Utility of the Oncotype DX ® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis

2015 ◽  
Vol 2 (6) ◽  
pp. 343-348 ◽  
Author(s):  
Marc A. Dall’Era ◽  
Tara Maddala ◽  
Louise Polychronopoulos ◽  
Jack R. Gallagher ◽  
Phillip G. Febbo ◽  
...  
Author(s):  
Alicia K. Morgans ◽  
Himisha Beltran

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice.


2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 54-54
Author(s):  
Julie Ann Lynch ◽  
Megan Rothney ◽  
Raoul Salup ◽  
Cesar Emilio Ercole ◽  
Sharad Mathur ◽  
...  

54 Background: Active surveillance (AS) is a recommended management approach for low risk prostate cancer (PCa). Studies have shown high rates of AS in the Veterans Administration (VA), but concerns about missing aggressive disease lead to variation between centers. The 17-gene Genomic Prostate Score (GPS) has been validated to predict likelihood of favorable pathology (LFP) in men with clinically low risk PCa. This study compared treatment patterns before and after introduction of the GPS to determine if the assay influenced treatment patterns. Methods: Men newly diagnosed with PCa who met NCCN criteria for very low (VL), low (L), or intermediate (INT) risk PCa were eligible. Chart review of men across 6 VA medical centers (VAMCs) established treatment in untested patients in 2013-2014. In 2015, Veterans at the same VAMCs were offered the assay in a prospective study measuring treatment recommendations before and after the assay and treatment implemented based on chart review. Results: There were 200 men in the untested cohort. Characteristics: age (median = 66, range:43-83), Gleason Score (GS) (3+3:64%, 3+4:37%), PSA (mean = 6.6, range:0.7-20), NCCN risk (VL:18%, L:37%, INT:46%). There were 190 men in the prospective study with complete data. NCCN risk group: age (median = 66, range:50-85), GS (3+3:74%, 3+4:26%), PSA (mean = 6.4, range:0.4-18.1), VL:22%, L:43%, INT:35%. GPS ranged from 0-61 and LFP ranged from 38%-91%. GPS identified 24 patients who had more favorable pathology and 13 patients who had less favorable pathology than would be expected using NCCN alone. 62% of untested Veterans pursued AS compared to 74% of tested Veterans. AS increases between untested and tested cohorts were 1% in VL, 16% in L, and 3% in INT. Conclusions: Both untested and tested patients had clinical characteristics representative of low risk PCa in the VA. Use of AS increased in tested Veterans compared to untested, with the largest increases observed in NCCN low risk patients. The 17-gene assay used biological information to provide refined risk estimates in tested Veterans, assisting physicians in appropriately identifying candidates for AS or immediate treatment.


2008 ◽  
Vol 11 (4) ◽  
pp. 157-161 ◽  
Author(s):  
Kelly K. Curtis ◽  
Terrence J. Adam ◽  
Shu-Chuan Chen ◽  
Rajiv K. Pruthi ◽  
Michael K. Gornet

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 82-82
Author(s):  
Ramdev Konijeti ◽  
Traci M. Blonquist ◽  
Barbara Halpenny ◽  
Fangxin Hong ◽  
Steven L. Chang ◽  
...  

82 Background: The Personal Patient Profile-Prostate (P3P) is an Internet-based decision support program for men with newly diagnosed prostate cancer (CaP), which significantly reduced decisional conflict in treatment selection in a multicenter trial (2007 to 2009). We performed an ad hoc analysis of data from the trial (including five sites in Washington, Pennsylvania, Georgia, and Texas) to determine factors associated with initial treatment selection (watchful waiting [WW], external radiation [XRT], brachytherapy, or surgery [RP]) in men with localized CaP. Methods: Baseline patient characteristics measured for 462 patients included age, income (less than $35,000 vs. more than $35,000), employment (working vs. not ), relationship status (married/partnered vs. not), state and trait anxiety, amount of confidence in a particular physician (a lot vs. less), and whether the patient was seen by a urologist only or both a urologist and radiation oncologist. Univariate and multivariable logistic regression were used to identify predictors of initial treatment choice within 6 months of diagnosis. Results: Common treatment choices were RP (48%), XRT (21%), and WW (15%). In both univariate and multivariable analyses, men seen by a urologist only were more likely to choose WW (p=0.03 and p=0.02, respectively); employed men were less likely to choose WW (p=0.01 and p=0.02, respectively). In multivariable analysis, married/partnered men were more likely to choose surgery (p=0.03); anxiety was not statistically significantly associated with any treatment choice. Conclusions: Our findings suggest that treatment choice is related to social infrastructure and type of specialist seen. These findings should guide counseling of patients with newly diagnosed localized CaP. Further studies related to the role of sociodemographic characteristics and access to specialty care in initial treatment choice are warranted.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19265-e19265
Author(s):  
Anannya Patwari ◽  
Vineel Bhatlapenumarthi ◽  
Antoine Joseph Harb ◽  
Adam Curtis

e19265 Background: ICIs are used for a variety of malignancies and have shown to improve survival, but they are associated with IRAEs. We aim to identify the frequency and severity of new IRAEs and flares of preexisting autoimmune (AI) disorders excluding thyroid disorders in cancer patients treated with ICIs at our institution. Methods: We conducted a retrospective chart review analysis of all cancer patients who received ICIs: nivolumab, pembrolizumab, atezolizumab and durvalumab at the Northern Light Cancer Institute from June 2015 to March 2019. We excluded patients who received ipilimumab. We then studied those who developed IRAEs. Results: Out of 465 who received ICIs, 115(24.7%) developed IRAEs. 83 out of 298 (27.9%) nivolumab recipients, 20/121 (15.7%) pembrolizumab recipients, 5/26 (19.2%) atezolizumab and 7/20 (35%) durvalumab recipients developed IRAEs. Some patients had multiple toxicities. Median age at cancer diagnosis was 66 years, evenly split among males and females. Majority (63%) were treated for Lung cancer, followed by melanoma (20%) and genitourinary cancers (12%). Summary of new IRAEs are as noted in the table below. In patients with new IRAEs treatment was held in 29(6%) for a median duration of 7.2 wks. Upon rechallenge with the same ICI in 27 patients, 20(74%) tolerated and 7 did not leading to permanent discontinuation. Majority were treated with steroids and some required immunomodulators. Interestingly 39(8%) patients with underlying AI condition received ICIs. Of these 11(28.2%) developed flares, resulting in permanent discontinuation of drug in 4. The majority tolerated the treatment well. Treatment was permanently discontinued in 70(15%), 26(6%) required hospital admission for IRAEs. Pneumonitis was the most common toxicity necessitating treatment discontinuation and hospital stay. Conclusions: In real world setting the frequency and severity of IRAEs was more than the reported literature data, leading to higher rates of permanent discontinuation of treatment. [Table: see text]


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5610-5610
Author(s):  
Benjamin A Derman ◽  
Sanjib Basu ◽  
Agne Paner

Abstract Introduction: Renal insufficiency (RI) in newly diagnosed multiple myeloma (NDMM) represents a poor prognostic factor (Knudsen, Hjorth, and Hippe 2000). Recent clinical trials have demonstrated that patients treated with novel agents, particularly proteasome inhibitors, may experience renal recovery with improvement in overall survival (Dimopoulos et al. 2013; Gonsalves et al. 2015). The majority of patients in these trials were Caucasians, although multiple myeloma is twice as common in African Americans (AA) as it is in Caucasians. Moreover, AA have a 5 times higher rate of stage 4 chronic kidney disease (CKD) and end-stage-renal-disease (ESRD) in the United States compared to Caucasians. The cause for this disparity is thought to be multifactorial, including a higher incidence of comorbidities such as diabetes and hypertension among AAs (Williams and Pollak 2013; Grams et al. 2013). There is currently a dearth of evidence regarding renal recovery in AA receiving therapy for MM. The goal of this study is to compare renal recovery between AA and non AA patients following initial treatment for NDMM. Methods: We performed a retrospective chart review of patients with NDMM at Rush University Medical Center from January 1, 2005 to August 1, 2016. 690 charts were selected and reviewed; patients who were on hemodialysis for alternative reasons prior to diagnosis, had a GFR > 90, or for whom records were incomplete were excluded. 118 patients with NDMM and a GFR < 90 (corresponding to National Kidney Foundation's chronic kidney disease stage 2 or worse) at the time of diagnosis were identified. Continuous variables were compared between the two groups using the Mann-Whitney U test, and binary variables were compared using Fisher's exact test. Results: We compared 59 AA and 59 non AA patients with RI at the time of diagnosis of MM. Both groups were comparable by age, gender, ISS and high risk cytogenetics. The degree of RI at the time of diagnosis was similar: median GFR at diagnosis was 47.89 in the AA group and 51.95 in the non AA group (p=0.56). Hypertension was more common in the AA group (78% vs. 52.5%, p=0.0064), while other comorbidities were statistically comparable. The majority of patients were treated with a bortezomib-based regimen (86.4% for the AA group and 84.7% for the non AA group, p=1). MM response rates to induction therapy were similar: very good partial response (VGPR) or better was achieved in 39% of AA and 25.4% of non AA (p=0.17). 45.8% of AA patients underwent autologous stem cell transplant (ASCT) compared to 64.4% of non-AA (p=0.0637, see table 3). 80% of AA and 88% of non AA patients received bisphosphonates (see table 1). Although median GFR at the time of diagnosis of MM was similar between the AA and non AA groups (47.89 vs. 51.95, p=0.56), the median absolute change in estimated GFR after initial therapy was significantly higher in the AA group (+33.64) vs. the non-AA group (+21.07, p=0.00183). This difference remained whether the baseline GFR at diagnosis was <90 or <60 (see table 2). The median time to best renal response was 91 days in AA and 79 days in non-AA (p=0.383). Conclusions: This is the first study to analyze disparities in renal dysfunction and recovery between AA and non-AA patients with NDMM. We demonstrate that in our institution AA patients with NDMM treated in the era of novel agents have greater improvement in renal function in comparison to non AA patients. Given that renal recovery in NDMM impacts overall survival, this finding suggests that further studies should be done to explore differences in the epidemiology and disease biology that could account for the racial disparities in renal dysfunction and recovery. Disclosures No relevant conflicts of interest to declare.


2012 ◽  
Vol 16 (2) ◽  
pp. 115-121 ◽  
Author(s):  
Janie Bertrand ◽  
Rita Sammour ◽  
Catherine Mccuaig ◽  
Josée Dubois ◽  
Afshin Hatami ◽  
...  

Background: Propranolol, a nonselective β-blocker, has been reported as efficient for controlling the growth of complicated infantile hemangiomas (IHs). No uniformly accepted protocol exists regarding the administration of oral propranolol for IH. Objective: We sought to share our experience using propranolol for problematic IH and to evaluate the efficacy of this treatment modality. Methods: A retrospective chart review analysis was performed for 35 consecutive children treated with propranolol as an oral solution on an outpatient basis in our dermatology/vascular anomalies clinic. A protocol was established with the help of our pediatric cardiologists, including pretreatment electrocardiography and echocardiography. Medical photographs taken after 2 months of treatment were rated by two independent evaluators. Results: We treated 31 girls and 4 boys with a median age of 3.5 months. Rapid improvement was reported in the first days of treatment in 34 patients. Mean improvement after 2 months was 61.5%. No serious adverse effects were reported. Conclusion: Propranolol was effective in controlling the proliferative phase of problematic IH. It was well tolerated in our study. Outpatient treatment is possible if parents follow strict guidelines. Propranolol should be a first-line treatment for problematic IH in carefully selected patients.


2018 ◽  
Vol 36 (15) ◽  
pp. 1521-1539 ◽  
Author(s):  
Michael J. Morris ◽  
R. Bryan Rumble ◽  
Ethan Basch ◽  
Sebastien J. Hotte ◽  
Andrew Loblaw ◽  
...  

Purpose This clinical practice guideline addresses abiraterone or docetaxel with androgen-deprivation therapy (ADT) for metastatic prostate cancer that has not been treated (or has been minimally treated) with testosterone-lowering agents. Methods Standard therapy for newly diagnosed metastatic prostate cancer has been ADT alone. Three studies have compared ADT alone with ADT and docetaxel, and two studies have compared ADT alone with ADT and abiraterone. Results Three prospective randomized studies (GETUG-AFU 15, STAMPEDE, and CHAARTED) examined overall survival (OS) with adding docetaxel to ADT. STAMPEDE and CHAARTED favored docetaxel (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; n = 2,962 and HR, 0.73; 95% CI, 0.59 to 0.89; n = 790, respectively). GETUG-AFU 15 was negative. LATITUDE and STAMPEDE examined the impact on OS of adding abiraterone (with prednisone or prednisolone) to ADT. LATITUDE and STAMPEDE favored abiraterone (HR, 0.62; 95% CI, 0.51 to 0.76; n = 1,199 and HR, 0.63; 95% CI, 0.52 to 0.76; n = 1,917, respectively). Recommendations ADT plus docetaxel or abiraterone in newly diagnosed metastatic non-castrate prostate cancer offers a survival benefit as compared with ADT alone. The strongest evidence of benefit with docetaxel is in men with de novo high-volume (CHAARTED criteria) metastatic disease. Similar survival benefits are seen using abiraterone acetate in high-risk patients (LATITUDE criteria) and in the metastatic population in STAMPEDE. ADT plus abiraterone and ADT plus docetaxel have not been compared, and it is not known if some men benefit more from one regimen as opposed to the other. Fitness for chemotherapy, patient comorbidities, toxicity profiles, quality of life, drug availability, and cost should be considered in this decision. Additional information is available at www.asco.org/genitourinary-cancer-guidelines .


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