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Biomedical subjects

L Balducci

Publications and source records attributed to L Balducci.

At least 73 records · Page 4Linked to original sources

A cost analysis of hematopoietic colony-stimulating factors.

The administration of hematopoietic colony-stimulating factors (CSFs) to reduce the severity and duration of neutropenia associated with systemic chemotherapy has become widespread, although the appropriate use of these agents has not yet been fully defined. A cost model based on decision theory is presented for three therapeutic choices in these patients: no CSF, prophylactic CSF, and therapeutic CSF. Baseline probabilities were derived from a prospective, randomized, placebo-controlled trial of G-CSF in patients receiving systemic chemotherapy. Application of the model to institutionally generated cost figures provides comparative estimates of excess cost favoring the prophylactic use of CSFs. Model thresholds were calculated based on sensitivity analysis comparing no CSF to prophylactic CSF, and therapeutic CSF to prophylactic CSF. Guidelines are provided based on this model that are consistent with those adopted by the American Society of Clinical Oncology.

Antineoplastic Agents↗

The effect of changing disease risk on clinical reasoning.

OBJECTIVE: To assess the ability of health care professionals to evaluate the effect of clinical test results in different settings. DESIGN: Subjects were presented with a series of generic clinical scenarios in which information about the test performance and the pretest probability of disease was varied. The subject estimates of posttest probability were compared with those calculated on the basis of Bayes' theorem. PARTICIPANTS: Fifty health care professionals, including 31 physicians and 19 nonphysicians, associated with a university teaching hospital. MEASUREMENTS AND MAIN RESULTS: Under a variety of testing conditions, both the physicians and the nonphysicians inaccurately estimated the posttest probability of disease. Based on a logarithmic transformation, the error in probability estimation was divided into a portion related to the pretest probability of disease and a portion related to the test performance. Most of the error in posttest probability estimation was associated with the incorrect use of pretest probabilities. The subjects consistently overestimated the posttest probability of disease expected under Bayes' theorem, with increasing error associated with decreasing pretest probability. Physician estimates of posttest probability increased with increasing likelihood ratios for each scenario. Nonphysician estimates of posttest probabilities increased with increasing likelihood ratios for a positive test, but the estimates associated with a negative test result were inconsistent. CONCLUSIONS: Physicians and nonphysicians overestimate posttest probabilities with increasing error associated with decreasing disease risk. Some nonphysicians may not fully understand the effect of test performance on risk estimation, particularly in the setting of a negative test. Health care professionals should receive training in the proper evaluation of test information, with particular emphasis on the influence of pretest disease risk on the posttest probability of disease.

Bayes Theorem↗

Breast irradiation in the older woman: a toxicity study.

OBJECTIVE: To establish the tolerance of breast irradiation by women aged 65 and older. DESIGN: Retrospective chart review. PATIENTS AND SETTING: Women undergoing partial mastectomy and postoperative radiation therapy at the H. Lee Moffitt Cancer Center and Research Institute between 1986 and 1990. Of 163 women eligible for the study, 100 were under age 65, and 63 were aged 65-78. MEASUREMENTS: Comparison of total treatment dose, treatment duration, number of treatment interruptions, incidence of cutaneous, mucosal, and hematological toxicity between women aged 65 and older and women younger than age 65. MAIN RESULTS: All study measurements were comparable among younger and older women: total radiation dose (P = 0.5); treatment interruptions (P = 0.063); treatment duration (P = 0.78); cutaneous toxicity (P = 0.37); anemia (P = 0.83); leukopenia (P = 0.07), and thrombocytopenia (P = 0.94). There was no mucosal toxicity, nor higher than grade 2 hematological or cutaneous toxicity. The incidence and severity of toxicity was not higher for women aged 70 and older. CONCLUSIONS: Postoperative breast irradiation is well tolerated by older women. Age is not a contraindication to breast preservation.

Aged↗

Perspectives on quality of life of older patients with cancer.

Cancer in older people is an increasingly common problem. Since survival benefits may decline and the risks of treatment progressively increase with age, preservation and improvement of quality of life (QOL) is a major goal of geriatric oncology. The concept of health-related QOL holds that the preservation of health and physical function is necessary to the maintenance and improvement of QOL, and encompasses several constructs, including physical, functional, emotional, social, and spiritual domains. Several instruments for the assessment of QOL have been validated, but none has been calibrated to the special problems of older people. Such problems involve diverse evolution of health and disease around variable models, potential age-related shifts in values and focus, and barriers to the use of questionnaires, such as poor visual and auditory function, easy fatiguability, slower reactions and dementia. Individualised questionnaires may represent the ultimate goal in the assessment of QOL in the elderly. The assessment of QOL in general oncology has provided new and important information related to the value of breast preservation in the management of breast cancer, to the value of sexual function in the management of prostate cancer, and to the effects of limb amputation on QOL. Also, QOL at the beginning of treatment has independent prognostic implications. In geriatric oncology, assessment of QOL may allow trade-off between QOL and survival, and may determine the choice among alternative forms of life-prolonging and palliative treatments.

Aged↗

A Practical Approach to the Screening of Asymptomatic Older Persons for Cancer.

Secondary prevention of cancer is aimed at the individual in whom the disease has begun but symptoms have not yet appeared, in order to diagnose and treat early disease and/or prevent spread. Secondary prevention is a reasonable strategy for cancer control in the aged in whom primary prevention, aimed at the individual who has not yet developed the disease, may no longer be feasible. Screening the asymptomatic population at risk may be justified if it enables diagnosis at an asymptomatic or preclinical phase and if treatment at this stage leads to a longer life or reduced morbidity for those individuals whose disease is thereby detected.

Journal Article↗

Management of Cancer in the Older Aged Person.

The management of cancer in the older person is an increasingly common aspect of oncologic practice. The central questions concern effectiveness and safety of antineoplastic therapy, clinical criteria to identify patients who may benefit from treatment, and individualized management plans. To address these questions, we review the influence of age on various forms of cancer treatment, explore the basis of treatment-related decisions in older persons with cancer, and propose areas for future investigation. Age itself is not a contraindication to cancer treatment. Individualized treatment plans, based on appropriate diagnosis, staging and comprehensive geriatric assessment, are most beneficial to the older patients.

Journal Article↗

Secondary Prevention of Breast Cancer in the Older Woman: Issues Related to Screening.

With advancing age, the prevalence of breast cancer and consequently the positive predictive value of screening tests increase. However, limited life expectancy may reduce the benefit of cancer screening. The integration of serial mammography, yearly or every two years, with yearly physical examination of the breast, reduces the breast cancer related mortality among women aged 50 to 70 years and may be beneficial for older women. Of all age-related barriers to screening, the lack of physician support has been the most significant. A reversal in this trend was witnessed by a recent increase in mammography use by women aged 69 to 75 years. On the basis of existing data, it is reasonable to recommend screening for women up to age 75 years and for older women whose life-expectancy is estimated at three years or longer.

Journal Article↗

Breast Cancer in the Older Woman: Therapeutic Controversies.

This article reviews several controversial issues related to treatment of in situ, localized, locally advanced, and metastatic breast cancer in the elderly. In particular we examine the management of both ductal and lobular carcinoma in situ, the benefits of breast preservation, the indications for postoperative irradiation following partial mastectomy, the role of axillary lymphadenectomy in patients with a clinically normal axilla, and the value of systemic treatment for localized breast cancer. In addition, we review the indications for and duration of adjuvant hormonal treatment with tamoxifen and adjuvant cytotoxic chemotherapy, neoadjuvant systemic therapy for locally advanced breast cancer, and approaches to the palliation of metastatic disease.

Journal Article↗

Decision analysis of hematopoietic growth factor use in patients receiving cancer chemotherapy.

BACKGROUND: Hematopoietic growth factors (HGFs) have been shown to reduce the incidence of neutropenia and fever in patients receiving cancer chemotherapy. PURPOSE: This cost analysis was designed to determine the conditions in which use of HGFs in patients receiving cancer chemotherapy is cost-effective. METHODS: We used a standard model based on decision theory; the model assumes that all patients experiencing neutropenia and fever will be hospitalized and treated with intravenous antibiotics. Data from a prospective, randomized clinical trial of granulocyte colony-stimulating factor in small-cell lung cancer treated with combination chemotherapy were used to determine baseline probabilities for control hospitalization risk and survival; proportional hospitalization risk with prophylactic HGF; and median durations of hospitalization and prophylactic HGF use. The model was analyzed by one-way and multivariate sensitivity analyses, with estimation of threshold values at which the expected cost is the same for either of two treatment options. One or more of the specific costs and durations and the probability for each group of threshold curves were varied in a sensitivity analysis that generated variable thresholds. Use of Monte Carlo analysis based on the available distributions of the main variables provided 90% confidence limits and an inference method for comparing decision options. RESULTS: The expected excess cost per treatment cycle, based on hospitalization for neutropenic fever and/or HGF administration, was $5500 for no HGF, $4750 for prophylactic HGF, and $6875 for therapeutic HGF. Sensitivity analysis provided the following thresholds for no HGF versus prophylactic HGF: control risk of hospitalization, 0.40; risk of hospitalization with HGF as a proportion of control, 0.64; total daily cost of hospitalization, $727; total daily cost of HGF, $344; duration of hospitalization, 7.3 days; and duration of HGF use, 11.0 days. Multivariate analysis revealed that conditions favoring the use of HGF on a cost basis become greater (a) as risk of hospitalization, total daily hospital cost, and duration of hospitalization increase and (b) as the proportional risk of hospitalization with HGF, daily cost of HGF, and duration of HGF treatment decrease. CONCLUSIONS: The major determinants of total excess cost were the control risk of hospitalization, the proportional reduction in risk with HGF, and the average daily hospital cost. IMPLICATIONS: Use of HGFs should be based on the risk of hospitalization for neutropenic fever and consideration of the patient population and institutional costs.

Colony-Stimulating Factors↗

Breast cancer care in old age: what we know, don't know, and do.

In this review of current pertinent literature from the fields of cancer epidemiology, oncology, health services research, and geriatrics, we describe the epidemiology and unique features of breast cancer and its victims in old age. In addition, we review the current evidence regarding treatment efficacy (i.e., beneficial under ideal circumstances) and effectiveness (i.e., beneficial under usual circumstances) in relation to primary tumor management and the use of adjuvant therapy in early stage disease and outline the challenges associated with studying breast cancer care in older women (> or = 65 years of age). Comorbidity, impaired functional status, lack of social support, and differences in host physiology are among the many factors that influence treatment efficacy and effectiveness, making extrapolation of study findings from younger to older women questionable. Indeed, with the exception of studies of adjuvant tamoxifen therapy, none of the clinical trials supporting the 1990 National Institutes of Health Consensus Development Conference on Treatment of Early-Stage Breast Cancer guidelines have included women over the age of 70 years. Because (a) breast cancer is becoming increasingly common in old age and (b) health-related quality of life is frequently more important to older women than is risk of recurrence or death, all three aspects (surgical management of the primary tumor, postoperative irradiation, and axillary lymph node dissection) of recommended primary treatment deserve fresh scrutiny. The value of adjuvant chemotherapy has yet to be defined. Substantial variations in breast cancer diagnosis, treatment, and care exist, and these differences become greater with increasing age of the patient. However, evidence regarding the reasons for these variations and their relationships with subsequent outcomes is lacking. Challenges for investigators in studies of older women include recruitment into studies, collection of reliable data from interviews or surveys, measurement of disease severity and comorbidity, and selection of relevant outcomes. Given current uncertainty about optimal treatment, clinicians can best serve older patients with early stage breast cancer by involving them in decision-making, taking into account available efficacy data, and individualizing care on the basis of such factors as comorbidity, social support, functional status, and patient preferences for outcomes. Future studies of treatment efficacy in older women should examine the roles of radiation therapy and axillary lymph node dissection that follow breast-conserving therapy and should focus on quality of life in addition to recurrence and mortality. Less aggressive treatments, tamoxifen therapy, and adjuvant chemotherapy should also be evaluated.

Age Factors↗

Cost-effectiveness of white cell-reduction filters in treatment of adult acute myelogenous leukemia.

The objective of this study was to compare the cost and cost-effectiveness of three transfusion strategies in the treatment of acute myelogenous leukemia: 1) the use of unfiltered pooled platelets until alloimmunization developed and of crossmatch-compatible single-donor platelets thereafter; 2) the use of filtered blood components until alloimmunization occurred and of crossmatch-compatible single-donor platelets thereafter; and 3) the use of single-donor platelets from the beginning. The data sources were English language articles on transfusion medicine in acute leukemia and the management of acute leukemia and review of the transfusion experience at the H. Lee Moffitt Cancer Center. The method was decision analysis with a software program for cost-effectiveness, sensitivity analysis, threshold evaluation, and Monte Carlo sensitivity analysis. In the basic models, the total costs of the first, second, and third strategies are, respectively, $12,557.14, $11,406.17, and $13,016.16 without bone marrow transplant and $14,002.72, $12,281.89, and $13,727.48 with bone marrow transplant. The threshold between the first and second strategies in regard to risk of refractoriness to filtered blood components and pooled platelets was 0.30 and 0.27, respectively, without bone marrow transplant and 0.28 and 0.40 with bone marrow transplant. According to a Monte Carlo sensitivity analysis of 500 samples, the second strategy is more cost-effective than the first in 76 percent of cases. It is concluded that the use of filtered blood components is unlikely to increase the cost of treatment.

Blood Component Transfusion↗

Overestimation of test effects in clinical judgment.

The purpose of this study was to assess the ability of health care professionals to evaluate the effect of test results on disease risk. Fifty health care professionals, including 29 physicians and 21 nonphysicians, associated with a university hospital were studied. Subjects were presented with two hypothetical scenarios involving a common clinical situation to assess the effect of test results on the estimation of disease risk. Estimates of the pretest and posttest probability of breast cancer and mammography sensitivity and specificity were elicited for hypothetical 30- and 70-year-old patients presenting with a breast lump. There was no significant difference between physician and nonphysician probability and sensitivity estimates, although physicians provided higher specificity estimates which were more consistent with literature-derived values. Both physicians and nonphysicians consistently overestimated the risk associated with a positive test result compared to probabilities derived from Bayes' theorem based on the subject's pretest probability and sensitivity and specificity estimates, as well as standard test performance estimates. There was no significant difference between posttest probability estimates for negative test results and those derived from Bayes' theorem utilizing the subject's pretest probability and sensitivity and specificity estimates. Physicians and nonphysicians both estimate test performance characteristics accurately but consistently overestimate the effect of positive test results on the probability of disease. In addition to experience with specific clinical problems, decision making by clinicians could be enhanced by training in the formal methods of decision analysis.

Adult↗

Non-Hodgkin's lymphoma in the older person: a review.

OBJECTIVE: To study the epidemiology of non-Hodgkin's Lymphoma (NHL) in the older person and to explore treatment strategies for older persons with NHL. DESIGN: Review of the English literature. MEASUREMENTS: Incidence of NHL in patients of different ages; prevalence of NHL of different grades and stages in persons of different ages; and response to treatment, disease free survival, and survival, for patients of different ages. RESULTS: The incidence of NHL in the aged has increased approximately 80% since 1970, and approximately one-half of the 40,000 annual new cases occur in persons aged 60 and older in the USA. The 2-4 phenoxy pesticides may be partly responsible for this increment. The treatment of low grade lymphoma is mostly palliative and well tolerated by the aged. Age may have an adverse effect on the prognosis of intermediate grade lymphomas, and the prevalence of poor prognostic factors and comorbidity increases with age. Among persons aged 65-75, the complete response rate (CRR) of intermediate grade NHL to chemotherapy is approximately 50%, and approximately one-third of complete responders remain alive and free of disease 5 years from diagnosis. Among those aged 75 and older, the CRR to chemotherapy is approximately 40%, and the median duration of response is 16 months. Strategies aimed to ameliorate treatment-related toxicity include lower doses of chemotherapy, choice of drugs better tolerated by older individuals, and prevention of chemotherapy-induced toxicity. CONCLUSIONS: NHL are an increasingly common problem for older persons. Approximately 80% of older patients with low grade lymphomas and 40%-50% of those with intermediate grade lymphomas may benefit from chemotherapy. Individualized treatment, based on life expectancy and comorbidity, is the key to effective management.

2,4-Dichlorophenoxyacetic Acid↗

Recombinant hemopoietic growth factors: comparative hemopoietic response in younger and older subjects.

OBJECTIVE: To study the effectiveness of hemopoietic growth factors in older patients. DESIGN: Literature review. All articles published in English language between 1987 and 1990 were reviewed. Those reporting studies without age limits as entry criteria and describing the effects of growth factors in individual patients were suitable for analysis. Bone marrow transplantation related articles were excluded. MAIN OUTCOME MEASURES: The meanfold increase of granulocytes for Granulocyte-Colony Stimulating Factor, Granulocyte Macrophage-Colony Stimulating Factor, and Interleukin 3 and of hemoglobin for erythropoietin were compared in subjects younger and older than 65, by Mann-Whitney U test. RESULTS: Of 68 studies, 23 were suitable for analysis. These included patients with myelodysplastic syndromes, aplastic anemia, chemotherapy-induced myelosuppression, chronic granulocytopenia, anemia, and myelosuppression of malignancies and of chronic disease. Of 204 patients, 67 were 65 years of age or older and 42 were over 70. No difference was seen in meanfold increase of granulocyte and hemoglobin in time of response to growth factors or in response in presence of an absolute neutrophil count lower than 1000/microliters between younger and older patients. CONCLUSION: Early response to hemopoietic growth factors appears well maintained with advanced age. Prospective studies of the prolonged effects of these factors in older and younger patients are needed.

Aged↗