Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov 12:12:243-249.
doi: 10.2147/BCTT.S261587. eCollection 2020.

Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial

Gabriella Macchia  1 , Savino Cilla  2 , Milly Buwenge  3 , Alice Zamagni  3 , Ilario Ammendolia  3 , Claudio Zamagni  4 , Giovanni P Frezza  5 , Vincenzo Valentini  6   7 , Francesco Deodato #  1 , Alessio G Morganti #  3
Affiliations

Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial

Gabriella Macchia et al. Breast Cancer (Dove Med Press). .

Abstract

Purpose: A concomitant boost (CB) in patients treated with postoperative radiotherapy after conservative surgery of invasive breast cancer (BC) has been suggested for treatment time reduction and therapy intensification. The aim of this analysis was to assess long-term tolerability of a CB in patients treated with postoperative intensity Modulated Accelerated RAdiotherapy (MARA).

Patients and methods: In this phase I-II trial, 321 patients with intermediate-high risk BC (pT1-4 with at least one of the following characteristics: pre or perimenopausal status, pN2-3, positive or close margins) were enrolled. Patients were treated with forward-planned intensity modulated radiotherapy (IMRT) and CB. A total dose of 50 Gy (2 Gy/fraction) and 60 Gy (2.4 Gy/fraction) was prescribed to the whole breast and the tumor bed, respectively. The potential impact of hypertension, diabetes, smoking habit, alcohol consumption, chemotherapy, and hormone therapy on both skin and subcutaneous late toxicity-free survival (LTFS) was evaluated. Survival curves were calculated using the Kaplan-Meier method.

Results: Median follow-up was 52 months (range: 3-115). Regional node irradiation, adjuvant chemotherapy and hormonal therapy were prescribed to 29.3%, 65.4% and 81.0% of patients, respectively. Five-year G2 and G3 skin LTFS were 95.6% and 100.0%, respectively. Five-year G2 and G3 subcutaneous LTFS were 80.0% and 98.6%, respectively. Only diabetes showed a significant correlation with worse G3 subcutaneous LTFS (p: 0.024). Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.

Conclusion: IMRT combined with CB was associated with a low risk of > G2 late toxicities (0.0% and 1.4% for skin and subcutaneous tissue, respectively). The cumulative actuarial incidence of local recurrences was 2.0% despite the exclusion of low-risk patients. Our results suggest that CB is safe and effective in patients with intermediate-high risk BC.

Trial registration: ClinicalTrials.gov: NCT03471741.

Keywords: IMRT; adjuvant radiotherapy; breast cancer; concomitant boost; toxicity.

PubMed Disclaimer

Conflict of interest statement

Claudio Zamagni reports grants, personal fees, and non-financial support from Roche, Novartis, AstraZeneca, and Pfizer, grants from Eisai, PharmaMar, Celgene, lilly, Amgen, Pierre Fabre, Takeda, TEVA, Medivation, Array BioPharma, Abbvie, Morphotek, Synthon, Seattle Genetics, Daiichi and Sankyo, grants and personal fees from Tesaro, personal fees from QuintilesIMS, and travel accommodation and research funding from Istituto Gentili, outside the submitted work. Alessio G. Morganti reports grants from Elekta, Beyer, and IGEA and personal fees from Astellas and Alfa-Sigma, outside the submitted work. The authors report no other potential conflicts of interest in this work.

Similar articles

See all similar articles

Cited by

References

    1. Female Breast Cancer - Cancer Stat Facts. Available from: https://seer.cancer.gov/statfacts/html/breast.html. Accessed March30, 2020.
    1. 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. N Engl J Med. 2002;347:1233–1241. doi:10.1056/NEJMoa022152 - DOI - PubMed
    1. Veronesi U, Cascinell N, Mariani L, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347:1227–1232. doi:10.1056/NEJMoa020989 - DOI - PubMed
    1. Macdonald S, Oncology R, General M. Breast cancer. Available from: https://www2.tri-kobe.org/nccn/guideline/breast/english/breast.pdf
    1. Senkus E, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26:v8–v30. doi:10.1093/annonc/mdv298 - DOI - PubMed

Associated data