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Biomedical subjects

Roberto Stasi

Publications and source records attributed to Roberto Stasi.

At least 19 recordsLinked to original sources
PubMed2006

Analysis of factors predicting survival in patients with hepatocellular carcinoma treated with percutaneous laser ablation.

BACKGROUND/AIMS: The factors which predict the long-term outcome in patients with hepatocellular carcinoma who are treated with percutaneous laser ablation (PLA) are not well established. METHODS: We prospectively analyzed treatment and survival parameters of 148 cirrhotic patients with nonsurgical hepatocellular carcinoma who had undergone PLA at a single institution during an 11-year period. RESULTS: Single tumors were seen in 129 of 148 (87%) patients, and 2-3 nodules were seen in 19 (13%) patients, for a total of 169 tumors. The median overall time survival was 39 months (95% confidence interval [CI], 30-47 months). The 1-, 2-, 3-, 4-, and 5-year cumulative survival rates were 89, 75, 52, 43, and 27%, respectively. From multiple regression analysis, the independent predictors of survival were found to be tumor grading (P=0.002; risk ratio [RR] 0.37, 95% CI 0.20-0.70), bilirubin levels < or =2.5mg/dl (P=0.014; RR 1.58, 95% CI 1.09-2.28), and the achievement of complete tumor ablation (P=0.020; RR 0.53, 95% CI 0.31-0.90). An initial complete tumor ablation was the only factor associated with longer survival in patients with Child-Turcotte-Pugh class A cirrhosis (P=0.012; hazard ratio [HR] 0.48, 95% CI 0.23-1.03). CONCLUSIONS: A complete tumor ablation results in improved survival in all patients with nonsurgical hepatocellular carcinoma. Ideal candidates for PLA are those with a well-differentiated histology, and normal bilirubin levels.

Aged↗
PubMed2006

Monoclonal antibodies and immunoconjugates in acute myeloid leukemia.

The use of monoclonal antibodies for patients with acute myeloid leukemia is based on targeting cell-surface antigens preferentially expressed on leukemic blasts while sparing normal cells and tissues. The majority of studies performed to date have used antibodies reactive with the CD33 antigen. Phase II studies have demonstrated antileukemic responses with all agents, although less so with unlabeled antibodies. The most promising results have been obtained in the treatment of minimal residual disease in patients with acute promyelocytc leukemia. Antibody-targeted chemotherapy with gemtuzumab ozogamicin has also shown significant activity in patients with relapsed acute myeloid leukemia. Radioimmunotherapy with beta-particle emitters may be most effective for the treatment of bulky disease or as part of a conditioning regimen for hematopoietic stem-cell transplantation, whereas radioimmunotherapy with alpha-particle emitters may be better suited to the treatment of small-volume or minimal residual leukemia. Whether or not monoclonal antibody therapy will improve disease outcome compared with conventional treatment regimens remains to be demonstrated by well-designed clinical trials.

Acute Disease↗
PubMed2006

Percutaneous laser ablation in patients with isolated unresectable liver metastases from colorectal cancer: Results of a phase II study.

We prospectively evaluated the safety, local tumor control, and impact on survival parameters of percutaneous laser ablation (PLA) in patients with colorectal liver metastases not amenable to surgical resection. The study included 44 individuals with 75 unresectable liver metastases and no known extrahepatic disease. The median number of metastases treated for each patient was one, with a range of 1-4. Metastases had a median diameter of 3.4 cm (range 0.5-9 cm), and a median volume of 16.8 cm(3) (range 0.4-176.4 cm(3)). All patients also received systemic chemotherapy with modalities that differed according to the type of response to PLA. After treatment, 61% (46/75) of the tumors were ablated completely. The likelihood of achieving a complete ablation was significantly higher when metastases had a diameter <3.0 cm (p = 0.004). Overall survival was 30.0+/-12.7 months in patients with a complete ablation, and 20.2+/-10.2 months in those with a partial ablation (p = 0.002). There were no major complications during or after PLA, the most frequent side effect being abdominal pain that required analgesics. These findings indicate that PLA can be safely used as an adjunct to chemotherapy in unresectable colorectal liver metastases, and may have a positive impact on survival.

Adult↗
PubMed2006

Long-term outcome of otherwise healthy individuals with incidentally discovered borderline thrombocytopenia.

BACKGROUND: The long-term outcome of individuals with mild degrees of thrombocytopenia is unknown. METHODS AND FINDINGS: In a prospective study conducted between August 1992 and December 2002, 260 apparently healthy individuals with incidentally discovered platelet counts between 100 x 10(9)/l and 150 x 10(9)/l were monitored for 6 mo to determine whether their condition persisted. The monitoring period was completed in 217 cases, of whom 191 (88%) maintained stable platelet counts. These 191 individuals were included in a long-term follow-up study to gain knowledge of their natural history. With a median time of observation of 64 mo, the thrombocytopenia resolved spontaneously or persisted with no other disorders becoming apparent in 64% of cases. The most frequent event during the study period was the subsequent development of an autoimmune disease. The 10-y probability of developing idiopathic thrombocytopenic purpura (ITP), as defined by platelet counts persistently below 100 x 10(9)/l, was 6.9% (95% confidence interval [CI]: 4.0%-12.0%). The 10-y probability of developing autoimmune disorders other than ITP was 12.0% (95% CI: 6.9%-20.8%). Most of the cases (85%) of autoimmune disease occurred in women. CONCLUSIONS: Healthy individuals with a sustained platelet count between 100 x 10(9)/l and 150 x 10(9)/l have a 10-y probability of developing autoimmune disorders of 12%. Further investigation is required to establish whether this risk is higher than in the general population and whether an intensive follow-up results in an improvement of prognosis.

Adult↗
PubMed2005

Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia: final results of AML-13, a randomized phase-3 study.

The role of glycosylated recombinant human granulocyte colony-stimulating factor (G-CSF) in the induction treatment of older adults with acute myeloid leukemia (AML) is still uncertain. In this trial, a total of 722 patients with newly diagnosed AML, median age 68 years, were randomized into 4 treatment arms: (A) no G-CSF; (B) G-CSF during chemotherapy; (C) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes; and (D) G-CSF during and after chemotherapy. The complete remission (CR) rate was 48.9% in group A, 52.2% in group B, 48.3% in group C, and 64.4% in group D. Analysis according to the 2 x 2 factorial design indicated that the CR rate was significantly higher in patients who received G-CSF during chemotherapy (58.3% for groups B + D vs 48.6% for groups A + C; P = .009), whereas no significant difference was observed between groups A + B and C + D (50.6% vs 56.4%, P = .12). In terms of overall survival, no significant differences were observed between the various groups. Patients who received G-CSF after chemotherapy had a shorter time to neutrophil recovery (median, 20 vs 25 days; P < .001) and a shorter hospitalization (mean, 27.2 vs 29.7 days; P < .001). We conclude that although priming with G-CSF can improve the CR rate, the use of G-CSF during and/or after chemotherapy has no effect on the long-term outcome of AML in older patients.

Acute Disease↗
PubMed2005

Helicobacter pylori eradication in the management of patients with idiopathic thrombocytopenic purpura.

PURPOSE: To investigate the relation between Helicobacter pylori infection and the clinical features of idiopathic thrombocytopenic purpura (ITP), and to examine the effects of H. pylori eradication on platelet counts. METHODS: A(13)C urea breath test for H. pylori infection was performed in a cohort of 137 consecutive patients with ITP. Patients who tested positive received standard eradication therapy if their platelet count was <50 x 10(9)/L or if they had symptoms of dyspepsia. RESULTS: H. pylori infection was detected in 64 patients (47%), and was not associated with dyspepsia or other clinical or laboratory features. Eradication therapy was successfully administered to 52 patients. Platelet responses were observed in 17 (33%) of these patients, which lasted for more than 1 year in 11 patients. Duration of ITP was shorter among responders than nonresponders. Only one response was observed among patients with severe thrombocytopenia (platelet count <30 x 10(9)/L). CONCLUSION: The prevalence of H. pylori infection in patients with ITP is similar to that found in the general population. Infection is not associated with distinctive features of the disease. H. pylori eradication may improve the platelet counts in adults in whom the ITP is of recent onset and in those with less severe degrees of thrombocytopenia, but was not effective in patients with chronic severe ITP.

Amoxicillin↗
PubMed2005

Infliximab chimeric antitumor necrosis factor-a monoclonal antibody as potential treatment for myelodysplastic syndromes.

Accumulating evidence indicates tumor necrosis factor-a (TNF-a) as a key cytokine in the pathogenesis of the myelodysplastic syndromes (MDS). The identification of TNF-a as a regulator of apoptosis and the increased susceptibility of MDS cells to this cytokine provided the basis for several clinical trials of TNF inhibitors. Infliximab is an IgG1 chimeric anti-TNF-a monoclonal antibody composed of human constant and murine variable regions that bind specifically to both soluble and membrane-bound TNF-a. To date, only 2 studies have investigated the use of infliximab in patients with low-risk MDS. In both reports the drug showed a limited but significant activity and a favorable side-effect profile. In some patients, hematopoietic response was associated with decreased apoptosis as well as a decrease in abnormal metaphases by 50%. Further studies are currently underway and should provide useful information to define the more responsive subtypes of MDS, the patient characteristics, and the proper dosing regimen.

Animals↗
PubMed2005

Percutaneous laser ablation in the treatment of hepatocellular carcinoma with small tumors: analysis of factors affecting the achievement of tumor necrosis.

PURPOSE: To identify the factors that affect the achievement of tumor necrosis with percutaneous laser ablation (PLA) in patients with hepatocellular carcinoma (HCC) and tumor size no larger than 4.0 cm. MATERIALS AND METHODS: Ultrasound-guided biopsy results were retrospectively studied in 99 lesions (range, 0.5-4.0 cm; mean, 2.7 cm) from 82 patients (44 men, 38 women; age range, 50-80 years; median, 68 y) who had undergone PLA. RESULTS: Complete tumor ablation was obtained in 90 lesions (90.9%). Of the nine cases in which complete tumor necrosis was not achieved, six had tumors located in sites that did not allow the optimal placement of fibers, and five of these had a tumor diameter greater than 3 cm. Early discontinuation of PLA as a result of decompensation of liver cirrhosis was the reason for not achieving a complete tumor ablation in three other cases. There was a clear relationship between the energy delivered and the volume of necrosis achieved (r = 0.56; P < .001) regardless of the initial size of HCC tumors. The number of illuminations required, and consequently the amount of energy delivered, was also affected by tumor location. In fact, lesions adjacent to large vessels (> or = 3 mm) required a greater number of illuminations than the other lesions to achieve complete ablation (2.9 +/- 1.4 vs 2.3 +/- 0.9; P = .043). The eight cases with undifferentiated histology required more illuminations than the cases with other histologic types (3.4 +/- 0.9 vs 2.2 +/- 0.9; P < .001). However, these cases were located in sites that did not allow the optimal placement of fibers, therefore requiring multiple treatments. CONCLUSION: PLA is a highly effective treatment in HCC with a tumor size of 4.0 cm or smaller. In this setting, two variables, tumor size and tumor location, affect the achievement of complete tumor ablation and the number of treatments required to obtain tumor necrosis.

Aged↗
PubMed2005

Management of cancer-related anemia with erythropoietic agents: doubts, certainties, and concerns.

The management of cancer-related anemia with erythropoietic agents presents many unresolved issues. We reviewed the literature relating to epoetin alfa (Eprex)/Epypo); Ortho Biotech/Janssen-Cilag, High Wycombe, United Kingdom, http://www.orthobiotech.co.uk; Procrit); Ortho Biotech Products, L.P., Bridgewater, NJ, http://www.orthobiotech.com), epoetin beta (NeoRecormon); Hoffman-La Roche, Basel, Switzerland, http://www.roche.com), and darbepoetin alfa (Aranesp); Amgen Inc., Thousand Oaks, CA, http://www.amgen.com) highlighting the results of published clinical trials, safety, and cost-effectiveness. Studies were identified through MEDLINE and the bibliographies of relevant articles. Epoetin alfa, epoetin beta, and darbepoetin alfa have differing pharmacokinetic and pharmacodynamic profiles. They are all effective at reducing transfusion requirements and improving health-related quality-of-life parameters, irrespective of tumor response. A direct comparison between epoetin alfa and darbe poetin alfa is based on limited evidence, which does not allow definitive conclusions about relative efficacy and cost-effectiveness. No predictive factors for response to erythropoietic agents have been validated in prospective trials. The most consistent adverse events are thrombotic and may occur irrespective of an increase in hemoglobin. Recent research indicates that the erythropoietin receptor is expressed in several cancer cell lines, raising the concern of possible stimulation of tumor cell growth by these drugs. Studies on the cost-effectiveness of erythropoietins, particularly compared with transfusion therapy, have been challenging to conduct and analyze and have generated ambiguous results. The use of erythropoietins needs to be optimized in terms of cost-effectiveness, and issues surrounding safety need to be clarified. A stronger methodology for clinical studies and the design of new, randomized, clinical trials is a major priority.

Anemia↗
PubMed2004

Selective B-cell depletion with rituximab for the treatment of patients with acquired hemophilia.

The activity and safety profile of selective B-cell depletion with rituximab, an anti-CD20 monoclonal antibody, were evaluated in 10 patients with acquired hemophilia. Rituximab was given intravenously at the dose of 375 mg/m(2) once weekly for 4 consecutive weeks. Infusion-related side effects were observed in 3 patients but were of mild intensity and did not require discontinuation of treatment. Eight patients with Factor VIII (FVIII) inhibitor titers between 4 and 96 Bethesda units per milliliter (BU/mL) achieved a complete remission, which was defined as a return to normal FVIII activity and undetectable FVIII inhibitor titers. Two more patients with inhibitor levels greater than 100 BU/mL experienced only a partial transient decrease of the inhibitor after rituximab alone, but they achieved a complete response after being challenged with a combination of rituximab plus pulse intravenous cyclophosphamide. With a median follow-up of 28.5 months (range, 12-41 months), 3 patients have thus far relapsed. Retreatment with the monoclonal antibody at the same dose and schedule resulted in a new sustained response in all these patients. In conclusion, rituximab appears an effective and well-tolerated treatment for patients with acquired hemophilia and low inhibitor titers. A reinforcement of therapy with other agents seems to be required to achieve a full and durable response in those patients with high inhibitor levels.

Adult↗
PubMed2004

The efficacy and safety of B-cell depletion with anti-CD20 monoclonal antibody in adults with chronic immune thrombocytopenic purpura.

Because of its B-cell depleting effect, rituximab has entered clinical trials in several autoimmune conditions. This study assesses the efficacy and safety of rituximab in 57 adults with chronic immune thrombocytopenic purpura (ITP). All patients had platelet counts < 30 x 10(9)/l, all had received two or more previous ITP treatments and 31 had undergone splenectomy. Patients received rituximab 375 mg/m(2) weekly for 4 weeks. Thirty-one patients (54%) responded, achieving a platelet count >50 x 10(9)/l: 18 achieved a complete response (CR: platelet count >150 x 10(9)/l) and 13 a partial response (PR: platelet count 50-150 x 10(9)/l). Twenty-nine responses occurred within 8 weeks of the first infusion. Sixteen of 18 CR patients (28% overall), including eight who had failed splenectomy, continued in CR after a median of 72.5 weeks; 15 of 16 are >1 year from the first infusion. Only two of 13 maintained a PR. Thirty-three patients experienced grade 1-2 adverse events and one a grade 3 event, but they all completed treatment. Circulating B cells fell to < 0.03 x 10(9)/l. No changes in immunoglobulin levels or infectious complications were seen. In summary, rituximab was well tolerated with no immediate complications and induced a lasting, substantial response in 32% of adults with chronic ITP.

Adult↗
PubMed2004

Management of immune thrombocytopenic purpura in adults.

Primary immune thrombocytopenic purpura (ITP), also referred to as idiopathic thrombocytopenic purpura, is an organ-specific autoimmune disorder in which antibody-coated or immune complex-coated platelets are destroyed prematurely by the reticuloendothelial system, resulting in peripheral blood thrombocytopenia. The disease is heterogeneous with regard to its severity and clinical course and is unpredictable in its response to therapy. Although the basic underlying pathophysiology of ITP has been known for more than 50 years, current treatment guidelines are based on expert opinion rather than on evidence because of a lack of high-quality clinical trials and research. The only patients for whom treatment is clearly required are those with severe bleeding and/or extremely low platelet counts (< 10 x 10(9)/L). Treatment of patients with ITP refractory to corticosteroids and splenectomy requires careful evaluation of disease severity, patient characteristics related to risk of bleeding, and adverse effects associated with treatment. Clinical trials with numerous new agents are under way, which we hope will add more effective and targeted strategies to our therapeutic armamentarium. We describe a logical and structured approach to the clinical management of ITP in adults, based on a literature review and our personal experience.

Adult↗
PubMed2003

Cancer-related fatigue: evolving concepts in evaluation and treatment.

BACKGROUND: Although fatigue is one of the most common complaints of patients with cancer, it went unrecognized or overlooked for many years, until clinicians achieved better control over the more acute symptoms of nausea, emesis, and pain. A number of treatment-related and disease-related factors may contribute to the development of fatigue, but its physiologic basis remains poorly understood, and many proposed interventions have not been studied systematically. The lack of a standard of care for the assessment or treatment of fatigue in patients with cancer has limited research in this field. A critical appraisal of these issues is presented in this review. METHODS: The published literature was reviewed for definition, prevalence, causes, and means of managing cancer-related fatigue (CRF). RESULTS: Fatigue was reportedly present at the time of diagnosis in approximately 50-75% of cancer patients. The prevalence of CRF increased to 80-96% in patients undergoing chemotherapy and to 60-93% in patients receiving radiotherapy. Two tested interventions that showed consistent effects to alleviate CRF were treatment of cancer-related anemia with erythropoietin agents (recombinant human erythropoietin and darbepotin alpha) and aerobic exercise. CONCLUSIONS: Several lines of research are needed to bridge the specific gaps in the current knowledge of CRF. These involve the pathophysiology of the symptom, the validation of diagnostic criteria, and specific therapeutic interventions. Current practice guidelines are based on a combination of research and expert clinical judgment and should be used to guide care with the expectation that they will evolve to incorporate the results of studies currently underway.

Antineoplastic Agents↗
PubMed2002

Sustained response to recombinant human erythropoietin and intermittent all-trans retinoic acid in patients with myelodysplastic syndromes.

In vitro studies suggest that all-trans retinoic acid (ATRA) synergizes with erythropoietin (EPO) for the stimulation of hematopoiesis in patients with myelodysplastic syndrome (MDS). A clinical trial was performed to evaluate whether a combination of these agents was effective in relieving the cytopenias associated with MDS. Twenty-seven patients with low- or intermediate-risk MDS were enrolled in a 12-week study. ATRA was administered orally at the dose of 80 mg/m(2) per day in 2 divided doses for 7 consecutive days every other week. Recombinant human EPO was given subcutaneously 3 times a week. The EPO dose was initiated at 150 U/kg and was increased to 300 U/kg if after 6 weeks there was no or there was suboptimal erythroid response. Patients who responded to therapy were continued on ATRA and EPO at the same doses for 6 additional months (extension phase). Further treatment was given to patients with a continued response. Clinically significant erythroid responses with increases of hemoglobin levels of at least 1 g/dL or reduction of transfusion needs were seen in 13 (48%) patients, with 4 showing improved responses after dose escalation of EPO. Ten (37%) patients displayed continued responses during 6 months of extended treatment, and 7 (26%) are still responsive after a follow-up period of 13 months. Neutrophil responses were observed in 5 of 12 patients with neutropenia, and platelet responses were observed in 6 of 9 patients with thrombocytopenia. Three patients displayed trilineage responses that were sustained during continuation therapy. Side effects were observed in all patients but were of mild entity and did not require discontinuation of therapy. It is concluded that the combination ATRA + EPO is an effective and well-tolerated treatment for patients with low- and intermediate-risk MDS. The optimal ATRA and EPO schedule and the role of maintenance treatment remain to be determined and warrant further investigation.

Aged↗
PubMed2002

Positive selection of CD34+ cells by immunoadsorption: factors affecting the final yield and hematopoietic recovery in patients with hematological malignancies and solid tumors.

There is a progressive increase in the use of selected hematopoietic progenitor cells after myeloablative therapy in patients affected by malignancies. Our goal was to determine which blood parameters, in the starting cell population, influence the concentration of CD34+ progenitors and the removal of unwanted cells in the final product. Also, we evaluated the hematopoietic recovery and toxicity associated with peripheral blood stem cell infusion. We retrospectively reviewed 53 procedures of positive selection of CD34+ cells, performed with the Ceprate SC immunoadsorption system, in 47 paticnts affected by various hematologic malignancies and solid tumors. An increased percentage of CD34+ cells in the starting fraction was associated both with the final purity and enrichment of CD34+ cells and with a decreased percentage of CD3+ and CD19+ cells in the final product. A low platelet count before selection had a borderlinc influence on the recovery of CD34+ cells. Forty patients received a median of 5 x 10(6) CD34+ cells per kg; the absolute neutrophil count (ANC) reached 0.5 x 10(9)/l in a median of 10 days whereas a PLT count above 20 x 10(9)/l was observed in 14 days. The reinfusion of selected CD34+ cells, containing a very low amount of dymethylsulfoxide. was well tolerated and no adverse reactions were observed. Autologous transplantation with selected CD34+ cells is a safe and well-tolerated procedure in patients affected by hematologic malignancies and solid tumors. Positive selection of CD34+ cells seems to be related to the quality of the apheresis products, particularly to the initial CD34+ cell and PLT content.

Antigens, CD34↗