Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial

被引:26
作者
Longo-Munoz, F. [1 ]
Argiles, G. [2 ]
Tabernero, J. [2 ]
Cervantes, A. [3 ]
Gravalos, C. [4 ]
Pericay, C. [5 ]
Gil-Calle, S. [6 ]
Mizuguchi, H. [7 ]
Carrato-Mena, A. [1 ]
Limon, M. L. [8 ]
Garcia-Carbonero, R. [4 ]
机构
[1] Hosp Univ Ramon & Cajal, Serv Oncol Med, Carretera Colmenar Viejo Km 9-100, Madrid 28034, Spain
[2] Univ Autonoma Barcelona, Hosp Univ Vall dHebron, P Vall dHebron 119-129, Barcelona 08035, Spain
[3] Univ Valencia, Biomed Res Inst INCLIVA, Av Menendez Pelayo 4 Accesorio, Valencia 46010, Spain
[4] Hosp Univ Doce Octubre, Serv Oncol Med, Ave Cordoba Km 5-4, Madrid 28041, Spain
[5] Hosp Univ Sabadell, Corp Sanitaria Parc Tauli, Parc Tauli 1, Sabadell 08208, Spain
[6] Hosp Carlos Haya, Av Carlos Haya S-N, Malaga 29010, Spain
[7] Taiho Oncol Inc, Carnegie Ctr 202, Suite 100, Princeton, NJ 08540 USA
[8] Hosp Univ Virgen del Rocio, Oncol Med S, Seville, Spain
关键词
TAS-102; Metastatic colorectal cancer; Trifluridine; Tipiracil hydrochloride; Fluoropyrimidine; Spain; SOLID TUMORS; ANTITUMOR-ACTIVITY; JAPANESE;
D O I
10.1007/s12094-016-1528-7
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer (mCRC) refractory or intolerant to standard therapies were evaluated in the phase 3 RECOURSE trial. Results of RECOURSE demonstrated significant improvement in overall survival (OS) and progression-free survival (PFS) with TAS-102 versus placebo [hazard ratio (HR) = 0.68 and 0.48 for OS and PFS, respectively; both P < 0.001]. The current analysis evaluates efficacy and safety of TAS-102 in the RECOURSE Spanish subgroup. Primary and key secondary endpoints were evaluated in a post hoc analysis of the RECOURSE Spanish subgroup, using univariate and multivariate analyses. Safety and tolerability were reported with descriptive statistics. The RECOURSE Spanish subgroup included 112 patients (mean age 61 years, 62 % male). Median OS was 6.8 months in the TAS-102 group (n = 80) versus 4.6 months in the placebo group (n = 32) [HR = 0.47; 95 % confidence interval (CI): 0.28-0.78; P = 0.0032). Median PFS was 2.0 months in the TAS-102 group and 1.7 months in the placebo group (HR = 0.47; 95 % CI: 0.30-0.74; P = 0.001). Eighty (100 %) TAS-102 versus 31 (96.9 %) placebo patients had adverse events (AEs). The most common drug-related >= Grade 3 AE was neutropenia (40 % TAS-102 versus 0 % placebo). There was 1 (1.3 %) case of febrile neutropenia in the TAS-102 group versus none in the placebo group. In the RECOURSE Spanish subgroup, TAS-102 was associated with significantly improved OS and PFS versus placebo, consistent with the overall RECOURSE population. No new safety signals were identified. NCT01607957.
引用
收藏
页码:227 / 235
页数:9
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