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Biomedical subjects

B Landi

Publications and source records attributed to B Landi.

At least 19 recordsLinked to original sources
PubMed2006

FOLFIRI.3, a new regimen combining 5-fluorouracil, folinic acid and irinotecan, for advanced pancreatic cancer: results of an Association des Gastro-Enterologues Oncologues (Gastroenterologist Oncologist Association) multicenter phase II study.

BACKGROUND: The purpose of the study was to prospectively evaluate the efficacy and tolerability of the FOLFIRI.3 regimen in patients with unresectable pancreatic adenocarcinoma. PATIENTS AND METHODS: Chemotherapy-naive patients with histologically proven advanced pancreatic adenocarcinoma were treated with the FOLFIRI.3 regimen, consisting of irinotecan 90 mg/m(2) as a 60-min infusion on day 1, leucovorin 400 mg/m(2) as a 2-h infusion on day 1, followed by 5-fluorouracil (5-FU) 2000 mg/m(2) as a 46-h infusion and irinotecan 90 mg/m(2), repeated on day 3, at the end of the 5-FU infusion, every 2 weeks. RESULTS: Forty patients were enrolled, of whom 29 (73%) had metastatic disease. A total of 441 cycles were delivered (1-53). Grade 3-4 neutropenia occurred in 35% of the patients, accompanied by fever in two cases. Other relevant grade 3-4 toxic effects were nausea-vomiting (27%) and diarrhea (25%). Grade 2 alopecia occurred in 48% of the patients. There were no treatment-related deaths. The confirmed response rate was 37.5%. Stable disease was observed in 27.5% of the patients. The median progression-free and overall survivals were 5.6 months and 12.1 months, respectively. The 1-year survival rate was 51%. CONCLUSION: The FOLFIRI.3 regimen seems to be active on advanced pancreatic cancer and to have a manageable toxicity profile. The lack of cross-resistance between FOLFIRI.3 and gemcitabine-based regimens allows efficient second-line therapies.

Adult↗
PubMed2006

A phase II study of FOLFIRI-3 (double infusion of irinotecan combined with LV5FU) after FOLFOX in advanced colorectal cancer patients.

In advanced colorectal cancer previously treated with oxaliplatin, efficacy of irinotecan-based chemotherapy is poor and the best regimen is not defined. We designed FOLFIRI-3 and conducted a phase II study to establish its efficacy and safety in advanced colorectal cancer patients previously treated with FOLFOX. FOLFIRI-3 consisted of irinotecan 100 mg m-2 as a 60-min infusion on day 1, running concurrently with leucovorin 200 mg m-2 as a 2-h infusion on day 1, followed by 46-h continuous infusion of 5-fluorouracil (5FU) 2000 mg m-2, and irinotecan 100 mg m-2 repeated on day 3, at the end of the 5FU infusion, every 2 weeks. Sixty-five patients entered the study. The intent-to-treat objective response rate was 23% (95% CI 13-33%). Disease was stable in 37% of patients, progressed in 26% and was not assessable in 14%. From the start of FOLFIRI-3, median progression-free survival was 4.7 months and median survival 10.5 months. Main toxicities (% of patients) were grade 3-4 diarrhoea 23% and grade 4 neutropenia 11%. FOLFIRI-3 is a promising regimen achieving high response rate and progression-free survival in patients previously treated with FOLFOX with a moderate toxicity.

Adult↗
PubMed2005

Video capsule endoscopy for investigation of obscure gastrointestinal bleeding: feasibility, results, and interobserver agreement.

BACKGROUND AND STUDY AIMS: The aim of the study was to assess the feasibility, diagnostic yield, and interobserver agreement of capsule endoscopy in the investigation of patients with obscure or occult gastrointestinal bleeding. PATIENTS AND METHODS: A total of 64 consecutive patients with occult bleeding (31 %) or overt bleeding (69 %) were assessed using capsule endoscopy after negative upper and lower endoscopy and small-bowel radiology. The quality of visualization of the small-bowel mucosa was scored from 1 (poor) to 4 (excellent). Thirty video capsule recordings with normal or abnormal findings were blindly assessed by four independent endoscopists. Interobserver agreement was evaluated using the kappa index. RESULTS: The small bowel was completely visualized in 57/64 patients (89 %). Incomplete small-bowel transit was most commonly due to prolonged gastric retention (five patients). The mucosa visualization scores (means) for the proximal, middle, and distal thirds of the small bowel were 3.7, 3.3, and 2.2 respectively. Visualization of the distal ileum was good (> or = 3) in 38 % and a bleeding site was found in 45 % of patients. Push-enteroscopy was also performed in 56 patients. The results of the two techniques were similar in 37 patients, capsule endoscopy was superior in 12 patients, and push-enteroscopy was superior in seven patients. Interobserver agreement was good for bleeding and for angiodysplasia, but poor for ulcers and tumors. Mean interobserver agreement was better among experienced endoscopists than among junior endoscopists. CONCLUSIONS: Capsule endoscopy allowed the whole small intestine to be explored in 89 % of patients, with good visualization of the mucosa, except distally. Interobserver agreement was better among the experienced endoscopists and was better for red-colored abnormalities (bleeding and angiodysplasia) than for ulcers and tumors.

Adult↗
PubMed2005

Push-and-pull enteroscopy in the small bowel using the double-balloon technique: results of a prospective European multicenter study.

BACKGROUND AND STUDY AIMS: The aim of this study was to evaluate the feasibility, safety, and clinical impact of push-and-pull enteroscopy (PPE) in patients with suspected or documented small-bowel diseases, in a prospective multicenter trial in three European medical centers. PATIENTS AND METHODS: A total of 100 patients (mean age 56 +/- 16 years; range 13 - 90) were included at the three institutions between July and November 2004. The leading symptoms were: acute recurrent or chronic gastrointestinal bleeding (n = 64), polyposis syndrome (n = 8), chronic abdominal pain (n = 7), chronic diarrhea (n = 7), and others (n = 14). RESULTS: No major PPE-associated complications such as perforation, bleeding, or relevant injury to the small-bowel tissue or mesentery were encountered. Minor complications occurred in 12 %. The mean time required to carry out the procedure from the oral and anal approaches was 75 +/- 19 min (32 - 150 min). The average insertion depths into the small bowel were 200 +/- 70 cm per PPE session (220 +/- 90 cm with the oral approach and 130 +/- 80 cm with the anal approach). The average radiation exposure (including diagnostic and therapeutic interventions) was 2.1 +/- 2.4 min and 155 +/- 159 dGy/cm2. PPE was fully diagnostic in 72 % of cases. The majority of the patients (34 %) were suffering from angiodysplasias; ulcerations and erosions of various etiologies were seen in 16 %, and polyps and tumors in 13 %. The PPE findings played a role in the subsequent treatment in 62 % of the patients. Endoscopic treatments, including argon plasma coagulation, polypectomy, dilation, and foreign-body extraction, were carried out in 42 %. Medical treatment was given in 12 %, and patients were referred for surgery in 8 % of cases. CONCLUSIONS: This prospective analysis shows that PPE is safe and has a high diagnostic and therapeutic yield in patients with suspected or known small-bowel disease.

Adolescent↗
PubMed2002

Long-term outcome of patients with gastrointestinal bleeding of obscure origin explored by push enteroscopy.

BACKGROUND AND STUDY AIMS: Little is known of the long-term outcome in patients with gastrointestinal bleeding of obscure origin, who undergo investigation by means of push enteroscopy. The aim of this study was to assess the rate of recurrent bleeding and its predictive factors in patients with gastrointestinal bleeding of obscure origin, after exploration by push enteroscopy. PATIENTS AND METHODS: 105 patients with gastrointestinal bleeding of obscure origin (iron-deficiency anemia: n = 56; overt bleeding: n = 49) underwent exploration by push enteroscopy from December 1994 to December 1998. They were classified into three groups according to enteroscopy findings: no lesion found (group A; 56 patients), arteriovenous malformations (group B; 18 patients), and other gastrointestinal lesions (group C; 31 patients). Actuarial rates of rebleeding during follow-up were calculated and factors associated with rebleeding were assessed by means of univariate and multivariate analysis. RESULTS: Follow-up data were obtained for 101 patients (96 %). The mean follow-up was 29 months (6 - 54 months). The 2-year actuarial rate of rebleeding was 31 % in the overall population, and 27.6 %, 56 % and 24 % in groups A, B, and C, respectively (P = 0.13). The number of previous bleeding episodes and the number of packed red cell units transfused were two independent factors predictive of recurrent bleeding. The modality of recurrent bleeding (anemia or overt bleeding) was similar to that of the initial episode in 94 % of cases. In group A, a gastrointestinal lesion was found after rebleeding in one of the 12 patients with iron-deficiency anemia, and in four of the five patients with overt bleeding. CONCLUSION: Recurrent bleeding occurs in about one-third of patients who undergo investigation by push enteroscopy for gastrointestinal bleeding of obscure origin, with a trend towards more frequent rebleeding in patients with arteriovenous malformations. Frequent previous bleeding episodes and transfusion requirements are predictive of recurrent bleeding.

Adolescent↗
PubMed2001

Phase II trial of bimonthly leucovorin, 5-fluorouracil and gemcitabine for advanced pancreatic adenocarcinoma (FOLFUGEM).

BACKGROUND: Gemcitabine alone or 5-fluorouracil (5-FU) according to several schedules are used for palliation of metastatic and locally advanced (LA) pancreatic adenocarcinoma. This study was designed to test the efficacy of the leucovorin 5-FU and gemcitabine combination. PATIENTS AND METHODS: This phase II trial combined a simplified bimonthly LV5FU2 with gemcitabine: leucovorin 400 mg/m2 in a two-hour infusion, followed by 5-fluorouracil 400 mg/m2 bolus and 2 or 3 g/m2 continuous infusion over 46 hours; gemcitabine 1 g/m2 was infused over 30 min on day 3 after 5-FU. Treatment was repeated every two weeks. Gemcitabine dose could be increased (250 mg/m2 every two cycles up to 1500 mg/m2) in the absence of NCI-CTC toxicity > 2. RESULTS: Among the 62 patients included in this study, 22 had LA and 40 had metastatic disease. Objective response rate for the 54 patients with measurable disease was 25.9% (95% confidence interval (CI): 14%-37.8%) and 22.6% (95% CI: 12%-33.2%) in the intent-to-treat population: the clinical benefit rate for the 59 assessable patients was 49.2%. Median progression-free survival and median overall survival were 4.8 and 9 months, respectively, with 32.3% of patients alive at 1 year. The most frequent toxicity (grade 3-4) was neutropenia (56.5%) usually asymptomatic (1.1% febrile neutropenia), but requiring decreases of 5-FU and gemcitabine doses. Unexpected complete alopecia occurred in 97% of patients. CONCLUSIONS: Palliative effects, response rate and survival observed in this multicenter study seem to be superior to those obtained with gemcitabine or 5-FU alone, despite a limiting hematological toxicity.

Adenocarcinoma↗
PubMed2001

Carcinoembryonic gene member 2 mRNA expression as a marker to detect circulating enterocytes in the blood of colorectal cancer patients.

BACKGROUND: The aim of this study was to report our experience with a new molecular tool to detect circulating enterocytes in the blood of patients with colorectal cancer. METHODS: The study included 193 individuals: 78 patients with colorectal cancer and 115 controls composed of patients with benign colorectal diseases (n = 16), patients with noncolorectal cancer (n = 31), healthy individuals (n = 62), and healthy bone marrow transplantation donors (n = 6). A nested reverse transcriptase-polymerase chain reaction with specific primers for the carcinoembryonic gene member 2 (CGM2) was used to detect circulating enterocytes in the peripheral blood of 78 patients with colorectal cancer. The blood (n = 109) or the bone marrow (n = 6) of the 115 controls was studied to test the absence of CGM2 illegitimate transcription in nucleated blood cells and nucleated blood cell progenitors. The assay sensitivity was effective in detecting 1 CGM2-positive cell per 10(6) nucleated blood cells. RESULTS: Fifty-nine percent (46/78) of patients with colorectal cancer were found positive whereas all negative controls remained negative. Positivity rates were 38% (3/8) in Dukes' A classification, 43% (9/21) in Dukes' B, 77% (23/30) in Dukes' C, and 58% (11/19) in Dukes' D. CONCLUSIONS: The clinical significance of enterocyte detection in the blood of colorectal cancer patients by means of this CGM2 messenger RNA assay needs further evaluation.

Adult↗
PubMed2001

Is push enteroscopy useful in patients with malabsorption of unclear origin?

OBJECTIVE: The aim of this study was to determine the diagnostic value of push enteroscopy in patients with chronic diarrhea and malabsorption of unclear origin. METHODS: From January, 1997, to September, 1999, 16 consecutive patients with chronic diarrhea and biological signs of intestinal malabsorption but no evidence of celiac disease were explored by push enteroscopy. Previous duodenal histological findings had been normal in seven patients and abnormal but inconclusive in nine patients. Endoscopic and histological findings in the duodenum and in the jejunum were compared. RESULTS: Push enteroscopy with jejunal biopsy yielded a diagnosis in comparison with duodenal biopsy in two of 16 (12%) patients, respectively, in two of the nine (22%) patients with abnormal but inconclusive findings on duodenal biopsy, and none of the seven patients with normal duodenal histology. In the two patients in whom jejunal biopsy had diagnostic value but duodenal biopsy did not, the final diagnoses were invasive intestinal lymphoma and microsporidiosis. CONCLUSION: Push enteroscopy had diagnostic value in only 12% of patients with malabsorption of unclear origin, all of whom had had abnormal but inconclusive duodenal histological findings. Push enteroscopy with jejunal biopsy appears to have limited diagnostic value in patients with chronic diarrhea and malabsorption, especially when duodenal biopsies are histologically normal.

Adolescent↗
PubMed2000

Biliary varices on endoscopic ultrasonography: clinical presentation and outcome.

BACKGROUND AND STUDY AIMS: Bile duct varices are not a well-recognized feature of portal venous obstruction. The aim of the present study was to describe the clinical and endosonographic features of biliary involvement in patients with extrahepatic portal venous obstruction (EPVO). PATIENTS AND METHODS: A retrospective study was conducted of the clinical features, outcome, and endosonographic findings (using Olympus EUM-3 or EUM-20 probes) in 21 patients with EPVO and endosonographic features of biliary varices. Biliary varices were defined as multiple, large, serpiginous, anechoic vascular channels in and/or surrounding the extrahepatic biliary tracts. RESULTS: Biliary varices have not previously been visible using conventional imaging methods (computed tomography and ultrasonography). They were identified using EUS in the wall of the common bile duct in 16 patients (76%), surrounding the common bile duct (CBD) in 11 patients (52%), and in the gallbladder in nine (43%). The varices were the cause of obstructive jaundice in three of the 21 patients (14%), but only when they were in the wall of the CBD. Two of these patients were treated using portosystemic shunting, and the other received a biliary endoprosthesis. The EUS examination also provided evidence of unrecognized pancreatic or biliary tumors in three other patients with EPVO of undetermined origin. CONCLUSIONS: EUS can serve to diagnose biliary varices in patients with EPVO and jaundice. Although biliary varices are mainly asymptomatic, they may cause obstructive jaundice when they are located in the wall of the CBD. EUS can also detect unrecognized malignant tumors in patients with EPVO of undetermined origin.

Adult↗
PubMed2000

Prospective multicenter study comparing a standard reusable sphincterotome with a disposable triple-lumen sphincterotome.

BACKGROUND: Few data are available on the comparative performance of different types of sphincterotome. The aim of this study was to compare the efficacy of endoscopic sphincterotomy performed with either a reusable, single-lumen sphincterotome or a disposable triple-lumen instrument. METHODS: Seventy-seven consecutive adults requiring endoscopic sphincterotomy were prospectively and randomly assigned treatment with either a standard reusable single-lumen sphincterotome (group A, n = 38) or a disposable triple-lumen sphincterotome with a guidewire (group B, n = 39). The success rate, complications, and cost of the procedure per patient were compared. RESULTS: Deep cannulation was successful in 87% of cases in each group and sphincterotomy was achieved in 76% and 84% of cases in group A and B, respectively (NS). In the endoscopists' opinion the two instruments performed almost equally well. Twelve procedure-related complications occurred: 5 (all hemorrhages) in group A and 7 (1 hemorrhage, 4 cases of pancreatitis and 2 of cholangitis) in group B (NS). Eight reusable sphincterotomes were used with a cost of $61 per patient, compared with 39 disposable sphincterotomes with a cost of $241 per patient (p = 0.02). CONCLUSIONS: A standard reusable sphincterotome is satisfactory for most endoscopic sphincterotomies, and yields a substantial cost savings without compromising the success or safety of the procedure.

Aged↗
PubMed2000

Right colonic involvement is associated with severe forms of ischemic colitis and occurs frequently in patients with chronic renal failure requiring hemodialysis.

OBJECTIVE: The aim of this study was to identify factors associated with severe outcome in patients with ischemic colitis. METHODS: The files of 60 consecutive inpatients (34 women, 26 men, mean age 67 yr) with ischemic colitis were reviewed. The following data were analyzed: age, sex, smoking, medications, history of cardiovascular disease, metabolic disease, chronic renal failure and hemodialysis, the time elapsed between the first symptoms and the diagnosis, and the site and extension of their colonic involvement. Patients were divided into two groups according to outcome: those with severe disease, including those who died from ischemic colitis (n = 3) or who required surgical resection (n = 21); and those with mild forms of colitis who were treated successfully without surgery (n = 36). The two groups were compared by means of univariate and multivariate analysis to identify factors associated with unfavorable outcomes. Only patients who had a complete examination of the colon (n = 51) were entered into the statistical analysis. RESULTS: By univariate analysis, chronic renal failure (p = 0.03), hemodialysis (p = 0.01), short delay between symptoms and diagnosis (p = 0.01), and right colonic involvement (p = 0.002) were significantly more common in the patients with severe colitis. By logistic regression, right colonic involvement was the only factor independently associated with severity (p = 0.01). Right-sided lesions were present in 82% of patients on dialysis but in only 26% of patients not on dialysis (p = 0.0005). CONCLUSIONS: Right colonic involvement is associated with severe forms of ischemic colitis and occurs frequently in patients with chronic renal failure requiring hemodialysis.

Adult↗
PubMed2000

Metastatic jejunal VIPoma: beneficial effect of combination therapy with interferon-alpha and 5-fluorouracil.

The VIPoma syndrome is rare. It is usually caused by a neuroendocrine tumor located in the pancreas. Somatostatin analogs and interferon-a can be helpful in the symptomatic control of the disease, but the efficacy of chemotherapy in metastatic disease is limited. We report the case of a 32-yr-old patient who had a primary intestinal VIPoma with peritoneal carcinomatosis and hepatic metastases. Somatostatin analogs and conventional chemotherapy regimens were not effective on VIPoma syndrome and tumor progression. The combination of 5- fluorouracil and interferon-alpha was associated with a major clinical improvement and tumor regression. Further investigations should evaluate the place of such a combination as a first line treatment for patients with metastatic neuroendocrine tumors.

Adult↗
PubMed2000

Endosonographic features predictive of benign and malignant gastrointestinal stromal cell tumours.

BACKGROUND/AIM: Some endoscopic ultrasonographic (EUS) features have been reported to be suggestive of malignancy in gastrointestinal stromal cell tumours (SCTs). The aim of this study was to assess the predictive value of these features for malignancy. METHODS: A total of 56 histologically proven cases of SCT studied by EUS between 1989 and 1996 were reviewed. There were 42 gastric tumours, 12 oesophageal tumours, and two rectal tumours. The tumours were divided into two groups: (a) benign SCT, comprising benign leiomyoma (n = 34); (b) malignant or borderline SCT (n = 22), comprising leiomyosarcoma (n = 9), leiomyoblastoma (n = 9), and leiomyoma of uncertain malignant potential (n = 4). The main EUS features recorded were tumour size, ulceration, echo pattern, cystic spaces, extraluminal margins, and lymph nodes with a malignant pattern. The two groups were compared by univariate and multivariate analysis. RESULTS: Irregular extraluminal margins, cystic spaces, and lymph nodes with a malignant pattern were most predictive of malignant or borderline SCT. Pairwise combinations of the three features had a specificity and positive predictive value of 100% for malignant or borderline SCT, but a sensitivity of only 23%. The presence of at least one of these three criteria had 91% sensitivity, 88% specificity, and 83% predictive positive value. In multivariate analysis, cystic spaces and irregular margins were the only two features independently predictive of malignant potential. The features most predictive of benign SCTs were regular margins, tumour size < or = 30 mm, and a homogeneous echo pattern. When the three features were combined, histology confirmed a benign SCT in all cases. CONCLUSIONS: The combined presence of two out of three EUS features (irregular extraluminal margins, cystic spaces, and lymph nodes with a malignant pattern) had a positive predictive value of 100% for malignant or borderline gastrointestinal SCT. Tumours less than 30 mm in diameter with regular margins and a homogeneous echo pattern are usually benign.

Adult↗