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目的:了解诺维本加表柔比星(表阿霉素)的联合新辅助化疗方案在局部晚期乳腺癌治疗中的疗效和毒性反应。方法:2001年9月～2003年2月,76例Ⅱb期至Ⅲb期的局部晚期乳腺癌病人入组本次临床试验。入组病例术前接受的新辅助化疗方案为:诺维本25 mg/m2,第1、8天;表阿霉素60 mg/m2,第1天,每三周为1个疗程,共3个疗程。分别观察新辅助化疗后肿瘤原发病灶和区域淋巴结的缓解情况,并观察新辅助化疗的毒性反应。结果:原发病灶临床有效率为84.2％,其中完全缓解(CR)19.7％,部分缓解(PR)64.5％,疾病稳定(SD)14.5％,疾病进展(PD)1.3％;病理完全缓解率为14.5％(11/76)。32例化疗前细针穿刺活检明确区域淋巴结转移阳性的病人中,9例(28.1％)术后病理腋淋巴结转移阴性。毒性反应主要为白细胞减少症、脱发和恶心/呕吐,共有39例(54.2％)病人发生了Ⅲ到Ⅳ度的白细胞减少症,但未有因此而发生的败血症和死亡病例。结论:诺维本加表阿霉素的新辅助化疗方案在局部晚期乳腺癌的治疗中疗效显著,耐受性良好。
OBJECTIVE: To investigate the efficacy and toxicity of a combination of nociceptin plus epirubicin and neoadjuvant chemotherapy in the treatment of locally advanced breast cancer. Methods: From September 2001 to February 2003, 76 patients with locally advanced breast cancer from stage Ⅱb to Ⅲb were enrolled in this study. Neoadjuvant chemotherapy regimens received preoperatively were enoxaparin 25 mg / m 2 on days 1 and 8; epirubicin 60 mg / m 2 on day 1 and once every three weeks for a total of 3 A course of treatment. To observe the neoadjuvant chemotherapy after the primary tumor lesions and regional lymph node response, and observe the neoadjuvant chemotherapy toxicity. Results: The effective rate of primary lesion was 84.2%, of which CR was 19.7%, partial remission (PR) 64.5%, stable disease 14.5% and disease progression 1.3%. The complete remission rate was 14.5% (11/76). Of the 32 patients who had positive regional lymph node metastasis by fine needle aspiration biopsy before chemotherapy, 9 patients (28.1%) had negative axillary lymph node metastasis after operation. Toxic reactions were mainly leucopenia, hair loss and nausea / vomiting. A total of 39 (54.2%) patients developed grade III to IV leukopenia but no sepsis or deaths were found. Conclusions: Neoadjuvant plus epirubicin neoadjuvant chemotherapy regimens are significantly effective and well tolerated in the treatment of locally advanced breast cancer.