dc.contributor.author | Woll, PJ | |
dc.contributor.author | Gaunt, P | |
dc.contributor.author | Gaskell, C | |
dc.contributor.author | Young, R | |
dc.contributor.author | Benson, C | |
dc.contributor.author | Judson, IR | |
dc.contributor.author | Seddon, BM | |
dc.contributor.author | Marples, M | |
dc.contributor.author | Ali, N | |
dc.contributor.author | Strauss, SJ | |
dc.contributor.author | Lee, A | |
dc.contributor.author | Hughes, A | |
dc.contributor.author | Kaur, B | |
dc.contributor.author | Hughes, D | |
dc.contributor.author | Billingham, L | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2024-01-08T11:26:50Z | |
dc.date.available | 2024-01-08T11:26:50Z | |
dc.date.issued | 2023-10-26 | |
dc.identifier | 10.1038/s41416-023-02416-6 | |
dc.identifier.citation | British Journal of Cancer, 2023, 129 (9), pp. 1490 - 1499 | en_US |
dc.identifier.issn | 0007-0920 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/6096 | |
dc.identifier.eissn | 1532-1827 | |
dc.identifier.eissn | 1532-1827 | |
dc.identifier.doi | 10.1038/s41416-023-02416-6 | |
dc.identifier.doi | 10.1038/s41416-023-02416-6 | |
dc.description.abstract | BACKGROUND: Axitinib is an oral vascular endothelial growth factor receptor inhibitor with anti-tumour activity in renal, thyroid, and pancreatic cancer. METHODS: Axi-STS was a pathologically-stratified, non-randomised, open-label, multi-centre, phase II trial of continuous axitinib treatment in patients ≥16 years, performance status ≤2, with pathologically-confirmed advanced/metastatic soft tissue sarcoma (STS). Patients were recruited within four tumour strata, each analysed separately: angiosarcoma, leiomyosarcoma, synovial sarcoma, or other eligible STSs. The primary outcome was progression-free survival at 12 weeks (PFS12). A Simon's two-stage design with activity defined as PFS12 rate of 40% determined a sample size of 33 patients per strata. RESULTS: Between 31-August-2010 and 29-January-2016, 145 patients were recruited: 38 angiosarcoma, 37 leiomyosarcoma, 36 synovial sarcoma, and 34 other subtypes. PFS12 rate for each stratum analysed was 42% (95% lower confidence interval (LCI); 29), 45% (95% LCI; 32), 57% (95% LCI; 42), and 33% (95% LCI; 21), respectively. There were 74 serious adverse events including two treatment-related deaths of pulmonary haemorrhage and gastrointestinal bleeding. Fatigue and hypertension were the most common grade 3 adverse events. CONCLUSIONS: Axitinib showed clinical activity in all STS strata investigated. The adverse event profile was acceptable, supporting further investigation in phase III trials. CLINICAL TRIAL REGISTRATION: ISRCTN 60791336. | |
dc.format | Print-Electronic | |
dc.format.extent | 1490 - 1499 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | SPRINGERNATURE | en_US |
dc.relation.ispartof | British Journal of Cancer | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
dc.subject | Humans | |
dc.subject | Axitinib | |
dc.subject | Leiomyosarcoma | |
dc.subject | Sarcoma, Synovial | |
dc.subject | Hemangiosarcoma | |
dc.subject | Vascular Endothelial Growth Factor A | |
dc.subject | Sarcoma | |
dc.subject | Soft Tissue Neoplasms | |
dc.subject | Angiogenesis Inhibitors | |
dc.subject | Treatment Outcome | |
dc.title | Axitinib in patients with advanced/metastatic soft tissue sarcoma (Axi-STS): an open-label, multicentre, phase II trial in four histological strata. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2023-08-23 | |
dc.date.updated | 2023-12-29T11:25:57Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1038/s41416-023-02416-6 | en_US |
rioxxterms.licenseref.startdate | 2023-10-26 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/37684354 | |
pubs.issue | 9 | |
pubs.organisational-group | ICR | |
pubs.organisational-group | ICR/Primary Group | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1038/s41416-023-02416-6 | |
pubs.volume | 129 | |
icr.researchteam | Sarcoma Clinical Trials | en_US |
dc.contributor.icrauthor | Judson, Ian | |
icr.provenance | Deposited by Prof Ian Judson on 2023-12-29. Deposit type is initial. No. of files: 1. Files: Axitinib in patients with advancedmetastatic soft tissue sarcoma (Axi-STS) an open-label, multicentre, phase II trial in fou.pdf | |