803P - Phase 1 study of selective internal radiation therapy (SIRT) with yttrium-90 (Y-90) resin microspheres in patients (pts) with renal cell carcinoma...

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Paul de Souza
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors P. de Souza1, P. Aslan2, W. Clark3, M. Patel4, J.A. Vass5, D. Cade6, S.J. de Silva7
  • 1Department Of Medical Oncology, Western Sydney University School of Medicine, 2170 - Sydney/AU
  • 2Department Of Urology, Watarah Private Hospital, 2220 - Sydney/AU
  • 3Department Of Radiology, St George Private Hospital, 2217 - Sydney/AU
  • 4Department Of Urology, Westmead Hospital, 2145 - Sydney/AU
  • 5Department Of Urology, Royal North Shore Hospital, 2065 - Sydney/AU
  • 6Medical Affairs, Sirtex Medical Limited, 2060 - Sydney/AU
  • 7Department Of Radiology, The Sutherland Hospital, 2229 - Sydney/AU

Abstract

Background

Some patients with RCC are unsuitable for nephrectomy. SIRT is used for unresectable liver cancers, and has properties that make it potentially useful for primary RCC. RESIRT is the first-in-human study to evaluate safety and feasibility of SIRT for primary RCC.

Methods

Pts not amenable for or who declined conventional therapy were eligible; metastases were permitted. A single transfemoral microcatheter administration of Y-90 resin microspheres (SIR-Spheres; Sirtex, Australia) was delivered superselectively via the renal artery to the tumour at intended radiation doses of 75, 100, 150, 200, 300 Gy and a final cohort with a procedural endpoint of imminent stasis, in a dose-escalation design. Post-SIRT follow-up was 12 months. The primary endpoint was safety and toxicity at 30 days post-SIRT. Secondary endpoints included tumour response (RECIST v1.1).

Results

The study enrolled 21 pts with RCC, mean age 74.9 years and WHO performance status of 0 (81%) or 1 (19%). Six (29%) pts had metastatic RCC, 7 (33%) had previously undergone total nephrectomy of the contralateral kidney, 1 (5%) received prior chemotherapy, 1 (5%) progressed after cryotherapy to the target organ and 3 (14%) received other prior therapy. Median follow-up was 11.9 months (95% CI 11.8–12.0). The intended doses were delivered without any dose-limiting toxicity. 15/21 (71%) pts experienced 44 AEs within 30 days post-SIRT. Eight (38%) pts had AEs grade ≥3, all unrelated to SIRT; 8 pts (38%) had 12 AEs that were related to SIRT (all grade 1–2, no SAEs), of which 1 occurred pre SIRT. Treatment-related AEs were fatigue/tiredness, pain, hypertension, lack of appetite, ‘heaviness’, bruised groin and hypomagnesemia. 15 SAEs were reported in 8 (38%) pts; 2 within 30 days post-SIRT (shortness of breath, prolonged hospitalisation). Best overall tumour responses were partial response 1/19 (5.3%), stable disease 17/19 (89.5%) and progressive disease 1/19 (5.3%).

Conclusions

This pilot study demonstrates good tolerability of SIRT at all dose levels including imminent stasis in treating primary tumours in RCC pts otherwise unsuitable for conventional therapy.

Clinical trial identification

Australian New Zealand Trials Registry: Trial ID ACTRN12610000690055

Legal entity responsible for the study

Sirtex Technology Pty Ltd.

Funding

Sirtex Medical Limited

Disclosure

P. de Souza: Australian Advisory Boards until 2014, nil afterwards: GSK, Pfizer, Janssen, Astellas. D. Cade: Full time employee of Sirtex Medical Limited Receives salary from Sirtex Medical Limited S.J. de Silva: Proctor for Sirtex (unpaid). All other authors have declared no conflicts of interest.