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A Phase II study of neoadjuvant axitinib for reducing the extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion (NAXIVA).

Authors :
Stewart GD
Welsh SJ
Ursprung S
Gallagher FA
Jones JO
Shields J
Smith CG
Mitchell TJ
Warren AY
Bex A
Boleti E
Carruthers J
Eisen T
Fife K
Hamid A
Laird A
Leung S
Malik J
Mendichovszky IA
Mumtaz F
Oades G
Priest AN
Riddick ACP
Venugopal B
Welsh M
Riddle K
Hopcroft LEM
Jones RJ
Source :
British journal of cancer [Br J Cancer] 2022 Oct; Vol. 127 (6), pp. 1051-1060. Date of Electronic Publication: 2022 Jun 23.
Publication Year :
2022

Abstract

Background: Surgery for renal cell carcinoma (RCC) with venous tumour thrombus (VTT) extension into the renal vein (RV) and/or inferior vena cava (IVC) has high peri-surgical morbidity/mortality. NAXIVA assessed the response of VTT to axitinib, a potent tyrosine kinase inhibitor.<br />Methods: NAXIVA was a single-arm, multi-centre, Phase 2 study. In total, 20 patients with resectable clear cell RCC and VTT received upto 8 weeks of pre-surgical axitinib. The primary endpoint was percentage of evaluable patients with VTT improvement by Mayo level on MRI. Secondary endpoints were percentage change in surgical approach and VTT length, response rate (RECISTv1.1) and surgical morbidity.<br />Results: In all, 35% (7/20) patients with VTT had a reduction in Mayo level with axitinib: 37.5% (6/16) with IVC VTT and 25% (1/4) with RV-only VTT. No patients had an increase in Mayo level. In total, 75% (15/20) of patients had a reduction in VTT length. Overall, 41.2% (7/17) of patients who underwent surgery had less invasive surgery than originally planned. Non-responders exhibited lower baseline microvessel density (CD31), higher Ki67 and exhausted or regulatory T-cell phenotype.<br />Conclusions: NAXIVA provides the first Level II evidence that axitinib downstages VTT in a significant proportion of patients leading to reduction in the extent of surgery.<br />Clinical Trial Registration: NCT03494816.<br /> (© 2022. The Author(s).)

Details

Language :
English
ISSN :
1532-1827
Volume :
127
Issue :
6
Database :
MEDLINE
Journal :
British journal of cancer
Publication Type :
Academic Journal
Accession number :
35739300
Full Text :
https://doi.org/10.1038/s41416-022-01883-7