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• W2897040606 abstract "The IMPORT LOW trial demonstrated that 40 Gy in 15 daily fractions to the partial breast (hypofractionated-partial breast irradiation [HF-PBI]) yielded optimal local control and cosmetic outcomes for women 50 and older with invasive breast cancer and negative margins (≥2mm) following segmental mastectomy. To build upon these findings, we designed a prospective, single-arm trial to shorten the treatment course to 35 Gy in 10 daily fractions to the partial breast and extend entry criteria to include patients with DCIS and/or close (<2mm) surgical margins. Herein, we report the planned early toxicity analysis for the first 30 patients. We enrolled patients age 50 and older with DCIS or ER+, node-negative invasive cancer measuring ≤ 3 cm in size and treated with segmental mastectomy. Radiation consisted of 35 Gy in 10 daily fractions to the tumor bed plus margin and could be delivered with mini-tangents, three-dimensional conformal radiation, or intensity modulated therapy. A boost of 9 Gy in 3 fractions was delivered to patients with close (<2mm) surgical margins. The primary endpoint is the proportion of patients with NCI CTCAE v.4 grade 2 or higher toxicity occurring during radiation through the 6 month post-radiation follow up visit. Study forms assessing toxicity were completed at the end of radiation treatment and at 3 weeks and 6 months after radiation. In a prior trial run by our institution, the risk of this outcome in patients treated with hypofractionated whole breast irradiation was 60%. The first 30 patients were enrolled between March 2017 to July 2017. Median age was 62 years. The primary outcome event rate was 23% (7/30). There was only one Grade 3 toxicity, a breast infection at the 3 week follow-up visit that subsequently resolved. Grade 2+ toxicities during radiation were dermatitis (n=1), breast infection (n=1), and breast pain (n=1). Grade 2+ toxicities through 6 months post-radiation were breast atrophy (n=4), fibrosis (n=2), skin induration (n=1), and fatigue (n=1). Early outcomes after HF-PBI are favorable with regard to toxicity within 6 months of radiation treatment as compared to toxicity with whole breast irradiation. Continued follow-up will assess secondary outcomes including cosmetic stability and disease-specific outcomes." @default.
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• W2897040606 date "2018-11-01" @default.
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• W2897040606 title "A Phase 2 Study of Hypofractionated Partial Breast Irradiation (HF-PBI) in Women with Early Stage Breast Cancer" @default.
• W2897040606 doi "https://doi.org/10.1016/j.ijrobp.2018.07.1611" @default.
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