初治晚期乳腺癌紫杉醇卡铂周方案序贯卡培他滨治疗单臂单中心Ⅱ期临床研究  

Weekly paclitaxel plus carboplatin followed by capecitabine as initial treatment for advanced breast cancer:A single arm,single center phase Ⅱ study

作　　者：杜瀛瀛[1] 张以若 笪洁[1] 徐晓军[2] 颜蕴文[2] 张敬杰[2] 潘跃银 DU Ying-ying;ZHANG Yi-ruo;DA Jie;XU Xiao-jun;YAN Yun-wen;ZHANG Jing-jie;PAN Yue yin(First Affiliated Hospital of Anhui Medical University,He f ei 230032,P.R.China;Department oJ Oncology,First Affiliated Hospital of University of Science and Technology of China,Hefei 230001,P.R.China)

机构地区：[1]安徽医科大学第一附属医院肿瘤内科,安徽合肥230032 [2]安徽医科大学第一附属医院乳腺外科,安徽合肥230032 [3]中国科学技术大学第一附属医院肿瘤内科,安徽合肥230001

出　　处：《中华肿瘤防治杂志》2018年第17期1258-1260,1265,共4页Chinese Journal of Cancer Prevention and Treatment

基　　金：安徽省2017年科技计划(1704a0802148;1704a0802163)

摘　　要：目的大肿块乳腺癌患者往往合并有远处转移,预后差。本研究前瞻性观察紫杉醇联合卡铂周方案序贯卡培他滨一线治疗晚期大肿块乳腺癌的有效性与安全性。方法 2015-01-01-2018-04-30就诊安徽医科大学第一附属医院的初诊Ⅳ期大肿块乳腺癌患者16例,乳腺原发肿块分期T3～T4,且合并远处器官转移,给予紫杉醇75mg/m2联合卡铂AUC=2方案,每7d重复,用药≤12周,客观疗效评价达到完全缓解(complete remission,CR)、部分缓解(partial response,PR)患者序贯卡培他滨单药2 000mg/m2,口服,2次/d,d1～d14,21d为1个周期。近期客观疗效评价采用RECIST 1.1标准,不良反应评价采用NCI-CTCAE 4.0标准。结果可评价疗效16例患者,使用紫杉醇卡铂周方案化疗达CR 1例(6.3%),PR 13例(81.3%),稳定(stable disease,SD)2例(12.5%),CR+PR患者共14例进入卡培他滨序贯治疗,1例患者达到CR,中位无进展生存时间(progression free survival time,PFS)达到9.8个月,中位总生存时间尚未达到,1年生存率93.7%。Ⅲ～Ⅳ度不良反应为白细胞下降11例(78.6%),血小板下降2例(14.3%),恶心2例(14.3%),转氨酶升高1例(7.1%)。结论紫杉醇联合卡铂周方案序贯卡培他滨一线治疗晚期大肿块乳腺癌起效快,疗效好,不良反应可控。OBJECTIVE Breast cancer patients with large masses often have distant metastasis with poor prognosis. This study aimed to prospectively observe the efficacy and safety of paclitaxel plus carboplatin weekly followed by capecit abine in the treatment of advanced large lump breast cancer. METHODS From January 1,2015 to April 30,2018, we presented 16 patients with advanced large-lump breast cancer in our hospital. All patients were newly diagnosed with T3- T4 stage,and distant organ metastases M1. Patients received a maximum of 12 weeks of paclitaxel （75 n,g/m2 , weekly） combined with carboplatin（AUC= 2, weekly）. Patients who had complete response or partial response followed by capecit- abine 2 000 mg/m2 orally a day for 14 days of a 21-day cycle. The recent objective evaluation of the efficacy is RECIST 1. 1 ,evaluation of adverse events using NCI-CTCAE4. 0. RESULTS Sixteen patients were evaluated for efficacy. After treatment with paclitaxel plus carboplatin regimen, one patient （6. 3%） had complete response （CR）, thirteen patients （81.3%） achieved partial response（PR） and two patients（12.5%） had stable disease（SD）. A total of 14 patients with CR ＋PR followed by capecitabine. In the treatment,one patient achieved CR with a median PFS of 9.8 months. The medianoverall survival was not yet reached, and the 1-year survival rate was 93. 7%. Grade Ⅲ- Ⅳtoxicity was leukopenia （11/14,78.6%） ,thrombocytopenia（2/14,14.3%） ,nausea（2/14,14.3%） and elevated transaminase（1/14, 7.1%）. CON- CLUSION Paclitaxel plus carboplatin weekly regimen followed by capecitabine as first line treatment of advanced large- lump breast cancer has good curative effect, controllable toxicity, rapid onset.

关 键 词：进展期乳腺癌 化疗 紫杉醇 卡铂 卡培他滨 

分 类 号：R737.9[医药卫生—肿瘤]