Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial
T. Waddell,Ian Chau,David Cunningham,David Gonzalez,Alicia Frances Clare Okines,Andrew Wotherspoon,C. Saffery,Gary Middleton,Jonathan Wadsley,David R. Ferry,Wasat Mansoor,Tom Crosby,Fareeda Y. Coxon,David J. Smith,Justin S. Waters,Timothy Iveson,Stephen Falk,Sarah Slater,Clare Peckitt,Yolanda Barbachano +19 more
TLDR
Addition of panitumumab to EOC chemotherapy does not increase overall survival and cannot be recommended for use in an unselected population with advanced oesophagogastric adenocarcinoma.Abstract:
Summary Background EGFR overexpression occurs in 27–55% of oesophagogastric adenocarcinomas, and correlates with poor prognosis. We aimed to assess addition of the anti-EGFR antibody panitumumab to epirubicin, oxaliplatin, and capecitabine (EOC) in patients with advanced oesophagogastric adenocarcinoma. Methods In this randomised, open-label phase 3 trial (REAL3), we enrolled patients with untreated, metastatic, or locally advanced oesophagogastric adenocarcinoma at 63 centres (tertiary referral centres, teaching hospitals, and district general hospitals) in the UK. Eligible patients were randomly allocated (1:1) to receive up to eight 21-day cycles of open-label EOC (epirubicin 50 mg/m 2 and oxaliplatin 130 mg/m 2 on day 1 and capecitabine 1250 mg/m 2 per day on days 1–21) or modified-dose EOC plus panitumumab (mEOC+P; epirubicin 50 mg/m 2 and oxaliplatin 100 mg/m 2 on day 1, capecitabine 1000 mg/m 2 per day on days 1–21, and panitumumab 9 mg/kg on day 1). Randomisation was blocked and stratified for centre region, extent of disease, and performance status. The primary endpoint was overall survival in the intention-to-treat population. We assessed safety in all patients who received at least one dose of study drug. After a preplanned independent data monitoring committee review in October, 2011, trial recruitment was halted and panitumumab withdrawn. Data for patients on treatment were censored at this timepoint. This study is registered with ClinicalTrials.gov, number NCT00824785. Findings Between June 2, 2008, and Oct 17, 2011, we enrolled 553 eligible patients. Median overall survival in 275 patients allocated EOC was 11·3 months (95% CI 9·6–13·0) compared with 8·8 months (7·7–9·8) in 278 patients allocated mEOC+P (hazard ratio [HR] 1·37, 95% CI 1·07–1·76; p=0·013). mEOC+P was associated with increased incidence of grade 3–4 diarrhoea (48 [17%] of 276 patients allocated mEOC+P vs 29 [11%] of 266 patients allocated EOC), rash (29 [11%] vs two [1%]), mucositis (14 [5%] vs none), and hypomagnesaemia (13 [5%] vs none) but reduced incidence of haematological toxicity (grade ≥3 neutropenia 35 [13%] vs 74 [28%]). Interpretation Addition of panitumumab to EOC chemotherapy does not increase overall survival and cannot be recommended for use in an unselected population with advanced oesophagogastric adenocarcinoma. Funding Amgen, UK National Institute for Health Research Biomedical Research Centre.read more
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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
Hansjochen Wilke,Kei Muro,Eric Van Cutsem,Sang Cheul Oh,György Bodoky,Yasuhiro Shimada,Shuichi Hironaka,Naotoshi Sugimoto,Oleg Lipatov,Tae You Kim,David Cunningham,Philippe Rougier,Yoshito Komatsu,Jaffer A. Ajani,Michael Emig,Roberto Carlesi,David Ferry,Kumari Chandrawansa,Jonathan D. Schwartz,Atsushi Ohtsu +19 more
TL;DR: The combination of ramucirumab with pac litaxel significantly increases overall survival compared with placebo plus paclitaxel, and could be regarded as a new standard second-line treatment for patients with advanced gastric cancer.
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Capecitabine and cisplatin with or without cetuximab for patients with previously untreated advanced gastric cancer (EXPAND): a randomised, open-label phase 3 trial
Florian Lordick,Yoon-Koo Kang,Hyun Cheol Chung,Pamela Salman,Sang Cheul Oh,György Bodoky,G. Kurteva,Constantin Volovat,Vladimir Moiseyenko,Vera Gorbunova,Joon Oh Park,Akira Sawaki,Ilhan Celik,Heiko Götte,Helena Melezínková,Markus Moehler +15 more
TL;DR: Addition of cetuximab to capecitabine-cisplatin provided no additional benefit to chemotherapy alone in the first-line treatment of advanced gastric cancer in the EXPAND trial.
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Progress in the treatment of advanced gastric cancer
TL;DR: Several common methods used to treat advanced gastric cancer are summarized and the progress made in the treatment of Gastric cancer in detail is discussed.
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Anal cancer: ESMO-ESSO-ESTRO clinical practice guidelines for diagnosis, treatment and follow-up
TL;DR: In this article, the authors provide guidelines which can assist medical, radiation and surgical oncologists in the practical management of this unusual cancer, which is strongly associated with human papilloma virus (HPV, types 16-18) infection.
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Management of gastric cancer in Asia: resource-stratified guidelines
Lin Shen,Yan Shen Shan,Huang Ming Hu,Timothy J. Price,Bhawna Sirohi,Kun-Huei Yeh,Yi-Hsin Yang,Takeshi Sano,Han-Kwang Yang,Xiaotian Zhang,Sook Ryun Park,Masashi Fujii,Yoon-Koo Kang,Li-Tzong Chen,Li-Tzong Chen +14 more
TL;DR: This work aims to provide a stepwise strategy for management of gastric cancer applicable to different levels of health-care resources in Asian countries, using the categories of basic, limited, enhanced, and maximum level.
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TL;DR: KRAS mutational status was shown to be a highly predictive selection criterion in relation to the treatment decision regarding the addition of cetuximab to FOLFOX-4 for previously untreated patients with metastatic colorectal cancer.
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