Planned Interim Analysis Results from a Prospective Multicenter Single-Arm Cohort Study of Patients Receiving Endocrine Therapy but Not Radiotherapy after Breast-Conserving Surgery for Early-Stage Breast Cancer with Favorable Biologic Features

Jagsi, Reshma; Griffith, Kent A.; Harris, Eleanor; Wright, Jean L.; Recht, Abram; Taghian, Alphonse G.; Lee, L.; Moran, Meena S.; Thomas, Tarita O.; Johnstone, Candice; Rahimi, Asal; Freedman, Gary M.; Muzaffar, Mahvish; Haffty, Bruce G.; Horst, K.C.; Powell, Simon N.; Sharp, Jon; Sabel, Michael S.; Schott, Anne F.; El‐Tamer, Mahmoud

doi:10.1016/j.ijrobp.2019.06.392

Cited by 6 publications

(4 citation statements)

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“…9 For patients younger than 65 years of age, ongoing studies demonstrate equipoise with regard to those who have biomarker-low disease that otherwise fits the previously mentioned clinicopathologic parameters, but no mature data exist in this domain. [10][11][12] Delaying RT Uncertainty surrounding the current public health emergency has made predictions about future resource allocation particularly challenging. Estimates of population-level relief range from weeks to over 1 year.…”

Section: Dcismentioning

confidence: 99%

Breast Radiation Therapy Under COVID-19 Pandemic Resource Constraints—Approaches to Defer or Shorten Treatment From a Comprehensive Cancer Center in the United States

Braunstein

Gillespie

Hong

et al. 2020

Advances in Radiation Oncology

109

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Breast radiation therapy accounts for a significant proportion of patient volume in contemporary radiation oncology practice. In the setting of anticipated resource constraints and widespread community infection with SARS-CoV-2 during the COVID-19 pandemic, measures for balancing both infectious and oncologic risk among patients and providers must be carefully considered. Here, we present evidence-based guidelines for omitting or abbreviating breast cancer radiation therapy, where appropriate, in an effort to mitigate risk to patients and optimize resource utilization. Methods and Materials: Multidisciplinary breast cancer experts at a high-volume comprehensive cancer center convened contingency planning meetings over the early days of the COVID-19 pandemic to review the relevant literature and establish recommendations for the application of hypofractionated and abbreviated breast radiation regimens. Results: Substantial evidence exists to support omitting radiation among certain favorable risk subgroups of patients with breast cancer and for abbreviating or accelerating regimens among others. For those who require either whole-breast or postmastectomy radiation, with or without coverage of the regional lymph nodes, a growing body of literature supports various hypofractionated approaches that appear safe and effective. Conclusions: In the setting of a public health emergency with the potential to strain critical healthcare resources and place patients at risk of infection, the parsimonious application of breast radiation therapy may alleviate a significant clinical burden without compromising long-term oncologic outcomes. The judicious and personalized use of immature study data may be warranted in the setting of a competing mortality risk from this widespread pandemic.

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Section: Dcismentioning

confidence: 99%

Breast Radiation Therapy Under COVID-19 Pandemic Resource Constraints—Approaches to Defer or Shorten Treatment From a Comprehensive Cancer Center in the United States

Braunstein

Gillespie

Hong

et al. 2020

Advances in Radiation Oncology

109

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“…A number of complementary studies investigating radiotherapy omission have been initiated since the opening of IDEA (Table 3). After reassuring early results from a preplanned interim analysis of this trial, 16 the DEBRA trial (NRG BR007, ClinicalTrials.gov identifier: NCT04852887) opened, using similar eligibility criteria to those in IDEA. Patients are randomly allocated to receive ET with or without breast radiotherapy.…”

Section: Discussionmentioning

confidence: 99%

“…An interim analysis was conducted at 400 person-years to ensure the 5-year rate was not predicted to be ≥6% with high probability, given an a priori expectation of a rate of 4%. 16 A valid 5-year assessment was defined as a clinical assessment within 4 months before the 5-year anniversary or later. Follow-up time was calculated from the date of BCS until first recurrence or to last clinical follow-up.…”

Section: Methodsmentioning

confidence: 99%

“…Genomic assays initially developed for determining overall prognosis and predicting the impact of systemic therapies may be useful for identifying patients at low risk for locoregional recurrence both in patients receiving radiotherapy and those treated with surgery alone. Given evidence suggesting that patients with low Oncotype DX recurrence scores have low risks of locoregional recurrence, 16 we designed a single-arm prospective trial to explore whether younger postmenopausal patients could also be successfully treated without radiotherapy using patient selection based on that commonly used genomic assay in addition to classic clinicopathologic selection factors.…”

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confidence: 99%

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

Jagsi,

Griffith,

Harris

et al. 2024

JCO

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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.

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Breast-conserving Surgery Without Radiation Therapy for Invasive Cancer

Montagna

Morrow

2021

Clinical Breast Cancer

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Planned Interim Analysis Results from a Prospective Multicenter Single-Arm Cohort Study of Patients Receiving Endocrine Therapy but Not Radiotherapy after Breast-Conserving Surgery for Early-Stage Breast Cancer with Favorable Biologic Features

Cited by 6 publications

References 0 publications

Breast Radiation Therapy Under COVID-19 Pandemic Resource Constraints—Approaches to Defer or Shorten Treatment From a Comprehensive Cancer Center in the United States

Breast Radiation Therapy Under COVID-19 Pandemic Resource Constraints—Approaches to Defer or Shorten Treatment From a Comprehensive Cancer Center in the United States

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

Breast-conserving Surgery Without Radiation Therapy for Invasive Cancer

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