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PubMed2001

Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a Phase II trial in patients with metastatic nonsmall cell lung carcinoma .

BACKGROUND: Eastern Cooperative Oncology Group (ECOG) Study E1594 compared paclitaxel and cisplatin with three newer chemotherapy doublets in the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC). The accrual of patients with an ECOG performance status (PS) of 2 was discontinued due to a perceived rate of unacceptable toxicity. METHODS: Patients were stratified by PS and randomized to one of the following treatments: 1) paclitaxel (135 mg/m2) over 24 hours with cisplatin (75 mg/m2) on a 21-day cycle; 2) cisplatin (100 mg/m2) with gemcitabine (1 g/m2) on Days 1, 8, and 15 on a 28-day cycle; 3) cisplatin (75 mg/m2) with docetaxel (75 mg/m2) on a 21-day cycle; and 4) paclitaxel (225 mg/m2) over 3 hours with carboplatin (area under the curve, 6). All tests of statistical significance were two-sided. RESULTS: Sixty-eight patients with an ECOG PS of 2 were enrolled, and 64 patients were evaluable for toxicity and response. Fifty-six percent of 64 evaluable patients were male, and 81% had Stage IV disease. Grade 3-4 hematologic toxicities occurred in > 50% of the patients in each treatment group. Nonhematologic Grade 3-4 toxicities occurred significantly less often in the paclitaxel and carboplatin arm (P = 0.0032). The overall rate of toxicity did not differ significantly from the rate of toxicity in the PS-0 or PS-1 cohorts. There were 5 deaths (7.35%) among 68 patients with a PS of 2 during therapy; however, only 2 of those deaths were attributed to therapy. The overall response rate for the 64 evaluable patients was 14%. The overall median survival of all 68 patients with a PS of 2, as determined by an intent-to-treat analysis, was 4.1 months. CONCLUSIONS: Patients with advanced NSCLC and a PS of 2 experienced a large number of adverse reactions and overall poor survival. A comparison with patients with a PS of 0-1 suggests that these events and the shorter survival were related to disease process rather than treatment. Alternative strategies need to be explored with therapy specifically tailored for this group of patients.

Aged↗

PubMed1995

Intrinsic epileptogenicity of human dysplastic cortex as suggested by corticography and surgical results.

Cortical dysplastic lesions (CDyLs) are often associated with severe partial epilepsies. We describe the electrographic counterpart of this high degree of epileptogenicity, manifested by continuous or frequent rhythmic epileptogenic discharges recorded directly from CDyLs during intraoperative electrocorticography (ECoG). These ictal or continuous epileptogenic discharges (I/CEDs) assumed one of the following three patterns: (1) repetitive electrographic seizures, (2) repetitive bursting discharges, or (3) continuous or quasicontinuous rhythmic spiking. One or more of these patterns were present in 23 of 34 patients (67%) with intractable partial epilepsy associated with CDyLs, and in only 1 of 40 patients (2.5%) with intractable partial epilepsy associated with other types of structural lesions. I/CEDs were usually spatially restricted, thus contrasting with the more widespread interictal ECoG epileptic activity, and tended to colocalize with the magnetic resonance imaging-defined lesion. Completeness of excision of cortical tissue displaying I/CEDs correlated positively with surgical outcome in patients with medically intractable seizures; i.e., three-fourths of the patients in whom it was entirely excised had favorable surgical outcome; in contrast, uniformly poor outcome was observed in those patients in whom areas containing I/CEDs remained in situ. We conclude that CDyLs are highly and intrinsically epileptogenic, and that intraoperative ECoG identification of this intrinsically epileptogenic dysplastic cortical tissue is crucial to decide the extent of excision for best seizure control.

Adolescent↗

PubMed2002

Quantitative evaluation of oxidative stress, chronic inflammatory indices and leptin in cancer patients: correlation with stage and performance status.

In advanced cancer patients, the oxidative stress could take place either at the onset of disease or as a function of disease progression. To test this hypothesis, the following parameters were investigated: the erythrocyte activity of the enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx), the serum activity of glutathione reductase (GR) and the serum total antioxidant status (TAS). The total antioxidant capacity of plasma LMWA was evaluated by the cyclic voltammetry methodology. We further determined the serum levels of proinflammatory cytokines (IL-6 and TNFalpha), IL-2, leptin and C-reactive protein (CRP). All of these parameters have been correlated with the most important clinical indices of patients such as Stage of disease, ECOG PS and clinical response. Eighty-two advanced stage cancer patients and 36 healthy individuals used as controls were included in the study. Our findings show that SOD activity was significantly higher in cancer patients than in controls and GPx activity was significantly lower in cancer patients than in controls. Serum values of IL-6, TNFalpha and CRP were significantly higher in patients than in controls. Serum leptin values of cancer patients were significantly lower than controls. SOD activity increased significantly from Stage II/ECOG 0-1 to Stage IV/ECOG 0-1, whereas it decreased significantly in Stage IV/ECOG 3. GPx activity decreased significantly in Stage IV/ECOG 2-3. An inverse correlation between ECOG PS and serum leptin levels was found. Serum levels of IL-2 decreased from Stage II/ECOG 0-1 to Stage IV/ECOG 2-3. A direct correlation between Stage/ECOG PS and serum levels of both IL-6 and CRP was observed. Cisplatin administration induced a significant increase of GPx after 24 hr. In conclusion, this is the first study that shows that several "biological" parameters of cancer patients such as antioxidant enzyme activity, cytokines, leptin and CRP strictly correlate with the most important clinical parameters of disease such as Stage and ECOG PS.

Adult↗

PubMed2002

The impact of performance status on survival in patients of 80 years and older with vulvar cancer.

OBJECTIVE: There are no data available on the impact of performance status on outcome in patients with vulvar cancer. It was the objective of this study to determine the impact of performance status on survival in a group of elderly patients. METHODS: A retrospective review of records of patients with vulvar cancer aged 80 years or greater and treated in a gynecological referral center was performed. Multiple clinical and pathological variables together with performance status were assessed and the impact on overall survival was determined both by univariate and multivariate analysis. RESULTS: Of 75 patients aged 80 years or older, 57 (76%) had standard treatment. The patients who had standard treatment were characterized by an earlier clinical stage and a better performance status compared with patients who had nonstandard treatment. When preoperatively available parameters of all patients were assessed in relation to survival in the total group, Eastern Cooperative Oncology Group (ECOG) performance status was the only independent prognostic indicator for survival. When all clinical and histopathological variables were assessed in the subgroup who had standard treatment, both ECOG performance status and extracapsular lymph node involvement were independent prognostic variables for overall survival. Age was not a significant prognostic variable. CONCLUSIONS: ECOG performance status is the only available pretreatment variable with independent prognostic value for survival in this group of elderly patients with vulvar cancer. These data show the importance of individualizing the treatment of patients with vulvar cancer. Performance status takes a more important place than age in the management process of these patients.

Age Factors↗

PubMed1984

Behavioural and electrocortical spectrum power changes after intraventricular injection of patulin in rats.

The effects of patulin when given into the third cerebral ventricle of rats, on behaviour and electrocortical spectrum power have been investigated. Patulin (10 micrograms i.v.t.) produced behavioural sedation, hypoalgesia, tail rigidity, piloerection and postural changes. This symptomatology lasted approx. 3 h and was accompanied by slower frequency and larger amplitude potentials in the electrocorticogram (ECoG) and by an increase in total voltage power. A larger dose (50 micrograms) produced a more dramatic picture characterized by catatonic posture with kyphosis, loss of the righting reflex, tail rigidity and on a few occasions short-duration episodes of tonic-clonic convulsions. Such a symptomatology was accompanied by a flattening of ECoG activity with a significant fall in total voltage power, as well as in preselected bands (0-3, 3-6, 6-9, 9-12, and 12-16 Hz). A lower dose (1 microgram) of patulin, on the other hand, produced behavioural sedation without significant changes in ECoG spectrum power.

Animals↗

PubMed1981

Behavioral effects of opiates: a pharmacogenetic analysis.

A number of studies are reviewed in relation to a pharmacogenetic approach to the effect of opiates. The behavioral effects of morphine and heroin in different species or strains of animals are considered. In particular, a number of behavioral, neurophysiological, and biochemical correlates of the opiates in different inbred strains of mice are cited. Recent studies concerning the effects of opiates on behavior have utilized the C57BL/6J and the DBA/2J strains, which are characterized by different brain levels and turnover of cholinergic and adrenergic mediators. It has been shown that the effects of opiates on running activity and on analgesia are strain-dependent, and a negative correlation is evident between the two measures in the strains considered. Experiments carried out on mice with septal lesions and on normal mice have confirmed that the motor and analgesic effects of morphine in the mouse are two distinct phenomena, which may be explained through different neurophysiological and biochemical models. Differences between the strains considered have also been observed when the ECoG response to morphine administration has been investigated. The results of these experiments have suggested: 1. The existence of a correlation between behavioral activation and sleep-like ECoG patterns. 2. The existence of a similarity between the effects of the anticholinergic drugs and those of morphine, since a dissociation between ECoG and behavior became evident following morphine administration. Some studies have also suggested that the environmental factors play an important role in determining the stimulating effects of morphine. This effect was absent in "experience" mice (i.e., in subjects already tested in the apparatus), as compared with naive "inexperienced" animals.

Animals↗

PubMed1995

Phase II trial of gallium nitrate, amonafide and teniposide in metastatic non-small cell lung cancer. An Eastern Cooperative Oncology Group study (E2588).

Fifty-five patients with metastatic non-small cell lung cancer (NSCLC) were entered into this phase II randomized study for evaluating three new agents: gallium nitrate, amonafide and teniposide. The patients had to have ECOG performance status 0 or 1, no prior chemotherapy, and adequate hematological, hepatic and renal functions. Forty-seven patients were eligible and evaluable. Fourteen were randomized to receive gallium nitrate, 18 to amonafide and 15 to teniposide. Seventy-four percent of eligible patients were male. The majority of patients (89%) had an ECOG performance status 1. ECOG grade 4 toxicity occurred twice in patients on gallium nitrate, seven times on amonafide and 18 times on teniposide. The cause of death was attributed to amonafide in one patients (from sepsis) and to teniposide in two patients (due to infection and leukopenia). There was no objective response in all the patients entered. The overall survival times ranged from 2 weeks to 156 weeks with a medium of 23 weeks. There were no survival differences among the three treatment arms. We conclude that gallium nitrate, amonafide and teniposide are inactive in metastatic NSCLC and do not warrant any further testing in this disease.

Adenine↗

PubMed1995

Prognostic factors for survival in patients with advanced renal cell carcinoma treated with interleukin-2 and interferon-alpha.

A group of 73 patients with advanced renal cell carcinoma, treated in different phase II trials with interferon alpha and/or interleukin-2, have been evaluated to identify potential baseline prognostic factors predicting their survival. The eligibility criteria were very similar across studies and included ECOG performance status < or = 2, measurable or evaluable disease and no CNS metastases. The overall response rate was 8%. The overall survival was 33% at 2 years and 18% at 1 year. In the univariate analysis three prognostic factors were correlated with disease outcome: ECOG performance status (0 versus > or = 1), time from diagnosis to treatment (< or = 12 months versus > 12 months) and number of metastatic sites (1 versus > or = 2). Multivariate analysis identified ECOG performance status and number of metastatic sites as important prognostic factors for survival. The true impact on patient survival of the selection of patients rather than the treatment itself should be evaluated in controlled trials.

Adult↗

PubMed1994

Remote epileptogenic focus detected by electrocorticogram in a case of cavernous angioma.

In a case of cavernous angioma, a remote gyrus, which was found to contain an epileptogenic focus by intraoperative electrocorticography (ECoG), was resected simultaneously with lesionectomy. The patient was a 27-year-old male who was referred to our hospital because of frequent systemic tonic-clonic convulsions. ECoG revealed an epileptogenic focus not only in the cortex around the angioma-affected tissue of the left frontal lobe but also in an angioma-free remote gyrus. These epileptogenic foci were removed in addition to lesionectomy. The postoperative course was uneventful. Now (two years after surgery), the patient is seizure-free without any anti-convulsive agent. In the surgical treatment of convulsions-accompanied by cavernous angioma, it is essential not only to detect epileptogenic foci by intraoperative ECoG but also to remove these foci together with the angioma.

Adult↗

PubMedDate not supplied

The role of the posterior hypothalamus in controlling the paradoxical phase of sleep.

Chronic experiments were performed on seven cats to study the effects of high-frequency electrical stimulation of the posterior hypothalamic area on the characteristics of paradoxical sleep; the excitability of this structure at different stages of paradoxical sleep was determined. These studies showed that at the stage showing ECoG desynchronization and phasic events (stage 1), the response threshold for behavioral arousal resulting from stimulation of posterior hypothalamus was 20-30% higher than at the stage characterized by alpha-like activity in the ECoG and the absence of phasic phenomena (stage 2). Transient stimulation of the posterior hypothalamus at stage 1, at a level which was subthreshold for arousal from this state, led to a transition to stage 2 or a reduction in phasic events in paradoxical sleep without altering the qualitative characteristics of phase 1. Stimulation of the posterior hypothalamus at a level subthreshold for arousal from stage 2 and applied continuously during paradoxical sleep led to a reduction in the duration of this stage by 25-50% and to an increase in the proportion of stage 2 in the structure of paradoxical sleep. These results provide evidence that the posterior hypothalamus is involved in the inhibitory control of the 'executive' mechanisms of paradoxical sleep responsible for the ECoG desynchronization and the phasic manifestations of this state. It is suggested that the functional activity of the posterior hypothalamus at stage 1 also increases at stage 2, thus evidently fulfilling a 'guard' function.

Animals↗

PubMed2001

Cerebral ganglioglioma with epilepsy: neuroimaging features and treatment.

Gangliogliomas are an increasingly recognized cause of epilepsy in children. In this study the clinical, neuroimaging, and neurophysiological data of five patients with cerebral ganglioglioma and epilepsy are reviewed retrospectively. The average age of these patients was 4.4 years at onset and the average duration of seizures before diagnosis was 11 months. Tumors were located in the frontal (3), parietal (1), and occipital (1) lobes. While one cystic and four solid tumors showed various densities on CT and MRI, one frontal lesion was not demonstrated by CT scan but clearly shown by MRI. Scalp electroencephalography (EEG) showed neither localized nor epileptiform abnormalities in three patients, while the remaining two had these abnormalities. In one patient, invasive chronic electrocorticography (ECoG) recordings with subdural electrodes revealed an ictal onset zone located in the hand motor area. In all patients, intraoperative ECoG failed to reveal any epileptiform activities, and tumor removal alone was performed. For a mean of 3.4 years after surgery, all patients are alive and seizure-free, with stable imaging findings. Tumor resection may be the most important factor for optimal seizure control and prevention of tumor recurrence despite the fact that EEG and ECoG findings may conflict on tumor location.

Adolescent↗

PubMed2005

A phase I trial of surgery, Gliadel wafer implantation, and immediate postoperative carboplatin in combination with radiation therapy for primary anaplastic astrocytoma or glioblastoma multiforme.

Two types of chemotherapy used in the treatment of patients with malignant glioma are carboplatin and Gliadel wafer [(3.85% 1,3-bis-(2-chloroethyl)-1-nitrosourea (BCNU)]. To date there have been no published data examining their concurrent use in this disease. The purpose of this study was to evaluate combination chemotherapy with Gliadel wafer and carboplatin in patients with high-grade, malignant glioma. In this prospective phase I study, 16 patients underwent surgery, Gliadel wafer implantation (up to 8 wafers), intravenous carboplatin given postoperatively (day 3 or 4) at a dose escalation range of area under the curve (AUC)=2-6, and external beam radiation. Median age was 55 years (range 27-66 years). Fourteen (88%) patients had glioblastoma multiforme and 2 (12%) had anaplastic astrocytoma. Performance status was as follows: Eastern Cooperative Oncology Group (ECOG)=0 (2 patients), ECOG=1 (13 patients), and ECOG=2 (2 patients). Three patients were treated at each dosing level (AUC=2-6), and 4 patients were treated at an AUC=5. Carboplatin was administered to all patients by postoperative day 4. Radiation was begun on day 14-36. No grade 3 or 4 toxicities were noted in this study. Median progression-free and overall survival was 266 and 679 days, respectively. We conclude that administering systemic carboplatin is safe and well tolerated in the postoperative period immediately following resection and implantation of Gliadel wafer for the treatment of malignant glioma. Further evaluation in a phase II setting, at maximal carboplatin dose to establish potential efficacy, with this combination is warranted.

Adult↗

PubMed1991

Magnetic fields associated with anoxic depolarization in anesthetized rats.

We have performed simultaneous measurements of the DC-magnetoencephalogram (DC-MEG) and DC-electrocorticogram (DC-ECoG) in rats (n = 6) subjected to 90 s of reversible anoxia. The onset of major shifts of electric and magnetic signals occurred at 52 +/- 18 (S.D.) and 68 +/- 14 (S.D.), respectively, and reached a peak at 83 +/- 27 and 102 +/- 19 (S.D.) s, respectively, after termination of mechanical ventilation. DC-ECoG signal deflections were always associated with DC-MEG deflections. The time of onset and peak signals in both DC-MEG and DC-ECoG changes caused by asphyxia were highly correlated (r + 0.83, 0.94; P less than 0.05, 0.001; respectively). Our observations suggest that the non-invasive technique of DC-MEG is reliable and may provide insight into the mechanisms of anoxic cerebral depolarization.

Anesthesia, General↗

PubMed1975

The effects of a spirolactone derivative on EEG and cortical single unit activity in the cat.

With systemic (60-150 mg/kg) and topical application, Aldactone exhibited strong convulsant action on the cat cerebral cortex. The most common abnormal interictal features of the surface ECoG pattern were sequences of fast waves and slow negative waves associated with positive sharp waves, negative field potentials and burst-like neuronal activation in the extracellular microelectrode record. Another abnormal pattern was a period of ECoG and neuronal inactivity subsequent to the negative transients. These series of sharp and slow waves and of inactivity were interrupted by tonic and clonic ECoG seizures characterized by regular surface positive spikes. Development of seizures, but not of interictal phenomena, could be prevented by intravenous application of Diazepam (1 mg), Nembutal (30 mg/kg) and--less effectively--by Phenhydane (20 mg/kg).

Administration, Topical↗

PubMed1979

Differential arousal response to gustatory stimuli in the awake rabbit.

ECoG arousal response as elicited by deionized water and by several concentrations of sweet, salty, sour and bitter tasting substances, all applied intraorally, were studied in the awake restrained rabbit. The study was carried out on 17 chronic preparations of adult male animals (2.6 kg average body weight). Water as a stimulant was presented in 60 trials and tastants across qualities and concentrations in 245 trials. Arousal was quantitatively characterized by its duration, frequency increment and amplitude decrement as compared to prestimulus conditions. Arousal induced by tastants was compared to that induced by water. Water and tastants induced arousals differentiable by the parameters measured. Further, most tastants produced a dose-dependent response. Comparison of ECoG and behavioral data clearly indicate that tastants inducing behavioral aversion also produce an arousal which significantly differs from response to water while behavioral preference was found not to show similar correspondence with ECoG data. The possibility of using arousal as an objective indicator for taste aversion is discussed.

Acetates↗

PubMed1992

Development of epileptic activity induced by iron injection into rat cerebral cortex: electrographic and behavioral characteristics.

Unilateral injection of ferrous chloride solution into the rat sensorimotor cortex produced epileptic discharges in the electrocorticograms (ECoGs). The discharges were isolated spikes and spike and wave complexes, and the epileptic activity lasted for more than 12 months after the injection. Isolated spike activity often appeared on the left or right side of the cortex, whereas spike and wave complex activity appeared bilaterally. In rats showing dominant isolated spike activity in the secondary epileptic cortex, there was a deviation in somatosensory evoked potentials (SEPs). Rats showing isolated spikes and spike and wave complexes exhibited vibrissa tremors and head nodding. Rats showing only isolated spikes exhibited no abnormal behavior, but their convulsion thresholds to pentylenetetrazol were lowered. The results including ECoGs, SEPs, behavior and convulsion threshold were characterized with reference to the development of iron-induced epilepsy. The profiles of ECoG discharge activity and SEP configuration suggest that the process of iron-induced epilepsy consists of 3 stages.

Animals↗

PubMed1987

Ontogenetic development of convulsant action of Ro 5-3663 in the rat.

Motor seizures were induced by Ro 5-3663 in 156 male albino rats aged 7,12,18,25, and 90 days. Both minimal and maximal seizures could be elicited in 18-day-old and older animals, whereas only maximal seizures were induced in the two youngest groups. ECoG changes were studied in other 21 young rats. First changes induced by Ro 5-3663 were formed by isolated sharp waves in 7- and 12-day-old rats and by episodes of rhythmic activity in older animals. An imperfect form of this rhythmic activity could be seen even in 12-day-old rats. Ictal ECoG activity exhibited an increase in frequency of individual graphoelements, in generalization and in synchronization of activity among different cortical regions with maturation. Correlation between motor and ECoG phenomena was poor in 7-day-old rats and ameliorated with age but it never reached perfection. The actions of Ro 5-3663 are identical with those induced by metrazol but they differ from those elicited by bicuculline or 3-mercaptopropionic acid.

Animals↗

PubMed1988

Aluminum induced encephalopathy in the rat.

Aluminum tartrate (AlT) but not sodium tartrate (NaT) produces a progressive encephalopathy when injected intracerebroventricularly in the rat. This syndrome, lethal within 30-35 days, is characterized by progressively deranged behavior. An early startle reaction (day 14), later joined by locomotor discoordination (day 19) is followed by locomotor and electrocorticographic (ECoG) seizures (day 21) in chronically instrumented AlT rats. There is early dissociation between ECoG and locomotor aspects. When tested in the shuttlebox for estimation of learning and memory function 7-8 days after AlT injection, marked impairment of both active and passive avoidance was observed. Glucose uptake capacity of synaptosomes from brain areas of AlT and NaT animals was indexed by the 2-deoxy-D-glucose method. Striatal and cortical synaptosomes showed reduced uptake activity 7 days following AlT injection. By day 14, hypothalamic areas also became affected, striatal uptake was further inhibited, and cortical uptake was reduced to 57% of control. The ECoG background rhythm remained unchanged until days 20-23, when the mean peak frequency was reduced. The model may be useful in the study of central aluminum toxicity and may have predictive validity in the testing of procedures to counter aluminum-associated encephalopathies in man.

Animals↗