第三期随机试验将息性全身疗法与晚期食道/GEJ癌症的最佳支持性护理进行比较
Vanita Noronha1, Vijay Maruti Patil2, Nandini Menon1
1Department of Medical Oncology, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.
International journal of cancer
|August 2, 2024
概括
化疗显著改善了晚期食道癌患者的生存率. 每周的帕克利塔塞尔提供了一种有价值的治疗选择,证明了显著的临床益处和改善生活质量.
科学领域:
- 在瘤学瘤学.
- 胃肠道瘤学 胃肠道瘤学
- 抚慰性护理是一种缓解性护理.
背景情况:
- 在晚期食道癌症中,化疗对生存的益处仍然没有得到证实.
- 最好的支持性护理 (BSC) 是标准,但仅仅它的有效性是有限的.
- 需要基于证据的治疗来改善不可切除/转移性疾病的结果.
研究的目的:
- 为了评估每周一次帕克利塔塞尔加BSC与单独BSC在一线晚期食道/GEJ癌症中的疗效.
- 确定对整体存活时间 (OS) 和其他关键临床终点的影响.
- 通过使用已建立的框架来评估息化疗的价值.
主要方法:
- 第三阶段随机对照试验涉及281名患者 (18-70岁,绩效状态0-2).
- 随机分配给单独使用BSC或每周使用帕克利塔塞尔 (80 mg/m2) 的BSC的患者.
- 主要终点:操作系统. 二级终点:PFS,反应率,毒性,生活质量 (QoL).
主要成果:
- 中位数的生存状况从4.2个月 (BSC) 改善到9.2个月 (化疗) (HR 0.49,p < .001).
- 化疗显著增加了反应率 (2.9%至39%) 和PFS中位数 (2.1至4.2个月).
- 化学疗法改善了无性生存率和QoL,但并没有显著增加≥3级毒性.
结论:
- 这项研究提供了1级证据,表明化疗可以延长晚期食道/GEJ癌症的存活时间.
- 每周的帕克利塔塞尔加BSC是单独比BSC更好的选择,并被推.
- 息化疗证明了实质性的价值,对低收入和中等收入国家尤其重要.
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