國家衛生研究院 NHRI:Item 3990099045/10838
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    题名: Interim safety and clinical activity of nivolumab (Nivo) in combination with S-1/capecitabine plus oxaliplatin in patients (pts) with previously untreated unresectable advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer: part 1 study of ATTRACTION-04 (ONO-4538-37)
    作者: Kang, YK;Kato, K;Chung, HC;Minashi, K;Lee, KW;Cho, H;Kang, WK;Komatsu, Y;Tsuda, M;Yamaguchi, K;Hara, H;Fumita, S;Azuma, M;Boku, N;Chen, LT
    贡献者: National Institute of Cancer Research
    摘要: Background: Nivo monotherapy demonstrated its efficacy with manageable safety for G/GEJ cancer refractory or intolerant to standard chemotherapy at the primary analysis (ATTRACTION-02[ONO-4538-12]: ASCO-GI 2017, Kang YK et al. J Clin Oncol. 2017; 35 [suppl 4S abstract 2]). This randomized phase 2/3 trial is to evaluate the efficacy and safety ofNivo in combination with 1st line chemotherapy in unresectable advanced or recurrent G/GEJ cancer (NCT02746796). Methods: This trial includes previously untreated pts aged 20 years with ECOG PS 01 and had measurable, unresectable advanced or recurrent HER2 (-) G/GEJ cancer. It consists of2 parts. Part 1 is a randomized, open-label trial to evaluate the feasibility of Nivo (360 mg, Q3W) in combination with oxaliplatin (130 mg/m2, Q3W) plus either S-1 (40 mg/m2 twice daily, day 1-14, SOX) or capecitabine (1000 mg/m2 twice daily, day 1-14, CapeOX) in terms ofactivity and safety. Part 2 is a randomized, doubleblind, placebo-controlled trial comparing Nivo to placebo in combination with SOX/ CapeOX in terms ofoverall survival and progression free survival (PFS). Results: A total of40 pts were included into part 1, 21 pts were randomized to NivoþSOX and 19 to NivoþCapeOX. The median age was 62.5 years, 27 pts (67.5%) were male, 20 pts (50.0%) had ECOG PS 1. Median duration oftreatment was 7.03 months (range 0.1-9.9) as of24 Feb 2017. Both treatments were well tolerated. Grade 34 treatment-related adverse events (AEs) were reported 23 pts (57.5%). No Nivorelated AEs leading to discontinuation were reported. Overall response rate was 68.4% (26/38, CR10, PR16) and disease control rate was 86.8%. Median PFS was not reached. 18 pts (46.2%) remain on treatment at the time ofthe data cut off. There were no significant differences in activity and safety between the 2 treatments. Conclusions: NivoþSOX/CapeOX were feasible with promising activity as the 1st-line chemotherapy in pts with previously untreated unresectable advanced or recurrent G/ GEJ cancer. Part 2 ofthe study is ongoing.
    日期: 2017-09
    關聯: Annals of Oncology. 2017 Sep;28(Suppl. 5):Meeting Abstract 671P.
    Link to: https://doi.org/10.1093/annonc/mdx369.055
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=0923-7534&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:000411324001186
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