Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae.

OBJECTIVE: Continuous intravenous infusion of somatostatin improves the natural course of digestive fistulae. Lanreotide 30 mg PR is a synthetic analogue of somatostatin with pharmacological activity extending to at least 10 days after intramuscular administration. Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study. METHODS: Patients demonstrating a reduction of at least 50% of fistula output within 72 hours after a first double-blind intramuscular injection of lanreotide or placebo were considered to be responders (primary end point) and continued the double-blind treatment to a maximum of 6 injections at 10-day intervals. Other endpoints included fistula closure rate and time to closure. Blind was lifted for nonresponders, and those initially on placebo were then treated with open-label lanreotide. RESULTS: Following the first double-blind injection, 35 of 54 patients (64.8%) on lanreotide were responders versus 20 of 53 (37.7%) on placebo, ie, a 3.1 times higher response likelihood on lanreotide compared with placebo (P = 0.006). Group mean reduction of fistula output at 72 hours was 45.1% and 8.9%, respectively (P = 0.005). Lanreotide compared with placebo had no effect on closure rate which averaged 77% but median time to fistula closure was shorter on lanreotide, based on Kaplan-Meier analysis, although no statistical significance was achieved. CONCLUSION: Compared with placebo, intramuscular lanreotide 30 mg PR significantly decreases digestive fistulae output at Day 3 and shortens time to fistula closure by 9 days. ClinicalTrials.gov registration number: NCT00729313.

Long-term prognostic value of detection of circulating colorectal cancer cells using CGM2 reverse transcriptase-polymerase chain reaction assay.

BACKGROUND: The criteria commonly used for prognosis of colorectal cancer remain histoprognostic and are based on primarily TNM classification. The lack of discrimination of purely histoprognostic criteria is evidenced by the development of different outcomes in similarly staged patients. The aim of this work was to study the long-term prognostic value of preoperative detection of circulating enterocytes in the blood of colorectal cancer patients using the CGM2 reverse transcriptase-polymerase chain reaction (RT-PCR) assay. METHODS: A nested RT-PCR with specific primers for CGM2 was used preoperatively to detect circulating enterocytes in 121 patients (64 men, 57 women; mean age, 70 years) with colorectal neoplasms. RESULTS: Circulating enterocytes were detected in 58/121 (48%) patients. The positivity rate was not correlated with American Joint Committee on Cancer (AJCC) staging (stage I, 11/28 (39%); stage II, 13/34 (38%); stage III, 15/23 (65%); stage IV, 17/32 (53%); sterilized (after radiotherapy, no residual neoplasm) 2/4 (50%); not significant [NS]), but circulating enterocytes were detected more frequently in patients with metastatic lymph nodes (60% vs 41%, P = .06). Overall 5-year survival rates (mean +/- SD) were 40 +/- 13% and 45 +/- 13% for patients without and with circulating enterocytes, respectively (P = NS). Similarly, recurrence-free survival rates were 71 +/- 4% versus 72 +/- 14% (P = NS). Using univariate analysis, AJCC stage (P < .0001) was correlated with survival. AJCC stage (P = .007) and obstructive neoplasms (P = .043) were correlated with recurrence-free survival. Using multivariate analysis, AJCC stage was correlated with survival and recurrence-free survival. CONCLUSIONS: Preoperative detection of circulating enterocytes using CGM2 RT-PCR assay provides no specific prognostic information and cannot be used as a decision criterion for adjuvant therapy.

Solid adenoma with exclusive hepatocellular differentiation: a new variant among pancreatic benign neoplasms?

We report a unique, previously unreported pancreatic tumor with hepatoid differentiation associated with serous microcystic adenoma in a 70-year-old man. These two lesions localized, respectively, at the body and the tail of the pancreas, were found incidentally on abdominal ultrasonography. Serum alpha-fetoprotein was not increased and no hepatic lesion was displayed on computed tomography. A subtotal pancreatectomy with splenectomy was performed. The patient is alive and well 12 months after resection. Pathological examination showed a very unusual encapsulated solid tumor with hepatocytic differentiation, bile production and immunoreactivity for hepatocyte paraffin-1 antibody. The tumor cells were negative for endocrine (neuron-specific enolase, chromogranin A, synaptophysin) and acinar (amylase, trypsin) markers. Ultrastructurally, zymogen and neurosecretory granules were absent. The features of the tumor were almost indistinguishable from those of hepatocellular adenoma; therefore, we believe that this solid hepatoid tumor may represent a variant of pancreatic adenoma. Recognition of this entity is important because the only reported pancreatic hepatoid tumors to date have been malignant. The main differential diagnoses include hepatoid ductal adenocarcinoma, hepatoid acinar cell carcinoma, primitive hepatoid endocrine tumor, and metastatic hepatocellular carcinoma.

Multiple peritoneal calcifying fibrous tumors revealed by ischemic colitis.

We report the case of a 41-year-old man presenting with multiple calcifying fibrous tumor (CFT) revealed by ischemic colitis. Peritoneal nodular lesions involved omental, mesenteric, mesorectal, and mesocolic serosal surfaces. Histologically, nodules were composed of dense bundles of collagen, calcifications, and lymphoplasmacytic infiltrate. These findings were diagnostic of CFTs, a rare and often asymptomatic benign fibrous process. Multiple peritoneal CFTs are very uncommon and usually occur in women. Calcifying fibrous tumors are usually cured by surgical excision. The differential diagnosis and histogenesis of this entity are discussed.