修改的EXTREME疗法与修改的TPEx疗法作为头部和部状细胞癌复发或转移的第一线治疗:一个多中心,开放标签,随机,探索性研究 (TEMPER研究)
Motoyuki Suzuki1, Akehito Kishino2, Masashi Sugasawa3
1Department of Otorhinolaryngology-Head and Neck Surgery, The University of Osaka, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
International journal of clinical oncology
|February 9, 2026
概括
修改后的EXTREME (mEXTREME) 和修改后的TPEx (mTPEx) 疗法在日本头癌患者中显示出相似的生存率和毒性. mTPEx疗法显示出优异的早期瘤缩,这表明它有可能成为亚洲患者的一线治疗方案.
科学领域:
- 在瘤学瘤学.
- 头部和部癌症 治疗 治疗
- 临床试验 临床试验
背景情况:
- 极端的方案是标准的第一线治疗复发性或转移性状细胞癌的头部和部 (R/M HNSCC).
- 这种疗法在亚洲人群中耐受性较差.
- 为了提高耐受性,开发了修改后的疗法 (mEXTREME和mTPEx).
研究的目的:
- 为了比较修改后的EXTREME (mEXTREME) 和修改后的TPEx (mTPEx) 疗程的疗效和安全性.
- 为了评估日本R/M HNSCC患者的治疗结果.
主要方法:
- 进行了一项多中心,随机,探索性研究.
- 与各自的标准疗法相比,mEXTREME的化疗剂量减少了25%,mTPEx的剂量减少了20%.
- 在疾病控制的情况下,每周对两种疗法进行 cetuximab 维持治疗.
主要成果:
- 在mEXTREME和mTPEx组之间没有观察到中位数无进展生存 (PFS) 或总生存 (OS) 的显著差异.
- 毒性概况相似,与3级或更严重不良事件的比较率相似.
- 与mEXTREME组 (20%) 相比,mTPEx组 (44%) 的早期瘤缩显著高于mEXTREME组 (20%).
结论:
- 无论mEXTREME还是mTPEx都没有显示出生存结果的显著差异.
- mTPEx疗法的优越的早期瘤缩表明,它可能是R/M HNSCC.亚洲患者首选的第一线选择.
- 对于不符合 pembrolizumab 治疗条件或需要快速缓解症状的患者来说,mTPEx 特别重要.
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