Multicenter randomized phase III study of the cardioprotective effect of dexrazoxane (Cardioxane®) in advanced/metastatic breast cancer patients treated with anthracycline-based chemotherapy
Multicenter randomized phase III study of the cardioprotective effect of dexrazoxane (Cardioxane®) in advanced/metastatic breast cancer patients treated with anthracycline-based chemotherapy
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DOI：
10.1093/annonc/mdj134
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发表时间：
2006-04-01
影响因子：
50.5
通讯作者：
Stahalova, V
中科院分区：
文献类型：
--
作者：
Marty, M;Espié, M;Stahalova, V
背景资料：蒽环类药物诱导的心脏毒性导致采用经验剂量限制，这可能会限制可能受益的患者继续使用蒽环类药物。右雷佐生是一种心脏保护剂，已被证明可降低蒽环类药物首次给药时蒽环类药物相关心脏毒性的风险。本研究旨在确认dexrazoxane在心脏毒性高风险患者中的获益，由于先前使用蒽环类药物。患者和方法：共有164名女性乳腺癌患者，先前用蒽环类药物治疗，接受蒽环类药物为基础的化疗（n = 85）或不（n = 79）dexrazoxane最多6个周期。与单独接受蒽环类药物治疗的患者相比，接受右雷佐生治疗的患者发生的心脏事件显著减少（39%对13%，P < 0.001），充血性心力衰竭的发生率较低且较轻（11%对1%，P < 0.05）。肿瘤缓解率不受右雷佐生治疗的影响。不良事件的频率是相似的组之间，有没有显着的组间差异的剂量修改/interruption.Conclusion：Dexrazoxane显着降低的发生率和严重程度的蒽环类药物引起的心脏毒性的患者心功能不全的风险增加，由于以前的蒽环类药物治疗，而不损害化疗方案的抗肿瘤疗效。
Background: Anthracycline-induced cardiotoxicity has led to the adoption of empirical dose limits that may restrict continued use of anthracyclines among patients who might benefit. Dexrazoxane, a cardioprotective agent, has been shown to reduce the risk of anthracycline-associated cardiotoxicity when given from first dose of anthracycline. This study sought to confirm the benefit of dexrazoxane in patients at high risk of cardiotoxicity due to prior anthracycline use.Patients and methods: A total of 164 female breast cancer patients, previously treated with anthracyclines, received anthracycline-based chemotherapy either with (n = 85) or without (n = 79) dexrazoxane for a maximum of six cycles.Results: Compared with those receiving anthracycline alone, patients treated with dexrazoxane experienced significantly fewer cardiac events (39% versus 13%, P < 0.001) and a lower and less severe incidence of congestive heart failure (11% versus 1%, P < 0.05). Tumor response rate was unaffected by dexrazoxane therapy. The frequency of adverse events was similar between groups and there were no significant between-group differences in the number of dose modifications/interruptions.Conclusion: Dexrazoxane significantly reduced the occurrence and severity of anthracycline-induced cardiotoxicity in patients at increased risk of cardiac dysfunction due to previous anthracycline treatment without compromising the antitumor efficacy of the chemotherapeutic regimen.