一个随机的Captem或Folfiri的II期试验作为神经内分泌癌症的二线治疗
Alberto Bongiovanni1, Chiara Liverani2, Flavia Foca3
1Osteoncology and Rare Tumor Center (CDO-TR), IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.
概括
在转移性神经内分泌癌患者中,二线FOLFIRI和CAPTEM化疗显示出可管理的安全性和可比活性. 生物标志物分析确定了与生存结果相关的microRNA.
科学领域:
- 在瘤学瘤学.
- 医学瘤学 医学瘤学
- 翻译研究是翻译研究.
背景情况:
- 神经内分泌癌 (NECs) 预后不好,在以为基础的第一线治疗后没有标准的二线治疗.
- 在治疗转移性NEC方面,FOLFIRI和CAPTEM疗法初步显示出前景.
- 这项研究旨在评估这些治疗方案在该患者群体中的有效性和安全性.
研究的目的:
- 评估FOLFIRI与CAPTEM作为转移性NEC的二线治疗的活性和安全性.
- 通过下一代测序 (NGS) 的miRNome分析,识别NEC预后的潜在循环生物标志物.
主要方法:
- 一个开放的,多中心的,随机的II期试验.
- 患者接受了FOLFIRI或CAPTEM的治疗.
- 主要终点包括12周疾病控制率 (12w-DCR) 和安全性;次要终点包括整体反应率 (ORR),无进展生存率 (PFS) 和整体生存率 (OS).
- 血清样本经过了NGS miRNome的分析.
主要成果:
- 这项研究因暂时分析的徒劳而提前停止.
- 12w-DCR为FOLFIRI的39.1%和CAPTEM的28.0%. 这是一个非常好的结果.
- 12个月的整体存活率为FOLFIRI的28.4%和CAPTEM的32.4%.
- 在这两种方案中都观察到可管理的安全概况.
- 三种微RNA被确定为NEC的独立预测因子,高表达与PFS和OS降低有关.
结论:
- 在转移性NEC的二线治疗中,FOLFIRI和CAPTEM证明了可管理的安全性和可比的活性.
- 鉴定的microRNAs可以作为潜在的循环生物标志物,用于预测NEC患者的生存率.
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