Kidney Transplantation in ≤15 kg Children: Outcomes and Prognostic Indicators-A Review of the Organ Procurement and Transplantation Database.

BACKGROUND: Approximately 2500 pediatric patients are awaiting kidney transplantation in the United States, with <5% comprising those ≤15 kg. Transplant in this cohort is often delayed by center-based growth parameters, often necessitating transplantation after the initiation of dialysis. Furthermore, prognostication remains somewhat ambiguous. In this report, we scrutinize the Organ Procurement and Transplantation Network (OPTN) data from 2001 to 2021 to help better understand specific variables impacting graft and patient outcomes in these children. METHODS: The OPTN kidney transplant dataset from 2001 to 2021 was analyzed. Inclusion criteria included age <18 years, weight ≤15 kg, and recipient of primary living donor kidney transplantation (LDKT) or deceased donor kidney transplantation (DDKT). Patient and graft survival probabilities were calculated using the Kaplan-Meier method. The Cox proportional hazards model was used to calculate hazard ratio (HR) and identify variables significantly associated with patient and graft survival. RESULTS: Two thousand one hundred sixty-eight pediatric transplant recipients met inclusion criteria. Patient survival at 1 and 3 years was 98% and 97%, respectively. Graft survival at 1 and 3 years was 95% and 92%, respectively. Dialysis was the sole significant variable impacting both patient and graft survival. Graft survival was further impacted by transplant era, recipient gender and ethnicity, and donor type. Infants transplanted at Age 1 had better graft survival compared with older children, and nephrotic syndrome was likewise associated with a better prognosis. CONCLUSION: Pediatric kidney transplantation is highly successful. The balance between preemptive transplantation, medical optimization, and satisfactory technical parameters seems to suggest a "Goldilocks zone" for many children, favoring transplantation between 1 and 2 years of age.

Controversy Over Liver Transplantation or Resection for Neuroendocrine Liver Metastasis: Tumor Biology Cuts the Deal.

BACKGROUND: In patients with neuroendocrine liver metastasis (NELM), liver transplantation (LT) is an alternative to liver resection (LR), although the choice of therapy remains controversial. In this multicenter study, we aim to provide novel insight in this dispute. METHODS: Following a systematic literature search, 15 large international centers were contacted to provide comprehensive data on their patients after LR or LT for NELM. Survival analyses were performed with the Kaplan-Meier method, while multivariable Cox regression served to identify factors influencing survival after either transplantation or resection. Inverse probability weighting and propensity score matching was used for analyses with balanced and equalized baseline characteristics. RESULTS: Overall, 455 patients were analyzed, including 230 after LR and 225 after LT, with a median follow-up of 97 months [95% confidence interval (CI): 85-110 months]. Multivariable analysis revealed G3 grading as a negative prognostic factor for LR [hazard ratio (HR)=2.22, 95% CI: 1.04-4.77, P =0.040], while G2 grading (HR=2.52, 95% CI: 1.15-5.52, P =0.021) and LT outside Milan criteria (HR=2.40, 95% CI: 1.16-4.92, P =0.018) were negative prognostic factors in transplanted patients. Inverse probability-weighted multivariate analyses revealed a distinct survival benefit after LT. Matched patients presented a median overall survival (OS) of 197 months (95% CI: 143-not reached) and a 73% 5-year OS after LT, and 119 months (95% CI: 74-133 months) and a 52.8% 5-year OS after LR (HR=0.59, 95% CI: 0.3-0.9, P =0.022). However, the survival benefit after LT was lost if patients were transplanted outside Milan criteria. CONCLUSIONS: This multicentric study in patients with NELM demonstrates a survival benefit of LT over LR. This benefit depends on adherence to selection criteria, in particular low-grade tumor biology and Milan criteria, and must be balanced against potential risks of LT.

Liver Transplantation in Patients with Sickle Cell Disease in the United States.

BACKGROUND: Up to 30% of patients with sickle cell disease (SCD) develop chronic liver disease via etiologies including sickle cell hepatopathy, acquired viral hepatitis, or secondary hemochromatosis. It is unclear how many patients with SCD ultimately undergo liver transplantation (LT) and what factors are associated with survival after LT. In this study, we examined LT outcomes in these patients by reviewing the Scientific Registry of Transplant Recipients (SRTR) and our institutional experience. METHODS: Analysis of the SRTR identified 23 LT recipients and five simultaneous liver and kidney transplantation (SLKT) recipients with SCD. Patient demographics and graft and patient survival were analyzed. Two patients with SCD at our institution underwent SLKT. RESULTS: Review of the SRTR revealed that recipients with SCD had significantly higher model for end-stage liver disease scores (33 versus 21, P = 0.004), preoperative intensive care unit admission (43.5% versus 19.1%, P = 0.007), preoperative dialysis (17.4% versus 4.9%, P = 0.009), and were more likely to be status 1 (26.1% versus 12.1%, P = 0.041) when compared with the reference population of African American LT recipients. Despite being higher risk at the time of LT, patients with SCD had equivalent posttransplant graft and patient survival when compared with the reference population (P = 0.5 and P = 0.2, respectively) and a 2:1 propensity score-matched group (P = 0.5 and P = 0.2, respectively). Two recent SLKT recipients with SCD from our institution have performed well with stable allograft function. CONCLUSIONS: Data from the SRTR demonstrate that patients with SCD can expect equivalent graft and patient survival after LT despite exhibiting more comorbidities at the time of LT. The low number of patients with SCD who underwent LT in the SRTR in comparison with the rate of chronic liver disease in this population raises the question as to whether a disparity in access to LT exists for this complex population.

Global experience and perspective on anonymous nondirected live donation in living donor liver transplantation.

Anonymous nondirected living liver donation (ANLLD), sometimes referred to as "altruistic" donation, occurs when a biologically unrelated person comes forward to donate a portion of his/her liver to a transplant candidate who is unknown to the donor. Here, we explore the current status of ANLLD with special consideration of published reports; US experience; impact on donor psychosocial outcomes; barriers to donation; and current global trends with respect to ethical considerations. Between 1998 and 2019, 105 anonymous nondirected living liver donor (ND-LLD) transplants have been documented in the US Scientific Registry of Transplant Recipients. Sixteen donors (15%) were reported to experience a postoperative complication. Currently, 89 donors remain alive (85%), 16 (15%) have unknown status, and none are confirmed deceased. Although there are only a handful of case series, these data suggest that ANLLD is a feasible option. While there are no liver-specific data, studies involving anonymous nondirected kidney donors suggest that anonymous donation does not adversely impact psychosocial outcomes in donors or recipients. There are substantial financial burdens and ethical considerations related to ANLLD. Further studies are required to assess donor demographics, psychosocial motivations, long-term health-related quality of life, and financial impact of ANLLD.

Nine-year prostate cancer survival differences between aggressive versus conservative therapy in men with advanced and metastatic prostate cancer.

BACKGROUND: To the authors' knowledge, the survival benefit of local therapy in the setting of advanced prostate cancer remains unknown. The authors investigated whether prostate-directed treatment with either surgery or radiotherapy versus conservative treatment in the setting of locally advanced or metastatic disease was associated with improved survival within a cohort of men from the Centers for Disease Control and Prevention's (CDC) Breast and Prostate Cancer Data Quality and Patterns of Care Study (CDC POC-BP). METHODS: Men diagnosed with locally advanced (cT3-T4 or N+ and M0) or metastatic prostate cancer were identified. The authors compared survival by treatment type, categorized as conservative (androgen deprivation therapy only) versus aggressive (radical prostatectomy or any type of radiotherapy). Nine-year overall survival and prostate cancer-specific survival were estimated using the Kaplan-Meier method. The Cox proportional hazards model was used to determine factors independently associated with 9-year prostate cancer-specific survival. RESULTS: For men with advanced, nonmetastatic prostate cancer, conservative treatment alone was associated with a 4 times higher likelihood of prostate cancer mortality compared with men treated with surgery (hazard ratio, 4.18; 95% confidence interval, 1.44-12.14). In contrast, no difference was found between conservative versus aggressive treatment after adjusting for covariates for men with metastatic disease. The 9-year prostate cancer-specific survival rate was 27% for those receiving aggressive treatment versus 24% for men undergoing conservative treatment. CONCLUSIONS: The authors did not observe a survival advantage with local therapy in addition to standard androgen deprivation therapy for men with metastatic prostate cancer. However, the results of the current study did affirm advantages in the setting of locally advanced disease. Aggressive local therapy in the setting of metastatic disease needs to be studied carefully before clinical adoption. Cancer 2018;124:1921-8. © 2018 American Cancer Society.

Attitudes and barriers to the use of donation after cardiac death livers: Comparison of a United States transplant center survey to the united network for organ sharing data.

Transplantation of liver grafts from donation after cardiac death (DCD) is limited. To identify barriers of DCD liver utilization, all active US liver transplant centers (n = 138) were surveyed, and the responses were compared with the United Network for Organ Sharing (UNOS) data. In total, 74 (54%) centers responded, and diversity in attitudes was observed, with many not using organ and/or recipient prognostic variables defined in prior studies and UNOS data analysis. Most centers (74%) believed lack of a system allowing a timely retransplant is a barrier to utilization. UNOS data demonstrated worse 1- and 5-year patient survival (PS) and graft survival (GS) in DCD (PS, 86% and 64%; GS, 82% and 59%, respectively) versus donation after brain death (DBD) recipients (PS, 90% and 71%; GS, 88% and 69%, respectively). Donor alanine aminotransferase (ALT), recipient Model for End-Stage Liver Disease (MELD), and cold ischemia time (CIT) significantly impacted DCD outcomes to a greater extent than DBD outcomes. At 3 years, relisting and retransplant rates were 7.9% and 4.6% higher in DCD recipients. To optimize outcome, our data support the use of DCD liver grafts with CIT <6-8 hours in patients with MELD ≤ 20. In conclusion, standardization of donor and recipient criteria, defining the impact of ischemic cholangiopathy, addressing donor hospital policies, and developing a strategy for timely retransplant may help to expand the use of these organs. Liver Transplantation 23 1372-1383 2017 AASLD.

Liver transplantation for metastatic neuroendocrine tumors: Outcomes and prognostic variables.

BACKGROUND: Patient selection for liver transplantation for metastatic neuroendocrine tumors remains a topic of debate. There is no established MELD exception, making it difficult to obtain donor organs. METHODS: A multicenter database was created assessing outcomes for liver and multivisceral transplantation for metastatic neuroendocrine tumors and identifying prognostic factors for survival. Demographic, transplant, primary tumor site and management, pathology, recurrent disease and survival data were collected and analyzed. Survival probabilities were calculated using the Kaplan-Meier method. RESULTS: Analysis included 85 patients who underwent liver transplantation November 1988-January 2012 at 28 centers. One, three, and five-year patient survival rates were 83%, 60%, and 52%, respectively; 40 of 85 patients died, with 20 of 40 deaths due to recurrent disease. In univariate analyses, the following were predictors of poor prognosis: large vessel invasion (P < 0.001), extent of extrahepatic resection at liver transplant (P = 0.007), and tumor differentiation (P = 0.003). In multivariable analysis, predictors of poor overall survival included large vessel invasion (P = 0.001), and extent of extrahepatic resection at liver transplant (P = 0.015). CONCLUSION: In the absence of poor prognostic factors, metastatic neuroendocrine tumor is an acceptable indication for liver transplantation. Identification of favorable prognostic factors should allow assignment of a MELD exception similar to hepatocellular carcinoma.

1,3-diarylpyrazolones as potential anticancer agents for non-small cell lung cancer: Synthesis and antiproliferative activity evaluation.

A series of pyrazolone compounds with different substitution patterns have been synthesized using microwave-assisted methods and evaluated their in vitro antiproliferative activity against human lung adenocarcinoma cell lines (A549 and NCI-H522). Among the tested compounds, the pyrazolone P7 exhibited high antiproliferative activity against both A549 and NCIH522 cancer cell lines while being 10 times less cytotoxic to non-cancerous cells. Moreover, our compounds P7 and P11 exhibited higher antiproliferative activity and selectivity against A549 and NCIH522 cells compared with the clinically approved drugs Afatinib and Gefitinib. The cell cycle analysis showed that the compound P7 and P11 arrests the cell cycle at G0/G1 phase, whereas the compounds P13 and P14 involved in G2/M phase arrest. The results from antiproliferative activity screening, cell cycle analysis, and kinase profiling indicate that the suitably substituted 1,3-diarylpyrazolones exhibit high antiproliferative activity against non-small cell lung cancer cells.

Localized prostate cancer: An analysis of the Centers for Disease Control and Prevention Breast and Prostate Cancer Data Quality and Patterns of Care study (CDC PoC-BP).

INTRODUCTION: Limited evidence exists on the comparative effectiveness of local treatments for prostate cancer (PCa) due to the lack of generalizability. Using granular national data, we sought to examine the association between radical prostatectomy (RP) and intensity-modulated radiation therapy (IMRT) treatment and survival. METHODS: Records were abstracted for localized PCa cases diagnosed in 2004 across seven state registries to identify patients undergoing RP (n=3019) or IMRT (n=667). Comorbidity was assessed by the Adult Comorbidity Evaluation-27 (ACE-27). Propensity score matching (PSM) was used to balance covariates between treatment groups. All-cause and PCa-specific mortality were primary endpoints. A subgroup analysis of patients with high-risk PCa (RP, n=89; IMRT, n=95) was conducted. RESULTS: Following PSM, matched patients (n=502 pairs) treated with either RP or IMRT were well-balanced with respect to covariates. With a median followup of 10.5 years (interquartile range [IQR] 9.9-11.0), the 11-year overall survival (OS) was 71.2% (95% confidence interval [CI] 66.9-75.8) for RP and 62.3% (95% CI 57.4-67.6) for IMRT. IMRT was associated with a 41% increased risk of all-cause mortality (hazard ratio [HR] 1.41, 95% CI 1.13-1.76) but not PCa-specific mortality (HR 1.75, 95% CI 0.84-3.64), as compared to RP. In patients with high-risk PCa, IMRT, as compared to RP, was not associated with a statistically significant difference in all-cause (HR 1.53, 95% CI 0.97-2.42) or PCa-specific mortality (HR 1.92, 95% CI 0.69-5.36). CONCLUSIONS: Despite a low mortality rate at 10 years and possible residual confounding, we found a significantly increased risk of all-cause mortality but no PCa-specific mortality associated with IMRT as compared to RP in this population-based study.

Impact of Morbid Obesity on Liver Transplant Candidacy and Outcomes: National and Regional Trends.

BACKGROUND: Body mass index (BMI) limits for liver transplant (LT) candidacy are controversial. In this study, we evaluate waitlist and post-LT outcomes, and prognostic factors and examine regional patterns of LT waitlist registration in patients with BMI ≥40 versus BMI 18-39. METHODS: United Network for Organ Sharing (UNOS) data were analyzed to assess waitlist dropout, post-LT survival, and prognostic factors for patient survival. The distribution of waitlisted patients with BMI ≥40 was compared with the Centers for Disease Control Behavioral Risk Factors Surveillance System data to explore the rates of morbid obesity in the general population of each UNOS region. RESULTS: Post-LT outcomes demonstrate a small but significantly lower 1- and 3-y overall survival for patients with BMI ≥45. Risk factors for post-LT mortality for patients with BMI ≥40 included age >60 y, prior surgery, and diabetes on multivariable analysis. Model for End-Stage Liver Disease >30 was significant on univariable analysis only, likely due to the limited number of patients with BMI ≥40; however, median Model for End-Stage Liver Disease scores in this BMI group were higher than those in patients with lower BMI across all UNOS regions. Patients with BMI ≥40 had a higher waitlist dropout in 4 regions. Comparison with BRFSS data illustrated that the proportion of waitlisted patients with BMI ≥40 was significantly lower than the observed rates of morbid obesity in the general population in 3 regions. CONCLUSIONS: While BMI ≥45 is associated with modestly lower patient survival, careful selection may equalize these numbers.

Big Data in Transplantation Practice-the Devil Is in the Detail-Fontan-associated Liver Disease.

BACKGROUND: As a result of the Fontan procedure, the prognosis of congenital single-ventricle heart disease has improved, with many affected children surviving into adulthood. However, the unanticipated consequences of chronic exposure to Fontan hemodynamics have revealed a new set of secondary noncardiac complications. Fontan-associated liver disease (FALD) is characterized by progressive hepatic fibrosis in nearly all patients post-Fontan, with the potential to develop cirrhosis, hepatocellular carcinoma, and the need for liver transplantation. A lack of data regarding FALD-related prognosis makes consideration of indications for and timing of heart alone versus combined heart-liver transplantation challenging. METHODS: A multidisciplinary group within the American Society for Transplantation analyzed several administrative datasets to study the epidemiology of FALD. RESULTS: This approach presented several obstacles, and efforts to characterize FALD were limited by a lack of Fontan- and FALD-specific diagnostic codes and an inability to follow individual patients through multiple health systems. Several ongoing Fontan registries were also reviewed but these do not adequately capture FALD-related variables. Such barriers highlight the need for large-scale data collection in patients post-Fontan to better understand and care for this complex population. CONCLUSIONS: This study emphasizes the challenges of studying emerging transplant-related diagnoses in existing datasets and the need for mechanisms to adapt registries to appropriately identify patients with rare or emerging conditions.

More Than Just Wait Time? Regional Differences in Liver Transplant Outcomes for Hepatocellular Carcinoma.

BACKGROUND: Regional allocation of deceased donor livers has led to variable wait times for hepatocellular carcinoma (HCC) patients on the liver transplant list. The purpose of our study was to evaluate how regional differences in wait time affect outcomes for HCC patients. METHODS: A retrospective, observational study was performed using the Organ Procurement and Transplantation Network database from February 27, 2002, to September 25, 2015. The cumulative incidences of transplant and waitlist death as well as intention-to-treat and posttransplant survival were evaluated for patients 18 years or older listed for deceased donor liver transplantation with stage II HCC exception points in each United Network for Organ Sharing region. A multivariable analysis of predictive factors for posttransplant survival was performed. RESULTS: Cumulative incidence of transplant decreased and cumulative incidence of waitlist death increased as regional wait time increased. Intention-to-treat survival decreased with increased regional wait time with long wait time regions 1, 5, and 9 having significantly lower intention-to-treat survival compared with many of the shorter wait time regions (P < 0.05). Wait time did not predict posttransplant survival. Significant predictive factors of posttransplant survival included alpha-fetoprotein, size of the largest tumor, number of tumors, age of the recipient, laboratory model for end-stage liver disease, donor risk index, period of transplantation, and region (P < 0.05). CONCLUSIONS: Wait time inequality affects waitlist mortality and intention-to-treat survival but does not affect posttransplant survival. Posttransplant survival is predicted by tumor biology, graft quality, recipient age, underlying liver function, and region. Regional environments of HCC care seem to drive posttransplant survival.

Outcomes of Liver Transplantation in Patients on Renal Replacement Therapy: Considerations for Simultaneous Liver Kidney Transplantation Versus Safety Net.

As the liver transplant (LT) waiting list continues to outpace organ availability, many patients require renal replacement therapy (RRT) before LT. It is unclear which patients will benefit from simultaneous liver kidney (SLK) transplant as opposed to awaiting a Safety Net kidney transplant (KT) post-LT. METHODS: In this study, a retrospective analysis of the United Network for Organ Sharing dataset was performed to identify risk factors associated with poor outcome for patients on RRT before LT who were listed for SLK and received either SLK vs LT alone (LTA). RESULTS: Between January 2003 and December 2016, 8971 adult LT recipients were on RRT at the time of LT. 5359 were listed for and received LTA (Group 1). Of 3612 patients listed for SLK, 3414 (38.1%) received SLK (Group 2) and 198 (2.2%) received LTA (Group 3). Overall, Group 3 had lower graft and patient survival post-LT when compared with Groups 1 and 2 (P < 0.001). Serum creatinine at 1 year post-LT and cumulative incidence for KT at 3 years post-LT were higher for Group 3 (P < 0.001). On multivariate analysis, pre-LT diabetes (P = 0.002), Model of End-Stage Liver Disease score (P = 0.01), and donor kidney donor profile index (P = 0.025) were significant in Group 2. Recipient age >60 (P < 0.001) and RRT pre-LT (>90 days; P = 0.001) were associated with lower patient survival in Group 3. CONCLUSIONS: Among LT recipients on RRT before LT who were listed for SLK, RRT >90 days, and age >60 were associated with poor outcome following LTA. This suggests that programs should carefully weigh the decision to proceed with LTA vs waiting for SLK in this patient population. Future access to Safety Net KT will be an important consideration for these patients moving forward.

Variability in intensive care unit length of stay after liver transplant: Determinants and potential opportunities for improvement.

PURPOSE: Recovery after liver transplant (LT) requires extensive resources, including prolonged intensive care unit stays. The objective of this study was to use an assessment tool to determine if LT recipients remain in ICU beyond designated indications. METHODS: Records from 100 consecutive LTs performed in a single institution were retrospectively reviewed. An admission, discharge, and triage screening (ADT) tool was utilized to assess the indications for each ICU day. Data collected included demographics; pre-, intra-, and post-operative course; and complications. Days not meeting ADT criteria were considered additional ICU days. RESULTS: 100 patients: mean age 55 years (range 24-78 years) and mean MELD score 30 (range 6-47). Three recipients who died within one week were excluded. Forty-eight (49.5%) patients had a total of 75 additional days on initial ICU stay. Univariate analysis revealed no significant differences between patients with and without additional days. 12/97 (12.4%) patients returned to ICU including 5/48 and 7/49 with and without additional days. CONCLUSION: Nearly half of the LT recipients remained in ICU an average of 1.6 additional days. Monitoring of organ function appeared to be the most common reason. Opportunities to improve resource utilization could include transfer to an intermediate/progressive care ("step-down") unit.

Predictors of intravesical therapy for nonmuscle invasive bladder cancer: results from the surveillance, epidemiology and end results program 2003 patterns of care project.

PURPOSE: In response to variations in cancer care organizations have developed clinical guidelines. In the case of nonmuscle invasive bladder cancer, also known as superficial bladder cancer, 2 similar sets of guidelines were released in the late 1990s that provide care recommendations. We examined patterns of intravesical therapy use in nonmuscle invasive bladder cancer in 2003 to determine whether disparities remained in the quality of cancer care. MATERIALS AND METHODS: Data from the SEER (Surveillance, Epidemiology and End Results) Program 2003 Bladder Cancer Patterns of Care project were used. Subjects newly diagnosed with nonmuscle invasive bladder cancer in 2003 were included. Clinical and sociodemographic data were obtained from the SEER Program and a detailed medical record review. Statistical analysis was performed to identify independent predictors of intravesical therapy in the entire cohort and in a subset of patients at high risk. RESULTS: A total of 685 patients were included in the study, of whom 216 (31.5%) received intravesical therapy. In addition to higher tumor stage and grade, intravesical therapy was independently associated with race/ethnicity and geographic region. Of the subset of 350 patients at high risk 42% received intravesical therapy. Stage, grade, race/ethnicity and geographic region were independently associated with intravesical therapy in this subcohort. CONCLUSIONS: These data suggest the underuse of intravesical therapy even in patients with high risk nonmuscle invasive bladder cancer as well as disparities in the quality of care. Barriers to using this cancer treatment must be identified, particularly in individuals at higher risk, and providers must become more aware of existing clinical guidelines.

The Role of Provider Characteristics in the Selection of Surgery or Radiation for Localized Prostate Cancer and Association With Quality of Care Indicators.

INTRODUCTION: We sought to identify the role of provider and facility characteristics in receipt of radical prostatectomy (RP) or external beam radiation therapy (EBRT) and adherence to quality of care measures in men with localized prostate cancer (PCa). MATERIALS AND METHODS: Subjects included 2861 and 1630 men treated with RP or EBRT, respectively, for localized PCa whose records were reabstracted as part of the Centers for Disease Control and Prevention Breast and Prostate Patterns of Care Study. We utilized multivariable generalized estimating equation regression analysis to assess patient, clinical, and provider (year of graduation, urologist density) and facility (group vs. solo, academic/teaching status, for-profit status, distance to treatment facility) characteristics that predicted use of RP versus EBRT as well as quality of care outcomes. RESULTS: Multivariable analysis revealed that group (vs. solo) practice was associated with a decreased risk of RP (odds ratio, 0.47; 95% confidence interval, 0.25-0.91). Among RP patients with low-risk disease, receipt of a bone scan that was not recommended was significantly predicted by race and insurance status. Surgical quality of care measures were associated with physician's year of graduation and receiving care at a teaching facility. CONCLUSIONS: In addition to demographic factors, we found that provider and facility characteristics were associated with treatment choice and specific quality of care measures. Long-term follow-up is required to determine whether quality of care indicators are related to PCa outcomes.

Treatment Decision Regret Among Long-Term Survivors of Localized Prostate Cancer: Results From the Prostate Cancer Outcomes Study.

Purpose To determine the demographic, clinical, decision-making, and quality-of-life factors that are associated with treatment decision regret among long-term survivors of localized prostate cancer. Patients and Methods We evaluated men who were age ≤ 75 years when diagnosed with localized prostate cancer between October 1994 and October 1995 in one of six SEER tumor registries and who completed a 15-year follow-up survey. The survey obtained demographic, socioeconomic, and clinical data and measured treatment decision regret, informed decision making, general- and disease-specific quality of life, health worry, prostate-specific antigen (PSA) concern, and outlook on life. We used multivariable logistic regression analyses to identify factors associated with regret. Results We surveyed 934 participants, 69.3% of known survivors. Among the cohort, 59.1% had low-risk tumor characteristics (PSA < 10 ng/mL and Gleason score < 7), and 89.2% underwent active treatment. Overall, 14.6% expressed treatment decision regret: 8.2% of those whose disease was managed conservatively, 15.0% of those who received surgery, and 16.6% of those who underwent radiotherapy. Factors associated with regret on multivariable analysis included reporting moderate or big sexual function bother (reported by 39.0%; OR, 2.77; 95% CI, 1.51 to 5.0), moderate or big bowel function bother (reported by 7.7%; OR, 2.32; 95% CI, 1.04 to 5.15), and PSA concern (mean score 52.8; OR, 1.01 per point change; 95% CI, 1.00 to 1.02). Increasing age at diagnosis and report of having made an informed treatment decision were inversely associated with regret. Conclusion Regret was a relatively infrequently reported outcome among long-term survivors of localized prostate cancer; however, our results suggest that better informing men about treatment options, in particular, conservative treatment, might help mitigate long-term regret. These findings are timely for men with low-risk cancers who are being encouraged to consider active surveillance.

Clinical and Demographic Factors Associated With Receipt of Non Guideline-concordant Initial Therapy for Nonmetastatic Prostate Cancer.

OBJECTIVES: To determine the extent to which initial therapy for nonmetastatic prostate cancer was concordant with nationally recognized guidelines using supplemented cancer registry data and what factors were associated with receipt of nonguideline-concordant care. METHODS: Initial therapy for 8229 nonmetastatic prostate cancer cases diagnosed in 2004 from cancer registries in 7 states was abstracted as part of the Centers for Disease Control's Patterns of Care Breast and Prostate Cancer study conducted during 2007 to 2009. The National Comprehensive Cancer Network clinical practice guidelines version 1.2002 was used as the standard of care based on recurrence risk group and life expectancy (LE). A multivariable model was used to determine risk factors associated with receipt of nonguideline-concordant care. RESULTS: Nearly 80% with nonmetastatic prostate cancer received guideline-concordant care for initial therapy. Receipt of nonguideline-concordant care (including receiving either less aggressive therapy or more aggressive therapy than indicated) was related to older age, African American race/ethnicity, being unmarried, rural residence, and especially to being in the high recurrence risk group where receiving less aggressive therapy than indicated occurred more often than receiving more aggressive therapy (adjusted OR=4.2; 95% CL, 3.5-5.2 vs. low-risk group). Compared with life table estimates adjusted for comorbidity, physicians tended to underestimate LE. CONCLUSIONS: Receipt of less aggressive therapy than indicated among high-risk group men with >5-year LE based on life table estimates adjusted for comorbidity was a concern. Physicians may tend to underestimate 5-year survival among this group and should be alerted to the importance of recommending aggressive therapy when warranted. However, based on more recent guidelines, among those with low-risk disease, the proportion considered to be receiving less aggressive therapy than indicated may now be lower because active surveillance is now considered appropriate.

Type and dose of radiotherapy used for initial treatment of non-metastatic prostate cancer.

BACKGROUND: We sought to describe patterns of initial radiotherapy among non-metastatic prostate cancer (PC) patients by recurrence risk groups. METHODS: Medical records were abstracted for a sample of 9017 PC cases diagnosed in 2004 as a part of the Center for Disease Control and Prevention's Prostate and Breast Patterns of Care Study in seven states. Non-metastatic PC cases are categorized as low-risk (LR), intermediate-risk (IR) or high-risk (HR) groups based on pretreatment PSA, tumor stage, and Gleason score per 2002 NCCN guidelines. Univariate and multivariate analyses were employed to determine factors associated with the type and dose of radiotherapy by the risk groups. RESULTS: Of the 9,017 patients, 3153 who received definitive radiotherapy either alone or in combination with hormone therapy (HT) were selected for in-depth analysis. Multivariate models showed that LR patients were more likely to receive seed implant brachytherapy (BT) than those in higher risk groups. Those in the IR group were most likely to receive external beam radiotherapy (EBRT) combined with BT or high-dose radiotherapy. Use of HT in combination with radiotherapy was more common in the IR and HR groups than for LR patients. Intensity modulated radiation treatment (IMRT) was used to treat 32.6% of PC patients treated with EBRT, with the majority (60.6%) treated with high-dose radiotherapy. CONCLUSIONS: Radiotherapy types and dosage utilization varied by PC risk groups. Patients in IR were more likely than those in LR or HR to receive high-dose radiotherapy. IMRT was used in about one third of patients to deliver high-dose radiotherapy.