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Biomedical subjects

F Perrone

Publications and source records attributed to F Perrone.

At least 73 records · Page 4Linked to original sources
PubMed1996

Interaction of Candida albicans, macrophages and fluconazole: in vitro and ex vivo observations.

In recent years, medical interest in evaluating the interaction among mycetes, phagocytes, and antimycotic drugs has increased notably due to higher incidences of fungal infections in immunocompromised subjects and to the long-term therapy they require. In this study the in vitro and ex vivo interaction of fluconazole, at plasma concentrations, with mouse macrophages was evaluated in the presence of different inocula of Candida albicans. The results showed that fluconazole did not interfere negatively with phagocyte functions; conversely, according to different experimental conditions, it was able to increase both phagocytosis and intracellular killing of candida, probably exerting its action on the yeast rather than on the phagocyte. A higher enhancement of macrophage functions was observed in vitro when the drug was present in the medium with macrophages and candida in a 1:1 ratio.

Animals↗
PubMed1996

c-erb B2 overexpression decreases the benefit of adjuvant tamoxifen in early-stage breast cancer without axillary lymph node metastases.

PURPOSE: We studied retrospectively the interaction between c-erbB2 overexpression and adjuvant tomoxifen in node-negative breast cancer patients enrolled in the Gruppo Universitario Napoletano 1 (GUN-1) trial. PATIENTS AND METHODS: c-erbB2, evaluated by immunohistochemistry in 145 of 173 patients randomly assigned to 2-year adjuvant tamoxifen or no further therapy, was considered overexpressed if greater than 10% of the cells showed specific membrane staining. The role of each prognostic variable and their independent effect were studied using the Cox model. Disease-free (DFS) and overall (OAS) survival curves were estimated by the Kaplan-Meier method. RESULTS: As of November 30, 1994, the median follow-up period was 12 years. c-erbB2 was overexpressed in 43 of 145 patients (29.7%), which directly correlated with tumor size and inversely with estrogen receptor (ER) level. At univariate analysis, overexpression of c-erbB2 did not affect either DFS or OAS; tamoxifen had a greater effect on reducing the risk of recurrence than of death. Addition of c-erbB2 to a multivariate Cox model that contained menopausal status, tumor size, nuclear grade, and treatment as covariates did not affect the significance of the model for DSF or OAS, whereas addition of the first-order interaction between c-erbB2 and tamoxifen was statistically significant both for DFS and OAS. The same result was obtained when the model contained ER status and ER-tamoxifen interaction. Indeed, adjuvant tamoxifen significantly prolonged DFS and OAS in c-erbB2-negative cases, whereas it had no effect on DFS and OAS in c-erbB2-positive patients. CONCLUSION: In early-stage breast cancer patients, overexpression of c-erbB2 is a marker of lack of efficacy of adjuvant tamoxifen.

Adult↗
PubMed1996

Age of onset, sex, and cardiomyopathy as predictors of disability and survival in Friedreich's disease: a retrospective study on 119 patients.

We performed a retrospective study on a series of 119 of our patients who have Friedreich's disease to assess the predictive value of age at onset, gender, and left ventricular hypertrophy in regard to disease progression. Outcome variables were survival, time to loss of independent gait, and time to confinement in a wheelchair. Diabetes was considered to be an outcome variable when defining time to diabetes and an explanatory variable when testing its effect on survival. Eleven patients died. The median estimated survival from onset was 36 years, and the median time to loss of independent gait was 8 years and to confinement in a wheelchair was 15 years from onset. Nineteen patients developed diabetes after a median time of 16 years. The presence of left ventricular hypertrophy or diabetes significantly reduced survival based on univariate analysis. Onset at the age of < or = 20 years and the presence of left ventricular hypertrophy predicted a faster rate of progression of the disease.

Adolescent↗
PubMed1995

The prognostic value of lymphatic and blood vessel invasion in operable breast cancer.

BACKGROUND: This study assessed the prognostic effect of lymphatic and blood vessel invasion (LVI and BVI) on survival in a retrospective sample of 1408 patients with breast cancer. METHODS: Survival analysis was evaluated by univariate (Kaplan-Meier product limit method and log rank test) and multivariate (Cox model) analysis. Correlations among variables were studied by contingency tables and statistical significance was evaluated by chi-square test. RESULTS: Lymphatic vessel invasion was present in 34.2% of cases, and BVI in 4.2%. Lymphatic vessel invasion correlated with BVI (P < 0.0001), and both were correlated with metastatic axillary lymph nodes and increasing tumor size and grade; BVI was sporadic (only 10 cases) among lymph node negative patients. Although LVI was more frequent among premenopausal patients and those with ductal carcinomas, BVI was unrelated to menopausal status and tumor type. Lymphatic vessel invasion and BVI were associated with poor survival by univariate analysis (P < 0.0001). By multivariate analysis, relative risk of death was significantly increased when LVI was present both in the whole series as well as in the lymph node negative and lymph node positive subgroups; the prognostic role of LVI was independent of menopausal and lymph node status, tumor size, tumor grade, or adjuvant treatment. In the lymph node negative sample, LVI had strong prognostic power. In the lymph node positive sample, the prognostic role of LVI was also independent of the number of lymph nodes with metastases. Blood vessel invasion had no prognostic role in any subgroup. CONCLUSION: The prevalence of BVI was particularly low in this study, and the question of its possible prognostic role for patients with breast cancer should be assessed with methods that amplify its detection. LVI is a strong prognostic factor for operable patients with breast cancer. In lymph node negative patients, LVI is a predictor of poor prognosis for those who are consequently candidates for adjuvant therapy. Similarly, in lymph node positive patients, LVI is a predictor for a high risk of death for those who are candidates for highly intensive adjuvant strategies.

Adult↗
PubMed1995

Informed versus randomised consent to clinical trials.

We compared different procedures for seeking consent to participate in a sham randomised clinical trial and assessed whether refusal is affected by awareness of the severity of outlook. 2035 healthy subjects aged between 20 and 80 years, who visited a scientific exhibition, were enrolled in a hypothetical trial of experimental versus standard therapy, and randomly assigned to groups asked for conventional informed consent or prerandomisation consent. There were four study groups: one-sided informed consent for randomisation (subjects who refused would receive standard treatment); two-sided informed consent for randomisation (subjects who refused could choose between standard and experimental treatment); randomised consent to experimental treatment (subjects who refused would receive standard treatment); and randomised consent to standard treatment (subjects who refused would receive experimental treatment). The refusal rates were 16.2%, 19.9%, 12.1%, and 49.2%, respectively. The perceived severity of the simulated disease affected the refusal rate: the worse the outlook, the lower the refusal rate for informed consent or for consent after randomisation to new treatment, and the higher the refusal rate for consent after randomisation to standard treatment. The prerandomisation design seems to be efficient in a one-sided clinical scenario (eg, a trial of a new drug that would not be given outside the trial) because the refusal rate was substantially lower for prerandomisation to the new treatment than for conventional one-sided informed consent. However, in a two-sided clinical scenario (eg, a trial comparing similar treatments) the prerandomisation design is potentially highly inefficient; the refusal rate was much higher for prerandomisation to standard treatment than for conventional two-sided informed consent.

Adult↗
PubMed1995

CMF vs alternating CMF/EV in the adjuvant treatment of operable breast cancer. A single centre randomised clinical trial (Naples GUN-3 study).

The aim of this study was to test the hypothesis of Goldie and Coldman that the use of non-cross-resistant regimens of chemotherapy could lead to maximal anti-tumour effect. We compared standard CMF (cyclophosphamide, methotrexate, fluorouracil) with alternating CMF/EV (epirubicin, vincristine) in the adjuvant therapy of early breast cancer. Stage II premenopausal node-positive or post-menopausal node-positive oestrogen receptor-negative and stage III breast cancer patients were eligible for the study. From January 1985 to December 1990, 220 patients were randomised (115 to CMF and 105 to CMF/EV). Toxicity was mild; neurotoxicity, vomiting and hair loss were more frequent in the CMF/EV group, while permanent amenorrhoea, diarrhoea, stomach ache and minor infections occurred more often in the CMF arm. At a follow-up of 48 months, 113 patients (51.4%) had had recurrence (62 on CMF and 51 on CMF/EV) and 54 (24.5%) had died (30 on CMF and 24 on CMF/EV). There was no significant difference in disease-free and overall survival between the two arms. After adjusting for menopausal status and stage, the relative risk (RR) of recurrence for CMF/EV patients was 0.93 (95% CL 0.64-1.35), while the RR of death was 0.85 (95% CL 0.49-1.47). In conclusion, the Goldie-Coldman model of alternating therapy is not confirmed in this trial of adjuvant therapy of early breast cancer, although in view of its design a difference of less than 20% in 3 year disease-free survival could not be excluded.

Age Factors↗
PubMed1995

[Carcinoid of Meckel's diverticulum].

The carcinoid of Meckel's diverticulum is a very rare lesion, and about 100 cases in the literature have been described. Most of these tumors are casually find out at autopsy or laparoscopy for other pathology. Seldom was described a sintomatology correlated to carcinoid of Meckel's diverticulum presence, except the rare case where was formed a carcinoid syndrome. Authors present a clinical case where was casually found by a carcinoid of Meckel's diverticulum during an appendicectomy. The intention is to underline the importance of research the Meckel's diverticulum every time, and in particular in case of young subjects, remove it and perform an histological valuation, to exclude the presence of a carcinoid that could give metastases to local lymph-nodes or liver.

Carcinoid Tumor↗
PubMed1995

[The request for consent in clinical research: a randomized study in healthy subjects].

To compare two strategies of consent requirement (classical informed consent and randomised consent according to Zelen), the Clinical Data Elaboration Centre of South Italy, within the special project Clinical Application of Oncological Research of the National Research Council of Italy (CNR-ACRO) invited healthy people visiting the 7th edition of the scientific exhibition "Futuro Remoto" to simulate of being ill and receiving the offer of entering a clinical trial. Within informed consent strategy patients are asked to agree to the randomisation process, while, in the randomised consent, randomised treatment assignment is performed before consent requirement and patients should agree directly to the assigned therapy. Major aims of the study were (a) to compare the strategies in terms of refusal rate to a hypothetical clinical trial, and (b) to estimate whether severity of prognosis affected subjects' decision. 3,217 visiting people participated to the simulation; they were prevalently young, males and with a high level of school education. The study was performed in two different scenarios. In the first one, with one choice option, subject refusing consent could receive standard therapy only; refusal rate was 16% after informed consent and 13.4% after randomised consent (for experimental therapy). In the other scenario, with two choice options, subjects refusing consent could choose the preferred therapy; refusal rate was 20.6% after informed consent, 48.1% after randomised consent (for standard therapy) and 13.4% after randomised consent (for experimental therapy).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1995

[Wolfram syndrome. Personal experience].

We report on a young patient who suffered from diabetes mellitus and neurosensorial deafness from the age of two. One year later she was noted to have deteriorated vision and the diagnosis of optic atrophy was made, her visual acuity decreased progressively. At the age of six she was admitted to our hospital because of thiamine responsive megaloblastic anemia, a rare clinical feature of Wolfram's syndrome (only 13 cases have been reported to date). Thiamine (75 mg/day) was commenced at a single oral dose with a rapid increase of Hb level after a few days of therapy. The insulin requirement didn't decrease during thiamine therapy, the C-peptide level after glucagon remained almost indosable. No improvement was observed in the deafness and in the optic atrophy. These findings suggest that diabetes mellitus and optic atrophy, in Wolfram's syndrome are not related to thiamine metabolism.

Autoantibodies↗
PubMed1994

Mitomycin C and mitoxantrone in anthracycline-pretreated advanced breast cancer patients. A phase II study.

Twenty-one patients with anthracycline-pretreated advanced breast cancer were treated with mitomycin C plus mitoxantrone (MM), 10 mg/m2, on day 1 of a 28-day cycle. All patients were evaluated for toxicity and response. Overall, 83 cycles were administered, with a median number of 4 cycles per patient. Hematologic toxicity, not requiring hospitalization, was the major side effect. Vomiting occurred in 19.2% of cycles. Objective response rate was 33.3% (95% confidence interval: 12.2-53.1%); best responses were 1 complete and 6 partial; also 7 stable and 7 progressive disease were recorded. The best responding site was the viscera, the worst was bone. Responses were seen preferentially in second- rather than in third-line therapy and in patients who had responded to previous chemotherapy, although differences were not statistically significant. Kaplan-Meier estimated median time to progression and overall survival were 26 weeks (range: 2-67 weeks) and 35 weeks (range: 6-79 weeks), respectively. In conclusion the MM regimen showed acceptable toxicity and appreciable activity in anthracycline-pretreated advanced breast cancer.

Adult↗
PubMed1993

Chemotherapy with mitomycin C and vinblastine in pretreated metastatic breast cancer.

AIMS: In February 1986 we began a study to test the activity of mitomycin C (12 mg/m2) plus vinblastine (6 mg/m2) on day 1 of a 28-day cycle (MV) as second or third-line chemotherapy for metastatic breast cancer patients. METHODS: As of February 1988 the study was stopped after 26 patients had been enrolled. The median age of the patients was 54 years (range 35-78); all patients were progressive from chemotherapy; 15 (57.7%) patients were treated as second and 11 (42.3%) as third line; 19 (73.1%) patients had received anthracyclines as first (13 patients) or second-line (6 patients) chemotherapy; 18 (69.2%) patients had visceral involvement; 7 (26.9%) had one metastatic site, 11 (42.3%) two sites, 6 (23.1%) three sites and 2 (7.7%) four sites. RESULTS: Overall, 86 cycles were administered, with a median number of 3 cycles per patient. Toxicity was mild; hematologic side effects required discontinuation of treatment in 3 cases. Vomiting occurred in 3 (11.5%) patients, nausea in 5 (19.2%). Moderate neurologic toxicity was recorded in 6 (23%) patients. No complete and 3 partial responses were observed. The objective response rate was 11.5% (exact 95% confidence interval, 2.4-30.1). Responses occurred independently of disease-free interval, dominant metastatic site, response to previous chemotherapy, previous anthracycline and line of treatment; all responses were recorded in patients under 50 years of age. Kaplan-Meier estimated median time to progression and overall survival were 13 and 40 weeks, respectively. CONCLUSION: The MV regimen was well tolerated but showed little activity in pretreated metastatic breast cancer.

Adult↗
PubMed1993

Prognostic significance of the CaMBr1 antigen on breast carcinoma: relevance of the type of recognised glycoconjugate.

An extensive study of the expression of the blood group-related antigen CaMBr1 has been performed by immunohistochemistry, immunoblotting and high performance thin layer chromatography both on frozen and paraffin-embedded (paraffin) samples from normal and neoplastic breast tissues. The glycolipid antigenic fraction (from frozen samples) was preferentially expressed on functioning breast epithelium. In a prospective series of 143 breast cancer cases CaMBr1 expression was associate, on frozen sections, with the transferrin receptor (P = 0.01), the positivity with oestrogen receptor immunochemical assay (P = 0.06), premenopausal status (P = 0.06) and node negativity (P = 0.07). Non-significant correlation with longer disease-free survival (DFS) was observed. In a retrospective series of 862 cases on paraffin sections the glycoproteic antigenic fraction was significantly associated with premenopausal status (P < 0.05) and lobular histotype (P < 0.01), but failed to predict survival, although a trend for longer DFS was observed for positive cases.

Antigens, Neoplasm↗
PubMed1992

Study of the biological and prognostic significance of the antigen CaMBr8 on breast carcinoma.

We previously reported that the expression on the primary tumour of the antigen CaMBr8 was related to a short survival, attributable either to higher tumour aggressiveness or a poor response to oophorectomy. To further verify the CaMBr8 prognostic value, we analysed retrospectively 862 breast cancer patients with a 19 year follow-up. In this series, CaMBr8 expression was found to be associated to some negative prognostic factors (premenopausal status, lymphnode invasion, a high number of mitosis and HER-2/neu oncoprotein expression), but had no influence on the patients' survival. Direct association with a poor prognosis was only evident in patients with lobular or mixed breast carcinoma, which however represent only a small fraction of the total breast cancers. Another possibility was that CaMBr8 could identify a subgroup of patients which did not respond to hormone therapy. To verify this hypothesis we evaluated on a second series of 116 patients the relationship between CaMBr8 expression and hormone-receptor levels. A negative association emerged which was also observed in vitro in the human breast cancer line MCF-7 treated with Sodium Butyrate, a differentiation inducer, which reduced hormone-receptor levels and increased CaMBr8 expression. In conclusion, the longer survival of CaMBr8 negative tumour patients observed in the initial study, was probably related to a better response to oophorectomy, due to the hormone-receptor level of their tumours.

Adult↗