By: Ed Susman

ATLANTA, GA – Patients who undergo radical cystectomy with robot-assisted technology appear to have survival rates similar to those of patients who are treated with the gold-standard open operations, researchers said here at the American Urological Association 2012 Annual Scientific Meeting.

“Overall survival was not different when looking at different surgical approaches,” said Kyle Richards, MD, Wake Forest University Baptist Hospital, Winston-Salem, North Carolina, “Bladder cancer-specific survival was not different either.”

Dr. Richards reported on survival outcomes among 225 bladder cancer patients. Of those with more than 6 months of follow-up, 97 patients underwent radical cystectomy with robot technology and were compared with 100 patients who had undergone open surgery. There were no statistical differences in pathological characteristics between the 2 patient groups.

“Hospital stay was a little bit less for the robotic group [6 vs 8 days],” Dr. Richards said. “Other groups have shown the same thing. We did not conduct a quality-of-life analysis.”

Twelve-month survival among the patients treated with the robot was 76%, versus 77% among patients who underwent open surgery. After 24 months, the overall survival among the robot-assisted patients was 69%,versus 64% for those undergoing open surgery, which was not statistically different (P[/i> =.35).

The bladder cancer-specific survival after 1 year was 81% among patients who were operated on with the robot versus 88% among those undergoing open surgery. After 2 years, the bladder cancer-specific survival was 75% in the robot-assisted group and 80% in the open surgery group (P =.11).

Among patients with positive lymph nodes, overall survival was decreased in both groups: 25% survived at least 2 years in the robot-assisted patient group, and 38% survived among patients who had open surgery (P =.09).

About 70% of the patients in the study were men. The median age was 67 years. Body mass index was about 27. Positive margins were observed in 10% of patients in each group. About 10% of patients were treated with neoadjuvant systemic chemotherapy. Robotic cystectomy has been performed at Wake Forest since 2008. The comparative open surgeries were performed from 2005 through 2011.

- MFP Wire Services
- 5-31-2012

By: Jill Stein

ATLANTA, GA – Fesoterodine is more effective than placebo in treating elderly patients with urgency urinary incontinence, researchers said at the American Urological Association 2012 Annual Scientific Meeting.

Catherine E. DuBeau, MD, University of Massachusetts Medical School, Worcester, Massachusetts, and colleagues randomised 562 patients to flexible-dose fesoterodine or placebo.

Despite the high rate of overactive bladder symptoms, including urgency urinary incontinence in elderly patients, there are no data on the efficacy, safety, and tolerability of antimuscarinics in this population.

Study participants were independently toileting outpatients aged ≥65 years who self-reported a mean of ≥2 but ≤15 urgency urinary incontinence episodes and ≥8 micturitions per 24 hours on 3-day bladder diaries completed at baseline.

They were also vulnerable to deteriorating health as determined by a score >3 on the Vulnerable Elders Survey (VES-13). A score >3 on VES-13, based on age, health status, and functional ability, indicates a 4-fold greater risk of functional decline or death over the next 2 years.

Patients also had a score ≥20 on the Mini-Mental State Examination.

After 4 weeks on fesoterodine or placebo, patients could escalate to 8 mg fesoterodine/placebo based on a discussion with the investigator on efficacy, tolerability, and postvoid residual volume. Patients escalating to the 8-mg dose could return to 4 mg at any time during the remaining 8 weeks but re-escalation was not allowed.

The primary endpoint was change from baseline to week 12 in urgency urinary incontinence episodes/24 hours.

The fesoterodine group had a significantly larger decrease in urgency urinary incontinence episodes at week 12 than the placebo group (-2.8 vs -2.2; P =.0018).

The fesoterodine group also had a significantly larger reduction in micturitions/24 h at week 12 than the placebo group (-2.3 vs -1.5; P=.0003).

Overall, fesoterodine was well tolerated. Serious adverse events were observed in 6 placebo-treated patients and in 8 fesoterodine-treated patients, but none was considered treatment-related. Urinary retention occurred in 9 patients who received fesoterodine and 3 patients (all women) required catheterisation.

Patients receiving individually titrated fesoterodine treatment for 12 weeks also had significantly larger improvements in other diary variables compared with placebo-treated patients.

Dr. DuBeau said that the study is the first to assess an antimuscarinic for use in a medically complex, vulnerable elderly population with urgency urinary incontinence.

Funding for this study was provided by Pfizer.

- MFP Wire Services
- 05-30-2012

By: Jill Stein

ATLANTA, GA – Denosumab appears to be superior to zoledronic acid for reducing the extent to which pain interferes with daily functioning in men with castrate-resistant prostate cancer and bone metastases, researchers said at the American Urological Association 2012 Annual Scientific Meeting.

Donald Patrick, MD, University of Washington, Seattle, Washington, and colleagues used the Brief Pain Inventory-Short Form to examine pain interference in 1,901 men who were randomised to either subcutaneous denosumab 120 mg and intravenous placebo or intravenous zoledronic acid 4 mg and subcutaneous placebo every 4 weeks in a phase 3 trial. Calcium and vitamin D were strongly recommended in both treatment groups.

The phase 3 trial found that denosumab was superior to zoledronic for the prevention of skeletal complications of bone metatases.

In the present analysis, the investigators assessed pain interference with daily functioning (overall; activity [general activity, walking, work] and affect [mood, enjoyment of life, relations with others]) at baseline and before each monthly visit.

Responses on a scale of 0, which refers to a complete absence of pain, to 10, which denoted complete interference with routine functioning, were analysed for all randomised patients through month 18.

An increase or decrease of ≥2 points was considered a meaningful result.

Results showed that the average relative percentage of patients who reported a pain interference increase of ≥2 point was 5% greater in the zoledronic acid group than in the denosumab group.

Of patients who reported no pain or mild pain at baseline, 13% more in the zoledronic acid group had increased pain interference relative to denosumab.

For pain interference activity and affect domains, the overall relative proportional differences between zoledronic acid and denosumab were 6% and 5%, respectively.

The difference between denosumab and zoledronic acid-treated patients was especially pronounced in the subgroup which had no pain or mild pain at baseline. The average relative proportional differences between the 2 groups for both the pain interference activity and affect domains were 13% each.

Overall, the results showed that in men with castrate-resistant prostate cancer and bone metastases, patients receiving denosumab had consistently less worsening of overall pain interference (defined as the combination of activity, affect and sleep) compared with zoledronic acid.

Funding for this study was provided by Amgen Inc.

- MFP Wire Servicess
- 05-30-2012