Impact of sorafenib on health‐related quality of life in Japanese patients with metastatic renal cell carcinoma: a prospective evaluation

Study Type – Therapy (case series)
Level of Evidence 4

OBJECTIVE

To characterize the impact of sorafenib treatment on health‐related quality of life (HRQL) in Japanese patients with mRCC.

PATIENTS AND METHODS

We performed a prospective observational study including 85 consecutive patients undergoing radical nephrectomy who were diagnosed as having mRCC refractory to cytokine therapy and subsequently treated with sorafenib for at least 3 months. HRQL in these patients was assessed using the Medical Outcomes Study 36‐Item Short Form (SF‐36).

RESULTS

Before treatment all eight scores in the 85 patients were significantly inferior to those in the age‐matched control population in Japan. Three months after sorafenib treatment, one score (mental health) in the 85 patients was significantly higher than what it was before treatment. Three scores (body pain, role limitations because of emotional problems, mental health) in patients who had some degree of tumour shrinkage were significantly better than those in the remaining patients, while there were no significant differences in all but one score (social function) between patients with and without severe AEs. Furthermore, there were no significant differences in any scores 3, 6 and 12 months after sorafenib treatment in 26 patients who could be followed for at least 12 months.

CONCLUSIONS

Despite non‐randomized study including a comparatively small number of patients, the findings of the present study suggest that sorafenib treatment may not impair HRQL in patients with mRCC, and HRQL in patients receiving sorafenib is likely to be affected by the efficacy rather than AEs during treatment.     

Impact of personality and psychological distress on health‐related quality of life in kidney transplant recipients

Health‐related quality of life (HRQoL) has become an important outcome in the evaluation of kidney transplantation (KT). Although the medical and sociodemographic predictors of HRQoL in patients after KT are well known, there is still a lack of knowledge about the psychological factors involved. This study focuses on the role of personality and actual psychological distress in predicting HRQoL after KT. Sociodemographic (gender, age, education, average income), medical (glomerular filtration, serum albumin, number of co‐morbid diseases) and psychological data (neuroticism, extroversion, psychological distress) were collected from 177 (60.5% male subjects; 48 ± 12.1 years) kidney transplant recipients, and physical and mental HRQoL were measured using the SF‐36. A univariate general linear model analysis was performed. Higher physical HRQoL was associated with younger age, higher education and income, a low number of co‐morbid diseases, lower neuroticism and distress. Higher mental HRQoL was associated with higher education and income, longer time from KT, higher extroversion, lower neuroticism and distress. In both physical and mental HRQoL, actual distress was the best predictor, even when controlled for neuroticism. These results confirm the importance of psychological distress in patients and its impact on their HRQoL after KT and can be applied in intervention programs focused on increasing HRQoL.     

Prospective assessment of health‐related quality of life in men with late‐onset hypogonadism who received testosterone replacement therapy

The objective of this study was to characterise the status of health‐related quality of life (HRQOL) in Japanese men with late‐onset hypogonadism (LOH) treated with testosterone replacement therapy (TRT). HRQOL in 69 consecutive Japanese men with LOH undergoing TRT for at least 6 months was prospectively evaluated before and 6 months after the initiation of TRT using the Medical Outcomes Study 8‐Item Short‐Form Health Survey (SF‐8). All eight‐scale scores except for bodily pain (BP) in the 69 patients at 6 months after the introduction of TRT significantly improved compared with those before TRT; however, all scale scores except for BP in the 69 patients were significantly inferior to those in age‐matched Japanese controls irrespective of the timing of SF‐8. Multivariate analyses of several parameters revealed that both age and Aging Male Symptom (AMS) score had an independent impact on mental health (MH), despite the lack of an independent association between any score and the remaining factors examined. TRT appeared to significantly improve the status of HRQOL in men with LOH; however, even after the introduction of TRT, HRQOL associated with MH remained significantly impaired in elderly men and/or those with a high AMS score.     

Quality‐of‐life evaluation in chronic wounds: comparative analysis of three disease‐specific questionnaires

The study directly compared the feasibility and performance of three instruments measuring health‐related quality of life (HRQoL) in chronic ulcers: the Freiburg Life Quality Assessment for wounds (FLQA‐w), the Cardiff Wound Impact Schedule (CWIS) and the Würzburg Wound Score (WWS). The questionnaires were evaluated in a randomly assigned order in a longitudinal observational study of leg ulcer patients. Psychometric properties (internal consistency, responsiveness and construct validity) were analysed. Patient acceptance was recorded. Analysis of n = 154 patients revealed good internal consistency (Cronbach's alpha ≥ 0·85) for all instruments. There were minor floor effects in all questionnaires (<1%) and some ceiling effects in the CWIS. Construct validity was satisfactory, for example, correlation with EuroQoL‐5D was r = 0·70 in the FLQA‐w, r = 0·47/0·67/0·68 in the CWIS dimensions and r = 0·60 in the WWS. The proportion of missing values was higher in the CWIS, and overall patient acceptance was highest in the FLQA‐w for wounds (54% best preferences) and lowest in the WWS (14%). In conclusion, the FLQA‐w, the CWIS and the WWS are reliable, sensitive and valid instruments for the assessment of HRQoL in leg ulcers. However, they show differences in clinical feasibility and patient acceptance.     

Patient‐reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments

To critically review conceptual frameworks for available patient‐reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient‐Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer‐specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer‐specific PROs: the Expanded Prostate Cancer Index Composite‐26 (EPIC‐26), Expanded Prostate Cancer Index Composite‐50 (EPIC‐50), University of California‐Los Angeles Prostate Cancer Index (UCLA‐PCI), Functional Assessment of Cancer Therapy ‐ Prostate Cancer Subscale (FACT‐P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – prostate specific 25‐item (EORTC QLQ‐PR25), Prostate Cancer – Quality of Life (PC‐QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health‐related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work is also needed to determine whether they can be used at the individual level.     

Impact of robot‐assisted radical prostatectomy on health‐related quality of life in patients with lower urinary tract symptoms

Objective: Lower urinary tract symptoms (LUTS) are a common complaint in patients with prostate cancer. We attempted to elucidate the effect of robot‐assisted radical prostatectomy (RARP) on patients having different preoperative LUTS severity through analysis of postoperative health‐related quality of life. Methods: From 1/2006 to 9/2009, over 500 patients underwent RARP at our institution. Preoperative American Urologic Association Symptom Score (AUA‐SS), preoperative Sexual Health Inventory for Men, and postoperative Expanded Prostate Cancer Index Composite were available in 183 of them. These patients were divided into three subgroups based on their AUA‐SS as follows: mild AUA‐SS (score 0–7) group, moderate AUA‐SS (8–19) group, and severe AUA‐SS (20–35) group. Results: Of the 183 men, 94 (51.4%), 70 (38.2%), and 19 (10.4%) were in the mild, moderate, and severe group, respectively. In the comparison of Expanded Prostate Cancer Index Composite domain subscales with mean score, only urinary domain had significant differences among subgroups. Patients with high preoperative LUTS persistently showed a statistical trend for decreased urinary function (P = 0.056) and suffered more from urinary bother postoperatively (P < 0.01). In the analysis of urinary bother items, all items except “bleeding with urination” showed statistically significant differences among the subgroups (P < 0.05). Conclusions: Even after RARP, patients with severe preoperative LUTS continue to have significant symptoms postoperatively. In analyzing urinary bother items, all LUTS items, including dysuria, storage symptoms, and postmicturition or voiding symptoms, were higher in patients with high preoperative AUA‐SS.