The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies.

The purpose of this study was to evaluate the potential collective opportunities and challenges of transforming real-world data (RWD) to real-world evidence for clinical effectiveness by focusing on aligning analytic definitions of oncology end points. Patients treated with a qualifying therapy for advanced non-small cell lung cancer in the frontline setting meeting broad eligibility criteria were included to reflect the real-world population. Although a trend toward improved outcomes in patients receiving PD-(L)1 therapy over standard chemotherapy was observed in RWD analyses, the magnitude and consistency of treatment effect was more heterogeneous than previously observed in controlled clinical trials.

Real-world Evidence of Diagnostic Testing and Treatment Patterns in US Patients With Breast Cancer With Implications for Treatment Biomarkers From RNA Sequencing Data.

Objective/background: We performed a retrospective analysis of longitudinal real-world data (RWD) from patients with breast cancer to replicate results from clinical studies and demonstrate the feasibility of generating real-world evidence. We also assessed the value of transcriptome profiling as a complementary tool for determining molecular subtypes.

Methods: De-identified, longitudinal data were analyzed after abstraction from records of patients with breast cancer in the United States (US) structured and stored in the Tempus database.

A Patient-Reported Outcome Instrument to Assess Symptom Burden and Predict Survival in Patients with Advanced Cancer: Flipping the Paradigm to Improve Timing of Palliative and End-of-Life Discussions and Reduce Unwanted Health Care Costs.

Background: Discussions regarding palliative care and end-of-life care issues are frequently delayed past the time of usefulness, resulting in unwanted medical care. We sought to develop a patient-reported outcome (PRO) instrument that allows patients to voice their symptom burdens and facilitate timing of discussions.

Subjects, Materials, And Methods: A seven-item PRO instrument (Cota Patient Assessed Symptom Score-7 item [CPASS-7]) covering physical performance status, pain, burden, and depression was administered (September 2015 through October 2016) with correlation to overall survival, correcting for time to complete survey since diagnosis.

Real-world economic value of a 21-gene assay in early-stage breast cancer.

Objectives: Value-based payment reforms shift cost-containment responsibilities to the physician. Although gene expression profiling (GEP) utilizing a 21-gene panel among patients with early-stage, axillary lymph node-negative, hormone receptor-positive, HER2/neu oncogene-negative breast cancer is able to identify a cohort that may achieve excellent outcomes without adjuvant chemotherapy, high up-front costs (list price, $4175) could dissuade usage.

Study Design: Retrospective review of consecutive patients with breast cancer treated at a single cancer center.

Genomic Profiling of Advanced Non-Small Cell Lung Cancer in Community Settings: Gaps and Opportunities.

Background: National guidelines have advocated broad molecular profiling as a part of the standard diagnostic evaluation for advanced non-small cell lung cancer (NSCLC), with the goal of identifying driver mutations for which effective therapies or clinical trials are available. However, adherence to genomic testing guidelines could present challenges to community oncologists.

Patients And Methods: We performed a retrospective review of genomic testing patterns in patients with nonsquamous NSCLC treated by 89 oncologists at 15 sites throughout New Jersey and Maryland from January 2013 to December 2015.

Size-adjusted Quantitative Gleason Score as a Predictor of Biochemical Recurrence after Radical Prostatectomy.

Background: The risk of biochemical recurrence (BCR) following radical prostatectomy for pathologic Gleason 7 prostate cancer varies according to the proportion of Gleason 4 component.

Objective: We sought to explore the value of several novel quantitative metrics of Gleason 4 disease for the prediction of BCR in men with Gleason 7 disease.

Design, Setting, And Participants: We analyzed a cohort of 2630 radical prostatectomy cases from 1990-2007.

Expression of phosphorylated-mTOR during the development of prostate cancer.

Background: The PI3K pathway plays a significant role in the progression of prostate cancer (PCa) to an advanced stage. Mouse models suggest that the downstream effector molecule of the PI3K pathway, mTOR, is also important in the development of PCa, where it plays a pivotal role in forming precursor lesions such as high grade prostatic intraepithelial neoplasia (HGPIN). This study was conducted to determine the status of phosphorylated-mTOR (p-mTOR the activated state of mTOR) across the PCa progression model by looking at expression in normal prostate tissue, proliferative inflammatory atrophy (PIA), HGPIN, and PCa.

High-dose rate brachytherapy compared with open radical prostatectomy for the treatment of high-risk prostate cancer: 10 year biochemical freedom from relapse.

Objective: • To compare long-term biochemical control of high-risk prostate cancer in those men receiving high-dose rate brachytherapy (HDRB) and radical prostatectomy (RP).

Patients And Methods: • The 10-year biochemical freedom from relapse (BFR) was calculated for 243 patients who underwent either RP or combined therapy with HDRB + external beam radiotherapy + androgen deprivation between 1998 and 2000. •

Inclusion Criteria: clinical stage ≥ T2b, or Gleason sum ≥ 8, or PSA level of > 20 ng/mL.

Accuracy of primary systematic template guided transperineal biopsy of the prostate for locating prostate cancer: a comparison with radical prostatectomy specimens.

Purpose: We determined whether systematic template guided transperineal biopsies can accurately locate and sensitively detect prostate cancer. In addition, we reported discrepancies between diagnostic and pathological Gleason scores, and investigated whether prostate size had an effect on the cancer detection rate.

Materials And Methods: This retrospective diagnostic accuracy study compares the results of primary transperineal biopsies with the radical prostatectomy pathology of 414 consecutive patients treated at a single institution between November 2002 and August 2010.

High Gleason grade carcinoma at a positive surgical margin predicts biochemical failure after radical prostatectomy and may guide adjuvant radiotherapy.

Unlabelled: Study Type - Prognosis (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Only 30-35% of patients with positive surgical margins after radical prostatectomy develop recurrent disease. Adjuvant radiotherapy reduces the rate of biochemical relapse or metastasis and improves overall survival after radical prostatectomy. Various pathological factors, such as location and extent of positive margins, have been proposed as possible prognostic factors in men with margin-positive prostate cancer, however, the recent International Society of Urological Pathology consensus meeting in Boston noted that there is limited data on the significance of Gleason grade of the carcinoma at a positive margin.

The impact of nerve sparing on incidence and location of positive surgical margins in radical prostatectomy.

Objective: •  To examine whether nerve-sparing surgery (NSS) is a risk factor for positive surgical margins (PSMs) in patients with either organ-confined prostate cancer or extracapsular extension (ECE).

Patients And Methods: •  Clinicopathological outcome data on 945 consecutive patients treated with radical prostatectomy (RP) were prospectively collected. •  All patients underwent RP (bilateral, unilateral or non-NSS) by one surgeon between 2002 and 2007.

Low AZGP1 expression predicts for recurrence in margin-positive, localized prostate cancer.

Background: Men with positive margins after radical prostatectomy (RP) for localized prostate cancer (PC) have a 40-50% biochemical relapse rate at 5 years. Adjuvant radiotherapy improves biochemical progression-free and overall survival in men with positive margins, but is associated with increased toxicity. There is an urgent need to identify new prognostic markers to define the group of patients who would benefit from multimodality therapy.

Epigenetic deregulation across chromosome 2q14.2 differentiates normal from prostate cancer and provides a regional panel of novel DNA methylation cancer biomarkers.

Background: Previously, we showed that gene suppression commonly occurs across chromosome 2q14.2 in colorectal cancer, through a process of long-range epigenetic silencing (LRES), involving a combination of DNA methylation and repressive histone modifications. We now investigate whether LRES also occurs in prostate cancer across this 4-Mb region and whether differential DNA methylation of 2q14.

Should experienced open prostatic surgeons convert to robotic surgery? The real learning curve for one surgeon over 3 years.

Objective: To critically analyse the learning curve for one experienced open surgeon converting to robotic surgery for radical prostatectomy (RP).

Patients And Methods: From February 2006 to December 2008, 502 patients had retropubic RP (RRP) while concurrently 212 had robot-assisted laparoscopic RP (RALP) by one urologist. We prospectively compared the baseline patient and tumour characteristics, variables during and after RP, histopathological features and early urinary functional outcomes in the two groups.

Robot-assisted laparoscopic prostatectomy: analysis of an experienced open surgeon's learning curve after 300 procedures.

To critically analyse the learning curve for a single experienced open surgeon converting to robotic surgery. From February 2006 to July 2009, 300 patients underwent a robot-assisted laparoscopic prostatectomy (RALP) by a single urologist. This study is a prospective analysis of the baseline patient and tumour characteristics, intraoperative and postoperative data, and histopathologic features.

Cyclin D1 splice variants: polymorphism, risk, and isoform-specific regulation in prostate cancer.

Purpose: Alternative CCND1 splicing results in cyclin D1b, which has specialized, protumorigenic functions in prostate not shared by the cyclin D1a (full length) isoform. Here, the frequency, tumor relevance, and mechanisms controlling cyclin D1b were challenged.

Experimental Design: First, relative expression of both cyclin D1 isoforms was determined in prostate adenocarcinomas.