- Title
- Apatinib in the treatment of gastric cancer in Henan Province: a multicenter prospective real-world observational study (Ahead-HAP01)
- Creator
- Ma, Yijie; Zhao, Weijie; Sun, Peichun; Deng, Wenying; Deng, Junli; Zong, Hong; Wang, Junsheng; Guo, Yanzhen; Liu, Huaimin; Cang, Shundong; Shang, Ke; Chen, Xiaobing; Wang, Jin; He, Dezhi; Wu, Gang; Zhang, Zhen; Zhang, Liguo; Xu, Feng; Tian, Chuntao; Qiao, Chaofeng; Eslick, Guy D.
- Relation
- Annals of Translational Medicine Vol. 10, Issue 24
- Publisher Link
- http://dx.doi.org/10.21037/atm-22-5995
- Publisher
- AME Publishing
- Resource Type
- journal article
- Date
- 2022
- Description
- Background: Apatinib 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. Methods: In 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. Results: The 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). Conclusions: Efficacy 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.
- Subject
- apatinib; effectiveness; gastric cancer; real world; safety
- Identifier
- http://hdl.handle.net/1959.13/1491651
- Identifier
- uon:53158
- Identifier
- ISSN:2305-5839
- Rights
- This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
- Language
- eng
- Full Text
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