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G Catalano

Publications and source records attributed to G Catalano.

At least 19 recordsLinked to original sources
PubMed2006

Weekly docetaxel and capecitabine is not effective in the treatment of advanced gastric cancer: a phase II study.

BACKGROUND: Capecitabine and docetaxel have demonstrated preclinical antitumor synergy and activity in advanced gastric cancer. We assessed the clinical activity and the toxicity of weekly docetaxel in combination with capecitabine in untreated patients with advanced gastric cancer. PATIENTS AND METHODS: A total of 38 patients were treated with docetaxel 36 mg/m2 on days 1, 8, and 15 i.v., plus capecitabine, 625 mg/m2 bid per os on days 5 to 18 repeated every 4 weeks. RESULTS: All patients were assessable for response to treatment and for toxicity. Major responses were observed in eight patients (21%), with three patients achieving a CR (7.8%) and five showing a PR (13%). The median time to progression was 5.4 months and the overall survival was 7.7 months. The safety profile of this schedule was acceptable with a low rate of myelossuppression, diarrhoea and hand-foot syndrome. CONCLUSIONS: The combination of docetaxel and capecitabine at the doses and schedule investigated in this study is safe, but does not show significant activity in untreated patients with advanced gastric cancer.

Adenocarcinoma↗
PubMed2006

Phase II study of gefitinib in combination with docetaxel as first-line therapy in metastatic breast cancer.

We have evaluated the activity and safety of gefitinib, a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with docetaxel as first-line treatment of women with metastatic breast cancer (MBC). In total, 41 patients with MBC were enrolled in a first-line combination therapy study with oral gefitinib (250 mg day(-1)) and intravenous docetaxel (75 mg m(-2), the first 14 patients; or 100 mg m(-2), the following 27 patients, on day 1 of a 3-week cycle). Out of 41 patients, 38 received at least one cycle of therapy. There were no differences in activity or tolerability between the two docetaxel doses. G3/4 toxicities were neutropenia (49%), diarrhoea (10%), acne-like rash (5%), and anaemia (2%). Complete plus partial responses (CR+PR) were observed in 22 out of 41 patients with a 54% response rate (95% confidence interval (CI) 45-75%). The 22 patients that achieved a response following six cycles of docetaxel plus gefitinib continued gefitinib monotherapy (median duration, 24 weeks; range, 2-108+ weeks). Two patients with PR following combination therapy achieved a CR during gefitinib monotherapy. Complete plus partial responses correlated with oestrogen receptor (ER) status, since they occurred in 19 out of 27 (70%) patients with ER-positive tumours as compared to three out of 14 (21%) patients with ER-negative tumours (P=0.01).

Adult↗
PubMed2006

Cost analysis of tumor downsizing for hepatocellular carcinoma liver transplant candidates.

We report the results of a prospective, intent-to-treat (ITT) trial on the costs of selective tumor downsizing (DS) before liver transplantation (LT) for patients affected with hepatocellular carcinoma (HCC). The trial started in January 1997 including adult patients with nodular-type HCC within and beyond the Milan criteria. Patients were downsized with transarterial chemoembolization (TACE), percutaneous ethanol injection (PEI) and/or radiofrequency ablation (RFA) according to clinical predictors. TACE and RFA were performed as inpatient procedures, while PEI was performed on an outpatient basis. Costs of DS were obtained according to the Tuscany Health Reimbursement Fee Catalog adjusted to yearly inflation rates from 1997 through 2005. Data analysis was performed at 1 year after the last enrollment of 198 patients, including 161 (81.3%) who were transplanted: 34 (17.2%) dropped out and 3 (1.5%) were still on the waiting list. One hundred and fifty-two patients (76.7%) underwent DS for a total of 201 procedures: 159 TACE, 39 PEI, and 3 RFA. Overall costs in Euros (euro) of waitlisting were 861,801.24 euro: 548,460 euro (63.7%) for pretransplantation evaluation; 197,994.84 euro (22.9%) for control visits and hospitalizations; and 115.346.4 euro (13.4%) for DS. Mean costs of DS were 758.58 euro +/- 270 euro per downstaged patient (747.53 euro +/- 257.1 euro Milan; 774.01 euro +/- 287.71 euro non-Milan); 582.85 euro +/- 398.87 euro per waitlisted patient (520.28 euro +/- 406.23 euro Milan; 520.28 +/- 364.48 euro non-Milan); and 716.4 euro per transplanted patient (580.67 euro Milan; 1026.76 euro non-Milan; +76.8%). A selective policy of tumor DS increased the costs of LT waitlisting by 13.4%, but due to higher dropout rates among non-Milan patients, the cost utility of DS was 76.8% higher in the Milan group.

Adolescent↗
PubMed2005

A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients.

The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil (5-FU) and folinic acid (FA) administered every 2 weeks (FOLFOX-4 regimen) in patients with advanced gastric cancer (AGC). A total of 61 previously untreated AGC patients were treated with oxaliplatin 85 mg m(-2) on day 1, FA 200 mg m(-2) as a 2 h infusion followed by bolus 5-FU 400 mg m(-2) and a 22 h infusion of 5-FU 600 mg m(-2), repeated for 2 consecutive days every 2 weeks. All patients were assessable for toxicity and response to treatment. Four (7%) complete responses and 19 partial responses were observed (overall response rate, 38%). Stable disease was observed in 22 (36%) patients, with progressive disease in the other six (10%) patients. Median time to progression (TTP) and median overall survival (OS) were 7.1 and 11.2 months, respectively. National Cancer Institute Common Toxicity Criteria grade 3 and 4 haematologic toxicities were neutropenia, anaemia and thrombocytopenia in 36, 10 and 5% of the patients, respectively. Grade 3 peripheral neuropathy was recorded in three (5%) patients. FOLFOX-4 is an active and well-tolerated chemotherapy. Response rate (RR), TTP and OS were comparable with those of other oxaliplatin-based regimens, suggesting a role for this combination in gastric cancer.

Adenocarcinoma↗
PubMed2005

Microcirculation and reperfusion injury in organ transplantation.

There are many interesting aspects regarding hemorheology and tissue oxygenation in organ transplantation (such as liver, kidney, heart, etc.). The ischemia-reperfusion injury syndrome is a very important problem. Much damage in organs appears to be induced by reperfusion injury syndrome. In fact, not only immunological etiopathogenesis but also biochemically-mediated microcirculation alterations can modulate the organ damage induced by ischemia-reperfusion injury during organ transplantation. During ischemia-reperfusion injury, xanthine oxidase activity, the increase in oxygen free-radicals, and the activation of neuthrophils are all very important. Platelet activating factor (PAT) and LTB4 (promoting neuthrophils adhesiveness), activated by the xanthine oxidase-derived oxidants during reperfusion, activates the final post-ischemia injury. Much research is necessary in order to gain a fuller knowledge of the microcirculation conditions and oxygenation during organ transplantation.

Adult↗
PubMed2005

Fast track in liver transplantation: 5 years' experience.

BACKGROUND AND OBJECTIVE: Reducing postoperative mechanical ventilation in patients undergoing liver transplantation may have clinical and organizational advantages. On the basis of our experience, we here evaluate the possibility of practising immediate tracheal extubation in the operating theatre. METHODS: In this prospective study, patients consecutively undergoing liver transplantation between 1 June 1999 and 31 May 2004 were extubated in the operating theatre at the end of surgery on the basis of standardized and universally accepted criteria, under conditions of haemodynamic and metabolic stability. RESULTS: Two hundred and seven of the 354 patients (58.5%) were extubated immediately after the completion of the surgical procedure (mean time between end of surgery and extubation: 0.4 +/- 1.4 min); two were re-intubated. In the last of the 5 yr of the study, the percentage of immediate extubations increased to 82.5%. During the study period, there was a progressive increase in the number of immediate extubations per individual member of the team of anaesthetists. The pre-transplant Child-Pugh severity of the underlying liver disease did not predict rapid extubation, but the Model for End-stage Liver Disease score of < 11 did (receiver operator characteristic area under the curve = 0.61; P < 0.05). CONCLUSIONS: Immediate extubation after liver transplantation is possible in a substantial percentage of cases; confidence, habit and a spirit of emulation are decisive factors in encouraging anaesthetists to extend this practice to the largest possible number of patients. A successful immediate extubation may be an important indicator of perioperative quality of care in liver transplantation.

Adolescent↗
PubMed2005

Adjuvant chemotherapy of gastric cancer: which regimens?

Gastric cancer is still a major health problem and a leading cause of cancer mortality despite a worldwide decline in incidence. Surgical resection with curative potential is the only treatment modality of scientific proven effectiveness. Many phase III trials of adjuvant therapy have been conducted, however, postoperative treatment modalities have not proven to be superior to pos-surgical observation alone. Therefore, at present the routine use of adjuvant therapy should be regarded as an investigational approach. Improved clinical trial designs with standardized surgical techniques and the incorporation of newer active drugs are needed.

Angiogenesis Inhibitors↗
PubMed2004

Hepatic resection after liver transplantation as a graft-saving procedure: indication criteria, timing and outcome.

BACKGROUND: Hepatic resection is uncommon after liver transplantation (LT), but can be a graft-saving procedure in selected cases. Herein we describe the criteria, outcome, and timing of this procedure in our series. METHODS: Between January 1996 and December 2002, 397 LTs were performed in 367 recipients, of whom 12 patients (3.2%) subsequently underwent liver graft resections because of ischemic-type biliary lesions (ITBLs) (n = 5, 41.6%), segmental hepatic artery thrombosis (S-HAT)(n = 3, 25%), recurrent hepatocellular carcinoma (HCC) (n = 2, 16.6%), liver abscess (n = 1, 8.3%), or liver trauma (n = 1, 8.3%). The patients were divided into group 1 (n = 3 all with S-HAT) who underwent early resections (within 3 months of LT), and group 2 (n = 9) who underwent late resections (after 3 months). The outcomes and postoperative mortality ratio (within 30 days) were compared. RESULTS: The resections consisted of four left lobectomies, three right hepatectomies, two extended right hepatectomies, one segmentectomy, one anterior trisegmentectomy, and one right lateral sectoriectomy. The perioperative mortality rate was 66.6% in group 1 (one case of myocardial infarction and one of sepsis), and 22% in group 2 (one case of sepsis and one of hepatic failure). CONCLUSIONS: Late resections in stable patients with damage confined to the graft yield good prognosis. Even major resections are feasible graft-saving procedures. In contrast, early hepatic resections in S-HAT are associated with a worse outcome. Retransplantation should be considered the first-choice option. Sepsis significantly affects the postsurgical course.

Carcinoma, Hepatocellular↗
PubMed2004

Intraabdominal pressure in liver transplant recipients: incidence and clinical significance.

BACKGROUND: The incidence and clinical relevance of increased intraabdominal pressure after orthotopic liver transplantation (OLT) has not yet been evaluated despite the finding that occurrence of this condition in postsurgical critically ill patients may impair various organ functions. The aim of this study was to assess whether the occurrence of abdominal hypertension among a population of OLT recipients was an important cofactor producing early postoperative complications. METHOD: This prospective clinical study measured abdominal pressure every 6 hours during the intensive care unit (ICU) stay using the urinary bladder method. A value of >/=25 mm Hg was considered high. Hemodynamic status was simultaneously evaluated and renal function assessed based on the hourly urinary output, and by calculating serum creatinine on postoperative days 2 and 4. Renal failure was defined as a serum creatinine level of >1.5 mg/dL, or an increase in peak of >1 mg/L within 72 hours of surgery. The filtration gradient and patient outcomes were also considered. RESULTS: Intraabdominal hypertension was observed in 32% of cases. The subjects displaying high IAP showed significantly lower artery pressure values (P <.01), but did not differ in terms of central venous pressure or cardiac output. High intraabdominal pressure was more frequently associated with renal failure (P <.01), a lower filtration gradient (P <.001), delayed postsurgical weaning from the ventilation (P <.001), and increased ICU mortality (P <.05). A receiver operator characteristic curve analysis showed that the critical IAP values, namely those with the best sensitivity/specificity, were 23 mm Hg for postoperative ventilatory delayed weaning (P <.05), 24 mm Hg for renal dysfunction (P <.05), and 25 mm Hg for death (P <.01). CONCLUSIONS: Abdominal hypertension occurs frequently after OLT and may be associated with a complicated postoperative course.

Abdomen↗
PubMed2004

Selection and preparation of candidates for combined liver-kidney transplantation: experience at a single center-two case reports.

BACKGROUND: The published experiences of combined liver-kidney transplantation (LKT) are favorable, but there is still no uniformity concerning the impact on hepatorenal syndrome, or in cases of symptomatic hepatorenal polycystic disease. Herein we describe our experience with two LKTs, with particular reference to the selection and preparation of the candidates, and the surgical approach. METHODS: Between 1996 and June 2003, we performed 430 liver transplants in 398 recipients, including two LKTs: one in a patient with hepatorenal polycystic disease (case 1) and the other in a patient with HBV(+) cirrhosis undergoing dialysis after a previous isolated kidney transplant (case 2). RESULTS: In case 1, LKT and right nephrectomy were performed 2 months after a left lumbar nephrectomy. In case 2, LKT was performed 10 months after an isolated kidney transplant, without removing the first graft, which recovered function after 3 months. Both patients are now in good health with functioning grafts. CONCLUSIONS: LKT requires careful selection and preparation of candidates to optimize the probability of success. In well-compensated dialyzed patients with cirrhosis due to viral hepatitis, we believe that a combined approach is indicated after antiviral therapy. In cases of hepatorenal cystic disease, a two-stage surgical approach makes it possible to eliminate the risk of infection and intracyst hemorrhage in nonfunctioning polycystic kidneys.

Adult↗
PubMed2004

Interventional ultrasound: experience in 426 orthotopic liver transplantations.

BACKGROUND: The purpose of this study was to analyze the role of interventional ultrasound in the treatment of nonvascular complications in liver transplant recipients. METHODS: Between August 1996 and May 2003, we performed 426 OLTs in 394 patients, 287 men (73%) and 107 women (27%), mean age of 50 +/- 9.5 years (range 17 to 68.2). A total of 2556 diagnostic ultrasound examinations were performed, resulting in a mean of 5.9 per patient (range 2 to 21). The interventional maneuvers included: echo-guided biopsies; drainage of abdominal or thoracic effusions; drainage of abdominal, intrahepatic, or splenic collections; positioning of biliary drains; and use of the "rendezvous" technique. RESULTS: Six hundred seventy-seven echo-guided interventional maneuvers were performed in 394 OTL patients, comprising 417 (61.6%) biopsies and 260 (38.4%) therapeutic maneuvers. Eighty-one ascite drains were positioned (31.1%); in 73 cases, pleural effusions were drained (28.1%). Sixty-seven abdominal or intrahepatic collections were drained (25.8%), of which 36 (53.7%) were due to bilomas or biliary peritonitis, 15 (22.4%) hematomas, 4 (5.9%) hepatic abscesses, 11 (16.4%) infected abdominal collections, and 1 (1.5%) splenic abscess. Thirty-nine cases (15%) of biliary drainage were performed. In 33 cases (7.9%), the parenchymal biopsies were not diagnostic because of an inadequate specimen. The treatment success rate was 96.1%. No complications related to the therapeutic maneuvers were recorded, but there were 5 biopsy-related complications (1.2%). CONCLUSIONS: Echo-guided interventional maneuvers are safe, produce a high success rate, and represent an important option in the management of OLT patients.

Adolescent↗
PubMed2004

An exploratory study on pharmacogenetics of inosine-monophosphate dehydrogenase II in peripheral mononuclear cells from liver-transplant recipients.

Mycophenolate mofetil (MMF) is an immunosuppressant used for the prophylaxis of rejection in renal, pancreas, and liver transplantation. It inhibits the inducible isoform of the enzyme inosine-monophosphate dehydrogenase (IMPDH II) via its active metabolite mycophenolic acid (MPA). IMPDH II is necessary for de novo purine synthesis in activated lymphocytes. The aims of the present study were to evaluate the feasibility of a real-time polymerase chain reaction (PCR) quantitative assessment of IMPDH II gene expression in liver transplant recipients as well as to provide a preliminary evaluation of possible correlations with drug tolerability. RNA was extracted from peripheral blood mononuclear cells of liver recipients after at least 6 months of MMF administration. IMPDH II gene expression was assessed using quantitative, real-time PCR and normalized using glyceraldheyde-3-phosphate dehydrogenase (GAPDH). Finally, adverse events associated with MMF administration were recorded. Real-time PCR quantitation of IMPDH II gene expression was reliable, sensitive, and specific. The intrapatient variability for both IMPDH II and GAPDH assays was lower than 0.6% in all patients. The results demonstrated a wide interpatient variability, with the mean value +/- standard deviation of 0.949 +/- 0.525 (95% confidence interval, 0.669-1.229) and a median value of 0.797. Patients with treatment-related toxicities displayed a trend to a higher level of IMPDH II expression than those without toxicity (mean, 1.126 vs 0.771). In conclusion, pharmacogenetic analysis of IMPDH II may represent a novel approach to MMF therapeutic monitoring.

Adult↗
PubMed2004

The use of extracorporeal photopheresis for allograft rejection in liver transplant recipients.

BACKGROUND: Originally introduced for cutaneous T-cell lymphomas and autoimmune diseases, extracorporeal photopheresis (ECP) has been proven effective to reverse allograft rejection. The aim of the present work was to show the results of a single-center experience with ECP for the treatment of biopsy-proven rejection in selected liver transplant (LT) recipients. PATIENTS AND METHODS: A retrospective review of five LT patients (M:F=4:1; median age 51 years) undergoing ECP for biopsy-proven allograft rejection between January 1996 and December 2003. In this period 476 LT were performed on 441 patients. RESULTS: The indications for LT were three cases of HCV-related cirrhosis, complicated by hepatocellular carcinoma in two; one HBV-HDV-alcoholic cirrhosis; and one fulminant HBV hepatitis. All patients received calcineurin-inhibitor (CNI)-based immunosuppression with induction using anti-IL2R monoclonal antibodies. Indications for ECP were: ductopenic rejection in one patient with HCV recurrence; steroid-resistant acute rejection in two; acute rejection in a major ABO-mismatched liver graft; and one acute rejection in a patient with a proven allergy to steroids. The median interval from LT to inception of ECP was 43 days. The median number of ECP sessions per patient was 20. During the course of ECP, two patients tested positive for CMV antigenemia, associated in one case with bacterial pneumonia. All patients tolerated ECP and there were no procedure-related complications. At a median follow-up of 7.9 months after start of ECP, neither rejection relapses nor HCV/HBV recurrences have been observed. Three patients are off ECP with complete reversal and low-dose immunosuppression. Two patients are still receiving ECP with full-dose immunosuppression: one has achieved normal liver function but ECP is indicated due to a major ABO-incompatible liver graft, while the other patient's liver functions have not yet returned to baseline values.

Adult↗
PubMed2003

Combined twice-daily plasma exchange and continuous veno-venous hemodiafiltration for bridging severe acute liver failure.

Aiming to remove the toxins produced during the course of severe hepatic failure, we combined hemodiafiltration and plasma exchange (patient plasma replaced by fresh frozen plasma in a twice-daily regimen) for treatment of five patients: two affected by primary nonfunction of a liver graft and three by fulminant hepatic failure. The simultaneous use of the two extracorporeal techniques allowed a rapid reduction in the administration of vasoactive drugs and a rapid, significant decrease in the indices of liver necrosis. Native liver functional recovery occurred in one case, and the wait for a second graft was made possible in the other four. Although it has been reported that the detoxifying efficacy of plasma exchange is optimal when the replaced volume of plasma is high, such a technique requires both long treatment times and high blood flows in the extracorporeal circuit, making it often hemodynamically intolerable. Our approach leads to replacement of smaller volumes, allowing lower blood flows that are better tolerated despite the often unstable hemodynamics of these patients. Liver transplantation and retransplantation remains the definite therapy for severe liver failure or primary nonfunction. However, the organ waiting time is unpredictable and often does not coincide with the patients' clinical needs. Thus alternative strategies must be developed until a suitable donor is found or there is spontaneous recovery. From this point of view, in our albeit limited experience, twice-daily plasma exchange combined with hemodiafiltration has proved to be an effective therapeutic approach.

Acute Disease↗