乳腺癌辅助化疗紫杉醇单周方案.ppt

Weekly Paclitaxel in the Adjuvant Treatment of Breast Cancer 河南省肿瘤医院乳腺科 研究背景 对可手术乳腺癌患者来说，辅助化疗能够 明显降低其复发转移危险 蒽环类药物+紫杉类药物 进一步降低乳腺癌患者复发的危险 证据： LN+ B-28 AC(3W)*4 P(3W)*4 BCIRG001 TAC 与FAC 方案相比 研究背景 问题任然存在：紫杉醇和多西他赛 哪个更有效？ 最佳给药间隔？ 前期临床工作和间接临床证据显示， 1.与紫杉醇相比，多西他赛效果可能更好 2.紫杉醇每周方案可能优于常规紫杉醇3周方案 3.一项3期临床试验显示在转移性乳腺癌中，多西他赛3周方案或紫杉醇每周方案要优于紫杉醇3周方案。 研究背景 本研究：在淋巴结阳性或者淋巴结阴性但高危风险乳腺癌中，标准AC*4 序贯 紫杉类 3W*4/1W*12 本研究要解决的问题： 比较紫杉醇与多西他赛的效果 两药 3周方案与每周方案的效果 Methods 4950 women with axillary lymph node-positive or high-risk,lymph node-negative breast cancer.After randomization, Study patients We included in the study women who had operable, histologically confirmed adenocarcinoma of the breast with histologically involved lymph nodes (tumor stage T1,T2,or T3 and nodal stage N1 or N2) or high-risk, axillary node-negative disease(T2 or T3,N0) without distant metastases.  Chemotherapy All women received doxorubicin (60mg per square meter of body-surface area, given by slow intravenous push during a period of 5 to 15 minutes) and cyclophosphamide (600mg per square meter by intravenous infusion for 30 to 60 minutes) every 3 weeks for 4 cycles 如图  Hormonal therapy and Irradiation  Patients who had breast-sparing surgery received radiotherapy according to accepted standards of care after completion of all chemotherapy. Women who had a modified radical mastectomy also were permitted to receive radiotherapy after completion of all chemotherapy Patients with hormone receptor–positive disease were required to take 20 mg of tamoxifen daily for 5 years. In June 2005, the protocol was modified to permit postmenopausal women who were taking tamoxifen to change to an AI (5Y or 5Y)  End Points The primary end point was DFS 局部复发； 无复发出现死亡； 对侧乳腺癌  研究参与组织 The protocol was coordinated by the Eastern Cooperative Oncology Group (ECOG) (ClinicalTrials.gov number, NC; the Southwest Oncology Group(SWOG)； The Cancer