This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.
The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.
Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
Synchronous bilateral breast cancer requiring bilateral radiation therapy.
Clinical or imaging evidence of distant metastases.
Prior ipsilateral breast or thoracic radiation.
Single group
Breast Radiotherapy
RadiationThe tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).
Rate of any moderate-marked adverse effects
The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.
In-breast tumor recurrence
In-breast tumor recurrence at 2 years is defined according to the standard definition as the time from enrollment to any of the following events: invasive ipsilateral recurrence and/or ipsilateral DCIS recurrence. Recurrence will be measured via medical record abstraction and clinical evaluation.
Quality of life at measured by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30)
Quality of life at 12 months will be measured as defined by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30). The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
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