Abstract
PurposeTo assess toxicity and clinical outcome, in breast cancer patients treated with external beam partial breast irradiation (PBI) consisting of 35 Gy in 7 daily fractions (5 Gy/fraction).Materials and MethodsPatients affected by early-stage breast cancer were enrolled in this phase II trial. Patients had to be 60 years old or over and treated with breast conservative surgery for early stage invasive carcinoma.ResultsSeventy-three patients were analyzed. Median follow-up was 40 months. The proposed schedule was well tolerated. No Grade 3 toxicity was documented. Late toxicity was assessable for all the treated patients. Two patients (2.7%) developed Grade 2 pain 6 months after PBI. Four patients (5%) developed asymptomatic fat necrosis. Grade 2 fibrosis was observed in 5 patients (6.7%). No correlation was found between early and late toxicity and the type of adjuvant systemic therapy (no therapy vs. hormonal therapy vs. chemotherapy). No statistical correlation between dosimetric parameters and toxicity was found. Patients who developed Grade 2 radiation fibrosis had not higher radiation volumes to the untreated normal breast than those without fibrosis. Cosmesis was judged good/excellent in the majority of the cases (93%). One patient relapsed locally, and one developed distant metastases, corresponding to a 5-year local control and distant metastases-free survival of 98% and 96.7%, respectively.Conclusions35 Gy in 7 daily fractions is an effective and well-tolerated regimen to deliver PBI.
Highlights
Introduction whole breast irradiation remains the standard of care after conservative surgery for early stage breast cancer, partial breast irradiation (PBI), namely the irradiation of only the breast tissue surrounding the lumpectomy cavity, is emerging
The most used fractionation scheme is that proposed by Vicini at al., who explored in a phase II trial the safety and efficacy of 38.5 Gy at 3.85 Gy/fraction delivered 2 fractions per day with three dimensional conformal external beam radiotherapy (3D-CRT) [2]
Due to the fact that some studies reported poor cosmetic and toxicity results using the above-mentioned radiotherapy schedule [4, 5], we treated our patients with PBI using a once daily fractionation scheme consisting of 40 Gy in 10 fractions, and we documented an excellent toxicity profile [6]
Summary
Whole breast irradiation remains the standard of care after conservative surgery for early stage breast cancer, partial breast irradiation (PBI), namely the irradiation of only the breast tissue surrounding the lumpectomy cavity, is emerging. The most used fractionation scheme is that proposed by Vicini at al., who explored in a phase II trial the safety and efficacy of 38.5 Gy at 3.85 Gy/fraction delivered 2 fractions per day with three dimensional conformal external beam radiotherapy (3D-CRT) [2]. The purpose of the present study is to assess prospectively the efficacy and toxicity in breast cancer patients treated who underwent PBI with a schedule consisting of 35 Gy in 7 daily fractions (5 Gy per fraction) We decided to continue to accelerate the radiation delivery, according to previously published radiobiological models [7, 8].
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