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Biomedical subjects

S B Green

Publications and source records attributed to S B Green.

At least 19 recordsLinked to original sources
PubMed1992

A randomized comparison of intra-arterial versus intravenous BCNU, with or without intravenous 5-fluorouracil, for newly diagnosed patients with malignant glioma.

This Phase III trial tested the efficacy and safety of intra-arterial 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) for the treatment of newly resected malignant glioma, comparing intra-arterial BCNU and intravenous BCNU (200 mg/sq m every 8 weeks), each regimen without or with intravenous 5-fluorouracil (1 gm/sq m three times daily given 2 weeks after BCNU). All patients also received radiation therapy. A total of 505 patients were randomly assigned within the study. Fifty-seven patients were excluded, primarily because of neuropathology error, and the remaining 448 patients constituted the Valid Study Group. Of the total 505 patients, 190 patients could not receive intra-arterial BCNU and 315 patients were randomly assigned to receive intra-arterial (167 patients) and intravenous (148 patients) BCNU. Actuarial analysis (log-rank) demonstrated reduced survival for the intra-arterial group (p = 0.03). Serious toxicity was observed in the intra-arterial group; 16 patients (9.5%) developed irreversible encephalopathy with computerized tomography evidence of cerebral edema, and 26 patients (15.5%) developed visual loss ipsilateral to the infused carotid artery. Administration of 5-fluorouracil did not influence survival. The survival rate between the intravenous and the intra-arterial BCNU patients with glioblastoma multiforme did not differ, but was worse for intra-arterial BCNU patients with anaplastic astrocytoma than for those receiving intravenous BCNU (p = 0.002). Neuropathologically, intra-arterial BCNU produced white matter necrosis. It is concluded that intra-arterial BCNU is neither safe nor effective in prolonging survival when administered by the methods used in this study of newly diagnosed patients with malignant glioma.

Adolescent↗
PubMed1991

Randomized, double-masked study of cyclosporine compared to prednisolone in the treatment of endogenous uveitis.

Fifty-six patients with bilateral sight-threatening noninfectious intermediate or posterior uveitis participated in a randomized double-masked study of the use of cyclosporine vs prednisolone in their treatment. Applying the end-point definitions, visual acuity or vitreal haze improved in only 13 of 28 (46%) patients in each group. The macular edema resolved in seven of 15 patients of the cyclosporine-treated group, and in ten of 16 patients of the prednisolone-treated group (P = .376). Patients whose therapies failed both cyclosporine and prednisolone trials were treated with both drugs, which resulted in additional patient improvements. Secondary effects were observed in both therapeutic alternatives, the most notable being alterations in serum creatinine concentration and hypertension with the dosage of cyclosporine used.

Adolescent↗
PubMed1991

Predicting with the MMPI the adjustment of juvenile delinquents to institutionalization: does gender make a difference?

Relationships between Minnesota Multiphasic Personality Inventory (MMPI) scales and criteria were evaluated to determine if the MMPI is gender biased when considering a juvenile delinquent population. The MMPI was administered to 549 juvenile delinquents: 105 Black men, 37 Black women, 331 White men, and 76 White women. In addition, behavioral and rating measures were collected; they served as adjustment criteria. Except for the criterion assessing neurotic symptomatology, equations that regressed criteria on MMPI scales neither underpredicted nor overpredicted for a gender. The MMPI tended to underpredict ratings of neurotic symptomatology for women. Significant differences in correlation coefficients for Black men and women occurred for the behavioral, nonrating criteria. Scale 4 was the best predictor for Black men, whereas Scales, 8, F, 1, and 2 tended to be the best predictors for Black women. Some possible explanations for these results are offered.

Adolescent↗
PubMed1990

Assessing the gain in efficiency due to matching in a community intervention study.

COMMIT (Community Intervention Trial for Smoking Cessation) is a randomized study employing a matched pairs design. Pairs of communities were selected on the basis of their geographical proximity and were chosen to be matched on variables strongly expected to relate to the outcome variable, the smoking quit rate. However, quantitative information was not available to evaluate the efficiency gain from matching. We have used baseline smoking quit rates in the communities as a surrogate for the outcome measure to evaluate the gain in efficiency from the matching. Our method takes account of the possible imperfection of the surrogate as a representative of the true outcome. The method estimates an efficiency gain of at least 50 per cent using the matched design. We also evaluate the further gains in efficiency which would be made by using the baseline quit rate to balance the randomization.

Bias↗
PubMed1990

Issues in the design of drug trials for AIDS.

Although the fundamental principles that drive the design, conduct, and analysis of clinical trials are as applicable to AIDS as to other diseases, there is no question that we have been confronted with unusually difficult challenges in studying therapeutic approaches in this disease area. Treatments are being developed that show great promise, but when investigated further some may be seen to offer no clinical benefit and others may do active harm through toxicity. A group of biostatisticians, meeting in association with the AIDS Clinical Trials Group (ACTG), has discussed and written a report on a number of issues, primarily related to principles of study design, with the goal of stimulating thought on new study designs and the timely implementation of well-designed trials to identify effective treatment strategies for HIV-infected populations. These issues include (1) progression of clinical trials through phases, (2) choices of outcomes, (3) breadth and complexity of clinical trials (eligibility criteria and "low-tech" trials, (4) alternative designs to be used in randomized trials, and (5) the concept of randomized clinical trials as a desirable option, both for patients and for science. The current HIV epidemic makes the requirements of obtaining valid scientific comparisons more important, not less so, but the challenge is to expedite this process.

Acquired Immunodeficiency Syndrome↗
PubMed1990

Development and validation of the situational appetite measures.

Based on a system to categorize high-risk situations for relapse in addictive disorders, instruments were developed to assess cue strength and self-efficacy relevant to weight loss attempts. Two versions of the Situational Appetite Measure (SAM) were developed, one to assess urges to overeat in selected situations and the other to assess self-efficacy in controlling urges to overeat. In a sample of college student dieters and enrollees in commercial diet centers, the measures were found to be highly correlated, such that as consummatory urges increased, self-efficacy to control overeating decreased. High-risk situations were represented by five relatively distinct and reliable subscales: relaxation, food present, hunger, reward, and negative feelings. Low cue strength and high self-efficacy for controlling overeating in situations involving negative feelings predicted weight reduction among female dieters in treatment. The multidimensional nature of the SAM allows for differential prediction of eating behavior across situations.

Adult↗
PubMed1989

Projecting individualized probabilities of developing breast cancer for white females who are being examined annually.

To assist in medical counseling, we present a method to estimate the chance that a woman with given age and risk factors will develop breast cancer over a specified interval. The risk factors used were age at menarche, age at first live birth, number of previous biopsies, and number of first-degree relatives with breast cancer. A model of relative risks for various combinations of these factors was developed from case-control data from the Breast Cancer Detection Demonstration Project (BCDDP). The model allowed for the fact that relative risks associated with previous breast biopsies were smaller for women aged 50 or more than for younger women. Thus, the proportional hazards models for those under age 50 and for those of age 50 or more. The baseline age-specific hazard rate, which is the rate for a patient without identified risk factors, is computed as the product of the observed age-specific composite hazard rate times the quantity 1 minus the attributable risk. We calculated individualized breast cancer probabilities from information on relative risks and the baseline hazard rate. These calculations take competing risks and the interval of risk into account. Our data were derived from women who participated in the BCDDP and who tended to return for periodic examinations. For this reason, the risk projections given are probably most reliable for counseling women who plan to be examined about once a year.

Adult↗
PubMed1989

Is alcohol consumption related to breast cancer? Results from the Framingham Heart Study.

We studied the relation between alcohol consumption and breast cancer among women in the Framingham Heart Study cohort. A total of 2,636 women aged 31-64 years provided information on alcohol consumption at the second biennial examination. They were followed for up to 32 years; during this period, breast cancer was diagnosed in 143 of these women. Alcohol intake was also assessed at 10 and 20 years of follow-up and every 2 years thereafter. In analyses using only baseline alcohol intake, the multiple risk factor-adjusted relative risk (RR) estimate of breast cancer for any drinking, compared with nondrinking, was 0.8 [95% confidence interval (CI), 0.5-1.1]. For three levels of alcohol intake (0.1-1.4 g/day, 1.5-4.9 g/day, and greater than or equal to 5.0 g/day), the baseline analyses yielded RRs (vs. nondrinking) of 1.0 (CI, 0.6-1.5), 0.7 (CI, 0.4-1.1), and 0.6 (CI, 0.4-1.0), respectively. In analyses incorporating repeated measures of alcohol, the comparable RRs were 0.9 (CI, 0.6-1.2) for any drinking (vs. nondrinking) and 0.7 (CI, 0.4-1.4), 1.1 (CI, 0.7-1.8), and 0.8 (CI, 0.5-1.2), respectively, for the three levels of intake (vs. nondrinking). Alcohol consumption was not associated with an increased risk of breast cancer in this cohort.

Adult↗
PubMed1989

Results of a randomized trial comparing BCNU plus radiotherapy, streptozotocin plus radiotherapy, BCNU plus hyperfractionated radiotherapy, and BCNU following misonidazole plus radiotherapy in the postoperative treatment of malignant glioma.

In Brain Tumor Cooperative Group Study 77-02, eleven institutions randomized 603 adult patients with supratentorial malignant glioma to one of four treatment groups following surgery: conventional radiotherapy (6000 cGy in 30-35 fractions) + BCNU, conventional radiotherapy + streptozotocin, hyperfractionated (twice daily) radiotherapy (6600 cGy in 60 fractions) + BCNU, and conventional radiotherapy with misonidazole followed by BCNU. Data were analyzed for the total randomized population and for the 557 patients (86% with glioblastoma multiforme) who met protocol eligibility specifications (including confirmed histopathology on central review). Median survival was approximately 10 months following randomization. Overall there was no statistically significant difference in survival among the four groups. Among non-glioblastoma patients, the misonidazole group appeared to have poor survival. Peripheral neuropathy was a dose-limiting toxicity with misonidazole. It is concluded that neither the addition of misonidazole nor hyperfractionated radiotherapy as given in this protocol offered any advantage over conventional radiotherapy plus either BCNU or streptozotocin for treatment of malignant glioma.

Adolescent↗
PubMed1989

Randomized trial of three chemotherapy regimens and two radiotherapy regimens and two radiotherapy regimens in postoperative treatment of malignant glioma. Brain Tumor Cooperative Group Trial 8001.

Within 3 weeks of definitive surgery, 571 adult patients with histologically confirmed, supratentorial malignant gliomas were randomly assigned to receive one of three chemotherapy regimens: BCNU (1,3-bis(2-chloroethyl)-1-nitrosourea) alone, alternating courses (every 8 weeks) of BCNU and procarbazine, or BCNU plus hydroxyurea alternating with procarbazine plus VM-26 (epipodophyllotoxin). Patients accrued in 1980 and 1981 were to receive 6020 rads of whole-brain radiotherapy concurrent with the first course of chemotherapy. Patients accrued in 1982 and 1983 were randomly assigned to receive either whole-brain irradiation as above, or 4300 rads of whole-brain radiotherapy plus 1720 rads coned down to to the tumor volume. The data were analyzed for the total randomized population and separately for the 510 patients, termed the "Valid Study Group (VSG)," who met protocol eligibility specifications (including central pathology review), 80% of whom had glioblastoma multiforme. The median survival times from time of randomization for the three chemotherapy groups of the VSG ranged from 11.3 to 13.8 months, and 29% to 37% of the patients survived for 18 months (life-table estimate); the differences between these groups were not statistically significant. Survival differences between the radiotherapy groups were small and not statistically significant. It is concluded that, for malignant glioma, giving part of the radiotherapy by coned-down boost is as effective as full whole-brain irradiation, and that multiple-drug chemotherapy as outlined in this protocol conferred no significant survival advantage over BCNU alone.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

The prognostic importance of tumor size in malignant gliomas: a computed tomographic scan study by the Brain Tumor Cooperative Group.

The prognostic importance of tumor size was studied in 510 patients with malignant glioma (80% with glioblastoma multiforme) in the Valid Study Group of Study 80-01 of the Brain Tumor Study Group (now the Brain Tumor Cooperative Group [BTCG]). The endpoint was length of survival from randomization, which occurred within 3 weeks of definitive surgery. Following randomization, patients were scheduled to receive radiotherapy (RT) (6,020 cGy) during a 7-week period, along with continuing courses of chemotherapy. Computed tomographic (CT) scan information was available for 124 patients preoperatively, 300 patients postoperatively (preradiation), and 218 patients 9 weeks post-RT (+/- 3 weeks). Tumor size was determined as area (length x width) on the contrast-enhanced scan and survival was compared by log rank statistics. Preoperative tumor area was unrelated to survival (P = .48), but postoperative area was significantly prognostic (P less than .0001); the smaller the residual tumor, the longer the patient lived. Patients with a 75% or greater resection, as determined by measuring the difference between the preoperative and the postoperative scans, tended to have better survival, but the difference was not significant (P = .16). The post-RT area was strongly related to survival (P less than .00001). The percent change in area between the pre- and post-RT scans was also prognostic. Tumor size was of prognostic importance independent of the other known prognostic variables: age, Karnofsky performance score, and whether the tumor was glioblastoma or anaplastic astrocytoma. We conclude that the amount of tumor remaining after surgery is an important baseline variable at the start of RT, and that the tumor size 9 weeks following RT is also prognostic. Surgical resection is most important when it leaves the least amount of residual tumor.

Actuarial Analysis↗
PubMed1988

Racial bias in prediction with the MMPI for a juvenile delinquent population.

Relationships between MMPI scales and criteria were evaluated to determine if the MMPI is racially biased with a juvenile delinquent population. The MMPI was administered to 333 white and 107 black male juvenile delinquents, and criterion data were collected. The regression equations developed for Blacks and whites resulted in similar accuracies. However, the weights of the regression equations tended to differ for the two races. How they differed depended on the criterion predicted by the equations. Consequently, it was impossible to state unconditionally that the use of the MMPI with Black delinquents will have an adverse impact. In fact, one interpretation of the results suggested that the MMPI may not be racially biased for predictions with juvenile delinquents because the amount of constant error in prediction for a racial group decreased toward zero as the apparent objectivity of the criteria increased.

Adolescent↗
PubMed1988

Reproducibility study on the Scheimpflug Cataract Video Camera.

The Zeiss Scheimpflug Cataract Video Camera was designed to photograph, store and analyze cataracts in a semi-automated fashion for cross-sectional and longitudinal studies. We conducted a reproducibility study of this system. Twenty-four normal and 61 cataractous eyes were photographed twice by each of two of the authors in the 90 degree meridian and microdensitometry was performed on each of the stored images. Reproducibility was then determined using the intraclass correlation coefficient to determine whether or not the differences encountered were due to variability in the system or due to actual differences among the images. The intraclass correlation in the lens nucleus was 0.995 with 95% confidence limits of .992-.996. Therefore, reproducibility was 99.5%. In the anterior cortex, intraclass correlation was .941 with 95% confidence limits of .919-.959. In the posterior cortex intraclass correlation was .905 with 95% confidence limits of .870-.932. Reproducibility with this instrument was therefore excellent and with certain limitations, this may be a useful instrument in monitoring lens changes in certain diseases and the effects of anti-cataract agents.

Cataract↗
PubMed1987

Patient age, histologic features, and length of survival in patients with glioblastoma multiforme.

Histologic sections from 71 patients with glioblastoma multiforme were reviewed to identify histologic prognostic factors and to explain the significantly shorter survival in older patients. Slides were studied for 14 histologic variables from a group of 35 patients aged less 45 years and from 36 patients aged 65 years or more. The relation of these histologic factors to the length of survival and age group was then investigated. The results document the marked histologic and cytologic heterogeneity of the glioblastoma and reaffirm the importance of necrosis as a prognostic factor. The results further suggest that patients whose glioblastomas contained microcysts, pseudopalisading, cells with astrocytic differentiation, and large areas of better differentiated glioma, did better than those patients whose lesions were homogeneously composed of small cells or whose lesion had a small median nuclear size. The study reaffirmed the strong (P less than 0.0001) negative relationship between advancing age and duration of postoperative survival. The presence of necrosis, a smaller standard deviation of nuclear size, the extent of vascular proliferation, the absence of well differentiated neoplastic fibrillary astrocytes, and neoplasms composed homogeneously of small cells were related to patient age and offered a possible explanation for at least part of the observed age effect. However, the strong relation between age and survival remained significant when adjusted for other variables, and the effect of age must rest largely on factors other than those detected in this morphologic study.

Adult↗