Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.     

Quality of life in patients before and after haematopoietic stem cell transplantation measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire QLQ-C30

The EORTC Quality of Life Core Questionnaire QLQ-C30 is widely used, but no reference values are available for patients receiving HSCT. We retrieved data for 38 samples from 33 papers in English and German that provided evaluable information on QLQ-C30 scores (mean, s.d.) covering about 2800 patients. Results are presented as a table that provides reference data that allow QLQ-C30 scores at different points during the disease trajectory to be put in context. With respect to their central tendency and their variance, scores vary over time. Quality of life is lowest during inpatient time. About 1 year after HSCT, the pre-transplant level is reached. Physical functioning is the scale reaching the highest level of all scales. Fatigue, dyspnoea and insomnia are symptoms that remain at an elevated level and should thus be considered as persisting problems after HSCT. For the interpretation of differences between scores, a very conservative recommendation would be to set the s.d. at 30 points. Doing so, one could be quite sure of having found a clinically significant change if the difference of two scores exceeds 15 points. Differences below 5 points should be interpreted with caution.     

The European organization for research and treatment of cancer quality of life questionnaire: implications for prognosis in pancreatic cancer

Background The goal of this study was to evaluate the association between patient quality of life (QoL) and survival in pancreatic cancer patients undergoing care in a community hospital comprehensive cancer center. Patients and Methods A consecutive case series of 55 histologically confirmed pancreatic cancer treated at Cancer Treatment Centers of America? at Midwestern Regional Medical Center was studied between 04/01 and 11/04. The EORTC QLQ-C30 was utilized to assess patient QoL. Kaplan–Meier method was used to calculate survival. Log-rank test was used to study the equality of survival distributions. Multivariate Cox regression analyses were then performed to evaluate the joint prognostic significance of those QoL and clinical factors that were shown to be prognostic upon univariate analyses. Results Of the 55 patients, 28 were newly diagnosed and 27 had prior treatment history. The median age was 55 years (range 33–74 years). Majority (34) had stage IV disease at diagnosis. The QLQ-C30 parameters to show statistically significant associations with survival were physical, role, and emotional functioning scales and fatigue, appetite loss, constipation, and diarrhea symptom scales. Conclusions We found that patient QoL, as measured by the QLQ-C30 physical functioning scale, provides useful prognostic information, independent of multiple cancer symptoms, in patients with pancreatic cancer. While these findings require further investigation in large patient cohorts, they may have important implications for patient stratification in clinical trials, as well as aid in clinical decision making.     

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.     

Development and validation of a disease-specific quality of life questionnaire (EQOL) for potentially curable patients with carcinoma of the esophagus

The objective was to develop, pretest and validate a disease-specific quality of life questionnaire for potentially curable patients with esophageal carcinoma, for use with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in order to assess the quality of life associated with the various treatment modalities available for this disease. Questionnaire development phase Patients were enrolled in three centres. Literature reviews, patients, family members, and health care professionals generated 195 items: symptoms (55); emotions (53); physical functioning (17); activities of daily living (ADL) (48); and leisure/social (22). Thirty-eight patients identified items of importance and assigned importance ratings on a 5-point Likert scale. Impact scores were calculated as frequency times mean item importance. Item impact scores<20/100 were excluded. Pearson's correlation co-efficients compared domains with the Medical Outcomes Study SF-20 (MOS SF-20). Fifteen items remained. Questionnaire validation phase EORTC QLQ-C30, Esophageal Quality of Life Questionnaire (EQOL), MOS SF-36 and a Global Rating of Change Questionnaire were completed at baseline, 1 week after baseline but prior to any treatment, 1 month, 3 months, and 6 months after treatment began. Reliability was assessed using paired samples correlations. Responsiveness was assessed between mean scores of changed and unchanged patients, and a responsiveness index was calculated. The MOS SF-36 was used for criterion validity. Construct validity included four a priori predictions. Sixty-five patients were enrolled in four centres in the validation phase. Paired samples correlations were high for all domains (0.749-0.889) indicating good reliability. Symptom, physical function and social domains were responsive to change at all time intervals (P<0.05). Emotional function was responsive at 1 and 3 months, activities of daily living (ADLs) at 1 and 6 months. Magnitude of change was significant when direction of change was stated. Between better and worse, magnitude of change was significant in all domains except at 6 months in symptoms, emotional and physical domains. The minimal clinically important difference was consistently around 0.5 for all domains. Minimal, moderate and large effect ranges were established. Only 2/16 time intervals had poor correlations with the SF-36, establishing criterion validity. Of the four a priori predictions for construct validity, only the second part of one prediction, in the emotional function domain, was not confirmed. We have developed a 15-item questionnaire (EQOL) which has good reliability, responsiveness and validity and is now in use in studies in Canadian centres with the EORTC QLQ-C30.     

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.     

Influence of adjuvant radio-chemotherapy for rectal cancer on quality of life

INTRODUCTION: Modern therapy for rectal cancer is associated with functional disorders. Dysfunction as a consequence of surgery has to be distinguished from disorders caused by postoperative therapy. Therefore we have compared the long-term functional results of patients who received postoperative radio-chemotherapy or no therapy in conjunction with low anterior resection of the rectum. PATIENTS AND METHOD: From 1997 to 2002, a total of 32 patients (16 males and 16 females) after low anterior rectal resection and postoperative radio-chemotherapy or surgical therapy alone was compared using standardized and validated instruments (Short-Form-36-Health-Survey, EORTC QLQ-C30, QLQ-CR 38 and ASCRS fecal incontinence questionnaire) in a matched-pair analysis (age, gender and time of surgery). Mean age was 61.8 (62.1) years and mean follow-up was 4 (3.8) years. RESULTS: Two out of the 40 examined parameters differed significantly. There were no significant differences in Short-Form-36-Health-Survey and EORTC QLQ-C30 scales between both groups. The QLQ-CR38 scale sexual enjoyment differed significantly, whereas future perspectives, sexual functioning, micturition problems, symptoms in the area of the gastrointestinal tract, weight loss, defecation problems, male and female sexual problems did not differ significantly. The scales Lifestyle, Coping/Behavior and Depression/Self-Perception of the ASCRS fecal incontinence questionnaire also did not differ significantly. The difference for embarrassment was significant. DISCUSSION: No differences in quality of life after postoperative radio-chemotherapy or no postoperative therapy in conjunction with low anterior rectal resection can be found. There are, however, tendencies that postoperative radio-chemotherapy has more adverse effects on continence and sexual function than low anterior rectal resection alone.     

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.     

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.     

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.     

Analysis of Postsurgical Health-Related Quality of Life and Quality of Voice of Patients With Laryngeal Carcinoma

This study aims to analyze the postsurgical health-related quality of life (HRQOL) and quality of voice (QOV) of patients with laryngeal carcinoma with an expectation of improving the treatment and HRQOL of these patients.Based on the collection of information of patients with laryngeal carcinoma regarding clinical characteristics (age, TNM stage, with or without laryngeal preservation and/or neck dissection, with or without postoperative irradiation and/or chemotherapy, etc.), QOV using Voice Handicap Index (VIH) scale and HRQOL using EORTC QLQ-C30 and EORTCQLQ-H&N35 scales, the differences of postsurgical HRQOL related to their clinical characteristics were analyzed using univariate nonparametric tests, the main factors impacting the postsurgical HRQOL were analyzed using regression analyses (generalized linear models) and the correlation between QOV and HRQOL analyzed using spearman correlation analysis.A total of 92 patients were enrolled in this study, on whom the use of EORTC QLQ-C30, EORTC QLQ-H&N35 and VHI scales revealed that: the differences of HRQOL were significant among patients with different ages, TNM stages, and treatment modalities; the main factors impacting the postsurgical HRQOL were pain, speech disorder, and dry mouth; and QOV was significantly correlated with HRQOL.For the patients with laryngeal carcinoma included in our study, the quality of life after open surgeries were impacted by many factors predominated by pain, speech disorder, and dry mouth. It is suggested that doctors in China do more efforts on the patients’ postoperative pain and xerostomia management and speech rehabilitation with the hope of improving the patients’ quality of life.     

Changes in hemoglobin and clinical outcomes drive improvements in fatigue,quality of life,and physical function in patients with paroxysmal nocturnal hemoglobinuria: post hoc analyses from the phase III PEGASUS study

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic, acquired, hematologic, life-threatening disease characterized by thrombosis, impaired bone marrow function, and complement-mediated hemolysis. The PEGASUS phase III clinical trial demonstrated superiority of pegcetacoplan over eculizumab regarding improvements in hemoglobin levels in patients with suboptimal response to prior eculizumab treatment. The objective of this post hoc analysis was to compare the patient-reported outcome (PRO) response rates observed among PEGASUS participants and the relationships between their PRO scores with clinical and hematological parameters. Data from the 16-week randomized, controlled (1:1 to pegcetacoplan or eculizumab) period of the PEGASUS trial included comparisons of weekly PRO measurements taken using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) scales. A clinically meaningful FACIT-F response was defined as an increase from baseline of ≥5 points. Convergent validity was assessed using conventional threshold correlations between FACIT-F, EORTC QLQ-C30, and laboratory parameters. A clinically meaningful improvement in FACIT-F score was seen in 72.2% of pegcetacoplan-treated patients compared to 22.9% of eculizumab-treated patients. At week 16, the FACIT-F total score correlated with hemoglobin levels (r=0.47, p< 0.0001), absolute reticulocyte count (r=−0.37, p<0.01), and indirect bilirubin levels (r=−0.25, p<0.05). Clinically meaningful improvements in pegcetacoplan-treated patients were also observed for multiple EORTC scales. Fatigue and other self-reported outcomes were correlated with clinically meaningful improvements in clinical and hematological parameters. Clinical trial registration: NCT03500549

     

Impact of gefitinib (‘Iressa’) treatment on the quality of life of patients with advanced non-small-cell lung cancer

Purpose: Patients with advanced non-small-cell lung cancer (NSCLC) have a short life expectancy; therefore, in addition to increasing their survival, improving their quality of life (QoL) is also an important treatment goal. Methods: We evaluated the QoL of patients with advanced NSCLC who were unfit to receive chemotherapy, failed to respond or progress following prior chemotherapy, who received subsequent treatment with gefitinib (‘Iressa’) on a compassionate use basis, using a standard QoL questionnaire, (EORTC) QLQ-C30 and the related lung cancer-specific module QLQ-LC13. Results: Analysis of the functional scales showed a trend towards improvement for role, emotional and cognitive scales, while a substantial stability was seen for general QoL scale. Analysis of the symptoms scales of QLQ-C30, showed a trend towards improvement for fatigue, dyspnoea, insomnia, and constipation, after one month of therapy. Fifty-six of the 57 patients were considered evaluable for response. One patient evidenced a partial response (patient is still on response), 29 patients had stable disease for a median duration of 5months (range 4–7 months), and 26 patients progressed. Conclusions: After treatment with Gefitinib, we observed maintenance of QoL in a group of patients with poor prognosis that would be expected to have a worsening QoL. Furthermore important symptoms like dyspnoea fatigue and pain in other parts, that usually afflict patients with NSCLC, showed a trend toward improvement after only one month of therapy. ‘Iressa is a trademark of the AstraZeneca group of companies     

European Organization for Research and Treatment of Cancer and International Society for Cutaneous Lymphoma consensus recommendations for the management of cutaneous B-cell lymphomas

Primary cutaneous B-cell lymphomas (CBCL) represent approximately 20% to 25% of all primary cutaneous lymphomas. With the advent of the World Health Organization-European Organization for Research and Treatment of Cancer (EORTC) Consensus Classification for Cutaneous Lymphomas in 2005, uniform terminology and classification for this rare group of neoplasms were introduced. However, staging procedures and treatment strategies still vary between different cutaneous lymphoma centers, which may be because consensus recommendations for the management of CBCL have never been published. Based on an extensive literature search and discussions within the EORTC Cutaneous Lymphoma Group and the International Society for Cutaneous Lymphomas, the present report aims to provide uniform recommendations for the management of the 3 main groups of CBCL. Because no systematic reviews or (randomized) controlled trials were available, these recommendations are mainly based on retrospective studies and small cohort studies. Despite these limitations, there was consensus among the members of the multidisciplinary expert panel that these recommendations reflect the state-of-the-art management as currently practiced in major cutaneous lymphoma centers. They may therefore contribute to uniform staging and treatment and form the basis for future clinical trials in patients with a CBCL.     

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.     

吉非替尼治疗晚期非小细胞肺癌疗效观察

目的 探讨表皮生长因子酪氨酸激酶抑制剂-吉非替尼对晚期非小细胞肺癌(NSCLC)的治疗效果。方法 对66例应用Iressa(250mg／d)治疗的晚期NSCLC患者生活质量、生存期等临床资料，采用Logistic回归分析、x^2检验、t检验的方法进行统计学分析。生活质量评估依据欧洲癌症研究和治疗组织QLQ-C30和QLQ-Lcl3问卷中文版进行。结果 本组患者用Iressa治疗的有效率为33％(22／66)，疾病控制率(有效 稳定)为70％(46／66)。患者生活质量及相关临床症状QLQ．C30评分中各功能状态和综合生活质量评分的均值显著增加，改善率为91％～100％；QLQ-LC13评分中各项疾病相关症状评分的均值显著降低，改善率为73％～100％。药物的不良反应主要为Ⅰ级或Ⅱ级皮疹和腹泻，经对症处理可缓解。结论 吉非替尼用于晚期NSCLC治疗疗效确切，同时可改善患者的相关症状、提高生活质量。     

Quality of life,taste, olfactory and oral function following high-dose chemotherapy and allogeneic hematopoietic cell transplantation

Multiple oral complaints develop following high-dose chemo/radiotherapy and hematopoietic cell transplantation (HCT) which can influence quality of life. The purpose of this investigation was to assess quality of life, oral function, taste and smell in a cohort of patients following HCT. A general quality of life survey (the European Organization for Research and Treatment of Cancer (EORTC)) Quality of Life (QOL) questionnaire (QLQ-C30), with an added oral symptom and function scale and assessment of taste and smell was administered to a consecutive series of patients at day 90-100 post HCT. General QOL was impacted by fatigue, affecting physical, social emotional and cognitive function. While oral function scales appeared to be little affected at day 90-100 post HCT, abnormalities of taste were reported. Reports of changes in taste and smell appeared to parallel each other and changes remained at the time of the survey post-HCT. Change in taste appeared to be closely associated with dry mouth. Patients appeared to have difficulty in differentiating sour and bitter, which had been more affected than salt and sweet taste. Females appeared to report greater changes in taste than males. Increased smell sensitivity and taste change resulted in changes in food preparation in some cases, as did reported increase in sensitivity to sour and bitter taste. Acute complications are well known to affect QOL during the early period following HCT, but little assessment of long-term changes in oral QOL and taste has been conducted following transplant. The EORTC QLQ C-30 questionnaire with the oral addendum provides a measure of the quality of life and oral function, and may provide useful outcome measures for assessment of oral care prevention and management in HCT patients.     

Quality of life measurement in patients with oesophageal cancer.

Quality of life (QOL) measurement may aid decision making in the treatment of patients with oesophageal cancer but must be clinically valid to be useful. This study considered if the European Organisation for Research and Treatment of Cancer QOL questionnaire, the QLQ-C30, showed differing results in two clinically distinct groups of patients with oesophageal cancer and also investigated the correlation between dysphagia grade and various scales of QOL. Patients treated by oesophagectomy reported significantly better physical, emotional, cognitive, and global health scores than those in the palliative treatment group. Patients who received palliative treatment had significantly worse pain, fatigue, appetite loss, constipation, and dysphagia. The correlations between dysphagia grade and each of the QOL scales and items in both groups of patients were poor. This questionnaire differentiates clearly between the two clinically distinct groups of patients, but to be an entirely appropriate indicator of QOL in patients with oesophageal cancer, an additional specific oesophageal module including a dysphagia scale is required.     

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.