A novel clinical decision aid to support personalized treatment selection for patients with CT1 renal cortical masses: Results from a multi-institutional competing risks analysis including performance status and comorbidity.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 610-610
Author(s):  
Sarah P. Psutka ◽  
Roman Gulati ◽  
Michael A.S. Jewett ◽  
Kamel Fadaak ◽  
Antonio Finelli ◽  
...  
Keyword(s):  
Competing Risks ◽  
Active Surveillance ◽  
Thermal Ablation ◽  
Prediction Models ◽  
Performance Status ◽  
Personalized Treatment ◽  
Risk Calculator ◽  
Selection For ◽  
Competing Causes

610 Background: Personalized treatment for clinical T1 renal cortical masses (RCMs) should account for competing risks related to tumor and patient characteristics. Using a contemporary multi-institutional cohort, we developed treatment-specific prediction models for cancer-specific mortality (CSM), other-cause mortality (OCM), and 90-day complication rates for patients managed with surgery, thermal ablation (TA), and active surveillance (AS). Methods: Preoperative clinical and radiological features were collected for eligible patients aged 18-91 years treated at four academic centers from 2000-2016. Prediction models used competing risks regressions for CSM and OCM and logistic regressions for 90-day Clavien >3 complications, adjusting for tumor size as well as patient age, sex, ECOG performance status (PS), and Charlson comorbidity index (CCI). Predictions accounted for missing data using multiple imputation. Results: After excluding 25 patients with no follow-up, the cohort included 4995 patients treated with radical nephrectomy (RN, n=1270), partial nephrectomy (PN, n=2842), thermal ablation (n=479), or active surveillance (n=404). Median follow-up was 5.1 years (IQR 2.5-8.5). Predictions from the fitted model are shown in an online calculator ( https://rgulati.shinyapps.io/rcc-risk-calculator ). To illustrate the use of this calculator for a specific patient, a 70-year-old female with a 5.5 cm RCM, PS of 2, and CCI of 3 has a predicted 5-year CSM of 4-7% across treatments, 5-year OCM of 34-49%, and 90-day risk of Clavien ≥3 complications of 4%, 10%, and 6% for RN, PN, and TA respectively. Conclusions: Personalized treatment selection for cT1 RCM is challenging. We present a competing risk calculator that incorporates pretreatment features to quantify competing causes of mortality and treatment-associated complications. Pending validation, this tool may be used in clinical practice to provide patients with estimated individualized treatment-specific probabilities of competing causes of death and complication risks to facilitate shared decision-making.

Incorporating mpMRI and biomarkers in active surveillance protocols: The prospective Stockholm3 Active Surveillance trial (STHLM3AS).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. TPS379-TPS379
Author(s):  
Anna Lantz ◽  
Henrik Olsson ◽  
Tobias Nordström ◽  
Fredrik Jäderling ◽  
Lars Egevad ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Active Surveillance ◽  
Cancer Progression ◽  
Multicenter Study ◽  
Prediction Models ◽  
Background Level ◽  
National Guidelines ◽  
Prospective Multicenter Study ◽  
Targeted Biopsies

TPS379 Background: Level one evidence shows that men with low-risk prostate cancer undergoing active surveillance (AS) with repeated PSA tests and systematic biopsies have low mortality. However, monitoring sometimes misses significant cancer progression and causes patient morbidity. The objective of this study is to evaluate a new proposed protocol for AS using the combination of the Stockholm3 test and MRI targeted biopsies in comparison to conventional follow-up using PSA and systematic biopsies. Methods: A prospective multicenter study with paired design was used to evaluate our proposed protocol (Stockholm3, MRI, targeted biopsies) compared with the conventional protocol according to Swedish National Guidelines (PSA, systematic biopsies) for follow-up of men on AS. The STHLM3 study was performed between 2012-2014. In the study 1 374 men were diagnosed with ISUP grade 1 disease. Out of these, 541 men currently on AS were invited to the STHLM3AS study. Eligible individuals had to be alive without any severe comorbidity, without contraindications for MRI and without a history of initiating prostate cancer treatment. The primary endpoint ISUP grade ≥2 cancer and the secondary endpoint number of performed biopsies will be evaluated using relative sensitivity (RS). At baseline a blood test for PSA and Stockholm3 test as well as a bi-parametric MRI was performed. For men with PIRADS ≥ 3 targeted and systematic biopsies were performed. For men with PIRADS < 3 only systematic biopsies were performed. The study is registered at ClinicalTrials.gov (NCTNCT03956108). Results: 301 men on AS have been included in the study. Since this is a trial in progress, no results will be presented. Conclusions: To our knowledge, this is the largest prospective multicenter study evaluating the performance of MRI for disease monitoring in an AS-cohort. Prediction models using biomarkers and MRI will likely both have an increasing role in the monitoring of AS patients in the future. We hypothesise that the sequential use of first Stockholm3 test followed by MRI will decrease the number of biopsies, while retaining the sensitivity to detect ISUP grade ≥2 cancer compared with using systematic biopsies in all men. Clinical trial information: NCTNCT03956108.

scholarly journals Incorporating Magnetic Resonance Imaging and Biomarkers in Active Surveillance Protocols - Results From the Prospective Stockholm3 Active Surveillance Trial (STHLM3AS)

2020 ◽  
Author(s):  
Henrik Olsson ◽  
Tobias Nordström ◽  
Fredrik Jäderling ◽  
Lars Egevad ◽  
Hari T Vigneswaran ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Magnetic Resonance ◽  
Active Surveillance ◽  
Prediction Models ◽  
Relative Sensitivity ◽  
Low Risk ◽  
Resonance Imaging ◽  
Increased Sensitivity ◽  
Targeted Biopsies

Abstract Background Active surveillance (AS) for men with low-risk prostate cancer (PC) can lead to patient morbidity and healthcare overutilization. The aim of this study was to evaluate an AS protocol using the Stockholm3 test and magnetic resonance imaging (MRI) to reduce biopsy intensity. Methods We conducted a prospective multicenter study of 280 invited men from a contemporary screening study (STHLM3), with Gleason Score (GS) 3 + 3 PC on a current AS protocol. Patients underwent prostate-MRI and blood sampling for analysis of the Stockholm3 test including protein biomarkers, genetic variants, and clinical variables to predict risk of GS ≥3 + 4 PC followed by systematic biopsies and targeted biopsies (for Prostate Imaging Reporting and Data System version 2 ≥3 lesions) in all men. Primary outcomes were reclassification to GS ≥3 + 4 PC and clinically significant PC (csPCa), including unfavorable intermediate risk PC or higher based on National Comprehensive Cancer Network guidelines. Results Adding MRI-targeted biopsies to systematic biopsies increased sensitivity of GS ≥3 + 4 PC compared with systematic biopsies alone (relative sensitivity [RS] = 1.52, 95% confidence interval [CI] = 1.28 to 1.85). Performing biopsies in only MRI positive increased sensitivity of GS ≥3 + 4 PC (RS = 1.30, 95% CI = 1.04 to 1.67) and reduced number of biopsy procedures by 49.3% while missing 7.2% GS ≥3 + 4 PC and 1.4% csPCa. Excluding men with negative Stockholm3 test reduced the number of MRI investigations at follow-up by 22.5% and biopsies by 56.8% while missing 6.9% GS ≥3 + 4 PC and 1.3% csPCa. Conclusion Including MRI and targeted/systematic biopsies in the follow-up for men on AS increased sensitivity of PC reclassification. Incorporation of risk prediction models including biomarkers may reduce the need for MRI use in men with low-risk PC.

scholarly journals Image-Guided Thermal Ablation as an Alternative to Surgery for Papillary Thyroid Microcarcinoma: Preliminary Results of an Italian Experience

2021 ◽  
Vol 11 ◽  
Author(s):  
Giovanni Mauri ◽  
Franco Orsi ◽  
Serena Carriero ◽  
Paolo Della Vigna ◽  
Elvio De Fiori ◽  
...  
Keyword(s):  
Laser Ablation ◽  
Thyroid Function ◽  
Active Surveillance ◽  
Thermal Ablation ◽  
Thyroid Function Tests ◽  
Papillary Thyroid ◽  
Technical Success ◽  
Image Guided ◽  
Thyroid Microcarcinoma

PurposeTo report the results of our preliminary experience in treating patients with papillary thyroid microcarcinoma (PTMC) with image-guided thermal ablation, in particular estimating the feasibility, safety and short-term efficacyMaterials and MethodsFrom 2018 patients with cytologically proven PTMC &lt; 10 mm were discussed in a multidisciplinary team and evaluated for feasibility of image-guided thermal ablation. In case of technical feasibility, the three possible alternatives (i.e., image-guided thermal ablation, surgery, and active surveillance) were discussed with patients. Patients who agreed to be treated with image guided thermal ablation underwent radiofrequency (RFA) or laser ablation under local anesthesia and conscious sedation. Treatment feasibility, technical success, technique efficacy, change in thyroid function tests, side effects, minor and major complications, patients satisfaction and pain/discomfort perception during and after treatment, and disease recurrence during follow-up were recorded.ResultsA total of 13 patients were evaluated, and 11/13 (84.6%) patients (9 female, 2 male, mean age 49.3 ± 8.7 years) resulted suitable for image-guided thermal ablation. All 11 patients agreed to be treated with image-guided thermal ablation. In addition, 3/11 (27.3%) were treated with laser ablation and 8/11 (72.7%) with RFA. All procedures were completed as preoperatively planned (technical success 100%). Technique efficacy was achieved in all 11/11 (100%) cases. Ablated volume significantly reduced from 0.87 ± 0.67 ml at first follow-up to 0.17 ± 0.36 at last follow-up (p = 0.003). No change in thyroid function tests occurred. No minor or major complications occurred. All patients graded 10 the satisfaction for the treatment, and mean pain after the procedure was reported as 1.4 ± 1.7, and mean pain after the procedure as 1.2 ± 1.1 At a median follow-up of 10.2 months (range 1.5–12 months), no local recurrence or distant metastases were found.ConclusionsImage guided thermal ablations appear to be feasible and safe in the treatment of PTMC. These techniques hold the potential to offer patients a minimally invasive curative alternative to surgical resection or active surveillance. These techniques appear to be largely preferred by patients.

Active surveillance: Do low-income patients adhere to the protocol?

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 53-53 ◽  
Author(s):  
Ryan Kraus ◽  
Lingyun Ji ◽  
Richard Jennelle ◽  
Susan Groshen ◽  
Leslie K Ballas
Keyword(s):  
Prostate Cancer ◽  
Competing Risks ◽  
Active Surveillance ◽  
Low Income ◽  
Multivariable Analysis ◽  
Safety Net ◽  
Median Income ◽  
Significant Difference ◽  
Safety Net Hospital

53 Background: Use of active surveillance (AS) in low-risk prostate cancer (PC) is up from 10% in 2006 to 40% in 2013 according to the CaPSURE registry. The data that provides evidence for the use of AS were among patients adhering to follow-up schedules. There are no data illustrating if patients not on a study follow through with their AS. Based on our experience at a large safety-net hospital with a multi-ethnic, low-income population and a nearby university-based hospital, we hypothesize that AS patients at a safety-net hospital fail to follow-up more frequently than those at a university-based hospital. Methods: We performed a retrospective chart review of patients with non-metastatic prostate cancer who initiated AS at Los Angeles County Hospital (LAC) and Norris Cancer Center (NCC) between 1/1/2008-1/1/2015. Competing-risks regression analyses were used to examine the difference in the rates of AS patients being lost to follow-up (LTFU) between the two institutions, as well as the association between LTFU and patient characteristics, with patients who ended AS due to any reasons treated as competing risks. Results: We found 116 patients at LAC and 90 patients at NCC who met the AS criteria of this study. Patients at both hospitals had similar tumor characteristics. Patients at LAC and NCC differed, however, in median income, race, primary language spoken, median miles residing from hospital, and mean percent that graduated from high school in their zip code. There was a statistically significant difference between the rates of AS patients being LTFU at the two institutions. After two years, 48% of patients at LAC were LTFU vs. 16% of AS patients at NCC. Patients stay on AS for a median of 7.4 months at LAC vs. 22.8 months at NCC. On multivariable analysis (MVA), patients at NCC were more likely to be LTFU if they had a lower household income. At LAC, the MVA found that patients that lived further from LAC were significantly more likely to adhere to AS. Conclusions: Patients undergoing AS at LAC were LTFU at a high rate. AS can only be an effective strategy if patients actually undergo surveillance. We need further investigation to evaluate whether we should recommend AS at safety-net hospitals.

Endovenous radiofrequency powered segmental thermal ablation (Closure FAST) of great saphenous veins

Phlebologie ◽  
2010 ◽  
Vol 39 (02) ◽  
pp. 69-71 ◽  
Author(s):  
T. M. Proebstle ◽  
Keyword(s):  
Side Effects ◽  
Thermal Ablation ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Duplex Ultrasound ◽  
Multicenter Trial ◽  
Saphenous Veins ◽  
Clinical Control ◽  
Prospective Multicenter Trial

Summary Background: Radiofrequency powered segmental thermal ablation Closure FAST has become a globally engaged technology for ablation of incompetent great saphenous veins (GSVs). Mid-term results of slowly resolving side effects are still not described. Methods: RSTA-treated GSVs (n = 295) were followed for 24 months in a prospective multicenter trial. Clinical control visits included flow and reflux analysis by duplex-ultrasound and assessment of treatment related side effects at all times. Results: 280 of 295 treated GSVs (94.9%) were available for 24 months follow-up. According to the method of Kaplan and Meier at 24 months after the intervention 98.6% of treated legs remained free of clinically relevant axial reflux. The average VCSS score improved from 3.9 ± 2.1 at screening to 0.7 ± 1.2 at 24 months follow-up (p < 0.0001). While only 41.1% of patients were free of pain before treatment, at 24 months 99.3% reported no pain and 96.4% did not experience pain during the 12 months before. At 24 months n=3 legs showed pigmentation along the inner thigh and one leg showed study-treatment related paresthesia. Conclusion: Radiofrequency powered segmental thermal ablation Closure FAST showed a very moderate side-effect profile in conjunction with a high and durable clinical success rate.

scholarly journals Brain Tumor Resection in Elderly Patients: Potential Factors of Postoperative Worsening in a Predictive Outcome Model

Cancers ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 2320
Author(s):  
Paolo Ferroli ◽  
Ignazio Gaspare Vetrano ◽  
Silvia Schiavolin ◽  
Francesco Acerbi ◽  
Costanza Maria Zattra ◽  
...  
Keyword(s):  
Brain Tumor ◽  
Postoperative Complications ◽  
Elderly Patients ◽  
Performance Status ◽  
Tumor Resection ◽  
Patient Specific ◽  
Invasive Treatment ◽  
Tertiary Referral Center ◽  
Surgical Complexity

The decision of whether to operate on elderly patients with brain tumors is complex, and influenced by pathology-related and patient-specific factors. This retrospective cohort study, based on a prospectively collected surgical database, aims at identifying possible factors predicting clinical worsening after elective neuro-oncological surgery in elderly patients. Therefore, all patients ≥65 years old who underwent BT resection at a tertiary referral center between 01/2018 and 12/2019 were included. Age, smoking, previous radiotherapy, hypertension, preoperative functional status, complications occurrence, surgical complexity and the presence of comorbidities were prospectively collected and analyzed at discharge and the 3-month follow-up. The series included 143 patients (mean 71 years, range 65–86). Sixty-five patients (46%) had at least one neurosurgical complication, whereas 48/65 (74%) complications did not require invasive treatment. Forty-two patients (29.4%) worsened at discharge; these patients had a greater number of complications compared to patients with unchanged/improved performance status. A persistent worsening at three months of follow-up was noted in 20.3% of patients; again, this subgroup presented more complications than patients who remained equal or improved. Therefore, postoperative complications and surgical complexity seem to influence significantly the early outcome in elderly patients undergoing brain tumor surgery. In contrast, postoperative complications alone are the only factor with an impact on the 3-month follow-up.

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