ASCO进展胰腺癌研究报告.pptx

A Randomized Phase II trial of Adjuvant Chemotherapy with S-1 vs S-1 and Gemcitabine(GS) vs Gemcitabine alone(GEM) in Patients with resected Pancreatic Cancer (CAP-002 study)Abstract No: 4056 Presenter: Hideyuki Yoshitomi, MD研究设计随机、开放、多中心II期研究胰腺癌术后患者主要终点：2年DFS次要终点：OS，安全性，可行性随机分层：JPS分期I-III期 vs IVa+b期，R0 vs R1，中心 A组GEMB组S-1C组GEM/S-1(GS)GEM组：GEM 1000mg/m2, d1,8,15，q4w×12S-1组：S-1 80/100/120mg/d, d1-14，q3w×16GS组：S-1 60/80/100mg/d, d1-14，GEM 1000mg/m2, d8,15，q3w×16Hideyuki Yoshitomi ,et al. 2013 ASCO abstract: 4056OSDFSHideyuki Yoshitomi ,et al. 2013 ASCO abstract: 4056毒性反应治疗组GEM组(N=30)S-1组(N=31)GS组(N=31)3级毒性16(53.3%)4(12.9%)25(80.6%) 血液性15(50.0%)3(9.7%)20(64.5%) 非血液性4(13.3%)3(9.7%)7(22.6%)4级毒性5(16.7%)0(0.0%)3(9.7%) 血液性4(13.3%)0(0.0%)3(9.7%) 非血液性1(3.3%)0(0.0%)0(0.0%)共计(3,4级)21(70.0%)4(12.9%)28(90.3%)无治疗相关死亡发生结果：2年DFS分别为25.1% vs 28.1% vs 34.4%; p=0.47 OS(月) 分别为46.9 vs 68.8 vs 53.1; p=0.48结论：S-1单药或S-1联合健择均与健择单药疗效无统计学差别再次证实健择的疗效无法被超越！Hideyuki Yoshitomi ,et al. 2013 ASCO abstract: 4056JASPAC 01: Randomized phase III trial of adjuvant chemotherapy with gemcitabine versus S-1 for patients with resected pancreatic cancerAbstract No: 4008 Presenter: Akira Fukutomi, MD研究设计胰腺癌根治性切除研究终点主要终点：OS次要终点：RFS、AEs(CTCv3.0)、健康相关QOL(EQ-5D)手术后10周分层因素： 研究中心 R0/R1 N0/N1随机GEM组1000mg/m2, d1,8,15，每4周重复 6个周期S-1组80, 100, 120 mg/天*，d1-28，每6周重复 6个周期*：依照体表面程(m2)BSA ＜1.25, 1.25 ≦BSA ＜1.5, BSA ≧1.5Akira Fukutomi,et al. 2013 ASCO abstract: 4008患者特征GEM(N=191)N (%)S-1(N=187)N (%)年龄*66岁(39-84岁)66岁(34-86岁)性别男104(54)106(57)女87(46)81(43)ECOG PS0128(67)131(70)163(33)56(30)CA 19-9**≦37146(76)151(81)＞3745(24)35(19)胰腺手术PD#136(71)121(65)远端50(26)66(35)总计5(3)0(0)手术至随机时间*48天(20-69天)手术至开始辅助治疗时间*56天(20-97天)*：中位（范围）**：S-1组1例患者未检测#：胰十二指肠手术Akira Fukutomi,et al. 2013 ASCO abstract: 4008肿瘤特征GEM(N=191)N (%)S-1(N=187)N (%)原发肿瘤T112(6)11(6)T214(7)11(6)T3165(86)163(87)T40(0)2(1)淋巴结N073(38)67(36)N1118(62)120(64)分期I18(9)15(8)II173(91)170(91)III0(0