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1.
Ir Med J ; 107(9): 295-6, 2014 Oct.
Article in English | MEDLINE | ID: mdl-25417393

ABSTRACT

Securing a place in medical school is extremely difficult-students who are successful all have similar high levels of academic achievement. So why do some students, and not others, have difficulty with the course, and in some cases, leave the programme? Studies on medical school attrition offer valuable insight into why medical students under-perform. Identification of the 'at-risk' student can trigger additional support and early remediation, helping some students remain in their chosen profession.


Subject(s)
Needs Assessment , Student Dropouts , Students, Medical , Adaptation, Psychological , Aptitude , Humans , Risk , Social Support , Student Dropouts/psychology , Student Dropouts/statistics & numerical data , Students, Medical/psychology , Students, Medical/statistics & numerical data , Underachievement
2.
J Public Health Manag Pract ; 16(5 Suppl): S11-20, 2010.
Article in English | MEDLINE | ID: mdl-20689369

ABSTRACT

Subject matter experts systematically reviewed evidence on the effectiveness of housing interventions that affect health outcomes, primarily asthma, associated with exposure to moisture, mold, and allergens. Three of the 11 interventions reviewed had sufficient evidence for implementation: multifaceted, in-home, tailored interventions for reducing asthma morbidity; integrated pest management to reduce cockroach allergen; and combined elimination of moisture intrusion and leaks and removal of moldy items to reduce mold and respiratory symptoms. Four interventions needed more field evaluation, 1 needed formative research, and 3 either had no evidence of effectiveness or were ineffective. The 3 interventions with sufficient evidence all applied multiple, integrated strategies. This evidence review shows that selected interventions that improve housing conditions will reduce morbidity from asthma and respiratory allergies.


Subject(s)
Asthma/prevention & control , Environmental Exposure/prevention & control , Housing , Air Pollution, Indoor/adverse effects , Air Pollution, Indoor/prevention & control , Allergens/adverse effects , Asthma/etiology , Bacteria/growth & development , Environmental Exposure/adverse effects , Evidence-Based Medicine , Humans
3.
Prev Chronic Dis ; 6(4): A129, 2009 Oct.
Article in English | MEDLINE | ID: mdl-19755005

ABSTRACT

BACKGROUND: Thirteen percent of Latinos in Massachusetts lack health insurance, the highest rate of any ethnic or racial group. Families without health insurance are more likely to be in poor or fair health, to lack a regular medical provider, and to not have visited a medical provider in the past year. CONTEXT: The Latino Health Insurance Program is designed as a response both to the high rate of uninsurance among Latinos in Boston and to the multiple obstacles that keep Latino parents from applying for insurance for their families. METHODS: In 2006, we designed and implemented a culturally competent model of health insurance outreach, education, enrollment and maintenance, and referral for primary care and social services for Latino families. CONSEQUENCES: Year 1 results of the Latino Health Insurance Program are promising. Six community members were hired and trained as case managers. A total of 230 children and adults were enrolled or re-enrolled in health insurance programs and received other needed services. Retention was near 100% after 1 year. INTERPRETATION: The Latino Health Insurance Program may serve as a model health insurance access program that can be adapted by community-based organizations and also can be incorporated into public agency programs for Latinos and other immigrant and minority groups. The program continues to serve East Boston residents and was expanded in 2008.


Subject(s)
Hispanic or Latino/psychology , Insurance, Health/organization & administration , Boston , Community Health Planning , Culture , Emigrants and Immigrants , Employment , Health Services Accessibility , Humans , Medically Uninsured/ethnology , Pilot Projects , Socioeconomic Factors
4.
Int J Soil Sediment Water ; 2(3)2009 Jan 01.
Article in English | MEDLINE | ID: mdl-21804925

ABSTRACT

Urban community gardens worldwide provide significant health benefits to those gardening and consuming fresh produce from them. Urban gardens are most often placed in locations and on land in which soil contaminants reflect past practices and often contain elevated levels of metals and organic contaminants. Garden plot dividers made from either railroad ties or chromated copper arsenate (CCA) pressure treated lumber contribute to the soil contamination and provide a continuous source of contaminants. Elevated levels of polycyclic aromatic hydrocarbons (PAHs) derived from railroad ties and arsenic from CCA pressure treated lumber are present in the gardens studied. Using a representative garden, we 1) determined the nature and extent of urban community garden soil contaminated with PAHs and arsenic by garden timbers; 2) designed a remediation plan, based on our sampling results, with our community partner guided by public health criteria, local regulation, affordability, and replicability; 3) determined the safety and advisability of adding city compost to Boston community gardens as a soil amendment; and 4) made recommendations for community gardeners regarding healthful gardening practices. This is the first study of its kind that looks at contaminants other than lead in urban garden soil and that evaluates the effect on select soil contaminants of adding city compost to community garden soil.

5.
J Air Waste Manag Assoc ; 58(10): 1297-302, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18939776

ABSTRACT

Many units in public housing or other low-income urban dwellings may have elevated pesticide residues, given recurring infestation, but it would be logistically and economically infeasible to sample a large number of units to identify highly exposed households to design interventions. Within this study, our aim was to devise a low-cost approach to identify homes in public housing with high levels of pesticide residues, using information that would allow the housing authority and residents to determine optimal strategies to reduce household exposures. As part of the Healthy Public Housing Initiative, we collected environmental samples from 42 public housing apartments in Boston, MA, in 2002 and 2003 and gathered housing characteristics; for example, household demographics and self-reported pesticide use information, considering information available with and without a home visit. Focusing on five organophosphate and pyrethroid pesticides, we used classification and regression tree analysis (CART) to disaggregate the pesticide concentration data into homogenous subsamples according to housing characteristics, which allowed us to identify households and associated networks impacted by the mismanagement of pesticides. The CART analysis demonstrated reasonable sensitivity and specificity given more extensive household information but generally poor performance using only information available without a home visit. Apartments with high concentrations of cyfluthrin, a pyrethroid of interest given that it is a restricted use pesticide, were more likely to be associated with Hispanic residents who resided in their current apartment for more than 5 yr, consistent with documented pesticide usage patterns. We conclude that using CART as an exploratory technique to better understand the home characteristics associated with elevated pesticide levels may be a viable approach for risk management in large multiunit housing developments.


Subject(s)
Air Pollution, Indoor/adverse effects , Air Pollution, Indoor/analysis , Pesticide Residues/adverse effects , Pesticide Residues/analysis , Pesticides/adverse effects , Pesticides/analysis , Adolescent , Animals , Child , Child, Preschool , Cockroaches , Ethnicity , Female , Humans , Insect Control , Male , Regression Analysis
6.
Environ Health ; 5: 25, 2006 Sep 18.
Article in English | MEDLINE | ID: mdl-16981988

ABSTRACT

Persistent trends in overweight and obesity have resulted in a rapid research effort focused on built environment, physical activity, and overweight. Much of the focus of this research has been on the design and form of suburbs. It suggests that several features of the suburban built environment such as low densities, poor street connectivity and the lack of sidewalks are associated with decreased physical activity and an increased risk of being overweight. But compared to suburban residents, inner city populations have higher rates of obesity and inactivity despite living in neighborhoods that are dense, have excellent street connectivity and who's streets are almost universally lined with sidewalks. We suggest that the reasons for this apparent paradox are rooted in the complex interaction of land use, infrastructure and social factors affecting inner city populations. Sometimes seemingly similar features are the result of very different processes, necessitating different policy responses to meet these challenges. For example, in suburbs, lower densities can result from government decision making that leads to restrictive zoning and land use issues. In the inner city, densities may be lowered because of abandonment and disinvestment. In the suburbs, changes in land use regulations could result in a healthier built environment. In inner cities, increasing densities will depend on reversing economic trends and investment decisions that have systematically resulted in distressed housing, abandoned buildings and vacant lots. These varying issues need to be further studied in the context of the totality of urban environments, incorporating what has been learned from other disciplines, such as economics and sociology, as well as highlighting some of the more successful inner city policy interventions, which may provide examples for communities working to improve their health. Certain disparities among urban and suburban populations in obesity and overweight, physical activity and research focus have emerged that are timely to address. Comparable research on the relationship of built environment and health is needed for urban, especially inner city, neighborhoods.


Subject(s)
Cities , Environment Design , Obesity , Physical Fitness , Population Density , Public Health , Exercise , Facility Design and Construction , Humans , Public Policy , Research/trends , Social Environment , Urban Population , Walking
7.
J Asthma ; 43(5): 335-43, 2006.
Article in English | MEDLINE | ID: mdl-16801137

ABSTRACT

In an environmental intervention study in public housing, we examined monthly Juniper Paediatric Asthma Quality of Life (QOL) Questionnaires for 51 children. Longitudinal analysis and spline models were used to identify time periods with significant improvements in QOL to inform judgments about causality. We found significant improvements in QOL, with moderate improvements before environmental interventions, increased rates of improvement immediately after, and reduced rates more than 5 months post-intervention. Effect modification analyses identified high-risk subpopulations and emphasized the importance of environmental, social, and economic conditions. Our results demonstrate the value of longitudinal techniques in evaluating the benefits of environmental interventions for asthma.


Subject(s)
Asthma/etiology , Asthma/prevention & control , Environmental Exposure/adverse effects , Public Housing , Quality of Life , Urban Health , Adolescent , Animals , Asthma/immunology , Beds , Child , Child, Preschool , Cockroaches/immunology , Female , Health Education/methods , Humans , Longitudinal Studies , Male , Pest Control , Pyroglyphidae/immunology , Risk Factors , Socioeconomic Factors
8.
Environ Health ; 3(1): 13, 2004 Dec 07.
Article in English | MEDLINE | ID: mdl-15585065

ABSTRACT

BACKGROUND: Children in urban public housing are at high risk for asthma, given elevated environmental and social exposures and suboptimal medical care. For a multifactorial disease like asthma, design of intervention studies can be influenced by the relative prevalence of key risk factors. To better understand risk factors for asthma morbidity in the context of an environmental intervention study, we conducted a detailed baseline evaluation of 78 children (aged 4-17 years) from three public housing developments in Boston. METHODS: Asthmatic children and their caregivers were recruited between April 2002 and January 2003. We conducted intake interviews that captured a detailed family and medical history, including questions regarding asthma symptom severity, access to health care, medication usage, and psychological stress. Quality of life was evaluated for both the child and caregiver with an asthma-specific scale. Pulmonary function was measured with a portable spirometer, and allergy testing for common indoor and outdoor allergens was conducted with skin testing using the prick puncture method. Exploratory linear and logistic regression models evaluating predictors of respiratory symptoms, quality of life, and pulmonary function were conducted using SAS. RESULTS: We found high rates of obesity (56%) and allergies to indoor contaminants such as cockroaches (59%) and dust mites (59%). Only 36% of children with persistent asthma reported being prescribed any daily controller medication, and most did not have an asthma action plan or a peak flow meter. One-time lung function measures were poorly correlated with respiratory symptoms or quality of life, which were significantly correlated with each other. In multivariate regression models, household size, body mass index, and environmental tobacco smoke exposure were positively associated with respiratory symptom severity (p < 0.10). Symptom severity was negatively associated with asthma-related quality of life for the child and the caregiver, with caregiver (but not child) quality of life significantly influenced by caregiver stress and whether the child was in the intensive care unit at birth. CONCLUSION: Given the elevated prevalence of multiple risk factors, coordinated improvements in the social environment, the built environment, and in medical management would likely yield the greatest health benefits in this high-risk population.


Subject(s)
Air Pollution, Indoor/analysis , Asthma/epidemiology , Caregivers/psychology , Public Housing , Quality of Life , Adolescent , Air Pollution, Indoor/adverse effects , Antigens, Dermatophagoides , Asthma/drug therapy , Asthma/physiopathology , Boston/epidemiology , Case-Control Studies , Child , Child, Preschool , Health Services Accessibility , Humans , Obesity/epidemiology , Regression Analysis , Respiratory Function Tests , Risk Factors , Stress, Psychological/epidemiology , Surveys and Questionnaires
9.
Pediatr Ann ; 33(7): 474-81, 2004 Jul.
Article in English | MEDLINE | ID: mdl-15298313

ABSTRACT

Housing hazards contribute to considerable morbidity and mortality among millions of children each year in the US, but few interventions are proven to control asthma and lead poisoning. Moreover, there is little evidence that many of the current recommendations to control residential hazards are safe and efficacious. The only interventions that have been found to work consistently are home visitation programs and home modification, such as installment of window guards and carpet removal. Altering the environment to protect the health of children requires pediatrician intervention. New models of cooperation between pediatricians and public health agencies must deal with residential hazards in an integrated manner and cannot be focused on one disease process or one method at a time. With research in more effective environmental interventions and pediatric-public-health partnerships, primary and secondary prevention of diseases from residential hazards may become a reality in the future.


Subject(s)
Child Welfare , Environmental Illness/prevention & control , Housing , Accidents, Home/prevention & control , Asthma/prevention & control , Bedding and Linens , Child , Environmental Health , Environmental Illness/etiology , Humans , Lead Poisoning/prevention & control , Pyroglyphidae
10.
Rev Environ Health ; 19(3-4): 271-89, 2004.
Article in English | MEDLINE | ID: mdl-15742674

ABSTRACT

The self-reported prevalence of asthma in the United States increased by 75% from 1980 to 1994, a trend found to be significant and evident in every region of the country. The increase was most marked in children from birth to 14 years of age; and growing evidence indicates that, as with lead poisoning, inner-city and urban populations are most at risk. Attention has turned to the role of indoor environmental risk factors, especially in homes and schools. Such factors include moisture and mold growth, pest infestation, dust mites, the building envelope, heating systems, inadequate ventilation, nitrogen dioxide, and environmental tobacco smoke. The Healthy Public Housing Initiative (HPHI) is a Boston-based community-centered research and intervention project designed to engage Boston Housing Authority residents in a collaborative process to improve respiratory health, quality of life, building conditions, and building maintenance in public housing. This article summarizes the significant research findings from four pilot studies in housing developments that laid the foundation for the larger HPHI asthma-related environmental intervention study. The research design for the pilot projects is informed by principles of community-collaborative research. The strengths of this model of research for our work are also discussed.


Subject(s)
Air Pollution, Indoor/adverse effects , Air Pollution, Indoor/analysis , Housing/standards , Public Sector , Respiratory Tract Diseases/etiology , Respiratory Tract Diseases/prevention & control , Asthma/etiology , Asthma/prevention & control , Boston , Community-Institutional Relations , Conservation of Energy Resources , Humans , Interinstitutional Relations , Poverty , Program Development , Quality of Life , Risk Factors
11.
Urban Aff Rev Thousand Oaks Calif ; 38(3): 325-355, 2003 Jan 01.
Article in English | MEDLINE | ID: mdl-16990927

ABSTRACT

Although sprawl is a growing national debate, there have been few efforts to measure or monitor changes in degree of sprawl over time. By using a methodology that employs census data, this sprawl index allows computation of levels of sprawl and examination of temporal and geographic changes. The results show that sprawl has increased over the past decade in many metropolitan areas. There are important geographic variations in sprawl, implying that it is neither inevitable nor universal.

12.
J Public Health Policy ; 24(3-4): 401-26, 2003.
Article in English | MEDLINE | ID: mdl-15015872

ABSTRACT

The self-reported prevalence of asthma increased by 75% from 1980 to 1994, a trend found to be significant and evident in every region of the country. The increase has been most marked in children 0-14 years of age, and there is evidence that, as with lead poisoning, inner-city and urban populations are most at risk. Attention has turned to the role of indoor environment risk factors, especially in homes and schools. Such factors include moisture and mold growth, pest infestation, dust mites, the building envelope, heating systems, inadequate ventilation, NO2, and environmental tobacco smoke. The Healthy Public Housing Initiative (HPHI) is a Boston-based community-centered research and intervention project designed to engage Boston Housing Authority residents in a collaborative process to improve respiratory health, quality of life, building conditions, and building maintenance in public housing. This article summarizes the significant research findings from four pilot studies in housing developments that lay the foundation for the larger HPHI asthma-related environmental intervention study. The research design for the pilot projects is informed by principles of community-collaborative research. The strengths of this model of research to our work are also discussed.


Subject(s)
Health Status Indicators , Humidity , Public Housing , Respiratory Tract Diseases/epidemiology , Adolescent , Air Pollution, Indoor , Boston/epidemiology , Child , Child, Preschool , Humans , Infant , Infant, Newborn , Pilot Projects , Public Health , Respiratory Tract Diseases/etiology , Urban Population
13.
New Solut ; 12(4): 319-34, 2002.
Article in English | MEDLINE | ID: mdl-17208776

ABSTRACT

Forty years ago, in the enormously praised and fiercely criticized book, "Silent Spring", Rachel Carson demonstrated the dangers of pesticides to humans and ecosystems and called for precaution in their use. Yet, the majority of environmental regulations passed since 1962 have primarily addressed pollutant discharge rather than cleaner products and technologies. The number of active ingredients in pesticides used in the United States has risen from 32 in 1939 to 860 in recent times, while the overall volume of agrochemicals applied has nearly doubled since the publication of Silent Spring. The last 40 years have brought significant changes with respect to environmental policies, agricultural technologies, urbanization, civil rights, women's rights, the roles of non-profit organizations and community development, and increased poverty, hunger, and economic inequality. In recent years, new voices, new analyses, and new movements have emerged offering fresh perspectives on how we can answer Carson's clarion call to protect our planet and ourselves.

14.
Blood ; 98(12): 3212-20, 2001 Dec 01.
Article in English | MEDLINE | ID: mdl-11719356

ABSTRACT

Cyclosporine A (CsA) inhibits P-glycoprotein (Pgp)-mediated cellular export of anthracyclines at clinically achievable concentrations. This randomized controlled trial was performed to test the benefit of CsA addition to treatment with cytarabine and daunorubicin (DNR) in patients with poor-risk acute myeloid leukemia (AML). A total of 226 patients were randomly assigned to sequential treatment with cytarabine and infusional DNR with or without intravenous CsA. Remitting patients received one course of consolidation chemotherapy that included DNR with or without CsA as assigned during induction. Addition of CsA significantly reduced the frequency of resistance to induction chemotherapy (31% versus 47%, P =.0077). Whereas the rate of complete remission was not significantly improved (39% versus 33%, P =.14), relapse-free survival (34% versus 9% at 2 years, P =.031) and overall survival (22% versus 12%, P =.046) were significantly increased with CsA. The effect of CsA on survival was greatest in patients with moderate or bright Pgp expression (median 12 months with CsA versus 4 months for controls) compared to patients with absent or low Pgp expression (median 6 months in both arms). The frequency of induction deaths was 15% with CsA and 18% in controls. Steady-state serum concentrations of DNR (P =.0089) and daunorubicinol (P <.0001) were significantly higher in CsA-treated patients. Survival (P =.0003) and induction response (P =.028) improved with increasing DNR concentration in CsA-treated patients but not in controls, suggesting a targeted interaction by CsA to enhance anthracycline cytotoxicity. These results indicate that addition of CsA to an induction and consolidation regimen containing infusional DNR significantly reduces resistance to DNR, prolongs the duration of remission, and improves overall survival in patients with poor-risk AML.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cyclosporine/therapeutic use , Drug Resistance, Neoplasm , Leukemia, Myeloid, Acute/drug therapy , ATP Binding Cassette Transporter, Subfamily B, Member 1/analysis , ATP Binding Cassette Transporter, Subfamily B, Member 1/genetics , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Cytarabine/administration & dosage , Cytarabine/adverse effects , Cytarabine/therapeutic use , Cytogenetic Analysis , Daunorubicin/administration & dosage , Daunorubicin/adverse effects , Daunorubicin/therapeutic use , Disease-Free Survival , Drug Interactions , Gene Expression , Humans , Leukemia, Myeloid, Acute/genetics , Leukemia, Myeloid, Acute/mortality , Male , Middle Aged , Remission Induction , Risk Factors
15.
J Urban Health ; 78(1): 199-211, 2001 Mar.
Article in English | MEDLINE | ID: mdl-11368198

ABSTRACT

Despite a general reduction in blood lead levels in children after lead was banned in gasoline and paint, lead poisoning remains an important health problem in many older urban areas. One factor that increases risk in these places is the high levels of lead in certain residential areas. A major intervention study found that reducing lead levels in urban soils results in a reduction in exposed children's blood lead levels. Removing lead from inner-city soils or reducing exposures to lead-contaminated soils typically is expensive, technologically challenging, or beyond the ability of low-income households to undertake. This project, in conjunction with residents and community-based institutions, developed a series of in situ, low-cost, low-technology measures that worked to reduce the exposure to lead-contaminated soils in one Boston, Massachusetts, neighborhood. The project demonstrated several important results. Government, universities, residents, and community based organizations can work together effectively to reduce exposures to lead in soil. Lead-contaminated soil can be mitigated at a fraction of the cost of conventional methods in ways that increase the ability of residents, community health centers, and others to have a positive impact on their neighborhoods. A lead-safe yard program can be replicated and institutionalized by municipal home de-leading programs and other community organizations.


Subject(s)
Child Welfare , Community Health Planning/organization & administration , Environmental Exposure/prevention & control , Lead Poisoning, Nervous System, Childhood/prevention & control , Lead/analysis , Soil Pollutants/analysis , Urban Health , Child , Child, Preschool , Environmental Exposure/analysis , Housing/standards , Humans , Infant , Lead Poisoning, Nervous System, Childhood/blood , Massachusetts , Models, Organizational , Pilot Projects , Program Development
16.
Br J Cancer ; 84 Suppl 1: 17-23, 2001 Apr.
Article in English | MEDLINE | ID: mdl-11308270

ABSTRACT

Darbepoetin alfa is a novel erythropoiesis stimulating protein (NESP), which stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO). NESP has been shown to be safe and efficacious in patients with chronic renal failure. NESP is biochemically distinct from rHuEPO, due to its increased sialic acid content. NESP has an approximately 3-fold greater half-life. rHuEPO has been shown to be safe and effective for the treatment of chemotherapy-induced anaemia. This study assessed the safety and efficacy of NESP administered once per week, under the supervision of a physician, to patients with solid tumours who were receiving multicycle chemotherapy for up to 12 weeks. Three dose cohorts are presented in this sequential, unblinded and dose-escalating study. Thirteen to 59 patients received NESP (0.5, 1.5 or 2.25 mcg kg(-1)wk(-1)) in each cohort. Patients were monitored for adverse events, including antibody formation to NESP and for effects on haemoglobin. NESP appeared to be well tolerated. Adverse events were similar across all cohorts and were consistent with the population being studied. No antibody formation was detected over the 16-week study period and follow-up. A dose-response relationship was evident for NESP and multiple measures of efficacy, including proportion of patients responding to NESP and the mean change in haemoglobin by week 4 and end of treatment for NESP 0.5, 1.5 and 2.25 mcg kg(-1)wk(-1)cohorts (mean change in haemoglobin at end of treatment was 1.24, 1.73 and 2.15 g dl(-1)respectively). Controlled studies of this agent at higher doses and less frequent schedules of administration are ongoing.


Subject(s)
Anemia/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Erythropoietin/administration & dosage , Neoplasms/complications , Adult , Aged , Anemia/etiology , Anemia/therapy , Blood Transfusion/statistics & numerical data , Cohort Studies , Combined Modality Therapy , Darbepoetin alfa , Dose-Response Relationship, Drug , Drug Administration Schedule , Erythrocyte Transfusion/statistics & numerical data , Erythropoiesis/drug effects , Erythropoietin/adverse effects , Erythropoietin/analogs & derivatives , Erythropoietin/chemistry , Erythropoietin/immunology , Erythropoietin/therapeutic use , Female , Half-Life , Hemoglobins/analysis , Humans , Injections, Subcutaneous , Male , Middle Aged , N-Acetylneuraminic Acid/chemistry , Neoplasms/blood , Neoplasms/drug therapy , Recombinant Proteins/administration & dosage , Recombinant Proteins/adverse effects , Recombinant Proteins/chemistry , Recombinant Proteins/immunology , Recombinant Proteins/therapeutic use , Safety , Treatment Outcome
17.
Ann Intern Med ; 132(10): 788-93, 2000 May 16.
Article in English | MEDLINE | ID: mdl-10819701

ABSTRACT

BACKGROUND: Hot flashes are the most frequently reported side effect of tamoxifen treatment. Although hormones are an effective treatment, their safety is questionable in women with breast cancer. It is therefore important to evaluate nonhormonal treatments for hot flashes. OBJECTIVE: To evaluate the effectiveness of oral clonidine for control of hot flashes associated with tamoxifen therapy in postmenopausal women with breast cancer. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: University of Rochester Cancer Center Community Clinical Oncology Program. PATIENTS: 194 postmenopausal women with breast cancer who were receiving adjuvant tamoxifen therapy. INTERVENTION: Oral clonidine hydrochloride, 0.1 mg/d, or placebo for 8 weeks. MEASUREMENTS: In a daily diary, patients recorded number, duration, and severity of hot flashes and overall quality-of-life score (on a 10-point scale) during a 1-week baseline period and during the 4th, 8th, and 12th weeks of the study. RESULTS: Patients in the placebo and treatment groups were similar in age, duration of tamoxifen use, reported frequency and duration of hot flashes at baseline, and dropout rates. One hundred forty-nine patients completed 12 weeks of follow-up. The mean decrease in hot flash frequency was greater in the clonidine group than in the placebo group after 4 weeks of treatment (37% compared with 20% [95% CI for difference, 7% to 27%]) and 8 weeks of treatment (38% compared with 24% [CI for difference, 3% to 27%]). Patients receiving clonidine were more likely than patients receiving placebo to report difficulty sleeping (41% compared with 21%; P = 0.02). A significant difference was seen in the mean change in quality-of-life scores (0.3 points in the clonidine group compared with -0.2 points in the placebo group; P = 0.02) at 8 weeks, although the median difference was 0 in both groups. CONCLUSION: Oral clonidine, 0.1 mg/d, is effective against tamoxifen-induced hot flashes in postmenopausal women with breast cancer.


Subject(s)
Adrenergic alpha-Agonists/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Breast Neoplasms/drug therapy , Clonidine/therapeutic use , Hot Flashes/prevention & control , Postmenopause , Tamoxifen/adverse effects , Administration, Oral , Adrenergic alpha-Agonists/administration & dosage , Clonidine/administration & dosage , Double-Blind Method , Follow-Up Studies , Hot Flashes/chemically induced , Humans , Patient Dropouts , Placebos , Quality-Adjusted Life Years
18.
Cancer Chemother Pharmacol ; 44(6): 461-8, 1999.
Article in English | MEDLINE | ID: mdl-10550566

ABSTRACT

PURPOSE: An all-oral regimen of etoposide and cyclophosphamide was developed for use in poor-prognosis extensive disease small-cell lung cancer. Limited pharmacokinetic sampling was used to derive a pharmacodynamic model predictive of myelosuppression early in the course of therapy. PATIENTS AND METHODS: Eligible patients were chemotherapy-naive and had extensive disease small-cell lung cancer with either SWOG performance status 2 or serum albumin <3.5 g/dl. The first cohort (n = 18) received etoposide orally at 50 mg daily and cyclophosphamide orally at 50 mg daily days 1-14 every 28 days. Due to good hematologic tolerance, the second cohort (n = 39) received both agents orally at 50 mg twice daily days 1-14 every 28 days. Plasma etoposide levels were determined in samples drawn at baseline, and at 1 h, 2 h, and 23.5 h (trough) after the first dose. Linear regression analysis was used to determine pharmacokinetic and demographic parameters predictive of myelosuppression. RESULTS: A total of 173 treatment cycles were delivered. Patients on the daily regimen had a 22% response rate (complete and partial), a 22% unconfirmed response rate, and a 5-month median survival, while patients on the twice-daily regimen had a 28% response rate (complete and partial), a 13% unconfirmed response rate, and a 7-month median survival. Granulocytopenia and alopecia were the most common toxicities seen. Significant granulocytopenia could be predicted for the twice-daily regimen according to the formula ln(AGC nadir)=7.80 - 1.88(trough), with an increased incidence of granulocytopenia if the etoposide trough value was >/=1.49 microg/ml. CONCLUSION: Oral etoposide and oral cyclophosphamide given days 1-14 every 28 days is well tolerated and results in an acceptable response rate and median survival in poor-prognosis (poor performance status or low serum albumin) extensive disease small-cell lung cancer. A trough etoposide level obtained within 24 h of starting therapy can predict severe granulocytopenia.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Small Cell/drug therapy , Lung Neoplasms/drug therapy , Administration, Oral , Aged , Aged, 80 and over , Cyclophosphamide/administration & dosage , Cyclophosphamide/pharmacokinetics , Drug Administration Schedule , Etoposide/administration & dosage , Etoposide/pharmacokinetics , Female , Humans , Male , Metabolic Clearance Rate , Middle Aged , Neoplasm Staging , Prognosis , Regression Analysis
19.
Leuk Res ; 23(9): 787-94, 1999 Sep.
Article in English | MEDLINE | ID: mdl-10475617

ABSTRACT

The aim of this study is to determine whether the addition of mitoxantrone to high dose cytarabine improves the outcome of treatment in patients with relapsed or refractory acute myeloid leukemia (AML). One hundred and sixty-two eligible patients, 14-76 years of age, with AML either in first relapse or that failed to respond to initial remission induction therapy, with no CNS involvement were randomized to receive therapy with cytarabine 3 gm/M2 i.v. over 2 h every 12 h for 12 doses on days 1-6 (Arm I) (HIDAC); or HIDAC plus mitoxantrone 10 mg/M2 i.v. daily on days 7 9 (Arm II) (HIDAC + M). Patients achieving complete remission were treated with three courses of consolidation including HIDAC (Ara-C 3 gm/M2 i.v. 12 h days 1 3; 2 gm/M2 over age 50) alone (ARM I) or with mitoxantrone (10 mg/M2 i.v. day 1) (ARM II). Among 162 patients (81 HIDAC, 81 HIDAC + M) evaluated for induction toxicity, there were 10 (12%) induction deaths with HIDAC and 13 (17%) with HIDAC + M (2-tailed P = 0.65). Most early deaths were due to infection and/or hemorrhage. Among 162 patients evaluated for responses to induction therapy, 26/81 (32%) HIDAC and 36/81 (44%) HIDAC + M patients achieved complete remission (two-tailed P = 0.15). Although this difference was not statistically significant in univariate analysis, it was after adjusting for the effects of WBC and PMN percentage in multivariate analysis (P=0.013). Median survivals from study entry were 8 months (HIDAC) and 6 months (HIDAC + M); 2-tailed logrank P = 0.58. Among 48 patients registered for consolidation, the median disease-free survivals from that registration were 8 months with HIDAC and 11 months with HIDAC + M (P = 0.60). There were three treatment-related deaths during consolidation (1 HIDAC, 2 HIDAC + M), all due to infections. In this randomized trial, the addition of mitoxantrone to high-dose cytarabine was associated with a trend toward a higher CR rate. There was less evidence for an advantage in disease-free or overall survival, although any such conclusion is limited by the size of the study.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Leukemia, Myeloid/drug therapy , Acute Disease , Adolescent , Adult , Aged , Cytarabine/administration & dosage , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Mitoxantrone/administration & dosage , Prognosis , Recurrence , Treatment Outcome
20.
Cancer ; 86(1): 64-71, 1999 Jul 01.
Article in English | MEDLINE | ID: mdl-10391565

ABSTRACT

BACKGROUND: Although 5-HT3 receptor antagonists are clinically more effective in controlling emesis, particularly that caused by high dose cisplatin, than previously available agents, they appear to be less effective against nausea. This report focuses on the effectiveness of these agents against nausea and emesis in patients receiving two moderately emetogenic combination chemotherapy regimens as treatment for breast carcinoma in community practice settings. METHODS: Six hundred ninety-two breast carcinoma patients (688 female, 4 male; mean age, 51 years) enrolled in a nonrandomized study completed the Morrow Assessment of Nausea and Emesis (MANE) following 4 consecutive chemotherapy treatments. The frequency, duration, and severity of postchemotherapy nausea (PN) and postchemotherapy emesis (PE) were compared by type of antiemetic (5-HT3 receptor antagonist vs. other) and chemotherapy regimen (cyclophosphamide and doxorubicin with or without 5-fluorouracil [CA/CAF] vs. cyclophosphamide, methrotrexate, and 5-fluorouracil [CMF]). RESULTS: Within each regimen, the mean duration of PN was significantly longer for patients who received a 5-HT3 receptor antagonist than for those who were not given an antiemetic of that type (CA: 40.3 hours vs. 29.6 hours, P < 0.05; CMF: 37.6 hours vs. 30.2 hours, P < 0.05). There were no significant differences in the frequency or severity of nausea or in the frequency, severity, or duration of emesis by type of antiemetic for patients receiving either regimen. CONCLUSIONS: The results of this observational study suggest that 5-HT3 receptor antagonists are no more effective than other commonly used medications in controlling postchemotherapy nausea and emesis in women with breast carcinoma who are treated with moderately emetogenic chemotherapy in community practice settings. In fact, they may be associated with significant prolongation of the course of postchemotherapy nausea.


Subject(s)
Antiemetics/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Carcinoma/drug therapy , Nausea/prevention & control , Serotonin Antagonists/therapeutic use , Vomiting, Anticipatory/prevention & control , Adult , Aged , Aged, 80 and over , Antiemetics/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms, Male/drug therapy , Female , Humans , Male , Middle Aged , Nausea/chemically induced , Serotonin Antagonists/administration & dosage , Treatment Outcome , Vomiting, Anticipatory/chemically induced
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