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Featured researches published by Guoping Sun.


Journal of Clinical Oncology | 2014

Lapatinib Plus Paclitaxel Versus Paclitaxel Alone in the Second-Line Treatment of HER2-Amplified Advanced Gastric Cancer in Asian Populations: TyTAN— A Randomized, Phase III Study

Taroh Satoh; Rui-hua Xu; Hyun Cheol Chung; Guoping Sun; Toshihiko Doi; Jianming Xu; Akihito Tsuji; Yasushi Omuro; Jin Li; Jinwan Wang; Hiroto Miwa; Shukui Qin; Ik-Joo Chung; Kun-Huei Yeh; Jifeng Feng; Akihira Mukaiyama; Mikiro Kobayashi; Atsushi Ohtsu; Yung-Jue Bang

PURPOSEnIn Asian countries, paclitaxel once per week is used as second-line treatment in advanced gastric cancer, including human epidermal growth factor receptor 2 (HER2) -positive tumors. The role of anti-HER2 agents, including lapatinib, in this setting and population is unclear.nnnPATIENTS AND METHODSnTyTAN was a two-part, parallel-group, phase III study in Asian patients. An open-label, dose-optimization phase (n = 12) was followed by a randomized phase (n = 261), in which patients who were HER2 positive by fluorescence in situ hybridization (FISH) received lapatinib 1,500 mg once per day plus once-per-week paclitaxel 80 mg/m(2) or paclitaxel alone. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), time to progression (TTP), overall response rate (ORR), time to response, response duration, and safety. Analyses were based on immunohistochemistry (IHC) and gastrectomy status, prior trastuzumab therapy, and regional subpopulations.nnnRESULTSnMedian OS was 11.0 months with lapatinib plus paclitaxel versus 8.9 months with paclitaxel alone (P = .1044), with no significant difference in median PFS (5.4 v 4.4 months) or TTP (5.5 v 4.4 months). ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone (odds ratio, 3.85; P < .001). Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC3+ compared with IHC0/1+ and 2+ patients and in Chinese compared with Japanese patients. A similar proportion of patients experienced adverse events with each treatment (lapatinib plus paclitaxel, 100% v paclitaxel alone, 98%).nnnCONCLUSIONnLapatinib plus paclitaxel demonstrated activity in the second-line treatment of patients with HER2 FISH-positive IHC3+ advanced gastric cancer but did not significantly improve OS in the intent-to-treat population.


Journal of Clinical Oncology | 2013

Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer: Results From a Randomized, Placebo-Controlled, Parallel-Arm, Phase II Trial

Jin Li; Shukui Qin; Jianming Xu; Weijian Guo; Jianping Xiong; Yuxian Bai; Guoping Sun; Yan Yang; Liwei Wang; Nong Xu; Ying Cheng; Zhehai Wang; Leizhen Zheng; Min Tao; Xiao-Dong Zhu; Dongmei Ji; Xin Liu; Hao Yu

PURPOSEnPatients with metastatic gastric cancer (mGC) who do not respond to or who experience progression with second-line chemotherapy have no treatment options that clearly confer a survival benefit. This trial investigated the safety and efficacy of apatinib, an inhibitor of vascular endothelial growth factor receptor, as a treatment option for heavily pretreated patients with mGC.nnnPATIENTS AND METHODSnPatients who experienced treatment failure with at least two chemotherapeutic regimens were randomly assigned to receive placebo (group A), apatinib 850 mg once daily (group B), or apatinib 425 mg twice daily (group C).nnnRESULTSnWe enrolled 144 patients onto this study. In groups A, B, and C, the median overall survival (OS) times were 2.50 months (95% CI, 1.87 to 3.70 months), 4.83 months (95% CI, 4.03 to 5.97 months), and 4.27 months (95% CI, 3.83 to 4.77 months), respectively, and the median progression-free survival (PFS) times were 1.40 months (95% CI, 1.20 to 1.83 months), 3.67 months (95% CI, 2.17 to 6.80 months), and 3.20 months (95% CI, 2.37 to 4.53 months), respectively. There were statistically significant differences between the apatinib and placebo groups for both PFS (P < .001) and OS (P < .001 and P = .0017). Nine patients had a partial response (three patients in group B and six patients in group C). Toxicities were tolerable or could be clinically managed. The most common grade 3 to 4 adverse events were hand-foot syndrome and hypertension. Hematologic toxicities were moderate, and grade 3 to 4 hematologic toxicities were rare.nnnCONCLUSIONnApatinib showed improved PFS and OS in heavily pretreated patients with mGC who had experienced treatment failure with two or more chemotherapy regimens.


Journal of Clinical Oncology | 2016

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; Honggang Zhang; Ying Cheng; Ningju Wang

PURPOSEnThere 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.nnnPATIENTS AND METHODSnThis 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).nnnRESULTSnBetween January 2011 and November 2012, 267 patients were enrolled. Median OS was significantly improved in the apatinib group compared with the placebo group (6.5 months; 95% CI, 4.8 to 7.6 v 4.7 months; 95% CI, 3.6 to 5.4; P = .0149; hazard ratio, 0.709; 95% CI, 0.537 to 0.937; P = .0156). Similarly, apatinib significantly prolonged median PFS compared with placebo (2.6 months; 95% CI, 2.0 to 2.9 v 1.8 months; 95% CI, 1.4 to 1.9; P < .001; hazard ratio, 0.444; 95% CI, 0.331 to 0.595; P < .001). The most common grade 3 to 4 nonhematologic adverse events were hand-foot syndrome, proteinuria, and hypertension.nnnCONCLUSIONnThese 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.


Oncotarget | 2015

S-1 plus Cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: A pilot study

Li Y; Miaozhen Qiu; Jianming Xu; Guoping Sun; Huishan Lu; Yunpeng Liu; Meizuo Zhong; Helong Zhang; Shiying Yu; Wei Li; Xiao-hua Hu; Wang J; Ying Cheng; Juntian Zhou; Zengqing Guo; Zhongzhen Guan; Rui-hua Xu

The safety and efficacy of S-1 plus cisplatin in Chinese advanced gastric cancer patients in first line setting is unknown. In this pilot study, patients with advanced gastric or gastro-esophageal junction adenocarcinoma were enrolled and randomly assigned in a 1:1 ratio to receive S-1 plus cisplatin (CS group) or 5-FU plus cisplatin (CF group). The primary endpoint was time to progression (TTP). Secondary end points included overall survival (OS) and safety. This study was registered on ClinicalTrials. Gov, number NCT01198392. A total of 236 patients were enrolled. Median TTP was 5.51 months in CS group compared with 4.62 months in CF group [hazard ratio (HR) 1.028, 95% confidential interval (CI) 0.758-1.394, p = 0.859]. Median OS was 10.00 months and 10.46 months in CS and CF groups (HR 1.046, 95%CI 0.709-1.543, p = 0.820), respectively. The most common adverse events in both groups were anemia, leukopenia, neutropenia, nausea, thrombocytopenia, vomiting, anorexia and diarrhea. We find that S-1 plus cisplatin is an effective and tolerable option for advanced gastric or gastro-esophageal junction adenocarcinoma patients in China.


Journal of Hematology & Oncology | 2017

Early presence of anti-angiogenesis-related adverse events as a potential biomarker of antitumor efficacy in metastatic gastric cancer patients treated with apatinib: a cohort study

Xinyang Liu; Shukui Qin; Zhichao Wang; Jianming Xu; Jianping Xiong; Yuxian Bai; Zhehai Wang; Yan Yang; Guoping Sun; Liwei Wang; Leizhen Zheng; Nong Xu; Ying Cheng; Weijian Guo; Hao Yu; T. Liu; Pagona Lagiou; Jin Li

BackgroundReliable biomarkers of apatinib response in gastric cancer (GC) are lacking. We investigated the association between early presence of common adverse events (AEs) and clinical outcomes in metastatic GC patients.Patients and methodsWe conducted a retrospective cohort study using data on 269 apatinib-treated GC patients in two clinical trials. AEs were assessed at baseline until 28xa0days after the last dose of apatinib. Clinical outcomes were compared between patients with and without hypertension (HTN), proteinuria, or hand and foot syndrome (HFS) in the first 4xa0weeks. Time-to-event variables were assessed using Kaplan–Meier methods and Cox proportional hazard regression models. Binary endpoints were assessed using logistic regression models. Landmark analyses were performed as sensitivity analyses. Predictive model was analyzed, and risk scores were calculated to predict overall survival.ResultsPresence of AEs in the first 4xa0weeks was associated with prolonged median overall survival (169 vs. 103xa0days, log-rank pxa0=xa00.0039; adjusted hazard ratio (HR) 0.64, 95% confidence interval [CI] 0.64–0.84, pxa0=xa00.001), prolonged median progression-free survival (86.5 vs. 62xa0days, log-rank pxa0=xa00.0309; adjusted HR 0.69, 95% CI 0.53–0.91, pxa0=xa00.007), and increased disease control rate (54.67 vs. 32.77%; adjusted odds ratio 2.67, pxa0<xa00.001). Results remained significant in landmark analyses. The onset of any single AE or any combinations of the AEs were all statistically significantly associated with prolonged OS, except for the presence of proteinuria. An AE-based prediction model and subsequently derived scoring system showed high calibration and discrimination in predicting overall survival.ConclusionPresence of HTN, proteinuria, or HFS during the first cycle of apatinib treatment was a viable biomarker of antitumor efficacy in metastatic GC patients.


Journal of Clinical Oncology | 2011

A randomized, double-blind, multicenter, phase II, three-arm, placebo-control study of apatinib as third-line treatment in patients with metastatic gastric carcinoma.

J. Li; Shukui Qin; Jianming Xu; W. j. Guo; Jianping Xiong; Yuxian Bai; Guoping Sun; Yan Yang; Liwei Wang; Nong Xu; Ying Cheng; W. Zhe-Hai; Leizhen Zheng; Min Tao


Journal of Clinical Oncology | 2013

A phase III study of S-1 plus cisplatin versus fluorouracil plus cisplatin in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Rui-hua Xu; Guoping Sun; Huishan Lu; Liu Yun Peng; Jianming Xu; Meizuo Zhong; Helong Zhang; Shiying Yu; Wei Li; Xiao-hua Hu; Jie Jun Wang; Ying Cheng; Juntian Zhou; Zengqing Guo; Zhongzhen Guan


Annals of Oncology | 2014

O-0029PHASE III STUDY OF APATINIB IN ADVANCED GASTRIC CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Jin Li; Shukui Qin; Jianming Xu; Jianping Xiong; Chen Wu; Yuxian Bai; Wei Liu; J. Tong; Liu Y; Rui-hua Xu; Zhenning Wang; Q. Wang; X. Ouyang; Yang Y; Yi Ba; Jun Liang; Xiaoyan Lin; D. Luo; Rongsheng Zheng; K. Wu; Guoping Sun; Liwei Wang; Leizhen Zheng; Hong Guo; Wu J; Nong Xu; J. Yang; H. Zhang; Y. Cheng; N. Wang


Journal of Clinical Oncology | 2013

The Chinese subgroup from a randomized phase III study of lapatinib in combination with weekly paclitaxel versus weekly paclitaxel alone as second-line treatment of HER2-amplified advanced gastric cancer (AGC) in Asian countries.

Guoping Sun; Sun Y; Rui-hua Xu; Jianming Xu; Jin Li; Jinwan Wang; Shukui Qin; Ji Feng Feng; Yi Ba; Lin Shen; Yuxian Bai; Yihong Sun; Hongming Pan; Ying Cheng; Shiying Yu; Haijun Zhong; Li Bai; Rongcheng Luo; Mikiro Kobayashi; Atsushi Ohtsu


Annals of Oncology | 2018

683PA real world study of apatinib treatment in gastric cancer: Current status and clinical benefit

Guoping Sun; D Li; Z Ning; Y He; J Chang; F Zhang; Chen Chen Jiang; Y Cheng; L Xia; B Hu; C Yu; Z Wang; D Wang; G Wang; Y Zhao; Jun Wang; H Liang; M Xiong; W Peng; H Qian

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Jianming Xu

Academy of Military Medical Sciences

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Shukui Qin

Huazhong University of Science and Technology

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Yuxian Bai

Harbin Medical University

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Liwei Wang

Shanghai Jiao Tong University

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Leizhen Zheng

Shanghai Jiao Tong University

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Rui-hua Xu

Sun Yat-sen University

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Yan Yang

Bengbu Medical College

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