Please use this identifier to cite or link to this item: http://ahro.austin.org.au/austinjspui/handle/1/12645
Title: EVERSUN: a phase 2 trial of alternating sunitinib and everolimus as first-line therapy for advanced renal cell carcinoma.
Authors: Davis, Ian D;Long, A;Yip, S;Espinoza, D;Thompson, J F;Kichenadasse, G;Harrison, M;Lowenthal, R M;Pavlakis, N;Azad, Arun A;Kannourakis, G;Steer, C;Goldstein, David B;Shapiro, J;Harvie, R;Jovanovic, L;Hudson, A L;Nelson, C C;Stockler, M R;Martin, A
Affiliation: Monash University Eastern Health Clinical School, Melbourne ANZUP Cancer Trials Group, Sydney ian.davis@monash.edu.
ANZUP Cancer Trials Group, Sydney NHMRC Clinical Trials Centre, University of Sydney, Sydney Sydney Catalyst Translational Cancer Research Centre, University of Sydney, Sydney.
ANZUP Cancer Trials Group, Sydney NHMRC Clinical Trials Centre, University of Sydney, Sydney.
ANZUP Cancer Trials Group, Sydney Flinders Centre for Innovation in Cancer, Flinders University, Adelaide.
ANZUP Cancer Trials Group, Sydney Chris O'Brien Lifehouse, Royal Prince Alfred Hospital, Sydney Liverpool Hospital, Liverpool.
ANZUP Cancer Trials Group, Sydney Royal Hobart Hospital and Menzies Institute for Medical Research, University of Tasmania, Hobart.
ANZUP Cancer Trials Group, Sydney Royal North Shore Hospital, University of Sydney, Sydney.
ANZUP Cancer Trials Group, Sydney Austin Health, Melbourne.
ANZUP Cancer Trials Group, Sydney Ballarat Oncology & Haematology Services and Fiona Elsey Cancer Research Institute, Ballarat Federation University, Ballarat.
ANZUP Cancer Trials Group, Sydney Border Medical Oncology, Wodonga.
ANZUP Cancer Trials Group, Sydney Prince of Wales Clinical School and Prince of Wales Hospital, University of New South Wales, Sydney.
ANZUP Cancer Trials Group, Sydney Cabrini Hospital, Melbourne.
ANZUP Cancer Trials Group, Sydney Bill Walsh Translational Cancer Research Laboratories, Kolling Institute, Sydney.
Australian Prostate Cancer Research Centre-Queensland, Institute of Health and Biomedical Innovation, Queensland University of Technology, Princess Alexandra Hospital, Translational Research Institute, Brisbane.
Bill Walsh Translational Cancer Research Laboratories, Kolling Institute, Sydney.
ANZUP Cancer Trials Group, Sydney Australian Prostate Cancer Research Centre-Queensland, Institute of Health and Biomedical Innovation, Queensland University of Technology, Princess Alexandra Hospital, Translational Research Institute, Brisbane.
ANZUP Cancer Trials Group, Sydney NHMRC Clinical Trials Centre, University of Sydney, Sydney Sydney Catalyst Translational Cancer Research Centre, University of Sydney, Sydney Chris O'Brien Lifehouse, Royal Prince Alfred Hospital, Sydney Concord Cancer Centre, Concord, Australia.
Issue Date: 20-Feb-2015
Citation: Annals of Oncology : Official Journal of the European Society For Medical Oncology / Esmo 2015; 26(6): 1118-23
Abstract: We hypothesised that alternating inhibitors of the vascular endothelial growth factor receptor (VEGFR) and mammalian target of rapamycin pathways would delay the development of resistance in advanced renal cell carcinoma (aRCC).A single-arm, two-stage, multicentre, phase 2 trial to determine the activity, feasibility, and safety of 12-week cycles of sunitinib 50 mg daily 4 weeks on / 2 weeks off, alternating with everolimus 10 mg daily for 5 weeks on / 1 week off, until disease progression or prohibitive toxicity in favourable or intermediate-risk aRCC. The primary end point was proportion alive and progression-free at 6 months (PFS6m). The secondary end points were feasibility, tumour response, overall survival (OS), and adverse events (AEs). The correlative objective was to assess biomarkers and correlate with clinical outcome.We recruited 55 eligible participants from September 2010 to August 2012. Demographics: mean age 61, 71% male, favourable risk 16%, intermediate risk 84%. Cycle 2 commenced within 14 weeks for 80% of participants; 64% received ≥22 weeks of alternating therapy; 78% received ≥22 weeks of any treatment. PFS6m was 29/55 (53%; 95% confidence interval [CI] 40% to 66%). Tumour response rate was 7/55 (13%; 95% CI 4% to 22%, all partial responses). After median follow-up of 20 months, 47 of 55 (86%) had progressed with a median progression-free survival of 8 months (95% CI 5-10), and 30 of 55 (55%) had died with a median OS of 17 months (95% CI 12-undefined). AEs were consistent with those expected for each single agent. No convincing prognostic biomarkers were identified.The EVERSUN regimen was feasible and safe, but its activity did not meet pre-specified values to warrant further research. This supports the current approach of continuing anti-VEGF therapy until progression or prohibitive toxicity before changing treatment.ACTRN12609000643279.
Internal ID Number: 25701452
URI: http://ahro.austin.org.au/austinjspui/handle/1/12645
DOI: 10.1093/annonc/mdv078
URL: http://www.ncbi.nlm.nih.gov/pubmed/25701452
Type: Journal Article
Subjects: angiogenesis inhibitors
clinical trial
everolimus
renal cell carcinoma
sunitinib
vascular endothelial growth factor receptors
Appears in Collections:Journal articles

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