Explore the vast range of titles available.

Background Bone metastases commonly occur in conjunction with solid tumors, and are associated with serious bone complications. Population-based estimates of bone metastasis incidence are limited, often based on autopsy data, and may not reflect current treatment patterns. Methods Electronic medical records (OSCER, Oncology Services Comprehensive Electronic Records, 569,000 patients, 52 US cancer centers) were used to identify patients ≥18 years with a solid tumor diagnosis recorded between 1/1/2004 and 12/31/2013, excluding patients with hematologic tumors or multiple primaries. Each patient’s index date was set to the date of his or her first solid tumor diagnosis in the selection period. Kaplan-Meier analyses were used to quantify the cumulative incidence of bone metastasis with follow-up for each patient from the index date to the earliest of the following events: last clinic visit in the OSCER database, occurrence of a new primary tumor or bone metastasis, end of study (12/31/2014). Incidence estimates and associated 95% confidence intervals (CI) are provided for up to 10 years of follow-up for all tumor types combined and stratified by tumor type and stage at diagnosis. Results Among 382,733 study patients (mean age 64 years; mean follow-up 940 days), breast (36%), lung (16), and colorectal (12%) tumors were most common. Mean time to bone metastasis was 400 days (1.1 years). Cumulative incidence of bone metastasis was 2.9% (2.9–3.0) at 30 days, 4.8% (4.7–4.8) at one year, 5.6% (5.5–5.6) at two years, 6.9% (6.8–7.0) at five years, and 8.4% (8.3–8.5) at ten years. Incidence varied substantially by tumor type with prostate cancer patients at highest risk (18% – 29%) followed by lung, renal or breast cancer. Cumulative incidence of bone metastasis increased by stage at diagnosis, with markedly higher incidence among patients diagnosed at Stage IV of whom11% had bone metastases diagnosed within 30 days. Conclusions These estimates of bone metastasis incidence represent the experience of a population with longer follow-up than previously published, and represent experience in the recent treatment landscape. Underestimation is possible given reliance on coded diagnoses but the clinical detail available in electronic medical records contributes to the accuracy of these estimates.

In the United States, colorectal cancer (CRC) is the third most common and second most lethal cancer. More than one-tenth of CRC cases (11% of colon cancers and 18% of rectal cancers) have a young onset (ie, occurring in individuals younger than 50 years). The CRC incidence and mortality rates are decreasing among all age groups older than 50 years, yet increasing in younger individuals for whom screening use is limited and key symptoms may go unrecognized. Familial syndromes account for approximately 20% of young-onset CRCs, and the remainder are typically microsatellite stable cancers, which are more commonly diploid than similar tumors in older individuals. Young-onset CRCs are more likely to occur in the distal colon or rectum, be poorly differentiated, have mucinous and signet ring features, and present at advanced stages. Yet, stage-specific survival in patients with young-onset CRC is comparable to that of patients with later-onset cancer. Primary care physicians have an important opportunity to identify high-risk young individuals for screening and to promptly evaluate CRC symptoms. Risk modification, targeted screening, and prophylactic surgery may benefit individuals with a predisposing hereditary syndrome or condition (eg, inflammatory bowel disease) or a family history of CRC or advanced adenomatous polyps. When apparently average-risk young adults present with CRC-like symptoms (eg, unexplained persistent rectal bleeding, anemia, and abdominal pain), endoscopic work-ups can expedite diagnosis. Early screening in high-risk individuals and thorough diagnostic work-ups in symptomatic young adults may improve young-onset CRC trends.

This study quantified the burdens of bipolar I disorder (BP-I) by examining patient characteristics, health-related quality of life (HRQoL), health care resource utilization (HCRU), and costs of patients with versus without BP-I. Additionally, these outcomes were assessed across BP-I severity levels. A retrospective, cross-sectional analysis of the 2020 National Health and Wellness Survey was conducted. Adults who self-reported a physician diagnosis of BP-I were assigned to the BP-I cohort, with severity-specific subgroups (mild, moderate, severe) created for analysis. A separate cohort of participants without BP-I or MDD was used for comparison. Exclusion criteria included a schizophrenia diagnosis. Bivariate analyses compared demographic and socioeconomic characteristics between cohorts. HRQoL (Short Form-36v2 Health Survey [SF36v2] mental and physical component scores, EuroQol Five-Dimension Visual Analogue Scale [EQ-5D VAS]), HCRU (health care provider visits, emergency department visits, hospitalizations), and annualized costs (direct and indirect) were evaluated for participants with versus without BP-I as well as across BP-I severity subgroups using multivariate analyses adjusted for key baseline differences. Because BP-I is often misdiagnosed as MDD, outcomes were evaluated in a subgroup of participants with MDD who according to the Mood Disorder Questionnaire screened as having probable BP-I (ie, potentially misdiagnosed BP-I) and were compared with the BP-I severity subgroups. Cohorts included 818 participants with BP-I (mild = 336, moderate = 285, severe = 197) and 53,021 participants without BP-I. Participants with BP-I reported significantly lower HRQoL scores on the SF-36v2 and EQ-5D VAS (all measures, P < 0.001), and increasing BP-I severity was predictive of declining HRQoL. Participants with BP-I had significantly greater HCRU (all measures, P < 0.05) than participants without BP-I and increasing BP-I severity was associated with greater HCRU versus the mild BP-I cohort (all measures, P < 0.05). Participants with BP-I incurred significantly greater total direct (P < 0.01) and indirect (P < 0.001) costs versus participants without BP-I. Direct costs were incrementally higher across BP-I severity, while indirect costs were high across all groups but did not differ significantly. Participants with potentially misdiagnosed BP-I (n = 302) had similar HRQoL to those with mild-to-moderate BP-I and similar HCRU and direct costs to those with mild BP-I. These results demonstrate the substantial clinical and economic burdens associated with BP-I, and these negative impacts generally increase with BP-I severity. The study also suggests that despite not having the diagnosis of BP-I, burdens of potentially misdiagnosed patients are similar to those with mild-to-moderate BP-I. Together, these results reveal substantial and diverse unmet needs among adults with BP-I.

: This study examined real-world treatment patterns with curative intent, adverse events, and health care resource utilization and costs in patients with relapsed or refractory large B-cell lymphoma (LBCL) to understand the unmet medical need in the United States. : Adult patients with ≥2 LBCL diagnoses between January 1, 2012, and March 31, 2019, were identified (index date was the date of the earliest LBCL diagnosis) from MarketScan® Commercial and Medicare Supplemental Databases. Patients had ≥1 claim for any LBCL treatment, ≥6 months of data before (baseline) and ≥12 months of data after (follow-up period) the index date, and no baseline LBCL diagnosis. Treatment patterns, adverse events, and all-cause and LBCL-related health care resource utilization and costs were examined. All patients had received first-line therapy of cyclophosphamide, doxorubicin, vincristine, and prednisone with or without rituximab; etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin hydrochloride with or without rituximab; or regimens with anthracycline and second-line therapy with stem cell transplant (SCT)–intended intensive therapy or platinum-based chemotherapy. Patients who received an SCT-intended second-line regimen or received an SCT regardless of second-line regimen were considered SCT eligible. : A total of 188 patients met the criteria of eligibility for SCT. Among the 119 patients who received a second-line regimen intended for SCT, only 22.7% received an SCT. Patients eligible for SCT started first-line therapy within 1 month of their LBCL index date, and the mean duration of first-line therapy was 4.1 months. The mean gap in therapy between first- and second-line therapy was 6.6 months, and the mean duration of second-line therapy was 3.0 months. During the second-line therapy treatment window (mean duration with SCT, 12.4 months; mean duration without SCT, 4.8 months), the most common regimens for patients eligible for SCT were ifosfamide, carboplatin, and etoposide with or without rituximab and gemcitabine and oxaliplatin with or without rituximab; the top 4 most common treatment-related adverse events were febrile neutropenia (56.4%), anemia (49.5%), thrombocytopenia (42.6%), and nausea and vomiting (36.2%), which were similar regardless of receipt of SCT; mean (SD) per-patient-per-month all-cause costs were $46,174 ($49,057) for patients with SCT and $45,780 ($52,813) for patients without SCT. : Treatment patterns among patients with relapsed or refractory LBCL eligible for SCT were highly varied. Only 22.7% of patients who received an SCT-preparative regimen ultimately received SCT, which highlights the magnitude of unmet needs in this population. The occurrence of treatment-related adverse events was similar regardless of SCT status. Per-patient-per-month all-cause costs were also similar with upfront SCT costs averaged during a longer follow-up.

Background Atypical antipsychotics are a common treatment for serious mental illness, but many are associated with adverse effects, including weight gain and cardiovascular issues, and real-world experience may differ from clinical trial data. Cariprazine has previously demonstrated a favorable safety and tolerability profile in clinical trials. Here, we evaluated the effects of cariprazine on body weight and blood pressure for bipolar I disorder (BP-I), schizophrenia, or as adjunctive treatment for major depressive disorder (MDD) using real-world data. Methods Symphony Health’s Integrated Dataverse® with electronic medical record access (3/1/2015–10/31/2018) was used to identify adults (≥ 18 years) diagnosed with BP-I depression, BP-I mania/mixed, schizophrenia, or MDD, with ≥ 2 cariprazine dispensings (first dispensing = index) and continuous clinical activity for ≥ 12 months pre-index (baseline) and ≥ 3 months post-index. The on-treatment period spanned from index to cariprazine discontinuation, exposure to another atypical or long-acting injectable antipsychotic, or end of clinical activity/data availability. Outcomes included estimated annual linear trajectories for weight, body mass index (BMI), systolic blood pressure (SBP), and diastolic blood pressure (DBP) during baseline and on treatment. Changes were estimated using linear mixed-effects models fitted over measurements pre-index and on treatment; 95% CIs were derived from nonparametric bootstrap procedures. Results The body weight analysis included 612 patients (BP-I, n = 331 [BP-I depression, n = 172; BP-I mania/mixed, n = 159]; schizophrenia, n = 75; MDD, n = 206). The mean patient age was 43.4 years, 75.2% were female, and the mean (SD) on-treatment period was 219 (185) days. Among patients with measurements before and during cariprazine treatment, estimated annual weight trajectories were + 3.55 (95% CI 2.38, 4.59) kg/year before cariprazine initiation and + 0.91 (− 1.17, 2.82) kg/year during cariprazine treatment. Additionally, annual linear trajectories evaluated across the on-treatment period were + 0.31 (− 0.42, 1.01) kg/m 2 /year for BMI, − 2.38 (− 4.27, − 0.76) mmHg/year for SBP, and − 0.57 (− 1.75, 0.61) mmHg/year for DBP. Conclusion In this real-world analysis, cariprazine was associated with an estimated weight gain of + 0.91 kg/year and had minimal impact on BMI and blood pressure when evaluated up to 12 months.

This study examined health care utilization and costs during the first year of life for preterm and full-term infants in the US. Preterm (<37 weeks gestational age [GA]) and full-term infants born 2003 to 2012 without complex medical conditions were identified in the MarketScan Commercial and Multi-State Medicaid claims databases using ICD-9-CM diagnosis and diagnosis-related grouping codes. Inpatient and outpatient claims from birth through the first year were analyzed for preterm and full-term subgroups. Results were stratified by payer. There were 1,692,935 commercially insured infants (12.5% preterm) and 1,873,324 Medicaid-insured infants (13.9% preterm). The majority (>75%) of preterm infants were admitted to the neonatal intensive care unit during their birth hospitalization. Generally, mean length of stay and costs for birth hospitalizations increased with decreasing GA. The average cost of a birth hospitalization was US $62,931 (SD $134,347) for commercially insured preterm infants and $43,858 (SD $115,412) for Medicaid-insured preterm infants compared to $2,401 (SD $7,399) and $1,894 (SD $5,444) for commercially insured and Medicaid-insured full-term infants, respectively. Post-neonatal hospitalization rates increased as GA decreased (in full-term to <29 weeks GA: commercial =3.3%-19.5%; Medicaid =6.1%-26.2%). Preterm infants had greater average numbers of outpatient office visits and pharmacy claims than full-term infants. Following birth discharge, mean monthly health care costs per infant increased as GA decreased (commercial = $334 to $3,126; Medicaid = $205 to $2,473). During the first year of life, post-neonatal hospitalization rates, outpatient office visits, pharmacy claims, and monthly costs increased as GA decreased.

Current information on the incidence and prevalence of bone metastases in women with breast cancer is scarce. This study examined the occurrence and predictors of bone metastases, as well as post-metastasis survival in a prospective cohort of Canadian women with breast cancer. We included women treated for early-stage (stage I, II, or III) breast cancer at the Henrietta Banting Breast Centre (HBBC) in Toronto, Canada between 1987 and 2000. Data were abstracted from medical records and pathology reports in the HBBC database; follow-up extended to end of data availability or August 31, 2015. Actuarial survival analyses provided cumulative incidence of bone metastases at 5, 10, and 15 years after breast cancer diagnosis. Kaplan–Meier curves describe breast cancer mortality. Regression models assessed patient, tumor, and treatment characteristics as predictors of bone metastases with all-cause mortality as a competing risk. Among 2097 women studied, the 5-, 10-, and 15-year probability of bone metastasis was 6.5, 10.3, and 11.3 % for the first recurrence, and 8.4, 12.5, and 13.6 % for any bone recurrence. At median follow-up (12.5 years), 13.2 % of patients had bone metastases. Median survival was 1.6 years following bone metastasis, and shorter if both bone and visceral metastases occurred. Advanced age and adjuvant treatment with tamoxifen were protective against bone metastasis. In this representative cohort of women diagnosed with early-stage breast cancer in Ontario, Canada, with long follow-up, the incidence of bone metastases was consistent with longitudinal studies from the United Kingdom, Denmark, and the US.

Background Survivors of myocardial infarction (MI) or ischemic stroke (IS) are at high risk for subsequent cardiovascular events. Hypothesis Older patients with prior MI or IS are at risk for recurrent cardiovascular events, and comorbidities such as diabetes may increase this risk. Methods Two cohorts were studied in a retrospective Medicare 20% random sample—a 2008 cohort with up to 6 years of follow‐up (MI, N = 26 460; IS, N = 17 566) and a 2012 cohort with 1 year of follow‐up (MI, N = 26 548; IS, N = 17 728). Results In older patients who survived an event of MI or IS (2012 cohort), 7.2% had a recurrent MI and 6.7% had a recurrent IS in the first year; 32% died. Accounting for multiple recurrent events (2012 cohort), the event rates per 100 patient‐years were 11.6 and 10.2 for the MI and IS cohorts, respectively. Cumulative incidence of recurrence (2008 cohort) increased from 7.7% at 1 year to 14.3% at 6 years for recurrent MI and from 6.7% at 1 year to 13.4% at 6 years for recurrent IS. Comorbid diabetes (2012 cohort) was significantly associated (adjusted risk ratio) with MI recurrence (1.44) and risk of coronary revascularization (1.23) in the MI cohort and with IS recurrence (1.26) in the IS cohort. Conclusion In this older population with prior MI or IS, high rates of recurrent cardiovascular events and multiple recurrent events were observed. These findings highlight the need for aggressive intervention for secondary prevention and management of comorbidities in high‐risk patients, particularly those with diabetes.

To evaluate the effects of formulary-related rejections of initial adjunctive cariprazine (Vraylar) claims on health care resource utilization (HCRU) among patients with major depressive disorder (MDD). Retrospective claims-based analysis. Using data from Symphony Health Integrated Dataverse from March 2015 through October 2020, we identified adults with MDD who were being treated with antidepressants and had an initial cariprazine claim that was either rejected for a formulary-related reason (eg, noncoverage, prior authorization requirement, step therapy requirement) or approved; rejected patients were required to receive a subsequent atypical antipsychotic (which helps balance the health status across cohorts but may induce bias and affect generalizability). Rejected and approved cohorts were matched (1:2) using propensity scores. Outcomes included all-cause and mental health (MH)-related HCRU (hospitalizations, emergency department [ED] visits, outpatient visits) and treatment patterns. HCRU was compared between cohorts using rate ratios (RRs), with 95% CIs and P values. Treatment patterns were analyzed using descriptive statistics. The rejected cohort comprised 566 patients, with 1132 matched patients in the approved cohort. All-cause and MH-related hospitalization rates were 61% and 89% higher, respectively, for the rejected vs approved cohort (all-cause: RR, 1.61; 95% CI, 1.15-2.32; P = .012; MH related: RR, 1.89; 95% CI, 1.18-2.89; P = .016). ED and outpatient visit rates were similar. Patients in the rejected cohort often never received cariprazine (68.4%), and those who did received it after a 6-month delay on average. Patients with MDD who had an initial adjunctive cariprazine claim rejected for a formulary-related reason and subsequently received an atypical antipsychotic experienced significantly higher hospitalization rates than those with approved initial cariprazine claims, suggesting that formulary restrictions on adjunctive cariprazine may be associated with negative downstream effects.

Many pharmacologic agents are approved for the prevention and treatment of osteoporosis, which is common among postmenopausal women. Evidence exists relating treatment persistence to fracture risk. Less is known about treatment persistence and the use of health care service and individual productivity. This study was undertaken to describe health care use and productivity loss relative to osteoporosis medication persistence using women's self-reported data from the Prospective Observational Scientific Study Investigating Bone Loss Experience (POSSIBLE US™), a large, longitudinal (October 2004–December 2009) osteoporosis cohort study of postmenopausal women. Analyses included women on pharmacologic osteoporosis therapy (alendronate, risedronate, ibandronate, calcitonin, raloxifene, or teriparatide) who provided health care use/productivity data collected using semiannual questionnaires over 1 year of follow-up. Participant characteristics, use, and productivity metrics were summarized. Logistic regression models and generalized linear models were used to examine use, time missed from usual activities, number of days spent in bed, and lost work time relative to treatment persistence, adjusting for potential confounders. At entry, of the 2528 women studied (91% white, 3.1% Hispanic/Latino, 2.3% African American/black, 1.1% Asian, and 2.1% American Indian/Native Alaskan, Native Hawaiian/Pacific Islander, or other; mean age, 64.6 [range, 37–97] years), 43.1% had osteoporosis and 23.4% had a previous fracture. After adjustment, subjects who switched therapies during follow-up were more likely to have had any kind of diagnostic testing (95.2% of switchers vs 91.2% of persistent subjects and 88.9% of discontinuers, P < 0.05). Discontinuers were less likely than persistent subjects to visit their primary care physicians (92.0% vs 94.4%, P = 0.0337). Variations in the number of days spent in bed, time missed from usual activities, and work loss (n = 852 employed subjects) by treatment persistence were not significant. Use of diagnostic testing differed significantly by osteoporosis treatment status. Compared with women who persisted with treatment, primary care provider visits were less common among those who discontinued treatment. Treatment persistence was not associated with significant differences in productivity measures.