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Biomedical subjects

E Marubini

Publications and source records attributed to E Marubini.

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

Poorly differentiated forms of papillary thyroid carcinoma: distinctive entities or morphological patterns?

The concept that poorly differentiated carcinomas (PDC) represent a group in an intermediate position in the spectrum of follicular cell-derived carcinomas of the thyroid gland is currently well established. Because at the well-differentiated end of the spectrum there are two groups of entities with distinct biological characteristics, ie, the papillary carcinoma (PC) and the follicular carcinoma (FC), we examined the group represented by PCs to ascertain whether papillary carcinoma-related PDCs (pPDC) represent merely a histologic variant or a distinct pathologic entity. For this purpose 227 consecutive PCs were reclassified according to current criteria. The association between the presence of a tumoral pattern consistent with pPDC (response variable), and prognostic factors such as gender age, pTNM (predictive variables) was evaluated in terms of odds ratio statistics. One hundred eighty-three of 227 cases, defined as PCs met the World Health Organization criteria of the not otherwise specified (NOS) (79 cases), microcarcinoma (65 cases), encapsulated (4 cases) and follicular (35 cases) variants. Forty-four cases, defined as pPDCs, met those of the tall cell (39 cases), columnar cell PC (2 cases) and mixed tall cell-columnar cell PC (3 cases) variants. Statistical analyses of the two groups of patients showed a significant correlation between differentiation and age above 40 years, extrathyroid tumor extension and low ratio of regional nodal involvement at the onset of disease. More strikingly they also showed that morphology, ie, a tumoral pattern consistent with pPDC (differentiation), is the strongest predictor of biological behavior including recurrences and recurrence-related deaths that appear to occur five and twenty times more frequently in pPDCs than in PCs, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Tumor microvessel density, p53 expression, tumor size, and peritumoral lymphatic vessel invasion are relevant prognostic markers in node-negative breast carcinoma.

PURPOSE: To determine the absolute and relative value of microvessel density (MVD), p53 and c-erbB-2 protein expression, peritumoral lymphatic vessel invasion (PLVI), and conventional prognosticators in predicting relapse-free (RFS) and overall survival (OS) rates in patients with node-negative breast carcinoma (NNBC). PATIENTS AND METHODS: We monitored 254 consecutive patients with NNBC for a median of 62 months. Intratumoral MVD was measured after microvessels were immunostained using anti-CD31 antibody. p53 and c-erbB-2 protein and hormone receptors were also determined immunocytochemically. Results were analyzed by both univariate and multivariate statistical analysis. RESULTS: Univariate analysis showed that MVD was significantly predictive of both RFS (odds ratio [OR], 8.30; P = .0001) and OS (OR, 4.50; P = .012) when tested as a continuous or dichotomous variable. Likewise, tumor size (OR, 3.16; P = .0012), PLVI (OR, 4.36; P = .0009), estrogen receptor (ER) status (OR, 2.35; P = .016), progesterone receptor (PR) status (OR, 2.00; P = .017), and expression of p53 protein (OR, 2.82; P = .004) were significantly associated with RFS. Tumor size (OR, 3.80; P = .0038) and expression of p53 protein (OR, 2.58; P = .024) were significantly associated with OS by univariate analysis. Multivariate analysis showed that MVD (P = .0004), p53 protein expression (P = .0063), tumor size (P = .0144), and PLVI (P = .0033) were all significant and independent prognostic factors for RFS. However, only tumor size (P = .004) and MVD (P = .047) were independent predictors for OS. c-erbB2 expression was not associated with outcome by either univariate or multivariate analysis. CONCLUSION: MVD, p53 expression, PLVI, and tumor size are independent prognostic indicators of recurrence, which are useful in selection of high-risk NNBC patients who may be eligible to receive adjuvant therapies.

Adult↗
PubMed1994

[Measurements of survival in the evaluation of a treatment. The cardiologist and the large clinical trials of coronary thrombolysis].

Since late eighties, large clinical trials on thrombolytic therapy have introduced in cardiology literature the use of survival measures in order to assess the consequences of treatment. In this article a systematic review of the more frequently adopted measures is presented, together with the proposal of other measures, more useful for the clinician.

Clinical Trials as Topic↗
PubMed1993

"Within patient"-dependent outcomes in graft occlusion after coronary artery bypass. SINBA Group.

In clinical trials aimed at assessing the efficacy of drugs after coronary artery grafting, statistical analysis is usually carried out on a per-patient basis and on a per-graft basis. Owing to the independence of responses among patients, the former outcome is analyzed by assuming a binomial model. However, this model cannot be directly adopted in analyzing the latter outcome because multiple vein grafts in the same patient do not act independently. It has been suggested that patients be considered as clusters of distal anastomoses, subsequently comparing the frequencies of occlusion under different treatments after adjusting the variance of each frequency for the size of the cluster. Alternatively, one can measure the intraclass (intrapatient) correlation coefficient and adopt distribution functions that include this quantity as one of the parameters. This approach has been adopted by many authors although the studies differed in the statistical model used to represent this kind of data. Two probability functions, Altham's and beta-binomial, have found wide application in different biomedical fields. Both are able to model the extrabinomial variability since their tails tend to zero more slowly than those of the binomial distribution. An alternative to adopting a specific probabilistic model consists of specifying a mixed model or a Markov-like susceptibility model. These models follow the same rationale since they assume the existence of two processes, one that causes an individual to become susceptible to occlusion, the other that determines the subsequent probability of occlusion in the individual. After presenting these models in a unified framework, this paper compares the estimates obtained by fitting the models to data gathered at coronary angiography 1 year after surgery by the SINBA group on a total of 847 saphenous vein anastomoses in 349 patients. Finally, the issue concerning the contribution of each patient to the effective sample size is discussed.

Coronary Angiography↗
PubMed1993

Treatment of FIGO (1971) stage I endometrial carcinoma with intensive surgery, radiotherapy and hormonotherapy according to pathological prognostic groups. Long-term results of a randomised multicentre study.

A multicentre trial on patients with apparent stage I endometrial carcinoma was conducted with the aims of defining a treatment plan on the basis of the pathological disease extension and of evaluating the effectiveness of adjuvant medroxyprogesterone acetate (MPA). After surgery, patients with disease limited to the endometrium did not receive any further treatment. Patients with inner myometrial invasion and well or moderate differentiation were randomised to no further treatment vs. MPA 100 mg orally twice a day for 12 months; patients with moderate or deep myometrial invasion or undifferentiated grade were randomised to radiotherapy on pelvis vs. radiotherapy plus MPA, and patients with node-positive disease (N+) were submitted to radiotherapy on pelvis and para-aortic nodes vs. radiotherapy plus MPA. At 84 months, analysis as intention to treat on 856 patients shows a high relapse-free survival, whereas it did not show any significant difference between the MPA-treated and untreated groups. The study indicates that relapse-free survival is influenced by a treatment based on the pathological extension of the disease and that adjuvant hormonotherapy does not improve the cure rate.

Adult↗
PubMed1993

A prognostic score for patients resected for gastric cancer.

This paper describes the construction, validation and use of a simple prognostic score suitable for predicting survival of patients undergoing a curative gastric resection. Using death from all causes as outcome, the prognostic significance of age, sex, tumour site, stage of disease (nodal status and wall invasion), surgical treatment and histological type was investigated in a set of 213 patients recruited in a multi-centre clinical trial. A Weibull multiple regression model was adopted to evaluate the joint effect of these variables on survival. From a full model, containing all the variables, a final parsimonious model was obtained by means of a backward selection procedure. The prognostic score is based on the final model, including four variables which are easily detected in every institution: age, wall invasion, site of tumour, and nodal status. Three groups of patients with different probabilities of surviving 5 years from surgery were identified: group I (survival probability > or = 70%), group II (30%-69%) and group III (< 30%). The prognostic score, obtained from the multicentre trial patients, was tested on a set of 135 consecutive patients in an independent institution, confirming its reliability in predicting survival. The score system presented can supply a simple tool for classifying patients radically operated for gastric cancer into three well discriminated groups from the prognostic point of view.

Age Factors↗
PubMed1993

HDL-cholesterol and breast cancer: a joint study in northern Italy and southern France.

The goal of the present study is to evaluate HDL-cholesterol (HDL-C) as a marker of breast cancer (BC) risk. It is based on several epidemiological and biological studies and is justified by the rising incidence of breast cancer throughout the world. A hospital-based study on host-related risk factors and breast cancer, conducted with similar methods in northern Italy and southern France, provided the biological data, the information on the established BC risk factors and on nutrition for 307 cases and 329 controls. This data set allowed for a thorough analysis of the relationship of HDL-C with established risk factors for BC and also of its association with BC at the time of diagnosis. Most of our findings on HDL-C determinants in the control sample are comparable to previous studies. The BC risk factors associated with reproductive life correlate with HDL-C levels: the protective factors are associated with a lower level of HDL-C and inversely. The same is true for nutritional factors such as alcohol. For these determinants, the trend is similar for cases and controls, and HDL-C level appears to be related to oestrogen metabolism. Thus it may be considered as a marker of BC risk. Our results indicate that high HDL-C levels should be especially checked in women aged > or = 60 years, or in premenopausal women presenting a low BMI, or in postmenopausal women with an early menopause.

Breast Neoplasms↗
PubMed1993

Factors influencing 1-year patency of coronary artery saphenous vein grafts. Studio Indobufene nel Bypass Aortocoronarico (SINBA).

BACKGROUND: To evaluate the possible influence of a series of clinical angiographic and surgical variables on the 1-year patency of saphenous vein (SV) coronary graft, data collected prospectively in a multicenter randomized clinical trial were analyzed. METHODS AND RESULTS: The study group included 349 patients--847 SV distal anastomoses--who underwent angiography at a median time of 374 days after surgery. By logistic binomial regression analysis, age, sex, smoking habits, hypertension, high cholesterol, previous myocardial infarction, and angina were not found to be significant factors leading to graft occlusion. Among the angiographic and surgical variables, the following were retained as predictive of higher occlusion risk: (1) vessel diameter (< or = 1.5 mm versus > 1.5 mm, odds ratio (OR) = 2.46); (2) the location of the grafted vessel, namely, the right coronary artery versus the left anterior descending (OR = 2.15); and (3) the wall motion of the vessel-dependent myocardial region (altered versus normal: OR = 2.12). The presence of two or three risk factors multiplied the occlusion risk up to 11-fold. CONCLUSIONS: The study suggests that vessel diameter, wall motion of the vessel-dependent myocardial region, and location of the grafted vessel are the main determinants of SV coronary graft patency during the first postoperative year. Knowledge of these artery-specific factors may provide a basis for estimating the risk of graft occlusion, thereby modifying surgical strategy and postoperative surveillance.

Aspirin↗
PubMed1993

Comparing surgical resection of limited hepatic metastases from colorectal cancer to non-operative treatment.

The survival of two groups of patients, affected by liver metastases (Stage I and II by Gennari et al.) from a previously operated colorectal cancer and treated by surgical resection (Group 1, 39 patients) or chemotherapy with various cytotoxic drugs (Group 2, 31 patients) at the Istituto Nazionale Tumori, Milan, is reported. In comparison with Group 2, Group 1 included more patients with metachronous lesions, with high level of serum bilirubin and with primary tumour originating from the colon. A univariate analysis (log rank test) identified a statistically significant prognostic role of type of treatment (surgery vs chemotherapy) and of the level of serum bilirubin. However the multivariate analysis by the Cox's regression model showed that the only independent statistically significant prognostic factor was type of treatment, since the hazard ratio of surgery vs chemotherapy was 0.490 with a 95% confidence interval of 0.256-0.936. The survival probabilities at 24 and 36 months were respectively 60% and 47% in surgical patients, vs 30% and 23% in those receiving chemotherapy, the difference between the curves being statistically different (P = 0.001). The median survival of Group 1 patients was 30 months whereas the median survival of Group 2 patients was 19 months, a value quite similar to that published in literature for untreated patients with limited metastatic disease-thus indicating that this patients' population was not selected according to unfavourable criteria. These findings suggest a beneficial role of surgical resection in patients with colorectal metastases confined to the liver in Stages I and II.

Adult↗
PubMed1992

Urinary testosterone measurement by gas chromatography after solid-phase extraction and high-performance liquid chromatography.

A method was developed for the rapid determination of testosterone in urine. The procedure consists of solid-phase extraction (SPE) followed by high-performance liquid chromatographic (HPLC) clean-up before gas chromatographic determination. Recovery was evaluated by adding [3H]testosterone (10(4) cpm) to urine samples; the mean recovery of radioactivity after SPE and HPLC was 82%. Precision was estimated by repeated measurement of testosterone in four different urine samples; the coefficient of variation was 7.9% (95% confidence limits 6.1-11.4%). Accuracy was evaluated by standard addition and dilution assays; a linear relationship was found between the expected and observed values (r2 = 0.982). The method is rapid, effective and suitable for routine analysis.

Chromatography, Gas↗
PubMed1992

Peritumoral lymphatic vessel invasion compared with DNA ploidy, proliferative activity, and other pathologic features as prognostic indicators in operable breast cancer.

In 164 breast carcinomas the presence of peritumoral lymphatic vessel invasion (PLVI) was evaluated and correlated with other known indicators of prognosis and with the clinical outcome of the patients. Overall 22% of tumors were PLVI-positive. The presence of PLVI was significantly associated with axillary node involvement (p less than 0.0001) and tumor size (p = 0.005), and tended toward an association with grading (p = 0.065). No significant association was found between PLVI and steroid hormone receptors, DNA ploidy, or proliferative activity. Univariate analysis shows that peritumoral vessel invasion was significantly associated with a higher risk of recurrence (p = 0.012) and with a trend toward shorter survival (p = 0.074). Besides the presence of PLVI, prognosis was significantly worse also for patients with high proliferative aneuploid tumors and with axillary node metastases. Moreover, within the subsets of patients generally considered to have good prognosis, the presence of PLVI identified patients with a trend for higher risk such as those with PLVI-positive diploid tumors, PLVI-positive low-proliferative tumors, and PLVI-positive node-negative tumors. Adopting multivariate analysis, PLVI failed to retain prognostic importance when adjusted for node status, DNA ploidy, and proliferative activity. In conclusion, we found that the presence of PLVI has prognostic significance when singly evaluated. Multivariate analysis shows that PLVI is not an independent prognostic factor in stage I-II breast cancer.

Adult↗
PubMed1992

Value of epidermal growth factor receptor status compared with growth fraction and other factors for prognosis in early breast cancer.

The epidermal growth factor receptor (EGFR) is a transmembrane glycoprotein whose expression is important in the regulation of breast cancer cell growth. The relationship between EGFR status (determined by an immunocytochemical assay) and various prognostic factors was investigated in 164 primary breast cancers. Overall 56% of tumours were EGFR-positive and the expression of EGFR was unrelated to axillary node status, tumour size and histological grade; and it was poorly associated with the tumour proliferative activity measured by Ki-67 immuno-cytochemistry. The relapse-free survival (RFS) probability at 3-years was significantly worse for patients with EGFR positive tumours (P = 0.003) and for those whose Ki-67 score was > 7.5% (P = 0.0027), as well as in patients with axillary node involvement (P = 0.01) and with poorly differentiated tumours (P = 0.04). Immunocytochemical determination of EGFR and cell kinetics gave superimposable prognostic information for predicting RFS with odds ratios of 3.51, when evaluated singly. In our series of patients EGFR, Ki-67 and node status retain their prognostic value concerning RFS in multivariate analysis. The 3-year probability of overall survival (OS) was significantly better in node-negative patients (P = 0.04) and was similar in EGFR-positive and negative patients. In conclusion, EGFR status appears to be a significant and independent indicator of recurrence in human breast cancer and the concomitant measurement of the tumour proliferative activity seems to improve the selection of patients with different risks of recurrence.

Adult↗
PubMed1992

Chemoprevention of breast cancer with retinoids.

Fenretinide [N-(4-hydroxyphenyl)retinamide, 4-HPR] is an effective agent for the inhibition of N-nitroso-N-methylurea-induced breast cancer in rats. This compound has been studied extensively and proved to be safer and less teratogenic than many other retinoids. A major characteristic of 4-HPR is its ability to concentrate in the granular and fat tissue of the breast instead of in the liver. Between January and June 1986, we carried out a phase I study on 101 patients divided into four randomized groups receiving placebo and 100, 200, and 300 mg/day of 4-HPR. Patients received the drug for 6 months without any major toxic effect. This finding was confirmed by another 6-month study in which patients received a common dose of 200 mg/day. In March 1987, a phase III study was started to evaluate the effectiveness of 4-HPR in preventing contralateral primary tumors in women who had already been treated for breast cancer. If 4-HPR succeeds in preventing second primaries in breast cancer patients, it may be useful for a wider group of subjects at high risk for breast cancer. This randomized study was designed with two arms: an intervention group versus a group receiving no treatment. Patients in the intervention group will be treated with 200 mg/day 4-HPR for 5 years. Patients in the control group will not be treated. A further 2 years of follow-up is planned for both groups. Currently, 2450 patients have been recruited. We expect a total accrual of 3500 patients by the end of 1992.

Adult↗
PubMed1991

The association between alcohol and breast cancer risk: evidence from the combined analysis of six dietary case-control studies.

Data from 1,575 cases and 1,974 controls enrolled in 6 previously conducted case-control studies of diet and breast cancer have been analysed with respect to alcohol intake. There appears to be an absence of any association between consumption of up to 40 g of alcohol per day and risk of breast cancer, and a highly statistically significant and consistent elevated risk of breast cancer for drinkers of 40 g or more of alcohol per day, for whom the relative risk, as compared with that of non-drinkers, is 1.69 (95% confidence interval 1.19 to 2.40). This association is not due to confounding by a number of diet-related factors, including total calories, fat, fibre and vitamin C.

Adult↗
PubMed1991

Zinc and copper in breast cancer. A joint study in northern Italy and southern France.

The relationship between breast cancer and two trace elements, zinc (Zn) and copper (Cu), was investigated by means of an hospital based case-control study at Milan (Italy) and Montpellier (France). Variables concerning dietary intake of Zn and Cu (in Milan) and their blood levels (both in Milan and Montpellier) were measured. Dietary intake, evaluated through a questionnaire of the dietary history type, and blood levels of Zn and Cu were measured in 261 cases and 261 controls. Cu blood level showed a contradictory tendency in the two samples (higher in controls in Milan, higher in cases in Montpellier), which tended to lessen after adjustment for related variables. No odds ratios (OR) in the different quantiles, nor X2 for trend reached statistical significance. A sharp difference was evidenced on the opposite with regard to Zn blood values in cases and controls. In both samples Zn mean values are significantly higher in cases than in controls, and the difference remains significant in the two samples even after adjustment for related variables. The pooled OR computed from the two samples, after adjustment for known risk factors and related variables, reaches in the fourth quartile a value of 9.5 (CI: 4.9-18.2). Dietary intake of the two minerals (measured only in Milan sample) showed no difference between cases and controls, but a stronger relationship between dietary and blood Zn was evidenced in cases with respect to controls. The authors suggest that the higher Zn level in cases might be related with an higher incorporation of Zn in cancer cases and that the same mineral might play a possible role in tumor growth promotion.

Adult↗
PubMed1991

Long-term tolerability of fenretinide (4-HPR) in breast cancer patients.

A group of 53 patients initially participating in a phase I trial with the synthetic retinoid fenretinide was assessed for the long-term tolerability of this compound. The patients were evaluated after 42 months of drug intake at a dose of 200 mg/day, including a 3-day drug interruption at the end of each month, by the following examinations: a dermatological visit; an ophthalmological evaluation including an ophthalmological questionnaire and an electroretinogram (ERG); a study on blood chemistry and plasma retinol levels; a study on bone densities and on skeletal X-rays; and finally a psychological evaluation including various tests for anxiety, depression and overall mood. The results show that prolonged administration of fenretinide is well tolerated. No acute nor severe toxicity was observed and thus this compound can be considered a good candidate for chemoprevention trials in a variety of patient populations.

Affective Symptoms↗