International cross-cultural field validation of an European Organization for Research and Treatment of Cancer questionnaire module for patients with primary liver cancer, the European Organization for Research and Treatment of Cancer quality-of-life questionnaire HCC18

This international field validation study examined the psychometric properties and clinical validity of the European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for hepatocellular carcinoma (HCC), the EORTC quality-of-life questionnaire (QLQ)-HCC18. The EORTC QLQ-HCC18 was administered with the core questionnaire, the EORTC QLQ-C30, to 272 patients from seven centers in 6 countries. Patient acceptability of the module was examined with a debriefing questionnaire, and psychometric and clinical properties were assessed. Multitrait scaling analyses confirmed the hypothesized scale structure without any scaling error, and the fatigue scale demonstrated satisfactory internal consistency. The test-retest reliability scores were high for all scales, except abdominal swelling and sexual interest. The correlations between all scales of the QLQ-HCC18 and the QLQ-C30 were low or moderate, and many scales could distinguish patients with different clinical conditions. The module demonstrated responsiveness to clinical change in pain before and after surgery and some borderline change in patients undergoing systemic treatment. Conclusion: The EORTC QLQ-HCC18 can be used as a supplementary module for the EORTC QLQ-C30 in clinical trials for patients with HCC.     

EORTC QLQ-C30 and FACT-BMT for the measurement of quality of life in bone marrow transplant recipients: a comparison

The purpose of the study was to compare two different quality-of-life self-rating instruments, namely the EORTC QLQ-C30, developed by the quality-of-life study group of the European Organisation for Research and Treatment of Cancer, and the FACT-BMT (version 3), the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation scale, which is the FACT-G(eneral measure) in combination with a module developed specifically for evaluating quality of life of bone marrow transplant (BMT) patients. Fifty-six BMT recipients completed both the EORTC QLQ-C30 and the FACT-BMT (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis and multiple linear regression. Correlations between corresponding subscales of EORTC QLQ-C30 and the FACT-BMT ranged from r=0.30 for the emotional domain (poor agreement) to r=0.77 for global QOL (good agreement). This suggests that the instruments, despite considerable overlap, possibly focus on different aspects of QOL, in particular in addressing emotional and social issues of BMT patients. It appears that the FACT-BMT gives a more comprehensive overview regarding the multidimensional construct of quality of life. The EORTC QLQ-C30 gives more insight into the physical aspects of quality of life and helps to identify symptoms which effectively decrease quality of life from the patient's perspective. The QLQ-C30 might be improved by the incorporation of a BMT-specific module currently under development. We therefore conclude that neither of the two instruments can be replaced by the other in the assessment of QOL of BMT patients and that a direct comparison of results obtained with the two instruments is likely to be misleading.     

Effect of thalidomide with melphalan and prednisone on health-related quality of life (HRQoL) in elderly patients with newly diagnosed multiple myeloma: a prospective analysis in a randomized trial

Thalidomide with melphalan/prednisone (MPT) was defined as standard treatment in elderly patients with multiple myeloma (MM) based on five randomized trials. In one of these trials, HOVON49, a prospective health-related quality-of-life (HRQoL) study was initiated in order to assess the impact of thalidomide on QoL. Patients aged >65 years with newly diagnosed MM were randomized to receive melphalan plus prednisone (MP) or MPT, followed by thalidomide maintenance in the MPT arm. Two hundred eighty-four patients were included in this side study (MP, n=149; MPT n=135). HRQoL was assessed with the EORTC Core QoL Questionnaire (QLQ-C30) and the myeloma-specific module (QLQ-MY24) at baseline and at predetermined intervals during treatment. The QLQ-C30 subscales physical function (P=0.044) and constipation (P<0.001) showed an improvement during induction in favour of the MP arm. During thalidomide maintenance, the scores for the QLQ-MY24 paraesthesia became significantly higher in the MPT arm (P<0.001). The QLQ-C30 subscales pain (P=0.12), insomnia (P=0.068), appetite loss (P=0.074) and the QLQ-MY24 item sick (P=0.086) scored marginally better during thalidomide maintenance. The overall QoL-scale QLQ-C30-HRQoL showed a significant time trend towards more favourable mean values during protocol treatment without differences between MP and MPT. For the QLQ-C30 subscales emotional function and future perspectives, difference in favour of the MPT arm from the start of treatment was observed (P=0.018 and P=0.045, respectively) with no significant 'time × arm' interaction, indicating a persistent better patient perspective with MPT treatment. This study shows that the higher frequency of toxicity associated with MPT does not translate into a negative effect on HRQoL and that MPT holds a better patient perspective.     

Measurement of health-related quality of life in multiple myeloma

When a randomized trial (NMSG 4/90) comparing treatment with melphalan/prednisone to melphalan/prednisone + interferon α-2b in newly diagnosed multiple myeloma was inititated in 1990, a quality-of-life assessment was integrated into the study. We used the questionnaire (QLQ-C30) developed by the European Organization of Research and Treatment of Cancer (EORTC) Study Group on Quality of Life. The QLQ-C30 incorporates five functional scales, three symptom scales, a global health and quality-of-life scale and some single symptom measures. The questionnaire was completed prior to treatment and after 1, 6, 12, 24, 36 and 48 months. 524 (90.2%) of 581 patients enrolled in the NMSG 4/90 completed the first questionnaire, and 484 (83.3%) completed all questionnaires given to them. All but one of the scales met the minimum criteria of reliability (Cronbach's alpha ≥0.70). Validity was shown by (1) the ability of the scales to discriminate clearly between patients differing in clinical status as defined by pre-treatment W.H.O. performance index and Durie & Salmon stage, and (2) the sensitivity to changes in objective disease status (response and relapse). This is the first report of the measurement of health-related quality of life in a prospective clinical trial in multiple myeloma. The results demonstrate that the QLQ-C30 is a reliable and valid instrument for the measurement of quality of life in these patients. The data will be used for a cost–utility analysis of the results of the NMSG 4/90 trial.     

Cost–utility analysis of high-dose melphalan with autologous blood stem cell support vs. melphalan plus prednisone in patients younger than 60 years with multiple myeloma

We evaluated the costs and the cost utility of high-dose melphalan and autologous stem cell support followed by interferon maintenance relative to conventional treatment with melphalan and prednisone, in patients less than 60 yr of age with multiple myeloma. From March 1994 to July 1997, 274 patients with newly diagnosed, symptomatic multiple myeloma were enrolled in a prospective, non-randomized, population-based, multicenter study to evaluate the treatment with high-dose melphalan and autologous blood stem cell support. Health-related quality-of-life was measured prior to treatment and during follow-up, using the EORTC QLQ-C30 questionnaire. Resource consumption was also recorded prospectively. The intensive treatment yielded a significant increase in median survival time from 44 to 62 months compared to conventionally treated patients. The corresponding gain in quality-adjusted life years (QALY) was found to be 1.2. Cost per QALY gained by the treatment with high-dose melphalan and autologous blood stem cell support was estimated at NOK 249,000 (USD 27,000).     

Symptoms and quality of life in chronic pancreatitis assessed by structured interview and the EORTC QLQ-C30 and QLQ-PAN26

BACKGROUND AND AIMS: Chronic pancreatitis (CP) produces disabling symptoms and requires major clinical interventions over a number of years. There is consensus that quality-of-life (QoL) assessment should be part of assessing the treatment and outcome of CP. These symptoms and treatments resemble those of pancreatic cancer, for which there are validated QoL assessment instruments. The aim of our study was to assess the appropriateness of using the EORTC QoL assessment system for pancreatic cancer (the EORTC QLQ-C30 and QLQ-PAN26) for patients with CP, and to document important issues that affect QoL in these patients. METHODS: A structured literature review was undertaken to determine current approaches to QoL in pancreatic disease. Sixty-six patients with newly diagnosed or treated CP were asked to complete the EORTC QLQ-C30 and QLQ-PAN26 in four countries (Germany, Italy, South Africa, and United Kingdom). Patients were asked to review the appropriateness of the content and structure of the instruments, during a directed interview. Standard psychometric tests were used to assess the reliability and validity of the instruments. Peer review was undertaken to review findings and adapt the QLQ-PAN26 on the basis of the responses obtained. RESULTS: The literature review highlighted the potential value of the EORTC QLQ-C30 and identified the lack of a CP-specific instrument, which had been appropriately developed. There was overwhelming consensus among experts that the EORTC assessment system appeared suitable for use in CP patients. This was endorsed by all patients. Patients identified additional issues related to guilt about the use of alcohol and the burden of trying to abstain. All but one scale (jaundice) exhibited adequate internal consistency (r > 0.70) Construct validity of the QLQ-C30 and QLQ-PAN26 showed strong associations between conceptually related scales (r > 0.6, p < 0.001) and significantly discriminated between patients on the basis of performance status and requirement for opiate analgesia. Significant issues affecting QoL in CP patients, in addition to recognized symptoms of the disease, were fear of future health problems, difficulty sleeping, and fatigue. CONCLUSION: The EORTC QLQ-C30 and QLQ-PAN26 appear to be an appropriate assessment system for CP, with the addition of items to cover guilt about alcohol consumption, and the burden of abstention. Patients' QoL is adversely affected by the fear of future health problems, difficulty sleeping, and fatigue.     

Development of a disease-specific quality of life questionnaire for patients with aplastic anemia and/or paroxysmal nocturnal hemoglobinuria (QLQ-AA/PNH)—report on phases I and II

Acquired aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are interrelated ultra-rare diseases. Quality of life (QoL) evaluation tools used in studies for AA and PNH are unspecific and designed for cancer patients (e.g., the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). Given the complexity of AA and PNH, variation in symptoms and treatments, younger age of many patients, and the fact that AA and PNH are not classified as malignant diseases, it is likely that cancer-specific questionnaires are inappropriate. We generate an AA/PNH-specific QoL questionnaire (QLQ-AA/PNH), performed according to EORTC guidelines. QoL issues were obtained from the literature and interviews with patients and physicians (phase I), then ranked by patients and physicians. In phase II, items were created. Patients in more than 25 German and Swiss cities were interviewed face to face. In phase I, interviews of 19 patients and 8 physicians specialized in AA/PNH treatment resulted in 649 QoL issues; these were condensed to 175 and graded according to their importance by 30 patients and 14 physicians (phase II). Five physicians took part in phases I and II. Altogether, 97 issues were rated important. Twelve EORTC QLQ-C30 items were not rated important, while several new QoL aspects were brought up. Modifications in wording and phrasing led to two questionnaires with 77 items regarding general QoL aspects and 20 items regarding medical care. Important QoL aspects of PNH/AA patients are inappropriately captured with available QoL tools. Developing a new QoL questionnaire specific for this patient group is warranted.     

Responsiveness and minimal important score differences in quality-of-life questionnaires: a comparison of the EORTC QLQ-C30 cancer-specific questionnaire to the generic utility questionnaires EQ-5D and 15D in patients with multiple myeloma

OBJECTIVES: The aims of this study were to (i) compare the responsiveness of the EORTC QLQ-C30 cancer-specific questionnaire and the generic questionnaires EQ-5D and 15D used for economic evaluation of healthcare interventions and (ii) determine the minimal important differences (MIDs) in these questionnaires. The MID is the smallest change in a quality-of-life score considered important to patients. Methods: Between 2006 and 2008, 239 patients with multiple myeloma completed the questionnaires at inclusion (T1) and after 3 months (T2). At T2, patients were asked whether they had noticed any change in their quality of life. Responsiveness and MIDs were determined by mean score changes (T2-T1) for patients who, in the interview, stated they had improved, deteriorated, or were unchanged. Responsiveness was also assessed using standardized response means. Wilcoxon tests for pair differences were used to evaluate the statistical significance of the changes. Results: Patients who improved had significantly (P < 0.01) higher scores at T2 in all three questionnaires. Patients who deteriorated reported lower scores at T2; however, for the 15D, the differences in score were not statistically significant. The MIDs for the QLQ-C30, EQ-5D, and 15D were 8, 0.08, and 0.03 in patients who improved and 12, 0.10 and 0.02 in patients who deteriorated, respectively. Conclusions: All three questionnaires showed an acceptable responsiveness in patients who improved. However, the 15D did not respond optimally in patients who deteriorate and cannot be recommended for use in patients with myeloma.     

Effect of interferon on the health-related quality of life of multiple myeloma patients: results of a Nordic randomized trial comparing melphalan–prednisone to melphalan–prednisone + α-interferon

In a Nordic multi-centre trial, 583 previously untreated multiple myeloma patients were randomized to receive melphalan–prednisone or melphalan–prednisone + interferon α-2b at a dose of 5 million units subcutaneously, 3 d/week. A quality-of-life study was integrated into the trial, using the EORTC QLQ C-30 questionnaire supplemented with 11 questions concerning interferon toxicity. The questionnaire was completed prior to treatment and after 1, 6, 12, 24, 36 and 48 months. 90% of the patients participated in the quality-of-life study, and 83% completed all questionnaires submitted to them. During the first year of treatment the patients on interferon reported significantly more fever, chills, dry skin, fatigue, pain, nausea/vomiting and appetite loss than the control patients. There was a moderate reduction of the global quality-of-life score and slight, non-significant, reductions of physical, emotional, cognitive, social and role functioning scores. After the first year there were no statistically significant differences in any toxicity, symptom or quality-of-life score, except for an increased frequency of dizziness in the interferon group. As only 60% of the patients remained on interferon after 24 months, our data probably underestimate the potential toxicity of the drug. Although there was no significant survival benefit for the interferon patients, a 5–6 months prolongation of the response and plateau phase duration was observed. However, by intention-to-treat analysis, there was no late quality-of-life benefit for the interferon patients to compensate for the early impairment. Thus, the clinical significance of the plateau-phase prolongation is uncertain.     

Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma

Measurement of health-related quality of life was integrated into a randomized trial (NMSG 4/90) comparing melphalan/prednisone to melphalan/prednisone + interferon α-2b in newly diagnosed multiple myeloma. One of the aims of the study was to assess the prognostic significance of quality-of-life scores, using the EORTC QLQ-C30 questionnaire. Univariate analysis showed a highly significant association with survival from the start of therapy for physical functioning as well as role and cognitive functioning, global quality of life, fatigue and pain. In multivariate analysis, physical functioning and W.H.O. performance status were independent prognostic factors ( P values=0.001 for both) when analysed in a Cox regression model with the somatic variables β-2 microglobulin, skeletal disease and age. The best prediction for survival from the start of therapy was obtained by combining the β-2 microglobulin and physical functioning scores in a variable consisting of three risk factor levels with an estimated median survival of 17, 29 and 49 months, respectively. At a 12 months landmark analysis, the relative risk for patients with physical functioning score 0–20 v 80–100 was 5.63 (99% CI 2.76–11.49), whereas the relative risk for patients without an objective response to chemotherapy compared to those with at least a minor response was 2.32 (99% CI 1.44–3.74). Quality-of-life assessment may be an independent and valuable addition to the known prognostic factors in multiple myeloma.     

Serum calcium is an independent predictor of quality of life in multiple myeloma

Bone disease is an important feature of multiple myeloma, and hypercalcaemia is a frequent complication of this disease. We examined the association between serum calcium and quality of life (QOL) scores of 686 multiple myeloma patients at the time of diagnosis. Data from two Nordic studies using the EORTC QLQ-C30 questionnaire were analysed by means of linear regression analysis and a curve fitting program. Serum calcium was independently related to appetite loss, nausea/vomiting and physical functioning (P < 0.001) and to cognitive functioning (P = 0.001), i.e. scores reflecting symptoms that are well known in non-malignant hypercalcaemia. In addition, we found a highly significant independent relationship between serum calcium and the scores for fatigue and pain (P < 0.001). Serum calcium appeared to be as strong a predictor for fatigue as the concentration of haemoglobin. A cubic model (y = a + bx3) fitted the data slightly better than the simple linear model (y = a + bx) and suggested worsening QOL scores at levels of serum calcium above 2.5-3.0 mmol/L. Hypercalcaemia in patients with multiple myeloma seems to be associated with the same symptoms as in non-malignant hypercalcaemia. In addition, an increased level of serum calcium may aggravate the pain and fatigue caused by the skeletal disease itself.     

Measurement of quality of life in carcinoid/neuroendocrine tumours

Quality of life is multi-dimensional, including issues relating to symptoms from the disease but also social, emotional, functional and financial domains. Debate remains on the true definition of quality of life and its measurement. Quality of life measurements are best done by patients themselves, although, in some situations a proxy such as carer or relative can be substituted. Healthcare workers can over- or underestimate overall quality of life. Currently used devices for measuring quality of life in cancer include the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, which is a generic tool for all cancers and which requires the use of add-on modules for specific cancers. We are developing a separate module for carcinoid/neuroendocrine tumours, in accordance with the EORTC guidelines on module development, which will be translated into five languages and will be available for use throughout Europe.     

Duodenopancreatectomy versus duodenum-preserving pancreatic head excision for chronic pancreatitis.

BACKGROUND: The aim of this study was to compare two surgical procedures in the treatment for chronic pancreatitis (CP): pancreatoduodenectomy resection (classical Whipple - PD procedure, or pylorus-preserving - PPPD) to duodenum-preserving pancreatic head excision with longitudinal pancreatojejunoanastomosis (DPPHE/PJA), to define the advantages of each procedure with regard to postoperative complications, pain relief, and the quality of life. MATERIAL AND METHOD: 104 consecutive patients were included into this study. Duodenopancreatectomy was chosen when the head pancreatic mass was present or pancreatic cancer could not be ruled out (48 patients); otherwise DPPHE/PJA was performed (56 patients). Quality of life was measured prospectively on two occasions, before the procedure and during follow-up (median 39 months after surgery) using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ-C30). The test was re-evaluated for patients suffering from CP. Pain intensity was quantified using a specially designed pain score. Early postoperative morbidity and mortality were assessed and evaluated in both groups of patients. RESULTS: Total pain score decreased significantly after surgery in both groups of patients. During the follow-up period, the global quality of life improved by 30.4% in the DPPHE/PJA group, and by 23.2% in the PD/PPPD group. Postoperative morbidity and mortality were higher in the resection group, but the differences were not significant. CONCLUSIONS: Both surgical procedures led to significant improvement in the quality of life and pain relief after surgery for CP. The EORTC QLQ-C30 was found to be a valid and readily available test for quality-of-life assessment in patients with CP.     

Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan,prednisone, thalidomide

We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexamethasone, and melphalan, prednisone, thalidomide improved patients’ health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalidomide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ-MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated-measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been associated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.     

The prognostic value of quality of life scores during treatment for oesophageal cancer

BACKGROUND: Quality of life (QL) data are useful to evaluate the effectiveness of treatment. Accumulating evidence suggests that QL data may predict survival. AIMS: In this study we investigated if baseline QL scores and changes in QL scores before and after intervention are prognostic for patients with oesophageal cancer. PATIENTS: Between 1993 and 1995, 92 consecutive new patients with oesophageal cancer were studied; 89 were followed until death or the end of the study period (survival of seven patients was censored in May 1999). METHODS: All patients completed the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30) and the dysphagia scale of the oesophageal module (EORTC QLQ-OES24) before treatment and at regular intervals throughout the study. Cox's proportional hazards models assessed the impact of baseline QL variables and changes in QL scores on survival. RESULTS: Cox's proportional hazards models, adjusting for associations between QL scores, age, and TNM stage, found that physical function at baseline was significantly associated with survival (p=0.002). An increase in physical function score of 10 points corresponded to a 12% reduction in the likelihood of death at any given time (95% confidence intervals 4--18%). Further exploratory multivariable analyses suggested that improvement in emotional function six months after treatment was significantly related to longer survival (p<0.0001). CONCLUSIONS: These data provide evidence to support a relationship between patient rated scores of QL and survival. Further understanding of the associations between QL and clinical variables is needed.     

Evaluation of Patient-Reported Outcome in Subjects Treated Medically for Acute Pancreatitis: A Follow-Up Study

Aims: To explore the quality of life in patients treated medically during the acute phase of pancreatitis as well as at 2 and 12 months after discharge from the hospital. Patients: 40 patients were studied. The etiology of the pancreatitis was biliary causes in 31 patients and non-biliary causes in 9; mild disease was present in 29 patients and severe disease in 11. 30 patients completed the two surveys at 2 and 12 months after hospital discharge. Methods: The SF-12 and EORTC QLQ-C30 questionnaires were used for the purpose of the study. Results: The two physical and mental component summaries of SF-12, all the domains of EORTC QLQ-C30 (except for physical functioning and cognitive functioning) and some symptom scales of EORTC QLQ-C30 (fatigue, nausea/ vomiting, pain, and constipation) were significantly impaired during the acute phase of pancreatitis. There was a significant improvement in the SF-12 physical component summary, and global health, role functioning, social functioning, nausea/vomiting, pain, dyspnea, and financial difficulties (EORTC QLQ-C30) at 2 months after discharge as compared to the basal evaluation. Similar results were found after 12 months except for the mental component score at 12-month evaluation, which was significantly impaired in acute pancreatitis patients in comparison to the norms. The physical functioning of the EORTC QLQ-C30 at basal evaluation was significantly impaired in patients with severe pancreatitis in comparison to patients with mild pancreatitis. Conclusions: Two different patterns can be recognized in the quality of life of patients with acute pancreatitis: physical impairment is immediately present followed by mental impairment which appears progressively in the follow-up period.     

Do patients who are treated with stem cell transplantation have a health-related quality of life comparable to the general population after 1 year?

Health-related quality of life (HRQOL) in leukemia and lymphoma patients treated with high-dose chemotherapy followed by allogeneic (SCT) and autologous (ASCT) stem cell transplantation or receiving combination chemotherapy (CT) was prospectively assessed by the EORTC QLQ-C30 and compared with reference data from a general population sample. One year after transplant, the SCT group had functional scores which were close to population values except for lower social (P < 0.0001) and role function (P = 0.0004). More symptoms and problems were reported, especially appetite loss (P = 0. 001) and financial difficulties (P = 0.0001). The ASCT patients reported a less than optimal HRQOL relative to the population 1 year post transplant. Cognitive, physical, role, and social function, dyspnoea, financial difficulties and global quality of life were most impaired (P < 0.001). In the CT group, physical, role and social function, dyspnoea and financial difficulties were impaired 1 year after start of chemotherapy, compared with the general population (P < 0.001). The EORTC QLQ-C30 was supplemented by a high-dose chemotherapy module, the HDC-19, at the 1-year assessment, but no consistent differences were found across groups. Fifteen to 34% of the patients expressed fears of relapse and worries about future health, while 24-30% indicated no participation in sexual activities.     

Quality of life may be affected more by disease parameters and response to therapy than by haemoglobin changes

Earlier studies showing a negative impact of anaemia on quality of life (QOL) lack adequate adjustment for confounding factors such as disease stage and tumour response. We examined the impact of haemoglobin concentration on QOL scores of 745 multiple myeloma patients followed from diagnosis, adjusting for objective disease parameters. Data from two Nordic studies with the EORTC QLQ-C30 questionnaire were analysed using linear regression analysis. Haemoglobin was independently related only to fatigue at baseline (P = 0.001) and at 12 months (P = 0.010). In multivariate analysis, extent of skeletal disease was at least as strong a predictor for fatigue at diagnosis as haemoglobin and was also related to other important QOL scores such as physical functioning, role functioning, global QOL and pain (P < 0.001). At 12 months' follow-up, response to therapy was related to physical functioning (P < 0.001) and pain (P = 0.001). In conclusion, haemoglobin and extent of skeletal disease were both predictors for fatigue in patients with newly diagnosed multiple myeloma, but extent of skeletal disease was also associated with other important QOL scores. During follow-up, response to therapy emerged as an important predictor variable. When examining the effect of haemoglobin on QOL, it is essential to adjust for disease parameters and response to therapy in order not to overestimate the impact of haemoglobin on QOL. Our findings imply that uncontrolled studies on the effect of erythropoietin (EPO) in cancer patients may be making exaggerated claims for the effect of EPO on QOL.     

Cardiovascular health-related quality of life in cancer: a prospective study comparing the ESC HeartQoL and EORTC QLQ-C30 questionnaire

Aims

Health-related quality of life (HRQoL) is highly relevant in cancer and often assessed with the EORTC QLQ-C30. Cardiovascular HRQoL in cancer can be measured with the ESC HeartQoL questionnaire. We compared these instruments and examined their prognostic value.

Methods and results

Summary scores for EORTC QLQ-C30 (0–100 points) and ESC HeartQoL (0–3 points) questionnaires were prospectively assessed in 290 patients with mostly advanced cancer (stage 3/4: 81%, 1-year mortality: 36%) and 50 healthy controls (similar age and sex). Additionally, physical function and activity assessments were performed. Both questionnaires demonstrated reduced HRQoL in patients with cancer versus controls (EORTC QLQ-C30: 67 ± 20 vs. 91 ± 11, p < 0.001; ESC HeartQoL: 1.8 ± 0.8 vs. 2.7 ± 0.4, p < 0.001). The instruments were strongly correlated with each other (summary scores [r = 0.76], physical [r = 0.81], and emotional subscales [r = 0.75, all p < 0.001]) and independently associated with all-cause mortality (best cut-offs: EORTC QLQ-C30 <82.69: hazard ratio [HR] 2.33, p = 0.004; ESC HeartQoL <1.50: HR 1.85, p = 0.004 – adjusted for sex, age, left ventricular ejection fraction, N-terminal pro-B-type natriuretic peptide [NT-proBNP], high-sensitivity troponin T, cancer stage/type), with no differences in the strength of the association by sex (p-interaction > 0.9). Combining both questionnaires identified three risk groups with highest mortality in patients below both cut-offs (vs. patients above both cut-offs: HR 3.60, p < 0.001). Patients with results below both cut-offs, showed higher NT-proBNP and reduced physical function and activity.

Conclusions

The EORTC QLQ-C30 and ESC HeartQoL – assessing cancer and cardiovascular HRQoL – are both associated with increased mortality in cancer patients, with even greater stratification by combing both. Reduced HRQoL scores were associated with elevated cardiovascular biomarkers and decreased functional status.