GC PROPOSED TREATMENT ALGORITHM APPENDIX I III Randomized controlled trials of perioperative or adjuvant treatment in gastric and gastro-esophageal junction cancer Study Disease stage and study Treatment details Primary Comments design endpoint MAGIC study Stage Ib-III Epirubicin 50mg/m2 3DFS D resection at (perioperative Arm 1: Surgery Cisplatin 60mg/m2 Arm1: 23% surgeons’ discretion Arm 2: 3 cycles ECF 5-FU 1000mg/m2 d1-21 Arm2: 35% chemotherapy) Surgery 3 cycles ECF (3 weeks cycles) mOS Only 65% received Arm1: 20mo postoperative Arm2: 24mo chemotherapy INT 0116 Stage Ib-IV(M0) 5FU 425 mg/m2 + L 20mg/m2 mOS 36% D0 resection (postoperative Arm 1: Surgery Arm1: 27 mo 54% D1 resection Arm2: 36 mo 10% D2 resection chemoradiotherapy) Arm 2: Surgery RT 4500cGy (25#, 5d/week x 1 cycle 5FU/L + 5weeks) with 5FU 400 mg/m2 + L 5FU/L/RT for 5 weeks + 2 cycles 5FU/L 20mg/m2 (with #1-4 and #23-25) S-1 Stage II-III S-1 orally 80 mg/m2 for 4 weeks 3 years OS D2 resection ≥ Postoperative Arm 1: Surgery on- 2 weeks off (for 1 year) Arm1: 70,1% chemotherapy Arm 2: Surgery S-1 Arm2: 81.1% Japanese only Pts CLASSIC II-IIIb 3 years DFS D2 resection Capecitabine 1000 mg/m2 BID Postoperative Arm 1: Surgery Arm1: 74% d1 Oxaliplatin 130 mg/m2 chemotherapy Arm 2: Surgery Arm2: 59% Korean, Chinese and Capecitabine + Every 3 weeks for 6 Taiwanese Pts Oxaliplatin months (8 cycles)
GC PROPOSED TREATMENT ALGORITHM APPENDIX I III Randomized controlled trials of perioperative or adjuvant treatment in gastric and gastro-esophageal junction cancer Study Disease stage and study design Treatment details Primary endpoint Comments MAGIC study (perioperative chemotherapy) Stage Ib-III Arm 1: Surgery Arm 2: 3 cycles ECF Surgery 3 cycles ECF Epirubicin 50mg/m2 Cisplatin 60mg/m2 5-FU 1000mg/m2 d1-21 (3 weeks cycles) 3DFS Arm1: 23% Arm2: 35% mOS Arm1: 20mo Arm2: 24mo D resection at surgeons’ discretion Only 65% received postoperative chemotherapy INT 0116 (postoperative chemoradiotherapy) Stage Ib-IV(M0) Arm 1: Surgery Arm 2: Surgery 1 cycle 5FU/L + 5FU/L/RT for 5 weeks + 2 cycles 5FU/L 5FU 425 mg/m2 + L 20mg/m2 RT 4500cGy (25#, 5d/week x 5weeks) with 5FU 400 mg/m2 + L 20mg/m2 (with #1-4 and #23-25) mOS Arm1: 27 mo Arm2: 36 mo 36% D0 resection 54% D1 resection 10% D2 resection S-1 Postoperative chemotherapy Stage II-III Arm 1: Surgery Arm 2: Surgery S-1 S-1 orally 80 mg/m2 for 4 weeks on- 2 weeks off (for 1 year) 3 years OS Arm1: 70,1% Arm2: 81.1% ≥ D2 resection Japanese only Pts CLASSIC Postoperative chemotherapy II-IIIb Arm 1: Surgery Arm 2: Surgery Capecitabine + Oxaliplatin Capecitabine 1000 mg/m2 BID Oxaliplatin 130 mg/m2 d1 Every 3 weeks for 6 months (8 cycles) 3 years DFS Arm1: 74% Arm2: 59% D2 resection Korean, Chinese and Taiwanese Pts
Teliko_Keimeno_Consensus_Karkinou_Stomaxou_0.docx