An Overview of European Clinical Trials of Accelerated Partial Breast Irradiation

Polgár, Csaba; Major, Tibor; Strnad, Vratislav; Niehoff, Peter; Ott, Oliver J.; Kovács, György

doi:10.1007/3-540-28203-3_16

Cited by 1 publication

(1 citation statement)

References 29 publications

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“…However, while side effects were generally acceptable and self-limiting, mild-to-moderate skin toxicity was very common, including a rate of 57% with erythema without desquamation, 13% dry desquamation and 6% moist desquamation. In a European study of MammoSite®, 88% developed erythema, 54% hyperpigmentation, 42% seroma formation, and 8% telangiectasias (with 1 year follow-up) [9]. Finally, in the recent updates of the American Society of Breast Surgeons (ASBS) MammoSite® registry trial of 1440 patients from 97 institutions, 90.6% had good-to-excellent cosmesis at 5-years, 16.4% developed fibrosis, 13% developed symptomatic seromas, 9.5% developed infections, and 2.3% developed fat necrosis [10,11].…”

Section: Introductionmentioning

confidence: 99%

A phase II trial of balloon-catheter partial breast brachytherapy optimization in the treatment of stage 0, I, and IIA breast carcinoma

et al. 2014

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Objective(s) (a) To prospectively determine if multidwell position dose delivery can decrease skin dose and resultant toxicity over single dwell balloon-catheter partial breast irradiation, and (b) to evaluate whether specific skin parameters could be safely used instead of skin-balloon distance alone for predicting toxicity and treatment eligibility. Methods A single-arm phase II study using a Simon two-stage design was performed on 28 women with stage 0-II breast cancer. All patients were treated with multiple dwell position balloon-catheter brachytherapy. The primary endpoint was ≥ grade 2 skin toxicity. Initial entry required a balloon-skin distance ≥ 7 mm. Based on the toxicity in the first 16 patients, additional patients were treated irrespective of skin-balloon distance as long as the Dmax to 1 mm skin thickness was < 130%. Results Compared to the phantom single dwell plans, multidwell planning yielded superior PTV coverage as per median V90, V95 and V100, but had slightly worse V150, V200 and DHI. Dmax to skin was decreased by multidwell planning at multiple skin thicknesses. The most common acute toxicity was grade 1 erythema (57%), and only two patients (7%) developed acute grade 2 toxicity (erythema). Late grade 1 fibrosis was seen in 32%. No patients experienced grade 3, 4, or 5 toxicity. Conclusions Multidwell position planning for balloon-catheter brachytherapy results in lower skin doses with equal to superior PTV coverage and an overall low rate of initial skin toxicity. Our data suggest that limiting the Dmax to < 130% to 1 mm thick skin is achievable and results in minimal toxicity.

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Section: Introductionmentioning

confidence: 99%