DGU 2011 - Phase-III trial to compare adjuvant versus progression-dependent chemotherapy of locally advanced urothelial cancer of the bladder following cystectomy: Gemcitabine monotherapy in patients not suitable for cisplatinum (AUO-trial AB 22/00)

HAMBURG, GERMANY (UroToday.com) - In this trial, 120 patients with locally advanced urothelial cancer of the bladder not suitable for cisplatinum-based chemotherapy were randomized to receive adjuvant monotherapy with gemcitabine (arm A) or progression-triggered gemcitabine (arm B).

Of 120 patients from 29 centers in this poorly-recruited trial, 114 patients were evaluable. Median age was 72 years (range 45-82 years). 47% of patients had lymph node-positive disease. After 3 years, progression-free survival (PFS) and overall survival (OS) were both in favor of arm A: 50% versus 40% and 23 months versus 17 months. Both results were not statistically significantly different. Despite early termination, the authors claimed that the trial is one of the largest with a control arm of patients that received no primary therapy.

Still cisplatinum-based chemotherapy represents the standard in patients with urothelial cancer requiring systemic therapy. Gemcitabine monotherapy may be associated with fewer side effects, but lacks efficacy. Despite these findings this therapy will likely continue to be applied in patients unfit for cisplatinum-based chemotherapy.

Presented by J. Lehmann et al. at the Deutsche Gesellschaft für Urologie (DGU) - 63rd Annual Congress - September 14 - 17, 2011 - Congress Center - Hamburg, Germany

Reported for UroToday by Christian Doehn, MD, PhD, Urologikum Lubeck, Lubeck, Germany.

The opinions expressed in this article are those of the UroToday.com Contributing Medical Editor and do not necessarily reflect the viewpoints of the Deutsche Gesellschaft für Urologie.

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