Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas

1978 ◽  
Vol 49 (3) ◽  
pp. 333-343 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Collin S. MacCarty ◽  
M. Stephen Mahaley ◽  
...  
Keyword(s):  
Performance Status ◽  
Randomized Study ◽  
Cranial Nerves ◽  
Age Distribution ◽  
Treated Group ◽  
Conventional Care ◽  
Surgical Biopsy ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Significant Difference

✓ A controlled, prospective, randomized study evaluated the use of 1,3-bis(2-chloroethyl)-l-nitrosourea (BCNU) and/or radiotherapy in the treatment of patients who were operated on and had histological confirmation of anaplastic glioma. A total of 303 patients were randomized into this study, of whom 222 (73%) were within the Valid Study Group (VSG), having met the protocol criteria of neuropathology, corticosteroid control, and therapeutic approach. Patients were divided into four random groups, and received BCNU (80 mg/sq m/day on 3 successive days every 6 to 8 weeks), and/or radiotherapy (5000 to 6000 rads to the whole brain through bilateral opposing ports), or best conventional care but no chemotherapy or radiotherapy. Analysis was performed on all patients who received any amount of therapy (VSG) and on the Adequately Treated Group (ATG), who had received 5000 or more rads radiotherapy, two or more courses of chemotherapy, and had a minimum survival of 8 or more weeks (the interval that would have been required to have received either the radiotherapy or chemotherapy). Median survival of patients in the VSG was, best conventional care: 14 weeks (ATG: 17.0 weeks); BCNU: 18.5 weeks (ATG: 25.0 weeks); radiotherapy: 35 weeks (ATG: 37.5 weeks); and BCNU plus radiotherapy: 34.5 weeks (ATG: 40.5 weeks). All therapeutic modalities showed some statistical superiority compared to best conventional care. There was no significant difference between the four groups in relation to age distribution, sex, location of tumor, diagnosis, tumor characteristics, signs or symptoms, or the amount of corticosteroid used. An analysis of prognostic factors indicates that the initial performance status (Karnofsky rating), age, the use of only a surgical biopsy, parietal location, the presence of seizures, or the involvement of cranial nerves II, III, IV, and VI are all of significance. Toxicity included acceptable, reversible thrombocytopenia and leukopenia.

Evaluation of mithramycin in the treatment of anaplastic gliomas

1976 ◽  
Vol 44 (6) ◽  
pp. 655-667 ◽  
Author(s):  
Michael D. Walker ◽  
Eben Alexander ◽  
William E. Hunt ◽  
Carl M. Leventhal ◽  
M. Stephen Mahaley ◽  
...  
Keyword(s):  
Randomized Study ◽  
Age Distribution ◽  
Gastrointestinal Symptoms ◽  
Treated Group ◽  
Anaplastic Glioma ◽  
Control Group ◽  
Duration Of Symptoms ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Significant Difference

✓ A controlled, prospective, randomized study evaluated the use of mithramycin in the treatment of anaplastic glioma compared to a similar group of patients receiving best conventional care. From a total of 116 patients in the study, 96 were within the valid study group. All patients were operated on, had histological confirmation of anaplastic glioma, and received radiotherapy at the discretion of the principal investigator. Fifty-two patients received mithramycin at a dose of 25 µg/kg/day for 21 days, while 44 patients were in the control group. There was no significant difference in the median survival from time of randomization in those receiving mithramycin (21 weeks) as compared to those not receiving mithramycin (26 weeks). There was no significant difference between the two groups in relation to age distribution, sex, location, diagnosis, tumor characteristics, signs or symptoms, or radiotherapy received. Duration of symptoms correlates positively with survival and was also significantly longer in the control group than in the treated group. This, however, did not account for the failure of mithramycin to be found an effective agent. Although the study was not designed to evaluate the efficacy of radiotherapy, patients who were so treated had a significant improvement in survival. The toxic complications of mithramycin included gastrointestinal symptoms, dermatological involvement, anemia, and liver dysfunction, indicating the need for close supervision.

Immunobiology of primary intracranial tumors

1981 ◽  
Vol 54 (2) ◽  
pp. 220-227 ◽  
Author(s):  
M. Stephen Mahaley ◽  
Paul Steinbok ◽  
Patricia Aronin ◽  
Lynn Dudka ◽  
Doug Zinn
Keyword(s):  
Treated Group ◽  
Active Immunization ◽  
Controlled Study ◽  
Survival Times ◽  
Pilot Studies ◽  
Content Type ◽  
Cell Counts ◽  
Anaplastic Gliomas ◽  
Significant Difference ◽  
Improvement In Survival

✓ Levamisole was evaluated as an immune stimulant in a randomized controlled study of patients with anaplastic gliomas, who had undergone surgical resection and who were also treated with radiotherapy and BCNU chemotherapy. Of 102 patients placed into the study, 85 were determined to comprise the adequately treated group (AGT): a full course of radiotherapy and two cycles of BCNU chemotherapy. Within the ATG, those patients who received levamisole did not demonstrate significantly different serial delayed hypersensitivity reactions, peripheral blood lymphocyte and T-cell counts, or serum IgM levels, compared to those patients not receiving levamisole. There was no significant difference in survival times of the two groups. Studies utilizing the avian sarcoma virus-induced glioma in rats also showed no improvement in survival with levamisole stimulation as the only immune agent, but the combination of active immunization and adjuvant stimulation with bacillus Calmette-Guerin plus levamisole was found to be therapeutically effective in this model and will be used in future pilot studies of active immunization in patients.

Does an impaired capacity for self-care impact the prevalence of social and emotional loneliness among elderly people?

2018 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Irena Canjuga ◽  
Danica Železnik ◽  
Marijana Neuberg ◽  
Marija Božicevic ◽  
Tina Cikac
Keyword(s):  
Health Care ◽  
Elderly People ◽  
Age Distribution ◽  
Self Care ◽  
The Elderly ◽  
The Self ◽  
Content Type ◽  
Care Assessment ◽  
Significant Difference ◽  
The Impact

Purpose The purpose of this paper is to explore the impact of self-care on the prevalence of loneliness among elderly people living in retirement homes and older people living in their homes/communities. Design/methodology/approach The research was conducted through standardized SELSA-L assessment loneliness questionnaires and the Self Care Assessment Worksheet for self-care assessment. The results were processed using the Kruskal–Wallis test. Findings The obtained results have shown that impaired self-care ability affects the prevalence of loneliness among the elderly almost the same in both groups of participants. However, regarding the relationship between the state of health and self-care, only a statistically significant difference in the prevalence of loneliness is found in the case of the participants living in their homes, with the worst health condition affecting the poorer psychological care. Research limitations/implications It is necessary to point out the limitations of the research, primarily sample limitations and the selected design of the study. The sample consisted of two different and relatively small groups of participants which could adversely affect the representativeness of the sample and reduce the possibility of generalising the results. The next limiting factor is the age distribution the authors used in the research, where the age of the participants as a very important variable was collected by age range and not precisely which consequently resulted in inequality in subgroup sizes. Thus, the middle age (75–85) covers up to ten years, which is a huge range at an older age and can mean major differences in functional ability, and can impact the self-care assessment. Practical implications Nurses are indispensable in care for the elderly and they need to promote and encourage self-care of the elderly through health care. Elderly people living in retirement homes should be allowed to participate equally in health care in order to preserve their own autonomy and dignity. However, to benefit those who live in their homes, nurses should be connected to the local community and thus stimulate various forms of preventative (testing blood sugar levels, blood pressure and educating on the importance of preventive examinations) or recreational activities in the environment of elderly people with the goal of preserving their functional abilities. Originality/value The impact of self-care on loneliness was not sufficiently researched, and this paper contributed to understanding the complexity of loneliness phenomena among the elderly with the aim of developing a model of prevention.

Endoscopic surgery versus medical treatment for spontaneous intracerebral hematoma: a randomized study

1989 ◽  
Vol 70 (4) ◽  
pp. 530-535 ◽  
Author(s):  
Ludwig M. Auer ◽  
Wolfgang Deinsberger ◽  
Kurt Niederkorn ◽  
Günther Gell ◽  
Reinhold Kleinert ◽  
...  
Keyword(s):  
Mortality Rate ◽  
Medical Treatment ◽  
Functional Recovery ◽  
Randomized Study ◽  
Treated Group ◽  
Surgical Patients ◽  
Lower Mortality ◽  
Intracerebral Hematoma ◽  
Content Type ◽  
Fine Print

✓ A controlled randomized study of endoscopic evacuation versus medical treatment was performed in 100 patients with spontaneous supratentorial intracerebral (subcortical, putaminal, and thalamic) hematomas. Patients with aneurysms, arteriovenous malformations, brain tumors, or head injuries were excluded. Criteria for inclusion were as follows: patients' age between 30 and 80 years; a hematoma volume of more than 10 cu cm; the presence of neurological or consciousness impairment; the appropriateness of surgery from a medical and anesthesiological point of view; and the initiation of treatment within 48 hours after hemorrhage. The criteria of randomization were the location, size, and side of the hematoma as well as the patient's age, state of consciousness, and history of hypertension. Evaluation of outcome was performed 6 months after hemorrhage. Surgical patients with subcortical hematomas showed a significantly lower mortality rate (30%) than their medically treated counterparts (70%, p < 0.05). Moreover, 40% of these patients had a good outcome with no or only a minimal deficit versus 25% in the medically treated group; the difference was statistically significant for operated patients with no postoperative deficit (p < 0.01). Surgical patients with hematomas smaller than 50 cu cm made a significantly better functional recovery than did patients of the medically treated group, but had a comparable mortality rate. By contrast, patients with larger hematomas showed significantly lower mortality rates after operation but had no better functional recovery than the medically treated group. This effect from surgery was limited to patients in a preoperatively alert or somnolent state; stuporous or comatose patients had no better outcome after surgery. The outcome of surgical patients with putaminal or thalamic hemorrhage was no better than for those with medical treatment; however, there was a trend toward better quality of survival and chance of survival in the operated group.

Low-dose aspirin prophylaxis and risk of intracranial hemorrhage in patients older than 60 years of age with mild or moderate head injury: a prospective study

2003 ◽  
Vol 99 (4) ◽  
pp. 661-665 ◽  
Author(s):  
Sergey Spektor ◽  
Samuel Agus ◽  
Vladimir Merkin ◽  
Shlomo Constantini
Keyword(s):  
Head Injury ◽  
Intracranial Hemorrhage ◽  
Ct Scanning ◽  
Treated Group ◽  
Control Group ◽  
Content Type ◽  
Significant Difference ◽  
Traumatic Intracranial Hemorrhage ◽  
Gcs Score ◽  
Fine Print

Object. The goal of this paper was to investigate a possible relationship between the consumption of low-dose aspirin (LDA) and traumatic intracranial hemorrhage in an attempt to determine whether older patients receiving prophylactic LDA require special treatment following an incidence of mild-to-moderate head trauma. Methods. Two hundred thirty-one patients older than 60 years of age, who arrived at the emergency department with a mild or moderate head injury (Glasgow Coma Scale [GCS] Scores 13–15 and 9–12, respectively), were included in the study. One hundred ten patients were receiving prophylactic LDA (100 mg/day) and these formed the aspirin-treated group. One hundred twenty-one patients were receiving no aspirin, and these formed the control group. There was no statistically significant difference between the two groups with respect to age, sex, mechanism of trauma, or GCS score on arrival at the emergency department. Most of the patients sustained the head injury from falls (88.2% of patients in the aspirin-treated group and 85.1% of patients in the control group), and had external signs of head trauma such as bruising or scalp laceration (80.9% of patients in the aspirin-treated group and 86.8% of patients in the control group). All patients underwent similar neurological examinations and computerized tomography (CT) scanning of the head. The CT scans revealed evidence of traumatic intracranial hemorrhage in 27 (24.5%) patients in the aspirin-treated group and in 31 patients (25.6%) in the control group. Surgical intervention was required for five patients in each group (4.5% of patients in the aspirin-treated group and 4.1% of patients in the control group). A surprising number of the patients who arrived with GCS Score 15 were found to have traumatic intracranial hemorrhage, as revealed by CT scanning (11.5% of patients in the aspirin-treated group and 16.5% of patients in the control group). Surgery, however, was not necessary for any of these patients. Conclusions. There was no statistically significant difference in the frequency or types of traumatic intracranial hemorrhage between patients who had received aspirin prophylaxis and those who had not. The authors conclude that LDA does not increase surgically relevant parenchymal or meningeal bleeding following moderate and minor head injury in patients older than 60 years of age.

The Effects of Short-Term Immunotherapy Using Molecular Standardized Grass and Rye Allergens Compared with Symptomatic Drug Treatment on Rhinoconjunctivitis Symptoms, Skin Sensitivity, and Specific Nasal Reactivity

2005 ◽  
Vol 133 (4) ◽  
pp. 538-543 ◽  
Author(s):  
L. Klimek ◽  
T. Mewes ◽  
H. Wolf ◽  
I. Hansen ◽  
J. Schnitker ◽  
...  
Keyword(s):  
Drug Treatment ◽  
Grass Pollen ◽  
Randomized Study ◽  
Provocation Test ◽  
Treated Group ◽  
Short Term ◽  
Skin Sensitivity ◽  
Double Blind ◽  
Nasal Provocation ◽  
Significant Difference

BACKGROUND: The efficacy and safety of short-term immunotherapy with molecular standardized allergens (STI) has been demonstrated by double-blind placebo-controlled clinical trials. The aim of this study was to compare STI with symptomatic drug treatment. METHODS: Forty-eight patients with rhinoconjunctivitis to grass and/or rye pollen were treated either with STI (ALK7, n = 24) plus anti-allergic drugs or anti-allergic drugs, alone (n = 24) in a prospective, randomized study. Symptoms and use of drugs were reported in patient diaries and titrated nasal provocation and skin prick tests were performed at baseline, before, and after season. RESULTS: Median overall symptom ( P = 0.022, U test) and medication scores ( P = 0.003) were significantly lower in the STI group, as was the result for a simultaneous analysis of conjunctival, nasal, and bronchial symptom scores and medication ( P = 0.005). Sensitivity in the nasal provocation test decreased in the STI group but not in the drug-treated group. These differences became significant directly after STI ( P = 0.027) as well as after the grass pollen season ( P < 0.001). Skin sensitivity did not change in the STI group but increased in the drug-treated group after season, with a significant difference between the two groups for the erythema ( P < 0.001). CONCLUSIONS: STI reduces grass pollen-induced rhinoconjunctivitis symptoms and drug use, and specific nasal reactivity and skin sensitivity, more efficiently than a standard symptomatic treatment.

Timing of operation for ruptured supratentorial aneurysms: a prospective randomized study

1989 ◽  
Vol 70 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Juha Öhman ◽  
Olli Heiskanen
Keyword(s):  
Aneurysmal Subarachnoid Hemorrhage ◽  
Anterior Part ◽  
Controlled Trial ◽  
Randomized Study ◽  
Prospective Randomized Study ◽  
Double Blind ◽  
Content Type ◽  
Acute Surgery ◽  
Significant Difference ◽  
Fine Print

✓ A total of 216 patients with a ruptured aneurysm of the anterior part of the circle of Willis were enrolled into this prospective randomized study of timing of the operation after aneurysmal subarachnoid hemorrhage (SAH). Only patients in clinical Grades I to III (according to the classification of Hunt and Hess) who were admitted and randomly assigned to a treatment group within 72 hours after the SAH were included in the trial. The patients were randomly assigned to one of three operation groups: acute surgery (AS: 0 to 3 days after the SAH; day of SAH = Day 0), intermediate surgery (IS: 4 to 7 days after the SAH), or late surgery (LS: 8 days to an indefinite time after the SAH). Three patients (4.3%) in the IS group and six patients (8.6%) in the LS group died before surgery was undertaken. At 3 months post-SAH, 65 patients (91.5%) from the AS group were classified as independent compared to 55 (78.6%) from the IS group and 56 (80.0%) from the LS group. The management mortality rate in the AS group was 5.6% compared to 12.9% in the LS group. Of the 216 patients enrolled in the timing study, 159 were randomly assigned to an independent double-blind placebo-controlled trial of nimodipine in Grade I to III patients. A total of 79 patients received nimodipine and 80 placebo. When the nimodipine group and the no-nimodipine group (the 80 placebo-treated patients plus the 52 patients who were not entered into the nimodipine trial) were analyzed separately, a significant difference was seen in the outcome of the no-nimodipine group (dependent AS vs. dependent IS, p = 0.01). Nimodipine treatment was associated with a significant reduction of delayed ischemic deterioration (all operation groups combined, nimodipine vs. no nimodipine p = 0.01; LS with nimodipine vs. LS with no nimodipine, p = 0.03).

A multicenter trial on the efficacy of using tirilazad mesylate in cases of head injury

1998 ◽  
Vol 89 (4) ◽  
pp. 519-525 ◽  
Author(s):  
Lawrence F. Marshall ◽  
Andrew I. R. Maas ◽  
Sharon Bowers Marshall ◽  
Albino Bricolo ◽  
Michael Fearnside ◽  
...  
Keyword(s):  
Placebo Group ◽  
Head Injury ◽  
Severe Head Injury ◽  
Treated Group ◽  
Good Recovery ◽  
Content Type ◽  
Significant Difference ◽  
Tirilazad Mesylate ◽  
Gcs Score ◽  
Fine Print

Object. The authors prospectively studied the efficacy of tirilazad mesylate, a novel aminosteroid, in humans with head injuries. Methods. A cohort of 1120 head-injured patients received at least one dose of study medication (tirilazad or placebo). Eighty-five percent (957) of the patients had suffered a severe head injury (Glasgow Coma Scale [GCS] score 4–8) and 15% (163) had sustained a moderate head injury (GCS score 9–12). Six-month outcomes for the tirilazad- and placebo-treated groups for the Glasgow Outcome Scale categories of both good recovery and death showed no significant difference (good recovery in the tirilazad-treated group was 39% compared with the placebo group in which it was 42% [p = 0.461]; death in the tirilazad-treated group occurred in 26% of patients compared with the placebo group, in which it occurred in 25% [p = 0.750]). Subgroup analysis suggested that tirilazad mesylate may be effective in reducing mortality rates in males suffering from severe head injury with accompanying traumatic subarachnoid hemorrhage (death in the tirilazad-treated group occurred in 34% of patients; in the placebo group it occurred in 43% [p = 0.026]). No significant differences in frequency or types of serious adverse events were shown between the treatment and placebo groups. Conclusions. Striking problems with imbalance concerning basic prognostic variables were observed in spite of the large population studied. These imbalances concerned pretreatment hypotension, pretreatment hypoxia, and the incidence of epidural hematomas. In future trials of pharmacological therapy for severe head injury, serious consideration must be given to alternative randomization strategies. Given the heterogeneous nature of head injury and the identification of populations that do relatively well with standard therapy, target populations with a higher risk for mortality and morbidity may be more suitable for clinical trials of such agents.

Outcome after lumbar sequestrectomy compared with microdiscectomy: a prospective randomized study

2005 ◽  
Vol 2 (3) ◽  
pp. 271-278 ◽  
Author(s):  
Claudius Thomé ◽  
Martin Barth ◽  
Johann Scharf ◽  
Peter Schmiedek
Keyword(s):  
Short Form ◽  
Randomized Study ◽  
Treated Group ◽  
Pain Patient ◽  
Recurrence Rates ◽  
Content Type ◽  
Early Outcome ◽  
Sf 36 ◽  
Fine Print

Object. Microdiscectomy currently constitutes the standard treatment for herniated lumbar discs. Although limiting surgery to excision of fragments has occasionally been suggested, prospective data are lacking. Therefore, the objective of this study was to compare early outcome and recurrence rates after sequestrectomy and microdiscectomy. Methods. Eighty-four consecutive patients 60 years of age or younger who harbored free, subligamentary, or transanular herniated lumbar discs refractory to conservative treatment were randomized to one of two treatment groups. Intraoperative parameters and findings were documented as well as pre- and postoperative symptoms such as pain, Patient Satisfaction Index (PSI), Prolo Scale score, and Short Form (SF)—36 subscale results. Follow up of at least 12 months was available in 73 patients (87%). Preoperative intergroup symptoms did not differ significantly. Surgery was significantly shorter in the sequestrectomy-treated group. Overall, low-back pain and sciatica were drastically reduced in both groups and most sensorimotor deficits improved. At 4 to 6 months, SF-36 subscales and PSI scores showed a trend in favor of sequestrectomy, leaving 3% of patients unsatisfied compared with 18% of those treated with discectomy. Outcome according to the Prolo Scale was good or excellent in 76% of discectomy-treated patients and 92% of sequestrectomy-treated patients. Reherniation occurred in four patients after discectomy (10%) and two patients after sequestrectomy (5%) within 18 months. Conclusions. Sequestrectomy does not seem to entail a higher rate of early recurrences compared with microdiscectomy. Analysis of early outcome demonstrated a trend toward superior results when sequestrectomy is performed. Although long-term follow-up data are mandatory, sequestrectomy may be an advantageous alternative to standard microdiscectomy.

Phase III comparison of BCNU and the combination of procarbazine, CCNU, and vincristine administered after radiotherapy with hydroxyurea for malignant gliomas

1985 ◽  
Vol 63 (2) ◽  
pp. 218-223 ◽  
Author(s):  
Victor A. Levin ◽  
William M. Wara ◽  
Richard L. Davis ◽  
Pamela Vestnys ◽  
Kenneth J. Resser ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Tumor Progression ◽  
Randomized Study ◽  
Malignant Gliomas ◽  
Phase Iii ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Risk Patients ◽  
Extent Of Surgical Resection ◽  
Time To Tumor Progression

✓ The authors report the results of a randomized study conducted to evaluate the relative benefit of treatment with 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) or the combination of procarbazine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea, and vincristine (PCV) administered after radiation therapy with hydroxyurea to 76 evaluable patients with glioblastoma multiforme and 72 patients with other anaplastic gliomas. The primary end-point of the study was time to tumor progression. For better-risk patients with Karnofsky performance scores of 70 to 100, results suggest that PCV was of greater benefit than BCNU (p = 0.15 for glioblastoma multiforme; p = 0.13 for other anaplastic gliomas). Median times to tumor progression were 31 and 32 weeks for patients with glioblastoma multiforme; 25th percentile times to progression were 70 and 40 weeks for patients treated with PCV and BCNU, respectively. For patients with other anaplastic gliomas treated with PCV and BCNU, median times to progression were 123 and 77 weeks, respectively. Multivariate analysis showed that the prognostic variables of age and Karnofsky scores were important for patients with glioblastoma multiforme and other anaplastic gliomas, and that the extent of surgical resection was important for those with other anaplastic gliomas.

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