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Biomedical subjects

G Masi

Publications and source records attributed to G Masi.

At least 37 records · Page 2Linked to original sources
PubMed2001

5-fluorouracil administered as a 48-hour chronomodulated infusion in combination with leucovorin and cisplatin: a randomized phase II study in metastatic colorectal cancer.

OBJECTIVE: The primary objective of this trial was to determine the objective response of two regimens with CDDP administered every 2 weeks immediately before or after an 'optimal' 48-hour chronomodulated infusion of 5-fluorouracil (5-FU) modulated with leucovorin (LV) in metastatic colorectal cancer patients. Secondary endpoints were toxicity, 5-FU and its metabolites, plasma pharmacokinetics and progression-free and overall survival. METHODS: Metastatic colorectal cancer patients with measurable disease who were chemotherapy-naive or pretreated only with a 5-FU-bolus-based chemotherapy were eligible for this study. The study was designed as a randomized phase II clinical trial. RESULTS: Eighty-three patients were entered into the study. Forty-two were randomized to CDDP given before 5-FU and 41 to CDDP given after 5-FU. Patient characteristics were similar among the two groups. Toxicities were also similar among the two arms and the most frequent WHO grade III-IV toxicities were stomatitis (14%) and neutropenia (39-50%). Plasma pharmacokinetic profiles of 5-FU and 5-FUH2 were not significantly affected by the sequence of CDDP and 5-FU administration. Antitumor activity was similar in the two arms and was very promising both in pretreated patients (response rate 29%; 95% confidence interval 15-46%) and in chemotherapy-naive patients (response rate 56%, complete response 9%, 95% confidence interval 40-71%). Median survival of the patients with and without pretreatment was 12 and 16 months, respectively. CONCLUSIONS: These results do not suggest a sequence dependence of the synergism between CDDP and 5-FU. However, they challenge the need of oxaliplatin to improve 5-FU/LV activity in advanced colorectal cancer. In fact, our results with an 'optimal' 5-FU dose and scheduling are very similar to those obtained with oxaliplatin plus 5-FU/LV. However, only a randomized phase III study will be able to give an answer to the hypotheses raised by this study.

Actuarial Analysis↗
PubMed2001

Anxiety disorders in children and adolescents with bipolar disorder: a neglected comorbidity.

OBJECTIVE: We describe a consecutive clinical sample of children and adolescents with bipolar disorder to define the pattern of comorbid anxiety and externalizing disorders (attention-deficit hyperactivity disorder [ADHD] and conduct disorder [CD]) and to explore the possible influence of such a comorbidity on their cross-sectional and longitudinal clinical characteristics. METHODS: The sample comprised 43 outpatients, 26 boys and 17 girls, (mean age 14.9 years, SD 3.1; range 7 to 18), with bipolar disorder type I or II, according to DSM-IV diagnostic criteria. All patients were screened for psychiatric disorders using historical information and a clinical interview, the Diagnostic Interview for Children and Adolescents-Revised (DICA-R). To shed light on the possible influence of age at onset, we compared clinical features of subjects whose bipolar onset was prepubertal or in childhood (< 12 years) with those having adolescent onset. We also compared different subgroups with and without comorbid externalizing and anxiety disorders. RESULTS: Bipolar disorder type I was slightly more represented than type II (55.8% vs 44.2%). Only 11.6% of patients did not have any other psychiatric disorder; importantly, 10 subjects (23.5%) did not show any comorbid anxiety disorder. Comorbid externalizing disorders were present in 12 (27.9%) patients; such comorbidity was related to the childhood onset of bipolar disorder type II. Compared with other subjects, patients with comorbid anxiety disorders more often reported pharmacologic (hypo)mania.

Adolescent↗
PubMed2001

Risperidone monotherapy in preschool children with pervasive developmental disorders.

The aim of this preliminary study was to examine the short-term efficacy and safety of the atypical antipsychotic risperidone in preschool autistic children. The sample consisted of 10 subjects (7 males and 3 females) aged 3 9/12 to 6 6/12 years (mean age 4.7 years). A 16-week open-label trial with risperidone monotherapy was initiated at a starting dose of 0.25 mg daily and was increased to a maximum dose of 0.50 mg (0.027 mg/kg daily). Outcome measures were the Childhood Autism Rating Scale, the Children's Psychiatric Rating Scale, Clinical Global Impression (improvement score), and the Children's Global Assessment of Functioning. Two subjects did not complete the trial because of side effects (tachycardia and flushes, fever and hyporexia). After the 16-week treatment, data from the eight children who completed the trial indicated a modest improvement in the Childhood Autism Rating Scale total score, Children's Psychiatric Rating Scale total score, and Children's Global Assessment of Functioning. According to the Clinical Global Impression, the global improvement score for four subjects was much improved or very much improved; the score for the other four children was minimally improved. None of the children exhibited behavioral deterioration. The side effects in the eight children were not severe.

Antipsychotic Agents↗
PubMed2001

Separation anxiety disorder in children and adolescents: epidemiology, diagnosis and management.

This paper provides an overview of the phenomenology, longitudinal outcome data, assessment and management of separation anxiety disorder (SAD) in children and adolescents. SAD is qualitatively different from early worries, and is characterised by an abnormal reactivity to real or imagined separation from attachment figures, which significantly interferes with daily activities and developmental tasks. Different epidemiological studies indicate a prevalence of 4 to 5% in children and adolescents. In contrast to other anxiety disorders, 50 to 75% of children with SAD come from homes of low socioeconomic status. The severity of symptomatology ranges from anticipatory uneasiness to full-blown anxiety about separation, but children are usually brought to the clinician when SAD results in school refusal or somatic symptoms. School refusal is reported in about 75% of children with SAD, and SAD is reported to occur in up to 80% of children with school refusal. Longitudinal studies have suggested that childhood SAD may be a risk factor for other anxiety disorders, but whether this link is specific to, for example, panic disorder and agoraphobia, or whether SAD represents a general factor of vulnerability for a broad range of anxiety disorders is still debated. Most relevant data are reported on nonpharmacological treatments (psychoeducational, behavioural, cognitive-behavioural, family and psychodynamic), and these are the first choice approach in SAD. Controlled studies show efficacy of cognitive-behavioural therapy in children with anxiety disorders and specifically in SAD-school phobia, supporting this approach as the best proven treatment. Pharmacotherapy should be used in addition to behavioural or psychotherapeutic intervention when the child's symptoms have failed to respond to those treatments, and he/she is significantly impaired by the symptoms. Selective serotonin (5-hydroxytryptamine; 5-HT) reuptake inhibitors (SSRI) have a good adverse effect profile and may be considered as first choice drugs in SAD. When different SSRIs fail to improve symptomatology, a trial with a tricyclic antidepressant (TCA) is indicated, with careful monitoring of cardiac functioning. Because of the adverse effect profile and the potential for abuse and dependence, benzodiazepines should be used only when a rapid reduction of symptomatology is needed, until the SSRI or the TCA have begun to be effective (few weeks). Buspirone should be considered in children who have not responded to other treatments. Further research is needed to confirm efficacy of newer antidepressants (venlafaxine, mirtazapine, nefazodone) in childhood anxiety disorders.

Adolescent↗
PubMed2000

Panic disorder in clinically referred children and adolescents.

Prevalence, phenomenology, comorbidity, functional impairment and familial correlates of juvenile panic disorder (PD) are described in this study. A clinical interview (Diagnostic Interview for Children and Adolescents-Revised) was administered to 220 children and adolescents consecutively referred to a Division of Child Neurology and Psychiatry. 23 subjects (10.4%), aged 7 to 18 years, fulfilled DSM-IV criteria for PD. Reported panic symptoms are described, according to gender and chronological age. High comorbidity with generalized anxiety disorder (74%) and depression (52%) was noted. Agoraphobia (56%) and other phobias (56%) were significantly more frequent than in two control groups of subjects with generalized anxiety disorder and with depression. Antecedent and/or associated separation anxiety disorder was reported in 73% of the patients. Functional impairment, assessed with a specific diagnostic instrument (Children's Global Assessment Scale) was significantly greater in PD patients than in depressed or anxious patients. 90% of patients had at least one parent with an anxiety disorder, 52% had one parent with depressive disorder, 33% had one parent with drug treated PD.

Adolescent↗
PubMed2000

Depressive comorbidity in children and adolescents with generalized anxiety disorder.

Aim of this study is to examine the effect of depressive comorbidity in 108 children and adolescents with Generalized Anxiety Disorder (GAD). Fifty-five patients with GAD and depression were compared with 53 patients with GAD without depression. Age, gender and socioeconomic status did not differentiate the groups. Patients with comorbid depression had significantly more anxiety symptoms than patients without depression. Clinical presentation of GAD and pattern of comorbidity was similar in the two groups. Subjects with comorbid depression showed a more severe functional impairment, assessed with C-GAS. Data are discussed in the light of conceptualizations about the relationship between anxiety and depression.

Adolescent↗
PubMed2000

Depression and school functioning in non-referred adolescents: a pilot study.

Self-image and self-perceived competencies have been considered to be related to depression in childhood and adolescence. Data from literature points to school functioning as one of the most important factors in self-esteem and self-worth during adolescence. Academic self image, defined as the way adolescents represent themselves as students, directly affects the global self-image; for this reason it has important psychopathological implications. The major aim of this preliminary report is to specifically analyze the relationship between academic self-image (assessed with a specific questionnaire), and self-reported depressive symptoms (assessed with the Children's Depression Inventory) in a school sample 150 adolescents. Our data indicate that the emotional beliefs about schooling and learning were significantly related to depressive symptomatology. Females scored higher in CDI and school anxiety. A real school failure did not affect the academic self image. These data seem to suggest that different components of the academic self-image can be differently associated with depressive feelings.

Adolescent↗
PubMed2000

Generalized anxiety disorder in adolescents and young adults with mild mental retardation.

This report examines clinical features of generalized anxiety disorder in adolescents and young adults with mild mental retardation (MR), compared with children and adolescents with normal IQ. Frequency of symptoms, comorbidity, agreement between reports of subjects and parents, correlation between IQ and severity of disorder, and comparison between frequency of symptoms in the experimental and control groups are described. Twenty-two subjects with MR (12 males and 10 females aged 11-25 years; mean age = 16.3), 30 children (19 males and 11 females aged 7-11.11; mean age = 10), and 30 adolescents (18 males and 12 females aged 12.1-18; mean age = 15.2) participated in the study. All the subjects were comprehensively diagnosed with diagnostic interviews (K-SADS or DICA-R). According to our data, generalized anxiety disorder can be diagnosed in adolescents with mild MR, with high agreement between self-reports and parent reports. Phenomenology of GAD in mildly developmentally delayed persons grossly paralleled that of normal IQ people, except for brooding, somatic complaints, and sleep disorders. Number and severity of symptoms did not correlate with Full Scale and Verbal IQs. High rates of comorbidity with depression were evident both in normal IQ and in developmentally delayed subjects.

Adolescent↗
PubMed2000

The Kleine-Levin syndrome as a neuropsychiatric disorder: a case report.

The Kleine-Levin syndrome (KLS) is characterized by periodic, sudden-onset episodes of hypersomnia, compulsive hyperphagia, and behavioral-emotional disorders (typically indiscriminate hypersexuality, irritability, impulsive behaviors), lasting from a few days to a few weeks, with almost complete remission in the intercritical periods. Depression, confusion, and thought disorders are frequently associated with the critical symptomatology, and they may suggest other psychiatric diagnoses (schizophrenia, mood disorder, conversion disorder) or a substance abuse. A diencephalic-hypothalamic dysfunction is suspected, even if this composite symptomatology cannot easily be linked to a simple mechanism. The aim of this article is to illustrate problems in differential diagnosis, using a case approach. History, course, and therapeutic intervention in a 21-year-old patient with KLS, associated with a clear psychiatric symptomatology and a critical affective pattern, is reported. Psychiatric correlates of KLS are discussed, including the relationship with affective disorders and the possible emotional impact of the attacks. Implications regarding a combined psychological and pharmacological treatment are also discussed.

Adult↗
PubMed2000

Somatic symptoms in children and adolescents referred for emotional and behavioral disorders.

Medically unexplained physical symptoms are frequently endorsed by children and adolescents in both clinical and community samples. The aim of this exploratory study is to examine the prevalence of somatic symptoms in a sample of 162 Italian children and adolescents consecutively referred to a Division of Child Neurology and Psychiatry from emotional and/or behavioral disorders. The role of age, gender, and psychiatric status was considered as a variable. Each patient received a DSM-IV assessment, including a diagnostic structured interview (DICA-R). The sample was divided according to gender (96 males, 66 females), age (70 children younger and 92 adolescents older than 12 years), and psychiatric diagnosis (Anxiety, Depression, Depression/Anxiety, Other). The presence of medically unexplained somatic symptoms was based on the responses to the DICA-R. Somatic complaints were reported in 69.2% of the patients. Headache was the most frequent somatic symptom (50.6%). Younger children showed higher rates of abdominal complaints than adolescents. No gender differences in frequency of somatic complaints were reported. Subjects with anxiety and/or depression reported significantly higher rates of somatic complaints, namely headache, than subjects with other mental disorders. No differences in frequency of somatic symptoms were evident between patients with anxiety, depression, and comorbid anxiety-depression. Our data suggest that an unexplained somatic symptom can be often considered as indicative of a neglected anxiety and/or depressive disorder. A collaboration between primary care physicians, pediatricians, and child psychiatrists may promote early diagnoses and timely treatments and prevent negative social and scholastic consequences.

Adolescent↗
PubMed2000

Oral doxifluridine in advanced hepatocellular carcinoma: A phase II study.

Hepatocellular carcinoma (HCC) remains one of the most common neoplasms in the world. Doxifluridine is an oral fluoropyrimidine derivative activated to 5-fluorouracil by uridine phosphorylase which is more expressed in malignant cells. Therefore, we conducted a phase II study to evaluate the activity of oral doxifluridine in patients with advanced hepatocellular carcinoma. Twenty-five advanced hepatocellular carcinoma patients entered the study; doxifluridine was given orally at the initial daily total dose of 2,250 mg for 4 consecutive days every week. All patients are evaluable for toxicity: these included mainly grade 1-2 (WHO) diarrhea, stomatitis, nausea and vomiting; 4 patients (16%) experienced grade 3-4 diarrhea. Twenty-four patients are evaluable for response and 1 complete and 3 partial responses have been observed (response rat 17%, 95% confidence interval: 5-37). Oral doxifluridine at the dose and schedule we used, although having only modest activity in advanced HCC, may represent an alternative to other frequently used chemotherapeutic agents, because of its favorable toxicity profile and its simple route of administration.

Administration, Oral↗
PubMed2000

Tourette's syndrome in children: neurological, neuropsychological and psychiatric issues.

The interplay between neurologic, neuropsychologic and psychiatric features makes Tourette's syndrome (TS) a paradigmatic model for neuropsychiatric disorders. The aim of this paper is to review this complex interplay of clinical features. After a survey of some epidemiological studies, the natural history of neurological, behavioral and psychological characteristics of the syndrome is described. The problem of high psychiatric comorbidity, firstly with obsessive-compulsive disorder and attention deficit-hyperactivity disorder, is discussed. Neuropsychological features of TS are considered, as they can negatively affect the quality of life of affected patients. Considerations on treatment, pharmacologic as well as educational and psychotherapeutic, conclude this review.

Child↗
PubMed2000

Tourette's syndrome in children: neurobiological issues in pathophysiology.

In recent decades significant advances in the understanding of neurobiological substrates of Tourette's Syndrome (TS) have led to the formulation of hypotheses regarding the ways in which the most salient features of the syndrome may occur. Pathophysiology of TS involves multiple intertwined neurobiological issues in different areas of the Central Nervous System. This review considers neuroimaging studies (MRI, PET, SPECT) in patients with TS. Neurochemical neurophysiological and electrophysiological studies are also reviewed. The role of the neuroendocrine and neuroimmunologic mechanism on pathogenesis of the disease is discussed. Advances in diagnostic techniques (fMRI, mMRI, PET, SPECT) and in neurophysiological research on neurotransmitter systems will allow us to better understand the pathophysiology of TS and to use more specific treatments.

Child↗
PubMed1999

Suramin in combination with weekly epirubicin for patients with advanced hormone-refractory prostate carcinoma.

BACKGROUND: Suramin and epirubicin are both active agents in the treatment of patients with hormone-refractory advanced prostate carcinoma, with demonstrated antitumor synergism in vitro on human prostate carcinoma cells and different dose-limiting toxicities. The authors conducted this Phase II study to determine the feasibility, toxicity, and antitumor activity of suramin in combination with epirubicin. METHODS: Only patients with hormone-independent advanced prostate carcinoma who had progressive disease after the last therapeutic maneuver they had undergone, including antiandrogen withdrawal, entered the study. Suramin was administered initially as a 6-day continuous infusion for 10 consecutive weeks and then for 6 days every 28 days for a maximum of 6 months. Doses were determined by a computer-assisted dosing system that used Bayesian pharmacokinetics to maintain suramin plasma concentrations of 200-250 microg/mL. Cortisone acetate 25 mg, administered at 8 a.m. and 8 p.m. daily, was begun 4 weeks after the initiation of suramin therapy. Epirubicin 25 mg/m2 was given as a weekly intravenous bolus beginning on Day 1 and was continued for a maximum of 6 months. RESULTS: Twenty-six patients entered the study. Toxicities mainly included World Health Organization Grade 1-2 nausea, fatigue, anorexia, neutropenia, peripheral neuropathy, creatinine elevation, proteinuria, and prolonged prothrombin time, whereas Grade 3 toxicities were uncommon. Among 11 patients with measurable disease, 3 (27%) demonstrated an objective response. Among 24 patients evaluated for prostate specific antigen (PSA) response, 8 (33%; 95% confidence interval 16-55%) had a > or =50% decrease in PSA levels, which lasted a median of 32 (range, 8-52) weeks. Median progression free and overall survival were both 8 months. CONCLUSIONS: The combination of suramin and epirubicin used in the current study is feasible, is associated with moderate toxicities, and has antitumor activity in advanced hormone-refractory prostate carcinoma. However, the results obtained with this combination do not represent major improvements in the treatment of patients with this disease, compared with suramin or epirubicin alone or other available treatments.

Aged↗
PubMed1999

Protracted continuous infusion of 5-fluorouracil and low-dose leucovorin in patients with metastatic colorectal cancer resistant to 5-fluorouracil bolus-based chemotherapy: a phase II study.

Continuous-infusion (c.i.) 5-fluorouracil (5-FU) can overcome resistance to bolus 5-FU, and leucovorin (LV) enhances the cytotoxic effects of 5-FU, mainly when the duration of exposure to the latter is prolonged. The main objective of this study was therefore to determine the activity of a prolonged infusion schedule of 5-FU + LV in patients with metastatic colorectal cancer resistant to a 5-FU bolus-based chemotherapy. Only patients with metastatic measurable disease in progression during or within 2 months of the end of a 5-FU bolus +/- LV-based chemotherapy were eligible for the study. 5-FU and l-LV were given as a 14-day c.i. every 28 days, the 5-FU dose being 200 mg/m2 per day and the l-LV dose being 5 mg/m2 per day. A total of 59 patients entered the study, of which 48 were resistant to 5-FU + LV and 11, to 5-FU + levamisole. Treatment was well tolerated, and WHO grade 3-4 toxicities were uncommon (11% of patients developed stomatitis and 7%, diarrhea). According to an intent-to-treat analysis, 10 of 59 patients obtained an objective response (1 complete response, 9 partial responses), for an objective response rate of 16% (95% confidence interval 8-25%). The median progression-free survival and overall survival were 4 and 9 months, respectively. The protracted 5-FU + LV c.i. schedule used in the present study is a well-tolerated and moderately active regimen in metastatic colorectal cancer patients resistant to 5-FU bolus +/- LV. Only randomized studies can determine whether this palliative treatment has advantages in comparison with other second-line therapies such as 5-FU c.i. without LV, irinotecan, or oxaliplatin.

Adult↗
PubMed1999

Psychopathological aspects of cryptorchidism in children and adolescents.

In the male sexual and aggressive drives are mostly centered on the penis, whose real or fantasied features strongly affect the way children and adolescents build up their own personal and gender identity. In some clinical conditions a shift of genital centrality from penis to testicles is evident. The most frequent is abnormality in the descent of testicles, especially cryptorchidism, characterized by an arrested descent of one or two testicles that remain in the abdomen. The aim of this paper is to define mechanisms by which cryptorchidism increases psychological vulnerability. Time of diagnosis and treatment, restoration of genital integrity, personality stability and familial interactions are considered as elements affecting psychopathological outcome. Behavioral and psychological features in children and adolescents with cryptorchidism are reviewed. A case report of an adolescent with unilateral cryptorchidism is reported and discussed, as an example of pubertal distortion in bodily and gender identity.

Adolescent↗
PubMed1999

Dysthymic disorder in adolescents with intellectual disability.

The present report examines the clinical features of dysthymic disorder in a sample of adolescents with mild intellectual disability (ID). Frequency of symptoms, comorbidity, agreement between reports of subjects and parents, comparison between the frequency of depressive symptoms in subjects with ID and in two different groups of normal IQ dysthymic subjects (aged 7-11, 11 and 12-18 years) are described. The sample consisted of 12 subjects (age range = 12-25.6 years; mean age = 16.3 years) screened from unselected consecutively referred patients with mild ID. All the subjects were comprehensively diagnosed with a structured diagnostic interview, the Kiddie-Schedule for Affective Disorder and Schizophrenia (K-SADS), according to DSM-IV criteria. A symptomatic profile in the group with ID showed that intrapsychic and cognitive symptoms, such as depressed mood, irritability, pathological guilt and low self-image, were frequently reported in people with ID. Parents were less aware of depressed mood, but they reported high rates of low self-esteem; the agreement between the depressive reports of ID subjects and their parents was higher than in previous findings in normal IQ children. The symptomatic profile of subjects with ID was more comparable to that of prepubertal dysthymic children than that of dysthymic adolescents, but more significant are the analogies between dysthymic disorder in ID and normal IQ subjects. High rates of comorbidity with generalized anxiety disorder were evident in the group with ID. According to the present data, dysthymic disorder can be diagnosed in adolescents with mild ID. The K-SADS clinical interview seems to be a reliable instrument for the diagnosis and clinical definition of depressive symptomatology in this special population.

Adolescent↗