Modifiable factors affecting older patients' quality of life and physical function during cancer treatment.

BACKGROUND: Maintaining physical function and quality of life (QoL) are prioritized outcomes among older adults. We aimed to identify potentially modifiable factors affecting older patients' physical function and QoL during cancer treatment. METHODS: Prospective, multicenter study of 307 patients with cancer ≥70 years, referred for systemic treatment. Pre-treatment, a modified geriatric assessment (mGA) was performed, including registration of comorbidities, medications, nutritional status, cognitive function, depressive symptoms (Geriatric Depression Scale-15 [GDS]), and mobility (Timed Up and Go [TUG]). Patient-reported physical function (PF)-, global QoL-, and symptom scores were assessed at baseline, two, four, and six months by the EORTC Quality of Life Core Questionnaire-C30. The impact of mGA components and symptoms on patients' PF and global QoL scores during six months was investigated by linear mixed models. To identify groups following distinct PF trajectories, a growth mixture model was estimated. RESULTS: 288 patients were eligible, mean age was 76.9 years, 68% received palliative treatment. Higher GDS-scores and poorer TUG were independently associated with an overall level of poorer PF and global QoL throughout follow-up, as were more pain, dyspnea, and appetite loss, and sleep disturbance. Three groups with distinct PF trajectories were identified: a poor group exhibiting a non-linear statistically (p < .001) and clinically significant decline (≥10 points), an intermediate group with a statistically (p = .003), but not clinically significant linear decline, and a good group with a stable trajectory. Higher GDS-scores and poorer TUG, more pre-treatment pain and dyspnea were associated with higher odds of belonging to the poor compared to the good PF group. CONCLUSION: Depressive symptoms, reduced mobility, and more physical symptoms increased the risk of decrements in older patients' PF and global QoL scores during cancer treatment, and represent potential targets for interventions aiming at improving these outcomes.

Associations between severe co-morbidity and muscle measures in advanced non-small cell lung cancer patients.

BACKGROUND: Studies show that low skeletal muscle index (SMI) and low skeletal muscle density (SMD) are negative prognostic factors and associated with more toxicity from systemic therapy in cancer patients. However, muscle depletion can be caused by a range of diseases, and many cancer patients have significant co-morbidity. The aim of this study was to investigate whether there were associations between co-morbidity and muscle measures in patients with advanced non-small cell lung cancer. METHODS: Patients in a Phase III trial comparing two chemotherapy regimens in advanced non-small cell lung cancer were analysed (n = 436). Co-morbidity was assessed using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G), which rates co-morbidity from 0 to 4 on 14 different organ scales. Severe co-morbidity was defined as having any grades 3 and 4 CIRS-G score. Muscle measures were assessed from baseline computed tomography slides at the L3 level using the SliceOMatic software. RESULTS: Complete data were available for 263 patients (60%). Median age was 66, 57.0% were men, 78.7% had performance status 0-1, 25.9% Stage IIIB, 11.4% appetite loss, 92.4% were current/former smokers, 22.8% were underweight, 43.7% had normal weight, 26.6% were overweight, and 6.8% obese. The median total CIRS-G score was 7 (range: 0-16), and 48.2% had severe co-morbidity. Mean SMI was 44.7 cm2 /m2 (range: 27-71), and the mean SMD was 37.3 Hounsfield units (HU) (range: 16-60). When comparing patients with and without severe co-morbidity, there were no significant differences in median SMI (44.5 vs. 44.1 cm2 /m2 ; 0.70), but patients with severe co-morbidity had a significantly lower median SMD (36 HU vs. 39 HU; 0.001), mainly due to a significant difference in SMD between those with severe heart disease and those without (32.5 vs. 37.9 HU; 0.002). Linear regression analyses confirmed the association between severe co-morbidity and SMD both in the simple analysis (0.001) and the multiple analysis (0.037) adjusting for baseline characteristics. Stage of disease, gender, and body mass index (BMI) were significantly associated with SMI in both the simple and multiple analyses. Age and BMI were significantly associated with SMD in the simple analysis; and age, gender, and BMI were significantly associated in the multiple analysis. CONCLUSIONS: There were no significant differences in SMI between patients with and patients without severe co-morbidity, but patients with severe co-morbidity had lower SMD than other patients, mainly due to severe heart disease. Co-morbidity might be a confounder in studies of the clinical role of SMD in cancer patients.

TECLA-an innovative technical approach for prostate cancer registries.

Objective: To present a code-driven, electronic database for patients TrEated with robotic-assisted radiCaL prostAtectomy (TECLA), developed at Innlandet Hospital (IH), Trust, Norway, for research, local quality control and to deliver data to the National Cancer Registry of Norway (CRN). Clinical data are directly extracted from the structured documentation in the electronic medical record (EMR).Materials and methods: The urological department at IH treats about 200 patients with robotic-assisted radical prostatectomy (RARP) annually. All consenting patients registered with the procedure code for RARP are included in TECLA. Clinical data are obtained automatically from the EMR, by structured forms. Patient-reported outcome and experience measures (PROMs and PREMs) are filled in by the patients on an iPad or a smartphone.Results: The basic construct of TECLA is presented. From August 2017 to June 2018, 200 men were treated with RARP, of which 182 (91%) provided consent for inclusion in the register. Of these, 97% completed the PROM survey before treatment and 91% at 3 months follow-up. PREMs were completed by 78%. All clinical variables for the hospital stay and for the 6-week follow-up were more than 95% complete.Conclusion: This entirely electronic surgical quality register is easy to use, both for patients and clinicians, and has a high capture rate. The data collection is linked to the clinicians' workflow, without double data entry, so entering data does not add any extra work. The register design can be used by other hospitals for various surgical procedures.

Screening for frailty among older patients with cancer using blood biomarkers of inflammation.

INTRODUCTION: As frailty is associated with inflammation, biomarkers of inflammation may represent objective measures that could facilitate the identification of frailty. Glasgow prognostic score (GPS), combines C-reactive protein (CRP) and albumin, and is scored from 0 to 2 points. Higher score indicates a higher degree of inflammation. OBJECTIVES: To investigate whether (1) GPS is associated with frailty, (2) GPS could be used to screen for frailty, (3) IL-6 and TNF-α add to the accuracy of GPS as a screening tool, and (4) GPS adds prognostic information in frail older patients with cancer. METHODS: Prospective, observational study of 255 patients ≥70 years with solid malignant tumours referred for medical cancer treatment. At baseline, frail patients were identified by a modified Geriatric Assessment (mGA), and blood samples were collected. RESULTS: Mean age was 76.7 years, 49.8% were frail, and 56.1% had distant metastases. The proportion of frail patients increased with higher GPS (GPS zero: 43.2%, GPS one: 52.7%, GPS two: 94.7%). GPS two was significantly associated with frailty (OR 18.5), independent of cancer type, stage, BMI and the use of anti-inflammatory drugs. The specificity of GPS was high (99%), but the sensitivity was low (14%). Frail patients with GPS two had poorer survival than patients with GPS zero-one. TNF-α and IL-6 did not improve the accuracy of GPS when screening for frailty. CONCLUSION: Frailty and GPS two are strongly associated, and GPS two is a significant prognostic factor in frail, older patients with cancer. The inflammatory biomarkers investigated are not suitable screening tools for frailty.

A comparison of CT based measures of skeletal muscle mass and density from the Th4 and L3 levels in patients with advanced non-small-cell lung cancer.

BACKGROUND: Muscle mass and density assessed from CT-images at the L3 level are prognostic for survival and predict toxicity in cancer patients. However, L3 is not always included on routine CT-scans. We aimed to investigate whether images at the Th4 level may be used instead. METHODS: Patients from three chemotherapy trials in advanced NSCLC were eligible (n = 1305). Skeletal muscle area (cm2), skeletal muscle index (SMI, cm2/m2) and skeletal muscle density (SMD) at Th4 and L3 levels were assessed from baseline CT-scans. SMI and SMD at the Th4 and L3 level were transformed into z-scores and the agreement between scores was investigated by Bland-Altman plots and estimated by intra-class correlation analyses. Linear regression was used to test if Th4 SMI and SMD z-scores predicted L3 SMI and SMD z-scores. RESULTS: CT-images from 401 patients were analysable at both levels. There was a moderate agreement between Th4 and L3 SMI z-scores with an intra-class correlation of 0.71 (95% CI 0.64-0.77) for men and 0.53 (95% CI 0.41-0.63) for women. Regression models predicting L3 SMI z-scores from Th4 SMI z-scores showed coefficients of 0.71 (95% CI 0.62-0.80) among men and 0.53 (95% CI 0.40-0.66) among women. R-squares were 0.51 and 0.28, respectively, indicating moderate agreement. A similar, moderate agreement between Th4 and L3 SMD z-scores was observed. CONCLUSION: There was only moderate agreement between muscle measures from Th4 and L3 levels, indicating that missing data from the L3 level cannot be replaced by analysing images at the Th4 level.

Post-discharge complications in frail older patients after surgery for colorectal cancer.

BACKGROUND: The incidence of postoperative complications after colorectal cancer surgery varies between publications. Complications occurring after discharge from hospital are often not reported. The aims of this study were to investigate the proportion of frail older colorectal cancer patients who developed complications only after discharge, the severity of post-discharge complications, and the time point at which the most frequent complications occurred. METHODS: Patients were included if they were 65 years and older, screened positively for frailty and were scheduled for colorectal cancer surgery. Included patients were followed prospectively both in hospital and after discharge for 30 days after surgery, and complications were graded according to the Clavien-Dindo classification. RESULTS: We included 114 patients. Median age was 79 years. Twenty-two patients (19%) were discharged without complications, but developed complications after discharge. These patients had shorter length of stay (6.5 versus 10 days), were more often discharged to their own home without assistance, and had higher 5-year survival (76% vs 54%) than patients who developed complications in hospital. Post-discharge complications were most frequently grade II. The most common types of complications that occurred late in the postoperative course were urinary tract infections and superficial surgical site infections. CONCLUSIONS: Complications after colorectal cancer surgery in frail older patients frequently arise after discharge from hospital. Doctors should be aware of this and inform their patients. This is increasingly important as length of stay after surgery decreases. When complications are used as a quality measure, it should be clear whether only in-hospital complications are registered.

Geriatric assessment is superior to oncologists' clinical judgement in identifying frailty.

BACKGROUND: Frailty is a syndrome associated with increased vulnerability and an important predictor of outcomes in older cancer patients. Systematic assessments to identify frailty are seldom applied, and oncologists' ability to identify frailty is scarcely investigated. METHODS: We compared oncologists' classification of frailty (onc-frail) based on clinical judgement with a modified geriatric assessment (mGA), and investigated associations between frailty and overall survival. Patients ⩾70 years referred for medical cancer treatment were eligible. mGA-frailty was defined as impairment in at least one of the following: daily activities, comorbidity, polypharmacy, physical function or at least one geriatric syndrome (cognitive impairment, depression, malnutrition, falls). RESULTS: Three hundred and seven patients were enroled, 288 (94%) completed the mGA, 286 (93%) were rated by oncologists. Median age was 77 years, 56% had metastases, 85% performance status (PS) 0-1. Overall, 104/286 (36%) were onc-frail and 140/288 (49%) mGA-frail, the agreement was fair (kappa value 0.30 (95% CI 0.19; 0.41)), and 67 mGA-frail patients who frequently had localised disease, good PS and received curative treatment, were missed by the oncologists. Only mGA-frailty was independently prognostic for survival (HR 1.61, 95% CI 1.14; 2.27; P=0.007). CONCLUSIONS: Systematic assessment of geriatric domains is needed to aid oncologists in identifying frail patients with poor survival.

Muscle mass and association to quality of life in non-small cell lung cancer patients.

BACKGROUND: Cancer wasting is characterized by muscle loss and may contribute to fatigue and poor quality of life (QoL). Our aim was to investigate associations between skeletal muscle index (SMI) and skeletal muscle radiodensity (SMD) and selected QoL outcomes in advanced non-small cell lung cancer (NSCLC) at diagnosis. METHODS: Baseline data from patients with stage IIIB/IV NSCLC and performance status 0-2 enrolled in three randomized trials of first-line chemotherapy (n = 1305) were analysed. Associations between SMI (cm2 /m2 ) and SMD (Hounsfield units) based on computed tomography-images at the third lumbar level and self-reported physical function (PF), role function (RF), global QoL, fatigue, and dyspnoea were investigated by linear regression using flexible non-linear modelling. RESULTS: Complete data were available for 734 patients, mean age 65 years. Mean SMI was 47.7 cm2 /m2 in men (n = 420) and 39.6 cm2 /m2 in women (n = 314). Low SMI values were non-linearly associated with low PF and RF (men P = 0.016/0.020, women P = 0.004/0.012) and with low global QoL (P = 0.001) in men. Low SMI was significantly associated with high fatigue (P = 0.002) and more pain (P = 0.015), in both genders, but not with dyspnoea. All regression analyses showed poorer physical outcomes below an SMI breakpoint of about 42-45 cm2 /m2 for men and 37-40 cm2 /m2 for women. In both genders, poor PF and more dyspnoea were significantly associated with low SMD. CONCLUSIONS: Low muscle mass in NSCLC negatively affects the patients' PF, RF, and global QoL, possibly more so in men than in women. However, muscle mass must be below a threshold value before this effect can be detected.

Drug Dose Per Kilogram Lean Body Mass Predicts Hematologic Toxicity From Carboplatin-Doublet Chemotherapy in Advanced Non-Small-Cell Lung Cancer.

BACKGROUND: Variations in lean body mass (LBM) have been suggested to explain variations in toxicity from systemic cancer treatment. We investigated if drug doses per kilogram of LBM were associated with severe hematologic toxicity (HT) in patients with stage IIIB/IV non-small-cell lung cancer (NSCLC) enrolled onto randomized trials comparing first-line carboplatin-doublets. PATIENTS AND METHODS: Patients received carboplatin (AUC [area under the plasma concentration vs. time curve] = 5) plus either pemetrexed 500 mg/m2, gemcitabine 1000 mg/m2, or vinorelbine 60 mg/m2. LBM was estimated from the cross-sectional muscle area at the third lumbar vertebra on computed tomographic scans. Administered doses on day 1, first cycle, were recalculated as milligram of drug per kilogram of LBM. Primary outcome was Common Terminology Criteria for Adverse Events version 3.0 grade 3/4 HT after cycle 1. RESULTS: Data from 424 patients were analyzed. Mean age was 65 years, 57% were men, and 78% had stage IV disease. Despite dose individualization by body surface area for the nonplatinum drugs, mean (range) doses expressed as mg/kg LBM showed ∼3-fold range: gemcitabine 38.0 (22.5-61.7) mg/kg LBM, pemetrexed 19.1 (8.1-27.9) mg/kg LBM, and vinorelbine 2.4 (1.4-3.6) mg/kg LBM. For these drugs, dose per kilogram of LBM was associated with HT in adjusted multivariate models (P = .004). Taking mean dose per kilogram LBM for each drug as reference, a 1% increase (odds ratio [OR] = 1.03; 95% confidence interval [CI], 1.01-1.06) or 1% decrease (OR = 0.97; 95% CI, 0.95-0.99) was associated with altered risk of grade 3/4 HT. For doses > 20% above and below mean (14% and 15% of patients, respectively) the risk of grade 3/4 HT was almost doubled (OR = 1.93, 95% CI, 1.21-3.10) and halved (OR = 0.52; 95% CI, 0.32-0.83), respectively. CONCLUSION: Dose per kilogram of LBM varied considerably and was an independent predictor of HT. Computed tomography-defined LBM may provide a future basis for better dose individualization.

Quality of life in older and frail patients after surgery for colorectal cancer-A follow-up study.

OBJECTIVE: The incidence of colorectal cancer is increasing, mainly due to the aging of the population. Frailty, describing a state of increased vulnerability, is common in older patients, but frailty and high age are not necessarily contraindications to surgical treatment. However, limited data describing long-term outcomes after surgery in this patient group exist. In this clinical follow-up study, we aimed to examine long-term health-related quality of life in older surgical patients with colorectal cancer. MATERIALS AND METHODS: Patients were recruited from a prospective multicenter study investigating frailty as a predictor of postoperative complications after surgery for colorectal cancer. A preoperative geriatric assessment was performed, and patients were classified as frail or non-frail. Patients responded to version 3.0 of The European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-C30 before surgery, 3months postoperatively and at a long-term follow-up 16-28months (median 22months) after surgery. One-way repeated-measures analyses of variance were performed to examine changes in scores over time. RESULTS: 180 patients with a mean age of 80years were included at baseline, 138 at 3months postoperatively, and 84 patients (69% of survivors) at long-term follow-up. A significant improvement in quality of life-scores was present 3months after surgery, also in the subgroup of frail patients. At long-term follow-up, scores decreased, but to values above baseline. CONCLUSION: Health-related quality of life may be improved in older patients after surgery for colorectal cancer, even in patients who are classified as frail preoperatively.

Skeletal muscle radiodensity is prognostic for survival in patients with advanced non-small cell lung cancer.

BACKGROUND & AIMS: Recent research indicates that severe muscular depletion (sarcopenia) is frequent in cancer patients and linked to cachexia and poor survival. Our aim was to investigate if measures of skeletal muscle hold prognostic information in advanced non-small cell lung cancer (NSCLC). METHODS: We included NSCLC patients with disease stage IIIB/IV, performance status 0-2, enrolled in three randomised trials of first-line chemotherapy (n = 1305). Computed tomography (CT) images obtained before start of treatment were used for body composition analyses at the level of the third lumbar vertebra (L3). Skeletal muscle mass was assessed by measures of the cross sectional muscle area, from which the skeletal muscle index (SMI) was obtained. Skeletal muscle radiodensity (SMD) was measured as the mean Hounsfield unit (HU) of the measured muscle area. A high level of mean HU indicates a high SMD. RESULTS: Complete data were available for 734 patients, mean age 65 years. Both skeletal muscle index (SMI) and muscle radiodensity (SMD) varied largely. Mean SMI and SMD were 47.7 cm2/m2 and 37.4 HU in men (n = 420), 39.6 cm2/m2 and 37.0 HU in women (n = 314). Multivariable Cox regression analyses, adjusted for established prognostic factors, showed that SMD was independently prognostic for survival (Hazard ratio (HR) 0.98, 95% CI 0.97-0.99, p = 0.001), whereas SMI was not (HR 0.99, 95% CI 0.98-1.01, p = 0.329). CONCLUSION: Low SMD is associated with poorer survival in advanced NSCLC. Further research is warranted to establish whether muscle measures should be integrated into routine practice to improve prognostic accuracy.

Comparing comorbidity scales: Attending physician score versus the Cumulative Illness Rating Scale for Geriatrics.

OBJECTIVES: Assessing comorbidity using the Cumulative Illness Rating Scale for Geriatrics (CIRS-G) and its comprehensive manual is time consuming. We investigated if similar information could be obtained by a simpler assessment based on the original CIRS. MATERIALS AND METHODS: Data from a randomized chemotherapy trial (RCT) on advanced NSCLC (non-small cell lung cancer) were analyzed. Baseline comorbidity was assessed by 1) trained oncologists using hospital records and the CIRS-G manual (CIRS-G), 2) by patients' oncologists/pulmonologists (local investigators=LI-score) using a brief set of instructions. By both methods, the severity of comorbidity in 14 organ systems was graded 0 (no problem) to 4 (extremely severe). The agreement between methods was assessed using Bland-Altman analysis and weighted kappa statistics. The impact of comorbidity on survival was analyzed by Cox regression. RESULTS: Complete data were available for 375/446 (84%) patients enrolled in the RCT. Median age was 65years (25-85). Overall, more comorbidities and higher severity were registered by the CIRS-G compared to the LI-score. Severe comorbidity was registered for 184 (49%) and 94 (25%) patients according to the CIRS-G and LI-scores, respectively. Mean total score was 7.0 (0-17) (CIRS-G) versus 4.2 (0-16) (LI-score), and mean severity index (total score/number of categories with score >0) was 1.73 (SD 0.46) versus 1.43 (SD 0.78). Neither the CIRS-G scores nor the LI-scores were prognostic for survival. CONCLUSION: The CIRS-G scores and LI-scores had poor agreement, indicating that assessment method affects the registration of comorbidity. Thorough descriptions of comorbidity registrations in trials are paramount due to lack of a standardized assessment.

Low muscle mass is associated with chemotherapy-induced haematological toxicity in advanced non-small cell lung cancer.

BACKGROUND: Recent research suggests a significant relationship between lean body mass (LBM) and toxicity from chemotherapeutic agents. We investigated if higher drug doses per kg LBM were associated with increased toxicity in stage IIIB/IV non-small cell lung cancer (NSCLC) patients receiving a first-line chemotherapy regimen dosed according to body surface area (BSA). METHODS: Data from patients randomised to receive intravenous gemcitabine 1000 mg/m(2) plus orally vinorelbine 60 mg/m(2) days 1 and 8 in a phase III trial comparing two chemotherapy regimens were analysed. LBM was estimated from assessment of the cross-sectional muscle area at the third lumbar level (L3) on computed tomography images obtained before chemotherapy commenced. Common terminology criteria for adverse events (CTCAE) grade 3-4 haematological toxicity and dose reduction and/or stop of treatment after the first course of chemotherapy were defined as primary and secondary toxicity outcomes. RESULTS: The study sample included 153 patients, mean age was 66 years, 55% were men, 87% had disease stage IV and 75% had performance status (PS) 0-1. Gemcitabine doses per kg LBM varied from 23.2 to 53.1 mg/kg LBM, and vinorelbine doses from 1.5 to 3.3 mg/kg LBM. Higher doses of gemcitabine per kg LBM were significantly associated with grade 3-4 haematological toxicity in bivariate (OR=1.12, 95% CI 1.03-1.23, p=0.008) and multivariate analyses (OR=1.15, 95% CI 1.01-1.29, p=0.018), as were also higher doses of vinorelbine per kg LBM. No significant association was found between drug doses per kg LBM and dose reduction and/or stop of treatment. CONCLUSION: The study showed that dose estimates according to BSA lead to a substantial variation in drug dose per kg LBM, and higher doses per kg LBM are a significant predictor for chemotherapy-induced haematological toxicity. The results indicate that taking LBM into account may lead to a better dose individualisation of chemotherapy.

Frailty is an independent predictor of survival in older patients with colorectal cancer.

BACKGROUND: Colorectal cancer (CRC) is prevalent in the older population. Geriatric assessment (GA) has previously been found to predict treatment tolerance and postoperative complications in older cancer patients. The aim of this study was to explore whether GA also predicts 1-year and 5-year survival after CRC surgery in older patients and to compare the predictive power of GA with that of established prognostic factors such as TNM classification of malignant tumors (TNM) stage and age. MATERIALS AND METHODS: A cohort of 178 CRC patients aged 70 and older were followed prospectively. All patients went through elective surgery, and GA was performed presurgery. The GA resulted in patients being divided into two groups: frail or nonfrail. All patients were followed for 5 years or until death. Data were analyzed by Kaplan-Meier plots and the Cox proportional hazards model. RESULTS: Seventy-six patients (43%) were frail, and one hundred and two (57%) were nonfrail. Twenty-three patients (13%) died during the first year after surgery. One-year survival was 80% in the frail group and 92% in the nonfrail group. Five-year survival was significantly lower in frail (24%) than nonfrail patients (66%), and this difference was apparent both within the stratums of TNM stages 0-II and TNM stage III. In multivariable analysis adjusting for TNM stage, age, and sex, frailty was an independent prognostic factor for survival. CONCLUSION: A GA-based frailty assessment predicts 1-year and 5-year survival in older patients after surgery for CRC. In localized and regional disease, the impact of frailty upon 5-year survival is comparable with that of TNM stage.

Frailty indicators and functional status in older patients after colorectal cancer surgery.

OBJECTIVES: The number of older survivors from colorectal cancer is increasing, but little is known regarding long-term consequences of cancer treatment in this patient group. Physical function is an important outcome for older patients, affecting both autonomy and quality of life. We aimed to investigate physical function in older patients with colorectal cancer before and after surgery, and to examine the role of individual frailty indicators as predictors of functional decline. MATERIAL AND METHODS: We present 16-28 months follow-up data of older patients after elective surgery for colorectal cancer. During a home-visit, physical function was evaluated by activities of daily living (ADL), instrumental activities of daily living (IADL), the timed up-and-go (TUG) test, and grip strength. Measurements were compared with those obtained preoperatively using the Wilcoxon signed rank test. Frailty indicators were dichotomized and implemented in logistic regression models to explore their associations to a decline in the physical function scores. RESULTS: Eighty-four patients were included and the median age was 82 years. There was a significant decrease in ADL (p = 0.04) and IADL scores (p ≤ 0.001) at follow-up. We found no associations between frailty indicators and the risk of decline in physical functioning. CONCLUSION: In our population of older patients with surgically treated colorectal cancer, there was a significant decline in ADL- and IADL-scores at follow-up. No change was found in TUG or grip strength, and frailty indicators did not predict decline in physical function.

The impact of nutritional status, physical function, comorbidity and early versus late start in dialysis on quality of life in older dialysis patients.

BACKGROUND: For the majority of the older patients in dialysis, the treatment will be lifelong. Thus, quality of life (QoL) is a crucial outcome. Our aim was to assess the QoL of older Norwegian dialysis patients and to investigate the impact of early (estimated glomerular filtration rate, eGFR ≥10 mL/min) versus late (eGFR <10 mL/min) start in dialysis, comorbidity, nutritional status and physical capacity. METHODS: A self-report questionnaire including SF-36 (QoL) and the Subjective Global Assessment (SGA; nutritional status) was mailed to all patients (n = 320) ≥75 years registered in the Norwegian Renal Registry (NRR) as being in dialysis by September 2009. Reply was received from 233 patients (73%). Medical data including comorbidities and eGFR at dialysis start (obtained for 194 patients) were retrieved from the NRR. Functional capacity was determined from the SGA. RESULTS: Compared to reports from younger dialysis patients, our patients scored poorer on all SF-36 subscales. Early start in dialysis was registered for 52 patients, 142 patients started late, 51.4% were well nourished (SGA A), 32.3% moderately malnourished (SGA B) and 16.4% were severely malnourished (SGA C). No significant association between any SF-36 scores and early versus late start, nutritional status or comorbidity was found. Better physical function was significantly associated with better scores on all SF-36 scales. CONCLUSIONS: Our results indicate that physical function is important to all QoL aspects. Increased focus on physical rehabilitation seems pertinent. Early start of dialysis treatment was not associated with better long term QoL scores.

Symptoms in advanced pancreatic cancer are of importance for energy intake.

PURPOSE: Cancer cachexia and low energy intake (EI) probably contribute to weight loss in advanced pancreatic cancer (PC). However, little is known about the actual EI in this disease. Aims were to assess EI, weight loss and symptoms during the disease course and investigate associations between symptoms and EI. METHODS: Thirty-nine patients (21 males) with advanced PC were consecutively included and followed every 4 weeks until the end of life. A 24-h dietary recall was used to assess EI. The Edmonton Symptom Assessment System (ESAS) and the PC-specific health-related quality of life questionnaire (QLQ-PAN26) were used for symptom assessment. RESULTS: Median age was 62 years (48-88), WHO performance status 1 (0-2) and survival 5 months (1-25). Seventeen (44 %) patients had unresectable cancer, 16 (41 %) metastatic and six (15 %) recurrent disease. Upon inclusion, 37 (95 %) reported weight loss (median 4.0 kg per month). During follow-up, median weight loss per month was <1.0 kg. Forty to 65 % had EI <29 kcal/kg/day (cut-off value for weight maintenance) during the observation period but they did not lose more weight than patients with EI ≥ 29 kcal. Strong negative correlations (r range) were found between EI and pain (0.51-0.61), fatigue (0.54-0.67), oral dryness (0.61-0.64) and loss of appetite (0.53-0.71). CONCLUSION: In this study, several symptoms influenced EI negatively. Low EI did not completely explain weight loss in this patient group, but careful monitoring and early follow-up of symptoms may be important interventions to reduce weight loss in advanced PC.

Nutritional problems, overhydration and the association with quality of life in elderly dialysis patients.

PURPOSE: The aim of this pilot study was to describe the hydration and nutritional status of a cohort of elderly dialysis patients and to explore the association between these parameters and the quality of life (QoL). METHODS: All patients over 75 years of age being in chronic dialysis by January 2008 at 3 dialysis units (n=34) were asked to participate in this pilot study, 24 patients were entered. Hydration status was assessed by bioimpedance spectroscopy (BIS) and nutritional status by the subjective global assessment (SGA), BIS, anthropometric measures and biochemical parameters. Based on these assessments the patients were classified as being cachectic or not according to newly defined criteria. QoL was measured using the SF-36. RESULTS: The results showed cachexia in 6 (25%), 37.5% had a body mass index below 24, whereas according to SGA 91% were malnourished. BIS showed low lean tissue index in 46% and overhydration in 35% of the patients. Compared to non-cachectic and normohydrated, cachectic and overhydrated patients reported consistently poorer QoL. For cachectic patients, the differences were clinically significant for all SF-36. BIS was easily applicable when used before dialysis. CONCLUSIONS: The high frequency of nutritional deficits in this study calls for more attention to nutritional status in elderly dialysis patients. There is a need for a general agreement on how nutritional status should be assessed and reported, both in clinics and in research.

End-stage renal disease and recruitment to randomized trials: why is it so difficult? Results from a survey among Norwegian nephrologists.

OBJECTIVE: Recruitment is one of the most serious challenges in randomized clinical trials (RCTs), especially in the old and frail population. A Norwegian multicentre RCT targeting end-stage renal disease (ESRD) patients older than 70 years was initiated to compare the impact on quality of life of early or late start of dialysis. Owing to poor inclusion the RCT was closed. The aim of the present study was to explore possible reasons for the recruitment failure. MATERIAL AND METHODS: A questionnaire was distributed to all Norwegian nephrologists. The questionnaire presented 11 statements which cited possible reasons for not including elderly ESRD patients in the RCT in question. RESULTS: The highest rated reasons for non-inclusion were the physician's wish to decide the timing of dialysis individually and the patient's wish to postpone the start of treatment. High mean scores were also found for reasons related to workload and capacity at the dialysis unit, whereas the influence of the doctor-patient relationship and competing studies were judged not to be important. CONCLUSIONS: The results indicate that confidence in individually decided treatment and fear of losing professional autonomy make Norwegian nephrologists reluctant to include patients in RCTs. To succeed in recruitment, there seems to be a need for cultural changes as well as increased resources to meet practical challenges.