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Biomedical subjects

G Balzano

Publications and source records attributed to G Balzano.

At least 19 recordsLinked to original sources
PubMed2006

Dose-intense PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) in advanced pancreatic adenocarcinoma.

BACKGROUND: PEFG regimen (cisplatin and epirubicin 40 mg/m2 day 1, gemcitabine 600 mg/m2 days 1 and 8, 5-fluorouracil (FU) 200 mg/m2/day continuous infusion) significantly improved the outcome of patients with advanced pancreatic adenocarcinoma (PA) with respect to standard gemcitabine in a previous phase III trial. This regimen was subsequently modified in a dose-finding study by increasing dose intensity of cisplatin and epirubicin (both at 30 mg/m2 every 14 days) and of gemcitabine (at 800 mg/m2 every 14 days). Results of a consecutive series treated by dose-intense PEFG regimen are herewith reported. MATERIAL AND METHODS: Dose-intense PEFG was administered to chemotherapy-naive patients with stages III-IV PA, < 75 years, performance status (PS) > 50, till progressive disease or for a maximum of 6 months. RESULTS: Between January 2004 and June 2005, 49 (31 or 63% metastatic) patients, median age 62 years, median PS 80, were treated with dose-intense PEFG. Partial response and stable disease was observed in 24 (49%) and 16 (33%) patients, respectively; 31 patients were progression-free at 6 months (PFS-6 = 63%). Median survival was 10.5 months and 1-year overall survival (OS) was 48% (95% confidence interval: 33-61%). Main grade 3-4 toxicity was: neutropenia in 26% of patients, stomatitis and fatigue in 8%, anaemia, diarrhoea, nausea/vomit in 6%, febrile neutropenia and thrombocytopaenia in 4%, hand-foot syndrome in 2%. CONCLUSION: When compared with 84 patients treated by classical PEFG at the same institution, dose-intense PEFG was not inferior in terms of PFS-6 (63 versus 57%), 1-year OS (48 versus 42%) and response rate (49 versus 49%); it allowed to increase dose intensity for gemcitabine by 32%, for cisplatin and epirubicin by 36% (FU reduced by 3%), to significantly reduce grade 3-4 hematological toxicity (neutropenia: 26 versus 86%; P < 0.00001; thrombocytopaenia: 4 versus 58%; P < 0.00001) and to reduce by one-third the number of outpatient accesses. The new PEFG schedule appears more suitable for clinical use and should be preferred as a basis for further development of therapeutic strategies against pancreatic cancer.

Adenocarcinoma↗
PubMed2006

Raltitrexed-eloxatin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer.

Limited information on salvage treatment in patients affected by pancreatic cancer is available. At failure, about half of the patients present good performance status (PS) and are candidate for further treatment. Patients >18 years, PS >or=50, with metastatic pancreatic adenocarcinoma previously treated with gemcitabine-containing chemotherapy, and progression-free survival (PFS) <12 months received a combination of raltitrexed (3 mg m(-2)) and oxaliplatin (130 mg m(-2)) every 3 weeks until progression, toxicity, or a maximum of six cycles. A total of 41 patients received 137 cycles of chemotherapy. Dose intensity for both drugs was 92% of the intended dose. Main grade >2 toxicity was: neutropenia in five patients (12%), thrombocytopenia, liver and vomiting in three (7%), fatigue in two (5%). In total, 10 patients (24%) yielded a partial response, 11 a stable disease. Progression-free survival at 6 months was 14.6%. Median survival was 5.2 months. Survival was significantly longer in patients with previous PFS >6 months and in patients without pancreatic localisation. A clinically relevant improvement of quality of life was observed in numerous domains. Raltitrexed-oxaliplatin regimen may constitute a treatment opportunity in gemcitabine-resistant metastatic pancreatic cancer. Previous PFS interval may allow the identification of patients who are more likely to benefit from salvage treatment.

Adult↗
PubMed2006

Euthyroid goitre and sleep apnea.

A number of predisposing factors (obesity, nasal obstruction, adenoidal hypertrophy, macroglossia, etc) have been related to obstructive sleep apnea syndrome (OSAS). In addition hypothyroidism and large goitres have been reported to be associated to OSAS, but this association has not been adequately studied. We describe an obese patient with euthyroid goitre associated with OSAS. The patient showed a body mass index (BMI) of 47 and a large neck with a circumference of 60 cm. The flow-volume curve demonstrated an expiratory plateau suggesting an intrathoracic upper airway obstruction. Arterial blood gas analysis results were: pH 7.39; PCO2 54.2 mmHg; P O2 47 mmHg. Nocturnal polisomnography showed an apnea/hypopnea index (AHI) of 31 episodes/hour. Upper airway collapse was overcome by a nasal continuous positive airway pressure (nCPAP) of 14 cmH2O. Weight loss obtained by a hypocaloric diet was not accompanied by any OSAS improvement. After thyroidectomy, a nCPAP of 4 cmH2O was sufficient to prevent upper airway closure. Discontinuation of nCPAP treatment for 4 consecutive nights did not determine worsening of sleep apnea symptoms, nor a worsening of overnight oxymetry. A new polysomnography carried out after 4 nights off nCPAP showed an AHI of 33 episodes/hour. OSAS should be suspected in patients with large goitres. Decisions regarding discontinuation of nCPAP treatment after thyroidectomy should be based on polisomnographic results.

Aged↗
PubMed2003

Surgical treatment of benign and borderline neoplasms of the pancreatic body.

BACKGROUND: Conventional operations for benign and borderline tumors of the pancreatic body are distal pancreatectomy and enucleation. An unusual operation allowing the preservation of the proximal and distal pancreas is median pancreatectomy. METHOD: A retrospective analysis of prospectively collected data on 67 patients with nonmalignant neoplasms of the pancreatic body was performed. The operations were: 32 median pancreatectomies (22 with duct occlusion of the distal pancreas, 10 with pancreaticojejunostomy), 21 distal pancreatectomies, and 14 enucleations. The operative and long-term outcomes of the different operations were compared. RESULTS: Enucleation had a shorter operative time and less blood loss than the other operations. No mortality was observed. The pancreatic fistula rate was 50% after median pancreatectomy (59% in case of distal duct occlusion, 30% in case of pancreaticojejunostomy), 14% after distal pancreatectomy and 14% after enucleation. Diabetes appeared in 3 patients after distal pancreatectomy and 3 patients after median pancreatectomy with duct occlusion. CONCLUSIONS: When indicated, enucleation is the operation of choice for a nonmalignant neoplasm of the pancreatic body. With respect to distal resection, the higher fistula rate of median pancreatectomy with pancreaticojejunostomy could be the price for a better long-term endocrine function; median pancreatectomy with duct occlusion had worse operative results and no long-term advantages.

Adolescent↗
PubMed2002

Leukotriene receptor antagonists in the treatment of asthma: an update.

Leukotriene receptor antagonists (LTRAs), such as montelukast and zafirlukast, have been demonstrated in a number of studies to possess bronchodilating and anti-inflammatory properties, that make these drugs ideal candidates for the treatment of asthma. The last 1998-updating of the GINA Guidelines for the diagnosis and therapy of asthma recommends the use of LTRAs in the treatment of moderate and mild asthma. In patients with moderate asthma not completely controlled with moderate doses of inhaled corticosteroids, the addition of a LTRA is indicated in alternative to either the increase of the inhaled corticosteroid dose or the addition of an inhaled long-acting beta2-agonist. Both in vitro and in vivo evidences indicate that LTRAs possess an anti-inflammatory activity that is presumably complementary to that presented by corticosteroids. Moreover, clinical studies show that the addition of an LTRA, montelukast, is able to improve clinical and functional indexes in patients with asthma not controlled with inhaled corticosteroids, and to allow a reduction in corticosteroid dosage in patients with asthma well controlled by inhaled corticosteroids. In patients with mild persistent asthma monotherapy with an LTRA is indicated in alternative to a low-dose inhaled corticosteroid, an inhaled cromone, or an oral slow-release theophylline. Previous clinical studies in patients with mild to moderate asthma had demonstrated that monotherapy with LTRAs is able to improve airway function, asthma symptoms, use of as-needed medications, exacerbation rate, and quality of life, without evidence of tolerance with prolonged use. Recently, in a subgroup analysis of patients with mild persistent asthma, a 6-week treatment with oral montelukast or inhaled beclomethasone gave similar improvements in "rescue-free" days, days with well controlled asthma, FEV1, blood eosinophils, beta-agonist use, and nocturnal awakes due to asthma.

Anti-Asthmatic Agents↗
PubMed2001

Effect on local control and survival of electron beam intraoperative irradiation for resectable pancreatic adenocarcinoma.

PURPOSE: To assess the impact on local control and survival of intraoperative radiotherapy (IORT) in resectable pancreatic adenocarcinoma. METHODS AND MATERIALS: The outcome of 127 patients surgically treated with curative intent combined with IORT was compared with the therapeutic results of 76 patients treated with surgery as exclusive treatment. RESULTS: Operative mortality and morbidity were similar in IORT and no-IORT patients. In 49 patients with locally limited disease (Stage I-II; LLD), IORT (n = 30) reduced the local failure rate and significantly prolonged time to local failure (TTLF), time to failure (TTF), and overall survival (OS) with respect to surgery alone (n = 19). The multivariate analyses, stratifying patients by age, tumor grade, resection margins, chemotherapy, and external-beam radiotherapy use, confirmed the independent impact of IORT on outcome. In patients with locally advanced disease (Stage III-IVA; LAD), IORT had an impact on local failure rate and on TTLF when combined with beam energies of greater than 6 MeV, whereas no effect on TTF and OS was observed. CONCLUSION: IORT did not increase operative mortality and morbidity and achieved a significant improvement in local control and outcome in patients with LLD. In patients with LAD, beam energies greater than 6 MeV prolonged TTLF.

Adenocarcinoma↗
PubMed2001

Definitive results of a phase II trial of cisplatin, epirubicin, continuous-infusion fluorouracil, and gemcitabine in stage IV pancreatic adenocarcinoma.

PURPOSE: To evaluate the efficacy and toxicity of a cisplatin, epirubicin, gemcitabine, and fluorouracil (PEF-G) schedule on stage IV pancreatic adenocarcinoma. PATIENTS AND METHODS: Patients < or = 70 years, with no prior chemotherapy and with bidimensionally measurable stage IV pancreatic adenocarcinoma, Eastern Cooperative Oncology Group performance status < or = 2, and adequate bone marrow, kidney, and liver function were eligible for this trial. Eligibility criteria for clinical benefit assessment were pain with at least a daily analgesic consumption of two nonsteroidal anti-inflammatory drugs or Karnofsky performance status between 50 and 70. Treatment consisted of 40 mg/m2 each of cisplatin and epirubicin day 1, gemcitabine 600 mg/m2 on days 1 and 8 every 4 weeks, and fluorouracil 200 mg/m2/d as a protracted venous infusion. RESULTS: Between April 1997 and April 1999, 49 patients from a single institution were eligible for the study. Altogether, 203 cycles (median, four cycles) of PEF-G were delivered. The objective response rate was 58% in 43 assessable patients and 51% in the intent-to-treat population. Fourteen patients had stable disease. Grade 3 or 4 World Health Organization neutropenia occurred in 51% of cycles, thrombocytopenia in 28%, anemia in 7%, stomatitis in 5%, and diarrhea, and nausea, and vomiting in 2%. The median duration of response was 8.5 months. The median time to tumor progression was 7.5 months. The median survival was 11 months in the assessable population and 10 months in the intent-to-treat population. Clinical benefit was achieved in 22 (78%) of 28 assessable patients. CONCLUSION: PEF-G is a well-tolerated and safe regimen; it obtained a very high rate of durable responses and deserves further evaluation in a phase III trial.

Adenocarcinoma↗
PubMed2000

Generation and functional characterisation of dendritic cells from patients with pancreatic carcinoma with special regard to clinical applicability.

BACKGROUND: We studied dendritic cell (DC) function in patients affected by pancreatic carcinoma, and the possibility of obtaining DC adequate for immunological treatment modalities. METHODS: Leucocytes were isolated from buffy coats obtained by autotransfusion of six patients undergoing pancreatico-duodenectomy. The leucocytes were cryopreserved and, after thawing, were purified by density gradient and/or plastic adhesion. They were then cultured in vitro in cytokine-enriched medium (granulocyte/macrophage-colony-stimulating factor + interleukin-4) with different sources of serum: 10% fetal calf serum (FCS), 2% autologous human serum or 2% pooled human AB serum. RESULTS: The DC obtained were identical to those from healthy donors in terms of phenotype, antigen uptake capacity, capacity for antigen presentation and their capacity to mature after exposure to stimuli like CD40L. DC differentiated in human serum demonstrated more mature behaviour than did DC cultured in FCS but, after exposure to CD40L, this difference disappeared. In one patient soluble factors in serum were able to inhibit the capacity of DC to stimulate T cells. CONCLUSION: It's possible to obtain DC from autotransfusion of patients with pancreatic carcinoma: these cells do not show evident quantitative or qualitative alterations, are able to present soluble antigen even when cultured in the presence of human serum and may be used in immunological tumour treatments.

Adenocarcinoma↗
PubMed2000

Effectiveness and acceptability of a domiciliary multidrug inhalation treatment in elderly patients with chronic airflow obstruction: metered dose inhaler versus jet nebulizer.

The aim of this study was to compare the immediate and long-term bronchodilator effect as well as the patient acceptability of a 2-week, multidrug, inhalation treatment delivered by a metered dose inhaler (MDI) versus a jet nebulizer in a group of elderly patients with chronic obstructive pulmonary disease (COPD) or asthma and an at least partially reversible airflow obstruction. Twenty elderly outpatients (17 men; mean +/- SD age, 67 +/- 2 years; mean +/- SD baseline forced expiratory volume in 1 second [FEV1], 46.5 +/- 14% of predicted value) with COPD or asthma participated in the study, which was of an open, randomized, crossover design. After a 1-day baseline evaluation, including patient history, clinical examination, and spirometry, participants were randomly assigned to receive a multidrug inhalation treatment (a combination of salbutamol, ipratropium, and flunisolide) with either an MDI or a jet nebulizer. Two weeks later, they were shifted to treatment with the alternative system for a further 2 weeks. FEV1 was measured on the first and fourteenth days of each treatment period, on each occasion both before and 30 minutes after the morning inhalation. At the end of the study, patients were asked to express a personal preference for one of the two inhalation treatments with regard to effectiveness and acceptability by filling out a simple questionnaire. Both the MDI and jet nebulizer had a significant immediate bronchodilator effect on the first and fourteenth days of treatment, with no differences between treatments. No long-term bronchodilator effect was seen with either aerosol delivery system. Patient preferences were clearly in favor of the jet nebulizer with regard to effectiveness and in favor of the MDI with regard to acceptability. In conclusion, in elderly patients with COPD or asthma and partially reversible airflow obstruction, a maintenance multidrug bronchodilator/anti-inflammatory inhalation treatment produced a statistically significant and clinically relevant bronchodilator effect without substantial differences between the two delivery systems. Most patients considered the MDI to be more acceptable and the jet nebulizer to be more effective. These preferences should be taken into consideration when prescribing a maintenance aerosol inhalation treatment.

Administration, Inhalation↗
PubMed2000

Artificial nutrition after pancreaticoduodenectomy.

Patients undergoing pancreaticoduodenectomy (PD) often require postoperative artificial nutrition. This trial was undertaken to evaluate whether the route of administration and the composition of the postoperative nutritional support could affect the immunometabolic response and outcome. A prospective, randomized trial was carried out in 212 subjects who underwent PD. Patients were randomized to receive a standard enteral formula (standard group, n = 73) or an enteral formula enriched with arginine, omega-3 fatty acids, and RNA (immunonutrition group, n = 71), or total parenteral nutrition (parenteral group, n = 68). Postoperative feeding started 6 hours after surgery. The three regimens were isocaloric and isonitrogenous. Assessed parameters were phagocytosis ability of polymorphonuclear cells, plasma interleukin-2 receptors, C-reactive protein, retinol binding protein, tolerance of enteral feeding, rate of postoperative complications, and length of hospital stay (LOS). Full nutritional goal (25 kcal/kg) was achieved in 87% of enterally fed patients versus 95% in the parenteral group. Subjects receiving immunonutrition had a significantly better recovery of the immunometabolic parameters on postoperative day 8 compared to the other two groups. The rate of postoperative complications was lower in the immunonutrition group (33.8%) than in either the standard (43.8%) or parenteral group (58.8%) (p = 0.005 immunonutrition vs. parenteral). Also, the mean LOS was shorter in the immunonutrition group than in the standard and parenteral groups (15.1 vs. 17.0 vs. 18.8 days, respectively; p < 0.05). Early postoperative enteral feeding may safely and effectively replace parenteral nutrition in patients undergoing PD. Immunonutrition ameliorates the immunometabolic response and improves outcome compared to parenteral feeding.

Adult↗
PubMed2000

Induced sputum cellularity. Reference values and distribution in normal volunteers.

Sputum induction has recently been proposed as the only direct noninvasive method for measuring airway inflammatory indices. The reference values and the distribution of cells in induced sputum in a control population have not yet been well defined. We therefore evaluated data from a large number of healthy volunteers. One hundred fourteen healthy, nonatopic, nonsmoking volunteers without airway hyperreactivity were enrolled (age: 38 +/- 13 yr [mean +/- SD]; FEV(1): 105 +/- 10% predicted; provocative dose of methacholine inducing a 20% decrease FEV(1) > 3,200 microgram). Ninety-six subjects (84%) produced adequate analysis samples. The subjects had a normal age distribution. Their induced sputum was rich in macrophages (69.2 +/- 13%) and neutrophils (27.3 +/- 13%), and poor in eosinophils (0.6 +/- 0.8%), lymphocytes (1.0 +/- 1.2%), and epithelial cells (1.5 +/- 1.8%). Only macrophages and neutrophils showed a normal distribution; total and differential counts of other cells did not. We propose that these data be used in comparison of the induced sputum cells of normal subjects and those of patients with airway inflammation.

Adult↗
PubMed1999

Pylorus-preserving pancreaticoduodenectomy versus conventional whipple operation.

During 1990 to 1997 a series of 39 patients underwent a classic pancreaticoduodenectomy and 74 a pylorus-preserving pancreaticoduodenectomy for pancreatic adenocarcinoma. The two groups had similar tumor characteristics and received comparable adjuvant treatments. No significant differences were found between the two groups in terms of mortality, morbidity, gastric emptying, food intake resumption, and hospital stay. Postoperative survival was not affected by the preservation of the pylorus, determined by both univariate and multivariate analyses. Postoperative nutritional outcome was similar in the two groups, although patients receiving adjuvant chemotherapy had a better nutritional recovery if the whole stomach was preserved. In our opinion pylorus-preserving pancreatoduodenectomy is the treatment of choice of pancreatic head cancer.

Adenocarcinoma↗
PubMed1999

Complications of pancreatic surgery and the role of perioperative nutrition.

BACKGROUND: According to international guidelines, artificial nutrition may be indicated after pancreaticoduodenectomy (PD). This clinical study was designed to evaluate whether the route of administration and the composition of the postoperative nutritional support could affect outcome. METHODS: One hundred patients who underwent PD for cancer of the pancreatic head were prospectively studied. Patients were randomized to receive a standard enteral formula (SEN; n = 35) or immunonutrition with an enteral formula enriched with arginine, omega-3 fatty acids, and RNA (IEN group; n = 33), or total parenteral nutrition (TPN; n = 32). Postoperative feeding was started within 12 h after surgery. The three regimens were isoenergetic and isonitrogenous. Tolerance of enteral feeding, rate and severity of postoperative complications, and length of hospital stay (LOS) were evaluated. RESULTS: Full nutritional goal (25 kcal/kg) was achieved in 84% of enterally fed patients versus 96% in the parenteral group (p = NS). The rate of postoperative complications was lower in the IEN group (33%) than in the SEN (40%) and TPN groups (59%). The severity of infectious complications (sepsis score) was lower in the IEN (5.5) than the SEN (7.9) and TPN groups (10.4; p < 0.05). LOS was shorter in the IEN than in the SEN and TPN groups (16.3 vs. 17.8 vs. 19.3 days, respectively; p < 0.05). CONCLUSIONS: In patients undergoing PD the established nutritional goal can be obtained by enteral feeding. Immunonutrition seems to improve outcome.

Adenocarcinoma↗
PubMed1999

Eosinophilic inflammation in stable chronic obstructive pulmonary disease. Relationship with neutrophils and airway function.

The number and significance of airway eosinophils in stable COPD is controversial. Aims of this study were to evaluate airway inflammation in patients with stable COPD compared with other groups, and to examine the correlations between inflammatory markers and functional indices of airway obstruction. Cellular analysis and evaluation of eosinophil cationic protein (ECP) levels in induced sputum were made in 46 subjects (10 patients with clinically stable COPD, 15 patients with asthma, 11 asymptomatic smokers, and 10 healthy control subjects). As expected, eosinophils were significantly (p < 0.01) higher in patients with asthma (22.2%) than in other groups (COPD, 0.7%; smokers, 0.2%; control subjects, 0.2%), and neutrophils were significantly (p < 0.01) higher in patients with COPD (77.5%) than in the other groups (asthma, 26.7%; smokers, 33.1%; control subjects, 35.9%). However, eosinophils were also increased in patients with COPD, as compared with healthy controls (p < 0.05). Sputum ECP levels were significantly and similarly higher in both asthma and COPD groups than in the other two groups (p < 0.01). In patients with COPD and asymptomatic smokers, considered as a whole, good correlations were found between eosinophils and ECP, on the one hand, and between FEV(1) and the FEV(1)/FVC ratio, on the other. Our data suggest that eosinophils may be involved in the airway inflammation of COPD.

Adult↗
PubMed1998

Effects of short-term transdermal estradiol administration on plasma levels of nitric oxide in postmenopausal women.

OBJECTIVE: To assess the effects of short-term transdermal E2 administration on nitric oxide (NO) plasma levels in postmenopausal women. DESIGN: Randomized, placebo-controlled trial. SETTING: Healthy volunteers in an academic research environment. PATIENT(S): Twenty-eight healthy postmenopausal women. INTERVENTION(S): Transdermal administration of E2 (100 microg/d) or placebo on days 1 and 4 of a 1-week treatment regimen. MAIN OUTCOME MEASURE(S): Serum concentrations of E2 and plasma concentrations of NO stable oxidation products were assessed on day 1, before placement of the patch, and subsequently on days 2, 3, and 6. RESULT(S): The mean concentration of NO metabolites on days 2, 3, and 6 was significantly greater in the E2 group (40.08+/-15.42 micromol/L, 38.05+/-18.82 micromol/L, and 42.03+/-16.81 micromol/L on days 2, 3, and 6, respectively) compared with both baseline levels (23.07+/-5.79 micromol/L) and the placebo group (23.51+/-4.06 micromol/L, 21.64+/-4.72 micromol/L, and 21.81+/-4.46 micromol/L on days 2, 3, and 6, respectively). CONCLUSION(S): During a 1-week treatment regimen with transdermal E2, plasma levels of NO in postmenopausal women were significantly higher than baseline levels on days 2, 3, and 6. This suggests that the effect of estrogens on NO synthesis is rapid and that it is maintained with repeated administration.

Administration, Cutaneous↗
PubMed1998

Pancreatic cancer resection in elderly patients.

BACKGROUND: Pancreatic cancer resection is considered a high-risk procedure in patients aged 70 years or older. METHODS: Some 398 patients with pancreatic adenocarcinoma, observed between 1990 and 1995, were reviewed. Operative outcome and survival of 33 patients aged 70 years or more were compared with findings in 85 younger patients who underwent resection. RESULTS: Resectability was not significantly different between the elderly and younger patients; neither were mortality or overall morbidity. However, patients aged 70 years or more had more relaparotomies (P < 0.01) and more haemorrhagic complications (P < 0.001). Nutritional recovery after resection was satisfying even for elderly patients (body-weight gain and increase in serum albumin concentrations, P < 0.05). Univariate analysis showed a moderately poorer survival in the elderly (P = 0.09). Multivariate analysis demonstrated that tumour diameter, grading and Union Internacional Contra la Cancrum stage were independent prognostic factors, whereas age was not. CONCLUSION: Patients aged 70 years or more can benefit from pancreatic cancer resection similarly to younger patients.

Adenocarcinoma↗