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Biomedical subjects

E Marubini

Publications and source records attributed to E Marubini.

At least 19 recordsLinked to original sources
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↗
PubMed1991

Alcohol and breast cancer risk: a case-control study from northern Italy.

From May 1982 to June 1985 a hospital-based case-control study of diet and breast cancer (214 cases and 215 controls) was conducted in Milan in northern Italy, an area where wine consumption is widespread. The study used a detailed diet questionnaire to obtain an estimation of total calories as well as major micro- and macro-nutrient intake. The data thus allowed an investigation of the role of alcohol in breast cancer risk, adjusting for other dietary factors, in particular total energy intake. We found positive associations between breast cancer risk and total caloric intake (chi 2 trend = 6.05, P = 0.014) but no effect for the other nutrients, when adjusted for total caloric intake. The relative risk of breast cancer, for women reporting more than 24.35 g/day of alcohol consumption (highest quintile), was 2.1 (95% confidence interval (CI): 1.1-3.9) when adjusted for non-dietary risk factors for breast cancer and 1.8 (95% CI: 1.0-3.3) when adjusted for non-alcohol caloric intake. The relative risks were moderately elevated (50% or less) for low levels of consumption and comparable to those recorded in most American studies. This finding provides further support for a moderate association between alcohol consumption and breast cancer risk, even when allowance is made for potentially relevant nutrients.

Adult↗
PubMed1990

Diet and cancer risk in northern Italy: an overview from various case-control studies.

A critical overview is presented of selected findings from a series of case-control studies conducted in the greater Milan area on cancers of the digestive tract, breast, female genital tract, prostate and bladder. Even using very simple data collection instruments (based on the frequency of use of a restricted number of food items), a number of consistent and strong associations emerged. In particular, frequent green vegetable consumption appeared to exert substantial protection against most of the cancer sites considered, which could not be explained in terms of information, selection or confounding bias. Other interesting clues, such as a moderately positive relation between fats and breast cancer, and a positive association between maize and esophageal or gastric cancer are discussed in order to illustrate the potential scope of studies of diet and cancer risk based on populations with considerable heterogeneity and modifications in dietary patterns, and recent changes in mortality from various common cancers.

Aged↗
PubMed1990

The role of diet history and biologic assays in the study of "diet and breast cancer".

Nutritional factors related to breast cancer were investigated by means of a hospital-based case-control study in Milan (Italy) and Montpellier (France). Liposoluble vitamins, cholesterol and triglycerides were measured in blood samples taken from interviewed subjects (319 cases and 344 controls). In addition serum zinc and copper was assessed in the Italian samples and serum fatty acids and malonyl-di-aldehyde in the French samples. A significant difference was found between cases and controls in total fat and cholesterol intake in both populations, and in saturated fatty acid and mono-unsaturated fatty acid consumption in the French samples. No difference emerged in liposoluble vitamin consumption in both populations nor in zinc and copper consumption in the Italian samples. A statistically significant higher serum level of cholesterol and plasma level of vitamin E was observed in cases compared to controls in both populations. The difference in plasma vitamin E was confirmed after adjustment on total cholesterol and triglycerides. Similarly, zinc serum level was higher in Italian cases than in Italian controls, while malonyl-di-aldehyde was lower in French cases than French controls. A multivariate analysis was performed after classification of cases and controls according to quantile distribution of controls. Nutrient consumption and relevant blood markers were directly or partially correlated in both populations. All known risk factors plus age, serum total cholesterol and triglycerides were used as covariates. The odds ratio values for the highest quantiles are: Dietary cholesterol, OR = 1.9 (1.1-3.4); total dietary lipids, OR = 1.9 (1.0-3.4); plasma vitamin E, OR = 4.2 (1.9-9.0); serum zinc, OR = 12.2 (5.4-27.7); serum malonyl-di-aldehyde, OR = 0.56 (0.33-0.97).

Breast Neoplasms↗
PubMed1990

Dietary factors and risk of breast cancer: combined analysis of 12 case-control studies.

We conducted a combined analysis of the original data to evaluate the consistency of 12 case-control studies of diet and breast cancer. Our analysis shows a consistent, statistically significant, positive association between breast cancer risk and saturated fat intake in postmenopausal women (relative risk for highest vs. lowest quintile, 1.46; P less than .0001). A consistent protective effect for a number of markers of fruit and vegetable intake was demonstrated; vitamin C intake had the most consistent and statistically significant inverse association with breast cancer risk (relative risk for highest vs. lowest quintile, 0.69; P less than .0001). If these dietary associations represent causality, the attributable risk (i.e., the percentage of breast cancers that might be prevented by dietary modification) in the North American population is estimated to be 24% for postmenopausal women and 16% for premenopausal women.

Body Height↗
PubMed1990

Clinically useful measures to assess the effectiveness of treatments: hints for a proper choice with special emphasis on cancer research.

Several absolute and relative measures useful to assess the consequences of treatments in cancer research are presented together with statistical methods suitable for computing the pertinent confidence intervals. The relationship of these measures with the parameters of the regression models commonly used in the analysis of survival data is elaborated upon. Three examples are elaborated, and conditions of interchangeability of the measures are discussed in detail. Finally, suggestions for the choice of the measure most appropriate for a specified data set are given.

Clinical Trials as Topic↗
PubMed1990

Long term survival analysis: breast cancer and age at diagnosis.

The role of age at surgery of breast cancer patients as a determinant of relative survival after making allowance for clinical profile was investigated on a case series of 716 women followed for more than 20 years in one single institution. Multiplicative and additive models for grouped data were adopted to model the standardized mortality ratio and the excess death rate respectively. The models were fitted by the GLIM system assuming a Poisson error function. We conclude that operable breast cancer has a relatively lower impact on total mortality in older patients (65 years or more) than in younger ones and, moreover, the older patients have a more favourable course.

Age Factors↗
PubMed1990

A linear model suitable for assessing graft patency in controlled clinical trials. SINBA Group.

In clinical trials carried out to assess the efficacy of different drugs in reducing the frequency of occlusion after coronary artery bypass, the ratio of the number of patients with at least one occluded anastomosis to the number of patients catheterized up to a given day is a widely adopted statistic. In the early evaluation (at 1 or 2 months after surgery), this is affected by the distribution of timing of angiography and it tends to underestimate the cumulative probability of occlusion because patients whose anastomoses are all patent at angiography and occlude between angiography and the day at which the ratio is estimated do not contribute their events to the numerator of the ratio. One may sensibly assume that this underestimate does not affect the evaluation of the efficacy of treatments tested "within" the trial. In contrast, since the distributions of the timing of angiography vary substantially from trial to trial, it can make comparisons "between" trials unclear and possibly biased. The aim of this article is to suggest an alternative approach of statistical analysis in terms of logistic regression. By modeling the dichotomous response given by each patient in function of time at angiography, type of treatment, and other possible covariates, asymptotically unbiased estimates of the cumulative probability of occlusion are attained. Furthermore, the pertinent hazard function can be estimated. The main features of the model are discussed and the results obtained by fitting early data collected in the Studio Indobufen Nel Bypass Aortocoronarico (SINBA) are given.

Anastomosis, Surgical↗
PubMed1990

Breast conservation is the treatment of choice in small breast cancer: long-term results of a randomized trial.

From 1973 to 1980, 701 women with small breast cancer (less than 2 cm in diameter) were randomized into two different treatments. 349 patients received classic Halsted mastectomy and 352 patients received quadrantectomy, axillary dissection and radiotherapy on the ipsilateral breast. 24.6% of the patients in the mastectomy group and 27.0% of the patients in the conservation group had axillary metastases. Overall 10 year survival was 76% in the Halsted patients and 79% in the quadrantectomy patients; 13 year survival was 69% and 71%, respectively. No differences were observed after analysis by site and size of the primary tumour and age of the patients. Patients with positive axillary nodes had consistently better survival curves in the quadrantectomy group compared with the Halsted group (not significant). Among the quadrantectomy patients there were 11 local recurrences (with 4 deaths) while among the Halsted patients, 7 had local recurrences (5 deaths). There were 19 cases of contralateral breast carcinomas in the quadrantectomy group and 20 in the Halsted group. At 16 years from the beginning of the trial no evidence of oncogenic radiation risk was observed. In patients with small size carcinomas total mastectomy should have no role.

Breast Neoplasms↗
PubMed1990

Identification of high risk groups for breast cancer by means of logistic models.

In order to identify high risk groups for breast cancer, unconditional multiple logistic regression models based on 5 widely recognized and easily identifiable risk factors (age at menarche, at menopause and at first birth, family history of breast cancer and body mass index) were applied to a large dataset including 2085 cases and 1936 controls aged 50 or over derived from two unmatched hospital-based case-control studies conducted in Italy. Although various models provided an excellent fitting, both on the whole dataset and using a training-testing approach to a priori identified separate subset, the observed extent of variation in breast cancer risk between highest and lowest decile of the distribution was limited to a factor 2. This indicates that the 5 variables considered did not allow identification of subgroups with substantially elevated risk of breast cancer to have practical implications for screening/prophylactic treatment purposes.

Adolescent↗
PubMed1989

Methodological issues in a multicentric study of gastric cancer and diet in Italy: study design, data sources and quality controls.

The authors examine the problems of planning and conducting a multicentric case-control study on diet and gastric cancer in Italy. The solutions chosen for the study design, cases and controls identification, dietary interview, production of a common protocol for the field work are discussed. Results on the evaluation of the quality and comparability of collected data are presented. Further, compliance of cases and controls to the interview and to the blood and urine sampling with reasons of non-response are shown. Finally, the phases of the study and the methods for improving and controlling homogeneity among Centers are summarized.

Aged↗