RAINBOW - jgca.jp

1 RAINBOW REGARD RAINBOW ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma ( RAINBOW ): a double-blind, randomised phase 3 trial Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A, for the RAINBOW Study Group Lancet Oncol 15: 1224-1235, 2014 Eli Lilly and Company RAINBOW 27 170 III 18 4 8mg/kg, days 1, 15 28 80mg/m2, days 1, 8, 15 28 1:1 2010 12 2012 9 665 330 335 95% 95% 95% p= 5% Grade 3 41% 19 17% 7 14% 2 12% 5 9% 10 6% 3 3% 2 REGARD ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD).

2 An international, randomised, multicenter placebo -controlled, phase 3 trial Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, Safran H, dos Santos LV, Aprile G, Ferry DR, Melichar B, Tehfe M, Topuzov E, Zalcberg JR, Chau I, Campbell W, Sivanandan C, Pikiel J, Koshiji M, Hsu Y, Liepa AM, Gao L, Schwartz JD, Tabernero J, for the REGARD Trial Investigators Lancet 383: 31-39, 2014 ImClone Systems REGARD 29 119 III 24 87 8mg/kg, 2 2:1 2009 10 2012 1 355 238 117 IQR IQR 95% p= 95% p= Grade 94% 88% 16% 8% 2 VEGFR-2.

3 RAINBOW RAINBOW 140 ASCO 2014 REGARD REGARD beyond progression 3 III III II III