Journal ArticleDOI
Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction
Jin Li,Shukui Qin,Jianming Xu,Jianping Xiong,Changping Wu,Yuxian Bai,Wei Liu,Jiandong Tong,Yunpeng Liu,Rui-Hua Xu,Zhehai Wang,Qiong Wang,Xuenong Ouyang,Yan Yang,Yi Ba,Jun Liang,Xiaoyan Lin,Deyun Luo,Rongsheng Zheng,Xin Wang,Guoping Sun,Liwei Wang,Leizhen Zheng,Hong Guo,Jingbo Wu,Nong Xu,Jianwei Yang,Hong-gang Zhang,Ying Cheng,Ningju Wang,Lei Chen,Zhining Fan,Piaoyang Sun,Hao Yu +33 more
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These data show that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy.Abstract:
PurposeThere is currently no standard treatment strategy for patients with advanced metastatic gastric cancer experiencing progression after two or more lines of chemotherapy. We assessed the efficacy and safety of apatinib, a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, in patients with advanced gastric or gastroesophageal junction adenocarcinoma for whom at least two lines of prior chemotherapy had failed.Patients and MethodsThis was a randomized, double-blind, placebo-controlled phase III trial. Patients from 32 centers in China with advanced gastric or gastroesophageal junction adenocarcinoma, for whom two or more prior lines of chemotherapy had failed, were enrolled. Patients were randomly assigned to oral apatinib 850 mg or placebo once daily. The primary end points were overall (OS) and progression-free survival (PFS).ResultsBetween January 2011 and November 2012, 267 patients were enrolled. Median OS was significantly improved in the apatinib group compared with t...read more
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Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial
Yoon-Koo Kang,Narikazu Boku,Taroh Satoh,Min Hee Ryu,Yee Chao,Ken Kato,Hyun Cheol Chung,Jen-Shi Chen,Kei Muro,Won Ki Kang,Kun-Huei Yeh,Takaki Yoshikawa,Sang Cheul Oh,Li Yuan Bai,Takao Tamura,Keun Wook Lee,Yasuo Hamamoto,Jong Gwang Kim,Keisho Chin,Do Youn Oh,Keiko Minashi,Jae Yong Cho,Masahiro Tsuda,Li-Tzong Chen,Li-Tzong Chen +24 more
TL;DR: In this phase 3 study, the survival benefits indicate that nivolumab might be a new treatment option for heavily pretreated patients with advanced gastric or gastro-oesophageal junction cancer.
Journal ArticleDOI
The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the diagnosis and treatment of gastric cancer.
Feng Hua Wang,Lin Shen,Jin Li,Zhiwei Zhou,Han Liang,Xiao Tian Zhang,Lei Tang,Yan Xin,Jing Jin,Yu Jing Zhang,Xiang Lin Yuan,T. Liu,Guoxin Li,Qi Wu,Hui Mian Xu,Jiafu Ji,Yuan Fang Li,Xin Wang,Shan Yu,Hao Liu,Wen Long Guan,Rui-Hua Xu +21 more
TL;DR: This guideline uses tables and is complemented by explanatory and descriptive notes covering the diagnosis, comprehensive treatment, and follow-up visits for gastric cancer in China.
Journal ArticleDOI
Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study.
Jianming Xu,Yun Zhang,Ru Jia,Chun Yan Yue,Lianpeng Chang,Rongrui Liu,Gairong Zhang,Chuan Hua Zhao,Yao Yue Zhang,Chun Xia Chen,Yan Wang,Xin Yi,Zhiyuan Hu,Jian Jun Zou,Quan Ren Wang +14 more
TL;DR: The RP2D for apatinib as combination therapy was 250 mg, which showed encouraging clinical activity in patients with advanced HCC, and demonstrated manageable toxicity at recommended single-agent doses of both drugs.
Journal ArticleDOI
Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial.
Kohei Shitara,Toshihiko Doi,M Dvorkin,Wasat Mansoor,Hendrik-Tobias Arkenau,Aliaksandr Prokharau,Maria Alsina,Michele Ghidini,C. Faustino,Vera Gorbunova,Edvard Zhavrid,Kazuhiro Nishikawa,Ayumu Hosokawa,Suayib Yalcin,Kazumasa Fujitani,Giordano D. Beretta,Eric Van Cutsem,Robert Winkler,Lukas Makris,David H. Ilson,Josep Tabernero +20 more
TL;DR: Trifluridine/tipiracil significantly improved overall survival compared with placebo and was well tolerated in this heavily pretreated population of patients with advanced gastric cancer and could be a new treatment option in this population who represent a high unmet medical need.
Journal ArticleDOI
Pan-Asian adapted ESMO Clinical Practice Guidelines for the management of patients with metastatic oesophageal cancer: a JSMO-ESMO initiative endorsed by CSCO, KSMO, MOS, SSO and TOS.
K. Muro,E. Van Cutsem,Yukiya Narita,Georgios Pentheroudakis,Eishi Baba,Jian Li,Min-Hee Ryu,W.I. Wan Zamaniah,W.P. Yong,K.-H. Yeh,Kyoko Kato,Zhihao Lu,Byoung Chul Cho,I.M. Nor,M. Ng,L.-T. Chen,Takako Eguchi Nakajima,Kohei Shitara,Hisato Kawakami,Takahiro Tsushima,Takayuki Yoshino,Florian Lordick,Erika Martinelli,Elizabeth C Smyth,Dirk Arnold,Hironobu Minami,Josep Tabernero,J.-Y. Douillard +27 more
TL;DR: These guidelines represent the consensus opinions reached by experts in the treatment of patients with metastatic oesophageal cancer representing the oncological societies of Japan (JSMO), China (CSCO), Korea (KSMO), Malaysia (MOS), Singapore (SSO) and Taiwan (TOS).
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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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