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The rabbit ECoG is characterised by alternating active and inhibitory signs. This suggests the necessity to take into consideration individual features and initial states of the rabbit CNS and the dynamics of their changes when studying the effects of various stimuli.
The Eastern Cooperative Oncology Group has conducted a retrospective review of their experience of 96 patients with a tissue diagnosis of malignant mesothelioma treated between 1972 and 1980 on four separate sarcoma chemotherapy protocols. Thirty-two of the 96 patients were diagnosed and treated in South Africa. There were 75 males and 21 females with an age range of 27 to 78 with a median of 58.1 years. All, except for 28 patients, had some form of prior therapy. The median time from the onset of symptoms to diagnosis was 12 weeks; from the diagnosis to randomization was 15.1 weeks. Only 12 of the 96 patients demonstrated an objective regression. The responses were 7/51 on Adriamycin with 2 complete responses (complete responses--38 weeks and 52 weeks), 2/24 on Adriamycin combinations, 2/7 on cycloleucine, 1/3 on bleomycin, and 0/10 on non-Adriamycin combinations. Only 1/28 responded to a cross-over therapy (Adriamycin). The median survival from the start of protocol chemotherapy was 7.4 months and 7.5 months for Adriamycin treated patients. The median survival for responders was 29.9 months, compared to 6.3 months for nonresponders. The median survival for this entire series from the time of first symptoms was 15.2 months. The median survival for the 7 patients with abdominal mesothelioma was 12 weeks. There was a slight improvement in survival for the South Africans as compared to the Americans. Malignant mesothelioma in this series, was a rapidly lethal, nonresponsive disease whose treatment will require new therapies.
This study was performed to determine the toxicity and effectiveness of megestrol acetate used with aminoglutethimide-hydrocortisone in the treatment of patients with metastatic breast cancer. Forty-five patients were treated, 29 of whom were fully eligible. Twelve of the 45 who had diabetes and/or hypertension were also analyzed. All had measurable sites of disease. The median age was 63 years, and the median time from first recurrence to on-study was 19 months. Approximately half the patients already had chemotherapy, and about 90% had hormone therapy for advanced disease. The most common side effects were skin rash, weight gain, hyperglycemia, and renal and neurologic problems. No life-threatening or lethal toxicities were reported. The overall response rate (complete or partial) among the fully eligible patients was 34% (90% confidence intervals from 20% to 51%), with a 5-month median duration of response. Patients with soft tissue, visceral, and osseous disease responded. Seventy-two percent of fully eligible patients have progressed or relapsed. The median time to failure of treatment was 6 months, and the median survival time was 15 months.
A combination of adriamycin, vincristine, dibromodulcitol, and hexamethylmelamine was piloted in patients with advanced breast cancer who had failed prior CMFP chemotherapy, as a part of ongoing trials by the Eastern Cooperative Oncology Group to improve second-line chemotherapy for this disease. The vincristine was given as an intensive 5 week induction regimen and hexamethylmelamine was administered on days 15-27 of a 28 day cycle, at the time of anticipated nadir peripheral blood counts. The study was terminated early after only 9 patients had been entered because of severe neurotoxicity related to the intensive schedule of vincristine as well as hematologic and gastrointestinal side effects. Three patients responded for 11, 18 and 21 weeks. The limited therapeutic benefit did not justify the toxicity produced, and suggested that intensive dosage schedules of vincristine, and use of low dose hexamethylmelamine during the time of anticipated hematologic nadir counts would not be of substantial benefit.
A group of 19 patients with advanced (Stage D) prostate cancer were treated with one of three dose levels of the anti-estrogen tamoxifen, 10 mg (3 patients), 20 mg (8 patients), or 30 mg (8 patients) daily. Five patients had received no prior systemic therapy. The treatment was tolerated well, but no objective responses occurred.
Using designs that several authors proposed, we reanalysed a large number of completed phase III clinical trials of the Eastern Cooperative Oncology Group as if each had been designed with group sequential stopping rules. With survival the primary endpoint of the large multicentre trials, we discuss the relative merits of each design, as well as the feasibility of group sequential designs in general.
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Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
The effects of increasing the brain monoamine content on the three types of localized rhythms identified in somatic area I ("mu-type rhythms") were studied in freely moving cats. Increases in brain monoamines (catecholamines and serotonin) were produced by injecting L-Dopa and 5-HTP, L-tyrosine, L-tryptophan and tryptamine were also tested. It is concluded that the two subsets of rhythms, one accompanying high levels of alertness and vigilance and the other appearing during quiet wakefulness, are related to the catecholaminergic systems, while those characterizing drowsiness seem to be controlled by a serotoninergic system. The latter, however, is distinct from that controlling slow sleep.
To investigate whether breast cancer cells with unusually high nuclear DNA content are associated with an adverse outcome, Eastern Cooperative Oncology Group investigators selected breast cancer trial patients who suffered an early death (ED) within two years after diagnosis to compare with other trial patients who had a survival of at least 7.5 years. Paraffin blocks of primary breast cancers were obtained from 93 evaluable patients who had been enrolled in two surgical adjuvant trials for lymph node positive (LN+) disease (T1-3N1M0). Single cell monolayer preparations from these blocks were stained with acriflavine-Feulgen and analyzed by image analysis for DNA content with the automated Leiden Television Analysis System (LEY-TAS). Standard prognostic variables (estrogen receptor (ER) status, number of lymph nodes with metastases, and size of the cancer) were compared with three DNA content characteristics: DNA ploidy status, number of nuclei with > 5C DNA content, and percent of nuclei with > 5 C. Estimates of the odds ratio in multivariate comparisons showed that ER negativity was associated with ED (p = 0.0005) and an odds ratio estimate using negative/positive of 4.87. The number of positive lymph nodes associated with ED had a p-value of 0.0005 and an odds ratio estimate of 4.63 when comparing the > 3 nodes group to the 1-3 nodes group. In contrast, the strongest association for any of the DNA content characteristics with ED had a p-value of 0.017 and an odds ratio estimate of 2.76. This power of association disappeared when stratified on ER status.(ABSTRACT TRUNCATED AT 250 WORDS)
Taxol was administered as a 24-hour continuous infusion at 250 mg/m2 in this Phase II trial in patients with adenocarcinomas of the upper gastrointestinal tract (UGIT). Twenty-five patients were entered between July 1991 and June 1992, twenty-three were eligible and were evaluated for toxicity and twenty-two were assessable for response. There was one partial response (4.5%) in a patient with liver metastases, with a duration of 6 months. Toxicity was primarily neutropenia. Taxol as a single agent appears to have little activity in adenocarcinoma of the UGIT.
Seventeen patients were treated with echinomycin for metastatic renal cell carcinoma. Echinomycin is a bifunctional DNA intercalating agent with broad preclinical antitumor activity. It was given at 1200 mg/m2 by intravenous infusion over 30-60 min weekly for 4 weeks. The treatment was repeated every 6 weeks. There were no responses observed in the study. No life threatening or lethal toxicity was documented in 13 eligible patients. The median survival of these patients was 13.7 months. We conclude that echinomycin is not active against metastatic renal cell carcinoma at the dose and schedule tested.
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Thirty-four chemotherapy-naive, ambulatory patients with advanced renal cell cancer were treated with the non-classical antifol trimetrexate at the intravenous dose of 12 mg/m2 daily x 5 every three weeks (8 mg/m2 qd x 5 for greater than 30% bone marrow previously irradiated). One patient experienced a partial response lasting 24 weeks for a response rate of 3% (exact 95% CI, 0.1 to 15.3%). Toxicity was manageable and primarily myelosuppression, gastrointestinal, and mucosal. Trimetrexate has little activity in advanced renal cell carcinoma at this dose and schedule.