Everolimus for previously treated advanced gastric cancer: Results of the randomized, double-blind, phase III GRANITE-1 study
Atsushi Ohtsu,Jaffer A. Ajani,Yu Xian Bai,Yung-Jue Bang,Hyun Cheol Chung,Hong Ming Pan,Tarek Sahmoud,Lin Shen,Kun-Huei Yeh,Keisho Chin,Kei Muro,Yeul Hong Kim,D. R. Ferry,Niall C. Tebbutt,Salah-Eddin Al-Batran,Heind Smith,Chiara Costantini,Syed Rizvi,David Lebwohl,Eric Van Cutsem +19 more
TLDR
Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy and the safety profile observed for Everolimus was consistent with that observed forEverolimus in other cancers.Abstract:
Purpose The oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer. Patients and Methods Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety. Results Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months ...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.
Journal ArticleDOI
Chemotherapy for advanced gastric cancer
Anna Dorothea Wagner,Nicholas Syn,Markus Moehler,Wilfried Grothe,Wei Peng Yong,Bee Choo Tai,Jingshan Ho,Susanne Unverzagt +7 more
TL;DR: Assessment of the efficacy of chemotherapy versus best supportive care (BSC), combination versus single-agent chemotherapy and different chemotherapy combinations in advanced gastric cancer found chemotherapy extends overall survival (OS) by approximately 6.7 months more than BSC.
Journal ArticleDOI
Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02) : an open-label, phase 3 randomised controlled trial
Hugo Ford,Andrea Marshall,John Bridgewater,Tobias Janowitz,Fareeda Y. Coxon,Jonathan Wadsley,Wasat Mansoor,D. Fyfe,Srinivasan Madhusudan,Gary Middleton,Daniel Swinson,Stephen Falk,Ian Chau,David Cunningham,Paula Kareclas,Natalie Cook,Jane M Blazeby,Janet A. Dunn +17 more
TL;DR: The findings suggest that docetaxel can be recommended as an appropriate second-line treatment for patients with oesophagogastric adenocarcinoma that is refractory to treatment with platinum and fluoropyrimidine.
Journal ArticleDOI
Gastric Cancer: Epidemiology, Risk Factors, Classification, Genomic Characteristics and Treatment Strategies.
TL;DR: Early-onset gastric cancer is a good model to study genetic alterations related to the carcinogenesis process, as young patients are less exposed to environmental carcinogens.
Journal ArticleDOI
Advanced gastric cancer: Current treatment landscape and future perspectives.
TL;DR: Current standards of care and major topics of drug development in gastric cancer are discussed and a recently published molecular classification of Gastric cancer is expected to improve patient stratification and selection for clinical trials and provide a roadmap for future drug development.
References
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Journal ArticleDOI
Global cancer statistics
TL;DR: A substantial proportion of the worldwide burden of cancer could be prevented through the application of existing cancer control knowledge and by implementing programs for tobacco control, vaccination, and early detection and treatment, as well as public health campaigns promoting physical activity and a healthier dietary intake.
Journal ArticleDOI
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Patrick Therasse,Susan G. Arbuck,Elizabeth Eisenhauer,Jantien Wanders,Richard Kaplan,Larry Rubinstein,Jaap Verweij,Martine Van Glabbeke,Allan T. van Oosterom,Michaele C. Christian,S. Gwyther +10 more
TL;DR: A model by which a combined assessment of all existing lesions, characterized by target lesions and nontarget lesions, is used to extrapolate an overall response to treatment is proposed, which is largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines.
Journal ArticleDOI
Cancer statistics, 2010
TL;DR: The American Cancer Society as mentioned in this paper estimated the number of new cancer cases and deaths expected in the United States in the current year and compiles the most recent data regarding cancer incidence, mortality, and survival based on incidence data from the National Cancer Institute, the Centers for Disease Control and Prevention, and the North American Association of Central Cancer Registries and mortality data from National Center for Health Statistics.
Journal ArticleDOI
Toxicity and response criteria of the Eastern Cooperative Oncology Group
Martin M. Oken,Richard H. Creech,Douglass C. Tormey,John Horton,Thomas E. Davis,Eleanor T. McFadden,Paul P. Carbone +6 more
TL;DR: The Eastern Cooperative Oncology Group criteria for toxicity and response are presented to facilitate future reference and to encourage further standardization among those conducting clinical trials.
Journal ArticleDOI
Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer
José Baselga,Mario Campone,Martine Piccart,Howard A. Burris,Hope S. Rugo,Tarek Sahmoud,Shinzaburo Noguchi,Michael Gnant,Kathleen I. Pritchard,Fabienne Lebrun,J. Thaddeus Beck,Yoshinori Ito,Denise A. Yardley,Ines Deleu,Alejandra T. Perez,Thomas Bachelot,L. Vittori,Zhiying Xu,Pabak Mukhopadhyay,David Lebwohl,Gabriel N. Hortobagyi +20 more
TL;DR: Everolimus combined with an aromatase inhibitor improved progression-free survival in patients with hormone-receptor-positive advanced breast cancer previously treated with nonsteroidal aromat enzyme inhibitors.
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