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Clinical Trial
. 2025 Jun:81:104459.
doi: 10.1016/j.breast.2025.104459. Epub 2025 Mar 22.

Long-term outcomes of three distinct once-daily schedules for accelerated partial breast irradiation

Lorenzo Vinante  1 , Michele Avanzo  2 , Angela Caroli  3 , Carlo Furlan  4 , Andrea Sacilotto  3 , Lorena Baboci  5 , Tiziana Perin  6 , Martina Urbani  7 , Alessandro Favero  8 , Simon Spazzapan  9 , Fabio Puglisi  10 , Maurizio Mascarin  3 , Samuele Massarut  11 , Marco Trovò  12
Affiliations
Clinical Trial

Long-term outcomes of three distinct once-daily schedules for accelerated partial breast irradiation

Lorenzo Vinante et al. Breast. 2025 Jun.

Abstract

Background and purpose: To date, accelerated partial breast irradiation (APBI) regimens are highly heterogeneous. Twice-daily schedules show comparable local control to whole-breast radiotherapy but with worse toxicity and cosmesis profiles. Conversely, once-daily regimens are better tolerated, though dose and number of fractions are yet not standardized. Therefore, the aim of this study was to evaluate the efficacy and tolerability of three different once-daily APBI schedules.

Materials and methods: Three consecutive phase-2 trials were conducted at a single national cancer center to assess three once-daily APBI schedules (40Gy in 10 fractions, 35Gy in 7 fractions, and 28Gy in 4 fractions) delivered with 3D-conformal radiotherapy. All patients were at least 60 years old and had early-stage breast cancer (pT1-2,pN0-N1mic). Toxicity and cosmesis were evaluated by physicians using the CTCAE 4.0 scale and the Harvard score, respectively. Recurrence rates and survival outcomes at 5 and 10 years were estimated using the Kaplan-Meier method.

Results: A total of 189 patients were enrolled, with a median follow-up of 10.2 years. Patients treated with 40Gy in 10 fractions, 35Gy in 7 fractions and 28Gy in 4 fractions were 80 (42%), 73 (39%), and 36 (19%), respectively. Acute toxicity was low and comparable across schedules, whereas grade≥2 late toxicity and poor cosmesis were significantly worse with the shorter schedule. The 10-year estimated in-breast tumour recurrence rate was 5.5%, comparable to the limited literature reporting long-term outcomes.

Conclusions: Once-daily APBI delivered with 3D-conformal radiotherapy was effective; however, regimens with fewer than 5 fractions may be associated with increased toxicity and worse cosmesis.

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Conflict of interest statement

Declaration of competing interest Michele Avanzo: consulting fee from L’Institut national de la santé et de la recherche médicale INSERM, France International Agency for Atomic Energy IAEA, Vienna International Centre for Theoretical Physics ICTP by Unesco and supporting grant from European Federation of Organizations for Medical Physics EFOMP Italian Association of Medical Physicists AIFM. Fabio Puglisi: research grant/consulting fees/honoraria from Astrazeneca, Daichii Sandoz, Eli Lilly, Exact Science, Lidead. Menarini, MSD, Novartis, Pfizer, Roche, Seagen. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Fig. 1
Fig. 1
Kaplan Meier plots of IBTR risk, regional recurrence disk, distant recurrence risk.
Fig. 2
Fig. 2
Kaplan Meier plots of IBTR risk among different schedules.
Fig. 3
Fig. 3
Kaplan Meier plots of overall survival, tumour-related survival and disease-free survival.
See this image and copyright information in PMC

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