A randomised double-blind placebo-controlled phase II study of AGI004 for control of chemotherapy-induced diarrhoea.

BACKGROUND: AGI004 is a controlled-release transdermal patch preparation of mecamylamine. We conducted a randomised placebo-controlled phase II study of two dose levels of AGI004 in chemotherapy-induced diarrhoea (CID). METHODS: Adult patients receiving chemotherapy who had experienced diarrhoea (NCI grade 1-2) during previous cycles of chemotherapy were eligible. In all, 64 patients were randomised to receive AGI004 4 mg then 8 mg per 24 h transdermal patch or placebo for two sequential cycles of chemotherapy. Patients' severity of diarrhoea was physician-assessed using NCI grade of diarrhoea and patient-assessed using information recorded in daily diaries of bowel movements. RESULTS: Overall AGI004 doubled the odds of a response to treatment on the first day of chemotherapy based on physician assessment of NCI grade of diarrhoea compared with placebo (odds ratio=2.0, 90% confidence interval: 0.9-4.5) and there was a trend to improved response rates for AGI004 for the full treatment cycle although these results were not statistically significant. There was also evidence of significantly improved response rates based on patient assessment of diarrhoea both overall (P=0.05) and at the 8-mg dose level (P=0.02) compared with placebo. CONCLUSION: AGI004 demonstrated effectiveness in reducing chemotherapy-associated diarrhoea, with results suggesting response across multiple measurements of diarrhoea. Treatment was well tolerated with no drug-related adverse events. Further evaluation of this agent in the management of CID is warranted.

[Intestinal obstruction caused by abdominal pseudotumoral endometriosis mimicking a peritoneal carcinomatosis--case report]. / Ocluzie intestinala prin endometrioza abdominala pseudotumorala cu aspect de carcinomatoza peritoneala--prezentare de caz.

A 40-year-old woman was admitted in emergency condition with the symptomatology of bowel obstruction. Intraoperative findings consists of a pelvic fixed tumoral mass, and numerous other tumors spread in the whole abdominal cavity mimicking a peritoneal carcinomatosis without liver metastases. Three of the tumors where about 4 cm in diameter producing stenosis of the terminal ileurn and sigma. We considered the case as it was a peritoneal carcinomatosis caused by an uterus or ovarian cancer and we decided for palliative surgery, performing ileo-transversostomy and sigmoidostomy above the obstruction. The histopathologic findings from more pieces of tumors revealed endometriosis without cancerous changes. Postoperative the patient underwent cytostatic and then hormonal therapy. After 3 month the CT scan revealed an important reducing in volume of the pelvic tumoral mass and the barium enema didn't showed any stenosis under the colostomy so, we closed it extraperitonealy. At 16 month after the first operation the patient was reoperated for a parietal defect. At the second look we found no tumors. The pelvic tumoral mass has disappeared, the uterus seemed to be normal but two big ovary cysts were present. We performed bilateral adnexectomy and the repair of the parietal defect. Postoperative evolution was favorable without any complication or complains at 3 month after the last operation.