Impact of CCP test on personalizing treatment decisions: Results from a prospective registry of newly diagnosed prostate cancer patients.

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 63-63
Author(s):  
Neal D. Shore ◽  
Judd Boczko ◽  
Naveen Kella ◽  
Brian Joseph Moran ◽  
E. David Crawford ◽  
...  

63 Background: The cell cycle progression (CCP) test is a validated molecular assay that assesses risk of prostate cancer−specific disease progression and mortality when combined with standard clinicopathologic parameters. PROCEDE−1000 is the largest prospective registry to evaluate CCP test impact on personalizing prostate cancer treatment. Results of an interim analysis are presented. Methods: Untreated patients with newly diagnosed (≤6 months), clinically localized prostate adenocarcinoma were enrolled (n=816). The physician’s initial therapy recommendation (pre−CCP) was recorded on the first questionnaire. The CCP test was then conducted on prostate biopsy tissue. Three post−CCP questionnaires recorded the physician’s revised treatment recommendation, physician/patient treatment decision, and actual treatment administered. Changes in treatments between the pre-CCP and post−CCP questionnaires demonstrated the impact of CCP testing on treatment decisions at each stage. Results: Visual analog scale measurements indicated a significant increase (p=0.0125) in the physician’s likelihood of recommending non−interventional treatment post−CCP test; there was an increase in active surveillance from the initial interventional therapy recommendation. From pre−CCP therapy recommendation, the CCP score caused a change in actual treatment administered in 44% of patients; 72% of changes were reductions in treatment. Reductions occurred in radical prostatectomy (27%), radiation therapy (44% primary; 56% adjuvant), brachytherapy (46% interstitial; 66% HDR) and hormonal therapy (33% neoadjuvant; 68% concurrent) treatments. While 35.9% of patients were recommended for conservative management pre−CCP testing, there was a 6.5% increase in non−interventional treatments during actual follow−up. Overall, there was a significant reduction in the number of treatment options at each successive evaluation (p<0.0001). Conclusions: The CCP risk assessment score has a significant impact in helping physicians and patients reach consensus on an appropriate personalized treatment decision, often with major reductions in interventional treatment burden. Clinical trial information: NCT01954004.

2021 ◽  
Vol 16 (2) ◽  
Author(s):  
Danielle Earis ◽  
Chris Wall ◽  
Nicolette Sinclair ◽  
Trustin Domes ◽  
Kunal Jana

Introduction: Small renal masses (SRMs) are managed with active surveillance (AS), thermal ablation (TA), irreversible electroporation (IRE), or surgery, depending on patient and tumor factors. A novel SRM multidisciplinary clinic (SRMC), involving urologists and interventional radiologists, was established to provide patients with information on treatments options. The objective of this study was to evaluate the impact of the SRMC on treatment decision-making Methods: Demographics, tumor characteristics, and treatment decisions were prospectively collected on patients (n=216) attending the SRMC between 2016 and 2019. A retrospective historic cohort (n=238) seen by urologists was used as a control group. Key variables were analyzed and compared. Patient satisfaction (n=27) was surveyed and responses were summarized and explored. Results: Mean age, tumor size, and pathology was similar between groups; however, the SRMC cohort had more male patients (65.7% vs. 53.8%, p=0.009). Chosen treatment modality differed significantly between cohorts (p<0.0001). Patients in the historic cohort were treated by AS (41.5%), surgery (37.9%), TA (11.9%), watchful waiting (7.9%), and IRE (0.8%). SRMC patients were treated by TA (42.2%), AS (26.7%), surgery (21.3%), IRE (7.6%), and watchful waiting (2.2%). Post-hoc analysis revealed statistically significant differences in proportions of AS, TA, IRE, and surgery between cohorts. Patients reported high satisfaction with the collaborative approach. Conclusions: A multidisciplinary approach may have an impact on patient treatment decision-making for SRMs. Consultations involving a urologist and an interventional radiologist resulted in more TA and IRE and less AS and surgery. Future studies should evaluate if these findings occur in other centers.


2015 ◽  
Vol 33 (15_suppl) ◽  
pp. e16042-e16042
Author(s):  
Neal Shore ◽  
Judd Boczko ◽  
Naveen Kella ◽  
Brian Joseph Moran ◽  
Fernando J. Bianco ◽  
...  

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 77-77 ◽  
Author(s):  
Joshua A. Roth ◽  
Scott David Ramsey ◽  
Josh John Carlson

77 Background: Clinico-pathologic factors alone are insufficient to predict the likelihood of progression of Gleason 3+3 and 3+4 prostate cancer at the time of biopsy. As a result, many patients receive treatment, despite having unaggressive tumors. There is a need for tests that provide a clearer picture of risk to enable more individualized treatment decisions. A novel prognostic assay (ProMark) that uses quantitative measurements of protein biomarkers has been validated to predict prostate cancer aggressiveness at the time of biopsy. Our objective was to evaluate the potential cost-effectiveness of using the 8-protein assay to inform treatment decisions. Methods: We developed a simulation model to estimate quality-adjusted life-year (QALY) and cost outcomes for assay and usual care (NCCN guidelines) strategies. The proportion of patients classified as low, intermediate, and high-risk by the assay and guidelines was derived from the assay’s validation study. Treatment distributions, costs, health state utilities, and mortality rates were derived from peer-reviewed literature. The health outcome impacts of the assay strategy come from increased use of active surveillance (AS) vs treatment, and we evaluated a base case increase in AS of 14.5% (vs usual care), and small and large shift scenarios with 7.8% and 20.2% increases, respectively. We calculated the incremental QALYs, costs, and cost-effectiveness ratio in each scenario. Results: The assay strategy was dominant in all scenarios evaluated. In the base case, the assay strategy resulted in 0.04 more QALYs and $700 less in costs. The small and large shift scenarios resulted 0.02 and 0.05 more QALYs, and $5 and $1,300 less in costs, respectively. Cost-effectiveness outcomes were most sensitive to the assay cost, the AS health state utility, and the proportion of low-risk patients receiving AS in usual care. Conclusions: Our results suggest that the 8-protein prognostic assay has the potential to be a cost-effective alternative to usual care in patients with Gleason 3+3 and 3+4 prostate cancer. Future studies will evaluate the impact of the assay on patient and physician treatment choices in real-world settings.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18012-e18012
Author(s):  
Lauren P. Wallner ◽  
Yun Li ◽  
Chandler McLeod ◽  
Ann S Hamilton ◽  
Kevin C. Ward ◽  
...  

e18012 Background: Little is known about the size and characteristics of informal decision support networks of women diagnosed with breast cancer and whether involvement of informal decision supporters (DSP) influences breast cancer treatment decisions. Methods: A population-based sample of newly diagnosed breast cancer patients reported to the Georgia and Los Angeles SEER registries in 2014-15 were surveyed approximately 6 months after diagnosis (N = 2,502, 68% response rate). Network size was estimated by asking women to list up to 3 of the most important DSPs who helped them with locoregional therapy decisions. For each individual DSP listed, respondents reported how important each DSP’s opinion was in treatment decision making, and how satisfied they were with their involvement (5 pt. scales, “not at all” to “very”). Decision deliberation was measured using 5-items assessing degree patients thought through the decision, with higher scores reflecting more deliberative treatment decisions. We compared network size (0-3 or more) across patient-level characteristics and estimated the association between network size and deliberation using multivariable linear regression. Results: Of the 2,502 women in this analysis, 51% reported having 3 or more DSPs, 20% reported 2, 18% reported 1, and 11% reported not having any DSPs. Married/partnered women, those younger than 45 years old, and black women were all more likely to report larger networks (all p < 0.001). Partnered women most often reported their partner as their main DSP (37.9%), whereas not partnered/unmarried women most often reported children (38.4%). The majority of women were highly satisfied with their DSP being involved in their decisions (76.5%) and 68.6% felt their DSP was very important in their decision making. Larger support networks were associated with more deliberative surgical treatment decision-making (p < 0.001). Conclusions: Most women engaged multiple DSPs in their treatment decision making, including spouses, children, and friends. Involving more DSPs was associated with more deliberative treatment decisions. Future initiatives to improve breast cancer treatment decision making should acknowledge and engage informal DSPs.


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