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Biomedical subjects

Jamie H Von Roenn

Publications and source records attributed to Jamie H Von Roenn.

15 recordsLinked to original sources
PubMed2006

Testosterone supplementation of megestrol therapy does not enhance lean tissue accrual in men with human immunodeficiency virus-associated weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.

CONTEXT: Reduced energy intake is a primary factor in HIV-associated wasting. Megestrol acetate (MA) stimulates appetite and weight gain. However, much of the weight gained is fat, possibly as a result of MA-induced hypogonadism. OBJECTIVE: The objective of the study was to determine whether coadministration of testosterone with MA could enhance lean body mass (LBM) accrual and evaluate the effects of MA, alone or combined with testosterone, on sexual functioning and the hypothalamic-pituitary-adrenal axis. DESIGN: This was a randomized, double-blind, placebo-controlled, multicenter trial. SETTING: Fourteen AIDS Clinical Trials Units in the United States participated in the study. SUBJECTS: Seventy-nine HIV-positive men with 5% or more weight loss or body mass index less than 20 kg/m2 took part in the study. INTERVENTION: Subjects were randomized to receive MA (800 mg daily) plus testosterone enanthate (200 mg; MA/TE; n = 41) or placebo (MA/PL; n = 38) biweekly for 12 wk. MAIN OUTCOME MEASURES: Weight, body composition (bioelectric impedance analysis), adrenal and gonadal hormones, and sexual functioning (questionnaire) were measured. RESULTS: Both groups experienced robust increases in weight (median 5.3 and 7.3 kg in MA/TE and MA/PL, respectively), LBM (3.3 and 3.3 kg), and fat (3.0 and 3.8 kg). There were no significant differences between groups in the magnitude or composition of weight gain (P = 0.44, 0.90, and 0.11 for weight, LBM, and fat, respectively). Trough testosterone concentrations decreased to a greater extent in MA/PL (-12.3 vs. -6.1 nmol/liter in MA/TE; P = 0.04). Cortisol levels became nearly undetectable in subjects with plasma MA levels greater than 150 ng/ml. Sexual functioning was preserved with MA/TE but worsened in MA/PL. CONCLUSIONS: MA produced robust weight gain. Coadministration of testosterone preserved sexual functioning but did not enhance LBM accrual.

Adult↗
PubMed2006

Interferon-alpha2b with protease inhibitor-based antiretroviral therapy in patients with AIDS-associated Kaposi sarcoma: an AIDS malignancy consortium phase I trial.

We evaluated the safety and maximum tolerated dose of interferon (IFN)-alpha2b in combination with protease inhibitor-based highly active antiretroviral therapy (HAART) in a phase 1 study in 14 patients with AIDS-associated Kaposi sarcoma (KS). Planned IFN dose levels were 0, 1, 5, 10, and 15 million IU administered by daily subcutaneous injection. Dose-limiting toxicities were neutropenia and malaise. The maximum tolerated IFN dose was 5 million IU/d. The median CD4 count increased from 260 cells/muL at baseline to a maximum on-study value of 359 cells/muL. In 6 patients with paired baseline and on-study values, the median HIV RNA level decreased from 20,179 copies/mL to a minimum on-study value of 309 copies/mL. Of 13 patients whose KS response could be evaluated, 5 showed objective tumor regression. Responses occurred in HAART-experienced and HAART-naive subjects. Five patients, including 2 responders, 2 with stable KS, and 1 with progression, had serial measurements of Kaposi sarcoma herpesvirus (KSHV) load. None of these patients, irrespective of treatment arm or KS response, showed durable clearance of KSHV from plasma or peripheral blood mononuclear cells. This study establishes a safe dose of IFN that can be used with HAART and, potentially, with other inhibitors of KS in future clinical trials.

AIDS-Related Opportunistic Infections↗
PubMed2005

Control of common, non-pain cancer symptoms.

Despite major advances in cancer biology and therapeutics, cancer and its treatment continue to cause devastating suffering. Patients with advanced cancer most often experience multiple physical and psychological symptom concurrently. We review here some of the common non-pain cancer symptoms, focusing on the assessment and treatment of fatigue, anorexia and cachexia, dyspnea, and symptoms common near the end of life.

Anorexia↗
PubMed2005

Defining higher order dimensions of self-reported health: further evidence for a two-dimensional structure.

We illustrate a method for understanding the extent to which a pool of fairly diverse health status questions can be examined for their dimensionality, by first fitting the data to a unidimensional measurement model, then examining item fit and residual factor analysis to determine the pattern of deviations from unidimensionality. We simultaneously administered five questionnaires to 1,714 people with cancer and HIV disease and combined all responses into one analysis. Item responses were cocalibrated onto one presumed underlying construct, often referred to as health-related quality of life (HRQOL). To identify significant, higher order substructures in the data, we then conducted a factor analysis of the data residuals, revealing two definable higher order dimensions: physical well-being and mental well-being. These results agree with other research and provide direction for further studies defining these dimensions within an item response theory (IRT) tradition.

Adolescent↗
PubMed2005

Final results of a phase II trial of preoperative TAC (docetaxel/doxorubicin/cyclophosphamide) in stage III breast cancer.

BACKGROUND: The use of preoperative chemotherapy for breast cancer has been demonstrated to result in similar disease-free survival (DFS) and overall survival (OS) as postoperative adjuvant chemotherapy. Additionally, the rate of pathologic complete response (pCR) in the breast after preoperative chemotherapy has been shown to correlate with survival. The objective of this study was to determine the pCR rate in patients with stage III breast cancer treated with 4 cycles of TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) on day 1 before surgery. PATIENTS AND METHODS: From November 1998 through August 2001, we treated 40 patients (mean age, 47 years) with stage III breast cancer with TAC administered every 3 weeks for 4 cycles. RESULTS: We now report follow-up at 24 months. Responses were seen in 83% of patients, with 25% experiencing a clinical complete response, of which 4 patients (10%) had pCRs. At a follow-up of 2 years, data on DFS and OS are available on 37 patients: 12 patients (38%) had disease progression, and 7 patients (21%) had died. Despite the use of prophylactic ciprofloxacin, some degree of myelosuppression was seen in all patients, with 24 patients (63%) experiencing grade 3/4 neutropenia. CONCLUSION: Based on the pCR rate seen in this trial, docetaxel given concomitantly with AC (doxorubicin/cyclophosphamide) for 4 cycles does not appear to be superior to 4 cycles of AC as preoperative treatment for stage III breast cancer. Based on other trials, longer durations of therapy and/or sequencing of AC and docetaxel may result in a higher pCR rate.

Adult↗
PubMed2004

Phase II trial of infusional cyclophosphamide, doxorubicin, and etoposide in patients with HIV-associated non-Hodgkin's lymphoma: an Eastern Cooperative Oncology Group Trial (E1494).

PURPOSE: To determine the effectiveness of an infusional chemotherapy regimen in patients with HIV-associated lymphoma treated before and after the use of highly active antiretroviral therapy (HAART) in routine clinical practice. PATIENTS AND METHODS: Ninety-eight assessable patients with HIV-associated intermediate- or high-grade non-Hodgkin's lymphoma received cyclophosphamide 200 mg/m(2)/d, doxorubicin 12.5 mg/m(2)/d, and etoposide 60 mg/m(2)/d (CDE) given by continuous intravenous infusion for 4 days (96 hours) every 4 weeks plus filgrastim. Concurrent antiretroviral treatment consisted of the nucleoside analog didanosine in the first 43 patients enrolled before December 1996 (pre-HAART group), or HAART in the remaining 55 patients enrolled after that time (HAART group). RESULTS: Complete response occurred in 44 patients (45%; 95% CI, 35% to 55%). Failure-free survival and overall survival (OS) at 2 years was 36% (95% CI, 26% to 46%) and 43% (95% CI, 33% to 53%), respectively. At the time of the analysis, 30% in the pre-HAART group were alive compared with 47% in the HAART group; when adjusted for varying length of follow-up, patients in the HAART group had improved OS (P =.039). Patients in the HAART group experienced less grade 4 nonhematologic toxicity (22% v 42%; P =.037), thrombocytopenia (31% v 52%; P =.033), and anemia (9% v 27%; P =.021), and had fewer treatment-associated deaths (0% v 10%; P =.013). CONCLUSION: Infusional CDE is an effective and potentially curative regimen for patients with HIV-associated lymphoma. Patients treated in the HAART era have less chemotherapy-associated toxicity and improved survival.

Adult↗
PubMed2004

Symptom management in the older adult.

Palliative care begins at the time of diagnosis of a life-threatening illness and continues beyond the time of death. Defined in the broadest sense, the goal of palliative care is to provide aggressive symptom management and address the psychological and spiritual needs of the patient and the family. This article reviews the management of some symptoms commonly observed in older patients, highlighting treatment considerations specific to the older population. Ultimately the approach to symptoms must be individualized, and treatment decisions must reflect the patient's goals of care. Although symptom management in older patients may be challenging, it is possible to provide care that significantly enhances quality of life throughout the course of illness.

Aged↗
PubMed2003

Clinical presentations and standard therapy of AIDS-associated Kaposi's sarcoma.

The treatment plan for a patient with AIDS-related KS should be based on tumor characteristics, control of HIV infection, comorbidities, and patient treatment goals (see Table 1). Institution of optimal antiretroviral therapy is an essential component of KS therapy. When available, enrollment in a clinical trial should be considered, except for patients who are naive to chemotherapy with symptomatic or life-threatening KS. For a patient with minimal, indolent cutaneous disease, after optimal control of HIV replication, local treatment, investigational treatment, or interferon are reasonable considerations. For the patient with rapidly progressive, cutaneous disease, tumor-related symptoms, or visceral disease, cytotoxic chemotherapy in combination with antiretroviral therapy is the first consideration. Future advances undoubtedly will include pathogenesis-based agents, either alone or in combination with currently available cytotoxic therapy.

AIDS-Related Opportunistic Infections↗
PubMed2003

Should symptoms be scaled for intensity, frequency, or both?

OBJECTIVE: This study evaluated the comparability of two 5-point symptom self-report rating scales: Intensity (from "not at all" to "very much") and Frequency (from "none of the time" to "all of the time"). Questions from the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue 13-item scale was examined. METHODS: Data from 161 patients (60 cancer, 51 stroke, 50 HIV) were calibrated separately to fit an item response theory-based rating scale model (RSM). The RSM specifies intersection parameters (step thresholds) between two adjacent response categories and the item location parameter that reflects the probability that a problem will be endorsed. Along with patient fatigue scores ("measures"), the spread of the step thresholds and between-threshold ranges were examined. The item locations were also examined for differential item functioning. RESULTS: There was no mean raw score difference between intensity and frequency rating scales (37.2 vs. 36.4, p = n.s.). The high correlation (r = .86, p < .001) between the intensity versus frequency scores indicated their essential equivalence. However, frequency step thresholds covered more of the fatigue measurement continuum and were more equidistant, and therefore reduced floor and ceiling effects. SIGNIFICANCE OF RESULTS: These two scaling methods produce essentially equivalent fatigue estimates; it is difficult to justify assessing both. The frequency response scaling may be preferable in that it provides fuller coverage of the fatigue continuum, including slightly better differentiation of people with relatively little fatigue, and a small group of the most fatigued patients. Intensity response scaling offers slightly more precision among the patients with significant fatigue.

Chronic Disease↗
PubMed2002

Phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressive AIDS-related Kaposi's sarcoma: an AIDS Clinical Trials Group clinical study.

PURPOSE: Liposomal anthracyclines and paclitaxel are considered the best available cytotoxic therapies for Kaposi's sarcoma (KS), but relapse is common. To identify new interventions for relapsed or progressive KS, a phase II study of low-dose etoposide to assess its toxicity and efficacy was conducted. PATIENTS AND METHODS: Thirty-six patients with high-risk KS were treated with oral etoposide 50 mg/d for 7 consecutive days of every 2-week cycle. All patients' disease had relapsed or progressed after prior combination chemotherapy or anthracycline therapy. For patients without a complete or partial response after two cycles of therapy and no toxicity greater than grade 2, the dose of etoposide was escalated to 100 mg/d orally on days 1 to 7 of each 14-day cycle. Treatment-related and disease-specific quality of life was evaluated using patient reports on the General Health Self-Assessment Form and a KS-specific measure. RESULTS: One patient achieved a complete response, 12 patients had a partial response (overall response rate, 36.1%), and stable disease was observed in 12 patients (33.3%). Tumor responses were seen in all disease sites. Fourteen patients had their dose escalated, of whom five responded. The median time to response was 17.7 weeks; the median duration of response was 25 weeks. The most frequent hematologic abnormality was neutropenia, which was grade 4 in seven patients and grade 3 in six. Opportunistic infections occurred in eight patients during the treatment period. Both response to treatment and toxicity influenced patient-reported quality of life. CONCLUSION: We conclude that low-dose oral etoposide at a dose of 50 mg/d is safe and effective for the treatment of refractory or progressed AIDS-related KS and has an overall positive effect on the quality of life of responding patients.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Efficacy of low-dose interferon with antiretroviral therapy in Kaposi's sarcoma: a randomized phase II AIDS clinical trials group study.

We wished to evaluate the efficacy and safety of a low and an intermediate daily dose of interferon-alpha2b (IFN-alpha2b) with didanosine in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi's sarcoma (KS). HIV-seropositive subjects with biopsy-confirmed cutaneous KS were randomized to receive either a low (1 million IU) or an intermediate (10 million IU) dose of IFN-alpha2b once daily with twice daily doses of didanosine. Treatment assignment was stratified by CD4 count. Response, toxicity, changes in CD4 counts, and survival were evaluated. Sixty-eight eligible subjects were accrued, 35 to low-dose and 33 to intermediate-dose IFN-alpha2b. The response rate was 40% in the low-dose group (95% CI, 24-58) and 55% in the intermediate-dose group (95% CI, 36-72) (p = 0.338). The median response duration was approximately 110 weeks in both groups. Intermediate-dose IFN induced grade 3/4 neutropenia more often (21% vs. 3%, p = 0.048) and grade 3/4 toxicity faster (p = 0.0231) and necessitated treatment discontinuation earlier for drug-related toxicities (p = 0.0416) than low-dose IFN. There were no significant differences in survival between the treatment groups. Baseline CD4 count was the only significant factor predicting response. Once-daily low-dose and intermediate-dose IFN-alpha2b induced similar response rates, which were achieved without optimal antiretroviral therapy. The slightly higher response rate in the intermediate-dose group was offset by its significantly poorer tolerance. These findings justify the use of lower, well-tolerated IFN doses for treatment of KS with currently used antiretroviral regimens.

Acquired Immunodeficiency Syndrome↗