Boér Katalin, Láng István, Juhos Eva, Pintér Tamás, Szántó János
V. Department of Internal Medicine - Oncology, Szent Margit Hospital, Budapest, H-1032, Hungary.
Pathol Oncol Res. 2003;9(3):166-9. doi: 10.1007/BF03033731. Epub 2003 Oct 7.
The adjuvant chemotherapy of breast cancer changed in the past two decades. Docetaxel containing regimens are highly active in metastatic breast cancer. A logical approach was their incorporation into trials of early breast cancer adjuvant therapy. The authors present the Hungarian interim analysis and experience with the BCIRG 001 randomized, multicentric, phase III clinical trial comparing TAC (docetaxel, doxorubicin, cyclophosphamide) and FAC (5-fluorouracil, doxorubicin, cyclophosphamide) in the adjuvant treatment of node positive breast cancer patients. The results are presented compared to the international data. Three Hungarian centers - Szt. Margit Hospital, Budapest, National Institute of Oncology, Budapest, Petz Aladár Hospital, Gyôr - participated in the international trial. Between June 1997 and June 1999, 61 patients with node positive breast cancer were enrolled in the study after the surgery. Thirty-four patients were randomized to TAC (75/50/500 mg/m2 6xq3wk) and 27 patients were randomized to FAC (500/50/500 mg/m2 6x q3wk) chemotherapy, with prospective stratification by node (1-3, 4+). Patients with hormone receptor positive tumors received tamoxifen for 5 years after the chemotherapy. Radiotherapy was performed after the 6th cycle of chemotherapy. 33 months of follow up was performed. In both arms the hematological toxicity was more frequent. The TAC group showed a higher incidence of neutropenia (76%) compared to the FAC (22%), as well as a higher incidence of febrile neutropenia (26 % versus none), without grade 3-4 infection and there was no cases of septic death. More grade 3-4 nausea and vomiting was observed in the FAC group. At three years follow up, results indicated improvement in disease-free survival (88% vs. 76%) in favour of TAC, and similar tendency was observed in the case of overall survival (97% vs. 88%). Based on the international data analysis TAC was superior to FAC chemotherapy, the results show statistically significant differences between the two arms. This benefit with TAC was seen regardless of hormone receptor status. Additional follow up data will evaluate the role of TAC in the adjuvant setting of early breast cancer treatment.
在过去二十年中，乳腺癌的辅助化疗发生了变化。含多西他赛的方案在转移性乳腺癌中具有高度活性。一种合理的方法是将其纳入早期乳腺癌辅助治疗试验。作者介绍了匈牙利对BCIRG 001随机、多中心、III期临床试验的中期分析及经验，该试验比较了TAC（多西他赛、阿霉素、环磷酰胺）和FAC（5-氟尿嘧啶、阿霉素、环磷酰胺）在淋巴结阳性乳腺癌患者辅助治疗中的效果。将结果与国际数据进行了比较。三个匈牙利中心——布达佩斯的圣玛尔吉特医院、布达佩斯的国家肿瘤研究所、杰尔的佩茨·阿拉达尔医院——参与了该国际试验。1997年6月至1999年6月，61例淋巴结阳性乳腺癌患者术后参加了该研究。34例患者被随机分配至TAC组（75/50/500mg/m²，6次，每3周一次），27例患者被随机分配至FAC组（500/50/500mg/m²，6次，每3周一次）化疗，按淋巴结情况（1-3个、4个及以上）进行前瞻性分层。激素受体阳性肿瘤患者化疗后接受5年他莫昔芬治疗。化疗第６周期后进行放疗。进行了33个月的随访。两组血液学毒性均较常见。TAC组中性粒细胞减少症发生率（76%）高于FAC组（22%），发热性中性粒细胞减少症发生率也更高（26%对0%），无3-4级感染，也无败血症死亡病例。FAC组观察到更多3-4级恶心和呕吐。三年随访结果显示，TAC组无病生存率提高（88%对76%），总生存率也有类似趋势（97%对88%）。基于国际数据分析，TAC优于FAC化疗，两组结果显示出统计学显著差异。无论激素受体状态如何，TAC均有此益处。更多随访数据将评估TAC在早期乳腺癌辅助治疗中的作用。
