Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study

Paola Pinnarò, Carolina Giordano, Alessia Farneti, Adriana Faiella, Giuseppe Iaccarino, Valeria Landoni, Diana Giannarelli, Patrizia Vici, Lidia Strigari, Giuseppe Sanguineti, Paola Pinnarò, Carolina Giordano, Alessia Farneti, Adriana Faiella, Giuseppe Iaccarino, Valeria Landoni, Diana Giannarelli, Patrizia Vici, Lidia Strigari, Giuseppe Sanguineti

Abstract

Background: To assess the oncologic outcomes of hypofractionated whole breast irradiation (Hypo-WBI).

Methods: Eligible patients had undergone breast conservative surgery for early breast cancer (pTis-2) and none/limited nodal involvement. Hypo-WBI consisted of 34 Gy in 10 daily fractions over 2 weeks to the whole breast three-dimensional conformal radiotherapy (3DCRT), followed by a single fraction of 8 Gy to the tumor bed after 1 week (electrons). Primary endpoint is freedom from ipsilateral breast tumor recurrence (IBTR). Minimum follow up for living & event-free patients is 3 yrs.; median follow up time of the whole analyzed patient population is 5.4 yrs. (range: 1.8-11.4 yrs).

Results: Two hundred fifty-one patients were accrued from 2004 to 2013. All patients underwent local excision of the primary tumor to negative margins. Four patients failed in the ipsilateral breast after a median time of 3.2 years (range: 1.7-5.7 yrs) for a 5-year IBTR-free survival of 98.7% (95%CI: 97.3%-100%). IBTR-free survival was significantly higher for patients with invasive cancer than for patients with intraductal carcinoma (p = 0.036). Within patients with invasive tumors, no clear trends or associations were detected between IBTR and age, grading, molecular subtype, pT or pN stage. At 5 years, the actuarial rates of GR2 fibrosis and GR2+ teleangectasia are 2.4% (95%CI: 0-6.5%) and 7.1% (95%CI: 0.4-13.7%), respectively. Cosmesis was scored as excellent/good by ≈95% of patients and ≈60% of clinicians.

Conclusions: Hypo-WBI in 3 weeks allows excellent oncologic outcomes for invasive breast cancer after conservative surgery. Patients with intraductal carcinoma should be treated with Hypo-WBI only within a controlled study.

Trial registration: IRE-IFO Ethical and Scientific Committee (cod. RS61/04).

Keywords: Breast carcinoma in situ; Breast neoplasms; Dose hypofractionation; Local neoplasm recurrence; Radiotherapy.

Conflict of interest statement

Ethics approval and consent to participate

The study has been approved by the Institutional Ethical and Scientific Committee. All enrolled patients signed an informed consent for study participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
IBTR-free survival for the overall population
Fig. 2
Fig. 2
IBTR-free survival for invasive and ductal carcinoma in situ (DCIS). Considering the DCIS subgroup as the reference one, the Hazard Ratio (HR) of IBTR for the invasive group is shown
Fig. 3
Fig. 3
Cumulative rates of both GR2 fibrosis and GR2+ teleangectasia
Fig. 4
Fig. 4
Cosmetic outcomes according to both clinicians (obs 1 and obs2: observer 1 & 2) and patients (PRO: patient reported outcomes)
Fig. 5
Fig. 5
Five-yr. IBTR (95%CI) from randomized controlled studies along with the present study (Invasive ca only)(IRE: Regina Elena Institute). The experimental arms of each study were as follow: OCOG (Ontario Clinical Oncology Group Trial), 42 Gy/16 fractions/3.2 wks, median follow up 5.75 yrs., 622 pts. [5]; START P (Standardization of Radiotherapy Pilot) trial, 39 Gy/13 fractions/5 wks and 42.9 Gy/13 fractions/5 wks, median follow up 9.7 yrs., 474 and 466 patients, respectively [12]; START A trial, 39 Gy/13 fractions/5 wks and 41.6 Gy/13 fractions/5 wks, median follow up 5.1 yrs., 737 and 750 patients, respectively [4]; START B trial, 40 Gy/15 fractions/3 wks, median follow up 6.0 yrs., 1110 patients [3]

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