J Clin Oncol:新辅助DOS化疗可在标准疗法基础上进一步改善可切除局部晚期胃癌患者预后

2021-06-18 Nebula MedSci原创

PRODIGY试验显示,新辅助DOS化疗,作为围手术期化疗的一部分,在LAGC患者中展现出了良好的治疗活性和安全性

D2胃切除术后进行辅助化疗是亚洲可切除局部晚期胃癌(LAGC)的标准疗法。基于在欧洲III期研究围手术期化疗的阳性结果,研究人员在韩国患者中开展了类似的III期PRODIGY试验,旨在与标准治疗相比,新辅助多西他赛、奥沙利铂和S-1(DOS)化疗继以手术和辅助 S-1 是否可以改善可切除的 LAGC 患者预后

该试验招募了20-75岁的、ECOG表现状态0-1分、组织学确诊的原发性胃癌或胃食管交界处腺癌(临床TNM分期:T2-3N+或T4Nany),随机分至SC组(D2手术+辅助S-1)或CSC组(新辅助DOS[多西他赛 +奥沙利铂+S-1]+D2手术+S-1)组。主要终点是无进展生存期(PFS)。

2012年1月18日至2017年1月2日,分别有266位患者被分至CSC组,264位患者被分至SC组,两组最终分别有238位和246位患者接受了研究治疗。截止2019年1月21日最后一次随访,中位随访了38.6个月,获得了176位患者随访数据。

两组的PFS

与SC组相比,CSC组患者的PFS明显改善(校正风险比 0.70,95%CI 0.52-0.95;p=0.023)。敏感性分析验证了该结果。治疗的耐受性良好。在新辅助治疗期间观察到了两例5级不良反应事件(发热性中性粒细胞减少和呼吸困难)。

综上所述,PRODIGY试验显示,新辅助DOS化疗,作为围手术期化疗的一部分,在LAGC患者中展现出了良好的治疗活性和安全性。

原始出处:

Yoon-Koo Kang, et al. PRODIGY: A Phase III Study of Neoadjuvant Docetaxel, Oxaliplatin, and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer. Journal of Clinical Oncology. https://ascopubs.org/doi/full/10.1200/JCO.20.02914

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    2022-01-14 minlingfeng
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    2021-06-20 chg122
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    2021-06-19 亭儿789

    学习学习

    0

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虽然吉西他滨辅助化疗是治疗切除胰腺癌患者的标准治疗方法,对于晚期疾病S-1已经显示出非劣效于吉西他滨的特性。该研究的目的是调查对于整体存活率方面,S-1对于吉西他滨作为辅助化疗胰腺癌的非劣效性。原始出处:Katsuhiko Uesaka,Narikazu Boku,Akira Fukutomi,et al.Adjuvant chemotherapy of S-1 versus gemcitabin