SAN DIEGO, CA USA (UroToday.com) - Dr. Ashish Kamat, of the M.D. Anderson Cancer Center, reported on a randomized, double-blind, placebo-controlled trial in radical cystectomy patients evaluating the potential benefit of alvimopan (alv).
Patients were randomized (1:1) to oral alv 12 mg or placebo; 1st dose preoperatively, then twice daily until hospital discharge or post-op day 7 (max 15 in-hospital doses). Primary endpoint was time to recovery of upper (1st toleration of solid food) and lower (1st bowel movement) GI function. Key secondary endpoints included time-to-discharge order written, postoperative length of stay (LOS), and postoperative ileus-related morbidity (POI), a composite endpoint including post-op nasogastric tube insertion, POI that prolonged hospital stay, or readmission ≤ 7 days for POI.
Two-hundred-eighty patients were randomized, with 277 in the modified-intent-to-treat population. The mean age was 65-years, the majority (80%) were male, and 27% had T2 tumor stage. An open approach was used in 84% of cases. All primary and key secondary endpoints achieved statistical significance in the study. Opioid consumption, incidence of treatment-emergent AEs (TEAE), and serious AEs were comparable across groups, with the exception of POI which was lower in the alv group than placebo (TEAE: 7% v. 26%; SAE: 3% v. 12%, respectively). AEs adjudicated as CV occurred in 8.4% (alv) and 15.3% (placebo) of patients (relative risk=0.55; P=0.09).
In this randomized, controlled trial, alvimopan (FDA-approved for acceleration of upper and lower GI recovery after bowel resection) was shown to significantly accelerate GI recovery, shorten LOS, and also improve in-hospital postsurgical outcomes in post cystectomy patients.
Presented by Ashish M Kamat, Sam S Chang, Cheryl Lee, Gilad Amiel, Timothy Beard, Amr Fergany, R Jeffrey Karnes, Venu Menon, Wade Sexton, Joel Slaton, Robert Svatek, Shandra Wilson, Lee Techner, Richard Bihrle, Michael Koch, and Gary D Steinberg at the American Urological Association (AUA) Annual Meeting - May 4 - 8, 2013 - San Diego Convention Center - San Diego, California USA
Reported for UroToday.com by Reza Mehrazin, MD
