Abstract
Purpose
To report long-term results of a randomized trial comparing accelerated partial breast irradiation (APBI) to whole-breast irradiation (WBI) in terms of efficacy, toxicity, and cosmesis.
Methods and materials
WBI group was treated with 3D conformal external irradiation, 2 Gy daily/fraction, 5 fractions/week, to a total dose of 50 Gy. APBI group was treated with 3D conformal external irradiation 3.75 Gy/fraction, twice a day, 5 fractions/week, to a total dose of 37.5 Gy in the APBI group. Patients were followed up every 6 months up to 5 years and yearly thereafter. During follow-up visits, the clinician evaluated chronic toxicity and scored cosmetic results with a four-scale system.
Results
After a median follow-up of 10.3 years, 43 patients in each group (84%) are alive without disease. One patient died after disease progression in the APBI arm, and there was no death in the WBI arm. The rest of the patients died from another disease different than breast cancer, similarly between groups. There was greater fibrosis in the APBI group (9 patients grade 1 and one grade 2) compared to WBI (3 patients grade 1 and one grade 2); p = 0.18. Regarding cosmesis, in APBI group, 19 and 21 (43.2 and 47%) patients had excellent or good results, similar to the WBI group with 18 patients (40.9%) in each cosmesis outcome. The WBI group did not have any patient with poor cosmesis but the APBI had 3 (6.8%; p = 0.24).
Conclusion
After a follow-up of 10 years, there were no differences in efficacy between the 2 treatment arms. Despite slight greater toxicity in the APBI group, the cosmesis was similar and satisfactory in both groups.
Similar content being viewed by others
Data availability
All data are avalaible for analysis and review in electronic records.
References
Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. New Eng J Med. 2002;347(16):1233–41.
Veronesi U, Cassinelli N, Mariani L, Marco G, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. New Eng J Med. 2002;347(16):1227–32.
Almahariq MF, Quinn TJ, Siddiqui Z, et al. Breast conservative therapy is associated with improved overall survival compared to mastectomy in early-stage, lymph node-negative breast cáncer. Radiother Oncol. 2020;142:186–94.
Holland R, Veling SH, Mravunac M, Hendriks JH. Histologic multifocality of Tis, T1–2 breast carcinomas. Implications for clinical trials of breast-conserving surgery. Cancer. 1985;56(5):979–90.
Guinot L, Arribas L, Guedea F, Polo A, Gutierrez C, Pera J. Irradiación parcial de la mama con braquiterapia: un nuevo enfoque terapéutico. Rev Senología Patol Mam. 2006;19(3):82–7.
Baglan KL, Sharpe MB, Jaffray DJ, et al. Accelerated partial breast irradiation using 3D conformal radiation therapy(3D-CRT). Int J Radiation Oncology Biol Phys. 2003;55(2):302–11.
Veronesi U, Orecchia R, Maisonneuve P, et al. Intraoperative radiotherapy versus external radiotherapy for early breast cancer (ELIOT): a randomized controlled equivalence trial. Lancet. 2013;14:1269–77.
Vaidya JS, Bulsara M, Saunders C, et al. Effect of delayed targeted intraoperative radiotherapy vs whole-breast radiotherapy on local recurrence and survival: long-term results from the TARGIT-A randomized clinical trial in early breast cancer. JAMA Oncol. 2020;6(7):e200249.
Correa C, Harris EE, Leonardi MC, et al. Accelerated partial breast irradiation: executive summary of the update of an ASTRO evidence-based consensus statement. Pract Radiat Oncol. 2017;7:73–9.
Rodríguez N, Sanz X, Dengra J, Foro P, Membrive I, Anna R, Quera JQ, Fernández VE, Pera O, Lio J, Lozano J, Algara M. Five-year outcomes, cosmesis, and toxicity with 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2013;87(5):1051–7.
Cox JD, Stetz J, Pajak TF, et al. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys. 1995;31:1341–6.
Harris JR, Levene MB, Svensson G, Hellman S. Analysis of cosmetic results following primary radiation therapy for stages I and II carcinoma of the breast. Int J Radiat Oncol Biol Phys. 1979;5(2):257–61.
Polgár C, Fodor J, Major T, Sulyok Z, Kásler M. Breast-conserving therapy with partial or whole breast irradiation: ten-year results of the Budapest randomized trial. Radiother Oncol. 2013;108(2):197–202.
Polgár C, Major T, Takácsi-Nagy Z, Fodor J. Breast-conserving surgery followed by partial or whole breast irradiation: twenty-year results of phase 3 clinical study. Int J Radiat Oncol Biol Phys. 2021. https://doi.org/10.1016/j.ijrobp.2020.11.006.
Schafer R, Strnad V, Polgar C, Uter W, Hildebrandt G, Ott OJ, et al. Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomized, phase 3 trial. Lancet Oncol. 2018;19(6):834e44.
Beitsch PD, Vicini F, Keisch M, et al. The American Society of Breast surgery mammosite registry: factors associated with optimal long-term cosmetic results. Int J Radiat Oncol Biol Phys. 2011;81(Suppl 2):S229.
Chen PY, Wallace M, Mitchell C, Grills I, Kestin L, Fowler A, Martinez A, Vicini F. Four-year efficacy, cosmesis, and toxicity using three-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2010;76(4):991–7.
Braunstein LZ, Thor M, Flunn BSJ, et al. Daily fractionation of external beam accelerated partial breast irradiation to 40 Gy is well tolerated and locally effective. Int J Radiat Oncol Biol Phys. 2019;104(4):859–66.
Hepel JT, Tokita M, MacAusland SG, et al. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009;75:1290–6.
Coles CE, Kirby AM, Titley J, et al. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicenter, randomized, controlled, phase 3, non-inferiority trial. Lancet. 2017;390(10099):1048–60.
Liu G, Dong Z, Huang B, Liu Y, Tang Y, Li Q, Zhu Y. Efficacy and safety of accelerated partial breast irradiation: a meta-analysis of published randomized studies. Oncotarget. 2017;8(35):59581–91.
Vicini FA, Cecchini RS, White JR, et al. Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomized, phase 3, equivalence trial. Lancet. 2019;394(10215):2155–64.
Olivotto IA, Whelan TJ, Parpia S, et al. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013;31:4038–45.
Whelan TJ, Julian JA, Berrang TS, et al. External beam accelerated partial breast irradiation versus whole-breast irradiation after breast-conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomized controlled trial. Lancet. 2019;394(10215):2165–72.
Bartelink H, Horiot JC, Poortmans PM, et al. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881–10882 trial. J Clin Oncol. 2007;25:3259–65.
Shah C, Wilkinson B, Lanni T, et al. Five-year outcomes and toxicities using 3-dimensional conformal external beam radiation therapy to deliver accelerated partial breast irradiation. Clin Breast Cancer. 2013;13:206–11.
Livi L, Meattini I, Marrazzo L, Simontacchi G, Pallotta S, et al. Accelerated partial breast irradiation using intensity-modulated radiotherapy versus whole-breast irradiation:5-year survival analysis of phase 3 randomized controlled trial. Eur J Cancer. 2015;51:451–63.
Corica T, Nowak AK, Saunders CM, Bulsara M, Taylor M, Vaidya JS, et al. Cosmesis and breast-related quality of life outcomes after intraoperative radiation therapy for early breast cancer: a substudy of the TARGIT-A trial. Int J Radiat Oncol Biol Phys. 2016;96(1):55e64.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
All authors declare they have no conflict of interest excepte Dr Algara that has received consulting honoraria from Sysmex and Aristo and speaking honoraria from Siemens and Roche.
Ethical approval
This study obtained approval by ethic commitee of our hospital prior to the onset of patient inclusion in 2003.
Informed consent
All patients included signed informed consent to the participation in the study.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Li, X., Sanz, J., Foro, P. et al. Long-term results of a randomized partial irradiation trial compared to whole breast irradiation in the early stage and low-risk breast cancer patients after conservative surgery. Clin Transl Oncol 23, 2127–2132 (2021). https://doi.org/10.1007/s12094-021-02618-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s12094-021-02618-5