Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial
DC Field | Value | Language |
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dc.contributor.author | Kang, Yoon-Koo | - |
dc.contributor.author | Ryu, Min-Hee | - |
dc.contributor.author | Di Bartolomeo, Maria | - |
dc.contributor.author | Chau, Ian | - |
dc.contributor.author | Yoon, Harry | - |
dc.contributor.author | Kim, Jong Gwang | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Oh, Sang Chul | - |
dc.contributor.author | Takashima, Atsuo | - |
dc.contributor.author | Kryzhanivska, Anna | - |
dc.contributor.author | Chao, Yee | - |
dc.contributor.author | Evesque, Ludovic | - |
dc.contributor.author | Schenker, Michael | - |
dc.contributor.author | Mcginn, Arlo | - |
dc.contributor.author | Zhao, Yufan | - |
dc.contributor.author | Lee, Jennifer | - |
dc.contributor.author | Wyrwicz, Lucjan | - |
dc.contributor.author | Boku, Narikazu | - |
dc.date.accessioned | 2024-02-13T05:00:07Z | - |
dc.date.available | 2024-02-13T05:00:07Z | - |
dc.date.issued | 2024-03 | - |
dc.identifier.issn | 1436-3291 | - |
dc.identifier.issn | 1436-3305 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/65451 | - |
dc.description.abstract | Background Rivoceranib is an oral, selective tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2. ANGEL (NCT03042611) was a global, randomized, double-blinded, placebo-controlled, phase 3 study evaluating rivoceranib as 3rd-line or >= 4th-line therapy in patients with advanced/metastatic gastric or gastroesophageal junction (GEJ) cancer. Methods Patients had failed >= 2 lines of chemotherapy and were randomized 2:1 to rivoceranib 700 mg once daily or placebo with best supportive care. Primary endpoint: overall survival (OS) in the intention-to-treat population. Secondary endpoints: progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR) by blinded independent central review (BICR). Results In total, 460 patients (rivoceranib n = 308, placebo n = 152) were enrolled. OS was not statistically different for rivoceranib versus placebo (median 5.78 vs. 5.13 months; hazard ratio [HR] 0.93, 95% CI 0.74-1.15; p = 0.4724). PFS by BICR (median 2.83 vs. 1.77 months; HR 0.58, 95% CI 0.47-0.71; p < 0.0001), ORR (6.5% vs. 1.3%; p = 0.0119), and DCR (40.3 vs. 13.2%; p < 0.0001) were improved with rivoceranib versus placebo. In patients receiving >= 4th-line therapy, OS (median 6.34 vs. 4.73 months; p = 0.0192) and PFS by BICR (median 3.52 vs. 1.71 months; p < 0.0001) were improved with rivoceranib versus placebo. The most common grade >= 3 treatment-emergent adverse events with rivoceranib were hypertension (17.9%), anemia (10.4%), aspartate aminotransferase increased (9.4%), asthenia (8.5%), and proteinuria (7.5%). Conclusions This study did not meet its primary OS endpoint. Compared to placebo, rivoceranib improved PFS, ORR, and DCR. Rivoceranib also improved OS in a prespecified patient subgroup receiving >= 4th-line therapy. | - |
dc.format.extent | 12 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Springer Verlag | - |
dc.title | Rivoceranib, a VEGFR-2 inhibitor, monotherapy in previously treated patients with advanced or metastatic gastric or gastroesophageal junction cancer (ANGEL study): an international, randomized, placebo-controlled, phase 3 trial | - |
dc.type | Article | - |
dc.publisher.location | 미국 | - |
dc.identifier.doi | 10.1007/s10120-023-01455-5 | - |
dc.identifier.scopusid | 2-s2.0-85183367348 | - |
dc.identifier.wosid | 001150734900001 | - |
dc.identifier.bibliographicCitation | Gastric Cancer, v.27, no.2, pp 375 - 386 | - |
dc.citation.title | Gastric Cancer | - |
dc.citation.volume | 27 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 375 | - |
dc.citation.endPage | 386 | - |
dc.type.docType | Article | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | SELECTIVE INHIBITOR | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | APATINIB | - |
dc.subject.keywordAuthor | Stomach neoplasms | - |
dc.subject.keywordAuthor | Tyrosine protein kinase inhibitors | - |
dc.subject.keywordAuthor | Vascular endothelial growth factor receptor-2 | - |
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