This thesis investigates the diffuse form of Tenosynovial Giant Cell Tumor (D-TGCT), a rare tumor predominantly affecting relatively young individuals. It highlights the complexity of D-TGCT,... Show moreThis thesis investigates the diffuse form of Tenosynovial Giant Cell Tumor (D-TGCT), a rare tumor predominantly affecting relatively young individuals. It highlights the complexity of D-TGCT, detailing the patient journey from diagnosis to evaluating treatment options. The Tenosynovial Giant Cell Tumour Observational Platform Project (TOPP) is the first prospective disease registry for TGCT. It reveals that diagnosis often takes years and that D-TGCT significantly impacts patients' daily lives. MRI scans are essential for diagnosing D-TGCT, and a structured assessment protocol has been developed. Surgery is generally the primary treatment, but a watchful waiting approach may be suitable for some. Surgical resection carries a high recurrence risk, and incomplete removal can lead to disease progression. Complete resection is advised but may not always be feasible without causing significant harm to the body. Systemic therapies, such as CSF1R-targeted treatments, offer new possibilities for patients unable or unwilling to undergo surgery. While these therapies show promise, further research is needed to understand their long-term effects. The benefits of systemic treatments must be weighed against potential side effects. This thesis emphasizes the importance of multidisciplinary collaboration for managing this complex disease. Show less
Veer, M.R. de; Hermus, M.; Zijden, C.J. van der; Wilk, B.J. van der; Wijnhoven, B.P.L.; Stiggelbout, A.M.; ... ; Kranenburg, L.W. 2023
Introduction: Few studies have been conducted into how physicians use steering behaviour that may persuade patients to choose for a particular treatment, let alone to participate in a randomised... Show moreIntroduction: Few studies have been conducted into how physicians use steering behaviour that may persuade patients to choose for a particular treatment, let alone to participate in a randomised trial. The aim of this study is to assess if and how surgeons use steering behaviour in their information provision to patients in their choice to participate in a stepped-wedge cluster randomised trial investigating an organ sparing treatment in (curable) oesophageal cancer (SANO trial).Materials and methods: A qualitative study was performed. Thematic content analysis was applied to audiotaped and transcribed consultations of twenty patients with eight different oncological surgeons in three Dutch hospitals. Patients could choose to participate in a clinical trial in which an experimental treatment of 'active surveillance' (AS) was offered. Patients who did not want to participate underwent standard treatment: neoadjuvant chemoradiotherapy followed by oesophagectomy.Results: Surgeons used various techniques to steer patients towards one of the two options, mostly to-wards AS. The presentation of pros and cons of treatment options was imbalanced: positive framing of AS was used to steer patients towards the choice for AS, and negative framing of AS to make the choice for surgery more attractive. Further, steering language, i.e. suggestive language, was used, and surgeons seemed to use the timing of the introduction of the different treatment options, to put more focus on one of the treatment options.Conclusion: Awareness of steering behaviour can help to guide physicians in more objectively informing patients on participation in future clinical trials.(c) 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). Show less
Objective: To analyze the effect of dizziness-related symptoms on the long-term quality of life (QoL) of patients with unilateral vestibular schwannoma. Methods: In this cross-sectional study,... Show moreObjective: To analyze the effect of dizziness-related symptoms on the long-term quality of life (QoL) of patients with unilateral vestibular schwannoma. Methods: In this cross-sectional study, patients with a unilateral vestibular schwannoma diagnosed between 2004 and 2013 completed a disease-specific QoL questionnaire (Penn Acoustic Neuroma Quality of Life [PANQOL]) and the Dizziness Handicap Inventory (DHI) in 2020. Linear regression was performed to assess the correlation between QoL and the DHI total score, and the scores of the DHI functional, emotional, and physical subdomains. Potential confounders such as age, sex, tumor size at baseline, and treatment modality (active surveillance, surgery, or radiotherapy) were included in the model. Results: In total, 287 of 479 patients (59%) experienced dizziness with a median follow-up of 10 years. The DHI total score was significantly associated with the PANQOL total score. On average, we found a reduction of 0.7 points on the PANQOL for each additional point on the DHI. The DHI emotional subdomain was the most prominent determinant of poorer QoL. Each point on the DHI emotional subscale was associated with a reduction of 1.3 on the PANQOL score. Treatment modality did not have a clinically relevant effect on dizziness-related QoL. Conclusions: Even mild dizziness can have a significant and clinically relevant effect on the QoL of patients with unilateral vestibular schwannoma in the long term. This holds true for all treatment modalities. Addressing the vestibular problems may improve QoL in vestibular schwannoma patients, and DHI subscale analysis may help tailor the optimal vestibular intervention. Show less
Context: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa)... Show moreContext: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa).Objective: To perform a qualitative systematic review (SR) to issue recommendations regarding inclusion of intermediate-risk disease, biopsy characteristics at inclusion and monitoring, and repeat biopsy strategy.Evidence acquisition: A protocol-driven, Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-adhering SR incorporating AS protocols published from January 1990 to October 2020 was performed. The main outcomes were criteria for inclusion of intermediate-risk disease, monitoring, reclassification, and repeat biopsy strategies (per protocol and/or triggered). Clinical effectiveness data were not assessed.Evidence synthesis: Of the 17 011 articles identified, 333 studies incorporating 375 AS protocols, recruiting 264 852 patients, were included. Only a minority of protocols included the use of magnetic resonance imaging (MRI) for recruitment (n = 17), follow-up (n = 47), and reclassification (n = 26). More than 50% of protocols included patients with intermediate or high-risk disease, whilst 44.1% of protocols excluded low-risk patients with more than three positive cores, and 39% of protocols excluded patients with core involvement (CI) >50% per core. Of the protocols, >= 80% mandated a confirmatory transrectal ultrasound biopsy; 72% (n = 189) of protocols mandated per-protocol repeat biopsies, with 20% performing this annually and 25% every 2 yr. Only 27 protocols (10.3%) mandated triggered biopsies, with 74% of these protocols defining progression or changes on MRI as triggers for repeat biopsy.Conclusions: For AS protocols in which the use of MRI is not mandatory or absent, we recommend the following: (1) AS can be considered in patients with low-volume International Society of Urological Pathology (ISUP) grade 2 (three or fewer positive cores and cancer involvement <= 50% CI per core) or another single element of intermediate-risk disease, and patients with ISUP 3 should be excluded; (2) per-protocol confirmatory prostate biopsies should be performed within 2 yr, and per-protocol surveillance repeat biopsies should be performed at least once every 3 yr for the first 10 yr; and (3) for patients with low-volume, low-risk disease at recruitment, if repeat systematic biopsies reveal more than three positive cores or maximum CI >50% per core, they should be monitored closely for evidence of adverse features (eg, upgrading); patients with ISUP 2 disease with increased core positivity and/or CI to similar thresholds should be reclassified.Patient summary: We examined the literature to issue new recommendations on active surveillance (AS) for managing localised prostate cancer. The recommendations include setting criteria for including men with more aggressive disease (intermediate-risk disease), setting thresholds for close monitoring of men with low-risk but more extensive disease, and determining when to perform repeat biopsies (within 2 yr and 3 yearly thereafter). (C) 2021 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology. Show less
Eyck, B.; Wilk, B.J. van der; Noordman, B.J.; Wijnhoven, B.P.L.; Lagarde, S.M.; Hartgrink, H.H.; ... ; SANO Study Grp 2021
Background: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant... Show moreBackground: The Surgery As Needed for Oesophageal cancer (SANO) trial compares active surveillance with standard oesophagectomy for patients with a clinically complete response (cCR) to neoadjuvant chemoradiotherapy. The last patient with a clinically complete response is expected to be included in May 2021. The purpose of this update is to present all amendments to the SANO trial protocol as approved by the Institutional Research Board (IRB) before accrual is completed.Design: The SANO trial protocol has been published (https://doi.org/10.1186/s12885-018-4034-1). In this ongoing, phase-III, non-inferiority, stepped-wedge, cluster randomised controlled trial, patients with cCR (i.e. after neoadjuvant chemoradiotherapy no evidence of residual disease in two consecutive clinical response evaluations [CREs]) undergo either active surveillance or standard oesophagectomy. In the active surveillance arm, CREs are repeated every 3 months in the first year, every 4 months in the second year, every 6months in the third year, and yearly in the fourth and fifth year. In this arm, oesophagectomy is offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant metastases. The primary endpoint is overall survival.Update: Amendments to the study design involve the first cluster in the stepped-wedge design being partially randomised as well and continued accrual of patients at baseline until the predetermined number of patients with cCR is reached. Eligibility criteria have been amended, stating that patients who underwent endoscopic treatment prior to neoadjuvant chemoradiotherapy cannot be included and that patients who have highly suspected residual tumour without histological proof can be included. Amendments to the study procedures include that patients proceed to the second CRE if at the first CRE the outcome of the pathological assessment is uncertain and that patients with a non-passable stenosis at endoscopy are not considered cCR. The sample size was recalculated following new insights on response rates (34% instead of 50%) and survival (expected 2-year overall survival of 75% calculated from the moment of reaching cCR instead of 3-year overall survival of 67% calculated from diagnosis). This reduced the number of required patients with cCR from 264 to 224, but increased the required inclusions from 480 to approximately 740 patients at baseline.Conclusion: Substantial amendments were made prior to closure of enrolment of the SANO trial. These amendments do not affect the outcomes of the trial compared to the original protocol. The first results are expected late 2023. If active surveillance plus surgery as needed after neoadjuvant chemoradiotherapy for oesophageal cancer leads to non-inferior overall survival compared to standard oesophagectomy, active surveillance can be implemented as a standard of care. Show less
Cacciamani, G.E.; Bassi, S.; Sebben, M.; Marcer, A.; Russo, G.I.; Cocci, A.; ... ; Artibani, W. 2020
Background: In the era of digital data, the Internet has become the primary source from which individuals draw healthcare information.Objective: The aim of the present study is to determine... Show moreBackground: In the era of digital data, the Internet has become the primary source from which individuals draw healthcare information.Objective: The aim of the present study is to determine worldwide public interest in prostate cancer (PCa) treatments, their penetrance and variation, and how they compare over time.Design, setting, and participants: An analysis of worldwide search-engine trends included electronic Google queries from people who searched PCa treatment options from January 2004 to August 2018, worldwide. Join-point regression was performed. Comparisons of annual relative search volume (ARSV), average annual percentage change (AAPC), and temporal patterns were analysed to assess loss or gain of interest.Outcome measurements and statistical analysis: Evaluations were made regarding (1) interest in PCa treatments, (2) comparison of people's interest, and (3) impact of the US Preventive Service Task Force (USPSTF) screening recommendation and National Comprehensive Cancer Network (NCCN) guideline endorsements on Internet searching for PCa treatments.Results and limitations: The mean ARSV for "prostatectomy" was 73% in 2004 and decreased thereafter, reaching a nadir of 36% in 2014 (APC: -7.2%; 95% confidence interval [CI] -7.8, -6.7; p < 0.01). Similarly, decreased interest was recorded for radiation therapy (AAPC: -3.2%; p = 0.1), high-intensity focused ultrasound (AAPC: -2.3%; p = 0.1), hormonal therapy (AAPC: -11.6%; p < 0.01), ablation therapy (AAPC: -4.1%; p < 0.01), cryotherapy (AAPC: -9.9%; p < 0.01), and brachytherapy (AAPC: -8.3%; p < 0.01). A steep interest was found in active surveillance (AS) (AAPC: +14.2%; p < 0.01) and focal therapy (AAPC: +27.5%; p < 0.01). When trends were compared before and after NCCN and USPSTF recommendations, a consistent decrease of all the treatment options was found, while interest in focal therapy and AS showed an augmented mean ARSV (+19.6 and +31.6, respectively).Conclusions: People are increasingly searching the Internet for PCa treatment options. A parallel decrease of interest was found for the nonmonitoring treatments, except for focal therapy, while an important growth of appeal has been recorded for AS. Understanding people inquisitiveness together with their degree of knowledge could be supportive to guiding counselling in the decision-making process and putting effort in certifying patient information.Patient summary: In the era of digital data, patients are increasingly searching the Internet for prostate cancer (PCa) treatment options. To safeguard patients' knowledge, it is mandatory to understand how people seek healthcare information, guaranteeing certified and evidence-based information pertaining to PCa treatments options. (c) 2019 European Association of Urology. Published by Elsevier B.V. All rights reserved. Show less
Recent studies demonstrated ongoing inverse stage migration in prostate cancer (PCa) patients towards more advanced and unfavorable tumors. The USPSTF grade D recommendation may impact this trend... Show moreRecent studies demonstrated ongoing inverse stage migration in prostate cancer (PCa) patients towards more advanced and unfavorable tumors. The USPSTF grade D recommendation may impact this trend in North American patients. We assessed contemporary stage migration and treatment trends in a large North American cohort diagnosed with PCa 2009-2014.Time-trend analyses were performed in patients within the Surveillance, Epidemiology, and End Results database, with complete data of clinical tumor stage, biopsy Gleason score, and validated PSA values, resulting in 211,645 assessable patients. Patients were stratified according to their different treatment methods [radical prostatectomy (RP), radiotherapy (RT), and no local treatment (NLT)] and according to clinical and pathological risk stratification (D'Amico and CAPRA-S score).Over time, proportions of D'Amico low-risk (LR) decreased, with an increase in intermediate-to-high-risk (IR/HR) patients. These trends were more distinct in men ae 70 years. NLT proportions increased, most notably in D'Amico LR and/or older patients. Conversely, RP proportions remained stable in younger HR and increased in older HR patients. Similar patterns were demonstrated in the RP-treated subgroup: D'Amico HR, pT3, and/or lymph-node invasion or CAPRA-S HR proportions increased from 23.5 to 30.8, 24.3 to 32.9, and 10.7 to 16.3% (each p ae 0.015).Inverse stage migration with increase of unfavorable PCa continues in most contemporary North American patients. However, a paradigm shift to treat LR patients with less invasive methods (NLT) was demonstrated. Contrary, HR patients increasingly undergo LT. Future studies with long-term follow-up might answer if inverse stage migration vs. treatment trends translate into different PCa metastases/mortality rates vs. proposed NLT benefits, particularly related to USPSTF-recommended reduced PSA screening. Show less
