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ASCO 2014:低剂量环磷酰胺加标准化疗有益于乳腺癌

2014-05-22 佚名 dxy

低剂量口服化疗节拍疗法可以间接通过抗血管生成活性,恢复抗肿瘤免疫应答或诱导肿瘤休眠而达到靶向作用于肿瘤细胞的目的。中国复旦大学的Leiping Wang等进行了一项II期研究(NCT01526499),该研究旨在评估口服低剂量环磷酰胺节拍疗法加多西紫杉醇一线治疗的疗效。 符合入组条件的未经既往治疗的ER或PR阳性或HER-2过表达的ABC患者经随机分组,分别接受第一天多西他赛75 mg/m2加或

低剂量口服化疗节拍疗法可以间接通过抗血管生成活性,恢复抗肿瘤免疫应答或诱导肿瘤休眠而达到靶向作用于肿瘤细胞的目的。中国复旦大学的Leiping Wang等进行了一项II期研究(NCT01526499),该研究旨在评估口服低剂量环磷酰胺节拍疗法加多西紫杉醇一线治疗的疗效。

符合入组条件的未经既往治疗的ER或PR阳性或HER-2过表达的ABC患者经随机分组,分别接受第一天多西他赛75 mg/m2加或不加持续口服环磷酰胺每日50mg治疗,21天为一周期。肿瘤HER2过表达的患者也接受曲妥珠单抗治疗。所有患者均接受多西他赛治疗直到疾病进展或出现不可接受的毒性事件或退出试验。内分泌和/或曲妥珠单抗维持治疗也被允许。试验主要终点为PFS。

2011年12月至2012年11月之间,共有31名患者被随机分为多西他赛(T)组,有35名患者分入环磷酰胺联合多西他赛(Metro-TC)组。大多数的患者(83.3%)为激素受体阳性;31.8%的患者有HER2过度表达;84.8%出现内脏转移、48.5%出现至少3处器官转移。病人特征有良好的组间平衡。两组多西他赛中位治疗周期均为8。

意向治疗人群的中位随访时间为18个月。与T组相比,Metro-TC组患者的中位PFS显著延长(Metro-TC组未得出数据,T组为13.6个月),试验未得出中位OS值。T 组和Metro-TC组的ORR分别为51.6%和71.4%。3/4组毒性事件无显著性组间差异。不良事件主要为多西他赛引起,包括3/4级中性粒细胞减少(100%)和发热性中性粒细胞减少症(N = 19,29.2%)。两种治疗之间出现的唯一显著性差异为粘膜炎(所有等级,10%VS 43%)。

从本试验结果来看,低剂量环磷酰胺节拍疗法加标准化疗一线治疗非三阴性ABC可获得PFS益处,同时并不明显增加毒性反应。临床试验信息:NCT01526499. 

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    2015-02-09 quxin068
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