剂量密集的帕克利塔塞尔每周一次,每3周与卡博普拉丁联合治疗晚期卵巢癌:一个第三期,开放标签,随机对照试验
Noriyuki Katsumata1, Makoto Yasuda, Fumiaki Takahashi
1Department of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. nkatsuma@ncc.go.jp
Lancet (London, England)
|September 22, 2009
概括
与标准的3周治疗方案相比,高剂量每周的帕克利塔塞尔和卡博普拉丁显著改善了晚期卵巢癌妇女的无进展生存率和整体生存率.
科学领域:
- 妇科瘤学 妇科瘤学
- 临床药理学 临床药理学
- 癌症治疗研究 癌症治疗研究
背景情况:
- 晚期卵巢癌的标准治疗包括每三周一次的帕克利塔塞尔和卡博普拉丁.
- 之前试图通过将其他药物添加到该疗程中来提高生存率的尝试一直没有成功.
- 这项研究研究了一种新型剂量密集的每周服用帕克利塔塞尔和卡博普拉丁的方法.
研究的目的:
- 为了比较剂量密集的每周帕克利塔塞尔-卡博普拉丁治疗方案的疗效和安全性,与传统的每3周治疗方案相比.
- 评估对晚期卵巢癌患者无进展生存 (PFS) 和整体生存 (OS) 的影响.
主要方法:
- 一个第三阶段,开放标签,随机对照试验在日本85个中心进行.
- 符合条件的患者 (第二至第四阶段的卵巢上皮癌,输卵管癌或初级腹癌) 被随机分配到常规疗法 (每3周服用帕克利塔塞尔180 mg/m2,卡博普拉丁AUC6) 或剂量密集疗法 (每3周服用帕克利塔塞尔80 mg/m21,8,15天,卡博普拉丁AUC6每3周服用卡博普拉丁1天).
- 主要终点是无进展生存期,通过治疗意图 (ITT) 分析.
主要成果:
- 剂量密集的治疗方案显示,中位数无进展存活时间明显长 (28.0个月与17.2个月;HR 0.71;p=0.0015).
- 与传统组相比,剂量密集组 (72.1%) 的三年整体存活率更高 (65.1%;HR 0.75;p=0.03).
- 剂量密集组中观察到3/4级贫血的比率更高 (69%对44%),中性质减退是两组中最常见的不良事件.
结论:
- 帕克利塔克塞尔加卡博普拉丁的每周剂量密度较高的剂量显著改善了患有晚期上皮卵巢癌的女性的生存结果.
- 这种方案为这种患者群体提供了一种新的有效治疗选择.
- 虽然毒性,特别是贫血,需要谨慎管理,但生存效益支持将其视为新的护理标准.
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