Introduction and Objectives: Our Phase I adenovirus/PSA vaccine trial has proved that this vaccine is safe. We are conducting a Phase II clinical trial with two separate protocols for patients with recurrent or hormone refractory prostate cancer assessing toxicity, immune responses, and changes in PSA levels. Methods: In Protocol #1 men with recurrent prostate cancer following definitive initial treatment for their disease were placed in one of two arms: Arm A; men receive the vaccine alone at days 0, 30, and 60; Arm B; men receive the vaccine 14 days after the initiation of androgen deprivation therapy (ADT). In Protocol #2 men with hormone refractory disease receive the vaccine alone using the same 3 injection schedule. Each injection consists of 108 pfu of the Ad/PSA vaccine suspended in a collagen matrix. All patients return at regular intervals for physical, chemical, radiologic, and immunologic evaluations. Results: To date forty four patients have been enrolled and have been followed a median of 12 months. The patients have a median age of 71.3 years, and median enrollment PSA levels of 0.62 ng/ml in Protocol #1 and 5.45 ng/ml in Protocol #2. In our preliminary results at this early stage of the trial, 100% of the patients in Protocol #1 and 67% of the patients in Protocol #2 demonstrated anti-PSA T cell responses above preinjection levels. Sixty four percent of the patients demonstrated an increase in PSA doubling time (PSADT). Conclusions: In an attempt to follow up on the success of our Phase I clinical trial of the Ad/PSA vaccine we have initiated a Phase II trial to investigate the therapeutic efficacy of the vaccine in men with recurrent prostate cancer, either following definitive therapy prior to other treatments or hormone refractory. Early results from the first four four patients demonstrate the induction of anti-PSA T cells responses in a high percentage of the vaccinated patients and increase in PSADT in more than half of the patients. No serious vaccine-related toxicities have been identified in the patients. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 2692. doi:1538-7445.AM2012-2692
This study aimed to identify differences between adolescent cancer survivors who participate in postsecondary education and those who do not, as well as factors that helped these survivors to cope. American College Testing records for 129,824 adolescents were meshed with Iowa's Cancer Registry to identify Iowans who had received a diagnosis of cancer between the ages of 12 and 17 years. The potential subject pool contained 85 persons. A questionnaire was sent to the 28 persons who agreed to participate in the study, and 75% responded. Most of the respondents were girls with normal levels of physical function. Measures of adjustment and mood state indicated low distress levels. Fatigue was their area of highest distress. All the respondents were enrolled in education programs or had graduated. Help from family, friends, and teachers was seen as supportive, but lack of knowledge about their disease was cited most frequently by this same group as interfering with their coping. The respondents demonstrated more discipline, stamina, and commitment than was expected. However, the accrual protocol and respondents' comments revealed a stigmatization of patients with cancer by professional health workers, indicating a need to confront the value that health professionals place on this stigmatized population and health professionals' contribution to this societal posture.
BUIldIng THE BUSInESS CASEThe idea of adding primary care to existing occupational health services evolved after it became clear ABSTRACT This article describes the process used by a large u.S. manufacturing company to successfully integrate full-service primary care centers at two locations. The company believed that by providing employees with health promotion and disease prevention services, including screening, early diagnosis, and uncomplicated illness treatment, its health care costs could be significantly reduced while saving employees money. To accurately demonstrate the cost-effectiveness of adding primary care to existing occupational health services, a thorough financial analysis projected the return on investment (rOI) of the program. Decisions were made about center size, the scope of services, and staffing. A critical part of the rOI analysis involved evaluating employee health claim data to identify the actual cost of health care services for each center and the projected costs if the services were provided on-site. The pilot initiative included constructing two onsite health center facilities staffed with primary care physicians, nurse practitioners, physical therapists, and other health care professionals. Key outcome metrics from the pilot clinics exceeded goals in three of four categories. In addition, clinic use after 12 months far exceeded benchmarks for similar clinics. Most importantly, the pilot clinics were operating with a positive cash flow within the first year and demonstrated an increasingly positive rOI.
As hospital nuclear medicine departments were established in the 1960s and 1970s, each department developed detailed policies and procedures to meet the specialized and specific handling requirements of radiopharmaceuticals. In many health systems, radiopharmaceuticals are still unique as the only drugs not under the control of the health system pharmacy; however, the clear trend-and now an accreditation requirement-is to merge radiopharmaceutical management with the overall health system medication management system. Accomplishing this can be a challenge for both nuclear medicine and pharmacy because each lacks knowledge of the specifics and needs of the other field. In this paper we will first describe medication management standards, what they cover, and how they are enforced. We will describe how we created a nuclear medicine and pharmacy team to achieve compliance, and we will present the results of their work. We will examine several specific issues raised by incorporating radiopharmaceuticals in the medication management process and describe how our team addressed those issues. Finally, we will look at how the medication management process helps ensure ongoing quality and safety to patients through multiple periodic reviews. The reader will gain an understanding of medication management standards and how they apply to nuclear medicine, learn how a nuclear medicine and pharmacy team can effectively merge nuclear medicine and pharmacy processes, and gain the ability to achieve compliance at the reader's own institution. Modernnucl ear medicine was born about 50 y ago with patenting of the Anger scintillation camera (1961) and introduction of 99m Tc as an ideal medical tracer (1960) (1,2). Most of the growth in nuclear medicine over the last half century has been the direct result of the introduction of new radiopharmaceuticals. Many of these agents (hepatobiliary agents, bone tracers, sestamibi, macroaggregated albumin, 18 F-FDG, and others) were revolutionary advances in functional imaging, leading to clinical use of multiple radiopharmaceuticals in most nuclear medicine departments. Many nuclear medicine procedures also use a variety of nonradioactive drugs (pharmacologic stress agents, cholecystokinin analog, furosemide, and others). As a result, most health system nuclear medicine departments today routinely dispense dozens of different radiopharmaceuticals and other medications (Fig. 1).Historically, radiopharmaceuticals have been managed separately from other medications in many health systems. Because of their radioactivity, radiopharmaceuticals require special handling within the medication use process and their own special procedures and safeguards to ensure safe and effective use. As nuclear medicine departments were established and evolved, many developed their own radiopharmaceutical policies and procedures intended to avoid improper administration and ensure safe use. Concurrently, many health system pharmacy departments, working hard to meet increasingly rigorous and expanding standards, have ...
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