| 1. |
- Almdalal, T., et al.
(author)
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Clinical T1a Renal Cell Carcinoma, Not Always a Harmless Disease-A National Register Study
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 39, s. 22-28
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Journal article (peer-reviewed)abstract
- Background: T1a renal cell carcinoma (RCC) is typically considered a curable dis-ease, irrespective of the choice of local treatment modality.& nbsp;Objective: To identify factors associated with the risk of local and distant recur-rence, and overall survival (OS) in patients with primary nonmetastatic clinical T1a RCC.& nbsp;Design, setting, and participants: A population-based nationwide register study of all 1935 patients with cT1a RCC, diagnosed during 2005-2012, identified through The National Swedish Kidney Cancer Register, was conducted.& nbsp;Outcome measurements and statistical analysis: Outcome variables were recur-rence (local or distant) and OS. Possible explanatory variables included tumor size, RCC type, T stage, surgical technique, age, and gender. Associations with disease recurrence and OS were evaluated by multivariable regression and Cox multivari-ate analyses, respectively.& nbsp;& nbsp;Results and limitations: Among 1935 patients, 938 were treated with radical nephrectomy, 738 with partial nephrectomy, and 169 with ablative treatments, while 90 patients had no surgery. Seventy-eight (4%) patients were upstaged to pT3. Local or metastatic recurrences occurred in 145 (7.5%) patients, significantly more often after ablation (17.8%). The risk of recurrence was associated with tumor size, upstaging, and ablation. Larger tumor size, disease recurrence, and older age adversely affected OS, whereas partial nephrectomy and chromophobe RCC (chRCC) were associated with improved survival. Limitations include register design and a lack of comorbidity or performance status data.& nbsp;Conclusions: Upstaging and recurrence occurred, respectively, in 4.0% and 7.5% of patients with nonmetastatic RCCs <= 4 cm. Tumor size upstaging and ablation were associated with the risk for recurrence, while tumor size and recurrence were associated with decreased OS. Patients with chRCC and partial nephrectomy had prolonged OS in a real-world setting.& nbsp;Patient summary: We studied factors that may influence the risk of disease recurrence and overall survival, in a large nationwide patient cohort having non metastatic renal cell carcinoma < 4 cm. Tumor size, tumor type, and treatment were associated with the risk of recurrence and overall death. Partial nephrectomy prolonged overall survival. (C)2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.
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| 2. |
- Bergengren, Oskar, et al.
(author)
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Satisfaction with Nurse-led Follow-up in Prostate Cancer Patients-A Nationwide Population-based Study
- 2022
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In: European Urology Open Science. - : Elsevier. - 2666-1691 .- 2666-1683. ; 38, s. 25-31
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Journal article (peer-reviewed)abstract
- Background: Satisfaction with nurse-led follow-up among men with prostate can-cer is high. However, it is unclear whether all men are satisfied or whether there are men who would benefit from being followed by a urologist or a nurse.Objective: To investigate the follow-up distribution between urologists and nurses, and whether the high self-reported satisfaction with nurse-led follow-up is inde-pendent of other factors such as age or comorbidity.Design, setting, and participants: All Swedish men, <= 70 yr of age, with a low-risk prostate cancer diagnosis in 2008, answered a questionnaire 7 yr after diagnosis. The extensive questionnaire included a question on satisfaction with care, answered on a seven-point scale. Participants were divided based on whether they were followed up by a nurse, a urologist, or both.Outcome measurements and statistical analysis: Factors that could influence the level of satisfaction were identified as age, edu-cation, comorbidity, treatment, disease progression, urinary bother, level of infor-mation, and participation in treatment decision. Likelihood ratio tests from ordinal regression were used to test the null hypothesis of similar satisfaction between groups.Results and limitations: Out of 1288 men, 1137 (88%) answered both the question on who performed the follow-up and the question regarding satisfaction. In all, 350 men reported that they were followed up by nurses (31%), 598 (52%) by urologists, and 189 (17%) by both. No differences in satisfaction where seen between the groups. Approximately 50% were satisfied completely, regardless of who performed the follow-up. Results were not affected by age, educational level, comorbidity, treatment, disease progression, urinary bother, information, or participation in treatment decision. Limitations include the nonrandomized, retrospective design and a potential recall bias.Conclusions: Satisfaction with nurse-led follow-up is high, regardless of factors such as age, level of education, comorbidity, and treatment.Patient summary: Men with prostate cancer can be offered nurse-led follow-up on a regular basis and still maintain their satisfaction with health care.
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| 3. |
- Bjartell, Anders, et al.
(author)
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Real-world Treatment Sequencing in Patients with Metastatic Castration-resistant Prostate Cancer: Results from the Prospective, International, Observational Prostate Cancer Registry
- 2022
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In: European Urology Open Science. - : Elsevier. - 2666-1691 .- 2666-1683. ; 45, s. 12-22
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Journal article (peer-reviewed)abstract
- Background: Prostate cancer has a multifaceted treatment pattern. Evidence is lacking for optimal treatment sequences for metastatic castration-resistant prostate cancer (mCRPC).Objective: To increase the understanding of real-world treatment pathways and outcomes in patients with mCRPC.Design, setting, and participants: A prospective, noninterventional, real-world analysis of 3003 patients with mCRPC in the Prostate Cancer Registry (PCR; NCT02236637) from June 14, 2013 to July 9, 2018 was conducted.Intervention: Patients received first- and second-line hormonal treatment and chemotherapy as follows: abiraterone acetate plus prednisone (abiraterone)-docetaxel (ABI-DOCE), abiraterone-enzalutamide (ABI-ENZA), abiraterone–radium-223 (ABI-RAD), docetaxel-abiraterone (DOCE-ABI), docetaxel-cabazitaxel (DOCE-CABA), docetaxel-enzalutamide (DOCE-ENZA), and enzalutamide-docetaxel (ENZA-DOCE).Outcome measurements and statistical analysis: Baseline patient characteristics, quality of life, mCRPC treatments, and efficacy outcomes (progression and survival) were presented descriptively.Results and limitations: Data from 727 patients were eligible for the analysis (ABI-DOCE n = 178, ABI-ENZA n = 99, ABI-RAD n = 27, DOCE-ABI n = 191, DOCE-CABA n = 74, DOCE-ENZA n = 116, and ENZA-DOCE n = 42). Demographics and disease characteristics among patients between different sequences varied greatly. Most patients who started on abiraterone or enzalutamide stopped therapy because of disease progression. No randomisation to allow treatment/sequence comparisons limited this observational study.Conclusions: The real-world PCR data complement clinical trial data, reflecting more highly selected patient populations than seen in routine clinical practice. Baseline characteristics play a role in mCRPC first-line treatment selection, but other factors, such as treatment availability, have an impact. Efficacy observations are limited and should be interpreted with caution.Patient summary: Baseline characteristics appear to have a role in the first-line treatment selection of metastatic castration-resistant prostate cancer in the real-world setting. First-line abiraterone acetate plus prednisone seems to be the preferred treatment option for older patients and those with lower Gleason scores, first-line docetaxel for younger patients and those with more advanced disease, and first-line enzalutamide for patients with fewer metastases and more favourable performance status. The benefit to patients from these observations remains unknown.
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| 4. |
- Gatto, Francesco, 1987, et al.
(author)
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Plasma and Urine Free Glycosaminoglycans as Monitoring Biomarkers in Nonmetastatic Renal Cell Carcinoma—A Prospective Cohort Study
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1683 .- 2666-1691. ; 42, s. 30-39
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Journal article (peer-reviewed)abstract
- Background: No liquid biomarkers are approved in renal cell carcinoma (RCC), making early detection of recurrence in surgically treated nonmetastatic (M0) patients dependent on radiological imaging. Urine- and plasma free glycosaminoglycan profiles—or free GAGomes—are promising biomarkers reflective of RCC metabolism. Objective: To explore whether free GAGomes could detect M0 RCC recurrence noninvasively. Design, setting, and participants: Between June 2016 and February 2021, we enrolled a prospective consecutive series of patients elected for (1) partial or radical nephrectomy for clinical M0 RCC (cohort 1) or (2) first-line therapy following RCC metachronous metastatic recurrence (cohort 2) at Sahlgrenska University Hospital, Gothenburg, Sweden. The study population included M0 RCC patients with recurrent disease (RD) versus no evidence of disease (NED) in at least one follow-up visit. Plasma and urine free GAGomes—consisting of 40 chondroitin sulfate (CS), heparan sulfate, and hyaluronic acid (HA) features—were measured in a blinded central laboratory preoperatively and at each postoperative follow-up visit until recurrence or end of follow-up in cohort 1, or before treatment start in cohort 2. Outcome measurements and statistical analysis: We used Bayesian logistic regression to correlate GAGome features with RD versus NED and with various histopathological variables. We developed three recurrence scores (plasma, urine, and combined) proportional to the predicted probability of RD. We internally validated the area under the curve (AUC) using bootstrap resampling. We performed a decision curve analysis to select a cutoff and report the corresponding net benefit, sensitivity, and specificity of each score. We used univariable analyses to correlate each preoperative score with recurrence-free survival (RFS). Results and limitations: Of 127 enrolled patients in total, 62 M0 RCC patients were in the study population (median age: 63 year, 35% female, and 82% clear cell). The median follow-up time was 3 months, totaling 72 postoperative visits —17 RD and 55 NED cases. RD was compatible with alterations in 14 (52%) of the detectable GAGome features, mostly free CS. Eleven (79%) of these correlated with at least one histopathological variable. We developed a plasma, a urine, and a combined free CS RCC recurrence score to diagnose RD versus NED with AUCs 0.91, 0.93, and 0.94, respectively. At a cutoff equivalent to ≥30% predicted probability of RD, the sensitivity and specificity were, respectively, 69% and 84% in plasma, 81% and 80% in urine, and 80% and 82% when combined, and the net benefit was equivalent to finding an extra ten, 13, and 12 cases of RD per hundred patients without any unnecessary imaging for plasma, urine, and combined, respectively. The combined score was prognostic of RFS in univariable analysis (hazard ratio = 1.90, p = 0.02). Limitations include a lack of external validation. Conclusions: Free CS scores detected postsurgical recurrence noninvasively in M0 RCC with substantial net benefit. External validity is required before wider clinical implementation. Patient summary: In this study, we examined a new noninvasive blood and urine test to detect whether renal cell carcinoma recurred after surgery.
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| 5. |
- Gongora, M., et al.
(author)
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Characteristics of Patients in SPCG-15-A Randomized Trial Comparing Radical Prostatectomy with Primary Radiotherapy plus Androgen Deprivation Therapy in Men with Locally Advanced Prostate Cancer
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 41, s. 63-73
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Journal article (peer-reviewed)abstract
- Background: There is no high-grade evidence for surgery as primary treatment for locally advanced prostate cancer. The SPCG-15 study is the first randomized trial comparing surgical treatment with radiotherapy. Objective: To describe the baseline characteristics of the first 600 randomized men in the SPCG-15 study. The study will compare mortality and functional outcomes. Design, setting, and participants: This study is a Scandinavian prospective, open, multicenter phase III randomized clinical trial aiming to randomize 1200 men. Intervention: Radical prostatectomy with or without consecutive radiotherapy (experimental) and radiotherapy with neoadjuvant androgen deprivation therapy (standard of care). Outcome measurements and statistical analysis: Cause-specific survival, metastasis-free survival, overall survival, and patient-reported bowel function, sexual health, and lower urinary tract symptoms were measured. Results and limitations: The distribution of characteristics was similar in the two study arms. The median age was 67 yr (range 45-75 yr). Among the operated men, 36% had pT3a stage of disease and 39% had pT3b stage. International Society of Urological Pathology grades 2, 3, 4, and 5 were prevalent in 21%, 35%, 7%, and 27%, respectively. Half of the men (51%) in the surgery arm had no positive lymph nodes. The main limitation is the pragmatic design comparing the best available practice at each study site leading to heterogeneity of treatment regimens within the study arms. Conclusions: We have proved that randomization between surgery and radiotherapy for locally advanced prostate cancer is feasible. The characteristics of the study population demonstrate a high prevalence of advanced disease, well-balanced comparison groups, and a demography mirroring the Scandinavian population of men with prostate cancer at large. Patient summary: This study, which has recruited >600 men, compares radiotherapy with surgery for prostate cancer, and an analysis at the time of randomization indicates that the study will be informative and generalizable to most men with locally advanced but not metastasized prostate cancer. (C) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.
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| 6. |
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| 7. |
- Lindskog, Magnus, et al.
(author)
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Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma: A Randomized Phase 2 Study
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 40, s. 38-45
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Journal article (peer-reviewed)abstract
- Background: The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial. Objective: To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC. Design, setting, and participants: A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients).Outcome measurements and statistical analysis: The primary endpoints were 18mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests.Results and limitations: The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42-1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival. Conclusions: The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy.Patient summary: We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
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| 8. |
- Lycken, M., et al.
(author)
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Changes in Characteristics of Men with Lethal Prostate Cancer During the Past 25 Years: Description of Population-based Deaths
- 2022
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In: European Urology Open Science. - Nederländerna : Elsevier BV. - 2666-1691 .- 2666-1683. ; 41, s. 81-87
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Journal article (peer-reviewed)abstract
- Background: Attempts to reduce prostate cancer (PC) mortality require an understanding of temporal changes in the characteristics of men with lethal PC. Objective: To describe the diagnostic characteristics of and time trends for a nationwide population-based cohort of Swedish men who died from PC between 1992 and 2016. Design, setting, and participants: Men with PC as the underlying cause of death from 1992 to 2016 according to the Swedish Cause of Death Register were included in the study. Characteristics at diagnosis were collected via links to other nationwide registries using personal identity numbers. Outcome measurements and statistical analysis: Data on disease duration, age at death, and risk category were analyzed. Missing data for risk categories for men with an early date of PC diagnosis were imputed according to the method of chained equations. Results and limitations: Between 1992 and 2016, age-standardized PC mortality decreased by 25%. Median PC disease duration increased from 3.3 yr (interquartile range [IQR] 1.6-6.3) to 5.9 yr (IQR 2.5-10.3) and the median age at death from PC increased from 78.9 yr (IQR 73.3-84.2) to 82.2 yr (IQR 75.2-87.5). The proportion of men with localized disease at diagnosis who died from PC increased from 34% to 48%, while the rate of distant metastases at diagnosis decreased from 56% to 42%. The rate of distant metastases at diagnosis was highest among the youngest men. Treatment trajectories could not be described owing to the large proportion of missing data before the start of registration in the National Prostate Cancer Registry. Conclusion: Age-standardized PC mortality has decreased substantially since 1992. However, there is still a high proportion of men who die from PC who had localized disease at diagnosis, which indicates that more attention is needed to identify the underlying causes to prevent disease progression. Since the proportion of men with distant metastases at diagnosis remains high, early detection of lethal tumors is essential to further reduce PC mortality. Patient summary: We investigated the characteristics of men who died from prostate cancer in Sweden between 1992 and 2016. We found that men with lethal prostate cancer live longer and are older when they die today in comparison to men who died at the beginning of the study period. However, the proportion of men with distant metastases at diagnosis remains high, which is why early detection of lethal tumors is essential to reduce mortality. (C) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology.
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| 9. |
- Saha, Sanjib, et al.
(author)
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Cost Effectiveness of the Use of Prophylactic Mesh To Prevent Parastomal Hernia After Urinary Diversion with an Ileal Conduit
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 40, s. 9-15
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Journal article (peer-reviewed)abstract
- Background: Prophylactic lightweight mesh in the sublay position reduced the cumulative incidence of parastomal hernia (PSH) after cystectomy with ileal conduit diversion in a randomised controlled trial.Objective: To investigate whether the use of prophylactic mesh is cost-effective in comparison to no mesh from the health care provider perspective.Design setting and participants: Data on health care resource utilisation (outpatient care and inpatient care) were obtained for 159 patients included in a randomised trial. The patients underwent surgery at Skåne University Hospital or Helsingborg County Hospital (80 with a prophylactic mesh and 79 without) and information about care was ascertained from the regional health care register. The patients underwent surgery between 2012 and 2017 and were followed until death or August 2020.Outcome measurements and statistical analyses: The primary outcome measure was the clinical incidence of PSH. Costs are reported in Euro in 2020 prices (€1 = 10.486 Swedish Krona) and presented as the incremental cost-effectiveness ratios (ICERs) with confidence intervals (CIs) calculated using a nonparametric bootstrap procedure. Sensitivity analyses and subgroup analyses were performed to capture the uncertainty for ICERs.Results and limitations: The mean difference in total costs between the mesh and no-mesh groups was -€2047 (95% CI -€16 441 to €12 348). Seventeen patients (21.5%) in the no-mesh group developed clinical PSH versus six patients (7.5%) in the mesh group ( p = 0.001). This indicates that mesh is less costly and more effective compared to no mesh from the health care provider perspective. Subgroup analyses showed that results were more advantageous for women and for patients younger than 71 yr and with less comorbidity than for their counterparts. Conclusions: The use of prophylactic mesh during ileal conduit reconstruction to prevent PSH is cost-effective from the health care provider perspective.Patient summary: In patients having their bladder surgically removed, a mesh implant can be inserted when a portion of the intestine is used to create an opening to drain urine from the body. Our results show that mesh use to prevent development of a hernia at the opening where urine exits the body is cost-effective from the perspective of health care providers.
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| 10. |
- Stenman, C., et al.
(author)
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Rates of Positive Abdominal Computed Tomography and Bone Scan Findings Among Men with Cambridge Prognostic Group 4 or 5 prostate cancer: A Nationwide Registry Study
- 2022
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In: European Urology Open Science. - : Elsevier BV. - 2666-1691 .- 2666-1683. ; 41, s. 123-125
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Journal article (peer-reviewed)abstract
- European and American guidelines recommend abdominal computed tomography (CT) and bone scans for staging of high-risk prostate cancer (PC). To improve clinical risk stratification of nonmetastatic PC a new, five-tier risk classification system has been developed, the Cambridge Prognostic Groups (CPG), in which "high-risk"PC is divided into favourable CPG 4 and unfavourable CPG 5. We used the National Prostate Cancer Register of Sweden (NPCR) to define the rates of positive CT and bone scan findings among men with CPG 4 or 5 cancer. Among men with CPG 4 and prostate-specific antigen (PSA) <50 ng/ml, only 3.6% (95% confidence interval 2.9-4.5%) of the CT scans showed regional lymph-node metastasis (N1M0), while 6.2% (95% confidence interval 5.4-7.0%) of the bone scans were positive. Rates for both were higher in the subgroups with PSA 50-99 ng/ml (10% and 15%) and with CPG 5 disease. The low positivity rate questions routine use of CT for men with CPG 4 cancer and PSA <50 ng/ml, particularly considering the poor sensitivity and specificity for detection of lymph node metastasis. The positivity rate was higher for bone scans, and as current clinical practice relies on trials using bone scans for staging (eg, to define low-versus high-volume metastatic disease), continued routine use of bone scans seems justified. Patient summary: Our analysis of data from the National Prostate Cancer Register of Sweden showed that for men with favourable high-risk prostate cancer (Cambridge Prognostic Group 4), the rate of positive computed tomography (CT) scans was low. This result suggests that CT scans may not be necessary for detecting cancer spread in men with Cambridge Prognostic Group 4 prostate cancer. (c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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