Accelerated partial breast irradiation using intensity-modulated radiotherapy technique compared to whole breast irradiation for patients aged 70 years or older: subgroup analysis from a randomized phase 3 trial.
The purpose of this study was to report the efficacy and the safety profile on the subset of selected early breast cancer (BC) patients aged 70 years or older from a single-center phase 3 trial comparing whole breast irradiation (WBI) to accelerated partial breast irradiation (APBI) using intensity-modulated radiation therapy technique. Between 2005 and 2013, 520 patients aged more than 40 years old were enrolled and randomly assigned to receive either WBI or APBI in a 1:1 ratio. Eligible patients were women with early BC (maximum diameter 2.5 cm) suitable for breast conserving surgery. This study is registered with ClinicalTrials.gov, NCT02104895. A total of 117 patients aged 70 years or more were analyzed (58 in the WBI arm, 59 in the APBI arm). At a median follow-up of 5-years (range 3.4-7.0), the ipsilateral breast tumor recurrence (IBTR) rate was 1.9 % in both groups. No significant difference between the two groups was identified (log-rank test p = 0.96). The 5-year disease-free survival (DFS) rates in the WBI group and APBI group were 6.1 and 1.9 %, respectively (p = 0.33). The APBI group presented significantly better results in terms of acute skin toxicity, considering both any grade (p = 0.0001) and grade 2 or higher (p = 0.0001). Our subgroup analyses showed a very low rate and no significant difference in terms of IBTR, using both WBI and APBI. A significant impact on patients compliance in terms of acute and early late toxicity was shown, which could translate in a consistent improvement of overall quality of life.
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy. icro.meattini@unifi.it.
Icro
I
Meattini
Molecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), Florence, Italy.
Calogero
C
Saieva
Medical Physics Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Livia
L
Marrazzo
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Lucia
L
Di Brina
Medical Physics Unit, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Stefania
S
Pallotta
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Monica
M
Mangoni
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Fiammetta
F
Meacci
Molecular and Nutritional Epidemiology Unit, ISPO (Cancer Research and Prevention Institute), Florence, Italy.
Benedetta
B
Bendinelli
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Giulio
G
Francolini
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Isacco
I
Desideri
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Carla
C
De Luca Cardillo
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Vieri
V
Scotti
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Ilaria Francesca
IF
Furfaro
Radiotehrapy Unit, Azienda Sanitaria 10, Florence, Italy.
Francesca
F
Rossi
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Daniela
D
Greto
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Pierluigi
P
Bonomo
Department of Surgery, University of Florence, Florence, Italy.
Donato
D
Casella
Department of Surgery, University of Florence, Florence, Italy.
Marco
M
Bernini
Department of Surgery, University of Florence, Florence, Italy.
Luis
L
Sanchez
Department of Surgery, University of Florence, Florence, Italy.
Lorenzo
L
Orzalesi
Department of Surgery, University of Florence, Florence, Italy.
Roberta
R
Simoncini
Diagnostic Senology Unit, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Jacopo
J
Nori
Division of Pathological Anatomy, University of Florence, Florence, Italy.
Simonetta
S
Bianchi
Department of Radiation Oncology, University of Florence, Azienda Ospedaliero-Universitaria Careggi, Largo G. A. Brambilla 3, 50134, Florence, Italy.
Lorenzo
L
Livi
D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor; D001943:Breast Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D020266:Radiotherapy, Conformal / Q000379:methods; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
D014408:Biomarkers, Tumor
Breast cancer; Elderly; Endocrine therapy; IMRT; Partial breast irradiation; Phase 3 trial