Abstract
Background
Accelerated partial breast irradiation (APBI) has been introduced as an alternative
treatment method for selected patients with early stage breast cancer (BC). Intensity-modulated
radiotherapy (IMRT) has the theoretical advantage of a further increase in dose conformity
compared with three-dimensional techniques, with more normal tissue sparing. The aim
of this randomised trial is to compare the local recurrence and survival of APBI using
the IMRT technique after breast-conserving surgery to conventional whole-breast irradiation
(WBI) in early stage BC.
Methods
This study was performed at the University of Florence (Florence, Italy). Women aged
more than 40 years affected by early BC, with a maximum pathological tumour size of 25 mm, were randomly assigned in a 1:1 ratio to receive either WBI or APBI using IMRT.
Patients in the APBI arm received a total dose of 30 Gy to the tumour bed in five daily fractions. The WBI arm received 50 Gy in 25 fractions, followed by a boost on the tumour bed of 10 Gy in five fractions. The primary end-point was occurrence of ipsilateral breast tumour
recurrences (IBTRs); the main analysis was by intention-to-treat. This trial is registered
with ClinicalTrials.gov, number NCT02104895.
Findings
A total of 520 patients were randomised (260 to external WBI and 260 to APBI with
IMRT) between March 2005 and June 2013. At a median follow-up of 5.0 years (Interquartile Range (IQR) 3.4–7.0), the IBTR rate was 1.5% (three cases) in
the APBI group (95% confidence interval (CI) 0.1–3.0) and in the WBI group (three
cases; 95% CI 0.0–2.8). No significant difference emerged between the two groups (log
rank test p = 0.86). We identified seven deaths in the WBI group and only one in the APBI group
(p = 0.057). The 5-year overall survival was 96.6% for the WBI group and 99.4% for the
APBI group. The APBI group presented significantly better results considering acute
(p = 0.0001), late (p = 0.004), and cosmetic outcome (p = 0.045).
Interpretation
To our knowledge, this is the first randomised study using the IMRT technique for
APBI delivery. No significant difference in terms of IBTR and overall survival was
observed between the two arms. APBI displayed a significantly better toxicity profile.
Keywords
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Article info
Publication history
Published online: January 17, 2015
Accepted:
December 22,
2014
Received in revised form:
October 13,
2014
Received:
September 5,
2014
Identification
Copyright
© 2015 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
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