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. 2024 Feb 1;42(4):390-398.
doi: 10.1200/JCO.23.02270. Epub 2023 Dec 7.

Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA

Reshma Jagsi  1   2 , Kent A Griffith  2 , Eleanor E Harris  3 , Jean L Wright  4 , Abram Recht  5 , Alphonse G Taghian  6 , Lucille Lee  7 , Meena S Moran  8 , William Small Jr  9 , Candice Johnstone  10 , Asal Rahimi  11 , Gary Freedman  12 , Mahvish Muzaffar  13 , Bruce Haffty  14 , Kathleen Horst  15 , Simon N Powell  16 , Jody Sharp  2 , Michael Sabel  2 , Anne Schott  2 , Mahmoud El-Tamer  16
Affiliations

Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA

Reshma Jagsi et al. J Clin Oncol. .

Abstract

Purpose: Multiple studies have shown a low risk of ipsilateral breast events (IBEs) or other recurrences for selected patients age 65-70 years or older with stage I breast cancers treated with breast-conserving surgery (BCS) and endocrine therapy (ET) without adjuvant radiotherapy. We sought to evaluate whether younger postmenopausal patients could also be successfully treated without radiation therapy, adding a genomic assay to classic selection factors.

Methods: Postmenopausal patients age 50-69 years with pT1N0 unifocal invasive breast cancer with margins ≥2 mm after BCS whose tumors were estrogen receptor-positive, progesterone receptor-positive, and human epidermal growth factor receptor 2-negative with Oncotype DX 21-gene recurrence score ≤18 were prospectively enrolled in a single-arm trial of radiotherapy omission if they consented to take at least 5 years of ET. The primary end point was the rate of locoregional recurrence 5 years after BCS.

Results: Between June 2015 and October 2018, 200 eligible patients were enrolled. Among the 186 patients with clinical follow-up of at least 56 months, overall and breast cancer-specific survival rates at 5 years were both 100%. The 5-year freedom from any recurrence was 99% (95% CI, 96 to 100). Crude rates of IBEs for the entire follow-up period for patients age 50-59 years and age 60-69 years were 3.3% (2/60) and 3.6% (5/140), respectively; crude rates of overall recurrence were 5.0% (3/60) and 3.6% (5/140), respectively.

Conclusion: This trial achieved a very low risk of recurrence using a genomic assay in combination with classic clinical and biologic features for treatment selection, including postmenopausal patients younger than 60 years. Long-term follow-up of this trial and others will help determine whether the option of avoiding initial radiotherapy can be offered to a broader group of women than current guidelines recommend.

Trial registration: ClinicalTrials.gov NCT02400190.

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Figures

Figure 1:
Figure 1:
Freedom from recurrence in relation to age cohort.
See this image and copyright information in PMC

References

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