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OBJECTIVE - To collect and analyze quality-of-life (QOL) data from PROvenge Treatment and Early Cancer Treatment trial (PROTECT, NCT00779402), a phase III, randomized controlled trial of sipuleucel-T in patients with asymptomatic androgen-dependent prostate cancer.
METHODS - Patients experiencing prostate-specific antigen relapse after radical prostatectomy entered a 3- to 4-month run-in phase of androgen-deprivation therapy (ADT), followed by 2:1 randomization to sipuleucel-T or control. QOL was assessed throughout the run-in and 26-week post-randomization phases using the Brief Fatigue Inventory (BFI), Linear Analog Self-Assessment (LASA) scale, Global Rating of Change (GRoC) scale, and an elicited symptoms list.
RESULTS - One hundred seventy-six patients were randomized into 2 groups, the sipuleucel-T group (n = 117) or the control group (n = 59). The sample provided 80% power to detect a difference in fatigue interference score between treatment arms of 0.9 points. QOL declined predictably during ADT. At week 26, 26.2% of sipuleucel-T-treated patients and 21.6% of control-treated patients (P = .68) reported fatigue in the previous week, and the mean score for fatigue interference in the past 24 hours was 0.9 for both arms (P = .88). Results were comparable for usual fatigue (P = .91) and worst fatigue (P >.99). Mean LASA scores decreased in both groups (P = .26). The proportion of patients reporting better overall QOL on GRoC was similar (P = .62).
CONCLUSION - There is no clinically significant negative impact on QOL after sipuleucel-T treatment compared with control after a period of ADT in patients with asymptomatic androgen-dependent prostate cancer.
Copyright © 2013 Elsevier Inc. All rights reserved.
INTRODUCTION - Noninvasive methods are needed to detect distal sensory polyneuropathy in HIV-infected persons on antiretroviral therapy (ART).
METHODS - Quantitative sudomotor axon reflex test (QSART) and Utah Early Neuropathy Scale (UENS), small-fiber sensitive measures, were assessed in subjects with and without clinical neuropathy. Pain was assessed by visual analog scale (VAS).
RESULTS - Twenty-two subjects had symptoms and signs of neuropathy, 19 had neither, and all were receiving ART. Median sweat volume (μL) was lower at all testing sites in those with neuropathy compared to those without (p<0.01 for all). UENS and VAS (mm) were higher in neuropathy subjects (p<0.05 for each). Lower sweat volume at all sites correlated with higher pin UENS subscore, total UENS, and VAS (p<0.05 for all). In multivariable analyses adjusting for age, CD4⁺ T cells, sex, and use of "d-drug" ART, QSART and UENS remained associated (p=0.003).
CONCLUSION - QSART and UENS have not been previously studied in this patient population and may identify small-fiber neuropathy in HIV-infected, ART-treated persons.
Copyright © 2012 Elsevier B.V. All rights reserved.
Several studies recognized an overlap between CFS (chronic fatigue syndrome) and POTS (postural tachycardia syndrome). We compared the autonomic and neurohormonal phenotype of POTS patients with CFS (CFS-POTS) to those without CFS (non-CFS-POTS), to determine whether CFS-POTS represents a unique clinical entity with a distinct pathophysiology. We recruited 58 patients with POTS, of which 47 were eligible to participate. A total of 93% of them reported severe fatigue [CIS (Checklist of Individual Strength), fatigue subscale >36], and 64% (n=30) fulfilled criteria for CFS (CFS-POTS). The prevalence of CFS symptoms (Centers for Disease Control and Prevention criteria) was greater in the CFS-POTS group, but the pattern of symptoms was similar in both groups. Physical functioning was low in both groups (RAND-36 Health Survey, 40±4 compared with 33±3; P=0.153), despite more severe fatigue in CFS-POTS patients (CIS fatigue subscale 51±1 compared with 43±3; P=0.016). CFS-POTS patients had greater orthostatic tachycardia than the non-CFS-POTS group (51±3 compared with 40±4 beats/min; P=0.030), greater low-frequency variability of BP (blood pressure; 6.3±0.7 compared with 4.8±1.0 mmHg2; P=0.019), greater BP recovery from early to late phase II of the Valsalva manoeuvre (18±3 compared with 11±2 mmHg; P=0.041) and a higher supine (1.5±0.2 compared with 1.0±0.3 ng/ml per·h; P=0.033) and upright (5.4±0.6 compared with 3.5±0.8 ng/ml per h; P=0.032) PRA (plasma renin activity). In conclusion, fatigue and CFS-defining symptoms are common in POTS patients. The majority of them met criteria for CFS. CFS-POTS patients have higher markers of sympathetic activation, but are part of the spectrum of POTS. Targeting this sympathetic activation should be considered in the treatment of these patients.
OBJECTIVE - To report on the response to therapy in a patient with autoimmune autonomic ganglionopathy with a high titer of an autoantibody directed against the α-3 subunit of the nicotinic acetylcholine receptor (nAChR) of the autonomic ganglia.
DESIGN - Case report.
SETTING - University-based referral center for autonomic dysfunction.
PATIENT - Patient with prior indolent B-cell lymphoma who presented with symptomatic orthostatic hypotension and autonomic failure and was found to have a high titer of nAChR antibody.
INTERVENTION - Plasma exchange and rituximab therapy (both initial 4-week therapy and maintenance therapy).
MAIN OUTCOME MEASURES - Autonomic ganglionic antibody titer; the autonomic assessments were the presence of orthostatic hypotension, the concentration of plasma norepinephrine, and quantitative sweat testing.
RESULTS - Treatment with rituximab followed by plasma exchange significantly decreased the nAChR antibody titers for a short time, and then the titers increased. The titers suppressed to almost undetectable levels once regular maintenance therapy with rituximab was initiated. Reduction in nAChR antibody titer resulted in a decrease in orthostatic hypotension, an increased concentration of upright plasma norepinephrine, improvement in some sweat function, and improvement in symptoms.
CONCLUSIONS - Long-term rituximab therapy suppressed autoantibody production to undetectable levels over the course of 2 years and resulted in sustained clinical improvement in this patient with debilitating autoimmune autonomic ganglionopathy. More data are needed before rituximab therapy can be recommended as routine therapy for this disorder.
Menopausal symptoms (MPS) after breast cancer treatment are associated with reduced health-related quality of life (QOL) among Caucasian women. Little is known about whether MPS similarly impact QOL in Asian women with breast cancer. QOL was assessed by using the generic quality of life instruments, Medical Outcome Study of Quality of Life Inventory (MOSQOL-74) or Short Form-36 Health Survey (SF-36) in 4,976 Chinese participants of the Shanghai Breast Cancer Survival Study who were treated for incident, non-metastatic breast cancer within the 6 months before the study interview. Relationships between MPS and QOL were assessed by multiple linear regression, controlling for potential confounders. About 71.4% of study participants experienced MPS, including hot flashes, night sweats, vaginal dryness, depressed mood, and/or dry skin. Women with MPS reported lower overall QOL than women without MPS [mean scores 61.0 vs. 64.0, respectively (MOSQOL-74) and 54.9 vs. 66.9, respectively (SF-36); P < 0.01]. Adjusted mean differences (beta) in overall QOL in the presence and absence of MPS were -3.1 (95% CI -3.8, -2.4) with the MOSQOL-74 and -12.3 (95% CI -13.8, -10.9) with the SF-36. Women with any MPS had lower scores for the MOSQOL-74 physical and psychological domains and for the SF-36 social and emotional subscales than those without MPS (P < 0.05 for all). Having several MPS predicted poorer QOL in all domains measured regardless of the instrument used (P (trend) < 0.01 for all). Our study indicates that in Chinese women recently treated for breast cancer, MPS adversely impacts QOL. Actively soliciting and treating MPS in these women should significantly improve their QOL.
INTRODUCTION - Autonomic dysfunction has been theorized to be responsible for the increased risk of cardiovascular disease in obstructive sleep apnea (OSA). Previous studies did not control for the presence of impaired glucose regulation (IGR, comprising impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and diabetes) which is also associated with abnormalities in autonomic function.
METHODS - Thirty-two patients were recruited for the study. Patients underwent autonomic testing consisting of heart rate response to deep breathing, valsalva maneuver, tilt-up, and quantitative sudomotor axon reflex testing. Polysomnography (PSG) and a 2-h oral glucose tolerance test were performed. Results were analyzed with logistic regression, with age, race, body mass index (BMI), and gender as covariates.
RESULTS - Nineteen of 24 patients with OSA had abnormal glucose (79%, p=0.04) compared to two of nine patients without OSA. The correlation between IGR, OSA and total autonomic dysfunction was similar (p=.10 for IGR, p=0.06 for OSA). However, cardiac autonomic function was more strongly associated with IGR than OSA (p=.10 vs. 0.50). Age was a significant confounder, as glucose correlated with adrenergic autonomic dysfunction significantly when age was removed from the model (p=0.006).
CONCLUSIONS - The presence of IGR may be a confounding factor in studies of autonomic function in OSA. Larger studies are needed to delineate whether OSA is directly associated with autonomic dysfunction or whether the previously described association between dysautonomia and OSA may have been due to glucose dysregulation.