| Title: |
Temporary treatment cessation compared with continuation of tyrosine kinase inhibitors for adults with renal cancer: the STAR non-inferiority RCT |
| Authors: |
Collinson, F.; Royle, K.-L.; Swain, J.; Ralph, C.; Maraveyas, A.; Eisen, T.; Nathan, P.; Jones, R.; Meads, D.; Min Wah, T.; Martin, A.; Bestall, J.; Kelly-Morland, C.; Linsley, C.; Oughton, J.; Chan, K.; Theodoulou, E.; Arias-Pinilla, G.; Kwan, A.; Daverede, L.; Handforth, C.; Trainor, S.; Salawu, A.; McCabe, C.; Goh, V.; Buckley, D.; Hewison, J.; Gregory, W.; Selby, P.; Brown, J. |
| Publisher Information: |
National Institute for Health and Care Research |
| Publication Year: |
2024 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
Background There is interest in using treatment breaks in oncology, to reduce toxicity without compromising efficacy. Trial design A Phase II/III multicentre, open-label, parallel-group, randomised controlled non-inferiority trial assessing treatment breaks in patients with renal cell carcinoma. Methods Participants Patients with locally advanced or metastatic renal cell carcinoma, starting tyrosine kinase inhibitor as first-line treatment at United Kingdom National Health Service hospitals. Interventions At trial entry, patients were randomised (1 : 1) to a drug-free interval strategy or a conventional continuation strategy. After 24 weeks of treatment with sunitinib/pazopanib, drug-free interval strategy patients took up a treatment break until disease progression with additional breaks dependent on disease response and patient choice. Conventional continuation strategy patients continued on treatment. Both trial strategies continued until treatment intolerance, disease progression on treatment, withdrawal or death. Objective To determine if a drug-free interval strategy is non-inferior to a conventional continuation strategy in terms of the co-primary outcomes of overall survival and quality-adjusted life-years. Co-primary outcomes For non-inferiority to be concluded, a margin of ≤ 7.5% in overall survival and ≤ 10% in quality-adjusted life-years was required in both intention-to-treat and per-protocol analyses. This equated to the 95% confidence interval of the estimates being above 0.812 and −0.156, respectively. Quality-adjusted life-years were calculated using the utility index of the EuroQol-5 Dimensions questionnaire. Results Nine hundred and twenty patients were randomised (461 conventional continuation strategy vs. 459 drug-free interval strategy) from 13 January 2012 to 12 September 2017. Trial treatment and follow-up stopped on 31 December 2020. Four hundred and eighty-eight (53.0%) patients [240 (52.1%) vs. 248 (54.0%)] continued on trial post week 24. The median treatment-break length was 87 days. ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
1366-5278 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/218237/1/3045873.pdf; Collinson, F. orcid.org/0000-0001-6964-6406 , Royle, K.-L. orcid.org/0000-0003-0225-1199 , Swain, J. orcid.org/0000-0003-2729-3029 et al. (28 more authors) (2024) Temporary treatment cessation compared with continuation of tyrosine kinase inhibitors for adults with renal cancer: the STAR non-inferiority RCT. Health Technology Assessment, 28 (45). ISSN: 1366-5278 |
| DOI: |
10.3310/jwtr4127 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/218237/; https://eprints.whiterose.ac.uk/id/eprint/218237/1/3045873.pdf; https://doi.org/10.3310/jwtr4127 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.ECEFF313 |
| Database: |
BASE |