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Biomedical subjects

L Leone

Publications and source records attributed to L Leone.

At least 55 records · Page 3Linked to original sources
PubMed1995

On-line solid-phase extraction of ceftazidime in serum and determination by high-performance liquid chromatography.

A column-switching high-performance liquid chromatographic assay is described for the determination of ceftazidime (a third-generation cephalosporin) in human serum. The method does not require prior sample pretreatment. Serum is directly injected in a first chromatographic column for sample clean-up and extraction. Thereafter, using an on-line column-switching system, the drug is quantitatively transferred and separated on a second, analytical column followed by determination using ultraviolet absorption at 258 nm. The technique allows direct, rapid, precise, and simple determination of ceftazidime in serum over the range of 1-250 micrograms/ml using 12.5 microliters of serum. This method was applied to study the pharmacokinetics of the drug in patients undergoing vascular surgery.

Ceftazidime↗
PubMed1995

Stability of ifosfamide in solutions for multiday infusion by external pump.

The stability of ifosfamide in Ringer lactate buffer solution either alone or mixed with mesna at 37 degrees C for a 7-day period was analyzed by HPLC. This study was performed to investigate the feasibility of continuous infusion of ifosfamide by a multiday pump in order to reduce the toxicity and to increase the production of active alkylating metabolites of the parent drug. The total decay of ifosfamide activity did not exceed 3.2% at day 7. We conclude that ifosfamide can be safely delivered in a 7-day infusion with no significant loss of activity.

Antineoplastic Agents, Alkylating↗
PubMed1995

Association between inflammatory bowel disease and sarcoidosis. Report of two cases and review of the literature.

BACKGROUND: Common etiopathogenic factors may explain the association of systemic sarcoidosis with inflammatory bowel disease. METHODS: We report two cases of such an association: one of sarcoidosis that developed 2 years after proctocolectomy for ulcerative colitis and one of sarcoidosis and Crohn's colitis. Factors like increased cellular immunity or circulating immunocomplexes or autoantibodies may have a role. Exogenous agents or familiarity may also be involved. CONCLUSIONS: It is postulated that the association between sarcoidosis and inflammatory bowel disease (both ulcerative colitis and Crohn's disease) does not occur by chance alone and that the two conditions may share some genetic or immunologic alterations. The two diseases, however, follow an independent clinical course.

Adult↗
PubMed1995

A Bayesian approach to drug disposition evaluation: application to teicoplanin.

We suggest a Bayesian method in order to evaluate the disposition kinetics of the drug plasma concentrations after intravenous (i.v.) and/or after extravascular administration of the drug in the same subject pooled with information obtained taking into account previous pharmacokinetics of the drug. This approach was applied to the investigation of teicoplanin pharmacokinetics after 200 mg i.v. administration to 10 healthy subjects.

Adult↗
PubMed1995

Piedmont region (Italy): setting quality standards and testing.

In this report we describe the two years (1991-1992) EQA programmes organized by the health committee of the Piedmont region (Italy). This programme was mandatory for all public and private laboratories. The parameters analysed were: PT and APTT (for coagulation); Hb, RBC, WBC, platelets and MCV (for haematology); glucose, urea, creatinine, total proteins, cholesterol, uric acid, triglycerides, AST, ALT, LDH, GGT, amylase, alkaline phosphatase, sodium, potassium, calcium, chloride, phosphorus and iron (for clinical chemistry). For haematology, the comparison between the first and the second year shows a significant decrease of imprecision, especially for platelets, WBC and MCV.

Hematologic Tests↗
PubMed1994

Cisplatin as a radiation sensitizer in the treatment of advanced head and neck cancers. Results of a phase II study.

BACKGROUND: Surgery and radiotherapy mainstays in the management of advanced head and neck cancer, although historically, only 20-30% of patients survive. Therefore, in an attempt to improve locoregional control and survival, a multimodal protocol using cisplatin as a radiosensitizer was implemented. METHODS: Between 1984 and 1990, 68 patients with advanced head and neck cancer (Stages III and IV) were treated with a regimen consisting of an induction phase of 4500 cGy and two cycles of cisplatin followed by an eradicative phase of either radical surgery (Group A, 27 patients) or radical radiotherapy (Group B, 41 patients). The maintenance phase chemotherapy consisted of adjuvant 5-fluorouracil (5-FU) and cisplatin after completion of locoregional treatment. Of the 68 patients, 19 had Stage III disease, and 49 had Stage IV; 21 had no regional lymph node metastases (N0), and 47 had regional lymph node metastases (N+). RESULTS: The induction phase yielded a 26% (18 patients) complete response (CR) rate and a 57% (39 patients) partial response (PR) rate (response > 50%), yielding an overall response rate of 83%. Eleven patients (16%) had stable disease (ST) (i.e., < 50% response). The 2-year survival rates by initial treatment response for patients who had a CR, a PR, and stable disease were 53%, 56%, and 36%, respectively; for Groups A and B, 63% and 45%, respectively; for Stages III and IV, 68% and 43%, respectively; and for N0 and N+, 69% and 43%, respectively. In Group A, 14 of 27 patients (52%) had no viable tumor in the surgical specimen (i.e. had pathologic complete tumor clearance [CTC]); this subgroup had a 5-year survival rate of 58%. Ten patients (37%) who had gross total resection of tumor with negative margins but had tumor present in the specimen had a 5-year survival of 22%. In Group B, the 5-year survival rate was 43% for 27 patients who achieved CR after completion of radical radiotherapy (total tumor dose, 6480-7020 cGy). The 5-year survival rate of the 14 patients who had a PR and stable disease after radical radiotherapy and 3 patients whose resection was incomplete was 0%. The overall 2- and 5-year survival rates for all patients were 53% and 32%, respectively. Of 21 patients in whom treatment failed, most (90%) had a locoregional recurrence: 13 local recurrences (62%), 5 regional (24%), and 1 locoregional (5%). Two patients (10%) experienced failure at distant sites (the lung). Major treatment-related morbidity developed in two patients. CONCLUSIONS: Although induction chemotherapy-radiotherapy produces a high clinical response rate, this does not translate into improved survival compared with historical controls. A subgroup that showed complete tumor clearance (CTC or pathologic complete response) at surgery had an apparent improved survival and merits further study. Patient selection did not appear to be a factor for the CTC group, because the majority of patients in this group had partial responses to induction therapy, nodal disease and advanced tumor stage, and tumor presence in unfavorable sites.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1994

Monitoring of cyclosporine blood levels from central venous lines: a misleading assay?

In order to assess the suspected influence of indwelling lines on the measurement of cyclosporine (CSA) blood levels, we evaluated CSA concentrations in samples drawn simultaneously from both silicone catheter lumens and peripheral veins of eight bone marrow transplant recipients. Blood samples were obtained at 30 min or 6-12 h after discontinuation of intravenous CSA. CSA concentrations were determined in whole blood by specific monoclonal antibody assay. Mean CSA levels from the lumen used for CSA administration were significantly higher than those from samples drawn from the second lumen (i.e., not used for CSA infusion) or peripheral vein. This difference, obtained when the infusion had been interrupted for 30 min, was still the case 6-12 h after discontinuation of CSA infusion. No difference was found between samples obtained from the second lumen and peripheral vein. These observations suggest that CSA might be adsorbed or bound by the silicon catheter and, thus, CSA blood level measurements may be misleading. The second lumen of the catheter or a peripheral vein should be used for accurate monitoring of CSA concentrations.

Adolescent↗
PubMed1994

Phase I trial of outpatient weekly paclitaxel and concurrent radiation therapy for advanced non-small-cell lung cancer.

PURPOSE: To determine the maximum-tolerated dose (MTD) and dose-limiting toxicities of paclitaxel administered weekly on an outpatient basis with concurrent thoracic radiation to patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: In this phase I clinical trial, paclitaxel was administered as a 3-hour intravenous (IV) infusion, repeated every week for 6 weeks. The starting dose of paclitaxel was 10 mg/m2. Doses were escalated at 10-mg/m2 increments in successive cohorts of three new patients if tolerated. Unacceptable toxicity was defined as grade 3 nonhematologic toxicity, excluding nausea and vomiting, and grade 4 hematologic toxicity according to Cancer and Leukemia Group B expanded common toxicity criteria. Radiation was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). RESULTS: Twenty-seven patients were entered onto this study through seven dose escalations (from 10 mg/m2/wk to 70 mg/m2/wk for 6 weeks). Severe esophagitis occurred at 70 mg/m2 (two patients with grade 4 disease and one patient with grade 2). One of six patients at 60 mg/m2 developed grade 3 esophagitis and three of seven patients had grade 2 esophagitis. One of 27 patients developed a hypersensitivity reaction. One of 27 patients developed grade 3 neutropenia. CONCLUSION: Esophagitis is the principle dose-limiting toxicity of weekly paclitaxel and thoracic radiation in the outpatient setting. A phase II trial using concurrent radiation and paclitaxel at the MTD of 60 mg/m2/wk is underway.

Adult↗
PubMed1994

[Strangulated laparoceles. Our experience].

The authors present their own experience of emergency in strangulated laparoceles. Between January 1984 and June 1992 they treated at the Division of Emergency Surgery of the Hospital "A. Cardarelli" in Naples 133 cases of laparocele, 63 of which were strangulated. 48 of the 63 cases were treated by simply vertical or transversal laparoplasty ("waistcoat"); in 4 cases a direct plastic surgery; was executed in 11 cases a synthetic patch was used: in 2 cases a Teflon prosthesis was used; in one case a double prosthesis: a reabsorbable Vicryl patch internally and an external Marlex reticulated; in 8 cases a Marlex prosthesis. Moreover in most cases, before the laparoplasty of the abdominal wall operations of viscerolysis, were carried out intestinal and/or epiploon resection because of ischemia, colostomy, a Hartmann (one case). Of the 11 patients treated with synthetic patches, only 4 presented local complications: a seroma, two suppurations of the wound and a skin necrosis. These complications were treated with a medical therapy. In no case it was necessary to remove the prosthesis, as there were no general complications or deaths. We have to underline that notwithstanding the great advances both in surgery and in prosthesis' materials, the problem of the strangulated laparocele still represent a great engagement for the surgeon. The main reasons are: concomitant pathologies ("eventration disease"') and complications. The complications may be local (infection of the wound) or general (cardiocirculatory and respiratory problems due the viscus reduction in the original abdominal cavity).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

[Use of cyclosporin and verapamil in association with chemotherapy in the treatment of pediatric patients with advanced-stage neoplasms. A pilot study].

Multidrug resistance represents one of the most important factors that may lead to a therapeutic failure in some patients affected by malignancies. One of the best known mechanisms is linked to the genic amplification or the overproduction of a membrane glycoprotein, GP170, that is the product of the gene MDR1. The existence of drugs (calcium blockers, cyclosporine, tamoxifen, reserpine, quinidine) able to bind themselves to gp170 and to paralyze its activity in vitro is well known. We studied 20 pediatric patients (median age 9 years) affected by acute lymphoblastic leukemia (ALL), osteosarcoma, neuroblastoma and medulloblastoma, in advanced stage of disease. We employed in all cases the association of cytostatics with verapamil (50-70 mg/m2 i.v.) and cyclosporine (5-8 mg/kg i.v.) with different infusion schedules. In leukemias we administered vincristine (1.5 mg/m2), and daunomycin (40 mg/m2), in solid tumors VP16 (150 mg/m2) and adriamycin (60 mg/m2). Seventy-two therapeutic courses were performed: 39 in ALL, 16 in osteosarcoma, 16 in neuroblastoma and 1 in medulloblastoma. On the whole 5 complete remissions were achieved in ALL patients and 1 in an osteosarcoma patient. We did not observe a significant myelosuppression during treatment, therefore few infectious complications occurred; furthermore electrocardiographic changes have been mild and promptly resolved after temporary discontinuation of verapamil infusion. Our data suggest a synergy of verapamil and cyclosporine in the inhibition of multidrug resistance induced by gp170, without the occurrence of heavy toxicity. The results obtained in ALL patients are encouraging., especially in view of a possible subsequent bone marrow transplantation, while in solid tumors they are not as satisfying.

Adolescent↗
PubMed1993

c-kit ligand reactivates fetal hemoglobin synthesis in serum-free culture of stringently purified normal adult burst-forming unit-erythroid.

We have analyzed the reactivation of fetal hemoglobin (HbF) synthesis under rigorous in vitro conditions, ie, in mature erythroblasts generated by erythroid burst-forming units (BFU-E) stringently purified from normal adult peripheral blood and grown in fetal calf serum(FCS)-free semisolid or liquid phase culture. In clonogenetic dishes, graded amounts of c-kit ligand (KL) were added together with saturating levels of erythropoietin (Ep) and variable amounts of interleukin-3 and granulocyte-macrophage colony stimulating factor (IL-3/GM-CSF), ie, high or low level, or no IL-3/GM-CSF addition. In all conditions, KL induced a sharp, dose-dependent increase in the percentage of F cells and HbF content from nearly normal levels (< 10% and < 2.5%, respectively, at 0.1 and 1 ng/mL) up to 40% to 50% and 10% to 15% at 100 to 200 ng/mL. This increase was not associated with significant differences of burst number or stage of maturation at the time of analysis (as evaluated on the basis of percent mature erythroblasts and Hb content per cell). However, the KL-induced reactivation of HbF synthesis was strictly and directly correlated with a sharp increase of colony size, ie, cell number per burst. Addition of large amounts of IL-3 and GM-CSF (10 to 100 U and 1 to 10 ng/mL, respectively) significantly potentiated the KL-induced reactivation of HbF, as compared with low levels (0.1 U and 0.01 to 0.1 ng) or no addition of these growth factors: this increase was highly significant at low KL doses (ie, 1 to 10 ng/mL). Single-burst analysis showed that the KL-induced HbF reactivation occurs homogeneously in the erythroid colonies within each of these culture conditions. We have analyzed the effect of KL in liquid phase BFU-E culture treated with the IL-3/GM-CSF/Ep combination at sequential times until terminal erythroid maturation: KL causes a sharp increase in the percentage of F cells and HbF content in all stages of maturation, whereas the IL-3/GM-CSF/Ep combination alone has a markedly lower effect. These results suggest that KL plays a key role in the reactivation of HbF synthesis in adult life, whereas IL-3/GM-CSF potentiate this effect at low KL levels. The KL-induced HbF reactivation is seemingly related to an enhanced proliferation of erythroid progenitors in the erythropoietic differentiation pathway.

Adult↗
PubMed1993

Randomized phase II trial of cisplatin with mitomycin or doxorubicin for malignant mesothelioma by the Cancer and Leukemia Group B.

PURPOSE: The Cancer and Leukemia Group B (CALGB) conducted a randomized phase II multicenter trial to evaluate the activity of two cisplatin-containing regimens (cisplatin and mitomycin [CM], or cisplatin and doxorubicin [CD]) in patients with malignant pleural or peritoneal mesothelioma (protocol CALGB 8435). PATIENTS AND METHODS: Seventy-nine patients were entered between June 1984 and October 1986. Eligibility included a performance status of 0 to 2 by CALGB criteria, and no prior chemotherapy. Central pathology review was performed. Randomization was stratified according to the cell type (epithelial v mixed or sarcomatous) and the presence of measurable versus assessable disease. Of the 79 patients entered, 70 were included in this analysis (35 on CM and 35 on CD), including 48 with epithelial cell type and 22 with mixed or sarcomatous cell types. Sixty-six patients had pleural mesothelioma and four had peritoneal mesothelioma. There were 34 cases with measurable disease and 36 with assessable disease. RESULTS: The overall response rate was 26% for CM (two complete responses [CRs], three partial responses [PRs], and four regressions) and 14% for CD (four PRs and one regression). Median time to treatment failure was 3.6 months for CM and 4.8 months for CD, and median survival duration from study entry was 7.7 and 8.8 months, respectively, with no significant differences between treatments. Good performance status (0 or 1) was associated with significantly longer survival duration (P = .013). Both regimens were well tolerated and there were no treatment-related deaths due to toxicity. CONCLUSION: Moderate antitumor activity has been observed with both regimens. In this randomized phase II trial, the overall response rates, time to treatment failure, and overall survival appear to be similar for the two regimens tested.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

[Bilateral breast tumors].

From a retrospective analysis of 181 cases observed in a ten-year period (1980-1990), the authors registered a frequency of bilateral breast cancer comparable to that reported in the literature (1-12%). Early diagnosis is the only factor able to modify positively the prognosis, through an accurate follow up, based on blood and X-ray tests (low-density mammography).

Breast Neoplasms↗
PubMed1990

Survival of premenopausal women with metastatic breast cancer. Long-term follow-up of Eastern Cooperative Group and Cancer and Leukemia Group B studies.

In premenopausal women with metastatic breast cancer, differences in survival curves early during follow-up can be misleading. The authors therefore analyzed long-term survival in 378 patients, entered in three randomized trials, started between 1973 and 1978. Combined data from the three trials were used to increase the power for identifying prognostic variables. Cancer and Leukemia Group B (CALGB) trial 7382 randomized patients to oophorectomy plus either cyclophosphamide or combination chemotherapy or observation. Eastern Cooperative Oncology Group (ECOG) 2174 randomized patients who had not progressed 3 months after oophorectomy to combination chemotherapy or combination chemotherapy or observation. Trial ECOG 2177 randomized estrogen receptor (ER) positive or ER-unknown patients to oophorectomy plus combination chemotherapy or immediate combination chemotherapy, and ER-negative patients were directly assigned to combination chemotherapy. Hence ER-negative patients need not have been healthy enough to be randomized to oophorectomy. With only 14% of the patients still alive, median survival on the three studies was 30, 24, and 28 months. The median survival of individual treatments changed noticeably in ECOG 2174 and ECOG 2177 with long-term follow-up. At this time there are no differences in survival between randomized regimens in any of the three trials. In a multivariate model, factors associated with significantly poorer survival were visceral-dominant disease, nodal metastases, breast metastases, age younger than 45 years, ER negativity, and not receiving chemotherapy immediately after oophorectomy. This treatment difference was thus not due to imbalances in the prognostic variables used in the model, but it may be due to imbalances of unknown prognostic factors or differences in patient selection.

Adult↗