Subgroup And Quality Of Life Analyses Of The Phase Iii Clinical Trial Of Novottf-100a Versus Best Standard Chemotherapy For Recurrent Glioblastoma

BACKGROUND: NovoTTF is a portable device delivering low-intensity, intermediate-frequency, electric fields using noninvasive, disposable scalp electrodes. These fields physically interfere with cell division. Preliminary studies in recurrent and newly diagnosed glioblastoma (GBM) have shown promising results. A phase III study in recurrent GBM has recently been concluded. METHODS: Adults (KPS ≥ 70%) with recurrent GBM (any recurrence) were randomized (stratified by surgery and center) to either NovoTTF administered continuously (20-24 hours/day, 7 days/week) or the best available chemotherapy (best physician choice [BPC]). Primary endpoint was overall survival (OS); 6-month progression-free survival (PFS6), 1-year survival, and QOL were secondary endpoints. RESULTS: Two hundred thirty-seven patients were randomized (28 centers in the United States and Europe) to either NovoTTF alone (120 patients) or BPC (117 patients). Patient characteristics were balanced, median age was 54 years (range, 23-80 years), median KPS was 80% (range, 50-100). One quarter had surgery for recurrence, and over half were at their second or more recurrence. A survival advantage for the device group was seen in patients treated according to protocol (median OS, 7.8 months vs. 6.1 months; n = 185; p = 0.01). Moreover, subgroup analysis in patients with better prognostic baseline characteristics (KPS ≥ 80%; age ≤ 60; 1st-3rd recurrence) demonstrated a robust survival benefit for NovoTTF patients compared to matched BPC patients (median OS, 8.8 months vs. 6.6 months; n = 110; p < 0.01). In this group, 1-year survival was 35% vs. 20% and PFS6 was 25.6% vs. 7.7%. Interestingly, in patients who failed bevacizumab prior to the trial, OS was also significantly extended by NovoTTF (4.4 months vs. 3.1 months; n = 23 vs. n = 21; p < 0.02). Quality of life was equivalent or superior in NovoTTF patients. CONCLUSIONS: NovoTTF, a noninvasive, novel cancer treatment modality shows significant therapeutic efficacy with improved quality of life. The impact of NovoTTF was more pronounced when patients with better baseline prognostic factors were treated. A large scale phase III clinical trial in newly diagnosed GBM is currently being conducted.

Host- rather than virus-related factors reduce health-related quality of life in hepatitis C virus infection.

BACKGROUND: Hepatitis C virus (HCV) infection is associated with decreased health-related quality of life (HRQOL). Although HCV has been suggested to directly impair neuropsychiatric functions, other factors may also play a role. PATIENTS AND METHODS: In this cross-sectional study, we assessed the impact of various host-, disease- and virus-related factors on HRQOL in a large, unselected population of anti-HCV-positive subjects. All individuals (n = 1736) enrolled in the Swiss Hepatitis C Cohort Study (SCCS) were asked to complete the Short Form 36 (SF-36) and the Hospital Anxiety Depression Scale (HADS). RESULTS: 833 patients (48%) returned the questionnaires. Survey participants had significantly worse scores in both assessment instruments when compared to a general population. By multivariable analysis, reduced HRQOL (mental and physical summary scores of SF-36) was independently associated with income. In addition, a low physical summary score was associated with age and diabetes, whereas a low mental summary score was associated with intravenous drug use. HADS anxiety and depression scores were independently associated with income and intravenous drug use. In addition, HADS depression score was associated with diabetes. None of the SF-36 or HADS scores correlated with either the presence or the level of serum HCV RNA. In particular, SF-36 and HADS scores were comparable in 555 HCV RNA-positive and 262 HCV RNA-negative individuals. CONCLUSIONS: Anti-HCV-positive subjects have decreased HRQOL compared to controls. The magnitude of this decrease was clinically important for the SF-36 vitality score. Host and environmental, rather than viral factors, seem to impact on HRQOL level.

Cannabis Use in Patients with Fibromyalgia: Effect on Symptoms Relief and Health-Related Quality of Life

Background: The aim of this study was to describe the patterns of cannabis use and the associated benefits reported by patients with fibromyalgia (FM) who were consumers of this drug. In addition, the quality of life of FM patients who consumed cannabis was compared with FM subjects who were not cannabis users. Methods: Information on medicinal cannabis use was recorded on a specific questionnaire as well as perceived benefits of cannabis on a range of symptoms using standard 100-mm visual analogue scales (VAS). Cannabis users and non-users completed the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI) and the Short Form 36 Health Survey (SF-36). Results: Twenty-eight FM patients who were cannabis users and 28 non-users were included in the study. Demographics and clinical variables were similar in both groups. Cannabis users referred different duration of drug consumption; the route of administration was smoking (54%), oral (46%) and combined (43%). The amount and frequency of cannabis use were also different among patients. After 2 hours of cannabis use, VAS scores showed a statistically significant (p<0.001) reduction of pain and stiffness, enhancement of relaxation, and an increase in somnolence and feeling of well being. The mental health component summary score of the SF-36 was significantly higher (p<0.05) in cannabis users than in non-users. No significant differences were found in the other SF-36 domains, in the FIQ and the PSQI. Conclusions: The use of cannabis was associated with beneficial effects on some FM symptoms. Further studies on the usefulness of cannabinoids in FM patients as well as cannabinoid system involvement in the pathophysiology of this condition are warranted

Glioblastoma in elderly patients: health-related quality of life (hrqol) in a randomized trial comparing 6-weeks of tadiotherapy (rt) vs hypofractionated rt over 2 weeks vs temozolomide chemotherapy (tmz)

BACKGROUND: Despite advances in treatment, survival of patients with GBM over 60 years is still often less than 1 year. In the perspective of a short expected survival, the quality of the remaining life and the effects of therapy on health-related quality of life (HRQoL) should be given special emphasis when recommending treatment for the individual patients. Several studies have focused on survival of the elderly, but few data are available on HRQoL for different treatments. In a randomized trial, we compared survival and HRQoL for 3 treatment options, 6 weeks of RT, vs hypofractionated RT, or chemotherapy with TMZ. MATERIALS AND METHODS: Newly diagnosed GBM patients, age ≥60 years with PS 0-2, were randomized to either standard RT (60 Gy in 2-Gy fractions over 6 weeks), hypofractionated RT (34 Gy in 3.4-Gy fractions over 2 weeks), or 6 cycles of chemotherapy with TMZ (200 mg/m2 day 1-5 every 28 days). QoL was determined by the EORTC QLQ 30 questionnaire and the Brain Cancer Module at inclusion, before start of therapy, at 6 weeks, 3 months, and 6 months after start of treatment. Patients were followed until death. The primary study endpoint was overall survival (OS) and secondary objectives were HRQoL, neurologic symptom control, and safety. RESULTS: A total of 342 patients were included and 292 patients were randomized between the 3 treatment options and 50 patients between hypofractionated RT and TMZ. Median age was 70 years (range 60-92) with 58% being male. Performance status was 0-1 for 75% of patients and 73% had undergone surgical resection. CONCLUSION: The results from the HRQoL analysis of this trial will be presented together with survival data at the upcoming EANO meeting.

Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer

Background: As the long-term efficacy of stereotactic body radiation therapy (SBRT) becomes established and other prostate cancer treatment approaches are refined and improved, examination of quality of life (QOL) following prostate cancer treatment is critical in driving both patient and clinical treatment decisions. We present the first study to compare QOL after SBRT and radical prostatectomy, with QOL assessed at approximately the same times pre- and post-treatment and using the same validated QOL instrument. Methods: Patients with clinically localized prostate cancer were treated with either radical prostatectomy (n = 123 Spanish patients) or SBRT (n = 216 American patients). QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) grouped into urinary, sexual, and bowel domains. For comparison purposes, SBRT EPIC data at baseline, 3 weeks, 5, 11, 24, and 36 months were compared to surgery data at baseline, 1, 6, 12, 24,and 36 months. Differences in patient characteristics between the two groups were assessed using Chi-squared tests for categorical variables and t-tests for continuous variables. Generalized estimating equation (GEE) models were constructed for each EPIC scale to account for correlation among repeated measures and used to assess the effect of treatment on QOL. Results: The largest differences in QOL occurred in the first 16 months after treatment, with larger declines following surgery in urinary and sexual QOL as compared to SBRT, and a larger decline in bowel QOL following SBRT as compared to surgery. Long-term urinary and sexual QOL declines remained clinically significantly lower for surgery patients but not for SBRT patients. Conclusions: Overall, these results may have implications for patient and physician clinical decision making which are often influenced by QOL. These differences in sexual, urinary and bowel QOL should be closely considered in selecting the right treatment, especially in evaluating the value of non-invasive treatments, such as SBRT.

APTIC : a social network to improve the quality of life of members of patients' associations

Peer-reviewed

Food allergy: Evaluation of the quality of life in Swiss children

Background: Food allergy in children, an increasingly prevalent disease, significantly affects the quality of life. Its impact can be analyzed by the recently validated French version of the Food Allergy Quality of Life Questionnaire (FAQLQ). Objectives: The aim of our study was to evaluate the quality of life in a small sample of Swiss children with IgE-mediated food allergy. Methods: Information were collected with the questionnaire among 0-12 years old children and their parents during a scheduled allergy visit, and analysed in term of emotional impact, food anxiety and social and food limitations. Patients were divided according to the questionnaire in three age groups: group 1 from 0 to 3 years, group 2 from 4 to 6 years and group 3 from 7 up to 12 years. Results: 30 food allergic patients were included, with a girl/boy ratio of 1:1.14. Median age was 6 years. 56% suffered from or had a history of eczema, 23% of rhino-conjunctivitis, 30% of asthma, and 13% reported a drug allergy. None had insect venom allergy. 57% were known to be allergic to one food, 20% to two foods, 20% to 3 foods and 3% had 3 or more food allergies. Tree nuts (51% of all allergies) as well as eggs (28 %) were the major allergies. Emotional impact had a total score of 1.54 but showed differences between age groups. In group 1 it was lower with 0.23, in group 2 the score was 2.03 and 1.77 in group 3. Food anxiety total score was 1.9; 0.76 in group 1, 2.31 in group 2 and 2.23 in group 3. Social and food limitations showed similar results with a total score of 1.73 and 1.23 in group 1, 2.05 in group 2 and 1.68 for group 3. Conclusion: Food allergy affects the quality of life of Swiss children. Our preliminary results on a small sample are comparable to previously published data. We show that the impact of food allergy on daily life increases when the child starts school and social activities.

Canakinumab Relieves Symptoms of Acute Flares and Improves Health-Related Quality Of Life (HRQoL) in Difficult-To-Treat Gouty Arthritis Patients by Suppressing Inflammation: Results of a Randomized, Dose-Ranging Study

RATIONALE:We investigated the impact of canakinumab, a fully human anti-interleukin-1b monoclonal antibody on inflammation and HRQoL in gouty arthritis patients.METHODS: In this 8-week, single-blind, dose-ranging study, patients with acute gouty arthritis flares, unresponsive/intolerant or contraindicated to NSAIDs and/or colchicine were randomized to single subcutaneous canakinumab (10, 25, 50, 90, or 150mg, N5143) or single intramuscular triamcinolone acetonide (TA, 40mg, N557). Patients assessed pain (Likert scale), physicians assessed clinical signs of joint inflammation, and HRQoL was recorded using SF-36.RESULTS: At baseline, 98% patients had moderate-to-extreme pain, 85% had moderate/severe joint swelling, 64-79% had elevated inflammatory markers and HRQoL scores indicated impaired physical function. Percentage of patients with no/mild pain was numerically greater in most canakinumab groups vs. TA, 24-72h post-dose; difference significant for 150mg group at these time-points (P<0.05). Canakinumab 150mg was associated with significantly lower Likert scores for tenderness [OR, 3.2; 95% CI, 1.27-7.89; P50.014] and swelling (OR, 2.7; 95% CI, 1.09-6.50, P50.032) at 72h vs. TA; erythema was not different. Median CRP and SAA levels normalized by 7 days post-dose in most canakinumab groups, but remained elevated in TA. Physical function improved at 7 days postdose in all groups, highest improvement for canakinumab 150mg. SF-36 scores for physical functioning and bodily pain with canakinumab 150mg approached US general population scores by 7 days post-dose and exceeded normal values by 8 weeks post-dose.CONCLUSION: Canakinumab 150mg produced significantly greater and rapid pain-relief and improvements in HRQoL vs. TAin acute gouty arthritis patients.

An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients.

Aims: The psychometric properties of the EORTC QLQ-BN20, a brain cancer-specific HRQOL questionnaire, have been previously determined in an English-speaking sample of patients. This study examined the validity and reliability of the questionnaire in a multi-national, multi-lingual study. Methods: QLQ-BN20 data were selected from two completed phase III EORTC/NCIC clinical trials in brain cancer (N=891), including 12 languages. Experimental treatments were surgery followed by radiotherapy (RT) and adjuvant PCV chemotherapy or surgery followed by concomitant RT plus temozolomide (TMZ) chemotherapy and adjuvant TMZ chemotherapy. Standard treatment consisted of surgery and postoperative RT alone. The psychometrics of the QLQ-BN20 were examined by means of multi-trait scaling analyses, reliability estimation, known groups validity testing, and responsiveness analysis. Results: All QLQ-BN20 items correlated more strongly with their own scale (r>0.70) than with other QLQ-BN20 scales. Internal consistency reliability coefficients were high (all alpha0.70). Known-groups comparisons yielded positive results, with the QLQ-BN20 distinguishing between patients with differing levels of performance status and mental functioning. Responsiveness of the questionnaire to changes over time was acceptable. Conclusion: The QLQ-BN20 demonstrates adequate psychometric properties and can be recommended for use in conjunction with the QLQ-C30 in assessing the HRQOL of brain cancer patients in international studies.

Health-related quality of life in patients with dual diagnosis: clinical correlates

Background: Although the studies published so far have found an affectation in the Health Related Quality of Life (HRQOL) in both psychiatric and substance use dependence disorders, very few studies have applied HRQOL as an assessment measure in patients suffering both comorbid conditions, or Dual Diagnosis. The aim of the current study was to assess HRQOL in a group of patients with Dual Diagnosis compared to two other non-comorbid groups and to determine what clinical factors are related to HRQOL. Methods: Cross-sectional assessment of three experimental groups was made through the Short Form 36 Item Health Survey (SF-36). The sample consisted of a group with Dual Diagnosis (DD; N=35), one with Severe Mental Illness alone (SMI; N=35) and another one with Substance Use Dependence alone (SUD; N=35). The sample was composed only by males. To assess the clinical correlates of SF-36 HRQOL, lineal regression analyses were carried out. Results: The DD group showed lower scores in most of the subscales, and in the mental health domain. The group with SUD showed in general a better state in the HRQOL while the group with SMI held an intermediate position with respect to the other two groups. Daily medication, suicidal attempts and daily number of coffees were significantly associated to HRQOL, especially in the DD group. Conclusions: The DD group showed lower self-reported mental health quality of life. Assessment of HRQOL in dual patients allows to identify specific needs in this population, and may help to establish therapeutic goals to improve interventions.

Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer

Background: As the long-term efficacy of stereotactic body radiation therapy (SBRT) becomes established and other prostate cancer treatment approaches are refined and improved, examination of quality of life (QOL) following prostate cancer treatment is critical in driving both patient and clinical treatment decisions. We present the first study to compare QOL after SBRT and radical prostatectomy, with QOL assessed at approximately the same times pre- and post-treatment and using the same validated QOL instrument. Methods: Patients with clinically localized prostate cancer were treated with either radical prostatectomy (n = 123 Spanish patients) or SBRT (n = 216 American patients). QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) grouped into urinary, sexual, and bowel domains. For comparison purposes, SBRT EPIC data at baseline, 3 weeks, 5, 11, 24, and 36 months were compared to surgery data at baseline, 1, 6, 12, 24,and 36 months. Differences in patient characteristics between the two groups were assessed using Chi-squared tests for categorical variables and t-tests for continuous variables. Generalized estimating equation (GEE) models were constructed for each EPIC scale to account for correlation among repeated measures and used to assess the effect of treatment on QOL. Results: The largest differences in QOL occurred in the first 1-6 months after treatment, with larger declines following surgery in urinary and sexual QOL as compared to SBRT, and a larger decline in bowel QOL following SBRT as compared to surgery. Long-term urinary and sexual QOL declines remained clinically significantly lower for surgery patients but not for SBRT patients. Conclusions: Overall, these results may have implications for patient and physician clinical decision making which are often influenced by QOL. These differences in sexual, urinary and bowel QOL should be closely considered in selecting the right treatment, especially in evaluating the value of non-invasive treatments, such as SBRT.

Quality of life after pulmonary embolism: Prospective validation of the German version of the PEmb-QoL questionnaire.

BACKGROUND: The Pulmonary Embolism Quality of Life questionnaire (PEmb-QoL) is a 40-item questionnaire to measure health-related quality of life in patients with pulmonary embolism. It covers six 6 dimensions: frequency of complaints, limitations in activities of daily living, work-related problems, social limitations, intensity of complaints, and emotional complaints. Originally developed in Dutch and English, we prospectively validated a German version of the PEmb-QoL. METHODS: A forward-backward translation of the English version of the PEmb-QoL into German was performed. German-speaking consecutive adult patients aged ≥18 years with an acute, objectively confirmed pulmonary embolism discharged from a Swiss university hospital (01/2011-06/2013) were recruited telephonically. Established psychometric tests and criteria were used to evaluate the acceptability, reliability, and validity of the German PEmb-QoL questionnaire. To assess the underlying dimensions, an exploratory factor analysis was performed. RESULTS: Overall, 102 patients were enrolled in the study. The German version of the PEmb-QoL showed a good internal consistency (Cronbach's alpha ranging from 0.72 to 0.96), item-total (0.53-0.95) and inter-item correlations (>0.4), and test-retest reliability (intra-class correlation coefficients 0.59-0.89) for the dimension scores. A moderate correlation of the PEmb-QoL with SF-36 dimension and summary scores (0.21-0.83) indicated convergent validity, while low correlations of PEmb-QoL dimensions with clinical characteristics (-0.16-0.37) supported discriminant validity. The exploratory factor analysis suggested four underlying dimensions: limitations in daily activities, symptoms, work-related problems, and emotional complaints. CONCLUSION: The German version of the PEmb-QoL questionnaire is a valid and reliable disease-specific measure for quality of life in patients with pulmonary embolism.

Resident health-related quality of life in Swiss nursing homes.

BACKGROUND: Health-related quality of life (HRQOL) levels and their determinants in those living in nursing homes are unclear. The aim of this study was to investigate different HRQOL domains as a function of the degree of cognitive impairment and to explore associations between them and possible determinants of HRQOL. METHOD: Five HRQOL domains using the Minimum Data Set - Health Status Index (MDS-HSI) were investigated in a large sample of nursing home residents depending on cognitive performance levels derived from the Cognitive Performance Scale. Large effect size associations between clinical variables and the different HRQOL domains were looked for. RESULTS: HRQOL domains are impaired to variable degrees but with similar profiles depending on the cognitive performance level. Basic activities of daily living are a major factor associated with some but not all HRQOL domains and vary little with the degree of cognitive impairment. LIMITATIONS: This study is limited by the general difficulties related to measuring HRQOL in patients with cognitive impairment and the reduced number of variables considered among those potentially influencing HRQOL. CONCLUSION: HRQOL dimensions are not all linearly associated with increasing cognitive impairment in NH patients. Longitudinal studies are required to determine how the different HRQOL domains evolve over time in NH residents.