Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial
| Autor: | Yan Song, Hanzhong Li, Hong Luo, Jianhui Ma, Ji-Yan Liu, Yuxian Bai, Dingwei Ye, Shukui Qin, Jinwan Wang, Aiping Zhou, Jianzhong Shou, Xiaodong Xie, Xianzhong Bai, Xiubao Ren, Cheng Fu |
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| Rok vydání: | 2020 |
| Předmět: |
second-line
0301 basic medicine Sorafenib Cancer Research medicine.medical_specialty medicine.drug_class Population Phases of clinical research lcsh:RC254-282 metastatic renal cell carcinoma Gastroenterology Tyrosine-kinase inhibitor 03 medical and health sciences tyrosine kinase inhibitor 0302 clinical medicine Renal cell carcinoma Internal medicine medicine Clinical endpoint anlotinib education Adverse effect education.field_of_study FGFR Sunitinib business.industry lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens medicine.disease Clinical Trial 030104 developmental biology Oncology 030220 oncology & carcinogenesis business medicine.drug |
| Zdroj: | Frontiers in Oncology Frontiers in Oncology, Vol 10 (2020) |
| ISSN: | 2234-943X |
| DOI: | 10.3389/fonc.2020.00664 |
| Popis: | Introduction: Sequential therapy with vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFR-TKIs) is effective in some patients with metastatic renal cell carcinoma (mRCC) progressed from or were intolerant to a prior TKIs. Anlotinib is a multi-kinase inhibitor targeting VEGFR1/2/3, PDGFR and FGFR, which has demonstrated efficacy and safety in first-line treatment of mRCC. This study assessed the potential of anloitnib as second-line treatment for patients with mRCC after prior one VEGFR-TKI. Methods: This is a single-arm, open-label, phase 2 study. Patients progressed after or were intolerant to sorafenib or sunitinib were enrolled. Anlotinib was administrated orally 12 mg once daily for 14 days every 3 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), safety and quality of life (QoL). Results: Forty three patients were enrolled and 42 received anlotinib, of whom 32 progressed after and 10 were intolerant to sorafenib or sunitinib. Median PFS were 14.0 months (95% CI 8.3–20.3) and 8.5 months (95% CI 5.6–16.6) for overall population and patients progressed after a previous VEGFR-TKI, respectively. Median OS was 21.4 months (95% CI 16.0–34.5), confirmed ORR and DCR were 16.7 and 83.3% in overall population. The most common adverse events included diarrhea (47.6%), hypertension (45.2%), hand and foot syndrome (42.9%), and fatigue (40.5%). Grade 3 hematological adverse events occurred in four cases, while no grade 4 hematological adverse events was observed. Conclusions: Anlotinib showed promising efficacy as well as favorable safety as second-line treatment for patients with mRCC. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02072044. |
| Databáze: | OpenAIRE |
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