P54. Evaluating the Wilms’ tumour antigen 1 as a target for the immunotherapy of prostate cancer

Abstract

were mandated as Serious Adverse Events (SAEs) and all dental related events reported as Adverse Events (AEs). Results: As of 01/08, 18 dental related SAEs have been reported in 18 patients (2 patients in the CT arm, 16 patients in the CT+Z arm) of these, 11 cases fulfil the current working definition for ONJ. All 11 cases have been reported in patients randomised to Z, onset at median 8 doses (range 1–13). One case resolved completely, 2 recovered with sequelae, 8 are ongoing. Detailed case review of each of these episodes is ongoing. As of 08/07, 172 dental related AEs in 147 patients (4.4% of all randomised patients) have been reported: 111 events in 92 (5.5%) patients in the CT+Z arm and 61 events in 55 (3.3%) patients in the CT arm. The AEs were wide-ranging but predominantly related to infection, jaw/tooth pain and extraction and will be examined in greater detail. Conclusions: Dental AEs are not uncommon in women receiving adjuvant treatment for early breast cancer. The majority are self-limiting and in this population the incidence of ONJ associated with a relatively intensive schedule of adjuvant zoledronic acid would appear to be <1%.