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A phase I/II feasibility study of cetuximab with 5FU and Mitomycin C or cisplatin with concurrent radiotherapy in muscle invasive bladder cancer

Journal of Clinical Oncology Feb 28, 2020

James ND, Pirrie S, Liu W, et al. - By performing phase 1/2 single-arm, multicentre, open-label study in 5 UK centres, researchers tested the effects of adding cetuximab to standard chemoradiotherapy (cRT) with 5FU and Mitomycin C (5FU/MMC) for treating patients with muscle invasive bladder cancer. The treatment regimen used was: RT: 64 Gy/32 fractions, 5FU 2.5g/m2 over days 1-5 & 22-26, MMC 12g/m2 day 1, cetuximab 400mg/m2 day -8, 200mg/m2 day 1 and weekly x7. RT was initiated in 30 evaluable pts, RT was not completed by 1 patient because of serious adverse event (interstitial pneumonitis), 3 with delays. In phase 1, 6/7 pts completed Cetux therapy, 1 omitted 1 dose for grade 3 rash. Local control was estimated to be 77%. Overall, the addition of cetuximab to cRT with 5FU/MMC, with high delivered dose intensities, was proved to be feasible and safe for treating muscle invasive bladder cancer, as demonstrated by phase 1 data. Although recruitment did not reach the pre-specified target for phase 2 exploratory study show the 3 month bladder control rates, as well as recurrence rates, were above those documented in BC2001 with good patient reported outcomes affords proof to think about the further assessment of cetuximab.
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