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Proffered Paper session - Genitourinary tumours, non-prostate 2

LBA28 - STAR: A randomised multi-stage phase II/III trial of standard first-line therapy (sunitinib or pazopanib) comparing temporary cessation with allowing continuation, in the treatment of locally advanced and/or metastatic renal Cancer (RCC)

Date

19 Sep 2021

Session

Proffered Paper session - Genitourinary tumours, non-prostate 2

Presenters

Janet Brown

Citation

Annals of Oncology (2021) 32 (suppl_5): S1283-S1346. 10.1016/annonc/annonc741

Authors

J.E. Brown1, K. Royle2, C. Ralph3, D. Meads4, A. Martin4, H. Howard5, C. Linsley2, J. Swain2, T.B. Powles6, R. Jones7, T. Eisen8, A. Maraveyas9, R. Griffiths10, O. Din11, V. Goh12, T. Wah13, P. Selby14, J. Hewison15, J. Brown16, F. Collinson17

Author affiliations

  • 1 Oncology And Metabolism, University of Sheffield, LS17 9LY - Leeds/GB
  • 2 Clinical Trials Research Unit, University of Leeds, Leeds/GB
  • 3 Oncology Department, St James's University Hospitalal, University of Leeds, Leeds/GB
  • 4 Academic Unit Of Health Economics, University of Leeds, Leeds/GB
  • 5 Clinical Trials Research Unit, University of Leeds, LS29JT - Leeds/GB
  • 6 Oncology Department, St. Bartholomew's Hospital - Barts Health NHS Trust, EC1A 7BE - London/GB
  • 7 Institute Of Cancer Sciences, BWSCC - Beatson West of Scotland Cancer Centre - NHS Greater Glasgow and Clyde, G12 0YN - Glasgow/GB
  • 8 Oncology, University of Cambridge, Cambridge/GB
  • 9 Medical Oncology, Castle Hill Hospital, HU16 5JQ - Hull/GB
  • 10 Medical Oncology, Clatterbridge Cancer Centre, CH63 4JY - Liverpool/GB
  • 11 Oncology, Sheffielkd Teaching Hospitals NHS Foundation Trust, Sheffield/GB
  • 12 Department Of Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King's College London, SE1 7EU - London/GB
  • 13 Radiology, Leeds Teaching Hospitals NHS Trust, Leeds/GB
  • 14 Oncology, University of Leeds, Leeds/GB
  • 15 Leeds Institute Of Health Sciences, University of Leeds, LS2 9JT - Leeds/GB
  • 16 Leeds Institute Of Clinical Trials Research, University of Leeds, LS2 9JT - Leeds/GB
  • 17 Oncology Department, St. James's University Hospital - Leeds Teaching Hospitals NHS Trust, LS9 7TF - Leeds/GB
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Resources

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Abstract LBA28

Background

There is increasing interest in using treatment breaks in oncology, to reduce toxicity without compromising efficacy. STAR was designed to determine if a tyrosine kinase inhibitor drug-free interval strategy (DFIS) was non-inferior to a conventional continuation strategy (CCS) in the first line treatment of advanced RCC. Outcomes were overall survival (OS) and Quality Adjusted Life Years (QALYs).

Methods

STAR is a UK Phase II/III multicentre, randomised controlled trial. Patients were randomised (1:1) to DFIS or CCS. After 24 weeks of sunitinib/pazopanib treatment, DFIS patients took a treatment break, until disease progression, with additional breaks dependent on disease response and patient/clinician choice. Trial strategy continued until intolerance, progression on treatment or death. Both co-primary endpoints (OS and QALYs) must demonstrate pre-defined non-inferiority (NI) (≤7.5% OS; ≤ 10% QALYs) in intention-to-treat (ITT) and per-protocol (PP) analyses for NI to be concluded. An economic evaluation was also conducted.

Results

920 patients were randomised (461 CCS vs 459 DFIS) from 13/01/12 to 12/09/17. 488 (53.0%) patients (240 (52.1%) vs 248 (54.0%)) continued on trial post-week 24. Median treatment break length was 87 days. ITT and PP analyses included 461 vs 458 and 453 vs 418 patients respectively. There was a difference in conclusion in the OS analysis precluding confirmation of NI (HR (95%CI) ITT: 0.97 (0.83, 1.12); PP: 0.94 (0.80, 1.09) NI Margin: 95%CI ≥0.812). However consistent NI conclusions were found for QALYs (Marginal Effect (95% CI) ITT: -0.05 (-0.15, 0.05); PP: 0.04 (-0.14, 0.21) NI Margin: 95%CI ≥-0.156). At two years, DFIS was associated with cost savings (£6,954 per-participant).

Conclusions

Although OS just fell short of overall defined NI using this rigorous approach, probably due to fewer than expected events, QALY NI was demonstrated and a DFIS was seen to be acceptable to patients and clinicians. DFIS also appeared to be highly cost-effective compared to CCS.

Clinical trial identification

EudraCT 2011-001098-16.

Editorial acknowledgement

Legal entity responsible for the study

University of Leeds.

Funding

UK National Institute for Health Research (NIHR).

Disclosure

C. Ralph: Financial Interests, Personal, Advisory Board, Travel, accommodation, expenses: Bristol, Myers, Squibb; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Viralytics; Financial Interests, Personal, Other, Travel, accommodation, expenses: Astellas Pharma; Financial Interests, Personal, Other, Travel, accommodation, expenses: GlaxoSmithKlyne; Financial Interests, Personal, Other, Travel, accommodation, expenses: Ipsen; Financial Interests, Personal, Other, Travel, accommodation, expenses: Jannsen; Financial Interests, Personal, Other, Travel, accommodation, expenses: Roche. T.B. Powles: Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Pfizer; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: MSD; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Merck; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Serano; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Roche; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Eisai; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Ipsen; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Seattle Genetics; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: Astellas; Financial Interests, Personal and Institutional, Advisory Board, Academic Funding: AstraZeneca. R. Jones: Financial Interests, Personal and Institutional, Other, Research funding, consultancy: Novartis; Financial Interests, Personal and Institutional, Invited Speaker, Research funding, consultancy, speaker: Pfizer. T. Eisen: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche; Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares, Research Support: AstraZeneca; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Pfizer. V. Goh: Financial Interests, Institutional, Other, Research Agreement: Siemens Healthcare. All other authors have declared no conflicts of interest.

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