LAUSR

Purpose/Objective(s): To prospectively compare late toxicity after accelerated partial breast irradiation (APBI) with 3D-conformal external beam radiotherapy (3D-CRT) or single-entry multi-lumen intracavitary brachytherapy. Patients/Methods: Two hundred eighty-one patients with pTis or pT2N0 (≤3.0 cm) breast cancer treated with segmental mastectomy were prospectively enrolled on a multi-institution observational protocol from 12/2008 – 8/2014. Patients were enrolled and treated at primary, satellite, and affiliated academic institutions. APBI was delivered using 3D-CRT or with a Contura®, MammoSite®, or SAVI® brachytherapy catheter. 3D-CRT patients were treated to 34.0 Gy (7%) or 38.5 Gy (93%) at 3.4-3.85 Gy/fx BID and brachytherapy patients were treated to 34.0 Gy at 3.4 Gy/fx BID. Per protocol, patients were clinically evaluated at 2, 6, 12, 18, and 24 months and then annually. At each clinical evaluation the radiation oncologist scored cosmetic outcome (excellent/good/fair/poor according to the Harvard Cosmesis Scale), toxicity (seroma/infection/fat necrosis/pain/telangiectasia/radiation dermatitis/hyperpigmentation/hypopigmentation/fibrosis/induration/edema/other according to CTCAE v3.0) and recurrence status. Results: The median age was 61 years. Of 281 patients, 211 (75%) had invasive breast cancer and 70 (25%) had in situ disease. Among patients with invasive disease, 90% were HR+/HER2-, and among patients with in situ disease, 83% were HR+. APBI was delivered with 3D-CRT in 29 (10%) patients and with single-entry multi-lumen intracavitary brachytherapy in 252 (90%) patients. Among the brachytherapy patients, APBI was delivered with the SAVI®, Contura®, and MammoSite® devices in 176 (70%), 56 (22%), and 20 (8%) patients, respectively. With a median follow-up of 49 months, rates of Grade 1 (G1) and Grade 2-3 (G2-3) toxicity are: Mean skin dose of the maximally-irradiated 0.1 cc (D0.1cc) of skin was significantly higher in patients who developed telangiectasia (103.4% ± 16.1% compared to 96.5% ± 18.6% of prescription dose, p=0.007) and fibrosis (100.1% ± 15.5% compared to 92.8% ± 23.0% of prescription dose, p=0.02). Crude rates of fair or poor cosmetic outcome at 2-4 and 4-6 years were 6.9% and 14.8%, respectively, for 3D-CRT and 14.8% and 21.3%, respectively, for brachytherapy (p>0.05 at both timepoints). Five-year recurrence-free survival was 96.3% with 3D-CRT and 96.1% for brachytherapy (p>0.05). Conclusion: APBI with single-entry multi-lumen intracavitary brachytherapy is associated with increased rates of grade 1 fibrosis and seroma than APBI with 3D-CRT. Higher mean skin D0.1cc is associated with increased risk of telangiectasia and fibrosis. Despite increased low-grade fibrosis, there is no significant difference in radiation oncologist-reported fair or poor cosmetic outcome out to six years, or rate of five-year ipsilateral breast recurrence. Citation Format: Stecklein SR, Babiera GV, Bedrosian I, Shaitelman SF, Ballo MT, Tereffe W, Arzu IY, Perkins GH, Strom EA, Reed VK, Dvorak T, Smith BD, Woodward WA, Hoffman KE, Schlembach PJ, Chronowski GM, Shah SJ, Kirsner SM, Nelson CL, Guerra W, Dibaj SS, Bloom ES. Prospective comparison of late toxicity and cosmetic outcome after accelerated partial breast irradiation with conformal external beam radiotherapy or single-entry multi-lumen intracavitary brachytherapy [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P2-11-12.