Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide
Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide
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DOI：
10.1200/jco.2003.03.034
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发表时间：
2003-09-15
影响因子：
45.3
通讯作者：
Marolla, P
中科院分区：
文献类型：
--
作者：
Papaldo, P;Lopez, M;Marolla, P
目的：氯尼达明（LND）对转移性乳腺癌患者的蒽环类药物有增效作用。本研究设计了一项多中心、前瞻性、随机试验，旨在确定LND联合大剂量表阿霉素加环磷酰胺（EC）与单用EC相比是否能改善早期乳腺癌（BC）患者的无病生存期（DFS）。方法：1991年10月至1994年4月，506例I/II期BC患者随机分为4组：（A）表阿霉素120 mg/m2和环磷酰胺600 mg/m2，静脉滴注，第1天，每21天1次，共4个周期结果：中位随访时间为55个月，治疗组124例，对照组B组125例，EC + LND 450 mg/d口服，治疗组129例，EC + G-CSF皮下注射，治疗组128例。LND（B+D组; 69.6%）与非LND组（A+C组; 70.3%）以及G-CSF（C+D组; 67.2%）与非G-CSF组（A+B组; 72.9%）的5年DFS率相似。LND（79.1%）与非AND组（81.3%）以及G-CSF（80.6%）与非G-CSF组（79.6%）的5年总生存期（OS）相当。LND组和G-CSF组的DFS和OS分布不随肿瘤大小、淋巴结、受体和绝经状态而变化。G-CSF显著降低血液学毒性，而对剂量强度没有显著影响（C+D和A+B组分别为98.1%和95.5%）。早期乳腺癌添加LND或G-CSF不会改善DFS或OS。（C）2003，美国临床肿瘤学会。
Purpose : Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity.Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC Were randomly assigned to four groups: (A) epirubicin 120 mg/m(2) and cyclophosphamide 600 mg/m(2) administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients).Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non-G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus nonAND arms (81.3%) and in G-CSF (80.6%) versus non-G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively).Conclusion: EC is active and well tolerated in patients with. early breast cancer. The addition of LND or G-CSF does not improve DFS or OS. (C) 2003 by American Society of Clinical Oncology.