摘要目的 评价卡铂联合紫杉醇方案治疗局部晚期三阴性乳腺癌的疗效、安全性和远期生存,探索三阴性乳腺癌的优选化疗方案.方法 收集31例经粗针穿刺病理确诊的ⅡA～ⅢC期浸润性乳腺癌患者的临床资料,分析其新辅助化疗效果、生存状况、手术效果及其与免疫组化检测指标的关系.结果 31例乳腺癌患者中,30例患者按计划完成新辅助化疗,1例因首次应用紫杉醇过敏而改用其他方案.28例可评价临床疗效,1例未评价疗效,1例化疗1周期无法评价疗效.客观有效率为85.7％,其中完全缓解(CR)4例(14.3％),部分缓解20例(71.4％),疾病稳定3例(10.7％),疾病进展1例(3.6％).临床降期率为85.7％.31例患者均可评价不良反应.主要不良反应为粒细胞减少,发生率为93.5％,其中3～4级发生率为74.2％,无粒细胞减少性发热.行保乳手术患者4例,改良根治术23例.术后获病理完全缓解(pCR)者11例,pCR率为40.7％,其中乳腺pCR率为44.4％(12/27),腋下淋巴结pCR率为77.8％ (21/27).新辅助化疗临床评价为CR的4例患者均获pCR.出现复发转移者8例,其中局部区域复发者1例,远处转移者7例;出现在确诊后2年内者6例.11例pCR患者中,无病生存者10例,确诊后45个月出现肺转移者1例,现带瘤生存.死亡6例.本组患者中位无病生存时间、总生存时间未达到,3年无病生存率、总生存率分别为62.0％和74.7％.结论 卡铂联合紫杉醇方案治疗局部晚期三阴性乳腺癌客观有效率高,pCR率优于蒽环类联合紫杉类方案,耐受性良好,是治疗局部晚期三阴性乳腺癌的优选化疗方案.

abstractsObjective To evaluate the efficacy,safety and survival of combination of carboplatin plus paclitaxel as neoadjuvant chemotherapy (NACT) for patients with locally advanced triple-negative breast cancer (TNBC),and explore an optimal regimen for TNBC.Methods Patients with core needle biopsy confirmed pathological diagnosis of Ⅱ A ～ ⅢC invasive breast cancer,negative for estrogen and progesterone receptors and HER2 by immunohistochemistry,and with indication for NACT were eligible in this study.The biopsy tumor tissues were tested for CK5/6,CK14,EGFR and Ki67.The patients received paclitaxel 175 mg/m2 on day 1,carboplatin at an area under the curve 5 mg· min/ml on day 2 of every 21 days.The clinical response was evaluated every 2 cycles according to Standard RECIST 1.0 criteria and surgery was done after four to six cycles.Pathological complete remission (pCR) was defined if absence of invasive tumor in the breast and axillary lymph nodes samples or residual carcinoma in situ only.Results Overall,thirtyone patients were enrolled from January 2008 to November 2010.The median age was 51 years and 83.9％ of the patients were diagnosed as stage Ⅱ B to Ⅲ C diseases.30 Patients completed chemotherapy as planed while one patient changed regimen due to paclitaxel allergy.Twenty-eight patients could be evaluated for clinical efficacy,of which CR,PR,SD,PD were achieved in 4,20,3 and 1 women,respectively.The objective response rate was 85.7％.The expression rate of CK5/6,CK14 and EGFR were 88.9％ (24/27),59.3％ (16/27) and 63％ (17/27),respectively.Among 27 patients who received modified radical mastectomy or breast-conserving surgery,11 patients obtained pCR,with a pCR rate of 40.7％ (95％ CI 22.2％-59.3％).Five of six CK5/6-and CK14-positive patients achieved pCR.All the 31 patients could be evaluated for toxicity according to the NCI-CTC v3.0 criteria.The major toxicities were neutropenia (93.5％),vomiting (45.2％) and ALT/AST increase (32.3％),and grade 3-4 toxicities accounted for 74.2％,3.2％,0,respectively.Until December 2011,at a median follow-up of 28.9 months (range 5-47.9),eight patients developed recurrence including 5 patients died.Among 11 patients with pCR,one suffered from lung metastasis at 45 months after diagnosis and survived with tumor until now.The other ten were alive and disease free.The 3-year DFS and OS were 62％ and 74.7％,respectively.Conclusions As a neoadjuvant treatment for triple-negative breast cancer,carboplatin plus paclitaxel regimen achieves notable higher objective response rate and pCR rate compared with the anthracycline plus paclitaxel regimen reported in the literature,and is well tolerable.It is an optimized regimen for TNBC.