Clin Cancer Res:3期试验| 阿霉素治疗对晚期软组织肉瘤患者的心脏毒性

2021-02-27 MedSci原创 MedSci原创

阿霉素治疗对晚期软组织肉瘤患者的心脏毒性

虽然新型系统性抗癌疗法不断在发展,但蒽环类药物仍然是多种癌症的一种重要的抗癌药物。不过,迄今为止,很少有前瞻性研究评估蒽环类药物对肉瘤患者的心脏毒性。

Jones等人在3期ANNOUNCE试验(NCT02451943)中评估了阿霉素对软组织肉瘤患者的心脏毒性。

受试患者为既往未采用过蒽环类药物治疗的局部晚期或转移性软组织肉瘤患者,左心室射血分数(LVEF)≥50%。患者可接受8个周期的阿霉素(75 mg/m2)治疗。心脏保护剂右雷佐生可由调查员自行决定使用。使用MedDRA记录有症状的心脏不良事件(AE),并使用CTCAE4.0进行分级。

LVEF的变化

504例患者接受了至少1个周期的阿霉素治疗(中位累积剂量为450.3 mg/m2[范围72.3-634.0])。心脏AE的中位随访时间为28周。接受阿霉素累积剂量较高的患者(38.6%患者累积剂量 <450 mg/m2,88.5%的为450-<600 mg/m2,90%的≥600 mg/m2)联合使用右雷佐生的频率更高,但不影响治疗效果。

不良反应

累积剂量<450 mg/m2、450-<600 mg/m2、≥600 mg/m2的患者的LVEF恶化率分别为40.5%(62/153)、51.6%(82/159)、56.2%(50/89),3级及以上的心功能不全发生率分别为2%、3%、1.1%。在所有剂量范围内,与治疗相关的心脏不良反应的发生率都很低。

总之,虽然本研究随访时间较短,但随访结果足以表明,在与心脏保护剂右雷佐生联合使用的情况下,阿霉素的累积剂量可以达到很高(>450 mg/m2),且心脏毒性发生率较低。

原始出处:

Jones Robin L,Wagner Andrew J,Kawai Akira et al. Prospective evaluation of doxorubicin cardiotoxicity in advanced soft tissue sarcoma patients treated in the ANNOUNCE Phase 3 randomized trial. Clin Cancer Res, 2021, 10.1158/1078-0432.CCR-20-4592

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    2021-03-01 科研科研科研

    阿霉素治疗心脏毒性,3期实验已完成

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    2021-03-01 qilu_qi
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    2021-02-27 14669a9cm19暂无昵称

    学习

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