This multi-centre phase II clinical trial is the first prospective evaluation of radioembolisation of patients with colorectal liver metastases (mCRC) who failed previous oxaliplatin- and irinotecan-based systemic chemotherapy regimens. Eligible patients had adequate hepatic, haemopoietic and renal function, and an absence of major hepatic vascular anomalies and hepato-pulmonary shunting. Gastroduodenal and right gastric arteries were embolised before hepatic arterial administration of yttrium-90 resin microspheres (median activity, 1.7 GBq; range, 0.9–2.2). Of 50 eligible patients, 38 (76%) had received 4 lines of chemotherapy. Most presented with synchronous disease (72%), >4 hepatic metastases (58%), 25–50% replacement of total liver volume (60%) and bilateral spread (70%). Early and intermediate (>48 h) WHO G1–2 adverse events (mostly fever and pain) were observed in 16 and 22% of patients respectively. Two died due to renal failure at 40 days or liver failure at 60 days respectively. By intention-to-treat analysis using Response Evaluation Criteria in Solid Tumours, 1 patient (2%) had a complete response, 11 (22%) partial response, 12 (24%) stable disease, 22 (44%) progressive disease; 4 (8%) were non-evaluable. Median overall survival was 12.6 months (95% CI, 7.0–18.3); 2-year survival was 19.6%. Radioembolisation produced meaningful response and disease stabilisation in patients with advanced, unresectable and chemorefractory mCRC.
Routine drainage after laparoscopic cholecystectomy is still debatable. The present study was designed to assess the role of drains in laparoscopic cholecystectomy performed for nonacutely inflamed gallbladder. After laparoscopic gallbladder removal, 53 patients were randomized to have a suction drain positioned in the subhepatic space and 53 patients to have a sham drain. The primary outcome measure was the presence of subhepatic fluid collection at abdominal ultrasonography, performed 24 h after surgery. Secondary outcome measures were postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting, and morbidity. Subhepatic fluid collection was not found in 45 patients (84.9 %) in group A and in 46 patients (86.8 %) in group B (difference 1.9 (95 % confidence interval −11.37 to 15.17; P = 0.998). No significant difference in visual analogue scale scores with respect to abdominal and shoulder pain, use of parenteral ketorolac, nausea, and vomiting were found in either group. Two (1.9 %) significant hemorrhagic events occurred postoperatively. Wound infection was observed in three patients (5.7 %) in group A and two patients (3.8 %) in group B (difference 1.9 (95 % CI −6.19 to 9.99; P = 0.997). The present study was unable to prove that the drain was useful in elective, uncomplicated LC.
Measurement of soluble (s) P‐selectin levels has been proposed as a diagnostic tool for monitoring the clinical course of human neoplasms. Thus, our study was aimed at analyzing the role of sP‐selectin in association with clinicopathological variables in 181 patients with primary (n=149) or metastatic (n=32) colorectal cancer (CRC), 34 patients with benign diseases and 181 control subjects. The results obtained showed that sP‐selectin levels were higher in patients with CRC compared either to patients with benign disease (p= 0.006) or controls (p= 0.003). No differences were observed between the latter and patients with benign diseases. Increased median sP‐selectin levels were significantly associated with the presence of distant metastasis (68.2 ng/ml vs. 48.6 ng/ml, p= 0.002). Of interest, carcinoembryonic antigen (CEA) levels were independently associated to sP‐selectin (regression coefficient= 0.28, p< 0.002). Cox's proportional hazards survival analysis of primary CRC patients demonstrated that beside the stage of disease sP‐selectin levels had an independent prognostic role in predicting recurrent disease (HR= 2.22, p= 0.019) and mortality from CRC (HR= 3.44, p= 0.017). These results suggest that measurement of plasma sP‐selectin might represent a prognostic indicator in the management of patients with CRC.
19 September 2008 in Journal of Experimental & Clinical Cancer Research
Patients with hereditary non-poliposys colorectal cancer (HNPCC) have better prognosis than sporadic colorectal cancer (CRC). Aim of our retrospective study was to compare the overall survival between sporadic CRC and HNPCC patients. We analyzed a cohort of 40 (25 males and 15 females) HNPCC cases with a hospital consecutive series of 573 (312 males and 261 females) sporadic CRC observed during the period 1970–1993. In 15 HNPCC patients we performed mutational analysis for microsatellite instability. Survival rates were calculated by Kaplan-Meier method and compared with log rank test. The median age at diagnosis of the primary CRC was 46.8 years in the HNPCC series versus 61 years in sporadic CRC group. In HNPCC group 85% had a right cancer location, vs. 57% in the sporadic cancer group. In the sporadic cancer group 61.6% were early-stages cancer (Dukes' A and B) vs. 70% in the HNPCC group (p = ns). The crude 5-years cumulative survival after the primary CRC was 94.2% in HNPCC patients vs. 75.3% in sporadic cancer patients (p < 0.0001). Our results show that overall survival of colorectal cancer in patients with HNPCC is better than sporadic CRC patients. The different outcome probably relates to the specific tumorigenesis involving DNA mismatch repair dysfunction.