Boér Katalin, Láng István, Juhos Eva, Pintér Tamás, Szántó János
Onkológiai Osztály, Szent Margit Kórház, Budapest, 1032 Hungary.
Magy Onkol. 2003;47(2):141-8. Epub 2003 Sep 16.
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 according to international data.
Three Hungarian centers - St. 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 6x q3wk) and 27 patients were randomized to FAC (500/50/500 mg/m2 6x q3wk) chemotherapy, with prospective stratification by node (1-3, 4+). In the case of patients with ER and/or PR positive tumours 5 years tamoxifen treatment was started. Radiotherapy was performed after the 6th cycle of chemotherapy.
36 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%), without grade 3-4 infection and there were no cases of septic death. Regarding non-hematological toxicity more grade 3-4 nausea and vomiting was observed in the FAC group. At three years follow up, the international results show statistically significant improvement in disease-free survival (82% vs. 74%, p=0.0011) in favour of TAC, and similar tendency was observed in the case of overall survival (92% vs. 87%, p=0.11). This benefit with TAC was seen regardless of hormone receptor status. Due to the low number of Hungarian patients we cannot declare the same results.
Based on the international analysis TAC was superior to FAC chemotherapy. Additional follow up data will evaluate the role of TAC in the adjuvant setting of early breast cancer treatment. The results indicate that TAC has the potential to be incorporated in the new strategies of adjuvant breast cancer treatments.
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，该试验比较了多西他赛、阿霉素、环磷酰胺（TAC）与5-氟尿嘧啶、阿霉素、环磷酰胺（FAC）在淋巴结阳性乳腺癌患者辅助治疗中的效果。结果根据国际数据呈现。
三个匈牙利中心——布达佩斯的圣玛吉特医院、布达佩斯的国立肿瘤研究所、杰尔的佩茨·阿拉达尔医院——参与了这项国际试验。1997年6月至1999年6月期间，61例淋巴结阳性乳腺癌患者术后纳入研究。34例患者随机接受TAC（75/50/500mg/m²，每3周6次）化疗，27例患者随机接受FAC（500/50/500mg/m²，每3周6次）化疗，并根据淋巴结情况（1 - 3个、4个及以上）进行前瞻性分层。对于雌激素受体（ER）和/或孕激素受体（PR）阳性肿瘤患者，开始进行5年的他莫昔芬治疗。化疗第6周期后进行放疗。
进行了36个月的随访。两组血液学毒性均更常见。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%），无3 - 四级感染，也无败血症死亡病例。关于非血液学毒性，FAC组观察到更多3 - 4级恶心和呕吐。三年随访时，国际结果显示TAC组无病生存率有统计学显著改善（82%对74%，p = 0.0011），总生存率也有类似趋势（92%对87%，p = 0.11）。无论激素受体状态如何，TAC均有此益处。由于匈牙利患者数量较少，我们无法宣称同样的结果。
基于国际分析，TAC化疗优于FAC化疗。更多随访数据将评估TAC在早期乳腺癌辅助治疗中的作用。结果表明TAC有潜力纳入辅助性乳腺癌治疗的新策略中。
