多西紫杉醇加表柔比星治疗局部晚期乳腺癌的多中心Ⅱ期临床研究

Neoadjuvant chemotherapy with docetaxel plus epirubicin for locally advanced breast cancer: a multi center phase Ⅱ study

目的 观察多西紫杉醇加表柔比星 (ET方案 )新辅助化疗方案治疗局部晚期乳腺癌(LABC)后的病理完全缓解率、客观缓解率、手术切除率以及毒性反应。方法 2 0 0 1年 3至 12月间共有 4 0例LABC患者入组 ,中位年龄 4 8(2 8～ 6 7)岁。Ⅲa期 2 0例 ,Ⅲb期 15例 ,单纯同侧锁骨上淋巴结转移 5例。化疗剂量为表柔比星 6 0mg/m2 ,多西紫杉醇 75mg/m2 ,静脉点滴 ,每 3周为 1个周期。化疗中预防性应用粒细胞集落刺激因子 (G CSF)。在 2个周期ET方案之后 ,由研究者对病灶进行首次评估 ,以决定是否再给予 1～ 2个周期ET后再接受手术或放射治疗。结果 38例患者接受 2～ 4个周期ET方案的新辅助化疗 ,病理完全缓解率、临床完全缓解率以及临床部分缓解率分别为 15 .0 %、2 0 .0 %和 5 2 .5 %。本组的手术切除率为 92 .5 %。Ⅲ、Ⅳ度中性粒细胞减少症的发生率分别占总周期数的 8.4 %和 14 .0 % ,3例患者出现中性粒细胞减少性发热。常见的非血液系统不良反应为脱发、恶心或呕吐、体液潴留、肌肉关节疼痛以及指甲改变 ,但多呈轻、中度反应。结论 多西紫杉醇联合表柔比星是针对LABC的一种安全而有效的新辅助化疗方案。

Objective To investigate the clinical response,pathological complete response(pCR), tumor resection rate and safety of neoadjuvant chemotherapy with docetaxel and epirubicin (ET) for locally advanced breast cancer (LABC). Methods From March to December 2001, 40 women with LABC, aged from 28 67 (medium 48) years were alloted. Twenty patients had clinical stage Ⅲa disease, 15 had stage Ⅲb disease and 5 stage Ⅳ patients who had epsilateral sura clavicular metastasis. The dose was: epirubicin(E) 60 mg/m 2, docetaxel(T) 75 mg/m 2 every 3 weeks,with G CSF given preventively. After 2 cycles of ET, a pilot clinical response evaluation was performed by investigators for each patient to decide if she should receive another 1 2 cycles of ET before surgery or radiation therapy. Results Thirty eight patients received 2 3 cycles of ET regimen.The pCR, clinical complete response(cCR) and clinical partial response(cPR) rates were 15.0%, 20.0% and 52.5%,respectively. Tumor resection rate in this group was 92.5%?Incidence of Ⅲ/Ⅳ Grade neutropenia was 8.4%/14.0% of cycles,and 3 patients suffered from neutropenia with fever. Non hematological adverse events were alopecia, nausea,vomiting, fluid retention, myalgia , arthralgia and nail disorders, which were mild to moderate. Conclusion Neo adjuvant chemotherapy with a combination of docetaxel and epirubicin is effective and well tolerated by women with locally advanced breast cancer.