Placebo-controlled trial of safety and efficacy of intraoperative controlled delivery by biodegradable polymers of chemotherapy for recurrent XXXX . The Polymer-brain Tumor Treatment Group.

@entity1 @entity137 @entity1313 @entity5 @entity11 @entity3600 @entity463
Chemotherapy for @entity1313 has been limited because of difficulty in achieving adequate exposure to the @entity5 without systemic @entity137 . We have developed a method for local sustained release of chemotherapeutic agents by their incorporation into biodegradable polymers. Implantation of the drug-impregnated polymer at the @entity5 site allows prolonged local exposure with minimal systemic exposure. We conducted a randomised, placebo-controlled, prospective study to evaluate the effectiveness of biodegradable polymers impregnated with @entity3600 to treat recurrent @entity11 . In 27 medical centres, 222 @entity1 with recurrent @entity1313 requiring re-operation were randomly assigned to receive surgically implanted biodegradable polymer discs with or without 3.85% @entity3600 . Randomisation balanced the treatment groups for all of the prognostic factors examined. Median survival of the 110 @entity1 who received @entity3600 polymers was 31 weeks compared with 23 weeks for the 112 @entity1 who received only placebo polymers (hazard ratio = 0.67, p = 0.006, after accounting for the effects of prognostic factors). Among @entity1 with @entity463 , 6-month survival in those treated with @entity3600 -polymer discs was 50% greater than in those treated with placebo (mortality = 32 of 72 [44%] vs 47 of 73 [64%], p = 0.02). There were no clinically important adverse reactions related to the @entity3600 polymer, either in the brain or systemically. Interstitial chemotherapy delivered with polymers directly to @entity1313 at the time of surgery seems to be a safe and effective treatment for recurrent @entity11 .
