A large scale trial conducted at the European Institute of Oncology (IEO) in Milan has proved a novel radiotherapy procedure to be a great success both in terms of medical results and cost effectiveness.
The study, published today in the peer-reviewed journal ecancermedicalscience, examined the use of Electron Intraoperative Therapy (ELIOT), which shortens the radiotherapy course from six weeks to one single session during surgery.
The conventional treatment for early breast cancer is breast conserving surgery (BCS) followed by a 5-7 week course of radiotherapy. However many women still undergo mastectomy because they do not have easy access to postoperative radiotherapy centres.
As 85% of local relapses after BCS occur near the initial site of disease there has been an increased interest in using partial breast irradiation (PBI) directed to the tissue immediately surrounding the site of tumour removal.
Investigators have evaluated the use of ELIOT alone for early-stage breast cancer since 1999. This technique uses radiotherapy machines kept or easily moved in the operating theatre. After removal of the tumour, a high accuracy, high dose radiation pulse is delivered to the breast tissue surrounding the site.
Since it was first piloted by the IEO in 1999, ELIOT has been given to 1246 patients, with an overall survival rate at five years of 96.5%. Only 24 out of the 1246 cases (1.9%) saw a breast-cancer related event after this period.
Apart from this success, the system has several other advantages: Cosmetic damage is greatly limited and post-op plastic surgery is easily conducted.
The flexible nature of the radiotherapy machine and its presence during surgery means that additional doses of radiotherapy can be given if needed for specific reasons.
Furthermore, the complete protection against radiation provided by the combination of pin-point doses and protective metal disk means that side effects from unwanted radiation are abolished.
The main advantage, however, is for those patients living in areas remote from radiotherapy centres, who would otherwise have to travel everyday for six weeks, and often decide on complete breast removal to avoid the huge stress of such an undertaking.
The investigators state that their results "confirmed the positive impact of ELIOT on patient quality of life: ELIOT is feasible and well accepted. We are waiting for the long-term results on local control from the ongoing randomised trial in progress at our institute to decide whether to adopt the technique in daily standard practice. However, as the data from the present large series are reassuring (97% of local control and 98.8% survival at 5 years) we believe that, at least for women living far from radiotherapy centres and with minimal risk of local recurrence (age > 50 and primary carcinoma <1.5 cm.), the ELIOT treatment might be considered an option, provided that the patient consents to the proposal."
Professor Gordon McVie, of the IEO, added "this is the largest experience in the world of sequential patients treated in a phase II trial with intra-operative radiotherapy. Its unprecedented size and positive results gives great hope for both this technique and breast cancer patients worldwide".