The Relationship Between Health-Related Quality of Life and Overall Survival in Patients With Advanced Renal Cell Carcinoma in CheckMate 214.

BACKGROUND: In CheckMate 214 (median follow-up, 25.2 months), nivolumab plus ipilimumab yielded greater overall survival (OS) benefit than sunitinib in patients with intermediate-/poor-risk advanced renal cell carcinoma (aRCC). Health-related quality of life (HRQoL) assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index-19 (FKSI-19) was also more favorable for the nivolumab plus ipilimumab group than the sunitinib group. We investigated whether HRQoL scores can predict OS of patients with 5 years follow-up in CheckMate 214. PATIENTS AND METHODS: CheckMate 214 was an open-label, phase III trial in previously untreated aRCC (N = 1096). Patients with intermediate-/poor-risk disease (International mRCC Database Consortium prognostic score ≥ 1; n = 847) were randomized to either nivolumab plus ipilimumab or sunitinib monotherapy. Pooled data for OS and FKSI-19 total and subscales (disease-related symptoms [DRS], DRS-physical [DRS-P], and function/well-being [FWB]) were analyzed. Relationships between HRQoL and OS were assessed using Cox proportional hazard models with baseline and longitudinal scores. Associations between HRQoL changes and OS were assessed by landmark analyses. RESULTS: Patients with higher FKSI-19 total and subscale scores at baseline had longer OS than patients with lower scores (HR ≤ 0.834; P < .0001). Longitudinal models indicated stronger associations between HRQoL and OS (HR ≤ 0.69; P < .001 for each). At 3 months after randomization, patients with stable/improved HRQoL versus baseline had longer median OS than patients with worsened/unobserved HRQoL versus baseline (55.9 and 26.0 months, respectively; HR = 0.56; 95% CI, 0.46-0.67; P < .0001). Results at 6-, 9-, and 12-month landmarks were consistent with these findings. CONCLUSION: In aRCC, patient-reported outcomes are important for HRQoL and prognostic evaluation. CLINICALTRIALS.GOV IDENTIFIER: NCT02231749; https://clinicaltrials.gov/ct2/show/NCT02231749.

A comparative analysis of fear of cancer recurrence in patients with small renal masses: Active surveillance versus cryoablation.

BACKGROUND AND PURPOSE: The aim of this study was to evaluate and compare the fear of cancer recurrence (FCR) in patients diagnosed with a small renal mass (SRM) and managed with either active surveillance (AS) or minimal invasive renal cryoablation (CA). PATIENTS/MATERIAL AND METHODS: A total of 398 patients with SRMs (263 AS and 135 CA patients) were retrospectively identified across three institutions and invited to complete the Fear of Cancer Recurrence-Short Form (FCRI-SF) questionnaire. RESULTS: No statistically significant differences in FCRI-SF score were observed between the AS (mean = 10.9, standard deviation [SD] = 6.9) and CA (mean = 10.2, SD = 7.2) (p = 0.559) patients, with the mean scores of both groups being below the suggested clinically significant cut-off of 16. A total of 25% of AS and 28% of CA patients reported sub-clinical or clinical levels of FCR (FCRI-SF score > 16). Within the AS group, a weak negative association between FCR severity and age was observed (r = -0.23, p = 0.006), and a statistically significant difference in FCRI-SF score between patients aged more or less than 73 years (p = 0.009). INTERPRETATION: FCR levels were comparable between AS and CA patients, suggesting that treatment decisions should prioritise clinical factors. Up to 28% of AS and CA patients report clinically significant FCR, highlighting the importance of considering the possibility of FCR, especially in younger patients.

Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial.

BACKGROUND: In the CheckMate 9ER trial, patients with advanced renal cell carcinoma who received first-line nivolumab plus cabozantinib had significantly better progression-free survival compared with those given sunitinib. In this study, we aimed to describe the patient-reported outcome (PRO) results from CheckMate 9ER. METHODS: In this open-label, randomised, phase 3 trial done in 125 cancer centres, urology centres, and hospitals across 18 countries, patients aged 18 years or older with previously untreated advanced renal cell carcinoma with a clear-cell component, a Karnofsky performance status of 70% or more, and available tumour tissue were randomly assigned (1:1) via interactive response technology to nivolumab 240 mg intravenously every 2 weeks plus oral cabozantinib 40 mg per day, or oral sunitinib 50 mg per day monotherapy for 4 weeks in 6-week cycles. The primary endpoint of progression-free survival was reported previously. PROs were analysed as prespecified exploratory endpoints at common timepoints (at baseline and every 6 weeks) until week 115. Disease-related symptoms were evaluated using the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), and global health status was assessed with the three-level EQ-5D (EQ-5D-3L) visual analogue scale (VAS) and UK utility index. PRO analyses were done in the intention-to-treat population. Change from baseline was assessed using mixed-model repeated measures. A time-to-deterioration analysis was done for first and confirmed deterioration events. This study is registered with ClinicalTrials.gov, NCT03141177, and is closed to recruitment. FINDINGS: Between Sept 11, 2017, and May 14, 2019, 323 patients were randomly assigned to nivolumab plus cabozantinib and 328 to sunitinib. Median follow-up was 23·5 months (IQR 21·0-26·5). At baseline, patients in both groups reported low symptom burden (FKSI-19 disease-related symptoms version 1 mean scores at baseline were 30·24 [SD 5·19] for the nivolumab plus cabozantinib group and 30·06 [5·03] for the sunitinib group). Change from baseline in PRO scores indicated that nivolumab plus cabozantinib was associated with more favourable outcomes versus sunitinib (treatment difference 2·38 [95% CI 1·20-3·56], nominal p<0·0001, effect size 0·33 [95% CI 0·17-0·50] for FKSI-19 total score; 1·33 [0·84-1·83], nominal p<0·0001, 0·45 [0·28-0·61] for FKSI-19 disease-related symptoms version 1; 3·48 [1·58-5·39], nominal p=0·0004, 0·30 [0·14-0·47] for EQ-5D-3L VAS; and 0·04 [0·01-0·07], nominal p=0·0036, 0·25 [0·08-0·41] for EQ-5D-3L UK utility index), reaching significance at most timepoints. Nivolumab plus cabozantinib was associated with decreased risk of clinically meaningful deterioration for FKSI-19 total score compared with sunitinib (first deterioration event hazard ratio 0·70 [95% CI 0·56-0·86], nominal p=0·0007; confirmed deterioration event 0·63 [0·50-0·80], nominal p=0·0001). INTERPRETATION: PROs were maintained or improved with nivolumab plus cabozantinib versus sunitinib. Compared with sunitinib, nivolumab plus cabozantinib significantly delayed time to deterioration of patient-reported outcome scores. These results suggest a benefit for nivolumab plus cabozantinib compared with sunitinib in the treatment of patients with advanced renal cell carcinoma. FUNDING: Bristol Myers Squibb.

Real-world symptoms, disease burden, resource use and quality of life in US patients with advanced renal cell cancer.

Aim: To assess symptoms, healthcare resource utilization and health-related quality of life in advanced renal cell carcinoma (aRCC) clinical practice. Materials & methods: The USA point-in-time survey of physicians and patients was conducted between February and September 2019. Results: Data were available for 227 patients. Mean (standard deviation) number of symptoms was 3.4 (3.2); differences were observed across International Metastatic RCC Database Consortium risk categories (p < 0.001), with fewer symptoms in favorable-risk patients. Disease burden, measured by greater healthcare resource utilization and worse health-related quality of life, was high, particularly in International Metastatic RCC Database Consortium intermediate- or poor- versus favorable-risk patients. In total, 45 patients (21.6%) were hospitalized due to aRCC within a 6-month period, 35 (16.8%) had one hospitalization and ten (4.8%) experienced ≥2 hospitalizations due to aRCC. Mean (standard deviation) 19-Item Functional Assessment of Cancer Therapy Kidney Symptom Index score was 53.6 (13.2) for this population, significantly lower than the reference value (59.8; p < 0.001). Conclusion: A clear need exists for improved disease management in patients with aRCC.

Lay abstract Late-stage/advanced renal cell carcinoma (aRCC) is kidney cancer that has spread to other body parts. aRCC is expensive to treat and affects patients in many ways. New treatments have become available, including tyrosine kinase inhibitors and immuno-oncology therapies. The type of treatment recommended depends on the patient's International Metastatic RCC Database Consortium risk score. This is a way of classifying patients as having a good, intermediate or poor survival risk. We asked physicians questions about their patients such as their age, how long they had aRCC, their treatment and symptoms, and asked patients how aRCC affected their lives, including how often they visited doctors and hospitals. aRCC had the greatest effect on patients with poor-risk scores. Those patients had more symptoms and worse quality of life than patients with intermediate or good risk scores. Treatment also affected patients' lives, although not as much as risk score. Patients with aRCC need better treatment options to help improve their quality of life.

Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: a systematic review.

Aims: Quality of life (QoL) assessment is frequently not included among the end points of clinical trials (CTs) on renal cell carcinoma. Herein we aimed to describe the assessment and reporting of QoL in Phase II and Phase III CTs published between 2010 and 2020. Methods: A total of 25 CTs were included; 76% of trials included were conducted in metastatic renal cell carcinoma patients, while 20% of studies evaluated adjuvant systemic treatments. Results: In 13/25 publications, QoL was not listed among the end points, with secondary publications dedicated to QoL present in a minority of cases. Conclusions: QoL was not included among the end points of a large percentage of CTs. Implementing the inclusion of QoL represents an urgent need.

Lay abstract Recent years have seen growing attention toward quality of life (QoL) in medical oncology clinical trials and statistical measurement of this aspect of cancer treatment. Nonetheless, although most clinicians and researchers agree that QoL should represent a fundamental component of clinical trials, the inclusion of QoL results is still inadequate, and our systematic review confirms that implementing the inclusion of QoL remains an urgent need.

Gender-based psychological and physical distress differences in patients diagnosed with non-metastatic renal cell carcinoma.

OBJECTIVES: To analyze gender-based differences in distress symptoms in patients with non-metastatic renal cell carcinoma (RCC) at different stages of disease. METHODS: The Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire includes a physical (PHSDSS) and a psychological distress sub-score (PDSS). The ESAS-r was used to measure psychological and physical distress symptoms in localized RCC patients in a major cancer referral center between 2014 and 2017 at four predefined time points: (a) diagnosis, (b) biopsy, (c) surgery, and (d) last follow-up. Results were gender stratified, and multivariable linear regression models were used to determine associations with increased sub-scores. RESULTS: Overall, 495 patients were included with 37.2% females. No significant gender differences were seen in mean age, relevant clinical parameters, and treatment. PDSS was significantly higher in females after diagnosis (8.5 vs. 5.1, p = 0.018), biopsy (8.9 vs. 4.1, p = 0.003), and surgery (6.5 vs. 4.4, p = 0.007), while being similar at the last follow-up. The multivariable model demonstrated a statistically significant association of female gender with higher PDSS after diagnosis (B = 3.755, 95% CI 0.761-6.750), biopsy (B = 6.076, 95% CI 2.701-9.451), and surgery (B = 1.974, 95% CI 0.406-3.542). PHSDSS was significantly higher in females after biopsy (10.0 vs. 5.7, p = 0.028) and surgery (8.6 vs. 6.1, p = 0.022). In the multivariable model, female gender conferred a higher PHSDSS only after surgery (B = 2.384, 95% CI 0.208-4.560). CONCLUSIONS: Gender-associated psychological distress differences exist in non-metastatic RCC patients throughout treatment, while dissipating at last follow-up. Emphasis should be placed on screening for distress symptoms and providing psychological support continuously, particularly for female patients.

Thiamine deficiency in a patient with recurrent renal cell carcinoma who developed weight loss with normal appetite and loss of energy soon after nivolumab treatment.

BACKGROUND: Nivolumab has become an effective treatment option for cancer in various sites; however, this drug may cause immune-related adverse effects due to its mechanism of action. Furthermore, little has been reported on thiamine deficiency (TD) in patients receiving nivolumab treatment. METHOD: From a series of cancer patients, we reported a patient with recurrent renal cell carcinoma who developed TD after the start of nivolumab treatment. RESULTS: A 74-year-old man with recurrent renal cell carcinoma was referred to the psycho-oncology department as he had lost about 4 kg and displayed a loss of energy after four cycles of nivolumab treatment. Psychiatric interviews revealed a decrease in energy. Neurological examination did not reveal any impairment in consciousness, ataxia, or ocular symptoms. He did not develop appetite loss. The malabsorption or overconsumption of some nutrients is thought to occur due to the rapid loss of weight; thus, a reduction in vitamin B1, which has a short storage period in the body and is often deficient in cancer patients, was suspected. The diagnosis of TD was supported by the patient's abnormally low serum thiamine level. SIGNIFICANCE OF RESULTS: In patients treated with nivolumab, it is necessary to pay careful attention to TD when proceeding with the treatment. It is hoped that future research may reveal the link between nivolumab administration and TD.

Does the Diagnosis of Bladder Cancer Lead to Higher Rates of Smoking Cessation? Findings from the Medicare Health Outcomes Survey.

PURPOSE: Smoking is the most common risk factor for bladder cancer and it is associated with adverse clinical outcomes. The bladder cancer diagnosis represents a teachable moment for smoking cessation. We investigated the likelihood of smoking cessation after bladder cancer diagnosis in a population database. MATERIALS AND METHODS: We evaluated the 1998 to 2013 SEER (Surveillance, Epidemiology and End Results)-MHOS (Medicare Health Outcomes Survey) data on all patients diagnosed with incident bladder cancer on whom survey data were available before and after diagnosis. We compared these patients to propensity matched noncancer controls and to a cohort of patients with incident renal cell carcinoma. Differences in smoking cessation were compared between the groups and multivariate logistic regression was performed to assess the likelihood of smoking cessation. RESULTS: We propensity matched 394 patients with newly diagnosed bladder cancer to 1,970 noncancer controls and compared them with 169 patients with incident renal cell carcinoma. Baseline smoking prevalence was more common in patients diagnosed with bladder cancer compared to renal cell carcinoma (16% vs 11%) but the difference was not significant. The smoking cessation rate in patients with bladder cancer was 27% compared with 21% in noncancer controls and 26% in patients with renal cell carcinoma (p = 0.30 and 0.90, respectively). There was no significant difference in the adjusted OR of quitting smoking in patients with bladder cancer vs those with renal cell carcinoma compared to noncancer controls (OR 1.3, 95% CI 0.7-2.5 vs OR 1.2, 95% CI 0.4-3.6). Independent predictors of smoking cessation in patients with bladder cancer included age (p = 0.03), African American race (p = 0.03) and college education (p = 0.01). CONCLUSIONS: Compared to propensity matched noncancer controls smoking cessation did not significantly differ after a diagnosis of bladder cancer. The proportion of individuals who quit was low overall, suggesting that improved efforts are needed to use this teachable moment in patients with bladder cancer.

Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol.

BACKGROUND: Two main therapies, pazopanib and sunitinib, are used in the first-line setting for metastatic renal cell carcinoma (mRCC). These two tyrosine kinase inhibitors (TKI) are equally effective in terms of survival; however, they frequently induce adverse events. In this setting, Health-Related Quality of life (HRQoL) is a key element in the choice between these two treatments and the evaluation of treatment effectiveness. It could be of interest to evaluate HRQoL in daily clinical practice to aid adequate therapy choice and management. Currently, the development of information and communication technology may allow HRQoL monitoring in routine practice. The objective of the QUANARIE study is to evaluate the use of HRQoL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic patient-reported outcomes (e-PRO). The present article describes the key elements of the study protocol. METHODS: The QUANARIE study is an interventional, prospective, multicentre trial. Patients diagnosed with mRCC initiating sunitinib or pazopanib treatment will be invited to complete the EORTC QLQ-C30 questionnaire, nine additional questions from the EORTC items library, and the EuroQoL EQ-5D, prior to each visit with the physician. Questionnaires will be completed by patients using tablets and/or computer terminals via the e-PRO software. The physician will have real-time access to a visual summary of the HRQoL evaluation. The primary objective is to assess the proportion of patients having good compliance with Routine Electronic Monitoring of HRQoL (REMOQOL) during the first 12 months. Physicians' satisfaction with REMOQOL will be assessed as a secondary objective. We hypothesise that 80% of patients having good compliance with REMOQOL would be meaningful. A sample size of 56 patients would be needed. DISCUSSION: The results of this study will show whether REMOQOL is feasible on a large scale and whether patients are receptive to this new practice. This study will also determine how real-time multidimensional evaluation of patient perception can help physicians in their daily practice and how they used it in conjunction with other clinical information to manage patient care. TRIAL REGISTRATION: ClinicalTrials.gov; Identifier: NCT03062410 ; First Posted: February 23, 2017; Last Update Posted: August 9, 2017.

Can levocarnitine supplementation improve fatigue caused by sunitinib as a treatment for renal cell carcinoma? A single-center prospective pilot study.

PURPOSE: To evaluate the potential role of levocarnitine supplementation for cancer-related fatigue in patients treated with sunitinib. METHODS: Patients treated with sunitinib for unresectable or metastatic renal cell carcinoma were enrolled prospectively. Assessment of fatigue in each patient was done using the Brief Fatigue Inventory (BFI) questionnaire. Evaluation of fatigue and the serum carnitine level was done at baseline, 2 weeks, and 4 weeks after sunitinib therapy was initiated. All patients were treated with sunitinib 37.5 mg or 50 mg/day orally, with a 4-week administration and 2-week discontinuation schedule. RESULTS: Ten patients were finally enrolled in the study. Seven of them had worsened fatigue at the 2-week assessment and levocarnitine was administrated. All these seven patients whose serum carnitine level at 2 weeks was worse than at the baseline improved after 2-week-L-carnitine supplementation. For six of the seven (85.7%) patients who had L-carnitine supplementation, the BFI score at 4 weeks decreased compared to that at 2 weeks, which indicated improvement of fatigue. CONCLUSIONS: Levocarnitine supplementation for cancer-related fatigue in patients treated with sunitinib appears to have a potential benefit. However, further study with a larger number of patients and longer follow-up is crucial to confirm this.

Biopsychosocial distress and clinical outcome in metastatic renal cell carcinoma.

OBJECTIVE: Limited research exists examining the biopsychosocial experience of patients diagnosed with metastatic renal cell carcinoma (mRCC), a disease commonly associated with a poor prognosis. The purpose of this study was to describe rates and types of distress in mRCC patients and explore the relationship between distress and overall survival. METHOD: A cohort of 102 patients with mRCC treated at a single institution was assessed by a touch screen-based instrument comprising 22 core items spanning physical, practical, functional, and emotional domains. Association between biopsychosocial distress and clinicopathologic criteria was interrogated. Overall survival was compared between patients with low distress versus high distress.ResultHigh rates of distress (20.7%) were found among patients newly diagnosed with mRCC. Among those domains contributing to distress, pain, fatigue, and financial comorbidity were the most commonly reported by patients with mRCC. A trend toward poorer overall survival in those patients with high distress versus low distress was observed among mRCC patients.Significance of resultsBased on data from a relatively large sample of patients, this study provides the first specific insights into the potential impact of biopsychosocial distress and outcomes among patients with mRCC.

A Case Study of Exercise Adherence during Stereotactic Ablative Radiotherapy Treatment in a Previously Active Male with Metastatic Renal Cell Carcinoma.

Stereotactic Ablative Radiotherapy (SABR) is increasingly replacing thoracotomy for resection of lung cancers and oligometastatic lung lesions but it is not known whether exercise can be maintained during SABR, the major side-effect of which is fatigue. This case study describes a 57-year-old male who exercised regularly (above American College of Sports Medicine minimum weekly exercise guidelines) and continued to exercise during SABR for a renal cell metastasis in his left lung. His exercise program included 5x60-minute moderate intensity aerobic exercise sessions and 3x45-minute resistance exercise sessions per week for 12 weeks post-treatment. Cardiorespiratory fitness and strength, as well as self-reported fatigue, depression, anxiety, physical wellbeing and sleep quality were assessed at baseline and fortnightly. Exercise adherence was 98% and no adverse events occurred. Fatigue was elevated from Weeks 2-8, which adversely impacted exercise intensity perception. Minimal changes were observed in cardiorespiratory fitness, depression, anxiety and sleep quality, but strength decreased, and physical wellbeing was improved above baseline levels. This is the first reported clinical case of exercise during SABR for a lung carcinoma. The data suggest that exercise may be feasible for patients undergoing SABR and may improve physical wellbeing. Larger controlled studies are needed to confirm these findings.

Quality of life outcomes in patients with localised renal cancer: a literature review.

PURPOSE: Patients with localised renal cell carcinoma (RCC) can expect excellent oncologic outcomes. As such, there has been a shift towards maximising health-related quality of life (HRQoL). A greater understanding of HRQoL outcomes associated with different treatment options for RCC can facilitate patient-centred care, shared decision-making and enable cost utility analyses to guide health policies. The aim of this literature review was to evaluate the evidence regarding HRQoL following different management strategies for localised RCC. METHODS: Three databases were searched to identify studies reporting HRQoL in patients with localised renal cancer, including Medline, the Tuft's Medical Centre Cost Effectiveness Analysis registry and the EuroQol website. RESULTS: Considerable methodological heterogeneity was noted. Laparoscopic nephrectomy was associated with significantly better short-term physical function compared to open surgery, although the effect on mental function was inconclusive. Nephron-sparing surgery was associated with better physical function compared to radical surgery. Patients' perception of remaining renal function was a significant independent predictor of HRQoL, rather than surgery type. Tumour size, stage, post-operative complications, age, body mass index, occupational status, educational level and comorbidities were significant predictors of HRQoL. Only three studies were available regarding non-surgical management options and very little data were available regarding the impact of follow-up protocols and long-term effects of "cancer survivorship." CONCLUSION: There is a need for validated and reproducible RCC-specific HRQoL instruments and standardisation amongst studies to enable comparisons. Increased awareness regarding determinants of poor HRQoL may enable high-risk patients to receive tailored support.

Health-related quality of life and its determinants in patients with metastatic renal cell carcinoma.

PURPOSE: Based on improvements of progression-free survival (PFS), new agents for metastatic renal cell carcinoma (mRCC) have been approved. It is assumed that one of the benefits is a delay in health-related quality of life (HRQoL) deterioration as a result of a delay in progression of disease. However, little data are available supporting this relationship. This study aims to provide insight into the most important determinants of HRQoL (including progression of disease) of patients with mRCC. METHODS: A patient registry (PERCEPTION) was created to evaluate treatment of patients with (m)RCC in the Netherlands. HRQoL was measured, using the EORTC QLQ-C30 and EQ-5D-5L, every 3 months in the first year of participation in the study, and every 6 months in the second year. Participation started as soon as possible following a diagnosis of (m)RCC. Random effects models were used to study associations between HRQoL and patient and disease characteristics, symptoms and treatment. RESULTS: Eighty-seven patients with mRCC completed 304 questionnaires. The average EORTC QLQ-C30 global health status was 69 (SD, 19) before progression and 61 (SD, 22) after progression of disease. Similarly, the average EQ-5D utility was 0.75 (SD, 0.19) before progression and 0.66 (SD, 0.30) after progression of disease. The presence of fatigue, pain, dyspnoea, and the application of radiotherapy were associated with significantly lower EQ-5D utilities. CONCLUSIONS: Key drivers for reduced HRQoL in mRCC are disease symptoms. Since symptoms increase with progression of disease, targeted therapies that increase PFS are expected to postpone reductions in HRQoL in mRCC.

Interconnection: A qualitative analysis of adjusting to living with renal cell carcinoma.

ABSTRACTObjective:Adjusting to cancer is an ongoing process, yet few studies explore this adjustment from a qualitative perspective. The aim of our qualitative study was to understand how patients construct their experience of adjusting to living with cancer. METHOD: Qualitative analysis was conducted of written narratives collected from four separate writing sessions as part of a larger expressive writing clinical trial with renal cell carcinoma patients. Thematic analysis and constant comparison were employed to code the primary patterns in the data into themes until thematic saturation was reached at 37 participants. A social constructivist perspective informed data interpretation. RESULTS: Interconnection described the overarching theme underlying the process of adjusting to cancer and involved four interrelated themes: (1) discontinuity-feelings of disconnection and loss following diagnosis; (2) reorientation-to the reality of cancer psychologically and physically; (3) rebuilding-struggling through existential distress to reconnect; and (4) expansion-finding meaning in interconnections with others. Participants related a dialectical movement in which disruption and loss catalyzed an ongoing process of finding meaning. SIGNIFICANCE OF RESULTS: Our findings suggest that adjusting to living with cancer is an ongoing, iterative, nonlinear process. The dynamic interactions between the different themes in this process describe the transformation of meaning as participants move through and revisit prior themes in response to fluctuating symptoms and medical news. It is important that clinicians recognize the dynamic and ongoing process of adjusting to cancer to support patients in addressing their unmet psychosocial needs throughout the changing illness trajectory.

Examination of moderators of expressive writing in patients with renal cell carcinoma: the role of depression and social support.

OBJECTIVE: To identify groups most likely to benefit from an Expressive Writing (EW) intervention, we examined psychosocial variables as intervention moderators. We hypothesized that EW would be particularly effective for participants with high levels of depressive symptoms and social support at study entry. METHODS: Patients (n = 277; 60.6% male) with kidney cancer were randomly assigned to either an expressive (EW) or neutral writing (NW) condition. Intervention outcomes included measures of depressive symptoms (CESD), cancer-related symptoms (MDASI), fatigue (BFI), and sleep disturbances (PSQI) assessed at baseline, 1, 4, and 10 months later. Moderators were measured at baseline. RESULTS: As hypothesized, depressive symptoms and social support moderated intervention efficacy. When examining both moderators simultaneously, EW appeared to be most effective in terms of cancer-related symptoms (p < 0.05) and depressive symptoms (p < 0.01) for participants with elevated depressive symptoms who received high levels of social support at baseline relative to their counterparts in the NW condition. Moreover, participants in EW with high levels of social support at baseline reported lower levels sleep disturbances (p = 0.005) than their counterparts in NW. CONCLUSIONS: Recognition of baseline depressive symptoms and social support as intervention moderators may lead to improved patient selection for EW interventions, as EW may be particularly beneficial regarding QOL outcomes for patients that have social support available including participants with depressive symptoms. EW may not be beneficial, or potentially even contraindicated, for participants lacking social support. Copyright © 2016 John Wiley & Sons, Ltd.

First-line therapy for treatment-naive patients with advanced/metastatic renal cell carcinoma: a systematic review of published randomized controlled trials.

In the recent years, a number of targeted therapies have been approved for first-line treatment of patients with metastatic renal cell carcinoma. A systematic review was conducted to assess the clinical efficacy, safety and effect of all first-line treatments evaluated to date on health-related quality of life (HRQoL). A systematic search of Embase, Cochrane and MEDLINE databases was performed to identify randomized controlled trials (1980-2015) evaluating any targeted therapy/immunotherapy against placebo or any other targeted intervention/immunotherapy in treatment-naive patients with metastatic renal cell carcinoma. Conference proceedings from major cancer congresses (2007-2015) were handsearched. Sixteen randomized controlled trials were identified, mostly phase III. Overall, targeted therapies were associated with either improved [sunitinib, bevacizumab+interferon α (IFNα) and temsirolimus] or comparable (sorafenib) progression-free survival (PFS) versus IFNα monotherapy. Sunitinib demonstrated comparable PFS and overall survival to pazopanib, comparable PFS to sorafenib and shorter PFS compared with bevacizumab+IFNα (although no conclusions were made with regard to superiority/inferiority). Compared with sorafenib, tivozanib demonstrated a significantly longer PFS, and both tivozanib and axitinib demonstrated higher response rates. Nintedanib demonstrated comparable PFS and overall survival to sunitinib in a phase II trial. Temsirolimus, sunitinib and sorafenib treatment led to better HRQoL versus IFNα; pazopanib was associated with better HRQoL versus sunitinib. No direct meta-analyses or indirect treatment comparison analysis were undertaken because of noncomparability of the trials. In general, targeted therapies demonstrated favourable clinical efficacy and improved HRQoL compared with IFNα monotherapy. The newer therapies, tivozanib and axitinib (but not nintedanib), appeared to exhibit greater clinical benefit (response rate) than older tyrosine kinase inhibitors.

[THE PATIENTS QUALITY OF LIFE ESTlMATION IN PRESENCE OF METASTASIS OF A RENAL-CELL CANCER IN THE BONES ON BACKGROUND OF THE BISPHOSPHONATES APPLICATION].

Results of the patients quality of life (QL) estimation, while presence of a renal-cell cancer metastasis in the bones, using questionnaire QLQ-C30 and Karnofsky index, as well as the pain visual-analogue scale on background of treatment with bisphosphonates (BPH), were adduced. After conclusion of the combined treatment the general state improvement, a trustworthy reduction of the pain syndrome severity, as well as the patients' psychoemotional and social state, were noted. Complex treatment of patients, using BPH, have promoted a positive impact on their QL as well as a reduction of a skeleton complications rate.

Posttraumatic stress and depressive symptoms in renal cell carcinoma: association with quality of life and utility of single-item distress screening.

OBJECTIVE: The purpose of this study was to examine the prevalence of posttraumatic stress symptoms (PTSS) in patients with renal cell carcinoma (RCC), the associations and co-occurrence between PTSS, depressive, and other cancer-related symptoms and the ability of a single-item distress question to identify patients with PTSS. METHODS: Patients with stage I-IV RCC completed assessments of depressive symptoms (Center for Epidemiologic Studies Depression Scale), PTSS (Impact of Event Scale), cancer-related symptoms (MD Anderson Symptom Inventory), fatigue (Brief Fatigue Inventory), and sleep disturbance (Pittsburgh Sleep Quality Index). We used the distress item on the MD Anderson Symptom Inventory as a distress screener and general linear model analyses to test study hypotheses. RESULTS: Of the 287 patients (29% stage IV; 42% female; mean age = 58 years), 46% (n = 131) reported psychiatric symptoms with 15% (n = 44) reporting comorbid clinical levels of depressive symptoms and PTSS, 24% (n = 70) PTSS alone, and 6% (n = 17) depressive symptoms alone. Controlling for age, gender, and stage, patients with comorbid depressive symptoms and PTSS reported more cancer-related symptoms (p < 0.0001), fatigue (p < 0.0001), and sleep disturbance (p = 0.0003) than those with PTSS alone and more cancer-related symptoms (p = 0.002) and fatigue (p = 0.09) than those with depressive symptoms alone. Sensitivity analyses revealed that 26.9% of negative cases on the distress item fell within the clinical range of the Impact of Event Scale and 9.3% of negative cases met caseness on the Center for Epidemiologic Studies Depression Scale. CONCLUSIONS: Posttraumatic stress symptoms occurred both independently and comorbid with depressive symptoms in patients with RCC. PTSS were correlated with overall cancer symptom burden. Single-item distress screening was less sensitive in detecting PTSS than depressive symptoms. Therefore, additional screening strategies are required in the clinical setting.