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Between the lines : a novel
Told in their separate voices, sixteen-year-old Prince Oliver, who wants to break free of his fairy-tale existence, and fifteen-year-old Delilah, a loner obsessed with Prince Oliver and the book in which he exists, work together to seek his freedom.
Book
Innovations in Research and Clinical Care Using Patient-Generated Health Data
Patient-generated health data (PGHD), or health-related data gathered from patients to help address a health concern, are used increasingly in oncology to make regulatory decisions and evaluate quality of care. PGHD include self-reported health and treatment histories, patient-reported outcomes (PROs), and biometric sensor data. Advances in wireless technology, smartphones, and the Internet of Things have facilitated new ways to collect PGHD during clinic visits and in daily life. The goal of the current review was to provide an overview of the current clinical, regulatory, technological, and analytic landscape as it relates to PGHD in oncology research and care. The review begins with a rationale for PGHD as described by the US Food and Drug Administration, the Institute of Medicine, and other regulatory and scientific organizations. The evidence base for clinic-based and remote symptom monitoring using PGHD is described, with an emphasis on PROs. An overview is presented of current approaches to digital phenotyping or device-based, real-time assessment of biometric, behavioral, self-report, and performance data. Analytic opportunities regarding PGHD are envisioned in the context of big data and artificial intelligence in medicine. Finally, challenges and solutions for the integration of PGHD into clini-cal care are presented. The challenges include electronic medical record integration of PROs and biometric data, analysis of large and complex biometric data sets, and potential clinic workflow redesign. In addition, there is currently more limited evidence for the use of biometric data relative to PROs. Despite these challenges, the poten-tial benefits of PGHD make them increasingly likely to be integrated into oncology research and clinical care.
Journal Article
Sexual dysfunction after cystectomy and urinary diversion
Key Points
Sexual dysfunction is a common, but often overlooked, consequence of radical cystectomy in both men and women
Sexual dysfunction after radical cystectomy results from a combination of iatrogenic, organic, and psychological factors
Health-related quality-of-life surveys specific to patients with bladder cancer have been developed in attempts to better understand the sources of sexual dysfunction
Treatment protocols must be tailored to the specific source of sexual dysfunction in each patient and often require both medical treatments and counselling
Surgical strategies such as nerve-sparing and vagina-sparing cystectomy might offer improved sexual outcomes while maintaining effective oncological control
Cystectomy with urinary diversion is a key approach to the management of bladder cancer. This Review provides an overview of a complication that is common among the men and women who undergo such surgical treatment: sexual dysfunction. In particular, the tools that can be used to assess sexual function in this context and its effect on quality of life, the various contributory aetiological factors underlying sexual dysfunction, as well as approaches to treating sexual issues are discussed.
Erectile dysfunction (ED) in men and sexual dysfunction in men and women are common after cystectomy and urinary diversion. Research has focused on both qualifying the prevalence of ED following cystectomy and identifying surgical approaches to limit sexual dysfunction after surgery, but most studies have been limited by small patient populations, an absence of control groups, and a lack of adjustment for confounding factors. Similarly, quality of life (QoL) research studies have also emerged in the context of bladder cancer and cystectomy, and increase our understanding of sexual outcomes associated with cystectomy. A number of instruments for collection of patient-reported outcomes among patients with bladder cancer treated with cystectomy are available for the assessment of condition-specific and procedure-specific QoL. However, other factors that negatively affect sexual function after removal of the bladder, such as psychological issues, age, and health-related competing risks for ED, body image, partner response, and change in life course and sexual priorities, have received less attention. Nevertheless, ED and sexual dysfunction are important complications of cystectomy and urinary diversion. Although changes in the approach to surgery, such as nerve-sparing cystectomy, might improve outcomes, evaluation and management of the source factors of ED and sexual dysfunction are necessary to optimize recovery of function.
Journal Article
Examining disparities in large‐scale patient‐reported data capture using digital tools among cancer patients at clinical intake
Background Patient‐reported data can improve quality of healthcare delivery and patient outcomes. Moffitt Cancer Center (“Moffitt”) administers the Electronic Patient Questionnaire (EPQ) to collect data on demographics, including sexual orientation and gender identity (SOGI), medical history, cancer risk factors, and quality of life. Here we investigated differences in EPQ completion by demographic and cancer characteristics. Methods An analysis including 146,142 new adult patients at Moffitt in 2009–2020 was conducted using scheduling, EPQ and cancer registry data. EPQ completion was described by calendar year and demographics. Logistic regression was used to estimate associations between demographic/cancer characteristics and EPQ completion. More recently collected information on SOGI were described. Results Patient portal usage (81%) and EPQ completion rates (79%) were consistently high since 2014. Among patients in the cancer registry, females were more likely to complete the EPQ than males (odds ratio [OR] = 1.17, 95% confidence interval [CI] = 1.14–1.20). Patients ages 18–64 years were more likely to complete the EPQ than patients aged ≥65. Lower EPQ completion rates were observed among Black or African American patients (OR = 0.59, 95% CI = 0.56–0.63) as compared to Whites and among patients whose preferred language was Spanish (OR = 0.40, 95% CI = 0.36–0.44) or another language as compared to English. Furthermore, patients with localized (OR = 1.16, 95% CI = 1.12–1.19) or regional (OR = 1.16, 95% CI = 1.12–1.20) cancer were more likely to complete the EPQ compared to those with metastatic disease. Less than 3% of patients self‐identified as being lesbian, gay, or bisexual and <0.1% self‐identified as transgender, genderqueer, or other. Conclusions EPQ completion rates differed across demographics highlighting opportunities for targeted process improvement. Healthcare organizations should evaluate data acquisition methods to identify potential disparities in data completeness that can impact quality of clinical care and generalizability of self‐reported data.
Journal Article
Development and evaluation of a bladder Cancer specific survivorship care plan by patients and clinical care providers: a multi-methods approach
Background, context and purpose
In spite of the mixed evidence for their impact, survivorship Care Plans (SCPs) are recommended to enhance quality of care for cancer survivors. Data on the feasibility of SCPs in bladder cancer (BC) is sparse. Using a mixed-methods approach, this study describes the iterative development, acceptability and feasibility of BC specific SCP (BC-SCP) in clinical settings.
Methods
In Phase I, we developed the BC-SCP. In Phase II, we conducted four focus groups with 19 patients and 15 providers to examine its acceptability and usability challenges. Data analyses using the Atlas.ti program, informed refinement of the BC-SCP. In Phase III, we conducted feasibility testing of the refined BC-SCP with 18 providers from 12 health-centers. An encounter survey was completed after each assessment to examine the feasibility of the BC-SCP. Chi-square and Fisher Exact tests were used for comparative analyses.
Results
During phase I, we observed high patient and provider acceptability of the BC-SCP and substantial engagement in improving its content, design, and structure. In Phase II, providers completed 59 BC-SCPs. Mean time for BC-SCP completion was 12.3 min. Providers reported that BC-SCP content was clear, did not hamper clinic flow and was readily completed with easy-to-access information. Comparative analyses to examine differences in SCP completion time by patient clinico-demographic characteristics and provider type revealed no significant differences.
Conclusions
Our BC-SCP has clinical relevance, and can be used in an active practice setting. However, considerable progress will be necessary to achieve implementation of and sharing the BC-SCP with patients and care providers, particularly within the electronic medical record. In summary, BC-SCPs are essential to improve the follow up care of BC survivors. Clinical resources are required to ensure appropriate implementation of BC-SCPs.
Trial registration
Study HUM00056082.
Journal Article
Epidural anesthesia and cancer outcomes in bladder cancer patients: is it the technique or the medication? A matched-cohort analysis from a tertiary referral center
Background
The perioperative period can be a critical period with long-term implications on cancer-related outcomes. In this study, we evaluate the influence of regional anesthesia on cancer-specific outcomes in a radical cystectomy (RC) cohort of patients.
Methods
We performed a retrospective analysis of patients with clinically-nonmetastatic urothelial carcinoma of the bladder who underwent RC at our institution from 2008 to 2012. Patients were retrospectively registered and stratified based on two anesthetic techniques: perioperative epidural analgesia with general anesthesia (epidural) versus general anesthesia alone (GA). Epidural patients received a sufentanil-based regimen (median intraoperative sufentanil dose 50 mcg (45,85). Propensity-score was used to make 1:1 case-control matching. Cumulative risk of recurrence with competing risks was calculated based on anesthetic technique. Kaplan-Meier curves were used to compare recurrence-free (RFS) and cancer-specific survival (CSS). Univariable and multivariable analyses were performed with Cox proportional hazard regression models for RFS and CSS.
Results
Only patients with complete data on anesthetic technique were included. Out of 439 patients, 215-pair samples with complete follow-up were included in the analysis. Median follow-up was 41.4 months (range: 0.20–101). Patients with epidurals received higher median total intravenous morphine equivalents (ivMEQ) versus those in the GA group (75 (11–235) vs. 50 ivMEQ (7–277),
p
< 0.0001). Cumulative risk of recurrence at two years was 25.2% (19.6, 31.2) for epidural patients vs. 20.0% (15.0, 25.7) for GA patients (Gray test
p
= 0.0508). Epidural analgesic technique was a significant predictor of worse RFS (adjusted HR = 1.67, 1.14–2.45;
p
= 0.009) and CSS (HR = 1.53, 1.04–2.25;
p
= 0.030) on multivariable analyses.
Conclusions
Epidural anesthesia using sufentanil was associated with worse recurrence and disease-free survival in bladder cancer patients treated with surgery. This may be due use of epidural sufentanil or due to the increased total morphine equivalents patient received as a consequence of this drug.
Journal Article
Reimbursement Policy and Androgen-Deprivation Therapy for Prostate Cancer
In the 1990s, administration of GnRH agonists for prostate cancer was profitable for physicians, and the use of these drugs increased substantially. After Medicare reduced reimbursement in 2004, the use of GnRH agonists decreased.
Androgen-deprivation therapy (ADT), through orchiectomy or the use of gonadotropin-releasing hormone (GnRH) agonists, has been a mainstay for palliation in men with prostate cancer.
1
,
2
In the 1990s, Medicare policies made the subcutaneous or intramuscular administration of GnRH agonists profitable for physicians, with reimbursement based on 95% of the average wholesale price. Later, the Government Accountability Office reported that physicians acquired GnRH agonists at an average of 82% of the average wholesale price and sometimes at a much lower price, which allowed profits constituting up to 40% of urologists' revenues in private practice.
3
,
4
Remarkable changes in patterns of use . . .
Journal Article
Using oncolytic viruses to ignite the tumour immune microenvironment in bladder cancer
The advent of immune checkpoint inhibition (ICI) has transformed the treatment paradigm for bladder cancer. However, despite the success of ICI in other tumour types, the majority of ICI-treated patients with bladder cancer failed to respond. The lack of efficacy in some patients could be attributed to a paucity of pre-existing immune reactive cells within the tumour immune microenvironment, which limits the beneficial effects of ICI. In this setting, strategies to attract lymphocytes before implementation of ICI could be helpful. Oncolytic virotherapy is thought to induce the release of damage-associated molecular patterns, eliciting a pro-inflammatory cytokine cascade and stimulating the activation of the innate immune system. Concurrently, oncolytic virotherapy-induced oncolysis leads to further release of neoantigens and subsequent epitope spreading, culminating in a robust, tumour-specific adaptive immune response. Combination therapy using oncolytic virotherapy with ICI has proven successful in a number of preclinical studies and is beginning to enter clinical trials for the treatment of both non-muscle-invasive and muscle-invasive bladder cancer. In this context, understanding of the mechanisms underpinning oncolytic virotherapy and its potential synergism with ICI will enable clinicians to effectively deploy oncolytic virotherapy, either as monotherapy or as combination therapy in the different clinical stages of bladder cancer.Despite the success of immune checkpoint inhibition (ICI) in other tumour types, the majority of ICI-treated patients with bladder cancer fail to respond. This lack of efficacy might be attributable to a lack of pre-existing immune reactive cells within the tumour immune microenvironment, which limits the efficacy of ICI. In this Review, Li and colleagues discuss how oncolytic virus therapy acts as a strategy to attract lymphocytes before implementation of ICI and consider the data supporting the use of combination approaches using oncolytic virotherapy with ICI in bladder cancer.
Journal Article
Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: a phase 1b trial
There is a critical unmet need for safe and efficacious neoadjuvant treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer. Here we launched a phase 1b study using the combination of intravesical cretostimogene grenadenorepvec (oncolytic serotype 5 adenovirus encoding granulocyte–macrophage colony-stimulating factor) with systemic nivolumab in cisplatin-ineligible patients with cT2-4aN0-1M0 muscle-invasive bladder cancer. The primary objective was to measure safety, and the secondary objective was to assess the anti-tumor efficacy as measured by pathologic complete response along with 1-year recurrence-free survival. No dose-limiting toxicity was encountered in 21 patients enrolled and treated. Combination treatment achieved a pathologic complete response rate of 42.1% and a 1-year recurrence-free survival rate of 70.4%. Pathologic response was associated with baseline free E2F activity and tumor mutational burden but not PD-L1 status. Although T cell infiltration was broadly induced after intravesical oncolytic immunotherapy, the formation, enlargement and maturation of tertiary lymphoid structures was specifically associated with complete response, supporting the importance of coordinated humoral and cellular immune responses. Together, these results highlight the potential of this combination regimen to enhance therapeutic efficacy in cisplatin-ineligible patients with muscle-invasive bladder cancer, warranting additional study as a neoadjuvant therapeutic option. ClinicalTrials.gov identifier:
NCT04610671
.
In a phase 1b trial, treatment of patients with muscle-invasive bladder cancer with intravesical oncolytic virus cretostimogene grenadenorepvec in combination with nivolumab was safe and led to encouraging preliminary clinical response rates.
Journal Article
Updates on the use of intravesical therapies for non-muscle invasive bladder cancer: how, when and what
IntroductionIntravesical therapy has been an important aspect of the management of non-muscle invasive bladder cancer (NMIBC) for 40 years. Bacillus Calmette–Guerin (BCG) is considered standard of care for intermediate and high-grade non-invasive disease, yet understanding the nuances of subsequent intravesical therapy is important for any provider managing bladder cancer. Herein, we review the literature and describe optimal use of intravesical therapies for NMIBC.MethodsA comprehensive search of the medical literature was performed and highlighted in this review of intravesical therapy for NMIBC.ResultsPost-resection intravesical Mitomycin C therapy for low-risk disease remains an important component of care, and gemcitabine now has level-one evidence demonstrating efficacy in this setting but is not yet a guideline recommendation. BCG intravesical therapy remains the most effective therapy preventing recurrence and progression of intermediate and high-risk NMIBC. Adequately characterizing BCG-failure is critical in determining the next step in management which includes radical cystectomy, additional intravesical immunotherapy, chemotherapy with intravesical gemcitabine ± docetaxel and clinical trials.ConclusionsIntravesical therapy remains the mainstay of treatment for NMIBC and bladder preservation. Intravesical induction BCG followed by maintenance therapy remains standard of care for intermediate and high-risk patients. Detailing the timing and characteristics of recurrence after intravesical therapy is crucial in determining subsequent treatment recommendations. Current clinical trials focus on systemic immunotherapy and enhancing the intravesical immune response by augmenting the delivery mechanism.
Journal Article