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

Ferlay, 2013 Wagner, 2006, Chemotherapy in advanced gastric cancer: A systematic review and meta-analysis based on aggregate data, J Clin Oncol, 24, 2903, 10.1200/JCO.2005.05.0245 Kang, 2012, Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone, J Clin Oncol, 30, 1513, 10.1200/JCO.2011.39.4585 Ford, 2014, Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial, Lancet Oncol, 15, 78, 10.1016/S1470-2045(13)70549-7 Thuss-Patience, 2011, Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer--a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO), Eur J Cancer, 47, 2306, 10.1016/j.ejca.2011.06.002 Jüttner, 2006, Vascular endothelial growth factor-D and its receptor VEGFR-3: two novel independent prognostic markers in gastric adenocarcinoma, J Clin Oncol, 24, 228, 10.1200/JCO.2004.00.3467 Suzuki, 2010, Clinicopathological significance of platelet-derived growth factor (PDGF)-B and vascular endothelial growth factor-A expression, PDGF receptor-β phosphorylation, and microvessel density in gastric cancer, BMC Cancer, 10, 659, 10.1186/1471-2407-10-659 Jung, 2002, Effects of combination anti-vascular endothelial growth factor receptor and anti-epidermal growth factor receptor therapies on the growth of gastric cancer in a nude mouse model, Eur J Cancer, 38, 1133, 10.1016/S0959-8049(02)00013-8 Ohtsu, 2011, Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study, J Clin Oncol, 29, 3968, 10.1200/JCO.2011.36.2236 Van Cutsem, 2012, Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial, J Clin Oncol, 30, 2119, 10.1200/JCO.2011.39.9824 Spratlin, 2010, Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2, J Clin Oncol, 28, 780, 10.1200/JCO.2009.23.7537 Hironaka, 2006, Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer, Gastric Cancer, 9, 14, 10.1007/s10120-005-0351-6 Kodera, 2007, A phase II study of weekly paclitaxel as second-line chemotherapy for advanced gastric Cancer (CCOG0302 study), Anticancer Res, 27, 2667 Cascinu, 1998, Phase II study of paclitaxel in pretreated advanced gastric cancer, Anticancer Drugs, 9, 307, 10.1097/00001813-199804000-00003 Ji, 2009, A retrospective analysis of second-line chemotherapy in patients with advanced gastric cancer, BMC Cancer, 9, 110, 10.1186/1471-2407-9-110 Seidman, 2008, J Clin Oncol, 26, 1642, 10.1200/JCO.2007.11.6699 Hironaka, 2013, Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial, J Clin Oncol, 31, 4438, 10.1200/JCO.2012.48.5805 Eisenhauer, 2009, New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Aaronson, 1993, The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology, J Natl Cancer Inst, 85, 365, 10.1093/jnci/85.5.365 1990, EuroQol—a new facility for the measurement of health-related quality of life, Health Pol, 16, 199, 10.1016/0168-8510(90)90421-9 DeMets, 1982, Asymmetric group sequential boundaries for monitoring clinical trials, Biometrika, 69, 661, 10.1093/biomet/69.3.661 Osoba, 1998, Interpreting the significance of changes in health-related quality-of-life scores, J Clin Oncol, 16, 139, 10.1200/JCO.1998.16.1.139 Dolan, 1997, Modeling valuations for EuroQol health states, Med Care, 35, 1095, 10.1097/00005650-199711000-00002 Hurwitz, 2004, Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer, N Engl J Med, 350, 2335, 10.1056/NEJMoa032691 Bang, 2010, Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial, Lancet, 376, 687, 10.1016/S0140-6736(10)61121-X Ohtsu, 2013, Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study, J Clin Oncol, 31, 3935, 10.1200/JCO.2012.48.3552 Lordick, 2013, Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial, Lancet Oncol, 6, 490, 10.1016/S1470-2045(13)70102-5 Shitara, 2010, Neutropenia as a prognostic factor in advanced gastric cancer patients undergoing second-line chemotherapy with weekly paclitaxel, Ann Oncol, 21, 2403, 10.1093/annonc/mdq248 Fuchs, 2014, Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial, Lancet, 383, 31, 10.1016/S0140-6736(13)61719-5 Waddell, 2013, Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial, Lancet Oncol, 14, 481, 10.1016/S1470-2045(13)70096-2