancer 2011;. © 2011 American Cancer Society.     

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.     

Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program

Background. A retrospective source review identifying predictive factors and assessing safety and efficacy in pretreated metastatic breast cancer (MBC) patients treated with capecitabine in a French compassionate-use program. Patients and methods. 197 patients received capecitabine at an initial total dose 0.25–3.0g/m²/day, twice daily for 14 consecutive days, every 3weeks. Results. Median patient age was 56years (range, 31–88), 19% had performance status (PS) 3–4. Prior palliative and adjuvant treatment was reported in 96 and 61% of patients respectively. Best overall response rate (ORR) was 15% (95% confidence interval [CI], 11–21%) and 49% had benefit (CR, PR or SD). Median time to progression (TTP) and overall survival were 4.8 and 14.7 months, respectively. Median TTP in responders was 8.9months (95%CI 6.1–11.7). Grade 3/4 neutropenia and grade 3 thrombocytopenia occurred in 8 and 3% of patients respectively. Hand-foot syndrome (grade 3/4 in 16% of patients), diarrhea, stomatitis and asthenia were prevalent. Multivariate analysis showed ORR was significantly influenced by PS2 (p=0.004), time from metastases diagnosis to capecitabine treatment (p=0.015) and presence of liver metastases at inclusion (p=0.047). Abnormal liver function tests at baseline were associated with severe thrombocytopenia and anemia. Four treatment-related deaths occurred. Conclusion. Capecitabine is active in heavily pretreated MBC patients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.     

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.     

多西紫杉醇联合卡培他滨治疗乳腺癌肝转移的临床观察

目的：观察多西紫杉醇联合卡培他滨（TX）序贯卡培他滨单药维持治疗乳腺癌肝转移（breast cancerliver metastases,BCLM）的疗效和安全性。方法：回顾性分析TX方案治疗蒽环/和紫杉类药治疗的乳腺癌肝转移患者39例。全组共化疗230周期,中位周期数6周期（4-8周期）。有效者TX方案化疗6-8周期后序贯卡培他滨单药维持直至不能耐受或病情进展。结果：全组39例患者,4周期化疗后CR0例,PR20例（51.3%）,SD14例（35.9%）,PD 5例（12.8%）,有效率51.3%,临床获益率87.2%。TTP 2.8-36.5月,中位TTP5月。结论：应用TX方案序贯卡培他滨维持治疗蒽环/和紫杉类治疗后乳腺癌肝转移疗效确切,毒副反应能耐受,值得临床推广。