Real-World Data on Apatinib Efficacy - Results of a Retrospective Study in Metastatic Breast Cancer Patients Pretreated With Multiline Treatment

Liu, Zhaoyun; Shan, Jing; Yu, Qian; Wang, Xinzhao; Song, Xiang; Wang, Fukai; Li, Chao; Yu, Zhiyong; J, Yu

doi:10.3389/fonc.2021.643654

Cited by 14 publications

(20 citation statements)

References 36 publications

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“…Previous research has shown that apatinib, an independently developed anticancer drug in China, competitively binds to the tyrosine ATP-binding site in the receptor cell and exerts an inhibitory effect on tumor angiogenesis. It is an oral antiangiogenesis-targeting drug that blocks VEGFR-2, thereby reducing the activation of mitogenic protein kinase (MAPK) and plays an antitumor role in inhibiting the proliferation of vascular endothelial cells in a variety of solid malignancies [20][21][22][23][24].…”

Section: Discussionmentioning

confidence: 99%

Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Lin

Zang

2022

Evidence-Based Complementary and Alternative Medicine

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Objective. To assess the effects of monotherapy with apatinib mesylate on the incidence of adverse events and immune function in breast cancer patients after a radical mastectomy. Methods. Between December 2018 and August 2020, 90 patients with breast cancer scheduled for a radical mastectomy in People’s Liberation Army Navy 971 Hospital were randomly recruited and assigned at a ratio of 1 : 1 to receive either conventional treatment (conventional group) or apatinib mesylate after radical mastectomy (study group). The primary endpoint was disease control rate (DCR), and the secondary endpoints were adverse events and the immune function of the patients. Results. Monotherapy with apatinib mesylate was associated with a higher DCR (86.67%) versus conventional postoperative treatment (42.23%). All patients in the study group had documented adverse events, including 2 (4.45%) cases of headache, 3 (6.67%) cases of dizziness, 9 (20.00%) cases of hypertension, 6 (13.34%) cases of hand-foot syndrome, 3 (6.67%) cases of thrombocytopenia, 1 (2.23%) case of tinnitus, 7 (15.56%) cases of fatigue, 2 (4.45%) cases of anemia, 2 (4.45%) cases of oral pain, and 10 (22.23%) cases of leukopenia. There were 23 cases of intermittent discontinuation due to adverse events during treatment, 15 cases of dose reduction, and 3 cases of discontinuation due to adverse events. The difference in preoperative and postoperative T-cell subsets and natural killer (NK) cells between the two groups did not come up to the statistical standard ( P > 0.05 ). Monotherapy with apatinib mesylate resulted in significantly lower levels of CD4+, CD4+/CD8+, and NK cells and higher CD8+ levels versus conventional treatment at 1 week and 4 weeks postoperatively ( P < 0.05 ). Conclusion. Apatinib mesylate monotherapy after radical mastectomy yields a high DCR, a lower incidence of adverse events, and improved immune recovery. Clinical trials are, however, required prior to clinical promotion.

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Section: Discussionmentioning

confidence: 99%

Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Lin

Zang

2022

Evidence-Based Complementary and Alternative Medicine

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“…We still included this study because the proportion of patients without meeting the inclusion criteria was low. Finally, six studies were included and deemed eligible for further quality evaluation and analysis ( 7 – 9 , 14 , 32 , 33 ).…”

Section: Resultsmentioning

confidence: 99%

“…Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that selectively binds to and inhibits VEGFR-2 ( 7 ). In 2014, two phase II clinical trials demonstrated the objective efficacy results and acceptable toxicity in pretreated metastatic TNBC and non-TNBC patients ( 8 , 9 ).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of apatinib monotherapy for patients with advanced breast cancer: a systematic review and meta-analysis

Huang

2022

Front. Oncol.

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BackgroundPatients with advanced breast cancer usually have poor prognosis. Apatinib is a small-molecule tyrosine kinase inhibitor, and the reports regarding the efficacy and safety of apatinib monotherapy for advanced breast cancer in the current literature are controversial. Therefore, we performed a systematic review and meta-analysis to collect and pool efficacy and safety data of apatinib monotherapy for advanced breast cancer with the aim of providing up-to-date evidence to aid clinical practice.MethodsThis study was registered at PROSPERO (CRD42020190049). Three literature databases, including PubMed, EMBASE, and Cochrane Library, were searched. For evaluating efficacy, the objective response rate and disease control rate were extracted or calculated. Safety was evaluated in terms of the proportions of patients with grade 3 or 4 treatment-related adverse events. The pooled proportions of the outcomes and their 95% confidence interval were shown. The Kaplan–Meier curves of overall survival and progression-free survival were pooled from the extracted data of the included studies. Furthermore, pooled medians for overall survival and progression-free survival were calculated. A p-value of < 0.05 was considered statistically significant.ResultsSix studies were included and deemed eligible for further quality evaluation and analysis. The pooled objective response rate and disease control rate were 20.4% and 71.6%, respectively. The pooled proportions of four hematologic adverse events ranged from 2.6% to 6.9%. The pooled proportions of hypertension, hand-foot syndrome, transaminase increased, and proteinuria ranged from 4.1% to 24.3%, and other non-hematologic adverse events were <1%. The pooled median progression-free survival and overall survival were 4.00 and 10.43 months, respectively, in cases of advanced breast cancer treated with apatinib.ConclusionsThis study confirms the reliable efficacy of apatinib monotherapy for advanced breast cancer. However, non-hematologic grade 3–4 adverse events, especially hypertension, are more frequently observed during apatinib treatment than during treatment with other tyrosine kinase inhibitors, such as sunitinib or sorafenib.Systematic Review Registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42020190049.

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“… 24 In addition, results from a retrospective study, which investigated the antitumor activity and safety of apatinib combined with chemotherapy in 66 pretreated advanced breast cancer patients, revealed that the median PFS and OS were 6.0 months and 10.0 months, respectively. 47 Another observational study analyzed the efficacy and safety of apatinib combined with chemotherapy in 85 patients with previously treated advanced breast cancer, and concluded that the median PFS and OS in the TNBC group were 5.2 months and 11.4 months, respectively, while the median PFS and OS in the non-TNBC group were 4.3 months and 11.3 months, respectively. 48 In consideration of the efficacy of apatinib in advanced TNBC, our study aimed to evaluate the efficacy and safety of neoadjuvant apatinib combined with standard chemotherapy for early-stage TNBC patients.…”

Section: Discussionmentioning

confidence: 99%

Low-dose apatinib combined with neoadjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (LANCET): a single-center, single-arm, phase II trial

Yang

Zhang

et al. 2022

Ther Adv Med Oncol

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Background: Antiangiogenic therapy combined with chemotherapy could improve pathological complete response (pCR) for breast cancer. Apatinib is an oral tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptor 2. We assessed the efficacy and safety of apatinib combined with standard neoadjuvant chemotherapy in patients with triple-negative breast cancer (TNBC). Materials and methods: This single-arm, phase II study enrolled patients aged 18–70 years with previously untreated stage IIA-IIIB TNBC. Patients received oral apatinib at a dose of 250 mg once daily and intravenously docetaxel every 3 weeks for four cycles, followed by epirubicin plus cyclophosphamide every 3 weeks for four cycles. The primary endpoint was the pCR rate in the breast and lymph nodes. Secondary endpoints included objective response rate, event-free survival (EFS), overall survival (OS), and safety. Results: In all, 31 patients were enrolled, and the median follow-up time was 22.9 months (range: 10.1–41.6 months). The pCRs in both breast and lymph nodes were achieved in 17 [54.8%; 95% confidence interval (CI): 36.0–72.7] of 31 patients. Objective responses were achieved in 29 patients (93.5%; 95% CI: 78.6–99.2), and disease control was achieved in 31 patients (100%; 95% CI: 88.8–100.0). The 2-year EFS and 2-year OS were 90.9% and 94.4%, respectively. The five most common treatment-related adverse events were fatigue (51%), hypertension (41%), anorexia (39%), hand–foot syndrome (35%), and diarrhea (32%). Few grade 3 or more adverse events were observed. Conclusion: The combination of apatinib with docetaxel followed by epirubicin plus cyclophosphamide showed excellent efficacy and manageable toxicities; and further randomized controlled phase III trials are warranted. Trial registration: This trial was registered with ClinicalTrials.gov (NCT03243838) on 5 August 2017.

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Real-World Data on Apatinib Efficacy - Results of a Retrospective Study in Metastatic Breast Cancer Patients Pretreated With Multiline Treatment

Cited by 14 publications

References 36 publications

Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Efficacy and safety of apatinib monotherapy for patients with advanced breast cancer: a systematic review and meta-analysis

Low-dose apatinib combined with neoadjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (LANCET): a single-center, single-arm, phase II trial

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