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. 2023 Dec:72:103582.
doi: 10.1016/j.breast.2023.103582. Epub 2023 Sep 17.

Expert UK consensus on the definition of high risk of recurrence in HER2-negative early breast cancer: A modified Delphi panel

E R Copson  1 , J E Abraham  2 , J P Braybrooke  3 , D Cameron  4 , S A McIntosh  5 , C O Michie  4 , A F C Okines  6 , C Palmieri  7 , F Raja  8 , R Roylance  9 , S Spensley  10 ; Delphi panellists
Affiliations

Expert UK consensus on the definition of high risk of recurrence in HER2-negative early breast cancer: A modified Delphi panel

E R Copson et al. Breast. 2023 Dec.

Abstract

Background: There is currently no standardised definition for patients at high risk of recurrence of human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC; stages 1-3) after surgery. This modified Delphi panel aimed to establish expert UK consensus on this definition, separately considering hormone receptor (HR)-positive and triple-negative (TN) patients.

Methods: Over three consecutive rounds, results were collected from 29, 24 and 22 UK senior breast cancer oncologists and surgeons, respectively. The first round aimed to determine key risk factors in each patient subgroup; subsequent rounds aimed to establish appropriate risk thresholds. Consensus was pre-defined as ≥70% of respondents.

Results: Expert consensus was achieved on need to assess age, tumour size, tumour grade, number of positive lymph nodes, inflammatory breast cancer and risk prediction tools in all HER2-negative patients. There was additional agreement on use of tumour profiling tests and biomarkers in HR-positive patients, and pathologic complete response (pCR) status in TN patients. Thresholds for high recurrence risk were subsequently agreed. In HR-positive patients, these included age <35 years, tumour size >5 cm (as independent risk factors); tumour grade 3 (independently and combined with other high-risk factors); number of positive nodes ≥4 (independently) and ≥1 (combined). For TN patients, the following thresholds reached consensus, both independently and in combination with other factors: tumour size >2 cm, tumour grade 3, number of positive nodes ≥1.

Conclusions: The results may be a valuable reference point to guide recurrence risk assessment and decision-making after surgery in the HER2-negative eBC population.

Keywords: Delphi panel; Early breast cancer; High risk; Recurrence.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: ERC: Consultant: AstraZeneca, Lilly, Novartis, Pfizer, Roche, Sanofi; Speaker fees: Novartis; Research grant: AstraZeneca; Educational grant: Daiichi Sankyo; Provision of research equipment: seca; Congress support: Novartis, Roche. JEA: Research grant: AstraZeneca; Speaker fees: Eisai, Pfizer. JPB: Nothing to disclose. DC: Consultant: AstraZeneca, Exact Sciences, Lilly, Novartis, Roche; Research funding: Exact Sciences, Novartis, Roche. SAMcI: Consultant: Lilly, MSD, Roche; Fees for non-CME services: BD; Congress support: Lilly, Roche; Research funding: Novartis. COM: Nothing to disclose. AFCO: Research funding: Pfizer, Roche; Consultant: AstraZeneca, Pfizer, Roche, Seagen; Speaker fees: AstraZeneca, Gilead, Lilly, Pfizer, Seagen; Congress support: AstraZeneca; Lilly. CP: Consultant: AstraZeneca, Daiichi Sankyo, Ellipses Pharma, Exact Sciences, Gilead, Lilly, Novartis, Pfizer, Seagen; Research funding: Daiichi Sankyo, Exact Sciences, Pfizer, Seagen; Congress support: Gilead, Roche. FR: Consultant: AstraZeneca, Daiichi Sankyo, Gilead, Lilly, MSD, Novartis, Pfizer, Roche; Congress support: AstraZeneca, MSD, Novartis, Roche. RR: Consultant: AstraZeneca, Daiichi Sankyo, G1 Therapeutics, IQVIA, Lilly, Pfizer; Congress support: BMS, Daiichi Sankyo, Roche; Grants to institution: NIHR. SS: Consultant: Lilly, Pfizer.

Figures

Fig. 1
Fig. 1
Delphi panel study design. Footnote:a From an initial pool of 79 UK-based clinicians contacted, 45 accepted the invitation to participate in the Delphi panel. Of the 29 respondents in Round 1, 22 practise in England, 4 in Scotland, 2 in Wales, and 1 in Northern Ireland, with a consistent split between oncologists and surgeons of roughly 5:1 across all rounds. The breakdown by NHS region among the English clinicians was as follows: 5 respondents practise in London, 5 in the South East, 3 in the East of England, 3 in the North West, 3 in the South West, 2 in the Midlands, and 1 in the North East and Yorkshire.
Fig. 2
Fig. 2
Responses to criterion-based statements: risk factors (Rounds 1–2) Footnote: Percentage agreement was calculated as a proportion of the number of respondents to a given question, i.e. excluding instances of ‘No response’. Abbreviations:BRCA1/2: breast cancer susceptibility gene 1/2; pCR: pathologic complete response.
Fig. 3
Fig. 3
Responses to criterion-based statements: patient populations (Round 1) Footnote: Percentage agreement was calculated as a proportion of the number of respondents to a given question, i.e. excluding instances of ‘No response’. Abbreviations: HER2: human epidermal growth factor receptor 2; HR: hormone receptor; pCR: pathologic complete response; TN: triple-negative.
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