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M Indelli

Publications and source records attributed to M Indelli.

At least 19 recordsLinked to original sources
PubMed2000

Impact of delirium on the short term prognosis of advanced cancer patients. Italian Multicenter Study Group on Palliative Care.

BACKGROUND: The objective of this study was to evaluate the impact of delirium on the survival of advanced cancer patients also assessed with a validated prognostic score (the palliative prognostic [PaP] score). METHODS: The study population was a prospective multicenter consecutive case series of advanced cancer patients for whom chemotherapy was no longer considered viable and who were referred to palliative care programs. Clinical and biologic prognostic factors included in the PaP score were assessed at study entry. The Confusion Assessment Method criteria were applied to screen patients presenting with delirium. Survival times were measured from time of enrollment and death taken as an outcome. Survival curves were traced with the Kaplan-Meier method and comparison were based on log rank tests. RESULTS: Delirium was found in 109 cases among 393 consecutive patients (27.7%). The diagnosis of delirium was independently associated with male gender, central nervous system metastases, lower performance status, worse clinical prediction of survival, and progestational treatment. The survival curve of patients with delirium was significantly different from the nondelirious patients curve (log rank, 31.6, P < 0.0001). The median survival time was 21 days (95% confidence interval [CI], 16-27) for the delirious patients and 39 days (95% CI 33-49) for the others. Multivariate analysis showed that the diagnosis of delirium and PaP score were independently associated with prognosis. CONCLUSIONS: The diagnosis of delirium significantly worsens life expectancy prognosticated with the PaP score. By using the PaP score together with the assessment of cognitive status, physicians can correctly predict patients 30-day survival in greater than 70% of cases.

Adolescent↗
PubMed1999

A new palliative prognostic score: a first step for the staging of terminally ill cancer patients. Italian Multicenter and Study Group on Palliative Care.

In recent years, extensive research has been performed to identify prognostic factors that predict survival in terminally ill cancer patients. This study describes the construction of a simple prognostic score based on factors identified in a prospective multicenter study of 519 patients with a median survival of 32 days. An exponential multiple regression model was adopted to evaluate the joint effect of some clinico-biological variables on survival. From an initial model containing 36 variables, a final parsimonious model was obtained by means of a backward selection procedure. The Palliative Prognostic Score (PaP Score) is based on the final model and includes the following variables: Clinical Prediction of Survival (CPS), Karnofsky Performance Status (KPS), anorexia, dyspnea, total white blood count (WBC) and lymphocyte percentage. A numerical score was given to each variable, based on the relative weight of the independent prognostic significance shown by each single category in the multivariate analysis. The sum of the single scores gives the overall PaP Score for each patient and was used to subdivide the study population into three groups, each with a different probability of survival at 30 days: (1) group A: probability of survival at 30 days > 70%, with patient score < or = 5.5; (2) group B: probability of survival at 30 days 30-70%, with patient score 5.6-11.0; and (3) group C: probability of survival at 30 days < 30%, with patient score > 11.0. Using this method, 178/519 (34.3%) patients were classified in risk group A, 205 (39.5%) patients were in risk group B, and 136 (26.2%) patients were in risk group C. The patients classified in the three risk groups had a very different survival experience (logrank = 294.8, P < 0.001), with a median survival of 64 days for group A, 32 days for group B, and 11 days for group C. The PaP Score based on simple clinical and biohumoral variables proved to be statistically significant in a multivariate analysis. The score is valid in this population (training set). An independent validation on another patient series (testing set) is required and is the object of a companion paper.

Algorithms↗
PubMed1999

Successful validation of the palliative prognostic score in terminally ill cancer patients. Italian Multicenter Study Group on Palliative Care.

The aim of this work was to validate a previously constructed prognostic score for terminally ill cancer patients in order to determine its value in clinical practice. The Palliative Prognostic Score (PaP Score) was tested on a population of 451 evaluable patients consecutively entered in the hospice programs of 14 Italian Palliative Care Centers. The score subdivided patients into three specific risk classes based on the following six predictive factors of death: dyspnea, anorexia, Karnofsky Performance Status (KPS), Clinical Prediction of Survival (CPS), total white blood count (WBC), and lymphocyte percentage. The performance of the PaP Score index in the training and testing sets was evaluated by comparing mortality rates in the 3 prognostic risk categories. The score was able to subdivide the validation-independent case series into three risk groups. Median survival was 76 days in group A (with a 86.6% probability of 30-day survival), 32 days in group B (with a 51.6% probability of 30-day survival), and 14 days in group C (with a 16.9% probability of 30-day survival). Survival medians were remarkably similar to those of the training set (64 days in group A, 32 days in group B, and 11 days in group C). In the complex process of staging terminally ill patients, the PaP Score is a simple instrument which permits a more accurate quantification of expected survival. It has been validated on an independent case series and is thus suitable for use in clinical practice.

Algorithms↗
PubMed1999

Intravenous itasetron: establishing the effective dose range for the prophylactic control of acute emesis in cancer patients undergoing high-dose cisplatin chemotherapy.

Nausea and vomiting induced by chemotherapy are a major cause of distress to patients and reduce compliance with potentially beneficial treatment. Itasetron hydrochloride is a new 5-hydroxytryptamine3 (5-HT3) antagonist with potent antiemetic properties. It is more potent than ondansetron in animal models and in early clinical studies it demonstrates a long half-life and does not undergo hepatic biotransformation before elimination. The aim of this open, uncontrolled study was to establish the effective dose range of itasetron hydrochloride given intravenously (i.v.) to patients due to receive high-dose cisplatin chemotherapy (50-120 mg/m2) for the first time. Thirty-nine patients were enrolled in the trial and received a single i.v. infusion of itasetron hydrochloride at a dose of 17-280 microg/kg body weight before commencing the cisplatin infusion (median dose 90-110 mg/m2). Antiemetic protection was demonstrated by doses in the range of 35-280 microg/kg. The 17 microg/kg dose was not effective. Treatment failure (>5 emetic episodes/24 hours) was reported in only six (16%) of the 38 evaluable patients over all treatment groups. Adverse events were generally mild or moderate and of a similar type and incidence to those of current 5-HT3 antagonists. Physicians' and patients' assessments of efficacy and tolerability of itasetron hydrochloride were similar, the majority rating the treatment as 'good' or 'very good'. In conclusion, itasetron hydrochloride is effective in the dose range 35-280 microg/kg in preventing cisplatin-induced emesis. Taken together with results from a larger dose-finding study, a dose corresponding to 35 microg/kg (equivalent to 2.5 mg itasetron, calculated as free base) has been pursued in Phase III studies with the i.v. formulation.

Acute Disease↗
PubMed1998

Modulation of biomarkers in minimal breast carcinoma: a model for human breast carcinoma progression.

BACKGROUND: The widespread use of diagnostic breast imaging has yielded an increase in the detection of in situ, microinvasive, and small invasive carcinomas and has provided opportunities to study the earliest stages of breast carcinoma development. The authors of this report analyzed the pathobiologic features of 577 minimal breast carcinomas (MBCs), including in situ carcinomas and invasive carcinomas < or =1 cm, according to the definition given by Hartmann in Cancer (1984;53:681-4). METHODS: Estrogen and progesterone receptors (ER and PR), proliferation index (PI), and p53 and neu expression were studied by immunohistochemical technique and measured by quantitative image analysis in 99 pure in situ carcinomas (ISCp); in 105 mixed invasive/in situ carcinomas, with a separate analysis of in situ (ISCm) and invasive (ICm) components; and in 373 invasive carcinomas < or =1 cm (IC). Follow-up data were available for 164 invasive carcinomas. RESULTS: A progressive increase in the levels of hormone steroid receptors, from the lowest in ISCm to the highest in IC, was observed (ER, P< 0.001; PR, P=0.005). Levels of PI and p53 expression were higher in ISCm than in the other categories (PI, P=0.007; p53, P=0.046). Overexpression of neu was greater in ICm than in IC (P=0.013). Younger women (< or =40 years) with invasive carcinoma had worse biologic profiles, with lower ER (P < 0.001) and higher PI (P=0.021), neu (P=0.008), and p53 (P=0.040). It was demonstrated clinically that PI and neu were the biologic markers with the highest predictive prognostic values in univariate analysis (PI for recurrence, P < 0.015; neu for recurrence and overall survival, P < 0.001 and P < 0.007, respectively) and in multivariate analysis (neu for recurrence and overall survival, P < 0.007 and P < 0.017, respectively). CONCLUSIONS: Biologic phenotypes of MBC can be interpreted as reflecting a dimension of neoplastic progression capacity that is independent of tumor size. This study suggests that biologic markers can be integrated with traditional pathologic indicators for accurate staging of patients.

Biomarkers↗
PubMed1997

Biological indices predictive of survival in 519 Italian terminally ill cancer patients. Italian Multicenter Study Group on Palliative Care.

The knowledge of prognostic factors capable of subdividing cancer patients into groups having homogenous survival times is useful even in very advanced stages of illness. This prospective multicenter study assessed these prognostic factors in 530 terminal patients with solid tumors who were undergoing only palliative care. Thirteen hematological and urinary parameters were assessed on admission and every 28 days thereafter. In 519 assessable patients with a median survival of 32 days, six biological parameters demonstrated a statistically significant predictive prognosis. A poor prognosis was predicted by high total white blood count (WBC) (P < 0.0001), high neutrophil percentage (P < 0.0001), low lymphocyte percentage (P < 0.0001), low serum albumin level (P = 0.0015), low pseudocholinesterase level (P < 0.0001), and high proteinuria (P = 0.0064). Multiple regression analysis showed that only WBC, lymphocyte percentage and pseudocholinesterase level were independent predictors of survival. The individualization of biological parameters having an independent prognostic capacity is a useful step in the attempt to identify subsets of patients with a homogeneous prognosis. The biological factors needed are easily detected by means of a simple blood test and do not require invasive operations on patients who are already debilitated.

Aged↗
PubMed1996

Depressive symptoms and quality of life in home-care-assisted cancer patients.

To examine the prevalence of depressive symptoms and its relationship with quality-of-life domains in home-care cancer patients at an advanced stage of illness, 86 patients were given psychological tests for depression (Hospital Anxiety Depression Scale) (HAD) and quality of life (EORTC-QLQ-C30) 1 week after admission to the home-care program. Using a proper cut-off score on the HAD-Depression subscale, depressive symptoms were reported by 45% of the patients. The quality of life of depressed patients was more affected than non-depressed patients in the social, emotional, cognitive, and physical domains. Significant correlations were found between depression scores and impairment in most quality-of-life areas. These findings support the importance of depression and quality-of-life evaluation in patients with advanced cancer who are followed in a home-care setting. This evaluation is needed to provide patients, their families, and caregivers with appropriate psychosocial interventions.

Adult↗
PubMed1996

MIB-1 proliferative activity in invasive breast cancer measured by image analysis.

AIMS: To determine cell proliferation in infiltrating breast carcinomas. METHODS: Using the MIB-1 monoclonal antibody, the proliferation index was measured in paraffin wax sections of 871 breast cancers. The MIB-1 proliferation index was compared with other markers of disease progression: size, lymph node status, histotype, oestrogen and progesterone receptor status, expression of p53 and Neu, and DNA ploidy. All parameters were measured using image analysis. In 347 tumours, the MIB-1 and Ki-67 proliferation indexes were compared. Follow up data were available for 170 cases (median 66.5 months). RESULTS: Of the tumours, 314 (36%) had a high proliferation index. The MIB-1 proliferation index was correlated directly with size, nodal status, overexpression of p53 and Neu, and the DNA index; and inversely with oestrogen and progesterone receptor status. The correlation between MIB-1 and Ki-67 proliferation indexes was statistically significant. In patients with pT1 tumours, a low proliferation index correlated with a longer relapse-free interval and overall survival; node negative patients with a low proliferation index had a longer overall survival. CONCLUSIONS: The MIB-1 proliferation index is a reliable, practical and useful method of measuring proliferative activity and is an important predictor of clinical behaviour.

Adult↗
PubMed1995

Application of quantitative analysis to biologic profile evaluation in breast cancer.

BACKGROUND: The biologic profile of 907 infiltrating breast carcinomas was determined considering estrogen receptor (ER) and progesterone receptor (PR), proliferation index (PI) and c-erbB-2/Neu expression. The relationship with pathologic parameters (lymph node status, size, histotype) were studied by a multivariate analysis. The clinical prognostic power of biologic profile also was evaluated for 265 patients. METHODS: In 907 infiltrating breast carcinomas, the quantitation of ER, PR, an PI was obtained with an image analysis system (CAS 200, Becton Dickinson Cell Analysis Systems, San Jose, CA); Neu was evaluated semiquantitatively. A clinical study of 265 patients was performed (median follow-up, 42.5 months). RESULTS: Seventy-seven percent of tumors were ER-positive, 70% were PR-positive, 58% had a high PI, and 35% were Neu-positive. The overall analysis indicated a direct correlation between ER and PR (Spearmans' rho [rs] = 0.47, P < 0.001) and an inverse correlation between PI and ER (rs = -0.39, P < 0.001), PI and PR (rs = -0.32, P < 0.001), Neu and ER (rs = -0.20, P < 0.001), and Neu and PR (rs = -0.21, P < 0.001). Cluster analysis, performed based on the biologic profile (ER, PR, PI, c-erbB-2/Neu expression), identified two final groups of tumors with different pathologic features. This study showed a longer relapse free interval for patients with ER- and PR- positive tumors (P = 0.016 and P = 0.007) and low PI and Neu-negative tumors (P < 0.001 and P = 0.047). CONCLUSIONS: These results stress the importance of the biologic profile for defining tumor behavior and patient management, leading to integration of, and eventually the substitution for, the actual staging system.

Adult↗
PubMed1995

Prediction of survival of patients terminally ill with cancer. Results of an Italian prospective multicentric study.

BACKGROUND: The individualization of prognostic factors in the various stages of cancer facilitates the planning of a therapeutic assistance program aimed at various subsets of patients. The prognostic factors for survival in patients terminally ill with cancer have been investigated in case studies that are often retrospective, monocentric and/or include a mixture of patients in advanced disease stages. The aim of this prospective multicentric study was to verify those clinical factors predictive of survival in a population of patients with terminal cancer. METHODS: This prospective and multicentric study was performed on 540 patients with solid tumors in the disseminated phase, no longer subject to specific therapy. Patients were evaluated at study entry and every 4 weeks thereafter. The analysis was performed for 23 clinical parameters. RESULTS: Of 530 assessable patients with a median survival of 32 days, 15 factors were found to be statistically significant prognostic factors. By univariate analysis, 13 factors were found to be indicators of a worse survival: age older than 65 years (P = 0.05); palliative corticosteroid treatment (P < 0.001), anorexia (P < 0.001); dry mouth (P < 0.001); dysphagia (P < 0.001); hospitalization (P < 0.001); transfusion (P < 0.001); weight loss greater than or equal to 10% (P = 0.001); dyspnea (P = 0.01); pain (P = 0.006); increasing amount of pain-killer treatment (P = 0.01); increasing number of symptoms (P < 0.001); and worse clinical prediction of survival (P < 0.001). Two factors that correlated with a better survival rate were palliative progestin treatment (P = 0.03) and a higher Karnofsky performance status (P < 0.001). Multiple regression analysis revealed that only clinical prediction of survival, anorexia, dyspnea, palliative steroidal treatment, Karnofsky performance status, and hospitalization were independent predictors of survival. CONCLUSIONS: The importance of certain clinical parameters as prognostic indicators for patients with terminal cancer (clinical experience, physical activity level, clinical symptoms relating to and unrelated to nutritional state) were confirmed; some others possible factors, such as treatment with corticosteroids and hospitalization, also were noted. These may be useful factors in the therapeutic, assistance decision-making process and may eliminate overtreatment and undertreatment resulting from philosophically preconceived attitudes, rather than from considering the patient's true pathologic condition.

Adrenal Cortex Hormones↗
PubMed1993

Immunoscintigraphy in malignant melanoma: a five-year clinical experience.

Immunoscintigraphy (IS) with 99Tcm-labelled anti-melanoma monoclonal antibody F(ab')2 fragments was performed in 135 melanoma patients, 64 males and 71 females, aged 19-82 years (mean 52.3 years) between December 1987 and December 1991. The first group of IS was performed in 50 patients before surgery to assess optimal management: seven true positive and one true negative were obtained in ocular and visceral melanomas, while in cutaneous MM sensitivity, specificity and accuracy in assessing lymph node involvement were, respectively, 61.5, 93.3 and 83.7%. The second group of 128 IS is relative to 85 patients in follow-up: excluding 13 cases with known metastatic disease and 12 inconclusive tests, sensitivity, specificity and accuracy were, respectively, 83.3, 98.8 and 96.1%. Immunoscintigraphy is free of side effects even after repeated administrations and is a useful adjunct to standard diagnostic techniques as a basis for treatment decisions.

Adult↗
PubMed1992

Clinical usefulness of estrogen receptor immunocytochemistry in human breast cancer.

We assessed the reliability of the immunocytochemical assay of estrogen receptor (ER-ICA) as a marker of clinical outcome. Relapse-free interval (RFI) and overall survival (OS) according to ER-ICA status were retrospectively evaluated on a series of 210 patients who had undergone surgery for primary breast cancer between January 1985 and December 1988. ER assay by the dextran-coated charcoal method (DCC) was also performed in 189 tumors. A significant positive correlation was found between the DCC and ER-ICA assays, with an overall agreement of 79%. ER-ICA status showed a prognostic predictive power with respect to OS and RFI in the whole series of patients and in the subset of node-positive patients. It was also a marker of outcome with respect to OS in the subsets of node-negative patients and patients with tumors < or = 2 cm in diameter. Moreover, the predictive value of the ER-ICA assay was higher than that of the DCC assay in the present study. These findings emphasize the clinical usefulness of the ER-ICA assay as a measure for prognosis.

Adult↗
PubMed1991

Aminoglutethimide in advanced breast cancer: plasma levels and clinical results after low and high doses.

Drug plasma levels, metabolism data and clinical results were evaluated after the daily administration of either 500 or 1,000 mg aminoglutethimide (AG, Orimeten, Ciba-Geigy) plus hydrocortisone acetate (20 mg b. i. d.). A total of 34 patients with advanced breast cancer entered the study: 17 were given 1,000 mg/day and 17 received 500 mg/day for at least 3 months. A novel HPLC method was developed to determine the levels of AG and its known metabolites [N-acetyl-AG (NAG), formyl-AG, nitroglutethimide, hydroxy-AG] in the biological samples. AG plasma concentration was significantly higher during the 1,000-mg/day regimen. NAG was the only metabolite observed in plasma, always occurring at concentrations lower than those of the parent drug. The ratios between NAG and AG levels distinguish two statistically different groups of patients. Irrespective of the dose, a partial response was observed in 44% of the patients; no change in 32% of cases; and progressive disease had an incidence of 24%. The probability of response was not dependent on the drug AUC or on the NAG/AG ratio and did not significantly depend on previous hormone treatment. Neither the plasmatic level of the AG or metabolite concentrations nor the NAG/AG ratio seemed to affect the incidence of side effects.

Adult↗
PubMed1991

Immunoscintigraphic localization in a benign thyroid neoplasm of a monoclonal antibody directed against melanoma.

In a prospective study for evaluation of the use of a monoclonal antibody directed against melanoma in the staging of patients affected by malignant melanoma, we report monoclonal antibody uptake in a follicular thyroid adenoma. Computed tomography, ultrasonography, and pertechnetate scintigraphy did not provide a certain diagnosis. Only pathologic examination of the surgical specimen was conclusive.

Adenoma↗
PubMed1989

Effects of two different hydrocortisone doses on human peripheral blood lymphocyte nucleologram.

The effect of 200 and 500 mg of hydrocortisone hemisuccinate given i.v. on the circulating lymphocyte nucleologram was studied in 12 healthy volunteers. Transient lymphopenia was observed in all treated subjects, with the nadir at 3 to 9 h after drug administration. An evaluation of the lymphocyte nucleologram, at this time, showed a statistically significant decrease in mono- and binucleolated lymphocytes. By 24-36 h, the number of total lymphocytes and the nucleologram had returned to baseline values. No differences were revealed among the two groups of subjects. The role of lymphocyte redistribution and of lymphocytolysis to explain the lymphocytopenia and the behaviour of lymphocyte nucleologram is discussed.

Adult↗