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Biomedical subjects

S Gori

Publications and source records attributed to S Gori.

At least 19 recordsLinked to original sources

Epirubicin versus CMF as adjuvant therapy for stage I and II breast cancer: a prospective randomised study.

We compared a relatively short regimen of monochemotherapy with epirubicin versus polychemotherapy with CMF (cyclophosphamide, methotrexate, 5-fluorouracil) as adjuvant treatment for stage I and II breast cancer patients. 348 patients with oestrogen receptor negative (ER-) node negative and ER- or ER+ node-positive with <10 nodes were accrued. CMF was given intravenously (i.v.) on days 1 and 8, every 4 weeks, for six courses; epirubicin was given weekly for 4 months. Postmenopausal patients received tamoxifen for 3 years. The primary endpoints were overall survival (OS), relapse-free survival (RFS) and event-free survival (EFS). Outcome evaluation was performed both in eligible patients and in all randomised patients according to the intention-to-treat principle. 8 randomised patients were considered ineligible. At a median follow-up of 8 years, there was no difference in OS (Hazard Ratio (HR)=1.11, 95% Confidence Interval (CI): 0.77-1.61, P=0.58), EFS (HR=1.14, 95% CI: 0.78-1.64, P=0.48), and RFS (HR=1.14, 95% CI: 0.8-1.64, P=0.48) between the two arms for all of the patients. At 8 years, the RFS percentages (+/-Standard Error (S.E.)) were 65.4% (+/-4%) in the CMF arm and 62.7% (+/-4%) in the epirubicin arm; for EFS these were 64.2% (+/-4%) for CMF and 60.8% (+/-4%) for epirubicin, respectively. A significant difference in RFS (P=0.015) was observed in patients with 4-9 positive nodes in favour of the CMF arm. Toxicity in the two arms was superimposable except for more frequent grade 3 alopecia in the epirubicin-treated patients (P=0.001). Overall, at a median follow-up of 8 years, there were no differences between the two arms in terms of OS, EFS and RFS.

Adult↗

The organization of rapid eye movement activity during rapid eye movement sleep is further impaired in very old human subjects.

Rapid eye movement activity (REMA) during rapid eye movement (REM) sleep was studied in seven very old ('old-old') subjects. Beyond global quantitative features (REMA density), we evaluated the organizational aspects of REMA, that is its occurrence in burst mode, which were compared to a group of younger elderly subjects ('young-old'). REMA density in 'old-old' subjects is not significantly different from that of 'young-old' subjects. The same lack of difference in the two groups is found for the number of REMA bursts. By contrast, the duration of REMA bursts is reduced in the 'old-old' subjects, as well as the 'burst state-to-burst-state' probability, i.e. the probability for successive inter-REMA time intervals to be part of the same REMA burst. Our results clearly show that the trend towards an impairment of REMA organizational aspects continues with aging. This is consistent with the hypothesis that sleep disorganization keeps worsening with age. However, it is of interest to observe that the capability of producing REMA bursts is preserved despite aging.

Age Factors↗

The importance of nasal resistance in obstructive sleep apnea syndrome: a study with positional rhinomanometry.

The importance of nasal obstruction in the pathogenesis of obstructive sleep apnea syndrome (OSAS) has not yet been totally defined. Numerous studies have reported an association between nasal obstruction and OSAS, but the precise nature of this relationship remains to be clarified. This study was undertaken to evaluate the prevalence of nasal obstruction disorders in a group of OSAS patients. For this purpose, we analyzed the nasal resistance of 36 OSAS patients by performing a traditional basal anterior active rhinomanometry test (AAR) and a positional AAR, with the patient in a supine position. Seven patients had a pathologic nasal resistance in the seated position that increased further in the supine position; 9 patients had normal resistance in the seated position but a pathologic resistance in the supine position. In 20 patients, nasal resistance was normal in both positions. No statistically significant differences in the degree of apnea/hypopnea index (AHI) was found between the 20 patients with normal positional AAR and the 16 with pathologic positional AAR (p = 0.13). Moreover, no statistically significant differences in the degree of AHI was found between the 7 patients with pathologic basal and positional AAR and the 9 patients with normal basal AAR and pathologic positional AAR (p = 0.38).

Adult↗

Neurophysiological evaluation of vigilance in epileptic patients on monotherapy with lamotrigine.

OBJECTIVE: Limited research has focused to date on daytime sleepiness in epileptic patients treated with either conventional or newer antiepileptic drugs. We evaluated the level of vigilance in 15 consecutive, newly diagnosed and never medicated adult epileptic patients, receiving initial monotherapy with lamotrigine (LTG). METHODS: Patients underwent the Multiple Sleep Latency Test (MSLT), visual reaction times (VRT) and Stanford Sleepiness Scale (SSS) on two separate occasions, i.e. before and 2 months after LTG treatment. A group of 15 age-matched healthy volunteers was taken as control. RESULTS: At baseline, mean sleep latencies on the MSLT were comparable in epileptic patients and in controls. In patients, 2 months after monotherapy with LTG 200 mg/day, MSLT scores did not significantly change as compared with pre-treatment values. Accordingly, subjective evaluation of vigilance by the SSS and psychomotor performance by VRT were superimposable in controls and in untreated patients, and did not change in patients after LTG treatment. CONCLUSIONS: These results suggest that in adult, newly diagnosed epileptic patients initial monotherapy with LTG does not impair vigilance.

Adult↗

The organization of rapid eye movement activity during rapid eye movement sleep is impaired in the elderly.

Rapid eye movement activity (REMA) during rapid eye movement activity (REM) sleep was studied in eight elderly subjects and six young adults as a control group. Beyond global quantitative features (REMA density), we evaluated the organizational aspects of REMA, that is its occurrence in burst mode, still largely unknown in the aged. REMA density in the elderly is not significantly different than that of young adults. By contrast, the duration of REMA bursts is reduced in the elderly, as well as the 'burst state-to-burst-state' probability, i.e. the probability for successive inter-REMA time intervals to be part of the same REMA burst. These results show that global aspects of the quantitative features of REMA are preserved in the elderly, whereas their organizational aspects are impaired. These data are consistent with the hypothesis that aging is associated with a difficulty in maintaining physiological processes over time.

Adult↗

Word recall correlates with sleep cycles in elderly subjects.

Morning recall of words presented before sleep was studied in relation to intervening night sleep measures in elderly subjects. Night sleep of 30 elderly subjects aged 61-75 years was recorded. Before sleep, subjects were presented with a list of paired non-related words and cued recall was asked immediately after the morning awakening. Recall positively correlated with average duration of NREM/REM cycles, and with the proportion of time spent in cycles (TCT) over total sleep time (TST). No significant correlations were found with other sleep or wake measures. These results suggest the importance of sleep structure for sleep-related memory processes in elderly adults.

Aged↗

Sleep stages preceding spontaneous awakenings in the elderly.

Spontaneous awakenings from sleep were studied in a group of 21 elderly subjects (mean age 69.29+/-3.02 years) free of neurological and somatic diseases. The prevalence of awakenings and the duration of waking bouts were analyzed with regard to the prior sleep state. The results showed an increased frequency of awakenings during Stage 2 NREM in the elderly, who wake out of Stage 2 NREM no less frequently than out of REM sleep. This trend is different from that observed in younger subjects (babies and young adults), where a clear prevalence of REM sleep awakenings has been reported. The duration of Stage 2 interrupted by awakening was shorter than Stage 2 followed by sleep. The duration of waking bouts did not differ according to the preceding sleep stage. It is suggested that the relative inability to sustain Stage 2 may be a mechanism which contributes to the difficulty of sleep maintenance in the elderly.

Aged↗

Slow wave sleep (SWS) distribution across night sleep episode in the elderly.

Slow wave sleep (SWS) distribution across night sleep was shown to be different between infants and young adults. The present research aimed at studying the SWS distribution across night sleep in elderly subjects. Nine healthy elderly subjects, 61-71 years old, were submitted to nocturnal polygraphic sleep recording. Eleven young subjects, 21-23 years old, were the control group. Recordings were visually analyzed according to Rechtschaffen and Kales rules; the method proposed by Webb and Dreblow was used for scoring SWS. An NREM-REM cycle was defined as a sequence of NREM and REM sleep not interrupted by a waking period longer than 15 minutes. SWS percentage was calculated for each successive NREM episode. No significant association between SWS percentage and cycle rank was shown in elderly subjects, whereas a significant association was observed in the young ones. This kind of SWS distribution could be interpreted as reflecting the restructuring of internal organization of sleep in the elderly.

Adult↗

Evaluation of acute ischemic stroke using quantitative EEG: a comparison with conventional EEG and CT scan.

The sensitivity of quantitative electroencephalogram (EEG) was compared with that of conventional EEG in patients with acute ischaemic stroke. In addition, a correlation between quantitative EEG data and computerized tomography (CT) scan findings was carried out for all the areas of lesion in order to reassess the actual role of EEG in the evaluation of stroke. Sixty-five patients were tested with conventional and quantitative EEG within 24 h from the onset of neurological symptoms, whereas CT scan was performed within 4 days from the onset of stroke. EEG was recorded from 19 electrodes placed upon the scalp according to the International 10-20 System. Spectral analysis was carried out on 30 artefact-free 4-sec epochs. For each channel absolute and relative power were calculated for the delta, theta, alpha and beta frequency bands and such data were successively represented in colour-coded maps. Ten patients with extensive lesions documented by CT scan were excluded. The results indicated that conventional EEG revealed abnormalities in 40 of 55 cases, while EEG mapping showed abnormalities in 46 of 55 cases: it showed focal abnormalities in five cases and nonfocal abnormalities in one of six cases which had appeared to be normal according to visual inspection of EEG. In a further 11 cases, where the conventional EEG revealed abnormalities in one hemisphere, the quantitative EEG and maps allowed to further localize abnormal activity in a more localized way. The sensitivity of both methods was higher for frontocentral, temporal and parieto-occipital cortical-subcortical infarctions than for basal ganglia and internal capsule lesions; however, quantitative EEG was more efficient for all areas of lesion in detecting cases that had appeared normal by visual inspection and was clearly superior in revealing focal abnormalities. When we considered the electrode related to which the maximum power of the delta frequency band is recorded, a fairly close correlation was found between the localization of the maximum delta power and the position of lesions documented by CT scan for all areas of lesion excepting those located in the striatocapsular area.

Acute Disease↗

Long-term results in patients with advanced epithelial ovarian carcinoma treated with a combination of cisplatin, doxorubicin, and cyclophosphamide.

From 1984 to 1988, thirty-nine untreated patients with epithelial ovarian cancer received Cisplatin 50 mg/m2, Doxorubicin 50 mg/m2, and Cyclophosphamide 750 mg/m2 (CAP), at 3 weekly intervals. All patients had FIGO stage III or IV tumors except 2 patients with stage IIb and IIc, respectively. After initial surgery 23 patients had residual disease > 2 cm in diameter. Twenty-five patients (64%) were evaluable for response to chemotherapy. Objective responses were observed in 13 out of 25 patients (52%, 95% confidence intervals (CI), 32.42% to 71.58%), 6 patients had a cCR (24%) and 7 had a cPR (28%). Seventeen out of the 39 patients (44%) had a second-look laparotomy. A pCR was achieved in 5 out of 17 patients (29%); a pPR was obtained in 8 patients (47%). Median duration of survival was 41,5 months (range 2-107+); median duration of time to failure was 21 months (range 2-107+). Median disease-free survival was 86 months (range 3,5-107+). Eleven patients (28%) are alive and 9 patients (23%) are free of recurrence at median follow-up of 86 months. Only 4 of 11 long-term survivors had a pCR. In univariate analysis, histology, clinical response to chemotherapy, and the presence of ascites at the time of diagnosis, achieved a significant correlation with survival and time to failure (TTF); in addition, TTF was significantly affected by pathological response to induction chemotherapy. The only important predictors of disease-free survival (DFS) were tumor grade and stage of disease. In multivariate analysis, the presence of ascites was the only significant prognostic factor with respect to survival and TTF. Our study confirms the effectiveness of CAP in the treatment of epithelial ovarian cancer and the relatively poor long term prognosis.

Adult↗

Alteration of cardiac function in patients with temporal lobe epilepsy: different roles of EEG-ECG monitoring and spectral analysis of RR variability.

PURPOSE: Because several reports have described the relation between epilepsy and cardiac arrhythmias and suggest that changes in autonomic neural control of the heart could be involved in the pathogenesis of sudden unexplained death in patients with epilepsy, the aim of this study was to evaluate cardiac function in patients with temporal lobe epilepsy. METHODS: Sixty-five patients with epilepsy were evaluated by simultaneous ambulatory 24-h EEG-ECG monitoring, and in 30 of these, power spectral analysis of relative-risk (RR) variability also was carried out, both in the supine position and in a passive tilt position at 60 degrees. The power spectrum of RR variability, the two major spectral components detectable at low frequency (LF) and at high frequency (HF), respectively, and the LF/HF ratio were calculated. RESULTS: By EEG-ECG monitoring, we recorded six partial seizures, and in four cases, discharges were associated with sinus tachycardia. However, interictally the occurrence of ventricular and supraventricular arrhythmias was not different from that in normal subjects. The spectral analysis of RR variability, on the other hand, demonstrated in patients with epilepsy a significant decrease in the total RR variability and in both of its components (LF and HF) in the supine position, and of the LF/HF ratio in orthostatic position. CONCLUSIONS: These findings suggest that the spectral analysis of RR variability may detect disorders of autonomic cardiac control in patients with epilepsy, even in the absence of abnormal findings during ECG monitoring. This alteration, which is more severe in cases with right EEG focus, could play a role in the pathogenesis of cardiac arrhythmias.

Arrhythmias, Cardiac↗

Functional uncertainty, aging and memory processes during sleep.

Disorganized sleep patterns, can be found both during normal development and in pathological conditions. Aging could also be accompanied by a disorganization of the night sleep episode; sleep could be interrupted by spontaneous awakening, sleep cycle could be shortened or incomplete, sleep states modified. These patterns suggest an inability to sustain a stable condition, i.e. a condition of functional uncertainty. Biological and cognitive implications of functional uncertainty conditions are discussed. In particular, the hypothesis has been put forward that disturbances of sleep could have a detrimental role on memory. Recent results obtained in our lab support this hypothesis: recall is correlated with NREM-REM cycles proportion. Future research should ascertain the role of the functional uncertainty with respect to the kind of memory being involved during sleep, and establish how much and for which cognitive processes (including those involved in dream production) the inability to sustain a steady condition impairs the functioning during sleep. The duration of the functional uncertainty condition is also important. The long-term study of the link between functional uncertainty and cognitive resources, could be important for the understanding of the night life and for an adequate treatment of patients.

Adult↗

Salvage chemotherapy in metastatic breast cancer: an experience with the combination of mitoxantrone, 5-fluorouracil, and L-leucovorin.

From January 1992 to July 1993, 28 patients with metastatic breast cancer were entered in a phase II trial to assess the activity and toxicity of the combination of mitoxantrone, 5-fluoruracil, and leucovorin. Patients were eligible if they had progressive disease after either adjuvant (2 patients) or previous chemotherapy for metastatic disease (26 patients). Twenty-five patients (89.2%) had received previous anthracycline-based therapy. Predominant site of metastatic disease was visceral in 22 patients, bone in 2 patients, soft tissue in 4 patients, and the majority of patients (89.2%) had two or more sites of disease. The regimen was administered according to the following schedule: Mitoxantrone 9-12 mg/m2 i.v. on day 1; L-Leucovorin 150 mg i.v. over 1 hour before 5-Fluorouracil 350 mg/m2 i.v. push days, 1, 2 and 3. Courses were repeated every 21 days. Twenty-six patients were evaluable for response. We observed 2 complete responses, 5 partial responses with a median duration of 38 weeks (range 23-68). The objective response rate was 27% (95% C.I., 10% to 44%). Myelo-suppression was the most frequent toxicity, but it was mild in the majority of patients. Nine episodes of fever and neutropenia occurred in six patients but none of these episodes was fatal. No clinical evidence of cardiotoxicity was observed. At a median follow-up of 78 weeks, the median time to progression was 20.5 weeks and the median overall survival was 48 weeks. We conclude that this regimen is well tolerated and in our experience the objective response rate is similar to other salvage chemotherapy regimens.

Adult↗

Induction chemotherapy with cisplatin, doxorubicin, and cyclophosphamide (CAP) in a combined modality approach for locally advanced and inflammatory breast cancer. Long-term results.

Thirty-one patients with locally advanced and inflammatory breast carcinoma (stage IIIA and IIIB) were treated with a combined modality approach between 1985 and 1989. All patients received as induction chemotherapy a combination of cisplatin, doxorubicin, and cyclophosphamide (CAP). Responsive patients and patients with operable stable disease underwent modified radical mastectomy followed by concurrent radiotherapy and CMF (cyclophosphamide, methotrexate, 5-fluorouracil) adjuvant chemotherapy. Thirty patients were evaluable for response to CAP. The rate of objective response to induction chemotherapy was 76.7% with 2 patients (6.7%) obtaining a complete response and 21 patients (70%) a partial response. Twenty-five patients were rendered disease-free after induction chemotherapy and surgery. Only 2 of these had pathological complete response (8%). The median overall survival was 48.7 months, the median time to progression was 22.4 months and the median disease-free survival was 29.1 months. The patients with noninflammatory breast tumor had a significantly better overall survival, disease-free survival, and time to progression. The overall survival and the time to progression were statistically superior in patients with primary tumor size < or = 8 cm. At a median follow-up of 6 years, 29% (95% CI, 13.05 to 45.01) of patients were alive and 28% (95% CI, 10.4 to 45.6) were disease-free. This combined modality treatment seems feasible with quite acceptable toxicity; the CAP combination is an effective alternative to the other standard chemotherapeutic regimens. Our results, although encouraging, are still poor, and new drugs and strategies are required to improve the long-term outcome.

Adenocarcinoma↗

[Variation in the plasma endothelin levels in relation to age].

In order to study the influence of ageing on the hormonal function of the endothelium in man, plasma endothelin levels were measured in 11 normal young persons (mean aged 25.7 +/- 1.8 years) and in 16 apparently healthy elderly subjects (mean 87.5 +/- 5.4 years) without anamnestic or clinical signs of symptomatic atherosclerosis. The mean plasma level +/- SD of endothelin was 2.72 +/- 0.61 pg/ml in elderly subjects and 2.09 +/- 0.66 in young subjects. The difference was statistically significant (p < 0.05). Various humoral or local age-related environmental factors may be responsible for this result. In particular increased vascular production of endothelin may be the response to endothelial cell damage caused by an asymptomatic atherosclerotic process. Studies still need to define whether enhanced plasma endothelin levels in elderly subjects not suffering from symptomatic atherosclerosis are the consequence of ageing alone or an ongoing but clinically silent atherosclerotic process.

Adult↗

Evaluation of olfactory function by topographic EEG analysis in patients with Parkinson's disease.

Olfactory function impairment has been observed in patients with idiopathic Parkinson's disease (PD) using psychophysical procedures. In this study, an electrophysiological technique based on spectral analysis and topographic EEG mapping was used to evaluate EEG arousal response to olfactory stimulation in ten normal subjects and ten PD patients in stage II according to Hoehn and Yahr's scale, all of whom had akinetic-rigid syndrome and were receiving chronic L-Dopa therapy. Olfactory function was stimulated using diluted benzaldehyde by means of an apparatus set up in our laboratory. Spontaneous and post-olfactory stimulus EEGs were recorded from 20 electrodes placed upon the scalp according to the Int. 10-20 System. Total EEG power (from 0.5 to 19.5 Hz) was evaluated over 10 sec. artefact-free epochs. An olfactory arousal reaction was detected in nine of the ten PD patients and was characterised by a significant decrease in total power similar to that observed in all of the 10 normal subjects; these variations in EEG were found in all but the anterior regions of the scalp. The use of this technique does not seem to reveal any clear alteration in the olfactory function of PD patients.

Aged↗

[Behavior of endothelin plasma levels during iloprost infusion in patients with severe ischemia in the lower extremities].

In order to clarify interactions between the various endothelial vasoactive substances, the authors studied the behaviour of endothelin plasma levels during acute iloprost infusion in 7 elderly patients with critical leg ischemia. Iloprost was administered i.v., diluted in saline solution (200 ng/ml, from 30 to 40 ml/h, for 6 hours/day over 4 weeks). Endothelin was assayed in plasma on day 4 of treatment at times 0, 2, 4, 6, 8, hours, or in other words before treatment and ten every 2 hours up until the 6th hour, and then 2 hours after the end of iloprost infusion. The control group consisted of 7 age-matched subjects suffering from peripheral obliterating arterial disease at Fontaine's stage 1 and 2 who where infused with saline solution alone. Patients receiving iloprost presented a mean endothelin plasma level +/- SD at time 0 of 5.40 +/- 1.23 pg/ml, 4.24 +/- 0.72 pg/ml at time 2, 4.22 +/- 0.74 pg/ml at time 4, 4.24 +/- 0.22 pg/ml at time 6, and 4.49 +/- 0.58 pg/ml at time 8. The difference between endothelin levels in basal conditions and those at time 2, 4 and 6 was statistically significant. The difference between the peptide at times 0 and 8 was not statistically significant. In the control group the mean +/- SD of endothelin plasma level was, at the same times, respectively 5.23 +/- 0.55 pg/ml, 4.88 +/- 1.39 pg/ml, 5.44 +/- 1.51 pg/ml, 5.10 +/- 0.86 pg/ml and 5.60 +/- 1.64 pg/ml. The difference between endothelin levels in basal conditions and those at later times was not statistically significant.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

Low-dose aminoglutethimide with and without hydrocortisone replacement as a first-line endocrine treatment in advanced breast cancer: a prospective randomized trial of the Italian Oncology Group for Clinical Research.

PURPOSE: A randomized study comparing low-dose aminoglutethimide (AG) with and without hydrocortisone (HC) was performed to investigate whether corticosteroid replacement contributes to the therapeutic effects of the drug administered as a front-line endocrine therapy in postmenopausal advanced breast cancer. PATIENTS AND METHODS: Postmenopausal patients who had not had prior endocrine therapy for advanced disease and with estrogen receptor (ER) or progesterone receptor (PgR) status positive or unknown were eligible. AG was administered at a dose of 250 mg twice a day orally (125 mg twice a day during the first month) with or without HC (20 mg twice a day orally). Seventy-nine and 74 patients were assessable for response on the AG plus HC arm and on the AG arm, respectively. The two treatment groups were well balanced and patients were largely untreated. Approximately 60% had not received any adjuvant treatment, and approximately 75% had not received any medical treatment after relapse. RESULTS: The overall responses (complete response [CR] plus partial response [PR]) were 44% and 41% for the AG plus HC and the AG arm, respectively, showing no significant difference. Time to progression (median, 8.1 and 6.3 months), duration of response (median, 15.8 and 13.7 months), and duration of survival (median, 34.2 and 36.3 months) were not significantly different between the two treatment arms. Side effects were infrequent and mild in both arms, with no significant differences. CONCLUSION: We conclude that half of the conventional daily dose of AG has optimal therapeutic activity as a front-line endocrine treatment of postmenopausal advanced breast cancer and that HC does not significantly contribute to the therapeutic effects.

Adenocarcinoma↗