Partial breast irradiation as sole therapy for low risk breast carcinoma: early toxicity, cosmesis and quality of life results of a MammoSite brachytherapy phase II study.
OBJECTIVE
The MammoSite is a device that was developed with the goal of making breast-conserving surgery (BCT) more widely available. Our objective was to evaluate the MammoSite device performances after an open cavity placement procedure and quality of life in highly selected patients with early-stage breast cancer.


METHODS
From March 2003 to March 2005, 43 patients with T1 breast cancer were enrolled in a phase II study. The median age was 72 years. Twenty-five (58%) patients were treated with high-dose rate brachytherapy using the MammoSite applicator to deliver 34Gy in 10 fractions. The main disqualifying factor was pathologic sentinel node involvement (10/43; 23%). There were no device malfunctions, migration or rupture of the balloon.


RESULTS
After a median follow-up of 13 months, there were no local recurrences and one contralateral lobular carcinoma. Seventeen (68%), 13 (52%), 8 (32%), 5 (20%) and 2 (8%) patients had erythema, seroma, inflammation, hematoma and sever infection, respectively. Only 2 patients developed telangiectasia. At 1 year the rate of "good to excellent" cosmetic results was 84%. Significant changes in QoL were observed for emotional and social well-being between 3 and 12 months. At 24 months, only emotional well-being subscore changes were statistically significant (p=0.015).


CONCLUSIONS
Our data in patients older than 60 years support the previously published data. Histologic features were the main disqualifying criteria. With higher skin spacing levels we observed very low incidence of telangiectasia. QoL evaluation indicates that baseline scores were satisfactory. Changes concerned emotional and social well-being.
Belkacémi
Yazid
Y
Department of Radiation Oncology, Oscar Lambret Anti-Cancer Center, Cedex, France. yazid.belkacemi@hmn.aphp.fr
Chauvet
Marie-Pierre
MP
Giard
Sylvia
S
Villette
Sylviane
S
Lacornerie
Thomas
T
Bonodeau
François
F
Baranzelli
Marie-Christine
MC
Bonneterre
Jacques
J
Lartigau
Eric
E
D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D002404:Catheterization; D019583:Dose Fractionation, Radiation; D004954:Esthetics; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011788:Quality of Life; D021701:Sentinel Lymph Node Biopsy; D018709:Statistics, Nonparametric; D016896:Treatment Outcome