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

被引：8

作者：

Mansoor, Wasat ^{[1
]}

Arkenau, Hendrik-Tobias ^{[2
]}

Alsina, Maria ^{[3
]}

Shitara, Kohei ^{[4
]}

Thuss-Patience, Peter ^{[5
]}

Cuffe, Sinead ^{[6
]}

Dvorkin, Mikhail ^{[7
]}

Park, David ^{[8
]}

Ando, Takayuki ^{[9
]}

Van den Eynde, Marc ^{[10
]}

Beretta, Giordano D. ^{[11
]}

Zaniboni, Alberto ^{[12
]}

Doi, Toshihiko ^{[4
]}

Tabernero, Josep ^{[13
]}

Ilson, David H. ^{[14
]}

Makris, Lukas ^{[15
]}

Benhadji, Karim A. ^{[16
]}

Van Cutsem, Eric ^{[17
,18
]}

机构：

[1] Christie NHS Fdn Trust, Manchester, Lancs, England

[2] UCL, Canc Inst, Sarah Cannon Res Inst, London, England

[3] Univ Autonoma Barcelona, Hebron Univ Hosp, Inst Oncol VHIO, Barcelona, Spain

[4] Natl Canc Ctr Hosp East, Chiba, Japan

[5] Charite Univ Med Berlin, Med Klin MS Hamatol Onkol & Tumorimmunol, Berlin, Germany

[6] St James Hosp, Dublin, Ireland

[7] Omsk Reg Clin Ctr Oncol, Omsk, Russia

[8] St Joseph Heritage Healthcare, St Jude Crosson Canc Inst, Fullerton, CA USA

[9] Univ Toyama, Toyama, Japan

[10] UCL Clin Univ St Luc, Brussels, Belgium

[11] Humanitas Gavazzeni, Bergamo, Italy

[12] Fdn Poliambulanza Ist Osped, Brescia, Italy

[13] Vall DHebron Univ Hosp, UVic UCC, IOB Quiron, Inst Oncol VHIO, Barcelona, Spain

[14] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[15] Stathmi Inc, New Hope, PA USA

[16] Taiho Oncol Inc, Princeton, NJ USA

[17] Univ Hosp Gasthuisberg Leuven, Leuven, Belgium

[18] Katholieke Univ Leuven, Leuven, Belgium

来源：

GASTRIC CANCER | 2021年 / 24卷 / 04期

关键词：

Trifluridine; tipiracil; Gastroesophageal junction cancer; TAGS; Phase; 3; Subgroup analysis; DOUBLE-BLIND;

D O I：

10.1007/s10120-021-01156-x

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：970 / 977

页数：8