Dataset Information

An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202).

ABSTRACT:

Background

Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting.

Methods

This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS).

Results

A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425-500 mg, 6.1%), and high-dose group (675-850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17-7.93) and 4.20 months (95% CI, 4.60-4.77), respectively, and were comparable among the low-, mid-, and high-dose groups.

Conclusion

Lower daily doses of apatinib achieved comparable OS and PFS versus higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients.

Clinical trial registration

ClinicalTrials.gov identifier: NCT02668380.

SUBMITTER: Wang X

PROVIDER: S-EPMC7082876 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202).

Wang Xiang X Zhang Ruixing R Du Nan N Yang Mudan M Zang Aimin A Liu Likun L Yu Junyan J Gao Jinghua J Zhang Junping J Fu Zhanzhao Z Ren Yuchuan Y Ma Liwen L Guo Jun J Li Qingshan Q Li Xiaomei X Fan Zaiwen Z Song Xiang X Liu Zheng Z Zhang Yan Y Li Guozhong G Yu Zhonghe Z Diao Jianfeng J Jia Junmei J Liang Feng F Wang Huaqing H Sun Junzhong J Gao Yunge Y Yang Ping P Bai Chunmei C Ren Xiubao X Zhong Diansheng D

Therapeutic advances in medical oncology 20200319

<h4>Background</h4>Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting.<h4>Methods</h4>This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS).< ...[more]

PMID: 32218807

Similar Datasets

Project description:BackgroundFor advanced gastric cancer (GC) patients who fail first-line treatment, chemotherapy alone is of limited benefit. Ramucirumab combined with paclitaxel and apatinib combined with docetaxel provided clinical benefit in previous studies, but the feasibility of apatinib combined with other chemotherapy agents remains unknown. The aim of the present study was to evaluate the efficacy and safety of apatinib combined with chemotherapy as a second-line treatment for advanced GC.MethodsPatients aged 18-75 years with histologically or cytologically confirmed advanced or metastatic GC or gastroesophageal junction adenocarcinoma that had progressed with first-line treatment were recruited and received apatinib 250 or 500 mg oral apatinib and chemotherapy regimens, including docetaxel, paclitaxel, tegafur, oxaliplatin, and capecitabine. Each treatment cycle was 28 days (4 weeks). During post-discontinuation follow-up, all patients were followed for survival [every 8 weeks (+0 to 7 days)] until disease progression, death, or study completion. Overall survival (OS) was the primary endpoint. Secondary endpoints were overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Adverse events (AEs) were also noted. Tumor response and progression were assessed according to RECIST 1.1. AEs were graded following the National Cancer Institute common terminology criteria for AEs (NCI-CTCAE 4.0).ResultsBetween August 31, 2016 and February 17, 2020, a total of 32 patients were enrolled in the present study, and 29 were evaluable. At the time of data cut-off, median follow-up was 7.00 months (IQR, 4.60-12.23 months). The ORR and DCR were 18.52% and 92.59%, respectively. The median PFS was 3.06 months, and the median OS was 6.93 months. In the population receipt of apatinib plus docetaxel, the median OS was 6.51 months. AEs were observed in 22 patients. Leukopenia was the most common AE (24.1%), followed by hypertension (24.1%) and neutropenia (17.2%). Patients did not develop any AEs that were grade 4 or higher.ConclusionsThe combination of apatinib and chemotherapy demonstrated clinical activity and acceptable toxicity as a second-line treatment for advanced GC, and may provide new second-line treatment options for advanced GC patients.

Project description:BackgroundApatinib is approved in China for the treatment of advanced gastric adenocarcinoma that had progressed or relapsed after standard systemic chemotherapy treatments. However, the effectiveness of Apatinib under real-world condition has not been evaluated and the drug performance under ideal and controlled circumstances has not been validated. In fact, genetic factors, poor healthcare access, social economic status, comorbidities compliance and other factors play significant role in drug performance under "real-world" conditions. Real-world experience can help validate the safety and efficacy of apatinib.MethodsIn this observational, prospective study we evaluated the safety and efficacy of Apatinib in patient treated in China. Between March 2018 and March 2019, a total of 943 patients with gastric cancer treated with Apatinib were enrolled. Response Evaluation Criteria in Solid Tumors, version 1.1 and Common Terminology Criteria for Adverse Events, version 4.0 were used to evaluate efficacy and adverse effects.ResultsThe median progression-free survival (PFS) was 5.65 months (5.22-6.05 months), and the median overall survival (OS) was 11.47 months (10.41-12.52 months). Apatinib in combination with more than two agents was superior to single agent apatinib in overall response rate (ORR) [18.18% vs. 9.43%, 95% confidence interval (CI): 1.03-5.90] and disease control rate (DCR) (82.82% vs. 77.87%, 95% CI: 1.21-2.59). Apatinib in combination with single agent chemotherapy was also superior to apatinib alone with DCR (86.29% vs. 77.87%, 95% CI: 1.47-2.99) irrespective of the dose (250 or 500 mg). In the patient cohort who received a starting dose of 250 mg, the DCRs of the combined treatment and monotherapy groups were 86.22% vs. 80.00% (95% CI: 1.18-3.09), respectively. The most common treatment-emergent adverse events were anemia, anorexia and thrombocytopenia (66.28%, 37.75%, 36.06%, respectively).ConclusionsEfficacy of Apatinib in this observational study is promising and toxicities are manageable. Combination of Apatinib with chemotherapy agents has a higher response rate and better disease control at the expense of increased serious adverse events. Better OS can be achieved by receiving apatinib treatment earlier. As a supplement and further validation of explanatory randomized controlled trials, the real-world study reflects the real efficacy of apatinib in practical application.

Dataset Information

An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202).

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202).

Similar Datasets

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