Authors' objectives:

The principal objectives of this report were: to assess the efficacy, effectiveness and safety of IORT in patients with breast cancer, in terms of survival and local control of the disease; and to ascertain its impact on the quality of life of such patients.

Authors' results and conclusions: The bibliographic search retrieved 394 studies. Of these, 14 that met the selection criteria were included. No study displayed a comparative design. Three systematic reviews were located, and the remainder were case-series studies. While most of the studies included patients in the initial stages of breast cancer (T0-T2), some also evaluated T3. IORT dosages ranged from 10Gy to 24Gy, with these being combined with subsequent administration of external beam radiation therapy (EBRT) (dosages of 45Gy-50Gy in most cases). Two studies exclusively administered IORT without postoperative EBRT, and used the highest IORT doses (20Gy to 24Gy). Overall local control of the disease surpassed 98% at 1 and 4 years, and overall survival was 99% at 5 years and 90.9% at 7 years. In the case of those studies that exclusively used IORT, local control of the disease was approximately 98% at 2-4 years, and overall survival was 99% at 2 years, though the latter finding was based on only one study. Toxicity was assessed using the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) and Late Effects Normal Tissue Task Force/Subjective, Objective, Management, Analytic (LENT/SOMA) scales. Insofar as acute complications were concerned, most were mild-tomoderate (grades 0-2) and cutaneous in nature (fibrosis, skin retraction and atrophy), though there were also cases of necrosis, telangiectasia or moderate pain (grades 2-3). Incidence of severe chronic complications was low, though mention should be made of one case of grade IV necrosis; in all the remaining cases, they were mainly mild-to-moderate, with the most frequent being fibrosis, whether localised or affecting the whole breast, and dermatologicaltype complications (changes of pigmentation, retraction or atrophy). There were also cases of pain, oedema and infection.

Authors' recommendations: Despite the fact that there is little evidence of the use of IORT in breast cancer and that the studies available are of low quality, patients treated with IORT appear to display a slightly better survival rate than do patients to whom other therapies are administered. Moreover, IORT would seem to be a relatively safe technique, since the adverse effects observed are comparable to those of treatment with external radiotherapy.

Project Status: Completed

URL for project: http://www.sergas.es/MostrarContidos_N3_T02.aspx?IdPaxina=60063&uri=/docs/Avalia-t/IA2010-01-RIO-mama-recto.pdf&hifr=1250&seccion=0

Year Published: 2010

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: Galician Agency for Health Technology Assessment (AVALIA-T)