Clinical outcomes by Child-Pugh Class in patients with advanced hepatocellular carcinoma in a community oncology setting.

Aim: Many pivotal trials in advanced hepatocellular carcinoma (HCC) require participants to have Child-Pugh A disease. However, many patients in real-world practice are Child-Pugh B or C. This study examined treatment patterns and clinical outcomes in patients with advanced HCC treated with first-line systemic therapy. Materials & methods: In this retrospective study, patients with HCC treated with first-line systemic therapy (2010-2017) were identified from US Oncology Network records. Outcomes included overall survival and progression-free survival, by Child-Pugh Class and prior liver-directed therapy. Results: Of 352 patients, 78.7% were Child-Pugh A or B, 96.6% received first-line sorafenib, and 33.8% received first-line-prior liver-directed therapy. Survival outcomes were similar for Child-Pugh A or B, and longer after first-line prior liver-directed therapy. Conclusion: First-line systemic therapy is beneficial in patients with Child-Pugh A or B, and after first-line prior liver-directed therapy. These findings may help position systemic therapy in the community setting.

Treatment of failed scaphoid nonunion fixation using free medial femoral condyle vascularized bone grafting.

BACKGROUND: Nonunion in scaphoid fractures may be considered a devastating problem. Union failure results in scaphoid deformity, resorption, and bone loss. Failed previous fixation decreases remaining bone stock and makes it more difficult to achieve union. Free vascularized graft represents a good option to achieve scaphoid union with revision fixation. Our study aims at the assessment of the management of scaphoid fractures non-union after failed previous fixation with the use of a free vascularized graft from the medial femoral condyle. METHODS: This is a retrospective study including 16 cases with persistent scaphoid nonunion after previous fixation managed by vascularized medial femoral condyle grafts. The mean follow-up was 24 months. Previous surgical attempts and nonunion duration were noted. We evaluated the union rate, together with ROM, Scapholunate angles and pain scores. RESULTS: the union was achieved in 13 of 16 cases. Pain improved in all patients (10/16 complete relief). Wrist ROM at follow-up was an average of 50° flexion 48° extension. There was no change in the relationship between lunate and scaphoid with an average angle of 37.5° preoperative and 38° postoperative. CONCLUSION: Free vascularized MFC grafts are considered a reliable method to treat persistent nonunion of scaphoid fractures after failed previous operations. Short-term follow-up data showed considerable union rates with adequate pain relief and satisfactory ROM.

Burden of illness associated with overweight and obesity in patients hospitalized with COVID-19 in the United States: analysis of the premier healthcare database from April 1, 2020 to October 31, 2020.

BACKGROUND: SARS-CoV-2 (COVID-19) continues to be a major public health issue. Obesity is a major risk factor for disease severity and mortality associated with COVID-19. OBJECTIVE: This study sought to estimate the healthcare resource use and cost outcomes in patients hospitalized with COVID-19 in the United States (US) according to body mass index (BMI) class. METHODS: Retrospective cross-sectional study analyzing data from the Premier Healthcare COVID-19 database for hospital length-of-stay (LOS), intensive care unit (ICU) admission, ICU LOS, invasive mechanical ventilator use, invasive mechanical ventilator use duration, in-hospital mortality, and total hospital costs from hospital charge data. RESULTS: After adjustment for patient age, gender, and race, patients with COVID-19 and overweight or obesity had longer durations for mean hospital LOS (normal BMI = 7.4 days, class 3 obesity = 9.4 days, p < .0001) and ICU LOS (normal BMI = 6.1 days, class 3 obesity = 9.5 days, p < .0001) than patients with normal weight. Patients with normal BMI had fewer days on invasive mechanical ventilation compared to patients with overweight and obesity classes 1-3 (6.7 days vs. 7.8, 10.1, 11.5, and 12.4, respectively, p < .0001). The predicted probability of in-hospital mortality was nearly twice that of patients with class 3 obesity compared to patients with normal BMI (15.0 vs 8.1%, p < .0001). Mean (standard deviation) total hospital costs for a patient with class 3 obesity is estimated at $26,545 ($24,433-$28,839), 1.5 times greater than the mean for a patient with a normal BMI at $17,588 ($16,298-$18,981). CONCLUSIONS: Increasing levels of BMI class, from overweight to obesity class 3, are significantly associated with higher levels of healthcare resource utilization and costs in adult patients hospitalized with COVID-19 in the US. Effective treatment of overweight and obesity are needed to reduce the burden of illness associated with COVID-19.

The COVID-19 pandemic has caused many people to be seriously ill. People who are overweight are more likely to get sicker from COVID-19 infection and to require hospitalization.In our study, we compared patients who have normal weight to people who have overweight or obesity to understand how excess weight affects their experiences with COVID-19. We looked at: (1) how overweight and obesity is related to how long patients with COVID-19 stay in the hospital, (2) if they stayed in the intensive care unit (ICU) and how long they spent there, (3) whether they needed help breathing with the use of a ventilator and how long they needed a ventilator, (4) if they died during their hospital stay, and (5) how much their hospital stay cost.We found that people who have overweight or obesity stayed in the hospital longer, were more likely to need to stay in the ICU, and were in the ICU longer. They were also more likely to need help breathing with the use of a ventilator and needed that help for a longer time. People who have overweight or obesity died during their hospital stay more often than people with a normal BMI. The costs associated with people who have overweight or obesity were higher than people who have a normal BMI.Overall, this study shows that having overweight or obesity is a significant risk factor for poor outcomes from COVID-19 infection. Treatment for obesity and overweight is needed to help improve outcomes from future pandemics.

Real-world Treatment Patterns and Reasons for Therapy Selection in Patients with Advanced Hepatocellular Carcinoma in US Oncology Practices.

BACKGROUND: The treatment landscape for advanced hepatocellular carcinoma (aHCC) is rapidly expanding beyond tyrosine kinase inhibitors (TKIs) in the first-line (1L) setting, with multiple TKIs and immune-checkpoint inhibitors (ICIs) now being evaluated in combination. Real-world evidence describing current treatment patterns and reasons for 1L and 2L treatment selection in aHCC is sparse. PATIENTS AND METHODS: A retrospective cohort study with a cross-sectional survey element was conducted using Cardinal Health's Oncology Provider Extended Network. U.S. medical oncologists identified adult aHCC patients initiating 1L systemic therapy between January 1, 2017 and July 31, 2019 and abstracted data from patient medical records. Data included provider characteristics, patient demographics and clinical characteristics, treatment regimens, and physician rationale for treatment regimen choice. RESULTS: A total of 44 medical oncologists provided data on 284 aHCC patients. The median age at 1L initiation was 61.5 years, and the majority were male (78%) and white (66%). Nearly half (47%) initiated 1L treatment in 2019, 34% were ECOG performance status 2+, and 63% were Child-Pugh Class B/C. Among the 284 aHCC patients, TKIs were used by 94% of patients in the 1L setting, comprised predominantly of sorafenib (54%) and lenvatinib (38%). ICIs were most common among the 90 patients (66%) who received 2L treatment. CONCLUSION: In the community-oncology practice setting, nearly all aHCC patients received sorafenib or lenvatinib in the 1L setting, while the majority of patients received an ICI in the 2L setting. With recent ICI approvals in aHCC, this marks the beginning of an increased use of ICIs in the 1L setting.

Healthcare costs related to adverse events in hepatocellular carcinoma treatment: A retrospective observational claims study.

BACKGROUND: Hepatocellular carcinoma (HCC) is an aggressive form of liver cancer with increasing incidence and mortality worldwide. For metastatic disease, systemic treatment is recommended. In addition to tumor characteristics, adverse events (AEs) may influence regimen choice. AIM: To analyze healthcare burden among patients with advanced HCC, by treatment type and AEs observed. METHODS: Included were adult commercial and Medicare Advantage enrollees with ≥2 non-diagnostic claims coded for HCC (the first setting the index date); ≥1 claim for systemic treatment of advanced/metastatic HCC; and continuous enrollment for a 6-month pre-index baseline period to ≥1 month post-index (follow-up). Patients were excluded by lack of systemic treatment; incomplete demographic information; pregnancy, liver transplant, other cancers during baseline or clinical trial participation. We describe patient characteristics, common AEs, overall survival, and healthcare burden in 2017 USD up to 12 months after initiation of tyrosine kinase inhibitor (TKI) monotherapy; immune checkpoint inhibitor (ICI) monotherapy; or FOLFOX combination therapy. RESULTS: The analytic sample consisted of 322 patients (median age 65.8 years, 76% male) who had 12 months' (unless death occurred prior) available follow-up, with median follow-up of 9 months. Among these, 241 (75%) had TKI monotherapy, 23 (7%) had ICI monotherapy, and 58 had FOLFOX (18%) first-line treatment. Overall, patients had a high burden of AEs (mean 3.2), with the most prevalent being pain (75%), infection (39%), ascites (34%), and bleeding (29%). After adjusting for covariates, infection ($50 374), fever ($47 443), and diarrhea ($29 912) imposed the highest incremental annual costs versus patients without the AE. Up to 90% of costs were attributable to inpatient admissions, with 56% to 60% involving intensive care. Median 1-year survival was 32%. CONCLUSIONS: This real-world study demonstrated AE burden in alignment with previous clinical studies. Regardless of regimen used, AEs are associated with substantial healthcare costs due to inpatient care.

Systematic literature review of trials assessing recommended systemic treatments in hepatocellular carcinoma.

AIM: To identify and evaluate the similarity of all trials assessing recommended treatments for advanced hepatocellular carcinoma. MATERIALS & METHODS: Single arm and randomized trials from any phase and published any time up to February 2021 were systematically searched. RESULTS: From 5677 records reviewed, 50 trials were included in the review, and 24 for assessed for similarity. In the first-line (1L) setting, several trials assessing sorafenib were noted for enrolling patients with more severe disease and/or performance status than other 1L trials; trials within the second-line (2L) setting were generally similar. Median survival was <2 years in all trial arms. CONCLUSIONS: Trials assessing recommended treatments are largely similar and appropriate for quantitative comparisons of several efficacy and safety outcomes.

Management of hepatocellular carcinoma from diagnosis in routine clinical practice.

Aim: To assess real-world management of patients diagnosed with hepatocellular carcinoma (HCC) within an integrated delivery network. Materials & methods: A retrospective cohort analysis of adults newly diagnosed with HCC from January 2014 to March 2019. Overall survival and treatment journey were assessed over the entire available follow-up period per patient. Results: Of the 462 patients, 85% had ≥1 treatment. The 24-month overall survival rate (95% CI) from first treatment was 77% (72-82%). Majority of Child-Pugh class A (71%) and B (60%) patients received locoregional therapy first. Half (53.6%) of the patients with liver transplantation first were Child-Pugh class C patients. Sorafenib was the predominant systemic therapy. Conclusion: This integrated delivery network data analysis offers a comprehensive insight into the real-world management of HCC.

Clinical Characteristics, Treatment Patterns, and Healthcare Costs and Utilization for Hepatocellular Carcinoma (HCC) Patients Treated at a Large Referral Center in Washington State 2007-2018.

INTRODUCTION: Though the treatment landscape for hepatocellular carcinoma (HCC) has evolved significantly with the refinement of liver-directed therapy techniques and the introduction of new drugs, few studies have investigated the impact of the changing treatment landscape on lifetime treatment costs, particularly in Barcelona Clinic Liver Cancer (BCLC) stage C disease. We sought to investigate real-world clinical characteristics, treatment patterns, and healthcare costs in a cohort of HCC patients treated at a single high-volume institution in Washington (WA) state. METHODS: We conducted a retrospective cohort study of patients diagnosed with HCC between 2007 and 2018 using abstracted electronic medical record (EMR) data linked to cancer registry data and health claims from commercial plans, Medicare, and Medicaid. We described clinical and treatment characteristics, including BCLC stage and Child Pugh score. We investigated median survival and mean lifetime treatment costs by BCLC stage using Kaplan-Meier cost estimator methods. A multivariate Cox proportional hazards model was used to investigate factors associated with overall survival. RESULTS: The final cohort included 215 patients, the majority of whom were white (71%), male (68%), and with underlying hepatitis C (61%). Mean per patient lifetime costs were highest in BCLC A and BCLC C patients. Mean lifetime costs in BCLC A patients ($292,134) was driven by surgery, hospital, pharmacy, imaging, and outpatient costs. Chemotherapy costs were highest in BCLC C patients, though not the predominant area of spending. Median survival was highest in patients with BCLC 0 and A disease; BCLC stage C and higher area deprivation index (ADI) were associated with poorer survival. CONCLUSION: In a cohort of WA state HCC patients, mean lifetime costs were highest in patients with BCLC A disease, attributable to surgery and hospital costs. As increased utilization of newer and less toxic therapies improves survival in BCLC C patients, mean lifetime costs in this group may also rise.

Locoregional therapy patterns and healthcare economic burden of patients with hepatocellular carcinoma in the USA.

AIM: To examine the locoregional therapy (LRT) patterns and the healthcare economic burden of patients with hepatocellular carcinoma (HCC) in the USA. PATIENTS & METHODS: Patients with newly diagnosed HCC were identified from the MarketScan® databases (1 July 2015-31 May 2018). The LRTs received and all-cause and HCC-related healthcare costs were measured. RESULTS: Among 2101 patients with HCC, most received embolization therapy as their first LRT treatment (57.8%, n = 1215); 17.1% (n = 360) received ablative therapy and 8.7% (n = 182) radiation therapy; 16.4% (n = 344) received multiple LRTs. After patients received their first LRT treatment, total all-cause healthcare costs averaged $20,316 per patient per month; 70.7% ($14,359) were HCC related. CONCLUSION: Among newly diagnosed HCC patients treated with LRT in the USA, the economic burden is high.

Medical oncology referral and systemic therapy of patients with advanced stage urothelial carcinoma.

Aim: To understand physician visit patterns among patients with stage IV (including nonmetastatic [M0] and metastatic [M1] disease) urothelial carcinoma (UC) and understand factors associated with a timely referral to a medical oncologist and systemic treatment. Patients & methods: Retrospective analysis of Surveillance, Epidemiology and End Results-Medicare data. Results: First physician encounter was with a urologist (M0: 69%; M1: 53%) or primary care physician ([PCP]; M0: 19%, M1: 25%) for the majority of patients around UC diagnosis. After the index urologist encounter, most patients had a subsequent medical oncologist visit at a median of 52 days (M0: 69.5 days, M1: 33 days). In an adjusted model, older age, index PCP visit, higher comorbidities and M0 disease were negatively associated with a medical oncologist referral. Among those referred to a medical oncologist, older age, Hispanic or non-Hispanic Black race and not being married were negatively associated with subsequent chemotherapy receipt (p < 0.05). Conclusion: Many patients with advanced UC encounter multiple specialists during their disease course. Older patients or those with a first UC-related encounter with a PCP are less likely to be referred to medical oncology. Once referred to medical oncology, social determinants, including race and marital status, are relevant predictors of receiving chemotherapy.

Treatment patterns and direct medical costs among patients with advanced hepatocellular carcinoma.

AIMS: This study assessed the real-world United States (US) treatment patterns and the associated economic burden in patients diagnosed with advanced hepatocellular carcinoma (HCC). METHODS: The MarketScan database was used to identify patients newly diagnosed with HCC who received systemic therapy between 2011 and 2018 and continuously enrolled for ≥6 months (baseline period) prior and ≥1 month following HCC diagnosis. Treatment patterns (systemic and locoregional therapy), healthcare resource utilization, and costs were reported during follow-up. RESULTS: The final sample included 1580 patients (median age, 61; 78% male; median follow up, 8.7 months). The most common first line of therapy (LOT) was sorafenib (78%). The median time from HCC diagnosis to start of sorafenib was 43 days, and the median duration of sorafenib therapy was 60 days. Only 17% of patients received second LOT, and non-sorafenib treatment use increased to 66% (mostly chemotherapy combination). Transarterial chemoembolization was the most commonly observed locoregional therapy prior to the first LOT. The multivariable-adjusted average all-cause total cost among sorafenib treated patients was $17,642 (95% CI: $16,711-$18,558) per-patient per-month), of which $11,393 were HCC-specific. CONCLUSIONS: In patients who received first-line therapy for HCC, the duration of therapy was short (potentially due to progression or tolerability). Most patients did not continue to second-line therapy. Despite the short duration of therapy, HCC patients still incur a high economic burden, and there is a need for more effective and tolerable treatments.

Epidemiologic, humanistic and economic burden of hepatocellular carcinoma in the USA: a systematic literature review.

AIM: To describe the epidemiologic, humanistic and economic burdens of hepatocellular carcinoma (HCC) in the USA. MATERIALS & METHODS: Studies describing the epidemiology and economic burden from national cohorts, any economic models, or any humanistic burden studies published 2008-2018 were systematically searched. RESULTS: HCC incidence was 9.5 per 100,000 person-years in most recent data, but was ∼100-times higher among patients with hepatitis/cirrhosis. Approximately a third of patients were diagnosed with advanced disease. Patients with HCC experienced poor quality of life. Direct costs were substantial and varied based on underlying demographics, disease stage and treatment received. Between 25-77% of patients did not receive surgical, locoregional or systemic treatment. CONCLUSION: Better treatments are needed to extend survival and improve quality of life for patients with HCC.

The Real-World Lifetime Economic Burden of Urothelial Carcinoma by Stage at Diagnosis.

BACKGROUND: Urothelial carcinoma (UC) is generally diagnosed early and may incur significant lifetime costs. This study estimated, from the payer's perspective, the lifetime costs among patients diagnosed with UC according to stage at diagnosis. METHODS: This retrospective analysis of the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database identified patients ≥66 years with newly diagnosed UC from 2004-2013. Patients were followed from UC diagnosis to death or last follow-up to estimate lifetime costs. Costs were allocated to 3 phases: diagnosis (≤3 months after diagnosis), terminal (≤3 months before death), and continuation (months between diagnosis and terminal phases). Survival-adjusted lifetime costs (total and major UC-related) were estimated for patients with UC based on stage at diagnosis (stages 0 through IV) and in a subgroup of patients receiving ≥1 systemic line of chemotherapy (LOC). RESULTS: The sample included 15,588 patients: 3,446 stage 0 (8% ≥1 LOC; median [IQR] follow-up in months: 44 [23-71]); 3,902 stage I (12% ≥1 LOC; 33 [15-62]); 4,301 stage II (26% ≥1 LOC; 17 [7-39]); 1,612 stage III (25% ≥1 LOC; 17 [7-42]); and 2,327 stage IV (33% ≥1 LOC; 8 [3-18]). Median age was 78 years and 72% were male. Mean lifetime costs were lowest for stage IV patients (stage 0, $151,626; stage 1, $150,123; stage II, $149,728; stage III, $190,996; stage IV, $117,503). Hospitalizations not involving a cystectomy contributed about half of lifetime costs across all stages. Cystectomy contributed 2-13% of the total lifetime UC costs ($3,356 stage 0; $7,011 stage I; $11,855 stage II; $25,509 stage III; $11,693 stage IV). UC-related office visits contributed 8-15% of lifetime costs ($11,717 stage 0; $14,611 stage I; $19,882 stage II; $21,480 stage III; $17,820 stage IV). CONCLUSION: UC continues to be a costly cancer with stage III patients having highest lifetime costs. Hospitalizations drive most of the lifetime costs across all stages; most of these hospitalizations did not involve costs related to cystectomy. Treatment plans requiring shorter and fewer hospitalizations may lessen the economic burden of UC.

Survival, costs, and health care resource use by line of therapy in US Medicare patients with newly diagnosed glioblastoma: a retrospective observational study.

BACKGROUND: Glioblastoma (GBM) is associated with poor prognosis, large morbidity burden, and limited treatment options. This analysis evaluated real-world treatment patterns, overall survival, resource use, and costs among Medicare patients with GBM. METHODS: This retrospective observational study evaluated Medicare patients age 66 years or older with newly diagnosed GBM using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data from 2007 through 2013. Patients were followed from diagnosis to death or end of follow-up. An algorithm defined treatment patterns as lines of therapy (LOTs). The Kaplan-Meier method was used to estimate overall survival for the full sample as well as by LOT, surgical resection, Charlson Comorbidity Index (CCI), tumor size, and age. Resource use and costs during the follow-up period were reported in terms of total and per-patient-per-month (PPPM) estimates. RESULTS: A total of 4308 patients with GBM were identified (median age, 74 years; CCI of 0, 52%). The most commonly used first LOT was temozolomide (82%), whereas chemotherapy + bevacizumab was most prevalent for second-line (42%) and third-line (58%) therapy. The median overall survival was 5.9 months for resected patients and 3 months for unresected patients, with considerable heterogeneity depending on patient characteristics. A great proportion of patients had claims for an ICU admission (86.2%), skilled nursing facility (76.9%), and home health (56.0%) in the postdiagnosis period. The cumulative mean cost was $95 377 per patient and $18 053 PPPM, mostly attributed to hospitalizations. CONCLUSIONS: Limited treatment options, poor survival, and economic burden emphasize the need for novel interventions to improve care for Medicare patients with GBM.

Nomogram for Estimating Overall Survival in Patients With Metastatic Pancreatic Cancer.

OBJECTIVES: This analysis investigated nomogram use to evaluate metastatic pancreatic cancer prognosis. METHODS: Thirty-four baseline factors were examined in the Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) (nab-paclitaxel plus gemcitabine vs gemcitabine) data set. Factors significantly (P < 0.1) associated with overall survival (OS) in a univariable model or with known clinical relevance were tested further. In a multivariable model, factors associated with OS (P < 0.1) were selected to generate the primary nomogram, which was internally validated using bootstrapping, a concordance index, and calibration plots. RESULTS: Using data from 861 patients, 6 factors were retained (multivariable analysis): neutrophil-lymphocyte ratio, albumin level, Karnofsky performance status, sum of longest diameter of target lesions, presence of liver metastases, and previous Whipple procedure. The nomogram distinguished low-, medium-, and high-risk groups (concordance index, 0.67; 95% confidence interval, 0.65-0.69; median OS, 11.7, 8.0, and 3.3 months, respectively). CONCLUSIONS: This nomogram may guide estimates of the range of OS outcomes and contribute to patient stratification in future prospective metastatic pancreatic cancer trials; however, external validation is required to improve estimate reliability and applicability to a general patient population. Caution should be exercised in interpreting these results for treatment decisions: patient characteristics could differ from those included in the nomogram development.

Overall survival, costs, and healthcare resource use by line of therapy in Medicare patients with newly diagnosed metastatic urothelial carcinoma.

Aims: Medicare patients with metastatic or surgically unresectable urothelial carcinoma (mUC) often receive platinum-based chemotherapy as first line of therapy (LOT), but invariably progress, requiring additional LOTs and healthcare resource use (HCRU). To better understand the evolving mUC treatment landscape, the economic burden of chemotherapy-based mUC treatments among US Medicare patients was estimated. Methods: Newly diagnosed Medicare patients with mUC were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Patients were followed from diagnosis to death, disenrollment, or end of study to characterize LOTs (first [LOT1], second [LOT2], and third or greater [LOT3+]). Kaplan-Meier methods were used to estimate overall survival (OS) by LOT. HCRU and mean costs were reported over the follow-up period, LOT duration, and maximum LOT received. Results: Among 1,873 eligible patients with mUC (median age = 77 years; median follow-up = 7.5 months), 1,035 (55%) received no chemotherapy. Among chemotherapy-treated patients, 61% had LOT1 only, 25% had LOT1 and LOT2 only, and 14% had LOT3+. Median OS was 8.1 months, range was 4.3 (untreated) to 29.8 (LOT3+) months. HCRU frequency increased with additional LOTs. Mean cumulative per-patient cost was $82,912 for all patients, increasing with additional LOTs (untreated = $57,207; LOT1 = $99,213; LOT2 = $125,190; LOT3+ = $163,884). Mean per patient per month cost was $18,827 for all patients, decreasing with increasing number of LOTs received (untreated = $27,211; LOT1 = $9,601; LOT2 = $7,325; LOT3+ = $6,017). Limitations: Potential for treatment misclassification when using the algorithm defining LOTs and non-generalizability of results to younger patients. Conclusions: Over 50% of Medicare patients with mUC received no chemotherapy. Among chemotherapy-treated patients, most received only one LOT. Additional LOTs led to higher mean costs and HCRU, but as patients were followed longer, monthly costs decreased. As treatments evolve to include immuno-oncology agents, these findings provide a clinically relevant economic benchmark for mUC treatment across different traditional LOTs.

Overall survival, costs and healthcare resource use by number of regimens received in elderly patients with newly diagnosed metastatic triple-negative breast cancer.

AIM: This analysis estimated the overall survival, treatment patterns and economic burden of elderly metastatic triple-negative breast cancer patients. MATERIALS & METHODS: Patients (≥66 years) with metastatic triple-negative breast cancer were identified from the SEER-Medicare database. Treatment patterns were defined in terms of first, second and third or more regimens. Healthcare resource use and costs were reported over the follow-up period and over the treatment duration of each regimen. RESULTS:  A total of 51% of patients did not receive chemotherapy. Taxanes were most commonly used. Median survival was 7 months. The mean cumulative (per patient per month) cost per patient was US$73,586 (US$10,084). Mean cost in first and second regimen were US$26,950 and US$33,347. CONCLUSION: About half of patients did not receive chemotherapy. Receipt of increasing regimens led to higher mean costs and healthcare resource use.

Patient-reported prevalence of metamorphopsia and predictors of vision-related quality of life in vitreomacular traction: a prospective, multi-centre study.

OBJECTIVES: To report the prevalence and severity of metamorphopsia, estimate its impact on vision-related quality of life (VRQoL) and evaluate predictors of VRQoL in patients with vitreomacular traction (VMT). PATIENTS AND METHODS: A prospective, cross-sectional multi-centre study in the United Kingdom of 185 patients with VMT, with or without a full thickness macular hole (FTMH). Self-reported metamorphopsia was determined using the metamorphopsia questionnaire. VRQoL was assessed using the Visual Function Questionnaire (VFQ-25). Physicians recorded clinical and ocular characteristics in both eyes including a physician assessment of metamorphopsia. ANOVA and predicted least-squares means were used to estimate the impact of metamorphopsia on VRQoL. Predictors of VRQoL were assessed using ordinary-least-squares regression adjusting for clinically important variables. RESULTS: The prevalence of self-reported metamorphopsia was 69.7% (95% CI 62.6-76.3%) and was higher in eyes with a concomitant FTMH vs. without FTMH (85.4% vs. 64.2%). Physician assessment of metamorphopsia was 53.0% (95% CI: 45.5-60.3%). Comparing eyes with metamorphopsia vs. without metamorphopsia, the VFQ-25 composite score was lower (82.3 vs. 91.4), and mean VA (LogMAR) was worse (0.44 vs. 0.33). The largest difference in VFQ-25 scores was observed for near activities (metamorphopsia: 75.3, No metamorphopsia: 90.2). The adjusted model showed that metamorphopsia severity and age were significantly associated with lower VFQ-25 scores. CONCLUSION: Metamorphopsia was highly prevalent in patients with VMT and associated with significantly lower VRQoL. Physician assessment of symptoms underestimated the self-reported presence of metamorphopsia. Metamorphopsia severity acts as a predictor of impaired VRQoL, over and above decrements due to reduced vision.

nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial.

AIM: The phase III MPACT trial (N = 861) demonstrated superior overall survival (OS) with first-line nab-paclitaxel plus gemcitabine versus gemcitabine alone (median, 8.7 months vs 6.6 months; hazard ratio [HR], 0.72; 95% confidence interval [CI], 0.62-0.83; P < 0.001) in patients with metastatic pancreatic cancer. The efficacy benefit of the combination over gemcitabine alone was observed across patient subgroups, including those based on region. This subset analysis was designed to examine the safety and efficacy of nab-paclitaxel plus gemcitabine in patients treated in Australia to understand whether differences in patient population or regional variations in patient care had any impact on clinical outcomes. METHODS: Patients with metastatic pancreatic cancer received first-line nab-paclitaxel plus gemcitabine or gemcitabine alone in the MPACT study; this analysis focused on those treated in Australia. RESULTS: In the Australian cohort, 120 patients were randomized to receive nab-paclitaxel plus gemcitabine (n = 61) or gemcitabine alone (n = 59). Median OS was 9.4 months with nab-paclitaxel plus gemcitabine versus 6.7 months with gemcitabine alone (HR, 0.64; 95% CI, 0.44-0.94; P = 0.022). Progression-free survival (median, 5.5 months vs 3.6 months; HR, 0.65; 95% CI, 0.42-1.00; P = 0.049) and the overall response rate (23% vs 2%; P < 0.001) were significantly improved with the combination. No new safety signals were observed. CONCLUSIONS: The results of this subset analysis confirm the efficacy and manageable safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated in Australia.

Physician visits and the timing of skeletal-related events among men newly diagnosed with metastatic prostate cancer: A cohort analysis.

INTRODUCTION: Men diagnosed with metastatic prostate cancer (PCa) are at increased risk for skeletal complications which are associated with significant morbidity and mortality. Although both the urologist and the medical oncologist play important roles in the management of patients with advanced PCa, there is limited information regarding their role in the context of skeletal complications. The current study investigated these relationships among newly diagnosed metastatic patients with PCa. METHODS AND MATERIALS: This retrospective cohort study used Surveillance, Epidemiology and End Results cancer registry data for incident stage IV metastatic (M1) cases diagnosed from 2000 to 2007 with linked Medicare claims. Postdiagnosis urologist and medical oncologist visits were identified using billing codes. We considered skeletal-related events (SREs) that occurred after the urologist or medical oncologist visit. We used Cox proportional hazards models to examine the relationship between a physician visit and the timing of the first SRE with and without propensity-score matching to account for observable selection. RESULTS: The sample included 5,572 patients with stage IV M1 prostate cancer. Seventy-six percent of the patients were non-Hispanic White, 16% were non-Hispanic African American, and 8% were of other races; 75% of patients saw a urologist (median time to first visit = 19 days) and 44% saw an oncologist (median = 80 days), whereas 41% experienced at least one SRE (median = 309 days). Covariate-adjusted Cox models showed a longer time to an SRE for patients with only a medical oncologist visit (hazard ratio [HR] = 0.53, 95% CI: 0.45-0.61), only a urologist visit (HR = 0.35, 95% CI: 0.31-0.39) or both a urologist and medical oncologist visit (HR = 0.34, 95% CI: 0.31-0.38), compared to individuals without these visits. Among men with a urologist visit, a medical oncologist visit was not associated with the time to the first SRE (HR = 0.97, 95% CI: 0.90-1.05). Among those without a urologist visit a medical oncologist visit was associated with a longer time to an SRE (HR = 0.54, 95% CI: 0.46-0.64). Results were comparable using propensity-score matched samples. CONCLUSION: Among men newly diagnosed with metastatic PCa, 4 of 10 patients experienced an SRE. Patients experienced a delay in skeletal complications when managed by a urologist or a medical oncologist compared to patients who did not see either specialist.