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PubMed2005

Phase II study of 5-fluorouracil, doxorubicin, and mitomycin C for metastatic small bowel adenocarcinoma.

BACKGROUND: Small bowel adenocarcinoma is a rare gastrointestinal malignancy that is treated primarily with surgery. Even with optimal resection, however, survival is poor and recurrences are common. Response rates to palliative combination chemotherapy are low, and the median duration of survival for metastatic disease is less than 1 year. This study aimed to document the response rate and survival time for patients with advanced small bowel adenocarcinoma who were not surgically curable and were treated with a regimen of 5-fluorouracil (5-FU), mitomycin C (Mutamycin; Bristol-Myers Squibb; Princeton, NJ), and doxorubicin (Adriamycin; Bedford Laboratories; Bedford, OH), the FAM regimen. METHODS: This multi-institutional study was performed by the Eastern Cooperative Oncology Group (ECOG). Between November, 1983 and December, 1985, 39 patients with advanced or recurrent disease were enrolled. Chemotherapy was given as follows: 5-FU, 600 mg/m(2) on days 1, 8, 29 and 36; mitomycin C, 10 mg/m(2) on day 1; and doxorubicin, 30 mg/m(2) on days 1 and 29. Eligibility criteria included an ECOG performance status score of 0-2, measurable disease, and adequate baseline organ function. Prior chemotherapy was allowed. Response was measured by examination and imaging techniques. Survival time and time to progression were evaluated by the method of Kaplan and Meier, and these outcomes were stratified by clinical and laboratory covariates. RESULTS: Of the 39 evaluated patients, 38 were eligible and 36 were evaluable for response. Grade 3-5 toxicities were experienced by a total of 26 patients (20 grade 3, 5 grade 4, 1 grade 5). The most common adverse events were neutropenia and vomiting. Responses were seen in a total of seven patients (2 complete responses, 5 partial responses), for a response rate of 18.4% (95% confidence interval of 7.8%-34.4%). The median survival time was 8 months. CONCLUSIONS: The FAM regimen was active and tolerable for patients with advanced small bowel adenocarcinoma; however, the results were no better than those seen with other chemotherapy combinations.

Adenocarcinoma↗

PubMed1985

The role of the corpus callosum in interhemispheric propagation of iron-induced epileptogenic activity in the rat.

In iron-induced epilepsy, partial section of the corpus callosum resulted in a decrease in rats showing dominant spike activity on the side of secondary focus and an increase in rats showing almost equal spike activity on the sides of primary and secondary focus in electrocorticograms (ECoGs). Changes in ECoG spike frequencies caused by sectioning the corpus callosum included an increase in unilateral spikes on the side of primary focus, a decrease in unilateral spikes on the side of secondary focus, and an increase in bilateral spikes appearing almost synchronously on both sides.

Animals↗

PubMed1997

Coexistence of ganglioglioma and cortical dysplasia in a patient with intractable epilepsy--case report.

An 8-year-old girl presented with coexistence of ganglioglioma and cortical dysplasia manifesting as intractable epilepsy. Preoperative computed tomography demonstrated a small calcified lesion in the left frontal lobe which was not diagnosed as ganglioglioma. Magnetic resonance imaging also failed to demonstrate positive evidence of ganglioglioma or cortical dysplasia. A calcified tumor and the surrounding epileptogenic areas were resected under electrocorticography (ECoG) guidance. Histological examination revealed coexistence of ganglioglioma and cortical dysplasia. The patient became seizure-free after surgery. Resection of the ganglioglioma together with the adjacent epileptogenic area under intraoperative ECoG guidance is important to achieve a successful surgical result in patients with ganglioglioma.

Brain Mapping↗

PubMed2006

Temporal lobe epilepsy caused by dermoid cyst.

A 15-year-old boy presented with a dermoid cyst in the left temporal lobe manifesting as complex partial seizures. Magnetic resonance imaging demonstrated a tumor with mixed signal intensity in the left anterior temporal subdural area, but no evidence of rupture. Intraoperatively, the tumor was located mainly in the deep sylvian fissure, adjacent to the amygdala, and had compressed the hippocampus. Intraoperative electrocorticography (ECoG) showed sporadic interictal spikes in both the adjacent areas of the tumor and over the anterior segment of the hippocampus. Total removal of the tumor and gliotic area of the surrounding tissue including the amygdala was performed. The hippocampal epileptic region was treated by transection of the pyramidal layer to preserve verbal memory function. Histological examination showed the dermoid tumor was closely attached to the brain parenchyma. The complex partial seizures ceased completely after surgery. Intraoperative recording of ECoG from the hippocampus and other limbic structures was very important to determine the epileptogenic area even if the tumor did not directly invade the hippocampus.

Adolescent↗

PubMedDate not supplied

Bone-conducted stimulation in electrocochleography.

The mechanical vibration patterns close to the cochlea in intact skulls of human cadavers have been studied by means of a miniature accelerometer. A Radioear B70A vibrator and a Brüel & Kjaer Mini Shaker have been used, fed with filtered clicks and with short tone bursts. The tone bursts were found to be superior to the clicks with regard to the vibration spectrum. At 500 Hz a considerable distortion was observed in the accelerometer signal, also when using tone bursts. This distortion was presumably due to resonant vibrations in the skull itself, and may be a source of error not only when using stimuli of short duration as in bone-conduction ECoG but also in conventional bone-conduction audiometry. When the vibrations were applied to the exposed bone surface of the mastoid, vibration levels increased by 10-25 dB compared with when soft tissues covered the point of application. This could be of advantage in bone-conduction ECoG performed at ear surgery.

Acoustic Impedance Tests↗

PubMedDate not supplied

Electrocochleography used as a clinical hearing test in difficult-to-test children.

Thirty difficult-to-test children have been tested with transtympanic ECoG. When possible, informal hearing tests and/or free-field testing were performed. Children in whom no action potential (AP) could be recorded were submitted to conventional radiography of the inner ear, and vestibular tests. The correlation between free-field test thresholds and AP "thresholds" was good, especially in subjects with relatively good hearing. Response amplitude increased, and latency decreased, with increasing frequency of the stimulus implying that different parts of the basilar membrane are stimulated according to the frequency of the stimulus. Input-output curves of response amplitude and latency were plotted, and three different types were distinguished. ECoG can contribute to the evaluation of peripheral hearing in difficult-to-test children, and vestibular tests should always be performed on a child with suspected deafness or sensorineural hearing loss. Conventional radiography of the inner ear, however, seems to be of little value.

Action Potentials↗

PubMedDate not supplied

Electrocochleography in an experimental animal model of acute endolymphatic hydrops.

A reliable animal model of acute type of endolymphatic hydrops was made with injection of artificial endolymph into the cochlear duct. In 12 animals without Reissner's membrane rupture, the endolymphatic potentials (EP) were kept normal after injection of artificial endolymph, but their electrocochleography (ECoG) showed as: a rise of summating potentials (SP) amplitude, a decrease of action potentials (AP) amplitude, an increase of SP/AP ratio, as well as a delay of N1 latency. In 7 animals with membrane rupture, the EP significantly decreased. ECoG showed as: a decrease of hearing function in all test frequencies, a distortion of SP-AP wave and even a loss of AP. Based on the results of our experiment it can be assumed that the dominant -SP may be seen in the acute stage of endolymphatic hydrops without a rupture of Reissner's membrane. Therefore, the dominant -SP may only be of value in the clinical diagnosis during episodic vertigo and fluctuating hearing loss of Meniere's disease.

Action Potentials↗

PubMed1991

Intraoperative electrocochleographic monitoring of inner ear surgery for endolymphatic hydrops. A review of cases.

The purpose of this review of cases was to determine whether or not the SP/AP amplitude ratio changes during unidirectional inner ear valved shunt surgery for the decompression of the hydropic labyrinth in Meniere's disease. A series of 62 patients underwent shunt surgery over a 20 month period. In 43 cases (43 ears), ECoG responses were successfully recorded throughout the duration of surgery. A pair of two-tailed paired t-tests were computed for SP/AP amplitude ratios acquired during intraoperative ECoG monitoring at the baseline and closing stage of surgery. The first t-test compared the mean SP/AP amplitude ratios at baseline and closing for those cases in which the SP/AP amplitude ratio at baseline was abnormal (baseline > 35%). The t was significant, t(19) = 4.63, p < 0.01). The second t-test compared the mean SP/AP amplitude ratios at baseline and closing for those cases in which the SP/AP amplitude ratio at baseline was WNL (baseline < or = 35%). The t was insignificant, t(20) = 0.31, p > 0.05. Variations between baseline and closing measurements were categorized as either a reduction, no change (very stable over time), or an increase in the SP/AP amplitude ratio. A change in the SP/AP amplitude ratio from baseline to closing of > or = 7% (x = 2%, SD = 2%) was considered statistically significant. Overall (43 cases), 49% of the variations fell into the no change category, with 42% and 9% of the cases placed in the reduction and increase categories, respectively. Of the cases (22) in which the baseline measurement was outside the limits of normal, 64% showed a reduction, 32% showed no change, and 4% showed an increase in the SP/AP amplitude ratio at closing. Changes in the SP/AP amplitude were observed at various stages of the surgical procedure. Reductions were found at each of the five surgical steps identified, with the majority of the changes almost evenly divided between the stages of mastoid drilling and opening sac. Increases in the SP/AP amplitude ratio were found in four cases. The increases were observed during drilling of the mastoid bone in two cases and sac decompression and opening the sac in the remaining cases.

Acoustic Stimulation↗

PubMed1991

The use of intraoperative electrocochleography in Meniére's surgery.

Intra-operative electrocochleography was undertaken during surgery for Meniére's disease. It was found that the electrocochleogram (ECoG) provided a stable measure which accurately reflected changes within the inner ear during surgery. During salt osmosis of the round window, a rapid change in the summating potential versus action potential ratio (SP/AP) occurred which showed when the endolymphatic hydrops (ELH) had been altered. During a modified cochleostomy procedure, the ECoG showed when the cochlear duct had been ruptured. Forty ears were monitored during endolymphatic sac surgery. Twenty-five of these ears showed stable ECochG which did not alter at any time during the procedure; however, 8 of these ears showed normal SP/AP ratios during the surgery despite having been abnormal in the week prior to surgery. The SP/AP ratio was reduced in 8 ears, increased in 3 ears and showed other changes which were probably due to unstable electrode positioning in 4 ears. It was concluded that endolymphatic sac or duct surgery altered the inner ear physiology in a significant number of ears affected by endolymphatic hydrops.

Acoustic Stimulation↗

PubMed1995

Middle ear imaging in neurotological work-up.

Middle ear imaging constitutes a homogeneous test battery for evaluation of neurotological disease. The imaging comprises infra-sound fistula test, ABR, tympanoscopy, ECoG, and trans-promontiorial cochlear blood flow measurement. We used a fistula test with infra-sound loading on posturography. In tympanoscopy we used 5 degrees and 25 degrees endoscopes with a diameter of 1.9 mm and length of 125 mm. In blood flow measurement we used laser-Doppler system with a stainless steel tip placed on the basal turn against stira vascularis. The flux was analyzed with a computer with custom-made software. In ECoG, a silver ball electrode was placed on the round window. In 64 cases evaluated we were not able to verify a spontaneous PLF by tympanoscopy. Symptoms typical for spontaneous PLF with positive fistula test turned out to be caused by endolymphatic hydrops. Sudden deafness usually did not show reduced cochlear blood flow, but often an endolymphatic hydrops. Fistula test was positive in about 25% of cases with endolymphatic hydrops. Tympanoscopy caused very few complication. The procedure takes about one hour and is done ambulatorily.

Adolescent↗

PubMed1982

Reliability of bone-conducted electrocochleography. A clinical study.

The correlation between pure-tone bone conduction thresholds (BC) and thresholds obtained by electrocochleography with bone conducted stimulation (BC-ECoG) for 1, 2, 4 and 8 kHz was studied in 26 ears due for ear surgery. The correlations proved to be statistically highly significant and the results lend support to the conclusion that BC-ECoG can be considered to be well adapted for clinical use in cases where conventional audiometry has failed to reveal the capacity of the cochlea.

Audiometry↗

PubMed1996

Is the MVP regimen less active than previously described? Results of a phase II study in advanced non-small cell lung cancer.

Combination chemotherapy with anti-proliferative agents is often used in patients with advanced non-small cell lung cancer (NSCLC) in good performance status. The mitomycin C, vinblastine and cisplatin (MVP) regimen has been the Eastern Cooperative Oncology Group (ECOG) standard for several years because of high response rates in spite of significant toxicity. In a phase II study, we observed 55 consecutive patients treated with MVP chemotherapy using the same dosage, schedule, and precautions as used by the ECOG group. The dose intensity reached for each drug was 85% of the projected dose. Fifty-one patients were assessable for response and toxicity, while all subjects were evaluable for survival. There was no complete remissions, 8 partial (15%), 34 stable (66%) and 9 progressive (17%) in patients. The median survival rate was 34 weeks (95% confidence interval 28-37 weeks). There were no treatment-related deaths and no grade 4 toxicity. Alopecia and emesis were the most significant adverse effects. Haematological toxicity was minimal. Other side-effects, such as neuropathy and nephrotoxicity, were also rare. Hence, response rates and toxic complications were lower than previously reported. We conclude that the MVP regimen has to be re-evaluated.

Adult↗

PubMed1997

Economic analyses of phase III cooperative cancer group clinical trials: are they feasible?

Both economic and clinical evaluations of new pharmaceutical agents are important to physicians who practice in the current health care environment. While cooperative cancer groups carry out large-scale phase III clinical evaluations of these agents, few cooperative group studies incorporate economic analyses because of concerns over overburdening of data management, investigators, and statistical center personnel. In this study, we describe the results and operational considerations of one of the first completed economic analyses of a phase III cooperative group trial of the Eastern Cooperative Oncology Group (ECOG). We developed an economic model estimating economic benefits of yeast-derived granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy for adult patients (56-70 years) with acute myelogenous leukemia. Clinical data were based on prospectively collected information from a recently reported double-blind phase III multi-institutional study carried out by ECOG. Retrospective economic data were obtained from financial information systems at our hospital, one of the study sites. The cost-minimization analyses were based on the perspective of a third-party payer. Indirect costs related to loss of earnings by patients and caregivers as well as quality-of-life adjustments were not incorporated into the model. Clinical trial results indicated that patients treated with GM-CSF had shorter times to recovery of absolute neutrophil count of 500 cells/mm3 and 1000 cells/mm3 and fewer serious infections than patients who received placebo following induction chemotherapy, while no significant differences were noted in red blood cell and platelet transfusion dependency, toxicities, and duration of hospitalization. The economic model estimated that the group treated with GM-CSF was estimated to have lower costs of care, associated with lower frequencies of serious infections and lower overall infection-related costs. Sensitivity analyses indicated that these results held true over a wide range of estimates of costs and infection rates. Prospective economic analyses of phase III cooperative cancer group clinical trials have not been completed to date. Strategies that are not likely to overburden data managers and statistical center personnel are possible to devise. However, these studies require careful planning and coordination between clinical trialists, economists, and health services researchers.

Adult↗

PubMed1997

Cerebral blood flow and temporal lobe epileptogenicity.

Long-term surface cerebral blood flow (CBF) monitoring was performed to test the hypothesis that temporal lobe epileptogenicity is a function of epileptic cortical perfusion. Forty-three bitemporal 2-hour periictal CBF studies were performed in 13 patients. Homotopic regions of temporal cortex maintained interictal epileptic cortical hypoperfusion and nonepileptic normal cortical CBF. At 10 minutes preictus, a statistically significant, sustained increase in CBF was detected on the epileptic temporal lobe. Two minutes preictus, there was approximation of CBF in the epileptic and nonepileptic temporal lobes. Thereafter, electrocorticographic (ECoG) and clinical seizure onset occurred. The linear relationship between CBF in the two hemispheres (epileptic and nonepileptic) was the inverse of normal (y = -0.347x + 62.767, r = 0.470, df = 95, p < 0.05). The data indicated a direct linear correlation between epileptic cortical CBF and seizure interval (frequency-1), a clinical measure of epileptogenicity (r = 0.610, df = 49, p < 0.05). Epileptogenicity was also found to be a logarithmic function of the difference between nonepileptic and epileptic cortical perfusion (r = 0.564, df = 58, t = 5.20, p < 0.05). The results showed that progressive hypoperfusion of the epileptic focus correlated with a decreased seizure interval (increased epileptogenicity). Increased perfusion of the epileptic focus correlated with an increased seizure interval (decreased epileptogenicity). The fact that CBF alterations precede ECoG seizure activity suggests that vasomotor changes may produce electrical and clinical seizure onset.

Adolescent↗

PubMed1999

Lack of correlation between neuronal hyperexcitability and electrocorticographic responsiveness in epileptogenic human neocortex.

OBJECT: The purpose of this study was to determine whether intrinsic neuronal properties and synaptic responses differed between interictally active and inactive tissue removed in neocortical resections from patients undergoing surgical treatment for epilepsy. METHODS: Whole-cell patch recordings were performed in layer 2 or 3 and layer 5 pyramidal cells in neocortical slices obtained from tissue surgically removed from patients for the treatment of medically intractable seizures. Synaptic responses to stimulation at the layer 6-white matter border were used to classify cells as nonbursting if they responded with only a single action potential for all above-threshold stimuli (80%). These responses were usually followed by biphasic inhibitory postsynaptic potentials (IPSPs). Cells were classified as bursting if they fired at least three action potentials in response to synaptic stimulation (20%). These cells typically showed no IPSPs and responded in either an all-or-nothing or graded fashion. Approximately twice as many cells at layer 2 or 3 (29%) than cells at layer 5 (14%) fired synaptic bursts. Synaptic bursting was not associated with an alteration in a cell's response properties to gamma-aminobutyric acid. It was notable that, in tissue samples determined by electrocorticography (ECoG) to be either interictally active or not active, the proportion of cells that burst was exactly the same in both groups (24%). We found no cells with intrinsic burst firing. CONCLUSIONS: We conclude that synaptic bursting was characteristic of a small proportion of cells from epileptic tissue; however, this did not correlate with interictal spikes on ECoG.

Electric Conductivity↗

PubMed2001

Computerized brain-surface voltage topographic mapping for localization of intracranial spikes from electrocorticography. Technical note.

The purpose of this paper is to describe the use of computerized brain-surface voltage topographic mapping to localize and identify epileptic discharges recorded on electrocorticographic (ECoG) studies in which a subdural grid was used during intracranial video electroencephalographic (IVEEG) monitoring. The authors studied 12 children who underwent surgery for intractable extrahippocampal epilepsy. Cortical surfaces and subdural grid electrodes were photographed during the initial surgery to create an electrode map that could be superimposed onto a picture of the brain surface. Spikes were selected from ictal discharges recorded at the beginning of clinically confirmed seizures and from interictal discharges seen on ECoG studies during IVEEG recording. A computer program was used to calculate the sequential amplitude of the spikes by using squared interpolation, and they were then superimposed onto the electrode map. Interictal discharges and high-amplitude spike complexes at seizure onset were plotted on the map. This mapping procedure depicted the ictal zone in nine patients and the interictal zone in 12, and proved to be an accurate and useful source of information for planning corrective surgery.

Action Potentials↗

PubMed2003

Epileptogenic foci on subdural recording in intractable epilepsy patients with temporal dysembryoplastic neuroepithelial tumor.

To investigate the epileptogenic foci in dysembryoplastic neuroepithelial tumor (DNT) in the temporal lobe, we studied extraoperative electrocorticography (ECoG) with subdural electrode arrays from nine patients with intractable epilepsy due to temporal DNT. Ictal onset zones and irritative zones were decided by the ECoG. The locations of these zones were compared to the location of the tumor. The number of ictal onset zone and irritative zone was 2.1+/-0.93 and 2.9+/-1.45 in a patient with a DNT. They were detected more frequently in the adjacent tissues of the tumor (88.9%) rather than within the tumor or in mesial temporal area (66.7%). Mesial temporal involvement was found in 6 patients (66.7%) as an ictal onset zone, and in 5 (55.6%) as an irritative zone. The 7 patients (77.8%) had ictal onset zone in areas different from active irritative zone. The surgical outcome was better, when ictal onset zone was completely resected rather than partially removed. Temporal DNT can make multiple ictal onset zones and irritative zones in different regions including the mesial temporal area. Deliberate resection of epileptogenic foci, including all ictal onset zones and irritative zones, ensures excellent seizure control.

Adolescent↗

PubMed2006

Treatment of Hodgkin's disease: a twenty-year follow-up of patients at a center in Korea.

Hodgkin's disease (HD) is a hematologic malignancy which shows common features regardless of race, but racial differences may be considered with certain clinical characteristics. HD in Korea shows somewhat different characteristics when compared to cases in Western countries. We evaluated the clinical and histopathologic characteristics of HD, the outcomes of various chemotherapy regimens, and prognostic factors of HD in Korea. One hundred and five patients with initial histopathologic diagnosis of Hodgkin's disease were retrospectively reviewed 20 years after diagnosis at Yonsei University College of Medicine. Nodular sclerosis was the most common histopathologic subtype (41%) and mixed cellularity was nearly as common (40%). The overall complete remission rate (CR) was 87.6%. The disease-free survival (DFS) and overall survival (OS) rate were 79.2% and 84.8% at 5-years, 70% and 79.2% at 10- and 20-years. There were no significant differences in CR rate and DFS, but OS rates were significantly higher in m-BACOP and ABVD regimen. Univariate analysis revealed that age, B-symptom, ECOG scale, Ann Arbor stage, international prognostic index, and serum beta2-microglobulin level were significant prognostic factors for both DFS and OS. Multivariate analysis demonstrated that age, B symptoms, and ECOG scale were significant prognostic factors for OS only. In conclusion, the survival rates of HD patients in our center were superior to those of previous reports in Korea and Western countries. Considering the higher OS rate and decreased incidence of side effects, the ABVD regimen may be recommended for the initial treatment of Hodgkin's disease.

Adolescent↗