Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors.

In 2006, the IOM released a report citing the importance of "survivorship plans" to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, "Facing Forward: Life after Cancer Treatment." The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.

Phase II study of glucosamine with chondroitin on aromatase inhibitor-associated joint symptoms in women with breast cancer.

PURPOSE: Many women with hormone receptor-positive breast cancer discontinue effective aromatase inhibitor (AI) treatment due to joint symptoms. METHODS: We conducted a single-arm, open-label, phase II study evaluating glucosamine-sulfate (1,500 mg/day) + chondroitin-sulfate (1,200 mg/day) for 24 weeks to treat joint pain/stiffness in postmenopausal women with early stage breast cancer who developed moderate-to-severe joint pain after initiating AIs. The primary endpoint was improvement in pain/stiffness at week 24 assessed by the Outcome Measure in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) criteria. Secondary endpoints assessed changes in pain, stiffness, and function using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index for hips/knees and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) for hands/wrists. The Brief Pain Inventory (BPI) assessed pain interference, severity, and worst pain. RESULTS: Of 53 patients enrolled, 39 were evaluable at week 24. From baseline to week 24, 46 % of patients improved according to OMERACT-OARSI criteria. At week 24, there were improvements (all P < 0.05) in pain and function as assessed by WOMAC and M-SACRAH, and in pain interference, severity, and worst pain as assessed by BPI. Estradiol levels did not change from baseline. The most commonly reported side effects were headache (28 %), dyspepsia (15 %), and nausea (17 %). CONCLUSIONS: In this single-arm study, 24 weeks of glucosamine/chondroitin resulted in moderate improvements in AI-induced arthralgias, with minimal side effects, and no changes in estradiol levels. These results suggest a need to evaluate efficacy in a placebo-controlled trial.

Association between patient reported outcomes and quantitative sensory tests for measuring long-term neurotoxicity in breast cancer survivors treated with adjuvant paclitaxel chemotherapy.

Neurotoxicity is a common side-effect during taxane therapy. The prevalence and severity of long-term neurotoxicity following therapy is unknown. The authors conducted a cross-sectional study of 50 consecutive patients with stage I-III BC, who were within 6 months and 2 years of completing adjuvant taxane therapy and a prospective study of 50 women initiating taxane therapy. Patients in the cross-sectional study underwent a one-time evaluation while patients in the prospective study underwent evaluation at baseline, following therapy, and 3, 6, 9, and 12 months after completing therapy. Assessments included quantitative sensory testing (QST) for touch perception and vibration threshold and the FACT-GOG Neurotaxane (FACT/GOG-Ntx). For the cross-sectional study, 81% of the women reported symptoms of numbness and/or discomfort in the hands and/or feet in the past week. Severe symptoms were reported in 27% of patients for the hands and 25% for the feet. In the cross-sectional analysis, hand numbness/discomfort correlated with hand vibration QST. In the prospective study, the mean scores on the FACT/GOG-Ntx decreased from 37.5 to 28.7 post-treatment (P = 0.0002), and remained low 12 months after treatment. The changes in hand/foot numbness/discomfort were significantly associated with change in vibration threshold. No significant change was seen in touch perception. Numbness and discomfort in the hands and feet are common for up to 2 years following taxane therapy, and are associated with vibration threshold. The FACT/GOG-Ntx is an appropriate outcome measure for clinical trials evaluating ways to prevent long-term neurotoxicity in BC survivors.

Incidence and risk factors of intracranial atherosclerotic stroke: the Northern Manhattan Stroke Study.

BACKGROUND: To assess the prevalence of risk factors as determinants of intracranial atherosclerosis (IATH)-related stroke in a multi-ethnic community-based cohort. METHODS: The Northern Manhattan Stroke Study included a population-based incidence study and a nested case-control study. Incident cases of first ischemic stroke were 1:2 when matched to community controls by age, sex, and race/ethnicity. Vascular risk factors were assessed among controls and compared against the following stroke subtypes: IATH, extracranial atherosclerosis (EATH), and non-atherosclerotic (NATH: cardioembolic, lacunar, and cryptogenic). Conditional logistic-regression was used to determine the association between risk factors and stroke subtypes. RESULTS: The crude incidence of IATH was 8/100,000 per year and the relative incidence of IATH was higher than that of EATH in blacks (5.9 vs. 3.2/100,000 per year) and in Hispanics (5.0 vs. 1.7/100,000 per year). The IATH group had a higher prevalence of diabetes mellitus (DM; 67% IATH, 60% EATH, 48% NATH, and 23% controls; p < 0.05 IATH vs. control) and of metabolic syndrome (62% IATH, 40% EATH, 40% NATH, and 35% controls; p < 0.05 IATH vs. control). In multivariate analysis, DM conferred a higher risk for IATH versus NATH stroke (OR, 10.8; 95% CI, 2.0-57 vs. OR, 2.7; 95% CI, 1.9-3.9; p < 0.05) and much lower for EATH (OR, 6.2; 95% CI, 1.2-32). The metabolic syndrome conferred a higher risk for IATH stroke subtype (OR, 4.6; 95% CI, 1.1-18.7) when compared to EATH (OR, 2.3; CI, 0.6-9.1) and NATH (OR, 2.4; CI, 1.7-3.3). CONCLUSIONS: DM is a more important determinant for IATH-related stroke than EATH or NATH.

Chronic kidney disease is associated with white matter hyperintensity volume: the Northern Manhattan Study (NOMAS).

BACKGROUND AND PURPOSE: White matter hyperintensities have been associated with increased risk of stroke, cognitive decline, and dementia. Chronic kidney disease is a risk factor for vascular disease and has been associated with inflammation and endothelial dysfunction, which have been implicated in the pathogenesis of white matter hyperintensities. Few studies have explored the relationship between chronic kidney disease and white matter hyperintensities. METHODS: The Northern Manhattan Study is a prospective, community-based cohort of which a subset of stroke-free participants underwent MRIs. MRIs were analyzed quantitatively for white matter hyperintensities volume, which was log-transformed to yield a normal distribution (log-white matter hyperintensity volume). Kidney function was modeled using serum creatinine, the Cockcroft-Gault formula for creatinine clearance, and the Modification of Diet in Renal Disease formula for estimated glomerular filtration rate. Creatinine clearance and estimated glomerular filtration rate were trichotomized to 15 to 60 mL/min, 60 to 90 mL/min, and >90 mL/min (reference). Linear regression was used to measure the association between kidney function and log-white matter hyperintensity volume adjusting for age, gender, race-ethnicity, education, cardiac disease, diabetes, homocysteine, and hypertension. RESULTS: Baseline data were available on 615 subjects (mean age 70 years, 60% women, 18% whites, 21% blacks, 62% Hispanics). In multivariate analysis, creatinine clearance 15 to 60 mL/min was associated with increased log-white matter hyperintensity volume (beta 0.322; 95% CI, 0.095 to 0.550) as was estimated glomerular filtration rate 15 to 60 mL/min (beta 0.322; 95% CI, 0.080 to 0.564). Serum creatinine, per 1-mg/dL increase, was also positively associated with log-white matter hyperintensity volume (beta 1.479; 95% CI, 1.067 to 2.050). CONCLUSIONS: The association between moderate-severe chronic kidney disease and white matter hyperintensity volume highlights the growing importance of kidney disease as a possible determinant of cerebrovascular disease and/or as a marker of microangiopathy.