bluuebunny/crossref_metadata_2025 huggingface dataset:
Do Psychological Characteristics Explain Socioeconomic Stratification of Self-rated Health?
Authors: Barger Steven D.
Published: November 2005

This study evaluated whether negative emotions explain socioeconomic status (SES) stratification of self-rated health (SRH) and whether this putative relation is independent of established SRH determinants. Mood disorders, trait negative affect and health status indices were assessed in a representative cross-sectional survey of 3032 adults in the National Survey of Midlife Development in the United States (MIDUS). Adjustment for health behaviors and health status appreciably reduced SES influence on SRH, but adjustment for negative emotions did not. However, both psychological resources (e.g. social support, extraversion) and negative emotions independently predicted SRH. Detection of SRH determinants was sensitive to binary versus ordinal SRH definitions.
Outcome Expectations and Physical Activity Participation in Two Samples of Older Women
Authors: Wilcox Sara , Castro Cynthia M. , King Abby C.
Published: November 2005

Outcome expectations have received little study in physical activity (PA) research. This study examined whether initial outcome expectations and their achievement at 6 months (i.e. outcome realizations) predicted subsequent PA participation (7-12 months) in 118 older women. Initial outcome expectations were not associated with PA participation. Outcome realizations at 6 months, however, predicted subsequent PA participation ( p < .05). Women with high expectations but low attainment had the lowest subsequent participation rates. Women with high attainment, regardless of expectations, had the highest rates. Findings replicate and extend an earlier study and argue for a more dynamic conceptualization of outcome expectations.
(De)constructing Body Image
Authors: Gleeson Kate , Frith Hannah
Published: November 2005

The reification of body image leads to unarticulated ideological and conceptual assumptions that obscure the most dynamic and productive features of the construct. These assumptions are that body image: (1) ‘exists’; (2) is a socially mediated product of perception; (3) is ‘internal’ and ‘of the individual’; (4) can be treated and measured as if real; and (5) individuals’ respond to body image measures as if neutrally providing information about pre-existing images held in their heads. We argue that it is more useful to consider body imaging as a process, an activity rather than a product.
Physician and Patient Perceptions of the Physician Explanations in Medical Encounters
Authors: Hagihara Akihito , Odamaki Misato , Nobutomo Koichi , Tarumi Kimio
Published: November 2005

Although, in actual practice, physicians have to subjectively judge the level of the explanation that they provide, little is known about this judgment. Therefore, making use of 630 physician-patient pairs in Japan, we investigated the association between patient and physician evaluations of physician explanations of medical test results and diagnoses. We found that the physician’s judgment does not always agree with that of the patient, with regard to the level of explanation necessary. In addition, we first identified factors relating to the accuracy of physician judgments with regard to their explanations to patients. More studies will be necessary to verify the present findings.
Coping with Patients with Medically Unexplained Symptoms
Authors: Ringsberg Karin C. , Krantz Gunilla
Published: November 2005

General practitioners (GPs) often meet patients with medically unexplained symptoms (MUS). From a patient perspective, MUS is a well-acknowledged problem within the primary health care services today, but less is known about the GPs’ perceptions. This study aims to elucidate GPs’ perceptions of patients with MUS, focusing on stressing situations, emotional reactions and coping strategies. Twenty-seven physicians participated in focus-group discussions. In the analysis, where a phenomenographic approach was used, six situations were identified as being especially stressful in the encounter with these patients. The GPs described how they used both problem-focused and emotion-focused strategies, but with emotion-focused strategies slightly dominating, indicating that the GPs had difficulties in managing their own stress when working with patients with MUS.
Exploring Patient Perceptions of Movement through the Stages of Change Model within a Diabetes Tele-care Intervention
Authors: Gambling Tina , Long Andrew F.
Published: November 2005

Achieving strict control of diabetes is challenging for many patients and most need regularly to depend on ongoing support from health care professionals. One approach that might successfully provide this in a cost-effective and acceptable way is the delivery of advice and support over the telephone (tele-care). To date the process and effects of tele-care have however rarely been studied. This article explores the potential of one behavioural model, the trans-theoretical stages of change model (TTM), to understand and theorize about behaviour change for this chronic disease. Case study data are drawn from a wider randomized controlled trial (RCT) set up to assess the effectiveness of a pro-active call centre-based stepped treatment support to people with type 2 diabetes. The case study demonstrates the relevance and importance of the TTM model in this area. Different experiential and behavioural processes were of particular significance and held different meanings for the various change groups.
A Prospective Study of the Effects of Psychological Resources and Depression in Essential Hypertension
Authors: Rueda Beatriz , Pérez-García Ana María
Published: November 2005

This study examined the influence of perceived health competence (PHC) and coping strategies in hypertension. Depressive mood state and dimensions of quality of life (QOL) (social support, satisfaction, well-being and free time) were also considered. One hundred and fifty participants were surveyed cross-sectionally and prospectively. Regression analysis revealed that the main predictors of the dimensions of QOL were PHC and depressive mood state. Emotional coping negatively predicted well-being. Unexpectedly, task-focused coping was unrelated to QOL domains. Longitudinal analyses did not support these relations. The data suggest that, in hypertension, PHC constitutes an important resource, whereas depressive mood state deteriorates QOL.
The Bases of Goal Setting in the Self-regulation of Hypertension
Authors: Taylor Stephanie D. , Bagozzi Richard P. , Gaither Caroline A. , Jamerson Kenneth A.
Published: November 2005

We apply a new methodology to investigate goal setting by hypertensive patients that uncovers the reasons why people have a goal to manage hypertension or not (e.g. to reduce/maintain one’s current blood pressure). The reasons are found to consist of superordinate goals in support of one’s focal hypertension goal and the hierarchical mental network underlying the superordinate goals. We show that, not only do such superordinate goals influence patients’ beliefs, feelings and decisions, but the relationships among superordinate goals are particularly efficacious in the formation of beliefs and attitudes, as well as intentions to self-regulate hypertension and actual efforts in doing so. Hypotheses were tested on a sample of 219 patients at a university-based hypertension clinic.
Female breadwinner families
Authors: Drago Robert , Black David , Wooden Mark
Published: November 2005

We develop a typology for understanding couple households where the female is the major earner - what we term female breadwinner households - and test it using data from the first two waves of the HILDA Survey. We distinguish temporary from persistent female breadwinner households and hypothesize, and confirm, that these two groups diverge on demographic, socio-economic status (SES), labour market and family commitment characteristics. Among the persistent group we further distinguish those couples where the dominance of a female earner is related to economic factors and those where it appears associated with a purposeful gender equity strategy. We again hypothesize and confirm that these household types significantly diverge, finding that men in the economic group exhibit low SES, poor labour market position, and low levels of commitment to family, while both the women and men in the equity type often achieve positive outcomes regarding gender equity and economic and family success.
Issues in the school-to-work transition
Authors: Marks Gary N.
Published: November 2005

The purpose of this article is to examine how accurate pessimistic accounts of the school-to-work transition are, given the substantial decline in unemployment since the 1991/93 recession. This examination is limited to young people who did not go to university, a group which is more likely to be experiencing problematic school-to-work transitions. The analyses use data from the first eight waves of data from the 1995 Year 9 cohort in the Longitudinal Surveys of Australian Youth (LSAY) project. In the years after leaving school, an increasing majority are in full-time work and there is considerable movement into full-time work from part-time work and unemployment. Furthermore, each year full-time workers show increases in job status and earnings. Only a small minority of non-university bound youth have problematic school-to-work transitions. These analyses also suggest that the policy emphasis on increasing participation in vocational education is misplaced. Except for apprenticeships and then only among males, vocational education does not appear to promote full-time employment.
The labour market dynamics of Indigenous Australians
Authors: Gray Matthew , Hunter Boyd
Published: November 2005

To date, the analysis of the reasons for the labour market disadvantage of Indigenous Australians has been constrained by the absence of longitudinal data on labour force status. This article uses the only extant large-scale longitudinal survey of the labour force outcomes of Indigenous Australians to analyse both labour market dynamics and the determinants of labour market success. The analysis reveals high rates of movements between labour force states by Indigenous Australians and that the Indigenous unemployed were around one-half as likely to move to employment over a 15-month period as were the non-Indigenous unemployed. The analysis presented in this article highlights the need for further longitudinal surveys of the labour market and social circumstances of Indigenous Australians.
Marriage and divorce’s impact on wealth
Authors: Zagorsky Jay L.
Published: November 2005

What impact do marriage and divorce have on wealth? US data from the National Longitudinal Survey of Youth (NLSY79), which tracks individuals in their 20s, 30s and early 40s, show that over time single respondents slowly increase their net worth. Married respondents experience per person net worth increases of 77 percent over single respondents. Additionally, their wealth increases on average 16 percent for each year of marriage. Divorced respondents’ wealth starts falling four years before divorce and they experience an average wealth drop of 77 percent. While in percentage terms divorce hurts women more than men, the absolute difference is relatively small in the US.
Exposing the interests: decoding the promise of the global knowledge society
Authors: McElhinney Stephen
Published: November 2005

Nico Stehr's idea of the knowledge society presents a vital alternative to orthodox beliefs about the organization of social, cultural, economic and political life. With the formation of a global market and institutions that seem to have entrenched inequalities, there is a need to examine how vested interests determine the use and application of information and communication technologies and intellectual property. Using examples from Australia and India, this article critiques the effect of vested interests and cultural effects in limiting the prospects of a global knowledge society before presenting some remedial advice to policymakers.
Policy Commentary
Authors: Samarajiva Rohan
Published: November 2005

The Indian Ocean tsunami of 26 December 2004 was one of the greatest natural disasters; it was also the first internet-mediated natural disaster. Despite the presumed ubiquity and power of advanced technologies including satellites and the internet, no advance warning was given to the affected coastal populations by their governments or others. This article examines the conditions for the supply of effective early warnings of disasters, drawing from the experience of both the 26 December 2004 tsunami and the false warnings issued after another great earthquake in the Sunda Trench on 28 March 2005. The potential of information and communication technologies for prompt communication of hazard detection and monitoring information and for effective dissemination of alert and warning messages is examined. The factors contributing to the absence of institutions necessary for the realization of that potential are explored.
Email forwardables: folklore in the age of the internet
Authors: Kibby Marjorie D.
Published: November 2005

Email communication fosters an environment where messages have an inherent ‘truth value’ while at the same time senders have reduced inhibitions about the types of messages sent. When this is combined with a convenience and ease of communication and an ability to contact huge numbers of people simultaneously, email becomes a rapid and effective distribution mechanism for gossip, rumour and urban legends. Email has enabled not only the birth of new folklore, but also the revival of older stories with contemporary relevance and has facilitated their distribution on an unprecedented scale.
Digitizing the dragon: challenges facing China's broadcasting industry
Authors: Weber Ian
Published: November 2005

China's aggressive strategy to develop a modern economy is matched only by an even more ambitious program of technological development. The Chinese government has earmarked digital broadcasting as the pre-eminent media technology to emerge in China's expanding and diversifying mediascape. Yet, in spite of predictions of 30 million subscribers by 2005 and $220 billion in revenue by 2015, there is still much to do to sell digital broadcasting to consumers and achieve these targets. This study examines the challenges facing China's digital broadcasting industry using the theory of controlled commodification to critique implementation strategies. Emerging from this analysis is a deeper understanding of the contested role of media in China's socialist market economy, which has had an impact on the successful adoption of digital broadcasting at a crucial stage of development.
Cellphones in public: social interactions in a wireless era
Authors: Humphreys Lee
Published: November 2005

Cellphones provide a unique opportunity to examine how new media both reflect and affect the social world. This study suggests that people map their understanding of common social rules and dilemmas onto new technologies. Over time, these interactions create and reflect a new social landscape. Based upon a year-long observational field study and in-depth interviews, this article examines cellphone usage from two main perspectives: how social norms of interaction in public spaces change and remain the same; and how cellphones become markers for social relations and reflect tacit pre-existing power relations. Informed by Goffman's concept of cross talk and Hopper's caller hegemony, the article analyzes the modifications, innovations and violations of cellphone usage on tacit codes of social interactions.
A new public service communication environment? Public service broadcasting values in the reconfiguring media
Authors: Harrison Jackie , Wessels Bridgette
Published: November 2005

In a complex and changing communication environment public service broadcasting is being subject to increasing scrutiny. Using a series of exemplars from various information society programmes, this paper explores the social relations of a new communication environment, audience participation and public service values in the reconfiguration of new media forms in the European Union. These developments require a new analytical framework of a new public service communication environment which enables us to identify ‘reconfiguring’ forms of media, constituted from both traditional and new media. Our mapping of new, traditional and reconfiguring forms of media helps us to identify under what circumstances and institutional conditions the public service ethos is being sustained and rethought.
Fetishism as social creativity
Authors: Graeber David
Published: November 2005

Originally, the term ‘fetishes’ was used by European merchants to refer to objects employed in West Africa to make and enforce agreements, often between people with almost nothing in common. They thus provide an interesting window on the problem of social creativity - especially since in classic Marxist terms they were surprisingly little fetishized. Starting with an appreciation and critique of William Pietz’s classic work on the subject, and reconsidering classic cases of Tiv spheres of exchange and BaKongo sculpture, this article aims to reimagine African fetishes, and fetishes in general, as ways of creating new social relations.
A not so multi-sited ethnography of a not so imagined community
Authors: Hage Ghassan
Published: November 2005

This article reflects on key analytical concepts used in the anthropology of migration in the light of the author’s own ethnographic work on Lebanese migrants in a number of international locations. It first examines the notion of multi-sited ethnography and argues that in the study of migrants sharing a unifying culture across a number of global locations, multi-sitedness is less helpful than a notion of a single geographically discontinuous site. The article also examines the excessive usage of the notion of ‘imagined community’ in diasporic research. It argues that there is often very little empirical evidence of ‘community’ presented in the literature that uses the concept. Finally, the article examines the uncritical assumption often made that the study of migration is the study of ‘mobility’. It argues that migrants do not really spend that much time ‘moving’ in the sense assumed by the notion of ‘mobility’.
Universals of child rearing
Authors: Quinn Naomi
Published: November 2005

This article delineates four universal features of child rearing that together explain how child rearing everywhere so effectively turns children into valued adults. Cultural models for child rearing, so variable in the substance of what they teach, are all equally designed to make the child’s experience of those important lessons constant, to link those lessons to emotional arousal, to connect them to evaluations of the child as approved or disapproved of, and to prime the child to be emotionally predisposed to learn them. This design insures that the child is receptive to these lessons, and that the lessons themselves are unmistakable, motivating, and memorable. The result, human adulthood, could not be accomplished otherwise.
Reduced Flavin: NMR investigation of N(5)-H exchange mechanism, estimation of ionisation constants and assessment of properties as biological catalyst
Authors: Macheroux Peter , Ghisla Sandro , Sanner Christoph , Rüterjans Heinz , Müller Franz
Published: November 2005

Background

The flavin in its FMN and FAD forms is a versatile cofactor that is involved in catalysis of most disparate types of biological reactions. These include redox reactions such as dehydrogenations, activation of dioxygen, electron transfer, bioluminescence, blue light reception, photobiochemistry (as in photolyases), redox signaling etc. Recently, hitherto unrecognized types of biological reactions have been uncovered that do not involve redox shuffles, and might involve the reduced form of the flavin as a catalyst. The present work addresses properties of reduced flavin relevant in this context.

Results

N(5)-H exchange reactions of the flavin reduced form and its pH dependence were studied using the 15N-NMR-signals of 15N-enriched, reduced flavin in the pH range from 5 to 12. The chemical shifts of the N(3) and N(5) resonances are not affected to a relevant extent in this pH range. This contrasts with the multiplicity of the N(5)-resonance, which strongly depends on pH. It is a doublet between pH 8.45 and 10.25 that coalesces into a singlet at lower and higher pH values. From the line width of the 15N(5) signal the pH-dependent rate of hydrogen exchange was deduced. The multiplicity of the 15N(5) signal and the proton exchange rates are little dependent on the buffer system used.

Conclusion

The exchange rates allow an estimation of the pKa value of N(5)-H deprotonation in reduced flavin to be ≥ 20. This value imposes specific constraints for mechanisms of flavoprotein catalysis based on this process. On the other hand the pK ≈ 4 for N(5)-H protonation (to form N(5)+-H2) would be consistent with a role of N(5)-H as a base.
Suppression of AC railway power-line interference in ECG signals recorded by public access defibrillators
Authors: Dotsinsky Ivan
Published: November 2005

Background

Public access defibrillators (PADs) are now available for more efficient and rapid treatment of out-of-hospital sudden cardiac arrest. PADs are used normally by untrained people on the streets and in sports centers, airports, and other public areas. Therefore, automated detection of ventricular fibrillation, or its exclusion, is of high importance. A special case exists at railway stations, where electric power-line frequency interference is significant. Many countries, especially in Europe, use 16.7 Hz AC power, which introduces high level frequency-varying interference that may compromise fibrillation detection.

Method

Moving signal averaging is often used for 50/60 Hz interference suppression if its effect on the ECG spectrum has little importance (no morphological analysis is performed). This approach may be also applied to the railway situation, if the interference frequency is continuously detected so as to synchronize the analog-to-digital conversion (ADC) for introducing variable inter-sample intervals. A better solution consists of rated ADC, software frequency measuring, internal irregular re-sampling according to the interference frequency, and a moving average over a constant sample number, followed by regular back re-sampling.

Results

The proposed method leads to a total railway interference cancellation, together with suppression of inherent noise, while the peak amplitudes of some sharp complexes are reduced. This reduction has negligible effect on accurate fibrillation detection.

Conclusion

The method is developed in the MATLAB environment and represents a useful tool for real time railway interference suppression.
Association of common variation in the PPARAgene with incident myocardial infarction in individuals with type 2 diabetes: A Go-DARTS study
Authors: Doney Alex SF , Fischer Bettina , Lee Simon P , Morris Andrew D , Leese Graham , Palmer Colin NA
Published: November 2005

Background

Common variants of the PPARA gene have been found to associate with ischaemic heart disease in non diabetic men. The L162V variant was found to be protective while the C2528G variant increased risk. L162V has also been associated with altered lipid measures. We therefore sought to determine the effect of PPARA gene variation on susceptibility to myocardial infarction in patients with type 2 diabetes. 1810 subjects with type 2 diabetes from the prospective Go-DARTS study were genotyped for the L162V and C2528G variants in the PPARA gene and the association of the variants with incident non-fatal myocardial infarction was examined. Cox's proportional hazards was used to interrogate time to event from recruitment, and linear regression for analysing association of genotype with quantitative clinical traits.

Results

The V162 allele was associated with decreased risk of non-fatal myocardial infarction (HR = 0.31, 95%CI 0.10–0.93 p = 0.037) whereas the C2528 allele was associated with increased risk (HR = 2.77 95%CI 1.34–5.75 p = 0.006). Similarly V162 was associated with a later mean age of diagnosis with type 2 diabetes and C2582 an earlier age of diagnosis. C2528 was also associated with increased total cholesterol and LDL cholesterol, which did not account for the observed increased risk. Haplotype analysis demonstrated that when both rare variants occurred on the same haplotype the effect of each was abrogated.

Conclusion

Genetic variation at the PPARA locus is important in determining cardiovascular risk in both male and female patients with diabetes. This genotype associated risk appears to be independent of the effect of these genotypes on lipid profiles and age of diagnosis with diabetes.
Choosing an appropriate bacterial typing technique for epidemiologic studies
Authors: Foxman Betsy , Zhang Lixin , Koopman James S , Manning Shannon D , Marrs Carl F
Published: November 2005

A wide variety of bacterial typing systems are currently in use that vary greatly with respect to the effort required, cost, reliability and ability to discriminate between bacterial strains. No one technique is optimal for all forms of investigation. We discuss the desired level of discrimination and need for a biologic basis for grouping strains of apparently different types when using bacterial typing techniques for different epidemiologic applications: 1) confirming epidemiologic linkage in outbreak investigations, 2) generating hypotheses about epidemiologic relationships between bacterial strains in the absence of epidemiologic information, and 3) describing the distributions of bacterial types and identifying determinants of those distributions. Inferences made from molecular epidemiologic studies of bacteria depend upon both the typing technique selected and the study design used; thus, choice of typing technique is pivotal for increasing our understanding of the pathogenesis and transmission, and eventual disease prevention.
Outcomes of Children With Intermediate-Risk Neuroblastoma After Treatment Stratified by MYCN Status and Tumor Cell Ploidy
Authors: Bagatell Rochelle , Rumcheva Pavlina , London Wendy B. , Cohn Susan L. , Look A. Thomas , Brodeur Garrett M. , Frantz Christopher , Joshi Vijay , Thorner Paul , Rao P.V. , Castleberry Robert , Bowman Laura C.
Published: November 2005

Purpose

The goal of Pediatric Oncology Group 9243 was to improve outcomes for children with intermediate-risk neuroblastoma (NB).

Patients and Methods

Patients were assigned to treatments on the basis of age, tumor MYCN status, and tumor cell ploidy. Children in the less intensive arm A received cyclophosphamide/doxorubicin and surgery. Patients not in complete remission postoperatively were treated with cisplatin/etoposide, cyclophosphamide/doxorubicin, and additional surgery. Patients with less favorable features were assigned to arm B, which consisted of carboplatin, etoposide, ifosfamide, and surgery. Survival rates were determined using an intent-to-treat approach.

Results

For arm-A patients, the 6-year event-free survival (EFS) was 86% with an SE of 3%. For arm-B patients, the 6-year EFS was 46% with an SE of 7%. MYCN status was the only statistically significant prognostic variable. Among patients whose tumors were MYCN nonamplified, a trend toward improved EFS was seen in children with hyperdiploid versus diploid tumors. However, many of these children responded well to salvage therapy, and overall survival rates did not differ on the basis of ploidy. Six-year EFS rates for arm B were patients with MYCN nonamplified, hyperdiploid tumors, 86% with an SE of 3%; patients with MYCN nonamplified, diploid tumors, 74% with an SE of 10%; patients with MYCN-amplified, hyperdiploid tumors, 46% with an SE of 15%; and patients with MYCN-amplified, diploid tumors, 22% with an SE of 10%.

Conclusion

Outcomes for patients with MYCN-nonamplified, hyperdiploid tumors were excellent. Therapy reductions for these patients merit study. A trend toward less favorable outcomes for patients with MYCN-nonamplified, diploid tumors was observed; more children may need to be evaluated before therapy is reduced for this subgroup. For patients with MYCN-amplified tumors, new strategies are needed.
Ototoxicity in Children Receiving Platinum Chemotherapy: Underestimating a Commonly Occurring Toxicity That May Influence Academic and Social Development
Authors: Knight Kristin R. Gilmer , Kraemer Dale F. , Neuwelt Edward A.
Published: November 2005

Purpose

To describe the frequency and severity of ototoxicity in a series of pediatric patients treated with platinum-based chemotherapy.

Patients and Methods

Serial audiologic evaluations were conducted for 67 patients aged 8 months to 23 years who received platinum-based chemotherapy. Audiologic data was analyzed to determine time to hearing-loss using American Speech-Language-Hearing Association (ASHA) criteria, and the effects of treatment and patient characteristics on the incidence and severity of ototoxicity.

Results

Bilateral decreases in hearing were seen in 61% of patients (median time to hearing loss, 135 days). Children treated for medulloblastoma, osteosarcoma, and neuroblastoma had greater incidence and severity of hearing loss. Agreement between the usually reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) and ASHA criteria was inadequate.

Conclusion

Traditional reporting of toxicity data (CTCAE) has under-reported ototoxicity and minimized the significance of hearing loss in children. As pediatric patients experience improved survival, the effects and implications of high-frequency hearing loss with regard to academic achievement and speech and language development are important considerations, especially in patients younger than 5 years.
Phase III Study of Fluorouracil, Leucovorin, and Levamisole in High-Risk Stage II and III Colon Cancer: Final Report of Intergroup 0089
Authors: Haller Daniel G. , Catalano Paul J. , Macdonald John S. , O'Rourke Mark A. , Frontiera Michael S. , Jackson Don V. , Mayer Robert J.
Published: November 2005

Purpose

In 1990, fluorouracil (FU) plus levamisole for 1 year became standard adjuvant treatment for patients with high-risk stages II and III colon cancer. Intergroup (INT) 0089 assessed the relative contributions of leucovorin and levamisole in such patients.

Patients and Methods

From 1988 to 1992, 3,794 patients were randomly assigned. Experimental treatment consisted of one of three chemotherapy regimens: the low-dose leucovorin plus FU (Mayo Clinic; LDLV) regimen, the high-dose leucovorin plus FU (Roswell Park; HDLV) regimen, and the low-dose leucovorin plus levamisole plus FU (LDLV plus LEV) regimen, each administered for 30 to 32 weeks. The control arm was levamisole plus FU (LEV) for 1 year.

Results

After a median follow-up of 10 years, of 3,561 eligible patients, 1,691 (47%) have died and 1,330 (37%) have experienced disease recurrence; 137 (10%) of those experiencing recurrence are still alive. A total of 481 patients (13%) died without evidence of recurrence, and 1,723 (48%) are alive and disease free. Although there were toxicity differences among the four arms, none was statistically superior in disease-free or overall survival.

Conclusion

The 6- to 8-month regimens of LDLV and HDLV without levamisole used in this trial, rather than the previous standard regimen of 12 months of LEV, have become widely used. INT-0089 has long-term follow-up of the largest clinical trial of patients with high-risk colon cancer, documenting not only the durability of the treatment effects, but also the natural history of patients with high-risk colon cancer, and analyses of treatment based on age, race, and comorbid conditions such as obesity, diabetes, and second primary cancers.
Caveat Medicus: Consequences of Federal Investigations of Marketing Activities of Pharmaceutical Suppliers of Prostate Cancer Drugs
Authors: McKoy June M. , Lyons E. Allison , Obadina Eniola , Carson Kenneth , Pickard A. Simon , Schellhammer Paul , McLeod David , Boyd Cynthia E. , McWilliams Norene , Sartor Oliver , Schumock Glen T. , McCaffery Kathryn , Bennett Charles L.
Published: November 2005

In the course of recent health care fraud investigations against TAP Pharmaceuticals (Lake Forest, IL) and AstraZeneca International (London, United Kingdom), each pled guilty to one violation of the Prescription Drug Marketing Act, settled claims related to alleged violations of the False Claims Act without admitting guilt, and paid fines, settlements for liabilities, and reimbursements of $850 million and $355 million, respectively. In a unique aspect of these cases, federal investigators brought criminal charges against 14 TAP employees and investigated the billing practices of several urologists. These investigations resulted in guilty pleas from both urologists and industry employees relative to the Prescription Drug Marketing Act or the False Claims Act and probationary sentences with payments of fines and restitution to the government for urologists who cooperated with federal investigations. One uncooperative urologist was found guilty of violating the Federal False Claims Act and sentenced to 6 months of home arrest, excluded from Medicare for 5 years, required to provide 600 hours of free medical care to indigent patients and patients covered by Medicare or Medicaid, and paid fines and restitution to the government. The cases against TAP and AstraZeneca have been followed by federal and state investigations of allegedly illegal marketing practices of other pharmaceutical firms and have resulted in negotiated settlements of $3.8 billion and $71.5 million, respectively. Believing that an Average Wholesale Price–based reimbursement system was an important driving factor for these marketing activities, Medicare has shifted to an Average Sales Price–based reimbursement system. This is expected to greatly impact the practice of outpatient oncology nationwide.
Phase II Trial of High-Dose Conformal Radiation Therapy With Concurrent Hepatic Artery Floxuridine for Unresectable Intrahepatic Malignancies
Authors: Ben-Josef Edgar , Normolle Daniel , Ensminger William D. , Walker Suzette , Tatro Daniel , Ten Haken Randall K. , Knol James , Dawson Laura A. , Pan Charlie , Lawrence Theodore S.
Published: November 2005

Purpose

A phase II trial was conducted to determine if high-dose radiation with concurrent hepatic arterial floxuridine would improve survival in patients with unresectable intrahepatic malignancies.

Patients and Methods

Three-dimensional conformal high-dose radiation therapy was delivered concurrently with hepatic arterial floxuridine in 128 patients. The radiation dose was based on a normal-tissue complication probability model and subjected the patient to an estimated maximum risk of radiation-induced liver disease of 10% to 15%. The study design provided more than 80% power to detect a two-fold increase in median survival compared with historical controls at a 5% significance level.

Results

The median radiation dose delivered was 60.75 Gy (1.5-Gy fractions bid). At a median follow-up time of 16 months (26 months in patients who were alive) the median survival was 15.8 months (95% CI, 12.6 to 18.3 months), significantly longer than in the historical control. The actuarial 3-year survival was 17%. The total dose was the only significant predictor of survival. Primary hepatobiliary tumors had a significantly greater tendency to remain confined to the liver than did colorectal cancer metastases. Overall toxicity was acceptable, with 27 patients (21%) and 11 patients (9%) developing grade 3 and 4 toxicity, respectively, and one treatment-related death.

Conclusion

The results suggest that, compared with historical controls, high-dose focal liver irradiation with hepatic artery floxuridine prolongs survival in patients with unresectable chemotherapy-refractory metastatic colorectal cancer and primary hepatobiliary tumors. This provides a rationale for intensification of local therapy for unresectable hepatobiliary cancers and integration of this regimen with newer systemic therapy for patients with colorectal cancer.
[18F]Fluorodeoxyglucose Positron Emission Tomography Predicts Outcome for Ewing Sarcoma Family of Tumors
Authors: Hawkins Douglas S. , Schuetze Scott M. , Butrynski James E. , Rajendran Joseph G. , Vernon Cheryl B. , Conrad Ernest U. , Eary Janet F.
Published: November 2005

Purpose

Response to neoadjuvant chemotherapy is a significant prognostic factor for the Ewing sarcoma family of tumors (ESFTs). [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET) is a noninvasive imaging modality that accurately predicts histopathologic response in several malignancies. To determine the prognostic value of FDG PET response for progression-free survival (PFS) in ESFTs, we reviewed the University of Washington Medical Center experience.

Patients and Methods

Thirty-six patients with ESFTs were evaluated by FDG PET. All patients received neoadjuvant and adjuvant chemotherapy. FDG PET standard uptake values before (SUV1) and after (SUV2) chemotherapy were analyzed and correlated with chemotherapy response, as assessed by histopathology in surgically excised tumors. Thirty-four patients had both SUV1 and SUV2.

Results

The mean SUV1, SUV2, and ratio of SUV2 to SUV1 (SUV2:1) were 7.9 (range, 2.3 to 32.8), 2.1 (range, 0 to 4.3), and 0.36 (range, 0.00 to 1.00), respectively. Good FDG PET response was defined as SUV2 less than 2.5 or SUV2:1 ≤ 0.5. FDG PET response by SUV2 or SUV2:1 was concordant with histologic response in 68% and 69% of patients, respectively. SUV2 was associated with outcome (4-year PFS 72% for SUV2 < 2.5 v 27% for SUV2 ≥ 2.5, P = .01 for all patients; 80% for SUV2 < 2.5 v 33% for SUV2 ≥ 2.5, P = .036 for localized at diagnosis patients). SUV2:1 ≤ 0.5 was not predictive of PFS.

Conclusion

FDG PET imaging of ESFTs correlates with histologic response to neoadjuvant chemotherapy. SUV2 less than 2.5 is predictive of PFS independent of initial disease stage.
Logistic Regression Model to Distinguish Between the Benign and Malignant Adnexal Mass Before Surgery: A Multicenter Study by the International Ovarian Tumor Analysis Group
Authors: Timmerman Dirk , Testa Antonia C. , Bourne Tom , Ferrazzi Enrico , Ameye Lieveke , Konstantinovic Maja L. , Van Calster Ben , Collins William P. , Vergote Ignace , Van Huffel Sabine , Valentin Lil
Published: November 2005

Purpose

To collect data for the development of a more universally useful logistic regression model to distinguish between a malignant and benign adnexal tumor before surgery.

Patients and Methods

Patients had at least one persistent mass. More than 50 clinical and sonographic end points were defined and recorded for analysis. The outcome measure was the histologic classification of excised tissues as malignant or benign.

Results

Data from 1,066 patients recruited from nine European centers were included in the analysis; 800 patients (75%) had benign tumors and 266 (25%) had malignant tumors. The most useful independent prognostic variables for the logistic regression model were as follows: (1) personal history of ovarian cancer, (2) hormonal therapy, (3) age, (4) maximum diameter of lesion, (5) pain, (6) ascites, (7) blood flow within a solid papillary projection, (8) presence of an entirely solid tumor, (9) maximal diameter of solid component, (10) irregular internal cyst walls, (11) acoustic shadows, and (12) a color score of intratumoral blood flow. The model containing all 12 variables (M1) gave an area under the receiver operating characteristic curve of 0.95 for the development data set (n = 754 patients). The corresponding value for the test data set (n = 312 patients) was 0.94; and a probability cutoff value of .10 gave a sensitivity of 93% and a specificity of 76%.

Conclusion

Because the model was constructed from multicenter data, it is more likely to be generally applicable. The effectiveness of the model will be tested prospectively at different centers.
Phase II Trial of Radiosurgery for One to Three Newly Diagnosed Brain Metastases From Renal Cell Carcinoma, Melanoma, and Sarcoma: An Eastern Cooperative Oncology Group Study (E 6397)
Authors: Manon Rafael , O'Neill Anne , Knisely Jonathan , Werner-Wasik Maria , Lazarus Hillard M. , Wagner Henry , Gilbert Mark , Mehta Minesh
Published: November 2005

Purpose

Long-term brain metastases survivors are at risk for neurologic morbidity after whole-brain radiotherapy (WBRT). Retrospective radiosurgery (RS) reports found no survival difference when compared with WBRT. Before RS alone was evaluated with delayed WBRT in a phase III trial, the feasibility of RS alone was tested prospectively.

Patients and Methods

Patients with renal cell carcinoma, melanoma, or sarcoma; one to three brain metastases; and performance status of 0 to 2 were enrolled. Exclusion criteria were leptomeningeal disease; metastases in medulla, pons, or midbrain; or liver metastases. On the basis of tumor size, patients received 24, 18, or 15 Gy RS. At recurrence, management was discretionary. The primary end point was 3- and 6-month intracranial progression.

Results

Between July 1998 and August 2003, 36 patients were accrued; 31 were eligible. Median follow-up was 32.7 months and the median survival was 8.3 months (95% CI, 7.4 to 12.2). Three- and 6-month intracranial failure with RS alone was 25.8% and 48.3%. Failure within and outside the RS volume, when in-field and distant intracranial failures were scored independently, was 19.3% and 16.2% (3 months) and 32.2% and 32.2% (6 months), respectively. Approximately 38% of patients experienced death attributable to neurologic cause. There were three grade 3 toxicities related to RS.

Conclusion

Intracranial failure rates without WBRT were 25.8% and 48.3% at 3 and 6 months, respectively. Delaying WBRT may be appropriate for some subgroups of patients with radioresistant tumors, but routine avoidance of WBRT should be approached judiciously.
Bexarotene and Erlotinib for Aerodigestive Tract Cancer
Authors: Dragnev Konstantin H. , Petty W. Jeffrey , Shah Sumit , Biddle Adrian , Desai Neil B. , Memoli Vincent , Rigas James R. , Dmitrovsky Ethan
Published: November 2005

Purpose

The epidermal growth factor receptor (EGFR) and cyclin D1 are overexpressed in lung carcinogenesis. The rexinoid, bexarotene, represses cyclin D1 and EGFR expression in vitro. It was hypothesized that combining bexarotene with the EGFR inhibitor, erlotinib, would augment clinical activity.

Patients and Methods

In vitro studies and a phase I clinical trial were performed. Twenty-four patients with advanced aerodigestive tract cancers were enrolled; 79% had non–small-cell lung cancer (NSCLC). The primary objective was to determine the maximum-tolerated dose. Clinical activity was a secondary objective.

Results

Combining erlotinib with bexarotene enhanced growth suppression in vitro compared with each single-agent treatment. This cooperatively repressed cyclin D1 expression. Clinically, the most frequent toxicities were mild hypertriglyceridemia and skin rash. Two serious treatment-related adverse events occurred (creatine phosphokinase elevation attributed to antilipid therapy and a case of generalized pain). Five objective responses (four partial and one minor) were observed in NSCLC patients. Responses were observed in males and smokers. EGFR sequence analyses did not reveal activating mutations in tumors from assessable responding patients. Median time to progression was 2.0 months; overall survival time was 14.1 months; and 1-year survival rate was 73.8%.

Conclusion

The recommended phase II doses are erlotinib 150 mg/d and bexarotene 400 mg/m2/d orally. These agents can be administered in combination at the recommended single-agent doses without added toxicity. Overall survival and clinical features of responding patients differ from prior reports of single-agent erlotinib treatment. These findings are encouraging and warrant further investigation of this regimen.
Phase I Study of Capecitabine With Concomitant Radiotherapy for Patients With Locally Advanced Pancreatic Cancer: Expression Analysis of Genes Related to Outcome
Authors: Saif M. Wasif , Eloubeidi Mohammaed A. , Russo Suzanne , Steg Adam , Thornton Jennifer , Fiveash John , Carpenter Mark , Blanquicett Carmello , Diasio Robert B. , Johnson Martin R.
Published: November 2005

Purpose

To establish the feasibility of capecitabine with concurrent radiotherapy (XRT) in patients with locally advanced (LA) pancreatic cancer and evaluate the effect of XRT on thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), and tumor necrosis factor-alpha (TNF-α).

Patients and Methods

Fifteen patients with LA pancreatic cancer received three-dimensional conformal XRT to a dose of 50.4 Gy with capecitabine at escalating doses from 600 to 1,250 mg/m2 bid (Monday through Friday). Following chemo-XRT, stable and responding patients were treated with capecitabine 2,000 mg/m2 orally bid for 14 days every 21 days. Tumor specimens were procured with endoscopic ultrasound–guided fine-needle aspiration 1 week before and 2 weeks after chemo-XRT to evaluate TP, DPD, and TNF-α mRNA levels.

Results

Dose-limiting grade 3 diarrhea was observed in two of six patients treated at a capecitabine dose of 1,000 mg/m2 with XRT. Three patients (20%) achieved partial response. Mean percent difference in TP pre- and post-XRT was 119.2% (P = .1934). There was no significant differences in mean TNF-α, or DPD levels pre- and post-XRT (P = .1934 and .4922, respectively). TP and TNF-α levels were not significantly correlated both at pre- and post-XRT (P = .670 and P < .154, respectively). Median value of TP:DPD ratios at baseline was 2.65 (range, 0.36 to 11.08). No association between TP:DPD ratio and efficacy of capecitabine or severity of toxicities was identified.

Conclusion

The recommended dose for phase II evaluation is capecitabine 800 mg/m2 bid (Monday through Friday) with concurrent XRT. This approach offers an easy alternative to intravenous fluorouracil as a radiosensitizer in these patients. Role of TP and TP:DPD ratio warrants further investigation in a larger clinical trial.