Median Weight Change Research Articles

Impact of a national treatment program in overweight adults women in primary care centers

Chile has a high prevalence of overweight and obesity and is important to implement and evaluate treatment and control strategies that are effective. To evaluate changes in nutritional status and fasting glucose in overweight women, pre-diabetic and/or pre-hypertension in primary care centers of public health sector. A retrospective cohort of the universe of women admitted to the program in the participating primary care centers for 18 months was studied. Intervention includes consultations and workshops with doctors, nutritionists, psychologists and physical therapists for 4 months, in primary heath center, promoting healthy eating and increased physical activity, not using drugs. Analysis of causes of admission, dropout, participation in scheduled activities and changes in baseline nutritional status and fasting glucose after 4 months of intervention. 1,528 women 18 to 65 years old, with initial BMI between 25 and 40 were studied and 1,222 completed treatment (71.6%). The median weight change was -3.9% (CI -4.1 to 3.7) of initial weight and -2.0 mg/dl (CI -2.0 to 1.0) of blood glucose. 36.8% of patient decreased ≥ 5% of initial weight, 12.5% of overweight and about one third of obese partly improved or normalized their nutritional status. There was significant reduction in the prevalence of pre-diabetes (16.6 to 8.8%, p < 0.001). The intervention was effective for good adhesion and impact in reducing cardiovascular risk factors as BMI, waist circumference and high fasting glucose. One challenge is to keep track of this population to ascertain the impact in the medium and long term.

Impacto de un programa nacional de tratamiento en mujeres adultas con exceso de peso en centros de atención primaria

Background: Chile has a high prevalence of overweight and obesity and is important to implement and evaluate treatment and control strategies that are effective. Objectives: To evaluate changes in nutritional status and fasting glucose in overweight women, pre-diabetic and/or pre-hypertension in primary care centers of public health sector. Material and methods: A retrospective cohort of the universe of women admitted to the program in the participating primary care centers for 18 months was studied. Intervention includes consultations and workshops with doctors, nutritionists, psychologists and physical therapists for 4 months, in primary heath center, promoting healthy eating and increased physical activity, not using drugs. Analysis of causes of admission, dropout, participation in scheduled activities and changes in baseline nutritional status and fasting glucose after 4 months of intervention. Results: 1,528 women 18 to 65 years old, with initial BMI between 25 and 40 were studied and 1,222 completed treatment (71.6%). The median weight change was -3.9% (CI -4.1 to 3.7) of initial weight and -2.0 mg/dl (CI -2.0 to 1.0) of blood glucose. 36.8% of patient decreased ≥ 5% of initial weight, 12.5% of overweight and about one third of obese partly improved or normalized their nutritional status. There was significant reduction in the prevalence of pre-diabetes (16.6 to 8.8%, p < 0.001). Conclusion: The intervention was effective for good adhesion and impact in reducing cardiovascular risk factors as BMI, waist circumference and high fasting glucose. One challenge is to keep track of this population to ascertain the impact in the medium and long term.

Weight Watchers on prescription: An observational study of weight change among adults referred to Weight Watchers by the NHS

BackgroundThe scale of overweight and obesity in the UK places a considerable burden on the NHS. In some areas the NHS has formed partnerships with commercial companies to offer weight management services, but there has been little evaluation of these schemes.This study is an independent audit of the Weight Watchers NHS Referral scheme and evaluates the weight change of obese and overweight adults referred to Weight Watchers (WW) by the NHS.MethodData was obtained from the WW NHS Referral Scheme database for 29,326 referral courses started after 2nd April 2007 and ending before 6th October 2009 [90% female; median age 49 years (IQR 38 - 61 years); median BMI 35.1 kg/m2 (IQR 31.8 - 39.5 kg/m2). Participants received vouchers (funded by the PCT following referral by a healthcare professional) to attend 12 WW meetings. Body weight was measured at WW meetings and relayed to the central database.ResultsMedian weight change for all referrals was -2.8 kg [IQR -5.9 - -0.7 kg] representing -3.1% initial weight. 33% of all courses resulted in loss of ≥5% initial weight. 54% of courses were completed. Median weight change for those completing a first course was -5.4 kg [IQR -7.8 - -3.1 kg] or -5.6% of initial weight. 57% lost ≥5% initial weight.ConclusionsA third of all patients who were referred to WW through the WW NHS Referral Scheme and started a 12 session course achieved ≥5% weight loss, which is usually associated with clinical benefits. This is the largest audit of NHS referral to a commercial weight loss programme in the UK and results are comparable with other options for weight loss available through primary care.

Exercise Program Adherence Using a 5-Kilometer (5K) Event as an Achievable Goal in People With Schizophrenia

People with schizophrenia have a higher prevalence of obesity than the general population. Many people with this illness struggle with weight gain, due, in part, to medications and other factors that act as obstacles to exercise and healthy eating. Several studies have shown the benefits of behavioral weight loss programs targeting eating and/or exercise in people with schizophrenia. Fewer studies have used competitive events as a goal for an exercise program. The current study tested the feasibility of preparing, using an exercise program, for a 5-kilometer (5K) event in people with schizophrenia. The exercise program was a 10-week training program consisting of three supervised walking/jogging sessions per week and a weekly educational meeting on healthy behaviors. Almost 65% (11/17) of the subjects participated in all of the training sessions, and 82% (14/17) participated in the 5K event. Participants did not gain a significant amount of weight during the exercise program (median weight change = 0.7 kg; 25th percentile 0.5, 75th percentile 3.9, p = .10). This study suggests that using an achievable goal, such as a 5K event, promotes adherence to an exercise program and is feasible in a population of people with chronic schizophrenia.

The Relationship Between Body Weight, Body Condition, and Survival in Cats with Heart Failure

Obese people with heart failure have improved survival compared with their normal or underweight counterparts. The purpose of this study was to determine if there is a relationship between body weight or body condition and survival in cats with heart failure. Body weight and body condition score (BCS) are predictors of survival in cats with heart failure. One-hundred and one cats with heart failure (International Small Animal Cardiac Health Council Classes II, IIIa, or IIIb) evaluated between March 2007 and June 2009. Data regarding initial body weight and BCS, subsequent changes in body weight, and treatment were collected from records and compared with survival times. Median initial body weight was 5.1 kg (range, 2.2-9.5 kg). Median BCS was 5 (range, 3-9). Of the 68 cats that were discharged from the hospital, median body weight change was 0.0 kg (range, -2.6 to +2.3 kg). Survival time for all 101 cats was 93 days (0-811 days). Survival could be predicted using a model combining initial body weight (P=.02), body weight squared (P=.02), and survival to discharge (P<.001) with a resulting global P value for this model of P<.0001. Cats with the lowest and highest body weights had reduced survival times compared with those with body weights in the intermediate ranges, suggesting a U-shaped relationship between body weight and survival. Additional research into the effects of body composition could help to determine optimal management of cats with heart failure.

The Obesity Paradox, Weight Loss, and Coronary Disease

Purpose Because obesity is a cardiovascular risk factor but is associated with a more favorable prognosis among cohorts of cardiac patients, we assessed this “obesity paradox” in overweight and obese patients with coronary heart disease enrolled in a cardiac rehabilitation and exercise training (CRET) program, making this assessment in patients classified as overweight/obese using both traditional body mass index (BMI) and percent body fat assessments. Additionally, we assessed the efficacy and safety of purposeful weight loss in overweight and obese coronary patients. Patients and Methods We retrospectively studied 529 consecutive CRET patients following major coronary events before and after CRET, and compared baseline and post program data in 393 overweight and obese patients (body mass index [BMI] ≥25 kg/m 2) divided by median weight change (median = −1.5%; mean +2% vs −5%, respectively). In addition, we assessed 3-year total mortality in various baseline BMI categories as well as compared mortality in those with high baseline percent fat (>25% in men and >35% in women) versus those with low baseline fat. Results Following CRET, the overweight and obese with greater weight loss had improvements in BMI (−5%; P <.0001), percent fat (−8%; P <.0001), peak oxygen consumption (+16%; P <.0001), low-density lipoprotein cholesterol (−5%; P <.02), high-density lipoprotein cholesterol (+10%; P <.0001), triglycerides (−17%; P <.0001), C-reactive protein (−40%; P <.0001), and fasting glucose (−4%; P = .02), as well as marked improvements in behavioral factors and quality-of-life scores. Those with lower weight loss had no significant improvements in percent fat, low-density lipoprotein cholesterol, triglycerides, C-reactive protein, and fasting glucose. During 3-year follow-up, overall mortality trended only slightly lower in those with baseline overweightness/obesity who had more weight loss (3.1% vs 5.1%; P = .30). However, total mortality was considerably lower in the baseline overweight/obese (BMI ≥25 kg/m 2) than in 136 CRET patients with baseline BMI <25 kg/m 2 (4.1% vs 13.2%; P <.001), as well as in those with high baseline fat compared with those with low fat (3.8% vs 10.6%; P <.01). Conclusions Purposeful weight loss with CRET in overweight/obese coronary patients is associated with only a nonsignificant trend for lower mortality but is characterized by marked improvements in obesity indices, exercise capacity, plasma lipids, and inflammation, as well as behavioral factors and quality of life. Although an “obesity paradox” exists using either baseline BMI or baseline percent fat criteria, these results support the safety and potential long-term benefits of purposeful weight loss in overweight and obese patients with coronary heart disease.

Exploratory study of the subcutaneous fat gene expression profile in patients with metastatic pancreatic carcinoma treated with standard gemcitabine chemotherapy regimen

e22220 Background: Most clinical trials are designed to assess the antitumor effect of the chemoterapeutic intervention. There are few examples where the endpoint is to assess the biology of the host response to the treatment of the tumor. A large number of patients with pancreatic cancer present features of the cachexia syndrome and specially a marked weight loss. It has been postulated that a “cytokine storm” is the cause of the profound effect that this cancer has on distant tissues. This trial analyzed changes in the subcutaneous fat gene expression profile in relation with the clinical benefit variable with standard gemcitabine (G) treatment. Methods: Patients with histology confirmed advanced pancreatic cancer, adequate organ function and written informed consent. Eligible pts were intended for a subcutaneous fat biopsy pretreatment and after 7 weeks of gemcitabine 1000 mg/m2 together with response assessment. Clinical benefit (CB) (pain, analgesic consumption, Karnofsky and weight), QLQ-C30, serum cytokines and tumor markers were evaluated pretreatment, at 4 and 8 weeks. Fat gene expression profile was analyzed using Affimetrix U133Plus2.0 with the corresponding bioinformatic software. Serum cytokines where analyzed with xMAP technology with the Luminex 200 platform. Results: 16 pts [8 m, 8 f, median age 62 yrs (range 47–72)]. Median weight change -0.75 kg (range -4.5 to 2). Nine pts had pre and post treatment biopsies and 7 only pretreatment. Three pts achieved CB at 8 weeks. Objective responses: 0 CR, 0 PR, 31% SD and 68%PD. Toxicity was similar to the one reported in gemcitabine's label. It was possible to extract quality RNA for microarray from subcutaneous fat use from all samples but 1. The limited number of samples precluded to obtain genes clearly involved in cachexia, however the IL-8 expression (p0.03) was significantly correlated with CB response either to gene and serum profile. Conclusions: It is feasible to study prospectively the impact of cancer treatment on different tissue biomarkers and correlated with standard antitumor evaluation system. The reduced number of samples in this exploratory trial precludes producing significant biological conclusions. No significant financial relationships to disclose.

Weight changes in breast cancer survivors who received adjuvant antiestrogen therapy

6588 Background: Antiestrogen therapy has dramatically improved breast cancer survival rates but weight gain may be problematic. Studies evaluating antiestrogen therapy-related weight gain have yielded mixed results. Our primary objective was to evaluate weight changes in female breast cancer survivors (BCS) who received adjuvant anti-estrogen therapy for stage 0-III breast cancer. Methods: A retrospective chart review was conducted to evaluate weight changes in female chemo naive BCS receiving anti-estrogen therapy. Weights at initiation of hormonal therapy and at 6, 12, 24, and 36 months of follow-up were recorded. Median weight changes were calculated and were compared with Wilcoxon's signed rank test or the Kurskall-Wallis test. Results: A total of 622 women were included. The majority were white (77%), had stage I disease (78%), and were postmenopausal (82%). The median age at diagnosis was 59 years (range, 26–87). Median weight at initiation of hormonal therapy among premenopausal women was 65 kg (range 45.4–122.9). Median weight gain in this group was 0.4 kg (p = 0.009), 0.7 kg (p = 0.013), 1.9 kg (p = 0.0001), and 2.4 kg (p &lt; 0.0001) at 6, 12, 24, and 36 months respectively. Among post-menopausal women, median weight at initiation of therapy was 71.7 kg (range 41.5–152.0) and median weight gain was 0.5 kg (p &lt; 0.0001), 1 kg (p &lt; 0.0001), 0.85 kg (p = 0.001), and 0.85 kg (p = 0.004) at 6, 12, 24, and 36 months respectively. Premenopausal patients had significantly more weight gain at 24 (p = 0.041) and 36 months (p = 0.005), as compared to postmenopausal patients. Among premenopausal women, 110/111 were treated with tamoxifen. Among post-menopausal women (n = 510), hormonal therapy was as follows: unknown n = 28 patients, tamoxifen n = 312, and AI n = 170. Overall, BCS treated with tamoxifen vs an AI had significantly more weight gain at 24 (p = 0.003) and 36 months (p = 0.009). Conclusions: Premenopausal patients are at higher risk for weight gain than postmenopausal patients. Further prospective research is warranted examining weight gain as a long-term side effect of anti-estrogen therapy in BCS. No significant financial relationships to disclose.

Marine phospholipids—a promising new dietary approach to tumor-associated weight loss

Advanced tumor disease very often evokes excessive loss of body weight. Among others, fish oil or marine fatty acid ethyl esters were investigated for treatment of cancer cachexia with controversial results. In this study, a new formulation of marine fatty acids was investigated, the marine phospholipids, with more than 50% of phospholipid-bound fatty acids being eicosapentaenoic and docosahexaenoic acid. Thirty-one tumor patients with various tumor entities suffering from weight loss were asked to take marine phospholipids (1.5 g/day) as softgel capsules for a period of 6 weeks. Compliance, body weight, appetite, and quality of life as well as the fatty acid profile in plasma and blood cells were monitored; 17 patients could be analyzed. Marine phospholipids were very well accepted; low-dose supplementation resulted in a significant increase of eicosapentaenoic and docosahexaenoic acid in plasma phospholipids; therefore, significantly reducing the n-6 to n-3 fatty acid ratio. A stabilization of body weight was achieved (median weight change of +0.6% after 6 weeks), while appetite and quality of life improved. These promising first results encourage further investigation of marine phospholipids in cancer care.

Weight effects associated with antipsychotics: A comprehensive database analysis

Background Available data on atypical antipsychotic-induced weight gain are limited by a number of methodological factors. The objective of this report is to evaluate short-term ( N = 1742) and long-term ( N = 1649) weight effects in patients receiving standard doses of amisulpride, haloperidol, olanzapine, risperidone, ziprasidone, and placebo based on 21 randomized, placebo-controlled, parallel-group studies from an integrated clinical trial database. Method Analyses of the integrated ziprasidone schizophrenia trials database were performed to estimate the weighted average of weight change and the percentage of subjects experiencing weight gain (or weight loss) across studies for each agent studied, based on fixed- and random-effects models. Durations of treatment exposure in long-term trials were controlled by well-defined time windows (6 month: 150 to 210 days; 1 year: 330 to 390 days). Weight gain or loss was defined using a 7% change from baseline threshold. Results During long-term therapy with 1-year treatment duration, incidence of weight gain for subjects treated with ziprasidone (17%) was not significantly different from the placebo (13%) or haloperidol (41%) groups based on 95% confidence interval. In contrast, significantly greater weight gain incidence was observed for the olanzapine (57%) and risperidone (39%) groups compared to placebo. Median weight change of + 0.49, − 0.18, + 1.50 and + 0.55 lb/month was observed for haloperidol, ziprasidone, olanzapine and risperidone subjects, respectively, indicating differential weight change patterns compared to placebo (− 0.32). Similar results were observed for the short-term (4–12 weeks) and 6-month treatment exposure cohorts. Conclusions Our results confirm significant differences in long-term weight effects among atypical antipsychotics, consistent with findings from prior meta-analysis of antipsychotic-induced weight gain [Allison, D.B., Mentore, J.L., Heo, M., Chandler, L.P., Capelleri, J.C., Infante, M.C., Weiden, P.J., 1999. Antipsychotic induced weight gain: a comprehensive research synthesis. Am J Psychiatry 156, 1686–1696] and the CATIE schizophrenia study [Lieberman, J.A., Stroup, T.S., McEvoy, J.P., et al., 2005. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 353, 1209–1223].

A Matched Cohort Pharmacoepidemiological Analysis of Steroid Free Immunosuppression in Renal Transplantation

This longitudinal, sequential, matched closed-cohort design pharmacoepidemiological analysis examined the influence of maintenance steroid therapy in 380 first graft recipients after renal transplantation under conditions of normal clinical practice. Nonexposed (steroid avoidance, n=190) and exposed (steroid treated, n=190) cohorts were matched 1:1 for key demographic factors, including donor source (living or deceased), diabetic status, panel reactive antibody level, recipient age (by decade), and sex. Cohorts were comparable for all variables except median human leukocyte antigen mismatch (4 vs. 3, P=0.03), use of tacrolimus (90.0% vs. 59.5%, P<or=0.0001), and of basiliximab (94.7% vs. 57.4%, P<or=0.0001), which were higher in the nonexposed cohort. Estimated glomerular filtration rate (mL/min/1.73 m) was comparable at 1 year (median: 58.1 vs. 58.3, P=0.92) and 2 years (median: 55.5 vs. 58.0, P=0.97) in nonexposed and in exposed cohorts (P=0.97). There was no difference in Kaplan-Meier estimates of biopsy-proven acute rejection (14.8% vs. 17.0%; hazard ratio: 0.88, P=0.60) or of 2-year death censored graft failure (4.7% vs. 3.2%; P=0.44) between nonexposed or exposed cohorts. Median total cholesterol (4.6 vs. 5.0 mmol/L, P=0.0002), low-density lipoprotein (2.6 vs. 2.8 mmol/L, P=0.005), high-density lipoprotein levels (1.1 vs. 1.3, P=0.0001), and median weight change from baseline (-1.7 vs. +1.0 kg, P=0.001) were significantly lower in the nonexposed cohort. Forty-five patients (29%) in the nonexposed cohort commenced steroid therapy, principally for graft dysfunction or acute rejection. In summary, steroid avoidance did not negatively impact 2-year graft function, biopsy-proven acute rejection rate, or short-term graft survival and offers clinical benefits, which weigh in the decision regarding maintenance therapy.

Enteral Feeding and Caloric Intake in Neonates After Cardiac Surgery

Adequate enteral nutrition may be difficult to achieve early in neonates after cardiac surgery, but it is essential for growth, wound healing, and immune function. To assess caloric intake in neonates receiving enteral nutrition after surgery. A retrospective chart review was conducted of daily enteral caloric intake in the cardiac intensive care unit of a tertiary children's hospital. Data on the institution of enteral feeding and the discontinuation of parenteral nutrition were assessed for full-term neonates who had undergone cardiac surgery. Caloric intake was assessed in 100 patients, 52 with biventricular cardiac defects and 48 with a functional single ventricle. The median duration of stay in the cardiac intensive care unit was 13 days (range, 4-69), and patients received enteral feeding exclusively for a median of 5 days (range, 1-43). In total, 705 patient days were evaluated. The median caloric intake per day was 93 kcal/kg (range, 43-142). A goal of 100 kcal/kg was achieved for 48.4% of patient days and 120 kcal/kg for only 19.7% of patient days. Median weight change for the period of enteral feeding was -20 g (range, -775 to 1485 g). Enteral feeding alone is often suboptimal after neonatal cardiac surgery. New strategies to improve caloric intake may enhance postoperative recovery.

Comparative study of rate of weight loss among premorbid and healthy restrictive eaters

Initial body mass index (BMI) and rate of weight loss are compared between cohorts of pathological and healthy dieters. The eating disordered sample consists of young adults reported in case studies in the past ten years with a primary diagnosis of anorexia nervosa (AN). The healthy dieters were adolescents who participated in the National Longitudinal Survey of Adolescent Health and indicated at the time of study enrollment that they were trying to lose weight. At diet initiation, the anorexic sample had a mean BMI (kg/m2) of 20.5 while the healthy dieters had a mean of 24.8. The median rate of weight loss was -1.87 kg per month (1 pound per week) for individuals later diagnosed with AN, while the median weight change was 0.24 kg per month for the Add Health dieters, reflecting an actual gain of 0.13 pounds per week. These findings suggest that measurable physiological characteristics during the early phase of a diet could be predictive of pathological food restriction.

C.06.02 Predictors of individual response and long-term compliance in schizophrenia treatment

Available data on atypical antipsychotic-induced weight gain are limited by a number of methodological factors. The objective of this report is to evaluate short-term (N = 1742) and long-term (N = 1649) weight effects in patients receiving standard doses of amisulpride, haloperidol, olanzapine, risperidone, ziprasidone, and placebo based on 21 randomized, placebo-controlled, parallel-group studies from an integrated clinical trial database.Analyses of the integrated ziprasidone schizophrenia trials database were performed to estimate the weighted average of weight change and the percentage of subjects experiencing weight gain (or weight loss) across studies for each agent studied, based on fixed- and random-effects models. Durations of treatment exposure in long-term trials were controlled by well-defined time windows (6 month: 150 to 210 days; 1 year: 330 to 390 days). Weight gain or loss was defined using a 7% change from baseline threshold.During long-term therapy with 1-year treatment duration, incidence of weight gain for subjects treated with ziprasidone (17%) was not significantly different from the placebo (13%) or haloperidol (41%) groups based on 95% confidence interval. In contrast, significantly greater weight gain incidence was observed for the olanzapine (57%) and risperidone (39%) groups compared to placebo. Median weight change of + 0.49, − 0.18, + 1.50 and + 0.55 lb/month was observed for haloperidol, ziprasidone, olanzapine and risperidone subjects, respectively, indicating differential weight change patterns compared to placebo (− 0.32). Similar results were observed for the short-term (4–12 weeks) and 6-month treatment exposure cohorts.Our results confirm significant differences in long-term weight effects among atypical antipsychotics, consistent with findings from prior meta-analysis of antipsychotic-induced weight gain [Allison, D.B., Mentore, J.L., Heo, M., Chandler, L.P., Capelleri, J.C., Infante, M.C., Weiden, P.J., 1999. Antipsychotic induced weight gain: a comprehensive research synthesis. Am J Psychiatry 156, 1686–1696] and the CATIE schizophrenia study [Lieberman, J.A., Stroup, T.S., McEvoy, J.P., et al., 2005. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 353, 1209–1223].

Weight change during chemotherapy as a potential prognostic factor for stage III epithelial ovarian carcinoma: A Gynecologic Oncology Group study

Objective Platinum/Paclitaxel-based chemotherapy is a current treatment for advanced epithelial ovarian cancer. We sought to explore the association between weight change during treatment and survival, as well as the association between pre-chemotherapy body mass index (BMI) and survival. Methods A retrospective data review was conducted of 792 advanced ovarian cancer patients who participated in a phase III randomized trial of cisplatin/paclitaxel versus carboplatin/paclitaxel. Pre-chemotherapy BMI was calculated following surgery. Weight change was defined as the ratio of body weight at completion of protocol therapy to pre-chemotherapy body weight. Progression-free survival (PFS) and overall survival (OS), classified by BMI or relative weight change, were estimated by Kaplan–Meier, and associations were assessed using a Cox model controlled for known prognostic variables (age, race, performance status, histology, tumor grade, tumor residual and treatment group). Results There was no association between pre-chemotherapy BMI and survival. There was a significant relationship between median OS and weight change as follows: > 5% decrease = 48.0 months; 0–5% decrease = 49.3 months; 0–5% increase = 61.1 months; and > 5% increase = 68.2 months. Adjusted for covariates, the relative risk of death increased by 7% for each 5% decrease in body weight (HR = 0.93, 95% CI = 0.88–0.99; p = 0.013). Conclusions Change of body weight during primary chemotherapy was a strong prognostic factor for overall survival. Loss of body weight during primary therapy is an indicator for poor OS; weight gain is an indicator for improved survival. This study supports the development of strategies to minimize weight loss that can be assessed in a prospective, randomized study to improve patient outcomes.

Acceleration of hyperfractionated chemoradiation regimen for advanced head and neck cancer

Our aim was to evaluate the acceleration of a hyperfractionated, concurrent chemoradiation regimen (HxCRT) for advanced head and neck squamous cell carcinoma (HNSCC). Patients with unresectable HNSCC were treated based on a previously published HxCRT regimen: 1.25 Gy twice daily to 70 Gy concurrent with cisplatin 12 mg/m(2)/day and 5-fluorouracil 600 mg/m(2)/day for 5 days, weeks 1, 5. This regimen was accelerated in this series by shortening the treatment from 7 to 6 weeks by omitting the planned mid-treatment 1-week break. Forty-six patients with T3-4/N3 disease were treated. The main acute toxicity was pharyngeal. Median weight change during therapy in patients with and without enteral feeding tubes was -3.8% and -7.9%, respectively (p = .08). Fifteen percent had late grade III pharyngeal toxicity. Local/regional and distant failure rates were 28% and 17%, respectively; 52% are alive without evidence of disease. In nonresectable HNSCC, acceleration of the HxCRT regimen is feasible, requiring enteral feeding tubes during therapy in most patients.

Change in patient weight during platinum/paclitaxel-based chemotherapy for ovarian cancer: A Gynecologic Oncology Group study

5073 Background: Platinum/paclitaxel (P)-based chemotherapy is current treatment (tx) for advanced epithelial ovarian cancer (EOC). Previous studies suggest this regimen may induce weight change, which is a surrogate for body reaction to tx and may predict quality of life and clinical outcomes. We sought to explore the association between weight change during treatment and survival. Methods: A retrospective data review was conducted of 792 patients who participated in a Gynecologic Oncology Group (GOG) phase III randomized treatment trial (GOG 158) using cisplatin (Cis)/P vs carboplatin (Carbo)/P in optimal stage III EOC. Pretreatment body mass index (BMI) was calculated based on patient height and weight following surgery. Weight change during tx was defined as the ratio of body weight at completion of protocol therapy to pretreatment body weight. Progression-free survival (PFS) and overall survival (OS), classified by BMI or relative weight change, were estimated by Kaplan-Meier, and the associations between BMI, relative weight change and PFS and OS were assessed using Cox model controlled for known prognostic variables. Results: The median BMI was 24.9. There was no significant difference in PFS or OS related to BMI; however, there was a significant relationship between median OS and weight change as follows: &gt;5% decrease = 48.0 months; 0–5% decrease = 49.3 months; 0–5% increase = 61.1 months; and &gt;5% increase = 68.2 months (p = 0.006). The relative risk of death increased by 7% for each 5% decrease in body weight (HR = 0.93, 95% CI = 0.88–0.99; p = 0.013) adjusted for covariates. Results suggest more evident weight loss in the Cis/P arm than the Carbo/P arm during the first cycle of tx (−2.2 kg vs. −1.2 kg), and decreased weight was more likely to return to pretreatment level in the Carbo/P arm. Conclusions: Loss of body weight, but not BMI, during platinum/P-based chemotherapy is an indicator for poor OS in EOC patients. Cis/P may be associated with more weight loss compared to Carbo/P. This exploratory study supports the development of treatment strategies that minimize weight loss-producing toxicities to improve outcomes in this patient population. No significant financial relationships to disclose.

Subcutaneous injection of depot medroxyprogesterone acetate compared with leuprolide acetate in the treatment of endometriosis-associated pain

To compare the efficacy and safety of SC depot medroxyprogesterone acetate (DMPA-SC 104) with that of leuprolide acetate in treatment of endometriosis. Phase 3, multicenter, randomized, evaluator-blinded, comparator-controlled trial. Clinical trial sites in Canada and United States. Two hundred seventy-four women with surgically diagnosed endometriosis. Intramuscular injections of DMPA-SC (104 mg) or leuprolide acetate (11.25 mg), given every 3 months for 6 months, with 12 months of posttreatment follow-up. Reduction in five endometriosis symptoms or signs (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, pelvic induration); change in bone mineral density (BMD), hypoestrogenic symptoms, bleeding, and weight. The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment (month 6) and in reducing all five symptoms after 12 months' follow-up (month 18). Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6, with scores returning to baseline at 12 months' follow-up. No statistically significant differences in median weight changes were observed between groups. Compared with leuprolide, DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding. Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain, with less impact on BMD and fewer hypoestrogenic side effects but more bleeding.

Evaluation of hospitalisation for Indigenous children with malnutrition living in Central Australia

To evaluate the effectiveness of hospital admissions for indigenous children with malnutrition in a rural/remote Australian centre. Retrospective review of the medical records. Rural secondary hospital. Remote and rural indigenous children aged less than four years managed for malnutrition in Alice Springs Hospital (ASH). The primary outcome measure was weight gain during hospitalisation and posthospitalisation. Secondary outcome measures were yield of investigations, diagnoses made, treatments given, social interventions, readmission rate and nosocomial infection. Median age of the 55 children was 15.1 months. Median weight change was 1.5 g day(-1)prior to hospitalisation, 36.7 g day(-1)during and 9 g day(-1)two months following hospitalisation (P < 0.05). Investigations performed had high yields (80% of children had a treatable organic contributor to malnutrition). Nosocomial infection occurred in 21 (38%) children. Readmission occurred at an average of 1.9 times per child (range 0-5), 34 (37%) occurred within three months and 48 (52%) within six months. In rural Indigenous children with malnutrition, hospitalisation was effective in re-establishing growth and defining organic contributors to malnutrition. However, the high readmission rate and nosocomial infection mandates that alternative models to nutritional rehabilitation, in addition to a broad psychosocial and public health approach to prevention and management of malnutrition, is required.

Zero pregnancies with new low dose depot medroxyprogesterone acetate subcutaneous injection for contraception

To assess efficacy, safety, and subject satisfaction with a new, low dose subcutaneous formulation of depot medroxyprogesterone acetate (DMPA-SC) contraceptive administered every 3 months (12–13 weeks). Two phase 3, open-label, noncomparator, multinational, multicenter 1-year studies were conducted; 1 in the Americas, the other in Europe and Asia. Sexually active, regularly menstruating women 18–49 years of age received DMPA-SC (104 mg) injection at 0, 13, 26, and 39 weeks. Subjects receiving ≥1 dose of study medication constituted the intent-to-treat (ITT) population. Subjects that successfully self-injected in the office were given the option of home self-injection for injections 3 and 4. Treatment failure cumulative pregnancy rate at 1 year was the primary endpoint. Safety endpoints included incidence of amenorrhea, irregular bleeding, and adverse events. Satisfaction with treatment was evaluated through a Patient Satisfaction Questionnaire (PSQ) at injection visit, weeks 25–27, and weeks 51–53, and an End of Treatment Questionnaire (EOTQ). The ITT population consisted of 722 and 1065 subjects in the Americas and European/Asian trials, respectively (BMI range, 14.7–57.7 kg/m2). None of the subjects in either trial became pregnant during 16,023 woman-cycles of exposure to DMPA-SC, excluding months in which barrier contraception was used at least sometimes or no intercourse occurred. Efficacy was independent of BMI or administrator. In both studies combined, no pregnancies were observed in overweight (BMI >25 to 30 kg/m2, 22.9%) or obese (BMI >30 kg/m2, 10.8%) subjects or in the 15.6% of subjects performing ≥1 home self-injection. A very high level of satisfaction with DMPA-SC was indicated in 3 PSQ and EOTQ measures: preferring it to other contraceptive methods, willingness to continue treatment and willingness to recommend it to a friend. The largest percentage (49.8%) of respondents indicated they would prefer home self-injection to injection by clinician (29.3%) or self-injection at the doctor's office (20.9%). Overall, DMPA-SC was well tolerated. Of the 1343 subjects assessed at month 12, most (63.7%) either lost or gained weight within a narrow range (-2.2 kg to +2.3 kg). Median weight change at month 12 was 1.7 kg (mean change, 1.7 kg) in the Americas trial and 1.0 kg (mean change, 1.4 kg) in the European/Asian trial. Most irregular bleeding decreased with time, whereas incidence of amenorrhea increased to 55% at month 12. Treatment-related side effects leading to discontinuation were reported in 8.8% of subjects. These studies show new DMPA-SC (104 mg every 12–13 weeks) contraceptive is highly effective and well tolerated, with efficacy uncompromised by BMI or administrator. Subjects reported a high level of satisfaction with DMPA-SC; in addition, more than 70% of subjects preferred the option of self-injection to injection by the clinician.