Randomized trial of adjuvant equitoxic dose-escalated anthracycline (A)-containing regimen of doxorubicin, cyclophosphamide (AC) versus cyclophosphamide, methotrexate, 5-FU (CMF) for stage I-II breast cancer (BrCa): Can equitoxicity compensate for agent selection?
Randomized trial of adjuvant equitoxic dose-escalated anthracycline (A)-containing regimen of doxorubicin, cyclophosphamide (AC) versus cyclophosphamide, methotrexate, 5-FU (CMF) for stage I-II breast cancer (BrCa): Can equitoxicity compensate for agent selection?
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含多柔比星、环磷酰胺 (AC) 与环磷酰胺、甲氨蝶呤、5-FU (CMF) 的辅助等毒剂量递增蒽环类 (A) 方案治疗 I-II 期乳腺癌 (BrCa) 的随机试验：等毒性能否补偿药物选择
DOI：
10.1200/jco.2005.23.16_suppl.818
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发表时间：
2005
影响因子：
45.3
通讯作者：
J. Ragaz
中科院分区：
文献类型：
--
作者：
O. Přibylová;L. Petruželka;K. Shumansky;J. Spinelli;J. Ragaz
818背景：我们过去的数据（J. Ragaz埃塔尔; ASCO; 1989，8：23）显示，如果剂量是等毒性的，则采用不同累积CMF递送剂量（低、中、高）治疗的BrCa病例的结局相似，这是通过可比的粒细胞最低值来判断的。其他已发表的数据一致认为蒽环类药物（ANTHR）（即AC）的BrCa结局获益优于CMF，心脏毒性是ANTHR的长期限制因素。目的：本随机试验的目的是确认每次访视时每种药物的剂量递增是否达到等毒性（根据粒细胞判断）AC和CMF方案将达到结局等效性。研究方法：将104例I-II期BrCa患者（患者）随机分配至AC或CMF（A=60，C=600 mg/m2，每21天一次）与CMF（C=500，M=40，F=600/m2，静脉注射，第1天+第8天，每28天一次）各4个周期。治疗当天粒细胞最低值>1500、2000时，两组药物剂量分别递增至110%或120%。结果是五年DFS%。两个治疗组，我们…
818 Background: Our past data (J. Ragaz, etal; ASCO; 1989, 8: 23) showed similar outcome of BrCa cases treated with varied cumulative delivered CMF dose (low, medium, high), providing the doses were equitoxic, as judged by comparable granulocyte nadir. Other published data agree on BrCa outcome benefit of anthracyclines (ANTHR) (i.e. AC) over CMF, with cardiotoxicity the limiting factor of ANTHR in long-term. Objective: The objective of this randomized trial was to confirm if dose escalation of each drug at each visit to reach equitoxicity (as judged by granulocytes) AC and CMF regimens would reach outcome equivalence. Methods: One hundred and four stage I-II BrCa patients (pts) were randomized to four cycles each of AC or CMF (A=60, C=600 mg/m2 q 21 days) versus CMF (C=500, M=40, F=600/m2 i.v. days 1+8 q 28 days). Both groups had dose of each drug escalated to 110% or 120% if granulocytes nadir was >1500, 2000 on the day of therapy, resp. Outcome was five year DFS%. The two treatment groups we...