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Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study.

ABSTRACT: Apatinib has been demonstrated to be effective and safe among patients with gastric cancer failing after at least two lines chemotherapy. This study aimed to evaluate its effectiveness and safety of low-dose apatinib for the treatment of gastric cancer in real-world practice. We performed a prospective, multicenter observation study in a real-world setting. Patients with advanced gastric cancer more than 18 years old were eligible and received low-dose apatinib (500 mg or 250mg per day) therapy. The median progression-free survival (PFS), median overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety were assessed. Between September 2017 and April 2019, a total of 747 patients were enrolled. The mPFS was 5.56 months (95% CI 4.47-6.28), and mOS was 7.5 months (95% CI 6.74-8.88). Four patients achieved complete response, 47 achieved partial response, and 374 patients achieved stable disease. The ORR was 6.83% and DCR was 56.89%. In addition, multivariate Cox regression analysis indicated that hand-foot syndrome was one independent predictor for PFS and OS. The most common adverse events (AEs) at any grade were hypertension (36.55%), proteinuria (10.26%), hand-foot syndrome (33.53%), fatigue (24.9%), anemia (57.35%), leukopenia (44.49%), thrombocytopenia (34.21%), and neutropenia (53.33%). Grade 3-4 AEs with incidences of 5% or greater were anemia (13.97%), thrombocytopenia (7.14%), and neutropenia (6.67%). No treatment-related death was observed during the treatment of apatinib. The prospective study suggested that low-dose apatinib was an effective regimen for the treatment of advanced gastric cancer with tolerable or controlled toxicity in real world. Trial registration: NCT03333967.

SUBMITTER: Du Y

PROVIDER: S-EPMC7367613 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study.

Du Yingying Y Cao Qisheng Q Jiang Congqiao C Liang Hui H Ning Zhongliang Z Ji Chushu C Wang Jinguo J Zhou Chaoping C Jiang Zonghui Z Yu Changjun C Li Lei L Zhao Yong Y Xu Yuemei Y Xu Tengyun T Hu Wenjun W Wang Daoqin D Cheng Huaidong H Wang Guihe G Zhou Jinhua J Wang Song S Zhang Yanshun Y Hu Zhiqiang Z Li Xinzhong X Lu Donghui D Zhang Jun J Xie Hua H Sun Guoping G

Cancer medicine 20200522 14

Apatinib has been demonstrated to be effective and safe among patients with gastric cancer failing after at least two lines chemotherapy. This study aimed to evaluate its effectiveness and safety of low-dose apatinib for the treatment of gastric cancer in real-world practice. We performed a prospective, multicenter observation study in a real-world setting. Patients with advanced gastric cancer more than 18 years old were eligible and received low-dose apatinib (500 mg or 250mg per day) therapy. ...[more]

PMID: 32441892

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Project description:ImportanceApatinib is a novel treatment option for chemotherapy-refractory advanced gastric cancer (GC), but it has not been evaluated in patients with locally advanced GC.ObjectiveTo investigate the effectiveness and safety of apatinib combined with S-1 plus oxaliplatin (SOX) as a neoadjuvant treatment for locally advanced GC.Design, setting, and participantsThis multicenter, prospective, single-group, open-label, phase 2 nonrandomized controlled trial was conducted in 10 centers in southern China. Patients with M0 and either clinical T2 to T4 or N+ disease were enrolled between July 1, 2017, and June 30, 2019. Statistical analysis was performed from December 1, 2019, to January 31, 2020.InterventionsEligible patients received apatinib (500 mg orally once daily on days 1 to 21 and discontinued in the last cycle) plus SOX (S-1: 40-60 mg orally twice daily on days 1 to 14; oxaliplatin: 130 mg/m2 intravenously on day 1) every 3 weeks for 2 to 5 cycles. A D2 gastrectomy was performed 2 to 4 weeks after the last cycle.Main outcomes and measuresThe primary end point was R0 resection rate. Secondary end points were the response rate, toxic effects, and surgical outcome.ResultsA total of 48 patients (mean [SD] age, 63.2 [8.2] years; 37 men [77.1%]) were enrolled in this study. Forty patients underwent surgery (38 had gastrectomy, and 2 had exploratory laparotomy), with an R0 resection rate of 75.0% (95% CI, 60.4%-86.4%). The radiologic response rate was 75.0%, and T downstaging was observed in 16 of 44 patients (36.4%). The pathological response rate was 54.2% (95% CI, 39.2%-68.6%); moreover, this rate was significantly higher in patients who achieved a radiologic response compared with those who did not (12 [80.0%] vs 1 [20.0%]; P = .03) and in those who had an Eastern Cooperative Oncology Group Performance Status score of 0 (20 [76.9%] vs 10 [45.5%]; P = .03) or had tumors located in the upper one-third of the stomach (16 [61.5%] vs 7 [31.8%]; P = .04). Patients who achieved a pathological response (vs those who did not) had significantly less blood loss (median [range]: 60 [10-200] mL vs 80 [20-300] mL; P = .04) and significantly more lymph nodes harvested (median [range]: 40 [24-67] vs 32 [19-51]; P = .04) during surgery. Postoperative complications were observed in 7 of 38 patients (18.4%). Grade 3 toxic effects occurred in 16 of 48 patients (33.3%), and no grade 4 toxic effects or preoperative deaths were observed.Conclusions and relevanceThis nonrandomized controlled trial found that apatinib combined with SOX was effective and had an acceptable safety profile as a neoadjuvant treatment for locally advanced GC. A large-scale randomized clinical trial may be needed to confirm the findings.Trial registrationClinicalTrials.gov Identifier: NCT03192735.

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.

Project description:The retrospective study was conducted to evaluate the efficacy and safety of careful dose modification of apatinib as third or further-line treatment in advanced gastric cancer (aGC) patients with poor performance status (PS = 2 or 3).Patients with aGC of poor PS who had received at least 2 lines of chemotherapy were treated with apatinib at a dose of 250 mg initially and best supportive care (BSC). During the whole treatment, the dose of apatinib was adjusted according to the status of PS (group treatment). Meanwhile, patients of poor PS (PS = 2 or 3) with aGC who received BSC alone after second or further-line treatment in the recent 5 years in our institution have been investigated for their median overall survival (mOS) as control. Kaplan-Meier curve was adopted for the description of OS in the 2 groups. Univariate analysis was conducted with log-rank test between OS and the potential characteristics including gender, age, PS status, primary tumor lesion, Her-2 status, and previous lines of treatment. Toxicities were assessed with the criteria of National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0.A total of 23 patients who received apatinib plus BSC treatment and 41 patients treated with BSC alone were reviewed in the present study. Median exposure time of apatinib was 2.4 months ranging from 0.2 to 5.1 months. The median OS in the group treatment was 4.3 months (95% CI, 2.735-5.865) comparing to the control as 2.1 months (95% CI, 1.473-2.727, P = .0004). In addition, PS status was shown as the only independently significant factor to influence the OS (P = .049). Fatigue (82.6%), appetite decrease (73.9%), and anemia (69.6%) appeared to be the most common adverse events at any grade during the therapy of apatinib.The outcomes of the present study revealed that therapeutic model of careful dose modification of apatinib therapy initiated with low dose plus BSC as third or further-line treatment might be more beneficial on survival time comparing to BSC alone in patients with aGC of poor PS, however, as well as apparent adverse events.

Dataset Information

Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study.

Publications

Effectiveness and safety of low-dose apatinib in advanced gastric cancer: A real-world study.

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