Cetuximab and irinotecan as third-line therapy in advanced colorectal cancer patients: a single centre phase II trial

The epidermal growth factor receptor (EGFR), which participates in signalling pathways that are deregulated in cancer cells, is frequently mutated in colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We evaluated the efficacy of cetuximab in weekly combination with irinotecan in metastatic colorectal cancer patients refractory to previous treatments based on oxaliplatin or irinotecan. We included 55 heavily pretreated patients (colon/rectum: 34/11, M/F: 16/29, median age 63 years, range: 27–79) whose disease had progressed during or within an oxaliplatin-based first-line chemotherapy and a irinotecan-based second-line regimen. Patients were followed for tumour response and were also evaluated for the time to tumour progression, and safety of treatment. Cetuximab was given at an initial dose of 400 mg m−2, followed by weekly infusions of 250 mg m−2. Irinotecan was administered weekly at the dose of 90 mg m−2. All patients were assessable for treatment efficacy and safety response rate was 25.4% (95% CI: 21.7–39.6%); 38.2% (95 CI: 18.6–39.8%) of patients showed a disease stability as the best response. As a consequence, the overall tumour control rate was 63.6% (95% CI: 46.4–70.6%). The median time to progression was 4.7 months (95% CI: 2.5–7.1 months) and the median survival time was 9.8 months (95% CI: 3.9–10.1 months). The most common G3-4 noncutaneous side toxicities were: diarrhoea (16.4%), fatigue (12.7%) and stomatitis (7.3%). 89.1% of patients developed skin toxicity and 32.6% of cases was of grade 3–4. No allergic reactions were identified at any courses in any patients. Fever was documented in 27.3% of patients and was most commonly recorded after the first administration. Cetuximab has clinically significant activity even in heavily pretreated colorectal cancer patients progressed after both oxaliplatin and irinotecan-based chemotherapy regimens

A View-Based Access Control Model for CORBA

Specifying and managing access control policies for large distributed systems is a non-trivial task. Commonly, access control policies are specified in natural language and later reformulated in terms of a particular access control model. This paper presents and discusses concepts for an object-oriented access model that is more suitable for describing access control policies for CORBA objects than the default access model specified in the OMG security service specification

Gabexate mesilate in the treatment of acute pancreatitis

Despite controversial experimental and clinical findings, the use of Aprotinin (A) in the treatment of acute pancreatitis (AP) is still widespread in our country. Compared to A, Gabexate Mesilate (FOY) should have the following advantages: lack of antigenicity, low molecular weight with better cellular penetrance, wide inhibitory spectrum (against phospholipase A2 too) and good tolerability. In order to verify the efficacy of FOY versus, we decided to carry out a prospective multicenter (34 centers) randomized double blind trial in moderate-severe AP with FOY 3g/day versus A 1,500,000 U.I.K./day infused for 7 days with central venous line. Based on standard clinical, biochemical and radiological data, 199 patients suffering from AP were enrolled to the study from January 1989 to December 1990. The main admission criteria were: onset of the disease from no more than 72 hours, at least 2 Ranson positive criteria and C.T. evidence of acute pancreatic damage. Seventeen no protocol patients were excluded. The Etiology in the 182 analyzed patients (106 male, 76 female; mean age 57.6 years, range 21-91) were: biliary 102 (56%), alcohol 47 (25.8%), post-operative 13 (7.1%), unknown causes 13 (7.1%) and others 7 (3.8%). Median Ranson's Score was 3. CT examination showed 66 AP with edema, while 116 cases (63.7%) were recognized as severe forms with pancreatic necrotic involvement of 30% of the gland in 71 (61.2%), 50% in 31 (26.7%), and more than 50% in 14 (12.1%). Out of 182 patients, 91 were treated with A and 91 with FOY. The two groups were comparable regarding the main prognostic factors.(ABSTRACT TRUNCATED AT 250 WORDS

Attending Training Courses on Barrett\u2019s Esophagus Improves Adherence to Guidelines: A Survey from the Italian Society of Digestive Endoscopy

Background: Little is known on practice patterns of endoscopists for the management of Barrett\u2019s esophagus (BE) over the last decade. Aims: Our aim was to assess practice patterns of endoscopists for the diagnosis, surveillance and treatment of BE. Methods: All members of the Italian Society of Digestive Endoscopy (SIED) were invited to participate to a questionnaire-based survey. The questionnaire included questions on demographic and professional characteristics, and on diagnosis and management strategies for BE. Results: Of the 883 SIED members, 259 (31.1%) completed the questionnaire. Of these, 73% were males, 42.9% had > 50 years of age and 68.7% practiced in community hospitals. The majority (82.9%) of participants stated to use the Prague classification; however 34.5% did not use the top of gastric folds to identify the gastro-esophageal junction (GEJ); only 51.4% used advanced endoscopy imaging routinely. Almost all respondents practiced endoscopic surveillance for non-dysplastic BE, but 43.7% performed eradication in selected cases and 30% practiced surveillance every 1\u20132 years. The majority of endoscopists managed low-grade dysplasia with surveillance (79.1%) and high-grade dysplasia with ablation (77.1%). Attending a training course on BE in the previous 5 years was significantly associated with the use of the Prague classification (OR 4.8, 95% CI 1.9\u201312.1), the top of gastric folds as landmark for the GEJ (OR 2.45, 95% CI 1.27\u20134.74) and advanced imaging endoscopic techniques (OR 3.33, 95% CI 1.53\u20137.29). Conclusions: Practice patterns for management of BE among endoscopists are variable. Attending training courses on BE improves adherence to guidelines