Validation of a breast cancer assay for radiotherapy omission: an individual participant data meta-analysis.
Autor: | Karlsson P; Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Sahlgrenska Comprehensive Cancer Center, Sahlgrenska University Hospital, Gothenburg, Sweden., Fyles A; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada., Chang SL; Exact Sciences Corporation, Madison, WI, USA., Arrick B; Exact Sciences Corporation, Madison, WI, USA., Baehner FL; Exact Sciences Corporation, Madison, WI, USA., Malmström P; Division of Oncology, Department of Clinical Sciences, Lund University, Lund, Sweden.; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden., Fernö M; Division of Oncology, Department of Clinical Sciences, Lund University, Lund, Sweden., Holmberg E; Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden., Sjöström M; Division of Oncology, Department of Clinical Sciences, Lund University, Lund, Sweden.; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA., Liu FF; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada., Cameron DA; Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.; Usher Institute, University of Edinburgh, Edinburgh, UK., Williams LJ; Usher Institute, University of Edinburgh, Edinburgh, UK., Bartlett JM; Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK., Dunlop J; Public Health Scotland, Edinburgh, UK., Caldwell J; Public Health Scotland, Edinburgh, UK., Loane JF; Queen Elizabeth University Hospital, Glasgow, Scotland., Mallon E; Queen Elizabeth University Hospital, Glasgow, Scotland., Piper T; Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK., Kunkler I; Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK., Feng FY; Department of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA., Speers CW; Department of Radiation Oncology, Case Comprehensive Cancer Center, OH, USA., Pierce LJ; Department of Radiation Oncology, Rogel Comprehensive Cancer Center, University of Michigan, Ann Arbor, MI, USA., Bennett JP; Exact Sciences Corporation, Madison, WI, USA., Taylor KJ; Cancer Research UK Scotland Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK. |
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Jazyk: | angličtina |
Zdroj: | Journal of the National Cancer Institute [J Natl Cancer Inst] 2024 Oct 18. Date of Electronic Publication: 2024 Oct 18. |
DOI: | 10.1093/jnci/djae262 |
Abstrakt: | Background: There are currently no molecular tests to identify individual breast cancers where radiotherapy (RT) offers no benefit. Profile for the Omission of Local Adjuvant Radiotherapy (POLAR) is a 16-gene molecular signature developed to identify low risk cancers where RT will not further reduce recurrence rates. Methods: An individual participant data meta-analysis was performed in 623 cases of node-negative ER+/HER2-negative early breast cancer enrolled in three RT randomized trials for whom primary tumor material was available for analysis. A Cox proportional hazards model on time to locoregional recurrence (LRR) was used to test the interaction between POLAR score and RT. Results: 429 (69%) patients' tumors had a high POLAR score and 194 (31%) had a low score. Patients with high POLAR score had, in the absence of RT, a 10-year cumulative incidence of LRR: 20% (15%-26%) vs 5% (2%-11%) for those with a low score. Patients with a high POLAR score had a large benefit from RT (hazard ratio [HR] for RT vs no RT: 0.37 [0.23-0.60], p < .001). In contrast, there was no evidence of benefit from RT for patients with a low POLAR score (HR: 0.92 [0.42-2.02], p = .832). The test for interaction between RT and POLAR was statistically significant (p = .022). Conclusions: POLAR is not only prognostic for locoregional recurrence but also predictive of benefit from radiotherapy in selected patients. Patients ≥ 50 years with ER+/HER2-negative disease and a low POLAR score could consider omitting adjuvant RT. Further validation in contemporary clinical cohorts is required. (© The Author(s) 2024. Published by Oxford University Press.) |
Databáze: | MEDLINE |
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