去甲长春花碱加表柔比星新辅助化疗方案治疗局部晚期乳腺癌的临床研究

The combination of navelbine and epirubicin as neoadjuvant chemotherapy in the treatment of locally advanced breast cancer

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。

Purpose: To evaluate the efficacy and toxicity of Navelbine( NVB) and Epirubicin ( Epi -ADM) as the neoadjuvant chemotherapy in the treatment of locally advanced breast cancer. Methods: From September 2001 to February, 2003, 76 cases, LABC patients ( II b ~ HI b ) were treated with NE chemotherapy before operation. Neoadjuvant chemotherapy regimens containing vinorelbine( N), 25 mg/m (days 1 and 8) and epirubicin( E), 60 mg/m (days 1) were administered every 3 weeks for three cycles before local treatment. The response in the primary tumor and the regional lymph nodes and the chemotherapy toxicity were observed for each patient. Results: The response in the primary tumor: clinical objective response was 84. 2% (19.7% (15/76) CR and 64. 5% (49/76) PR) , 14. 5% (11/76) SD and 1.3% (1/76) PD. Pathological complete response was found in 11 cases( 14. 5%). 9 cases (28. 1%) who have positive FNA result in the regional lymph node before chemotherapy showed negative result in the surgery specimen. The most common toxicities are leukocytopenia, nausea/vomiting and alopecia. Leucopenia grade 3-4 was reported in 54. 2% of the patients but there were no chemotherapy related toxic deaths. Conclusions: The combination of Vinorelbine and Epirubicin is a very active and well-tolerated regimen as neoadjuvant chemotherapy for the LABC.