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Biomedical subjects

M Feldstein

Publications and source records attributed to M Feldstein.

At least 19 recordsLinked to original sources
PubMed1998

Open-label phase I study of combination therapy with zidovudine and interferon-beta in patients with AIDS-related Kaposi's sarcoma: AIDS Clinical Trials Group Protocol 057.

The aim of this study was to identify a safe and tolerable dose of recombinant interferon-beta (IFN-beta) used in conjunction with a fixed dose of zidovudine in patients with early-stage, good-prognosis AIDS-related Kaposi's sarcoma. We conducted a phase I, dose-escalation controlled trial of 22.5, 45 of 90 million units of IFN-beta given by daily subcutaneous injection with 500 mg per day of oral zidovudine. At the time of this study, this was standard of care for HIV infection. Patients were sequentially enrolled at three medical centers. Tumor response, drug tolerance, antiviral studies and CD4 changes were assessed. Four patients were enrolled at each dose level, and escalation proceeded when at least four patients had tolerated two weeks of therapy without dose-limiting toxicity. ACTG Kaposi's sarcoma tumor response criteria were used to assess response. Fifteen patients were enrolled. The combination of IFN-beta and zidovudine was well tolerated, and the dose-limiting toxicities were local skin necrosis and systemic symptoms. Despite generally good prognostic characteristics, only two patients achieved a clinical complete response and three addition patients had stable disease for a prolonged period of time (range 24-44 weeks). There was no correlation between baseline CD4 cell counts and tumor response, nor between the antiviral effect of IFN-beta as measured by decreases in immune-complex dissociated p24 antigen and tumor response. Higher doses of IFN-beta did not result in more tumor responses or in greater antiviral activity. The maximum tolerated dose of IFN-beta in combination with 500 mg per day of zidovudine was 45 million units by subcutaneous injection per day. IFN-beta is well tolerated in patients with AIDS-related Kaposi's sarcoma when used in conjunction with zidovudine. However, the antitumor response rate in good-prognosis patients is low. Further studies of this agent should be in the context of four-drug antiretroviral regimens where viral suppression is greatest and any antitumor activity of IFN-beta may be observed.

Anti-HIV Agents↗
PubMed1994

Phase I AIDS Clinical Trials Group (075) study of adriamycin, bleomycin and vincristine chemotherapy with zidovudine in the treatment of AIDS-related Kaposi's sarcoma.

OBJECTIVE: To determine the toxicity and maximum tolerated dose of doxorubicin (adriamycin) in combination with fixed doses of bleomycin, vincristine (ABV) and zidovudine in patients with advanced AIDS-related Kaposi's sarcoma. PATIENTS AND METHODS: Twenty-six HIV-seropositive men with Kaposi's sarcoma were treated daily with 100 mg zidovudine orally every 4 h, along with combination chemotherapy using bleomycin 10 U/m2 and vincristine 1.4 mg/m2 (maximum, 2 mg) given intravenously in 2-week cycles. In addition, three successive cohorts of eight patients received escalating doses of doxorubicin each beginning with no doxorubicin (level I), doses of 10 mg/m2 (level II), and 15 mg/m2 (level III). RESULTS: The major dose-limiting toxicity experienced with the combination therapy was severe neutropenia in eight patients, four of whom received level III doxorubicin (15 mg/m2). Therefore, 10 mg/m2 of doxorubicin in combination with zidovudine and BV chemotherapy was defined as the maximum tolerated dose. Other dose-limiting toxicities included neuropathy (n = 2), cutaneous toxicity associated with bleomycin (n = 1), and diarrhea (n = 1). Seventeen patients (71%; 95% confidence interval, 46-85) experienced either partial (n = 13) or clinical complete remission (n = 4) to therapy after a median of five cycles (range, 2-9). CONCLUSION: The maximum tolerated dose of doxorubicin is 10 mg/m2 when given in combination with zidovudine and BV chemotherapy. Response rates observed with the combined antiretroviral and chemotherapy regimen are similar to those previously reported with ABV chemotherapy alone.

Acquired Immunodeficiency Syndrome↗
PubMed1992

Increasing radiation dose intensity using hyperfractionation in patients with malignant glioma. Final report of a prospective phase I-II dose response study.

We attempted to show a dose effect relationship for radiation therapy by treating patients harbouring malignant glioma with increasing doses of radiation in a step-wise fashion. We postulated that no increase in delayed toxicity would be seen because we used hyperfractionation technique. Between January 1981 and December 1988 we treated 280 patients three times daily at 4 hour intervals. 100 patients received a total dose of 6141 cGy, 73 patients received 7120 cGy, and 107 patients received 8000 cGy. CCNU was given at the time of tumor progression following radiotherapy. Median time to tumor progression was 28 weeks for patients who received 6141 cGy, 27 weeks for patients who received 7120 cGy and 36 weeks for patients who received 8000 cGy. Median survival was 46 weeks for patients who received 6141 cGy, 38 weeks for patients who received 7120 cGy and 45 weeks for patients who received 8000 cGy. There was no statistically significant difference in either time to tumor progression or survival among the three treatment arms and no dose response effect was seen. There was no increase in delayed radiation toxicity when the total radiation dose was increased up to 8000 cGy.

Adolescent↗
PubMed1991

Quality of life research in oncology. Past achievements and future priorities.

The status of quality of life research in oncology is assessed, and priorities for future research with regard to conceptual and theoretical developments, focus and content of research, research designs and practical strategies for research implementation, and transferring information to clinical practice and medical policy decision-making are identified. There is general agreement that quality of life is a subjective and multidimensional construct, yet comprehensive theoretical models have not been developed and applied fully. We recommend that future research be based on conceptual models that explicate the interrelationships among quality of life domains throughout the stages of cancer care. These models, and the longitudinal research that follows from them, should attend specifically to cross-class and cross-cultural issues to avoid overgeneralization from theory and research that are based largely on the views of the majority culture. We encourage the inclusion of this theory-based quality of life assessment as a standard component of clinical trials. Success in this endeavor will require additional standardization of quality of life measures for use across a range of cancer patient populations, including the development of age-specific norms and instruments designed to assess the entire family system.

Humans↗
PubMed1991

A randomized clinical trial of alprazolam versus progressive muscle relaxation in cancer patients with anxiety and depressive symptoms.

A randomized nonblinded study was performed in three cancer centers to test over a 10-day period the efficacy of (1) a triazolobenzodiazepine, alprazolam, 0.5 mg three times a day and (2) use of a behavioral technique in which patients were trained in progressive muscle relaxation at an initial session with a behavioral psychologist and then asked to listen at home to an audiotape of the session three times a day. Of 147 cancer patients who met entry levels of distress and completed the study, uncontrolled for site or disease stage, 70 were randomized to drug, 77 to relaxation. Four measures of anxiety and depression were used: Covi, Raskin, Affects Balance, and Symptoms Checklist-90 (SCL-90). Results showed that both treatment arms resulted in significant (P less than .001) decrease in observer and patient-reported anxious and depressed mood symptoms. Although both treatment arms were effective, patients receiving the drug showed a slightly more rapid decrease in anxiety and greater reduction of depressive symptoms. These findings confirm efficacy of both alprazolam and relaxation to reduce cancer-related anxiety and depression. As safe, inexpensive, and effective interventions, physicians should consider their use in cancer patients experiencing anxiety and depressive symptoms.

Adult↗
PubMed1990

Consultative geriatric assessment for ambulatory patients. A randomized trial in a health maintenance organization.

Previous studies have shown that comprehensive geriatric assessment and follow-up can improve the health of hospitalized elderly patients. To evaluate the effectiveness of consultative geriatric assessment and limited follow-up for ambulatory patients, we randomized 600 elderly patients who were enrolled in a health maintenance organization into three groups: (1) consultation by a geriatric assessment team, (2) consultation by a "second opinion" internist, and (3) only traditional health maintenance organization services (control patients). The geriatric assessment team identified previously unrecognized problems in 35% of patients and advised changes in medication regimens for more than 40%. Nevertheless, patients who received assessment achieved only a small benefit in cognitive function after 3 months, which was not sustained for 1 year. There was no difference among groups in other measures of health status. Consultative geriatric assessment with limited follow-up did not benefit most older ambulatory patients in a health maintenance organization; if such care can be used effectively for ambulatory patients, it will require either additional targeting or continuing care or both.

Aged↗
PubMed1990

Patient activity and outcome in group psychotherapy: new findings.

The relation of patient verbal activity to pretherapy symptom status and outcome was examined for ninety patients in time-limited group psychotherapy. For each half-hour segment the most verbally active member, or main actor (MA), was identified. Verbal activity was measured by counting the number of times each patient was MA during the course of the group. Outcome was assessed by administering a battery of instruments pre- and posttherapy and by obtaining direct ratings of patient benefit from the patient, therapist, and an independent rater: the number of times MA was found to be significantly correlated with four pretherapy measures, indicating that the most disturbed patients were most active in these groups; the number of times MA was also correlated with patient and therapist benefit ratings, indicating that therapists and patients themselves agreed that those who spoke the most benefited the most. However, partial correlations between number of times MA and other outcome measures did not produce any significant relationships. Thus, it does not appear that patient verbal activity is related to outcome, as measured by objective instruments.

Adaptation, Psychological↗
PubMed1990

Older patients' health status and satisfaction with medical care in an HMO population.

Few studies have examined the relationship between older patients' satisfaction with medical care and their health status, and none of these investigations has been based at an HMO. To examine this question, data on 532 patients older than 70 years in an HMO were analyzed. Patients' reports of satisfaction with medical care were examined in relation to several dimensions of health status (based on self-reports, chart data, and physicians' ratings), their own sociodemographic characteristics, and characteristics of their primary physicians. Greater satisfaction was significantly associated with better self-rated health and physical function, less emotional distress, and more social activity but was not related to physicians' health ratings, number of diagnoses, or cognitive function. Mean levels of satisfaction were also significantly different for patients of different physicians but not appreciably related to patients' sociodemographic characteristics. When patient sociodemographic characteristics were controlled for, the relations of health status variables to satisfaction were essentially unchanged. It was concluded that the key issues to be resolved are whether better health leads to greater satisfaction or vice versa, and, in either case, whether the relations are mediated by factors relating to the patient's experience of medical care.

Aged↗
PubMed1989

Perceptions of control, competence, and contingency as influences on the stress-behavior symptom relation in school-age children.

Analyzed data from 154 school-age children and their mothers to examine the relations between stress, perceived competence and contingency, and behavior symptoms. Analyses focused on the relative merits of unidimensional vs multidimensional measures of control in predicting symptoms. The stress of undesirable life events and behavior symptoms were related in the expected direction. Multiple regression models with R2 ranging from .11 to .14 (all ps less than .0002) included significant main effects for stress, competence, and control. Analyses supported the relative superiority of the multidimensional measure of control. Models containing main effects and interaction terms were of equivalent magnitudes in accounting for variance in symptom scores. Findings support the idea of perceived control as a moderator of the stress-illness relation and are consistent with earlier suggestions that simple main effects models may be the most useful in examining these relations.

Achievement↗
PubMed1989

Cohesion, alliance and outcome in group psychotherapy.

Cohesiveness has been viewed as the group psychotherapy equivalent of the therapeutic alliance in individual treatment. Although researchers have attempted to study the concept of cohesion in group treatment, understanding of this so-called "curative" group factor remains quite primitive. In this study of 12 time-limited psychotherapy groups, with a total of 90 nonpsychotic outpatients, we explore the relationships between cohesion, alliance and treatment outcome. Our cohesion measure is a new instrument, the Harvard Community Health Plan Group Cohesiveness Scale, developed for use with group therapy videotapes. To measure alliance we have modified the Penn Helping Alliance Scale (Group Alliance Scale) to be scored from videotapes of group sessions. Both of these instruments use trained observers to make ratings for the group-as-a-whole. The outcome battery for patients in these groups included a widely varied set of measures, enabling us to view change from a number of perspectives. Our findings indicate that cohesion and alliance as measured here are related concepts. We also find that both cohesion and alliance appear to have strong relationships with improved self-esteem and reduced symptomatology for patients in these groups. In addition, it appears that outcome is most related to cohesion in the first 30 minutes of a group session. Implications of these and other findings are discussed.

Adult↗
PubMed1989

No clinical effect of back schools in an HMO. A randomized prospective trial.

In a prospective trial, 222 adults with low-back pain of at least 2 weeks' duration in a Health Maintenance Organization (HMO) were randomly assigned to usual care (UC), a 4-hour back school psychoeducational session (LBS), or the same back school plus a 1-year "compliance package" program designed to encourage appropriate self-management for back pain (CP). Sixty-four percent of LBS and CP subjects attended their back school sessions. Follow-up measurement of pain level (using the Visual Analogue Scale), functional status (using the Sickness Impact Profile), and various other indicators of health status showed no measurable effect of either treatment condition (LBS or CP) compared with UC at 3, 6, 12, and 18 months after entry into the study. Initial disability resolved by 3 months in most patients, and a minority of subjects (10-15%) showed residual or recurrent functional impairment 1 year after entry. Health care utilization tended to be slightly higher after intervention in the CP group. With or without follow-up encouragement, back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO.

Adult↗
PubMed1989

Double-blind study of true vs. sham plasma exchange in patients treated with immunosuppression for acute attacks of multiple sclerosis.

We enrolled 116 patients in a multicenter, randomized, double-blind controlled trial of an 8-week course of 11 plasma exchange (PE) treatments in exacerbations of MS. The control group received sham PE, and both groups received identical treatment with IM ACTH and oral cyclophosphamide. Serum IgG decreased in the PE and sham treatment groups by 76% versus 22% by treatment 5, and by 64% versus 14% by treatment 11. PE also produced significant reductions in IgA, IgM, C3, and fibrinogen. PE patients had moderately enhanced improvement at 2 weeks relative to the sham group. PE patients with relapsing/remitting disease had significantly enhanced improvement at 4 weeks and there was also an increased improvement at 12 months, although this latter effect disappeared when we analyzed relapsing/remitting patients as a separate subgroup. Life table analysis showed the median time to recover preattack disability status was shorter in PE- than in sham-treated relapsing/remitting patients (4 vs. 13 weeks), a result confirmed by raw disability status scores in which there was recovery to their average preattack disability score by 3 months. PE given with ACTH plus cyclophosphamide enhances recovery from an exacerbation of disease in relapsing/remitting patients, although we observed no clear long-term benefits.

Acute Disease↗