Biomarker Testing, Treatment, and Outcomes in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Using a Real-World Database.

BACKGROUND: Little is known about the impact of up-front biomarker testing on long-term outcomes in patients with advanced or metastatic non-small cell lung cancer (a/mNSCLC). This study compared overall survival (OS) by biomarker testing status and by receipt of guideline-concordant therapy in a large real-world cohort of patients with a/mNSCLC in the United States. PATIENTS AND METHODS: This retrospective study used an a/mNSCLC database derived from real-world electronic healthcare records. Patients diagnosed with nonsquamous a/mNSCLC who initiated first-line therapy on or after January 1, 2015, were included. We describe the testing of patients for actionable biomarkers and whether they subsequently received guideline-recommended first-line treatment. OS was defined as the number of months from the initiation of first-line therapy to the date of death or end of follow-up, and was described using Kaplan-Meier analysis. Multivariable Cox proportional hazard modeling was conducted to compare OS between groups adjusting for baseline covariates; adjusted hazard ratios (HRs) were reported. RESULTS: A total of 21,572 patients with a median age of 69 years (IQR, 61-76 years) and follow-up of 9.5 months (IQR, 3.5-21.5 months) were included. Among patients in the database, 88% had a record of receiving testing for at least 1 biomarker at any time, and 69% of these patients received testing before or at the start of first-line treatment. The adjusted hazard of death was 30% higher in patients who never (vs ever) received biomarker testing in the database (HR, 1.30; 95% CI, 1.24-1.37), and 12% higher in patients who did not receive (vs did receive) biomarker testing before or at the start of first-line treatment (HR, 1.12; 95% CI, 1.08-1.16). The adjusted hazard of death was 25% higher in patients who did not receive guideline-concordant first-line treatment (vs those who did) after having a biomarker-positive disease (HR, 1.25; 95% CI, 1.13-1.40). CONCLUSIONS: Findings suggest that receipt of first-line treatment that is concordant with biomarker testing results and treatment guidelines is associated with improved survival outcomes in patients with a/mNSCLC in the United States.

Characteristics and outcomes of patients with RET-fusion positive non-small lung cancer in real-world practice in the United States.

BACKGROUND: Contradictory and limited data are available about the presentation and outcomes of patients with RET-fusion positive metastatic NSCLC as compared to patients without RET fusions. This observational study utilizing a linked electronic health records (EHR) database to genomics testing results was designed to compare characteristics, tumor response, progression-free (PFS) and overall survival (OS) outcomes by RET fusion status among patients with metastatic NSCLC treated with standard therapies. METHODS: Adult patients with metastatic NSCLC with linked EHR and genomics data were eligible who received systemic anti-cancer therapy on or after January 1, 2011. Adjusted, using all available baseline covariates, and unadjusted analyses were conducted to compare tumor response, PFS and OS between patients with RET-fusion positive and RET-fusion negative disease as detected by next-generation sequencing. Tumor response outcomes were analysed using Fisher's exact test, and time-to-event analyses were conducted using Cox proportional hazards model. RESULTS: There were 5807 eligible patients identified (RET+ cohort, N = 46; RET- cohort, N = 5761). Patients with RET fusions were younger, more likely to have non-squamous disease and be non-smokers and had better performance status (all p < 0.01). In unadjusted analyses, there were no significant differences in tumor response (p = 0.17) or PFS (p = 0.06) but OS was significantly different by RET status (hazard ratio, HR = 1.91, 95% CI:1.22-3.0, p = 0.005). There were no statistically significant differences by RET fusion status in adjusted analyses of either PFS or OS (PFS HR = 1.24, 95% CI:0.86-1.78, p = 0.25; OS HR = 1.52, 95% CI: 0.95-2.43, p = 0.08). CONCLUSIONS: Patients with RET fusions have different baseline characteristics that contribute to favorable OS in unadjusted analysis. However, after adjusting for baseline covariates, there were no significant differences in either OS or PFS by RET status among patients treated with standard therapy prior to the availability of selective RET inhibitors.

Arkansas community's attitudes toward the regulation of medical cannabis and the pharmacist's involvement in Arkansas medical cannabis.

OBJECTIVES: This study explored the attitudes of the Arkansas community toward medical cannabis (MC) regulation and the role of pharmacists in dispensing MC before the product became available and examined whether participants' demographics (e.g., age, gender) and characteristics (e.g., history of cannabis use) were associated with these attitudes. DESIGN: Cross-sectional survey. SETTING AND PARTICIPANTS: Using social media, a university research registry, and posted flyers, we invited residents of Arkansas to participate in the self-administered online survey study during a 3-month period, February to April, in 2018. OUTCOME MEASURES: Five questions that inquired about participants' attitudes toward MC regulation and pharmacists' roles regarding MC use. RESULTS: Participants (n = 1343) who completed at least 1 of the 5 questions were included. The majority were aged 40-64 years (52.2%), female (69.1%), and white (88.7%). Most participants reported a history of cannabis use (81.8%) and possession or intention to apply for an MC card (52.9%). Among the conditions approved for MC use, pain (20.3%), arthritis (15.4%), and posttraumatic stress disorder (14.5%) were reported frequently. Likewise, prescription use for mood disorders (46.1%) and pain (37.4%) were also reported. In multivariable regression analyses, participants' history of cannabis use was associated with a preference for lesser oversight of MC, disagreement with MC being available through a pharmacy only, and disagreement on whether MC should be regulated before it is legalized for recreational use (all P < 0.001). It was also associated with a decrease in agreement that pharmacists are well-trained to improve patient safety (P < 0.001) and counsel patients regarding appropriate MC use (P = 0.032). CONCLUSION: Participants who had previously used cannabis were in favor of fewer restrictions and negatively perceived pharmacists' involvement in ensuring appropriate dispensing and MC use. The findings may highlight the need for Arkansas pharmacists to explore alternative ways to promote the safe and proper MC use.

Validation of Newly Developed Surveys to Evaluate Patients' and Providers' Satisfaction with Telehealth Obstetric Services.

Background: Patient and/or provider satisfaction and experience are among the most important indicators for quality assurance of health care services, including telehealth. Validated surveys should be used for this purpose to provide reliable information for a program evaluation. Objective: To validate the newly developed satisfaction surveys, report patient, and provider satisfaction with Antenatal and Neonatal Guidelines, Education and Learning Systems (ANGELS) telehealth services. Methods: Two self-administered paper surveys were developed by a multidisciplinary team. The surveys were validated among obstetric patients who received telehealth services in 2016 and providers in Arkansas from July to August 2017. Psychometric testing was performed to establish reliability and validity of both the surveys. Descriptive statistics was performed to describe patient and provider satisfaction. Results: A total of 89 patient- and 66 provider surveys were analyzed. Construct validity and internal consistency reliability (Cronbach's α >0.7) were confirmed on both the surveys. The majority of patients were highly satisfied with telehealth services and reported positive perceptions toward future use of services. In the past 12 months, telehealth (78.6%) was the most used ANGELS service by providers. Finally, >90% of the providers reported high satisfaction and rated telehealth services as "excellent." Conclusions: The newly developed patient and provider telehealth surveys were reliable and valid. The surveys also demonstrated that the telehealth services were well-accepted and highly valued in a sample of obstetric patients and providers. As both surveys are short, they can be used in routine evaluation of patient and provider satisfaction with similar telehealth programs in the country.

Effect of Etomidate on Pneumonia Development in Critically Ill, Nontrauma Patients.

PURPOSE:: To determine whether etomidate use before intubation increased development of hospital-acquired pneumonia (HAP) in critically ill, nontrauma patients. MATERIALS AND METHODS:: A single-center, retrospective, cohort study of critically ill, nontrauma patients admitted to the medical intensive care unit (ICU) from 2012 to 2015 and intubated with or without etomidate was conducted. Demographics, comorbidities, primary diagnosis, critical illness scores, concomitant medications, and outcomes were obtained from medical records. Student t, chi-square, and Fisher exact tests were performed as appropriate. Relevant characteristics were modeled using logistic regression techniques to determine whether any predicted HAP independently. RESULTS:: Of the 174 patients, 94 (54%) received etomidate and 80 (46%) did not. There was no difference in HAP between etomidate and no etomidate groups (13.8% vs 23.7%, P = .092). Duration of mechanical ventilation (4.4 vs 4.6 days, P = .845), ICU length of stay (7.4 vs 6.9 days, P = .547), ICU mortality (14.9% vs 12.5%, P = .648), and hospital mortality (17% vs 16.2%, P = .892) were similar between the groups. For each 1-day increase in mechanical ventilation duration, the likelihood of HAP development increased by 21%. Patients who received etomidate but no neuromuscular-blocking drug were 80% less likely to develop HAP than those who did not receive etomidate or a neuromuscular-blocking drug (odds ratio: 0.202, 95% confidence interval: 0.045-0.908). CONCLUSION:: Etomidate use was not associated with a difference in HAP development in critically ill, nontrauma patients.

Assessment of Reliability and Validity of SF-12v2 among a Diabetic Population.

OBJECTIVES: To validate the Medical Outcomes Study Short Form version 2 (SF-12v2) in diabetic patients. METHODS: Adults with self-reported diabetes from the Medical Expenditure Panel Survey (2011-2013) were identified. Reliability (internal consistency and test-retest) and validity (construct, concurrent, criterion, and predictive) of the SF-12v2 were assessed. The SF-12v2 consists of two normalized composite scores: the physical component summary score (PCS12) and the mental component summary score (MCS12). Confirmatory factor analysis was conducted to assess the instrument structure. Concurrent (convergent and discriminant) validity was assessed by a multitrait-multimethod matrix using the Patient Health Questionnaire, the Kessler Scale, and perceived health and mental health questions. The predictive validity was assessed by estimating future limitations. The concurrent validity was tested by comparing the MCS12, PCS12, and utility scores (six-dimensional health state short form) across comorbidity scores. RESULTS: The final sample comprised 2214 diabetic patients with mean normalized (population mean 50; range 0-100) PCS12 and MCS12 scores of 40.81 (standard error 0.33) and 49.82 (standard error 0.26), respectively. The PCS12 and MCS12 scores showed good internal consistency (Cronbach α: PCS12 0.85; MCS12 0.83) and acceptable test-retest reliability (intraclass correlation coefficient: PCS12 0.72; MCS12 0.63) and produced acceptable goodness-of-fit indices (normed fit index 0.95; comparative fit index 0.95; root mean square error of approximation 0.11 [95% confidence interval 0.1017-0.1188]). The PCS12 and MCS12 were moderately correlated with perceived health and perceived mental health. The MCS12 was highly correlated with the Patient Health Questionnaire and the Kessler Scale. Both the PCS12 and the MCS12 could predict the future health limitations. The PCS12, MCS12, and utility scores demonstrated sensitivity to the presence of comorbidity scores. CONCLUSIONS: The SF-12v2 is a valid generic instrument for measuring quality of life in diabetic patients.

Integrated budget impact model to estimate the impact of introducing selpercatinib as a tumor-agnostic treatment option for patients with RET-altered solid tumors in the US.

OBJECTIVE: To estimate the potential budget impact on US third party payers (commercial or Medicare) associated with addition of selpercatinib as a tumor-agnostic treatment for patients with Rearranged during Transfection (RET)-altered solid tumors. METHODS: An integrated budget impact model (iBIM) with 3-year (Y) time horizon was developed for 19 RET-altered tumors. It is referred to as an integrated model because it is a single model that integrated results across multiple tumor types (as opposed to tumor-specific models developed traditionally). The model estimated eligible patient populations and included tumor-specific comparator treatments for each tumor type. Estimated annual total costs (2022USD, $) included costs of drug, administration, supportive care, and toxicity. For a one-million-member plan, the number of patients with RET-altered tumors eligible for treatment, incremental total costs, and incremental per-member per-month (PMPM) costs associated with introduction of selpercatinib treatment were estimated. Uncertainty associated with model parameters was assessed using various sensitivity analyses. RESULTS: Commercial perspective estimated 11.68 patients/million with RET-altered tumors as treatment-eligible annually, of which 7.59 (Y1), 8.17 (Y2), and 8.76 (Y3) patients would be selpercatinib-treated (based on forecasted market share). The associated incremental total and PMPM costs (commercial) were estimated to be: $873,099 and $0.073 (Y1), $2,160,525 and $0.180 (Y2), and $2,561,281 and $0.213 (Y3), respectively. The Medicare perspective estimated 55.82 patients/million with RET-altered tumors as treatment-eligible annually, of which 36.29 (Y1), 39.08 (Y2), and 41.87 (Y3) patients would be selpercatinib-treated. The associated incremental total and PMPM costs (Medicare) were estimated to be: $4,447,832 and $0.371 (Y1), $11,076,422 and $0.923 (Y2), and $12,637,458 and $1.053 (Y3), respectively. One-way sensitivity analyses across both perspectives identified drug costs, selpercatinib market share, incidence of RET, and treatment duration as significant drivers of incremental costs. CONCLUSIONS: Three-year incremental PMPM cost estimates suggest a modest impact on payer-budgets associated with introduction of tumor-agnostic selpercatinib treatment.

Initial versus early switch to targeted therapy during first-line treatment among patients with biomarker-positive advanced or metastatic non-small cell lung cancer in the United States.

OBJECTIVES: This study compared outcomes between patients with biomarker-positive advanced/metastatic non-small cell lung cancer (a/mNSCLC) who initiated treatment with targeted therapy versus those who initiated chemotherapy-based treatment and switched to targeted therapy during the first ∼3 cycles (defined as the first 56 days) of first-line treatment. MATERIALS AND METHODS: This was an observational study of patients with a/mNSCLC who received targeted therapy from a nationwide electronic health record (EHR)-derived de-identified database. Outcomes were compared between those who initiated targeted therapy versus those who switched from chemotherapy to a targeted agent. Time-to-event outcomes were evaluated using Kaplan-Meier method; Cox proportional hazards models (adjusted for baseline covariates) were used to compare outcomes between groups. RESULTS: Of the 4,244 patients in this study, 3,107 (73.2%) initiated the first line with targeted therapy and 346 (8.2%) switched to targeted therapy. Patients who received initial targeted therapy were significantly more likely to be non-smokers, treated in an academic practice setting, and of slightly older age (all p < 0.05). Patients who received initial targeted therapy also had a significantly longer time to start of first-line treatment (35.8 vs 25.3 days, p < 0.001). No significant differences were observed for clinical outcomes between groups. CONCLUSION: In both unadjusted and adjusted analyses, there were no differences in the clinical outcomes observed among patients with a/mNSCLC in this study. This study found that initiating chemotherapy with an early switch to targeted therapy (within 56 days) of receiving biomarker positive results may be an acceptable strategy for a patient for whom immediate care is needed.

Biomarker testing in patients diagnosed with advanced/metastatic medullary thyroid cancer in the USA.

Aim: To describe real-world testing patterns for RET in US patients with advanced/metastatic medullary thyroid cancer and determine consistency of real-world testing practices with national guidelines. Materials & methods: The authors performed a retrospective medical record analysis of patients with advanced/metastatic medullary thyroid cancer who initiated systemic therapy between 2013 and 2018. Seventy-five US-based oncologists collected the data using a customized electronic data collection form. Results: A total of 59.6% (121 of 203) of patients underwent testing for RET, and 37.2% (45 of 121) had a RET mutation, of which 55.6% were identified as RET mutation-positive before initial diagnosis. Overall, 90 (44.3%) patients were tested for biomarkers on or after initial diagnosis, with RET being the most tested (95.6%) biomarker. Conclusion: The authors' findings suggest an opportunity to improve testing rates in accordance with treatment guidelines.

Mutations in the RET gene are common in patients with medullary thyroid cancer (MTC). As RET mutations are involved in the development of MTC, several treatment guidelines recommend counseling patients and testing for mutations in the RET gene in all patients with MTC. However, limited data are available on RET testing patterns in the USA in this patient population. In this study, the authors determined testing patterns for RET in patients with advanced or metastatic MTC in the USA using real-world data and found that only 60% of patients were tested for RET (i.e., testing for presence of RET mutations was observed in less than two-thirds of all patients included in the study). These results demonstrate the need for improved testing for RET mutations in patients with MTC in alignment with the treatment guidelines in routine clinical practice in the USA.

Diagnostic characteristics, treatment patterns, and clinical outcomes for patients with advanced/metastatic medullary thyroid cancer.

BACKGROUND: Medullary thyroid cancer (MTC) accounts for approximately 1.6% of new cases of thyroid cancer. The objective of this study was to describe patient characteristics, biomarker testing, treatment patterns, and clinical outcomes among patients with advanced/metastatic MTC in a real-world setting in the United States and to identify potential gaps in the care of these patients. METHODS: Selected oncologists retrospectively reviewed medical records of patients aged ≥ 12 years diagnosed with advanced MTC. Patients must have initiated ≥ 1 line of systemic treatment for advanced/metastatic MTC between January 2013-December 2018 to be eligible. Patient characteristics, biomarker testing, and treatment patterns were summarized descriptively; progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS: The 203 patients included in this study had a mean (SD) age of 52.2 (10.4) years; mean (SD) duration of follow-up from start of first-line treatment was 24.5 (16.0) months. Most patients (82.8%) were initially diagnosed with stage IVA, IVB, or IVC disease. Among all patients, 121 (59.6%) had testing for RET mutations, of whom 37.2% had RET-mutant MTC. The RET-mutation type was reported for 28 patients; the most common mutations reported were M918T (64.3%) and C634R (32.1%). Of the 203 patients, 75.9% received only one line of systemic treatment for advanced disease, and 36% were still undergoing first-line therapy at the time of data extraction. Cabozantinib (30.0%), vandetanib (30.0%), sorafenib (17.2%), and lenvatinib (4.9%) were the most common first-line treatments. Among 49 patients who received second-line treatment, most received cabozantinib (22.4%), vandetanib (20.4%), lenvatinib (12.2%), or sunitinib (12.2%). Median PFS (95% confidence interval [CI]) from start of first- and second-line treatments was 26.6 months (20.8-60.8) and 15.3 months (6.6-not estimable [NE]), respectively. Median OS from initiation of first- and second-line treatment was 63.8 months (46.3-NE) and 22.4 months (12.4-NE), respectively. CONCLUSIONS: For the treatment of advanced/metastatic MTC, no specific preference of sequencing systemic agents was observed in the first- and second-line settings. Considering the recent approval of selective RET inhibitors for patients with RET-mutant MTC, future research should investigate how treatment patterns evolve for these patients.

Evaluating health-related quality of life as a prognostic tool for overall survival in routine cancer care for older patients with bladder cancer: A US based study.

PURPOSE: Health-related quality of life (HRQoL) outcomes, in addition to being useful for monitoring a person's health and well-being, may also predict overall survival (OS) in cancer patients. This study's objective was to examine the association of longitudinally assessed HRQoL and OS in patients with a history of bladder cancer (BC). MATERIALS AND METHODS: This longitudinal retrospective cohort study used the 1998 to 2013 Surveillance, Epidemiology and End Results database linked with Medicare Health Outcomes Survey. Study cohort included patients having HRQoL assessments both pre- and post-BC diagnosis using Short Form-36/Veterans Rand-12. Using Cox Proportional Hazards adjusted for demographics, tumor characteristics, and surgery type, we studied the associations of 3-point difference in HRQoL assessed pre- and post-BC diagnosis and change from pre-to-post diagnosis with overall survival. RESULTS: The study cohort included 438 BC patients with deceased patients (n = 222; 50.7%) being significantly older than those alive (77.2 vs. 75.4 years; P = 0.004). Adjusting for covariates, a 3-point difference in physical HRQoL (physical component summary [PCS]) pre-, post-, and pre-to-post BC diagnosis was associated with respectively 6.1%, 8.7%, and 7.3% (P < 0.01 for all) decreased risk of death for higher PCS. Similarly, a 3-point difference in mental HRQoL (mental component summary [MCS]) post-BC diagnosis was associated with 4.5% (P < 0.05) decreased risk of death for higher MCS. CONCLUSIONS: Associations between PCS/MCS and OS imply that elderly BC patients with better physical/mental health are more likely to survive longer. Monitoring HRQoL in routine cancer care would facilitate early detection of HRQoL decline and enable timely intervention by clinicians to improve OS.

Diagnostic Value and Cost-Effectiveness of Next-Generation Sequencing-Based Testing for Treatment of Patients with Advanced/Metastatic Non-Squamous Non-Small-Cell Lung Cancer in the United States.

The study evaluated the diagnostic value and cost-effectiveness of next-generation sequencing (NGS)-based testing versus various combinations of single-gene tests (SGTs) for selection of first-line treatment for patients with advanced/metastatic non-squamous non-small-cell lung cancer in the United States. A dynamic decision analysis model was developed comparing NGS versus SGT from a payer perspective. Inputs were obtained from published sources and included diagnostic performance, biomarker-positive disease rates, biomarker-directed recommendations for treatment, and survival outcomes. Costs were reported in 2020 US dollars. In the base case, NGS improved the detection of actionable biomarkers by 74.4%, increased the proportion of patients receiving biomarker-driven therapy by 11.9%, and decreased the proportion of patients with biomarker-positive disease receiving non-biomarker-driven first-line treatment by 40.5%. The incremental cost-effectiveness ratio per life-year gained of NGS testing versus SGT was $7224 (excluding post-diagnostic costs); the incremental cost-effectiveness ratio for NGS-directed therapy was $148,786 versus SGT-directed therapy. Sensitivity analyses confirmed the robustness of these findings; survival outcomes and targeted therapy costs had the greatest impact on results. Testing strategies with NGS are more comprehensive in the detection of actionable biomarkers and can improve the proportion of patients receiving biomarker-driven therapies. NGS testing may provide a cost-effective strategy for advanced/metastatic non-squamous non-small-cell lung cancer; however, the value of NGS-directed therapy varies by the willingness-to-pay threshold of the decision-maker.

Healthcare costs and resource utilization associated with renal cell carcinoma among older Americans: A longitudinal case-control study using the SEER-Medicare data.

OBJECTIVES: To determine 1-year and 5-year total healthcare costs and healthcare resource (HRU) associated with renal cell carcinoma (RCC) in older Americans, from a healthcare sector perspective. MATERIALS AND METHODS: This was a longitudinal, retrospective cohort study using the Surveillance, Epidemiology and End Results-Medicare linked data (2006-2014), which included older (≥66 years) patients with primary RCC and 1:5 matched noncancer controls. Patients/controls were followed from diagnosis (pseudo-diagnosis for controls) until death or up to loss-to-follow-up (censored). Per-patient average 1-year and 5-year cumulative total and incremental total healthcare costs and HRU were reported. RESULTS: A total of 11,228 RCC patients were matched to 56,140 controls. Per-patient cumulative average 1-year (incremental = $38,291 [$36,417-$40,165]; $57,588 vs. $19,297) and 5-year (incremental = $68,004 [$55,123-$80,885]; $183,550 vs. $115,547) total costs (excluding prescription drug costs) were 3 and 1.6 times higher for RCC vs. controls. These estimates were 3.6 and 1.7 times higher for RCC vs. controls when prescription costs were included in total costs. Prescription drug costs accounted for 8.4% (incremental = $3,715) and 18.1% (incremental = $15,375) of the 1-year and 5-year incremental total costs, respectively. RCC patients had greater cumulative number of hospitalizations, emergency department visits and prescriptions in 1- and 5-years, compared to controls. CONCLUSIONS: Average first year total cost for a patient with incident diagnosis of RCC is substantially higher than that for controls and it varies depending on the stage at diagnosis. Study findings could help in planning future resource allocation and in determining research and unmet needs in this patient population.

Efficacy of immune checkpoint inhibitor therapy in patients with RET fusion-positive non-small-cell lung cancer.

Aim: To describe outcomes of patients with rearraned during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) who received immune checkpoint inhibitor (ICI)-based treatments in the US. Patients & methods: Using de-identified Flatiron Health-Foundation Medicine NSCLC Clinico-Genomic and Guardant Health databases, treatment patterns and outcomes of 69 patients with advanced/metastatic RET fusion-positive NSCLC who received ICI-based treatment were described. Results: Median real-world progression-free survival and overall survival months were 4.2 (95% CI: 1.4-8.4) and 19.1 (6.9-not reached), respectively, among patients in Clinico-Genomic database (n = 17) receiving first-line ICI-based therapy. In the Guardant Health database, progression-free survival was unavailable, and the median overall survival was not reached (n = 29). Conclusion: Outcomes associated with ICI-based treatments in the first-line setting among patients with RET fusion-positive NSCLC are consistent with unselected populations reported in literature.

Lay abstract Treatment options are rapidly expanding for patients who are diagnosed with advanced/metastatic non-small-cell lung cancer. The current standard of care for patients who do not have an actionable genomic alteration includes immune checkpoint inhibitor (ICI)-based therapy. However, the role of ICI-based therapy is not well understood in patients with rearranged during transfection (RET) fusions. In this study, the survival outcomes observed in patients with RET fusion-positive non-small-cell lung cancer who received first-line ICI-based therapy were comparable with published data from patients without genomic alterations. This study is limited due to the small sample size.

Association of Health-Related Quality of Life with Overall Survival in Older Americans with Kidney Cancer: A Population-Based Cohort Study.

BACKGROUND: Our purpose was to evaluate associations between health-related quality of life (HRQoL) and overall survival (OS) in a population-based sample of kidney cancer (KC) patients in the US. METHODS: We analyzed a longitudinal cohort (n = 188) using the Surveillance, Epidemiology, and End Results (SEER) database linked with the Medicare Health Outcomes Survey (MHOS; 1998-2014). We included KC patients aged ≥65 years, with a completed MHOS during baseline (pre-diagnosis) and another during follow-up (post-diagnosis). We reported HRQoL as physical component summary (PCS) and mental component summary (MCS) scores and OS as number of months from diagnosis to death/end-of-follow-up. Findings were reported as adjusted hazard ratios (aHRs (95% CI)) from Cox Proportional Hazard models. RESULTS: The aHRs associated with a 3-point lower average (baseline and follow-up) or a 3-point within-patient decline (change) in HRQoL with OS were: (a) baseline: PCS (1.08 (1.01-1.16)) and MCS (1.09 (1.01-1.18)); (b) follow-up: PCS (1.21 (1.12-1.31)) and MCS (1.11 (1.04-1.19)); and (c) change: PCS (1.10 (1.02-1.18)) and MCS (1.02 (0.95-1.10)). CONCLUSIONS: Reduced HRQoL was associated with worse OS and this association was strongest for post-diagnosis PCS, followed by change in PCS and pre-diagnosis PCS. Findings highlight the prognostic value of HRQoL on OS, emphasize the importance of monitoring PCS in evaluating KC prognosis, and contribute additional evidence to support the implementation of patient-reported outcomes in clinical settings.

Concurrent Penile Prosthesis and Artificial Urinary Sphincter versus Penile Prosthesis and Male Sling: A National Multi-Institutional Analysis of National Surgical Quality Improvement Program Database Comparing Postoperative Morbidity.

PURPOSE: We aimed to assess the 30-day morbidity in patients undergoing combined insertion of penile prosthesis (PP) and artificial urinary sphincter (AUS) vs. PP and male sling (MS). MATERIALS AND METHODS: The National Surgical Quality Improvement Program database was queried to identify patients who underwent placement of AUS or MS combined with PP. Patient demographics, postoperative morbidity including complications, readmission and reoperation rates were recorded. Student t-test and chi-square or Fischer's exact test were used as appropriate. RESULTS: Forty-one patients met selection criteria between 2010 and 2016. Overall, 26 patients received PP and AUS vs. 15 that received PP and MS. Average age was similar in both groups (64.8±6.6 years vs. 62.3±6.3 years, p=0.254). Diabetes mellitus was more prevalent in PP+MS group compared to AUS+PP group (46.7% vs. 11.5%, p=0.022). Average length of stay was higher in PP+AUS group compared to PP+MS group (2.2±0.6 days vs. 1.8±0.4 days, p=0.017). Postoperative morbidity was reported in four patients in PP+AUS group. No reported complications in PP+MS group. In PP+AUS group, complications included one patient who developed urinary tract infection, one developed surgical site infection, readmission in two for postoperative infection, and one return to the operating room. No reported prosthesis explantation or revision in either groups. CONCLUSIONS: Our results showed that 30-day morbidity was recorded in the PP+AUS group and none in the PP+MS group. The complication and readmission rates remain comparable to the previous reports in both groups.

Early Postoperative Complications and Factors Associated with Early vs Late Discharge of Patients Undergoing Colporrhaphy for Pelvic Organ Prolapse: A National Report.

INTRODUCTION: Pelvic organ prolapse is a highly prevalent condition that is commonly managed with surgical intervention. Our purpose was to determine associated factors and postoperative morbidity rates of early (≤1 day) vs late (>1 day) hospital discharge after outpatient colporrhaphy. METHODS: From the National Surgical Quality Improvement Program® database, 11,652 female patients who received colporrhaphy between 2005 and 2016 were identified; 3,728 were stratified into the early discharge group and 7,924 into the late discharge group. Patient characteristics, surgical data and 30-day postoperative complications were recorded, and variables were compared between groups. RESULTS: In comparison to the late discharge group, the early discharge group had a shorter mean operating time (p <0.001) and overall was less likely to suffer from 30-day morbidity (OR 0.67 [95% CI 0.55-0.82]), reoperation (OR 0.59 [95% CI 0.39-0.90]) or readmission (OR 0.40 [95% CI 0.26-0.90]). Factors independently associated with a lower likelihood of early discharge included age ≥55 years, higher body mass index, White race, current smoker, American Society of Anesthesiologists® classification IV/V and longer operating time. Increased likelihood of early discharge was associated with receiving colporrhaphy after 2012 and posterior colporrhaphy. CONCLUSIONS: Patients discharged from the hospital early had lower rates of postoperative morbidity than those discharged later. Early discharge was associated with procedures performed after 2012 and with isolated posterior colporrhaphy. Longer hospital stays were associated with longer operating times and older age, White race, obesity, comorbidities and history of smoking.

Changing Trends in Management Following Artificial Urinary Sphincter Surgery for Male Stress Urinary Incontinence: An Analysis of the National Surgical Quality Improvement Program Database.

OBJECTIVE: To characterize the safety and practice patterns of artificial urinary sphincter (AUS) placement on a population level. Increasingly AUS implantation has shifted to be an outpatient surgery; however, there is a lack of large-scale research evaluating factors associated with early (≤ 24 hours) versus late (>24 hours) discharges and complications in men following AUS placement. We utilized the National Surgical Quality Improvement Program (NSQIP) database to identify and compare factors and outcomes associated with each approach. METHODS: NSQIP database was queried for men undergoing AUS placement between 2007 and 2016. Patients were classified as either early discharge (ED ≤ 24 hours) and late discharge (LD > 24 hours). Baseline demographics, operating time, and complications were compared between the 2 groups. Multivariate logistic regression evaluated factors associated with discharge timing and 30-day complications. RESULTS: A total of 1176 patients were identified and were classified as ED in 232 and LD in 944 patients. Operative time was shorter in ED (83 minutes) compared to LD (95 minutes, P < .001). Hypertension was more prevalent among LD patients (60.3% vs 69.1% for ED and LD respectively, P < .001). The 30-day complication rate was similar in both groups (ED: 4.3% vs LD: 3.4%, P = .498). Multivariable analysis revealed that surgery after 2012 was associated with ED (OR = 3.66, P < .001). CONCLUSION: At the national level, there are no differences in postoperative morbidity between early and late discharges. There is a trend toward more ED, specifically after 2012. A prospective study on the feasibility and safety of outpatient AUS is needed.

Changes in health-related quality of life outcomes in older patients with kidney cancer: A longitudinal cohort analysis with matched controls.

BACKGROUND: Current evidence regarding health-related quality of life (HRQoL) changes among patients with kidney cancer (KC) is limited. We characterized HRQoL changes from before (baseline) to after (follow-up) diagnosis of KC in older Americans relative to matched controls, and identified sociodemographic and clinical factors associated with HRQoL changes in older patients with KC. MATERIALS AND METHODS: This longitudinal, population-based, retrospective cohort study used data from Surveillance, Epidemiology and End Results linked with Medicare Health Outcomes Survey, 1998-2013. Participants aged ≥65 years with baseline and follow-up survey data were identified. Those with primary KC (n = 186) were matched to adults without cancer (n = 558). HRQoL (physical component summary and mental component summary [MCS]) changes in KC patients were compared using generalized linear mixed-effects models to those of controls. Regression models were used to identify baseline factors associated with HRQoL changes. RESULTS: The adjusted least squares mean (95% confidence interval) reduction in physical component summary from baseline to follow-up was greater in KC patients vs. controls (-4.1 [-5.6, -2.7] vs. -2.3 [-3.1, -1.4], P = 0.025). While the reduction in MCS was similar in both groups (-2.4 [-3.9, -0.8] vs. -1.5 [-2.4, -0.6], P = 0.338). Lower income and distant stage KC predicted greater declines in MCS among KC patients. CONCLUSION: KC significantly affects overall general health in older patients, with sociodemographic factors and distant KC predicting greater reductions in HRQoL. Findings may help clinicians set patient expectations about their HRQoL post-diagnosis and increase clinician awareness of risk factors for HRQoL deterioration.