Ramucirumab for the treatment of gastric adenocarcinoma

References

• Ferro A, Peleteiro B, Malvezzi M, et al. Worldwide trends in gastric cancer mortality (1980–2011), with predictions to 2015, and incidence by subtype. Eur J Cancer. 2014;50:1330–1344.
   PubMed Web of Science ®Google Scholar
• McCracken M, Olsen M, Chen MS Jr, et al. Cancer incidence, mortality, and associated risk factors among Asian Americans of Chinese, Filipino, Vietnamese, Korean, and Japanese ethnicities. CA Cancer J Clin. 2007;57:190–205.
   PubMed Web of Science ®Google Scholar
• Smyth EC, Verheij M, Allum W, et al. Gastric cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016;27(suppl_5):v38–v49.
   PubMed Web of Science ®Google Scholar
• Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355:11–20.
   PubMed Web of Science ®Google Scholar
• Ychou M, Boige V, Pignon JP, et al. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011;29:1715–1721.
   PubMed Web of Science ®Google Scholar
• Cunningham D, Starling N, Rao S, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36–46.
   PubMed Web of Science ®Google Scholar
• Al-Batran SE, Hartmann JT, Hofheinz R, et al. Biweekly fluoruracil, leucovorin, oxaliplatin, and docetaxel (FLOT) for patients with metastatic adenocarcinoma of the stomach or esophagogastric junction: a phase II trial of the Arbeitsgeimeinschaft Internistische Onkologie. Ann Oncol. 2008;19(11):1882–1887.
   PubMed Web of Science ®Google Scholar
• Foo M, Leong T. Adjuvant therapy for gastric cancer: current and future directions. World J Gastrenterol. 2014;20(38):13718–13727.
   PubMed Web of Science ®Google Scholar
• Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017 Aug 29;8:CD004064. CD004064.pub4.
   PubMed Web of Science ®Google Scholar
• Glimelius B, Ekström K, Hoffman K, et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997;8:163–168.
   PubMed Web of Science ®Google Scholar
• Bouché O, Raoul JL, Bonnetain F, et al. Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study—FFCD 9803. J Clin Oncol. 2004;22:4319–4328.
   PubMed Web of Science ®Google Scholar
• Bang YJ, Van Cutsem E, Feyereislova A, et al. 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. 2010;376:687–697.
   PubMed Web of Science ®Google Scholar
• Thuss-Patience PC, Kretzschmar A, Bichev D, et al. 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. 2011;47:2306–2314.
   PubMed Web of Science ®Google Scholar
• Ford HE, Marshall A, Bridgewater JA, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an openlabel, phase 3 randomised controlled trial. Lancet Oncol. 2014;15:78–86.
   PubMed Web of Science ®Google Scholar
• Kang JH, Lee SI, Lim DH, et al. 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. 2012;30:1513–1518.
   PubMed Web of Science ®Google Scholar
• Roy AC, Park SR, Cunningham D, et al. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013;24:1567–1573.
   PubMed Web of Science ®Google Scholar
• Lordick F, Allum W, Carneiro F, et al. Unmet needs and challenges in gastric cancer: the way forward. Cancer TreaT Rev. 2014;40(6):692–700.
   PubMed Web of Science ®Google Scholar
• cancer.org [Internet]. Georgia: American Cancer Society, Inc.; [cited 2018 Jan 5]. Available from: https://www.cancer.org/cancer/stomach-cancer/about/key-statistics.html
   Google Scholar
• seer.cancer.gov [Internet]. Bethesda (MD): National Cancer Insitute; SEER Cancer Stat Facts: Stomach Cancer; [cited 2017 Apr]. Available from: https://seer.cancer.gov/statfacts/html/stomach.html
   Google Scholar
• Kim BJ, Jang HJ, Kim HS, et al. Current status of immune checkpoint inhibitors in gastrointestinal cancers. J Cancer. 2017;8(8):1460–1465.
   PubMed Web of Science ®Google Scholar
• cancer.org [Internet]. Georgia: American Cancer Society, Inc.; [cited 2014 Apr 24]. Available from: hhttps://www.cancer.org/latest-news/fda-approves-cyramza-ramucirumab-for-stomach-cancer.html (Accessed February 01, 2018)
   Google Scholar
• www.ema.europa.eu [Internet]. London: European Medicines Agency; [cited 2014 Dec 19]. Available from: www.ema.europa.eu/Findmedicine/Humanmedicines/EuropeanPublicAssessment (Accessed February 01, 2018)
   Google Scholar
• Sakai D, Kudo T, Kato A, et al. Retrospective study of ramucirumab in patients with advanced gastric cancer. J Clin Oncol. 2017;35(4_suppl):199.
   Google Scholar
• investor.lilly.com [Internet]. Netherlands: Eli Lilly and Company; [cited 2014 Nov 5]. Available from: .cfm?ReleaseID=880745
   Google Scholar
• www.ema.europa.eu [Internet]. London: European Medicines Agency, Committee for Orphan Medicinal Products; [cited 2012 Jul 19]. Available from: www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2012/07/WC500130310.PDF (Accessed February 01, 2018)
   Google Scholar
• Henkel J. Orphan drug law matures into medical mainstay. FDA Consumer. 1999;33(3):29–32.
   PubMedGoogle Scholar
• Gerke S, Pattinson Shaun SD. EU marketing authorisation of orphan medicinal products and its impact on related research. Eur J Health Law. 2017;24(5):541–564.
   Web of Science ®Google Scholar
• pi.lilly.com [Internet]. Indianapolis (IN): Eli Lilly and Company, Ramucirumab (Cyramza) package insert-Prescribing Information; [cited 2014; revised 2017]. Available from: pi.lilly.com/us/cyramza-pi.pdf
   Google Scholar
• cancer.gov [Internet]. Bethesda (MD): National Cancer Institute, Definition of ramucitumab-NCI Drug Dictionary; Available from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ramucirumab (Accessed February 01, 2018)
   Google Scholar
• Franklin MC, Navarro EC, Wang Y, et al. The structural basis for the function of two anti-VEGF receptor 2 antibodies. Structure. 2011;19(8):1097–1107.
   PubMed Web of Science ®Google Scholar
• Aprile G, Bonotto M, Ongaro E, et al. Critical appraisal of ramucirumab (IMC-1121B) for cancer treatment: from benchside to clinical use. Drugs. 2013;73(18):2003–2015.
   PubMed Web of Science ®Google Scholar
• Grothey A, Galanis E. Targeting angiognesis: progress with anti-VEGF treatment with large molecules. Nat Rev Clin Oncol. 2009;6:507–518.
   PubMed Web of Science ®Google Scholar
• Lu D, Jimenez X, Zhang H, et al. Selection of high affinity human neutralizing antibodies to VEGFR2 from a large antibody phage display library for antiangiogenesis therapy. Int J Cancer. 2002;97:393–399.
   PubMed Web of Science ®Google Scholar
• Spratlin JL, Cohen RB, Eadens M, et al. 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. 2010;28:780–787.
   PubMed Web of Science ®Google Scholar
• Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383:31–39. doi:10.1016/S0140-6736(13)61719-5. PubMed PMID: 24094768.
   PubMed Web of Science ®Google Scholar
• Wilke H, Muro K, Van Cutsem E, et al. 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. Lancet Oncol. 2014;15:1224–1235. doi:10.1016/S1470-2045(14)70420-6.
   PubMed Web of Science ®Google Scholar
• Davidson M, Chau I. Variations in outcome for advanced gastric cancer between Japanese and Western patients: a subgroup analysis of the RAINBOW trial. Transl Gastroenterol Hepatol. 2016 May 27;1:46.
   PubMed Web of Science ®Google Scholar
• prnewswire.com [Internet]. Indianapolis (IN): Eli lilly and company, Lilly Reports Top-Line Results from Cyramza® Phase 3 Study in FIRST-Line Advanced Gastric Cancer –PR Newswire; [cited 2017 Dec 8]. Available from: https://www.prnewswire.com/news-releases/lilly-reports-top-line-results-from-cyramza-ramucirumab-phase-3-study-in-first-line-advanced-gastric-cancer-300569229.html
   Google Scholar
• Yoon HH, Bendell JC, Braiteh FS, et al. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016;27(12):2196–2203.
   PubMed Web of Science ®Google Scholar
• Ohtsu A, Shah MA, Van Cutsem E, et al. 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. 2011;29(30):3968–3976.
   PubMed Web of Science ®Google Scholar
• Zhu P, Hu C, Hui K, et al. The role and significance of VEGFR2+ regulatory T cells in tumor immunity. Onco Targets Ther. 2017;10:4315–4319.
   PubMed Web of Science ®Google Scholar
• Hodi FS, Lawrence D, Lezcano C, et al. Bevacizumab plus Ipilimumab in patients with metastatic melanoma. Cancer Immunol Res. 2014 Jul;2(7):632–642.
   PubMed Web of Science ®Google Scholar
• Juttner S, Wissmann C, Jons T, et al. Vascular endothelial frowth factor-D and its receptor VEGF-3: two novel independent prognostic markers in gastric adenocarcinoma. J Clin Oncol. 2006;24:228–240.
   PubMed Web of Science ®Google Scholar
• Fuchs CS, Tabernero J, Tomasek J, et al. Biomarker analyses in REGARD gastric/GEJ carcinoma patients treated with VEGFR2-targeted antibody ramucirumab. Br J Cancer. 2016 Oct 11;115(8):974–982.
   PubMed Web of Science ®Google Scholar