Abstract

356 Background: The mainstay of radical organ preserving treatment in muscle-invasive bladder cancer is radiotherapy (RT). Radiosensitising agents have been shown to improve treatment response and survival. Chemoradiotherapy is the most commonly used regime, however, hypoxia modification has also been shown to be effective. BCON is a phase III clinical trial which showed that the addition of carbogen and nicotinamide (CON) significantly improved recurrence-free survival (RFS) and overall survival (OS) (Hoskin et al, 2010). The long term outcomes twelve years after the trial closed to recruitment are reported. Methods: Outcomes from the original BCON trial were updated and analysed. Patients excluded from the original analysis were excluded once again. Cox regression analysis adjusted for known prognostic factors was performed. Results: 333 patients were randomized to receive RT alone or RT+CON. 9 patients from the RT+CON arm and 3 from RT alone arm were excluded from the analysis. The median age of patients in both arms was 74 (51-90) and the median follow-up was 10.3 years. There was a statistically significant improvement in 5 year RFS (41% vs 33%, p = 0.04) with the difference maintained at 10 years (27% vs 20%). The 5 year OS was 49% vs 40% (p = 0.068) with a continued effect seen at 10 years when OS was 32% vs 24%. These differences remained following adjustment for known prognostic factors. Conclusions: The survival advantage for CON in the original analysis which demonstrated a significantly improved 3 years OS (59% vs 47%, p = 0.020) is maintained in long term follow up. At 5 years there is a statistically significant improvement in RFS and at 5 and 10 years the addition of hypoxia modification to radiotherapy continues to show an impact on overall survival, These results confirm a sustained benefit of hypoxia modification in bladder preservation treatment for muscle-invasive bladder cancer. Clinical trial information: NCT00033436.

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