Feasibility and delivery of patient-reported outcomes in clinical practice among racially diverse bladder and prostate cancer patients

ObjectiveTo assess the feasibility of enrollment and collecting patient-reported outcome (PRO) data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time.Subjects/Patients and MethodsWe recruited 76 patients (n = 29 Black and n = 47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy.Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at 3 time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time.ResultsSixty three percent of study participants completed all PRO measures at all 3 time points. Black patients were more likely to select IVR as their survey mode (40% vs. 13%, P < 0.05), and less likely to complete all surveys (55% vs. 74%, P = 0.13). Patients using IVR were also less likely to complete all surveys (41% vs. 69%, P = 0.046).ConclusionsReported preferences for survey mode and completion rates differ by race, which may influence survey completion rates and highlight potential obstacles for equitable implementation of PROs into clinical care.     

A national cross-sectional survey of financial toxicity among bladder cancer patients

ObjectiveFinancial toxicity (FT) has been defined as the patient-level impact of the costs of cancer care. Our objective was to better characterize FT among bladder cancer patients as well as oncologic, demographic and insurance characteristics related to FT.MethodsWe conducted a cross-sectional survey of the Bladder Cancer Advocacy Network Patient Survey Network using the validated COST (COmprehensive Score for financial Toxicity) questionnaire. Our primary outcome was relative degree of FT, with lower COST scores corresponding to worse FT. Wilcoxon rank sum tests and multiple regression were used to evaluate differences in demographic, diagnostic and treatment characteristics as they related to degree of FT.ResultsAmong 226 patients, median age was 68 years with 64% male, 83% married, and 49% with Medicare with supplemental insurance. Respondents reported an average of 65 months since diagnosis, with 62% reporting noninvasive disease. Mean COST was 28.4 (range 0–44). On multivariable analysis, patients who were younger, with a household annual income less than $50,000, not retired, or with insurance that was neither Medicare nor employer paid were significantly more likely to have worse FT. A majority of respondents (63.5%) agreed or strongly agreed that they would be interested in discussing cost in the context of their treatment preferences, independent of COST score (P = 0.24).ConclusionsA national cross-sectional survey demonstrated high prevalence of FT which was worse among younger patients with lower incomes, not retired, and without employer-paid or Medicare insurance. Most patients preferred to discuss treatment costs with their bladder cancer provider.     

Pretransplant solid organ malignancy and organ transplant candidacy: A consensus expert opinion statement

Patients undergoing evaluation for solid organ transplantation (SOT) often have a history of malignancy. Although the cancer has been treated in these patients, the benefits of transplantation need to be balanced against the risk of tumor recurrence, especially in the setting of immunosuppression. Prior guidelines of when to transplant patients with a prior treated malignancy do not take in to account current staging, disease biology, or advances in cancer treatments. To develop contemporary recommendations, the American Society of Transplantation held a consensus workshop to perform a comprehensive review of current literature regarding cancer therapies, cancer stage-specific prognosis, the kinetics of cancer recurrence, and the limited data on the effects of immunosuppression on cancer-specific outcomes. This document contains prognosis based on contemporary treatment and transplant recommendations for breast, colorectal, anal, urological, gynecological, and nonsmall cell lung cancers. This conference and consensus documents aim to provide recommendations to assist in the evaluation of patients for SOT given a history of a pretransplant malignancy.     

New onset vesicovaginal fistula after transurethral collagen injection in women who underwent cystectomy and orthotopic neobladder creation: presentation and definitive treatment

PURPOSE: We present our experience with collagen injection for treating urinary incontinence after cystectomy and orthotopic bladder substitution in women. We discuss the efficacy of collagen injection, specific complications and subsequent definitive therapy. MATERIALS AND METHODS: We performed cystectomy and orthotopic bladder substitution in 2 women for muscle invasive transitional cell carcinoma of the bladder. In each case new onset stress urinary incontinence developed after surgery that was refractory to conservative therapy. Intrinsic sphincter deficiency was diagnosed in each patient by video urodynamic studies. Initial treatment involved transurethral collagen injections but subsequent intervention was required due to resultant complications and primary therapy inefficacy. RESULTS: Collagen (3.5 cc per session) was injected in 1 case at 2 treatment sessions and in the other at 3. Incontinence symptoms did not significantly improve in either patient and a new onset vesicovaginal fistula developed 2 days and 1 month after collagen injection, respectively. Subsequently in each case 1-stage transvaginal primary fistula repair was done in multiple layers with a pubovaginal sling procedure. Six months after repair there has been no recurrent fistula and the women remain hypercontinent, requiring intermittent self-catheterization. They are satisfied with their eventual lower tract function and overall outcome. CONCLUSIONS: Collagen injection for type 3 stress urinary incontinence after cystectomy and orthotopic bladder replacement in women may not be as effective and innocuous as in patients with a native bladder. Initial treatment with a pubovaginal sling procedure should be considered.     

Tuberculosis of clavicle in children: a report of 3 cases with review of literature

Tubercular osteomyelitis is an important differential diagnosis of non-traumatic lesions of clavicle in children, particularly in developing countries. Diagnosis at this site is difficult due to poor visualization caused by overlapping anatomical structures. We report 3 cases of tubercular osteomyelitis of clavicle in children. All the cases were proven histologically before start of antitubercular treatment. One case required surgical debridement, and other 2 cases were treated with medical management only. Suspicion and obtaining tissues from multiple sites for examination is the key to diagnosis of this rare pathology. Multidrug antitubercular drugs with or without debridement is curative.     

Hemostatic gene polymorphisms and the prevalence of thrombotic complications in polycythemia vera and essential thrombocythemia.

Patients with polycythemia vera and essential thrombocythemia are at risk for thrombotic and bleeding complications. Currently, no diagnostic test can predict thrombohemorrhagic complications. In a prospective study of 86 patients with polycythemia vera (43 patients) or essential thrombocythemia (43 patients), we examined the possible role of polymorphisms of platelet adhesion receptors [glycoprotein (GP) Ibalpha, GPIa, GPIIIa) and clotting factor II (prothrombin's G20210A mutation) and clotting factor V (Leiden mutation) in determining the risk of thrombotic or bleeding complications. Except for an association between vasomotor symptoms and prothrombin mutation (P < 0.001), no significant correlation between polymorphism of clotting factors and thrombohemorrhagic complications was identified. When the entire patient cohort was considered, the polymorphisms of platelet adhesion receptors were not associated with the risk for thrombotic or bleeding complications. However, among patients with polycythemia vera, the presence of the PlA2 allele of GPIIIa was associated with an increased risk of arterial thrombosis. In view of previous studies linking the presence of the PlA2 allele of GPIIIa to a higher risk for coronary artery thrombosis, our data have physiologic relevance. However, they need to be confirmed in a larger study.     

ICUD-EAU International Consultation on Bladder Cancer 2012: Non–Muscle-Invasive Urothelial Carcinoma of the Bladder

Context

Our aim was to present a summary of the Second International Consultation on Bladder Cancer recommendations on the diagnosis and treatment options for non–muscle-invasive urothelial cancer of the bladder (NMIBC) using an evidence-based approach.

Objective

To critically review the recent data on the management of NMIBC to arrive at a general consensus.

Evidence acquisition

A detailed Medline analysis was performed for original articles addressing the treatment of NMIBC with regard to diagnosis, surgery, intravesical chemotherapy, and follow-up. Proceedings from the last 5 yr of major conferences were also searched.

Evidence synthesis

The major findings are presented in an evidence-based fashion. We analyzed large retrospective and prospective studies.

Conclusions

Urothelial cancer of the bladder staged Ta, T1, and carcinoma in situ (CIS), also indicated as NMIBC, poses greatly varying but uniformly demanding challenges to urologic care. On the one hand, the high recurrence rate and low progression rate with Ta low-grade demand risk-adapted treatment and surveillance to provide thorough care while minimizing treatment-related burden. On the other hand, the propensity of Ta high-grade, T1, and CIS to progress demands intense care and timely consideration of radical cystectomy.     

A phase II study of lapatinib,a dual EGFR and HER-2 tyrosine kinase inhibitor,in patients with castration-resistant prostate cancer

ObjectivesEpidermal growth factor receptor (EGFR) and HER-2 tyrosine kinases may be involved in activation of androgen receptor and progression of prostate cancer. They represent potential therapeutic targets in prostate cancer. Lapatinib is an oral inhibitor of EGFR and HER-2. The objective of this study is to assess the preliminary clinical efficacy of lapatinib in the therapy of castration-resistant prostate cancer.MethodsIn this multicenter, open-label trial, patients with rising PSA on androgen deprivation therapy and not having received chemotherapy were eligible. They were treated with lapatinib at a dose of 1,500 mg once daily. The primary end point was a >50% confirmed PSA decline from baseline; safety, tolerability, and time to PSA progression were secondary outcomes.ResultsTwenty-nine patients enrolled in the study had a median age of 73 years and a baseline PSA of 21.6 ng/ml. Seven patients had no radiologic evidence of metastatic disease, while the remaining patients had bone or measurable disease or both. Treatment was well tolerated with only grade 3 treatment-related toxicities being diarrhea (14%) and rash (3%). One of 21 evaluable patients had >50% reduction in PSA, while another patient had 47% reduction in PSA with an ongoing duration of response of 45+ months. The median time to PSA progression was 29 days.ConclusionsLapatinib showed single agent activity in a small subset of unselected patients with castration-resistant prostate cancer, as measured by PSA. Future trials should explore a trial design with time-to-event end points and predictive biomarkers and a combination with other agents.