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These studies suggest that breast-conserving surgery (BCS) alone is non-inferior to BCS plus radiotherapy (RT) for in-breast cancer control and breast preservation in women with stage 1 breast cancer intending appropriate endocrine therapy, while partial breast irradiation and preoperative single-dose radiation therapy may offer alternative benefits.
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Stage 1 breast cancer, characterized by small tumors confined to the breast with no lymph node involvement, represents approximately 50% of newly diagnosed breast cancer cases. The majority of these cases are hormone receptor-positive (HR+), HER2-negative (HER2-), which significantly influences treatment strategies .
Recent research has focused on the potential to de-escalate radiation therapy following breast-conserving surgery (BCS) in patients with stage 1 breast cancer. The DEBRA trials (NRG-BR007) hypothesize that BCS alone, followed by endocrine therapy, may be non-inferior to BCS plus radiation therapy (RT) in terms of in-breast recurrence (IBR) and breast preservation . These trials stratify patients by age, tumor size, and Oncotype DX Recurrence Score (RS), aiming to identify those who might safely omit RT without compromising outcomes .
Another significant study, the NSABP B-39/RTOG 0413 trial, compares whole breast irradiation (WBI) with partial breast irradiation (PBI) in patients with stage 0, 1, or 2 breast cancer. This trial investigates whether PBI, which targets only the tumor bed and can be completed in a shorter timeframe, offers similar outcomes to WBI in terms of in-breast tumor recurrence (IBTR) and overall survival. Preliminary data suggest that PBI may be a viable alternative, potentially reducing treatment burden and improving quality of life.
A 20-year follow-up study on the use of a radiation boost after WBI in early-stage breast cancer patients found that while a radiation boost improved local control, it did not significantly affect long-term overall survival. The study highlighted that the additional radiation dose could be avoided in most patients older than 60 years to reduce the risk of severe fibrosis.
For HR+ and HER2- stage 1 breast cancer, endocrine therapy remains a cornerstone of treatment. The DEBRA trials emphasize the use of endocrine therapy (tamoxifen or aromatase inhibitors) for at least five years, whether or not RT is included . This approach aims to reduce the risk of recurrence while minimizing treatment-related toxicity.
A phase 3 trial explored the addition of the oral fluoropyrimidine S-1 to standard endocrine therapy in patients with ER-positive, HER2-negative primary breast cancer. The study found that combining S-1 with endocrine therapy significantly improved invasive disease-free survival compared to endocrine therapy alone, suggesting a potential new treatment option for intermediate to high-risk patients.
Current research in stage 1 breast cancer treatment is increasingly focused on de-escalating therapy to minimize toxicity while maintaining efficacy. The DEBRA trials and other studies are exploring the potential to safely omit radiation therapy in certain low-risk patients, while alternative radiation strategies like PBI offer promising results. Additionally, the combination of endocrine therapy with agents like S-1 may provide enhanced disease control for higher-risk patients. These advancements aim to tailor treatment more precisely to individual patient risk profiles, improving outcomes and quality of life.
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