Citations

BACKGROUND: Four-meter gait speed (4MGS) has been associated with functional capacity and overall mortality in elderly patients, and may easily be translated to daily practice. We evaluated the association of 4MGS with meaningful outcomes. METHODS: In 70 subjects we conducted the 4MGS, 6-min walk test (6MWT), objectively measured physical activity, and assessed dyspnea, quality of life, and self-efficacy for walking and routine physical activity. 4MGS was measured in 3 separate time epochs during the 6MWT, to explore 4MGS variability. RESULTS: Diagnoses included COPD (51.4%), interstitial lung disease (38.6%), and other pulmonary conditions (10%). The mean ± SD values were: 4MGS 0.85 ± 0.21 m/s, 6-min walk distance (6MWD) 305 ± 115 m, and physical activity level 1.28 ± 0.17, which is consistent with severe physical inactivity. The gait speeds within the time epochs 1–2, 3–4, and 5–6 min during the 6MWT were not significantly different: 1.01 ± 0.29 m/s, 0.98 ± 0.31 m/s, and 1.00 ± 0.31 m/s, respectively. 4MGS had a significant correlation with 6MWD ( r = 0.70, P < .001). 6MWD was the dominant variable for predicting 4MGS. Other significant predictors of 4MGS included dyspnea, self-efficacy, quality of life, and objectively measured physical activity. CONCLUSIONS: 4MGS is significantly and independently associated with 6MWD, and may serve as a reasonable simple surrogate for 6MWD in subjects with chronic lung disease. Gait speed was remarkably stable throughout the 6MWT, which supports the validity of an abbreviated walk test such as 4MGS.

Objectively measured severe physical inactivity (SPI) has been reported as the strongest independent predictor of mortality in patients with chronic obstructive pulmonary disease (COPD). Activity monitoring is not feasible in routine clinical practice; therefore, we set out to determine the utility of simple clinical measures for predicting SPI in patients with COPD. A total of 165 patients with COPD wore an activity monitor for 5 days to define the presence or absence of SPI. Logistic models were generated including the modified Medical Research Council (MMRC) dyspnea grade, spirometry and the age–dyspnea–airflow obstruction (ADO) index. Physical Activity Scale for the Elderly (PASE) and Stanford Brief Activity Scale (SBAS) were also tested for validity and reliability in a subgroup of 67 patients. The MMRC dyspnea grade, PASE score, ADO index and SBAS score were associated with SPI, but general self-efficacy and spirometry were not. An MMRC dyspnea grade ≥3 was the best independent predictor of SPI (AUC: 0.74; PPV: 0.83; NPV: 0.68) followed closely by a PASE score of <111. The combination of MMRC dyspnea grade and PASE score provided the most robust model (AUC: 0.83; Positive Predictive Value (PPV): 0.95; Negative Predictive Value (NPV): 0.63). The results were confirmed using 5000 bootstrapped models from the cohort of 165 patients. MMRC dyspnea grade ≥3 may be the best triage tool for SPI in patients with COPD. The combination of the MMRC and PASE score provided the most robust prediction. Our results may have significant practical applicability for clinicians caring for patients with COPD.

Purpose Evidence has suggested a clinically meaningful relationship between self-reported quality of life (QOL) of a patient with cancer at the time of receiving a cancer diagnosis and overall survival (OS). This study evaluated the prognostic value of QOL assessments with regard to OS in a large cohort of patients with lung cancer. Patients and Methods A total of 2,442 patients with non–small-cell lung cancer were observed between 1997 and 2007 and completed a single-item measure of overall QOL within the first 6 months of receiving a lung cancer diagnosis; these were dichotomized using an a priori definition of a clinically deficient score (CDS; ≤ 50 v > 50). Kaplan-Meier estimates and Cox models were used to evaluate the prognostic importance of QOL on OS alone and in the presence of covariates. Logistic regression modeling was used to identify which clinical and patient characteristics were related to a clinically meaningful deficit in QOL. Results QOL deficits at time of lung cancer diagnosis were significantly associated with OS (hazard ratio [HR], 1.55; P < .001), as were performance status, older age, smoking history, male sex, treatment factors, and stage of disease. The median survival for patients with CDS QOL was 1.6 years versus 5.6 years for patients with non-CDS QOL. After controlling for all these covariates, the indication of a clinically deficient baseline QOL still contributed significantly to the prediction of patient survival (HR, 0.67; P < .001). Conclusion Overall QOL measured by a simple single item at the time of lung cancer diagnosis is a significant and independent prognostic factor for survival in patients with lung cancer.

Noncyclic breast pain is a common breast disorder prompting women to seek medical evaluation. We aimed to perform a pilot study on the relief of noncyclic breast pain using acupuncture. Thirty-seven women seen at a diagnostic breast clinic between April 2003 and January 2009 were enrolled. Treatment consisted of four acupuncture sessions over two weeks, with three months of follow-up. Response to treatment was measured with use of a breast pain questionnaire, a quality of life (QOL) questionnaire, and the Cleeland Brief Pain Inventory (BPI) assessed at baseline, end of treatment, and three months after treatment. Data were analyzed using standard descriptive statistics. Twenty-two patients completed four acupuncture sessions. Pain described as throbbing and heavy decreased significantly after acupuncture (p = 0.04 and p = 0.03, respectively). After treatment, pain scores (on the 10-point BPI scale) decreased by an average of 3.5 points for the worst pain during the previous month (p = 0.001), by 2.7 points for average pain (p < 0.001), and by 2.3 points for pain interference (p = 0.002). The percentage of patients reporting a clinically meaningful decrease of 2 points from baseline to the end of treatment included 67% (12/18) for the worst pain, 65% (11/17) for average pain, and 56% (10/18) for pain interference. QOL data showed no improvement in QOL measures (mental, physical, emotional, social, or spiritual well-being). The results of this preliminary study suggest that a randomized controlled trial may be warranted to evaluate the effect of acupuncture on noncyclic breast pain, as well as the optimal frequency of acupuncture treatments.

Abstract Background: Changes in cognitive function are commonly reported in breast cancer (BC) survivors. Longitudinal studies have only recently been completed and are few. In particular, long term studies are lacking. The purpose of this abstract is to describe self-reported cognitive changes in women before the start, or after the first cycle of chemotherapy, through 12 months. Methods: The data for this analysis were collected as part of a placebo-controlled randomized trial evaluating ginkgo biloba for the prevention of cognitive decline during adjuvant chemotherapy for BC. As there was no evidence that gingko biloba impacted cognitive function in any way, the sample was combined. Descriptive statistics were calculated to obtain the percent of women reporting worse perceived functioning or changes in their cognitive function at the start of chemotherapy, at the completion of treatment, and at 6, 12 and 24 months later (24 month data still being analyzed). 210 women, mostly white and mostly beginning anthracycline based chemotherapy, completed self report measures of cognition throughout the study. Women rated 10 areas of functioning by choosing a number from 1, signifying “functioning extremely less than normal”, to 7, signifying “extremely better than normal”. A score of 4 represented functioning perceived as “normal” for the respondent. Results: At baseline and after chemotherapy, the means for all 10 self reported cognitive items indicated “less than normal” functioning. Areas with the worst functioning included memory, ability to think clearly, staying focused, and planning ahead. At 6 and 12 months after chemotherapy, a percentage of participants reported worse functioning compared to baseline in every area. Changes in functioning are in the table below. Table 1 At 12 months, the mean for only 4 items indicated these areas were at “normal” functioning. These were the ability to learn, solve problems, react quickly and balance a checkbook. Discussion: For a subgroup of women, cognitive changes continue to worsen throughout 12 months and for many, perceived deficits remain. Areas most negatively impacted relate to attention, memory and executive function. Future research should focus on identifying predictors of worse functioning and continued research is needed to elucidate targets for intervention research to prevent unwanted cognitive changes. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-14-10.

Purpose The characteristics and natural history of the paclitaxel–acute pain syndrome (P-APS) and paclitaxel's more chronic neuropathy have not been well delineated. Methods Patients receiving weekly paclitaxel (70 to 90 mg/m 2 ) completed daily questionnaires and weekly European Organisation for Research and Treatment of Cancer (EORTC) Chemotherapy-Induced Peripheral Neuropathy (CIPN) –20 instruments during the entire course of therapy. Results P-APS symptoms peaked 3 days after chemotherapy. Twenty percent of patients had pain scores of 5 to 10 of 10 with the first dose of paclitaxel. Sensory neuropathy symptoms were more prominent than were motor or autonomic neuropathy symptoms. Of the sensory neuropathy symptoms, numbness and tingling were more prominent than was shooting or burning pain. Patients with higher P-APS pain scores with the first dose of paclitaxel appeared to have more chronic neuropathy. Conclusion These data support that the P-APS is related to nerve pathology as opposed to being arthralgias and/or myalgias. Numbness and tingling are more prominent chronic neuropathic symptoms than is shooting or burning pain.

Purpose Cumulative sensory neurotoxicity (sNT) is the dose-limiting toxicity of oxaliplatin, which commonly leads to early discontinuation of oxaliplatin-based therapy in the palliative and adjuvant settings. In a nonrandomized, retrospective study, intravenous (IV) calcium/magnesium (Ca/Mg) was associated with reduced oxaliplatin-induced sNT. Methods Patients with colon cancer undergoing adjuvant therapy with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) were randomly assigned to Ca/Mg (1g calcium gluconate plus 1g magnesium sulfate pre- and post-oxaliplatin) or placebo, in a double-blinded manner. The primary end point was the percentage of patients with grade 2 or greater sNT at any time during or after oxaliplatin-based therapy by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3) criteria. An oxaliplatin-specific sNT scale and patient questionnaires were also used to assess sNT. After 104 of 300 planned patients were enrolled, the study was closed. This was due to preliminary reports from another trial that suggested that Ca/Mg decreased treatment efficacy; these data were subsequently found to be incorrect. Results Overall, 102 patients were available for analysis. Ca/Mg decreased the incidence of chronic, cumulative, grade 2 or greater sNT, as measured by NCI CTCAE (P = .038) and also by the oxaliplatin-specific sNT scale (P = .018). In addition, acute muscle spasms associated with oxaliplatin were significantly reduced (P = .01) No effect on acute, cold-induced sNT was found. No substantial differences in adverse effects were noted between Ca/Mg and placebo. Conclusion Despite early termination and decreased statistical power, this study supports IV Ca/Mg as an effective neuroprotectant against oxaliplatin-induced cumulative sNT in adjuvant colon cancer.

Purpose Functional iron deficiency may impair response to erythropoiesis-stimulating agents (ESAs) in iron-replete patients with chemotherapy-associated anemia (CAA). This study evaluated whether coadministration of parenteral iron improves ESA efficacy in patients with CAA. Patients and Methods This prospective, multicenter, randomized trial enrolled 502 patients with hemoglobin (Hb) less than 11 g/dL who were undergoing chemotherapy for nonmyeloid malignancies. All patients received darbepoetin alfa once every 3 weeks and were randomly assigned to receive either ferric gluconate 187.5 mg intravenously (IV) every 3 weeks, oral daily ferrous sulfate 325 mg, or oral placebo for 16 weeks. Results There was no difference in the erythropoietic response rate (ie, proportion of patients achieving Hb ≥12 g/dL or Hb increase ≥ 2 g/dL from baseline): 69.5% (95% CI, 61.9% to 76.5%) of IV iron-treated patients achieved an erythropoietic response compared with 66.9% (95% CI, 59.1% to 74.0%) who received oral iron and 65.0% (95% CI, 57.2% to 72.3%) who received oral placebo (P = .75). There were also no differences in the proportion of patients requiring red cell transfusions, changes in quality of life, or the dose of darbepoetin administered. Adverse events (AEs) tended to be more common in the IV iron arm: grade 3 or higher AEs occurred in 54% (95% CI, 46% to 61%) of patients receiving IV iron compared with 44% (95% CI, 36% to 52%) who received oral iron and 46% (95% CI, 38% to 54%) who received oral placebo (P = .16). Conclusion In patients with CAA, addition of IV ferric gluconate to darbepoetin failed to provide additional benefit compared with oral iron or oral placebo.