Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer: a subgroup analysis from the phase 3 TAGS study,Gastric Cancer

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Trifluridine/tipiracil in patients with metastatic gastroesophageal junction cancer: a subgroup analysis from the phase 3 TAGS study
Gastric Cancer ( IF 7.4 ) Pub Date : 2021-03-13 , DOI: 10.1007/s10120-021-01156-x
Wasat Mansoor ₁ , Hendrik-Tobias Arkenau ₂ , Maria Alsina ₃ , Kohei Shitara ₄ , Peter Thuss-Patience ₅ , Sinead Cuffe ₆ , Mikhail Dvorkin ₇ , David Park ₈ , Takayuki Ando ₉ , Marc Van Den Eynde ₁₀ , Giordano D Beretta ₁₁ , Alberto Zaniboni ₁₂ , Toshihiko Doi ₄ , Josep Tabernero ₁₃ , David H Ilson ₁₄ , Lukas Makris ₁₅ , Karim A Benhadji ₁₆ , Eric Van Cutsem ₁₇

Affiliation

The Christie NHS Foundation Trust, Manchester, UK.
Sarah Cannon Research Institute, Cancer Institute, University College London, London, UK.
Vall D, Institute of Oncology (VHIO), Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.
National Cancer Center Hospital East, Chiba, Japan.
Charité-Universitätsmedizin Berlin, Medizinische Klinik M.S. Hämatologie, Onkologie Und Tumorimmunologie, Berlin, Germany.
St. James's Hospital, Dublin, Republic of Ireland.
Omsk Regional Clinical Centre of Oncology, Omsk, Russian Federation.
St. Jude Crosson Cancer Institute/St, Joseph Heritage Healthcare, Fullerton, CA, USA.
University of Toyama, Toyama, Japan.
UCL Cliniques Universitaires Saint-Luc, Brussels, Belgium.
Humanitas Gavazzeni, Bergamo, Italy.
Fondazione Poliambulanza-Istituto Ospedaliero, Brescia, Italy.
Institute of Oncology (VHIO), Vall D'Hebron University Hospital, UVic-UCC, IOB-Quiron, Barcelona, Spain.
Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Stathmi, Inc, New Hope, PA, USA.
Taiho Oncology, Inc, Princeton, NJ, USA.
University Hospitals Gasthuisberg Leuven and KU Leuven, Leuven, Belgium.

Background

Patients with advanced gastroesophageal junction cancer (GEJC) have poor survival outcomes, and GEJC-specific data from trials evaluating agents in gastric cancers (GCs) as a whole are lacking. Trifluridine/tipiracil (FTD/TPI) was approved for previously treated metastatic GC or GEJC (mGC/mGEJC) based on results of the phase 3 TAGS trial. Subgroup analyses by primary tumor type (GC or GEJC) in TAGS are reported here.

Methods

Pa tients with mGC/mGEJC treated with ≥ 2 prior chemotherapy regimens were randomized (2:1) to receive FTD/TPI or placebo, plus best supportive care. A pre-planned sub-analysis was performed to evaluate efficacy and safety outcomes by primary tumor type (GEJC or GC).

Results

Of 507 randomized patients, 145 (29%) had GEJC and 360 (71%) had GC as the primary disease site. Baseline characteristics were generally similar between the GEJC and GC subgroups, except that more patients in the GEJC subgroup had received ≥ 3 prior regimens (72 vs. 59% in the GC subgroup). Survival benefit with FTD/TPI was observed in both subgroups. The overall survival hazard ratio for FTD/TPI vs placebo was 0.75 (95% CI 0.50–1.11) and 0.67 (95% CI 0.52–0.87) in the GEJC and GC subgroups, respectively. Grade ≥ 3 adverse events of any cause were reported in 75 (77%) and 192 (81%) FTD/TPI-treated patients in the GEJC and GC subgroups, respectively. No new safety concerns were noted with FTD/TPI.

Conclusion

As in patients with GC, FTD/TPI showed an efficacy benefit in patients with GEJC in the TAGS trial, along with demonstrating a manageable safety profile.

中文翻译：

转移性胃食管结合部癌患者的曲氟尿苷/替吡嘧啶：来自 3 期 TAGS 研究的亚组分析

背景

晚期胃食管结合部癌 (GEJC) 患者的生存结果较差，并且缺乏来自评估整个胃癌 (GC) 药物试验的 GEJC 特异性数据。根据 3 期 TAGS 试验的结果，曲氟尿苷/替吡嘧啶 (FTD/TPI) 被批准用于先前治疗的转移性 GC 或 GEJC (mGC/mGEJC)。本文报道了 TAGS 中按原发肿瘤类型（GC 或 GEJC）进行的亚组分析。

方法

接受≥2 种既往化疗方案治疗的 mGC/mGEJC 患者随机 (2:1) 接受 FTD/TPI 或安慰剂，以及最佳支持治疗。进行了预先计划的子分析，以评估原发肿瘤类型（GEJC 或 GC）的疗效和安全性结果。

结果

在 507 名随机患者中，145 名 (29%) 患有 GEJC，360 名 (71%) 患有 GC 作为主要疾病部位。GEJC 和 GC 亚组之间的基线特征基本相似，除了 GEJC 亚组中有更多患者接受了≥ 3 种先前方案（GC 亚组中为 72% 对 59%）。在两个亚组中都观察到了 FTD/TPI 的生存获益。在 GEJC 和 GC 亚组中，FTD/TPI 与安慰剂的总生存风险比分别为 0.75（95% CI 0.50–1.11）和 0.67（95% CI 0.52–0.87）。GEJC 和 GC 亚组分别有 75 名 (77%) 和 192 名 (81%) 接受 FTD/TPI 治疗的患者报告了任何原因的 ≥ 3 级不良事件。FTD/TPI 没有发现新的安全问题。