Hospice care in a commercial preferred provider organization population in Tennessee.

This study was undertaken to examine two aspects of care at the end of life. First, we wanted to see whether the cost savings demonstrated repeatedly in the US Medicare hospice population would also be observed in a commercial population in Tennessee. They were. The second primary interest we had was whether there were certain medical services that seemed to presage death. We found four categories of services that profoundly increase in number as the end of life is approached: primary care, hospital-based specialist, non-hospital based specialist, and oncologist services. It is hoped that these findings could lead to a simple predictive model based on readily available claims data to help identify candidates for Hospice Care earlier.

Collecting subjective and rating scale data within a single case study design: cognitive behavioural therapy for a person experiencing psychosis.

This paper reports on a case study for a person with a diagnosis of schizophrenia using cognitive behavioural therapy. A range of scales was used to detect treatment effect and outcome. No significant clinical changes were detected using the scales, which are routinely used with such interventions. Subjective data were also collected in the form of a narrative, with the recipient of therapy identifying outcomes, which are not reflected within the rating scale data. Implications for practice include valuing the subjective experience reported by service users. The paper concludes that rating scale data and subjective accounts should be seen on an equal footing when evaluating specific therapeutic interventions.

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

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

m-BACOD treatment for intermediate- and high-grade malignant lymphomas: a Southwest Oncology Group phase II trial.

One hundred six eligible patients with advanced intermediate- or high-grade malignant lymphoma were treated with methotrexate with leucovorin rescue, bleomycin, doxorubicin, cyclophosphamide, vincristine, and dexamethasone (m-BACOD) in a Southwest Oncology Group phase II trial. Patients were stratified by estimated bone marrow reserve, and impaired marrow reserve patients received reduced doses of cyclophosphamide and doxorubicin. The complete remission rate for normal marrow reserve patients was 65%, while the complete remission rate for impaired marrow reserve patients was 29%. With a median follow-up period of 41 months, 64% of complete responders in the normal marrow group are disease-free 3 years after their response. Three-year survival is 61% in the normal marrow reserve group and is 29% in the impaired marrow reserve group. Eighty-seven percent of treatment courses were given in accordance with protocol dosing and schedule. For doxorubicin, relative dose intensities were 0.75 and 0.61 (normal and impaired marrow reserve arms, respectively), for cyclophosphamide, 0.76 and 0.61, and for methotrexate, 0.55 and 0.45. Serum lactic dehydrogenase (LDH) level was the only pretreatment characteristic found to have a significant effect on overall survival. Severe or greater toxicity occurred in 97% and 89% of the normal and impaired marrow reserve groups, respectively, with granulocytopenia the principal toxicity. Treatment-related fatalities occurred in 8% of patients. m-BACOD is an effective but toxic treatment program for intermediate- and high-grade malignant lymphomas.

Beta-interferon therapy in patients with poor-prognosis Kaposi sarcoma related to the acquired immunodeficiency syndrome (AIDS). A phase II trial with preliminary evidence of antiviral activity and low incidence of opportunistic infections.

STUDY OBJECTIVE: To study the efficacy of high doses of beta-ser-interferon (recombinant human 17-serine beta-interferon) in patients with human immunodeficiency virus (HIV) infection and Kaposi sarcoma. DESIGN: A nonrandomized, controlled trial of two high-dose regimens of beta-ser-interferon administered until tumor progression, toxicity, or an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection occurred. SETTING: An AIDS treatment clinic at a tertiary care center. PATIENTS: A sequential sample of 39 patients with biopsy-proven, AIDS-related Kaposi sarcoma were enrolled during a 2-year period. Thirty-eight patients were evaluable for response. Most patients (35 of 38) had one or more of the following clinical or laboratory predictors for a poor response to interferon therapy: HIV p24 antigenemia, low CD4 cell numbers, elevated beta 2-microglobulin levels, previous opportunistic infections, or previous systemic chemotherapy. INTERVENTIONS: Beta-ser-interferon was self-administered subcutaneously at home 5 days per week. The first 21 patients used 90 million IU/d, and the remainder used 180 million IU/d. MEASUREMENTS AND MAIN RESULTS: Six patients (16%) had a major clinical response, and 15 (39%) had stable disease for prolonged periods. Toxicities were minimal; the major toxicity was a skin reaction at the injection site. The HIV p24 antigen level declined more than 50% in 8 of the 19 patients with initial values greater than 50 pg/mL. Antiretroviral activity and antitumor activity were seen only in patients with normal initial beta 2-microglobulin levels. Minimal changes were seen in CD4 and CD8 cell numbers. Only 1 patient had an opportunistic infection while on study, but five other patients developed infections after treatment was discontinued for an incidence of six opportunistic infections in 285 patient-observation months. CONCLUSIONS: The high doses of interferon did not improve the major response rate in patients with poor-prognosis, AIDS-related Kaposi sarcoma. There was, however, a suggestion of antiviral activity in patients with normal beta 2-microglobulin levels and a decrease in the expected incidence of opportunistic infections.

A-phase II study of intravenous 6-thioguanine (NSC-752) in multiple myeloma. A Southwest Oncology Group study.

Thirty-three patients with relapsing or refractory multiple myeloma were treated with 6-Thioguanine (6TG) at a dose of 1 g/M2, with therapy given over four hours every three weeks. The major toxicity seen was myelotoxicity; thrombocytopenia was more commonly noted than neutropenia. One patient achieved a PR, two were clinically improved. 6TG in this short infusion schedule proved to be myelotoxic, but demonstrated little activity in previously treated myeloma patients.

Mitoxantrone, cisplatin, and methyl-glyoxal bis-guanylhydrazone chemotherapy for refractory malignant lymphoma: a Southwest Oncology Group phase II trial.

A phase II trial of combination chemotherapy with mitoxantrone, cisplatin, and methyl-glyoxal bix-guanylhydrazone (MGBG) was conducted in 32 patients with unfavorable histology malignant lymphoma. All patients had relapsed after only one prior chemotherapy regimen (CHOP--56%; mBACOD--28%). There were three complete and eight partial responses (overall response rate--34%) among 32 eligible patients. The median duration of remission was 6.0 months. Severe granulocytopenia was common, with 19/32 patients (63%) suffering life-threatening, and 1/32 (3%) suffering fatal, granulocytopenia. We conclude that mitoxantrone-cisplatin-MGBG has modest activity as salvage treatment in malignant lymphoma patients, but produces severe toxicity.

Magnetic field effects on surgical ligation clips.

Magnetic forces exerted on surgical clips and the magnetic resonance imaging distortion they create in phantoms and rabbits at magnetic field strengths of 1.5 Tesla were investigated. Results are reported for both ligation and aneurysm clips manufactured from three types of stainless steel as well as titanium, tantalum and niobium metals. Paramagnetism and eddy currents were measured in a customized moving Gouy balance. Direct measurements of other magnetic forces were carried out in a 1.5T MRI system. The titanium and tantalum clips showed the least interaction with the magnetic field, both in terms of forces exerted and the observed image distortion with the larger clips generating the larger interactions. The strongest field distortions and attractive forces occurred with 17-7PH stainless steel clips. These interactions were ferromagnetic in origin and of sufficient strength to present significant risk to patients having this type of clip present during an MRI scan.

Auger analysis of surface films on Ag3Sn.

The surface properties of Ag3Sn are important in the amalgamation process so that mechanical abrasion is generally necessary to get a satisfactory amalgam. Therefore, the present study was undertaken to characterize the surface of Ag3Sn after several types of surfaces treatments. Homogeneous polycrystalline rods of Ag3Sn were prepared in vacuo from high purity (99.99%) Ag and Sn. Specimens were sliced from these rods and prepared as follows: (1) mechanically polished, (2) polished as in (1) and allowed to sit in air for three days and (3) polished as in (1) and electrolytically etched. Each of these specimens was examined by Auger electron spectroscopy. The results showed that after mechanical abrasion the surface film was primarily oxide and the Ag to Sn ratio was lower than the bulk composition, indicating preferential oxidation of Sn. After sitting in air sulfur was also present on the surface and the Ag to Sn ratio was greater than that immediately after polishing, indicating the formation of Ag2S. After electrolytic etching some oxide was still present, but only a trace of sulfide was found. However, the Ag to Sn ratio was greater than that for mechanically polished specimens, indicating preferential dissolution of Sn. Therefore, it is seen that the surface preparation of Ag3Sn has a marked effect on Ag and Sn concentrations and the nature of films at the surface.