256P - Five Years Follow Up of Prospective Randomized Study to Assess the Effect of Prophylactic Cranial Irradiation in High Risk Breast Cancer Patients

Abstract

ABSTRACT Aim To assess the effect of Prophylactic cranial irradiation (PCI) in patients with high risk early breast cancer with primary end point CNS relapse where the secondary end point is to assess the toxicity and QOL. At 5 years the aim is to assess CNS relapse, Overall Survival, NCF and QOL re-evaluation. Methods It is 5 years re-evaluation of 62 patients with high risk invasive breast cancer. After adjuvant treatment, patients were randomized into: arm I who didn't receive PCI, arm II who received PCI. Patients were collected from Jan. 2005 and followed up till Dec. 2007 with re-evaluationone on April 2012. After a signed informed consent, the whole brain received 240 cGy per fraction, once daily, five times per week to a total dose of 2400cGy. Brain assessment by MRI studies as a baseline before PCI, at 6 months in the first year, and then annually for at least 5 years, and Assessment of Neuro-cognitive Function (NCF): basically before PCI, 6 months, 1 year after PCI using Mini-Mental State Exam (MMSE). Health related quality of life was assessed for all patients with the Functional Assessment of Cancer Therapy-Brain (FACT-Br) Questionnaire Version 4, before PCI and 3 weeks, three months after PCI. Patients were followed up till April 2012. Results At the end of the study, there is no incidence of CNS metastasis in PCI arm compared to 3.2% in control arm. In PCI arm, there is no statistical difference in MMSE (before and after PCI, p = 0.619 ) and QOL assessment. At 5 years, in PCI arm, the incidence of CNS metastasis is 3.2 (only one case) while in Control arm it is 12.9 (four cases). In PCI arm,there was no statistically significant change in NCF and QOL in all items of FACT-Br questionnaire except in additional concerns (p 0.05, Log rank of 5 years survival = 0.59 Conclusion The rationale behind PCI is to control or eradicate undetectable micro-metastases before they become clinically significant without inducing severe adverse effects. PCI associated with decreased incidence of CNS metastases with tolerated toxicities and did not negatively affect patient survival. This may be translated into therapeutic gain at least for this short follow up period which warrants further evaluation after a longer follow up period. Disclosure All authors have declared no conflicts of interest.