Bacterial Vaginosis Treatment Patterns, Associated Complications, and Health Care Economic Burden of Women With Medicaid Coverage in the United States.

BACKGROUND: Bacterial vaginosis (BV) is a highly prevalent vaginal infection. OBJECTIVES: Primary objectives of this study were to examine treatment patterns among female patients with Medicaid coverage who were diagnosed with incident BV, the frequency of BV-associated complications, and health care resource utilization (HCRU) and associated costs of incident BV and its recurrence. Secondary objectives were to identify predictors of total all-cause health care costs and number of treatment courses. METHODS: Female patients aged 12-49 years with an incident vaginitis diagnosis and ≥1 pharmacy claim for a BV medication were selected from the Merative MarketScan Medicaid database (2017-2020). Additional treatment courses were evaluated during a ≥12-month follow-up period, in which new cases of BV-associated complications and HCRU and the associated costs were also measured. Generalized linear models were used to identify baseline predictors of total all-cause health care costs and number of treatment courses. RESULTS: An incident vaginitis diagnosis and ≥1 BV medication claim were present in 114 313 patients (mean age: 28.4 years; 48.6% black). During the follow-up, 56.6% had 1 treatment course, 24.9% had 2, 10.2% had 3, and 8.3% had ≥4; 43.4% had BV recurrence. Oral metronidazole (88.5%) was the most frequently prescribed medication. Nearly 1 in 5 had a new occurrence of a BV-associated complication; most (76.6%) were sexually transmitted infections (STIs). Total all-cause and BV-related costs averaged $5794 and $300, respectively, per patient; both increased among those with more treatment courses. Older age, pregnancy, comorbidity, any STIs, postprocedural gynecological infection (PGI), and infertility were predictive of higher total all-cause health care costs, while race/ethnicity other than white was predictive of lower costs. Older age, black race, any STIs, pelvic inflammatory disease, and PGI were predictive of >1 treatment courses. CONCLUSION AND RELEVANCE: The high recurrence of BV represents an unmet need in women's health care and better treatments are necessary.

Treatment patterns and economic burden of bacterial vaginosis among commercially insured women in the USA.

Aim: Bacterial vaginosis (BV) is a common vaginal dysbiosis associated with adverse clinical sequelae, most notably, increased risk of sexually transmitted infections (STIs). The aims of this study were to estimate the frequency of BV recurrence, treatment patterns, other gynecological (GYN) conditions, and the associated healthcare resource utilization (HCRU) and costs among commercially insured patients in the USA. Patients & methods: Female patients aged 12-49 years with an incident vaginitis diagnosis and ≥1 pharmacy claim for a BV medication (fungal treatment only excluded) were selected from the Merative™ MarketScan commercial database (2017-2020). During a minimum 12-month follow-up, additional treatment courses, treatment patterns, frequency of other GYN conditions, and HCRU and costs were assessed. Generalized linear models were used to identify baseline predictors of total all-cause healthcare costs and number of treatment courses. Results: The study population included 140,826 patients (mean age: 31.5 years) with an incident vaginitis diagnosis and ≥1 BV medication claim. During the follow-up, 64.2% had 1 treatment course, 22.0% had 2, 8.1% had 3, and 5.8% had ≥4; 35.8% had a BV recurrence (≥2 BV medication claims). The most commonly prescribed BV medication was oral metronidazole (73.6%). Approximately 12% (n = 16,619) of patients had a new diagnosis of another GYN condition in the follow-up; 8.2% had a new STI, which were more common among patients with ≥4 treatment courses (12.9%). During follow-up, total all-cause healthcare costs averaged $8987 per patient per year (PPPY) of which $470 was BV-related. BV-related healthcare costs increased from $403 PPPY among those with 1 treatment course to $806 PPPY among those with ≥4 with nearly half the costs attributed to outpatient office visits. Conclusion: BV recurrence among this population represented a substantial clinical and healthcare economic burden warranting improvements in women's healthcare.

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device.

OBJECTIVE: To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. METHODS: Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). RESULTS: In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. CONCLUSION: For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT04995887.

Durvalumab real-world treatment patterns and outcomes in patients with stage III non-small-cell lung cancer treated in a US community setting.

Background: For eligible patients with unresectable stage III non-small-cell lung cancer, durvalumab consolidation therapy following chemoradiotherapy is the standard of care. Methods: This was a retrospective study of durvalumab-treated patients diagnosed between 1 August 2017 and 29 February 2020. Electronic health record data were assessed descriptively, with Kaplan-Meier methods used for duration of treatment and overall survival (OS). Results: Among 528 patients (median age 70 years, 51.5% male), the median duration of treatment was 7.1 months (95% CI: 6.0-9.0). Estimated 1- and 2-year OS rates were 83.5 and 64.0%, respectively, with median OS not reached. Conclusion: This study confirmed an OS benefit with durvalumab after chemoradiotherapy in a real-world setting, consistent with the results from the PACIFIC phase III clinical trial.

What is this article about? Durvalumab is a treatment approved for patients with a specific type of lung cancer. Clinical trials have shown durvalumab is an effective therapy for these patients. We conducted this study to better understand what happens to patients treated with durvalumab who were not enrolled in clinical trials. What were the results? Patients who were treated with durvalumab in this study tended to survive as long as patients who received it as part of a clinical trial. What do the results of the study mean? Studies like this one may better represent patients who are less likely to take part in clinical trials. Future studies may examine long-term outcomes of durvalumab and factors associated with better outcomes.

Estimating Productivity Loss from Breast and Non-Small-Cell Lung Cancer among Working-Age Patients and Unpaid Caregivers: A Survey Study Using the Multiplier Method.

Background. Traditional approaches to capturing health-related productivity loss (e.g., the human capital method) focus only on the foregone wages of affected patients, overlooking the losses caregivers can incur. This study estimated the burden of productivity loss among breast cancer (BC) and non-small-cell lung cancer (NSCLC) patients and individuals caring for such patients using an augmented multiplier method. Design. A cross-sectional survey of BC and NSCLC patients and caregivers measured loss associated with time absent from work (absenteeism) and reduced effectiveness (presenteeism). Respondents reported pre- and postcancer diagnosis income, hours worked, and time to complete tasks. Exploratory multivariable analyses examined correlations between respondents' clinical/demographic characteristics-including industry of employment-and postdiagnosis productivity. Results. Of 204 patients (104 BC, 100 NSCLC) and 200 caregivers (100 BC, 100 NSCLC) who completed the survey, 319 participants (162 BC, 157 NSCLC) working ≥40 wk/y prediagnosis were included in the analysis. More than one-third of the NSCLC (33%) and BC (43%) patients left the workforce postdiagnosis, whereas only 15% of caregivers did. The traditional estimate for the burden of productivity loss was 66% lower on average than the augmented estimate (NSCLC patients: 60%, BC patients: 69%, NSCLC caregivers: 59%, and BC caregivers: 73%). Conclusions. Although patients typically experience greater absenteeism, productivity loss incurred by caregivers is also substantial. Failure to account for such impacts can result in substantial underestimation of productivity gains novel cancer treatments may confer by enabling patients and caregivers to remain in the workforce longer. Our results underscore the importance of holistic approaches to understanding this impact on both patients and their caregivers and accounting for such considerations when making decisions about treatment and treatment value. Highlights: Cancer can have a profound impact on productivity. This study demonstrates how the disease affects not only patients but also the informal or unpaid individuals who care for patients.An augmented approach to calculating health-related productivity loss suggests that productivity impacts are much larger than previously understood.A more comprehensive understanding of the economic burden of cancer for both patients and their caregivers suggests the need for more support in the workplace for these individuals and a holistic approach to accounting for these impacts in treatment decision making.

Patient and Caregiver Preferences for First-Line Treatments of Metastatic Non-Small Cell Lung Cancer: A Discrete Choice Experiment.

PURPOSE: The approval of immune checkpoint inhibitors for metastatic non-small-cell lung carcinomas (mNSCLC) treatment has presented more care options. Therefore, it is important to identify the benefit-risk trade-offs patients and caregivers are willing to make among potential treatment options. This study quantified the preferences of patients and caregivers for attributes of mNSCLC treatment. METHODS: Patients with mNSCLC and caregivers completed an online survey assessing preferences using a discrete choice experiment. Respondents chose between hypothetical treatment profiles, with varying levels for 7 attributes associated with first-line treatment, including overall survival (OS), progression-free survival, select adverse events (AEs), and regimen (caregivers). Hierarchical Bayesian modeling was used to estimate attribute-level preference weights. RESULTS: Patients (n = 308) and caregivers (n = 166) most valued increasing OS from 11 to 30 months, followed by decreasing the risk of a serious AE (grade 3/4) that may lead to hospitalization from 70% to 18%. These attributes were over twice as important to both sets of respondents as the other attributes measured. Patients and caregivers would accept increases in the risks of a serious AE (grade 3/4) from 18% to 70% and all grades nausea from 10% to 69% if OS increased by 16.8 and 4.0 months, respectively. The least valued attributes were all grades of pneumonitis (patients) and all grades of skin rash (caregivers). CONCLUSION: Patients and caregivers are willing to make trade-offs between efficacy and toxicity and may require up to 1.5 years of increased OS to accept a higher risk of AEs. These results can provide guidance to oncologists when engaging in shared-decision making discussions.

Chemoradiation treatment patterns among United States Veteran Health Administration patients with unresectable stage III non-small cell lung cancer.

BACKGROUND: The Veterans Health Administration (VHA) is the largest integrated health care system in the United States (US). Among VHA patients, the rate of use of concurrent chemoradiation therapy (CCRT) among those with unresectable, stage III non-small cell lung cancer (NSCLC) is unknown. The objective was to report recent CCRT treatment patterns in VHA patients and identify characteristics associated with receipt of CCRT. METHODS: Using Department of Veteran Affairs (VA) Cancer Registry System data linked to VA electronic medical records, we determined rates of CCRT, sequential CRT (SCRT), radiation therapy (RT) only, chemotherapy (CT) only, and neither treatment. RESULTS: Among 4054 VHA patients who met study criteria, CCRT rates slightly increased from 44 to 50% between 2013 and 2017. Factors associated with decreased odds of CCRT receipt compared to any other treatment included increasing age (adjusted odds ratio [aOR] per 10 years = 0.67; 95% CI: 0.60-0.76) and Charlson-Deyo comorbidity score (aOR = 0.94; 95% CI: 0.91-0.97). White race was associated with increased odds of CCRT receipt (aOR = 1.24; 95% CI: 1.004-1.53). In a chart review sample of 200 patients, less than half (n = 85) had a documented reason for not receiving CCRT. Among these, 29% declined treatment, and 71% did not receive CCRT due to "not being a candidate" for reasons related to frailty or lung nodules being too far apart for radiation therapy. CONCLUSIONS: CCRT rates among VHA patients with unresectable, stage III NSCLC slightly increased from 2013 to 2017; however in 2017, only half were receiving CCRT. Older patients and those with multiple comorbidities were less likely to receive CCRT and even when controlling for these factors, non-white patients were less likely to receive CCRT.

Cost-Effectiveness of Durvalumab After Chemoradiotherapy in Unresectable Stage III NSCLC: A US Healthcare Perspective.

BACKGROUND: Durvalumab was approved by the FDA in February 2018 for patients with unresectable stage III NSCLC that has not progressed after platinum-based concurrent chemoradiotherapy (cCRT), and this regimen is the current standard of care. The objective of this study was to examine the cost-effectiveness of durvalumab following cCRT versus cCRT alone in patients with locally advanced, unresectable stage III NSCLC. METHODS: A 3-state semi-Markov model was used. Modeling was performed in a US healthcare setting from Medicare and commercial payer perspectives over a 30-year time horizon. Clinical efficacy (progression-free and post progression survival) and utility inputs were based on PACIFIC study data (ClinicalTrials.gov identifier: NCT02125461; data cutoff March 22, 2018). Overall survival extrapolation was validated using overall survival data from a later data cutoff (January 31, 2019). The main outcome was the incremental cost-effectiveness ratio (ICER) of durvalumab following cCRT versus cCRT alone, calculated as the difference in total costs between treatment strategies per quality-adjusted life-year (QALY) gained. RESULTS: In the base-case analysis, durvalumab following cCRT was cost-effective versus cCRT alone from Medicare and commercial insurance perspectives, with ICERs of $55,285 and $61,111, respectively, per QALY gained. Durvalumab was thus considered cost-effective at the $100,000 willingness-to-pay (WTP) threshold. Sensitivity analyses revealed the model was particularly affected by variables associated with subsequent treatment, although no tested variable increased the ICER above the WTP threshold. Scenario analyses showed the model was most sensitive to assumptions regarding time horizon, treatment effect duration, choice of fitted progression-free survival curve, subsequent immunotherapy treatment duration, and use of a partitioned survival model structure. CONCLUSIONS: In a US healthcare setting, durvalumab was cost-effective compared with cCRT alone, further supporting the adoption of durvalumab following cCRT as the new standard of care in patients with unresectable stage III NSCLC.

Long-term survival trends in patients with unresectable stage III non-small cell lung cancer receiving chemotherapy and radiation therapy: a SEER cancer registry analysis.

BACKGROUND: To evaluate the value of new therapies for non-small cell lung cancer (NSCLC), it is necessary to understand overall survival (OS) rates associated with previous standard therapies and how these rates have evolved over time. METHODS: We retrospectively analyzed data from patients enrolled in the Surveillance, Epidemiology, and End Results (SEER) cancer registry. Adults with unresectable, stage III NSCLC treated with chemoradiotherapy were grouped by diagnosis year (2000-2002; 2003-2005; 2006-2008; 2009-2011; 2012-2013). The primary endpoint was OS (data cut-off, December 31, 2014), estimated using the Kaplan-Meier estimator. Temporal survival-trend significance was tested using a two-sided log-rank trend test. RESULTS: Of 12,865 eligible patients, 59.1% were male, 59.9% had stage IIIB disease, and 62.7% had non-squamous histology. Median age at diagnosis was 67 years. Overall, 10,899 (84.7%) patients died and 1966 (15.3%) were censored/lost to follow-up. Median follow-up (95% confidence interval [CI]) was 80 (77-82) months; median OS (95% CI) was 15 (15-16) months; 1- and 3-year survival probabilities (95% CI) were 57.7% (56.9-58.6) and 24.1% (23.3-24.8), respectively. Stratification by diagnosis year showed consistent improvements in survival over time (p < 0.0001 for trend). Median OS was 12, 14, 15, 18, and 19 months in successive cohorts. CONCLUSIONS: OS in patients diagnosed with unresectable, stage III NSCLC between 2003 and 2013 was consistent with that from clinical studies of sequential/concurrent chemoradiotherapy. Despite improvement over time, median OS was < 2 years and mortality remained high during the first year post-diagnosis.

Utilization of novel systemic therapies for multiple myeloma: A retrospective study of front-line regimens using the SEER-Medicare data.

The landscape of treatment for multiple myeloma (MM) has significantly changed over the last decade due to novel agents that have shown superiority in efficacy such as proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs) over traditional therapies. However, the real-world utilization of these new agents has not been studied well. This study evaluated year-to-year changes in treatment choices in a cohort of patients aged 66 or older in the Surveillance, Epidemiology, and End Results (SEER) registry linked with Medicare claims (SEER-Medicare) data who were diagnosed with MM between 2007 and 2011. We identified 2477 symptomatic newly diagnosed patients who were followed for 6 months or more postdiagnosis and treated with systemic therapies but not with stem cell transplantation. Symptomatic patients were identified by evidence of hypercalcemia, renal failure, anemia, or bone lesions (CRAB criteria). The minimum follow-up was imposed to ensure sufficient data to characterize treatment. Our analysis found that the proportion of treated patients increased from 75% in the 2007 cohort to 79% in the 2011 cohort. The share of PI-based regimens including PI plus alkylating agents, PI plus IMiD, and PI-only increased from 9% to 21%, 3% to 11%, and 16% to 22%, respectively, between 2007 and 2011. These findings translate to the share of PI-based regimens having increased from 28% to 55% and that of IMiDs-based regimens (excluding PI plus IMiD) having decreased from 43% to 27%. In conclusion, while the usage of PIs among elderly MM patients increased significantly replacing IMiD-based regimens (with or without alkylating agents but not with PI) between 2007 and 2011, this significant shift did not increase the proportion of treated patients.

Costs Associated with Productivity Loss Among U.S. Patients Newly Diagnosed with Multiple Myeloma Receiving Oral Versus Injectable Chemotherapy.

BACKGROUND: The use of novel drug agents in the treatment of multiple myeloma (MM) has been associated with improved therapeutic outcomes and survival; however, MM continues to pose a significant economic burden on patients and health care systems. Evaluating economic implications of therapies can provide key points of distinctions between available treatment options. Patients with MM may experience productivity loss, including lost days from work or inability to work due to MM symptoms or to undergoing treatment. Although direct costs of illness have been well described in the literature, indirect costs associated with MM are understudied. OBJECTIVE: To compare the extent of disability benefit use and resultant workplace productivity loss among U.S. adult patients with newly diagnosed MM who received oral versus injectable MM therapy. METHODS: A retrospective cohort study was conducted using the Truven Health Analytics MarketScan Commercial Claims and Encounters, Medicare Supplemental Coordination of Benefits, and Health and Productivity Management databases (2008-2015). Workplace absenteeism, as measured by disability benefit use, was evaluated 1 year before and 1 year after first MM diagnosis. Patients receiving only oral chemotherapy were compared with those who received injectable therapy. Absenteeism days and associated costs were compared among study groups using multivariable zero-inflated Poisson regression. RESULTS: The final study cohort included 299 patients with newly diagnosed MM, of whom 73 received oral therapy only and 226 received injectable therapy. Treatment type was a significant predictor of disability benefit use. Patients who received injectable therapy missed an average of 110 work days in the 1 year after diagnosis, compared with 87 for patients receiving only oral therapy (difference of 23 days, 95% CI = 19-26, P < 0.001). Treatment type was also a significant predictor of costs associated with lost productivity. Patients who received injectable therapy experienced productivity loss valued at $18,315, compared with patients who only received oral drug therapy ($14,429). The difference between these estimates was statistically significant ($3,886, 95% CI = $3,540-$4,231, P < 0.001). CONCLUSIONS: Patients newly diagnosed with MM face significant losses in productivity. Patients receiving injectable MM therapy use significantly more disability benefits and incur higher productivity costs, compared with those receiving oral MM therapy. Further studies elucidating the nature of the differences between injectable and noninjectable chemotherapy users are needed. DISCLOSURES: This study was funded by Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical Company. Yong and Noga are employees of Millennium Pharmaceuticals. Merola reports personal fees from Millennium Pharmaceuticals during the time of this study.

Prevalence and risk of skeletal complications and use of radiation therapy in elderly women diagnosed with metastatic breast cancer.

OBJECTIVE: Real-world data regarding patient factors associated with the occurrence of spinal cord compression (SCC) or pathological fracture (PF), or need for bone surgery (BS), or use of radiation therapy (RAD) (i.e. skeletal complications and radiation therapy; SCRT) are limited for women with metastatic breast cancer (BCa). Given the substantial clinical and economic burden of these events in advanced BCa, we conducted the present study to understand the prevalence and identify the risk factors associated with these events among elderly women presenting with de novo metastatic BCa. METHODS: Using linked Surveillance, Epidemiology, and End Results and Medicare data, we identified women with incident metastatic BCa diagnosed during 2005-2009. Associations between patient demographics and select clinically relevant factors, and SCRT were examined using the Cox proportional hazards model, accounting for death as a competing risk. RESULTS: Of 3,731 Medicare beneficiaries with incident metastatic BCa, 1,808 (48.5%) experienced at least one SCRT event during a median follow-up of 13.2 months; a majority (69%) experienced a subsequent SCRT event. The proportions of women who had RAD, PF, BS, and SCC were: 32%, 28%, 8%, and 4%. Older women (80+ years), or those with more comorbid conditions (CCI≥2) had a statistically significant lower risk of SCRT (HR 0.78 [CI: 0.67-0.92, p<0.01]; HR 0.77 [CI: 0.67-0.89, p<0.01], respectively), primarily due to lower frequency of radiotherapy (p<0.01). Compared to Caucasians, African Americans had lower risk of SCRT (HR 0.70 [CI: 0.60-0.82, p<0.01]), as well as all SCRT subtypes defining this group except for SCC, which was the same for both race groups. CONCLUSION: This study highlights that certain patient characteristics and clinical factors are associated with the risk of spinal cord compression or pathologic fractures, or need for bone surgery or radiation among women with metastatic BCa. In future studies, it will also be important to consider the clinical and economic burden based on these components of skeletal complications and radiation therapy use in order to guide and improve the management of women with advanced BCa.

Treatment patterns and health care resource utilization among patients with relapsed/refractory systemic light chain amyloidosis.

BACKGROUND: Treatment for patients with systemic light chain (AL) amyloidosis remains challenging. Our study aims to describe treatment patterns for both newly diagnosed and relapsed/refractory AL (RRAL) amyloidosis, and to assess clinical outcomes, healthcare costs, and resource utilization during the first year following a diagnosis of RRAL amyloidsis. METHODS: This was a retrospective observational study of adult patients with AL amyloidosis using the US Optum administrative claims data during 1/1/2008 to 6/30/2015. Diagnosis was based on both ICD-9 codes and treatments with a claim for AL-amyloidosis-specific anticancer systemic agents. RESULTS: Of 334 patients with AL amyloidosis, 43.1% were considered as RRAL amyloidosis. The majority (75%) of RRAL amyloidosis patients had organ involvement prior to the second line treatment. Proteasome-inhibitor-based regimens were most frequently used (41.0% for first-line AL, 30.6% for RRAL amyloidosis). Organ deterioration and mortality rates were 49.3% and 10.4%, respectively, during the two years following relapse. The average monthly cost was $14,369 per patient for RRAL amyloidosis including medical costs ($9441) and drug costs ($4928). CONCLUSIONS: RRAL amyloidosis is associated with high morbidity from target organ failure and mortality, which emphasizes the need for novel medications to improve care for patients with RRAL amyloidosis.

The impact of age and comorbidities on practice patterns and outcomes in patients with relapsed/refractory multiple myeloma in the era of novel therapies.

OBJECTIVES: One-third of patients with multiple myeloma (MM) are diagnosed at age≥75years. Older patients have increased incidence of cardiovascular disease (CVD) and renal insufficiency (RI), hallmark complications of MM. We examined cumulative incidence of CVD and RI in relapsed/refractory MM (RRMM) and outcomes by age and RI/CVD. MATERIALS AND METHODS: Retrospective cohort study using a large US electronic medical records database of adult patients with RRMM initiating first- and second-line therapy (2LT) between 1/2008-06/2015. RI and CVD comorbidities were based on diagnosis codes and/or lab values. RESULTS: Among 628 patients, 37.1% were ≥75years. Cumulative incidence of CVD and/or RI increased from 47.7% at MM diagnosis to 67.8% at first relapse. Age≥75years had a trend toward higher risk of relapse post 2LT, proxied by time to next treatment (TTNT), (adjusted HR: 1.28; 95% CI: 1.00, 1.65; P=0.05). TTNT was significantly higher with comorbid CVD+RI (adjusted HR: 1.50; 95% CI: 1.11, 2.02; P<0.01). Age≥75years, RI, CVD, and CVD+RI were associated with increased mortality risk from 2LT initiation; adjusted HR: 1.66 (95% CI: 1.19, 2.33; P<0.01), 1.51 (95% CI: 1.01, 2.26; P=0.04), 1.75 (95% CI: 1.03, 2.96; P=0.04), and 1.95 (95% CI: 1.29, 2.93; P<0.01), respectively. CONCLUSION: Despite treatment with novel agents for RRMM in 86% of patients, an outcome gap persists for older patients and those with RI and/or CVD. Personalized treatment approaches that account for age and comorbidities, and further evaluation of innovative regimens and dosing schedules, are needed to improve outcomes for these patients.

Skeletal-related events and mortality among men diagnosed with advanced prostate cancer: The impact of alternative measures of radiation to the bone.

PURPOSE/OBJECTIVE(S): Skeletal-related events (SREs), which include radiation to the bone (RtB), can occur among patients with bone metastasis (BM). There is a recognized potential for misclassification of RtB when using claims data. We compared alternative measures of RtB to better understand their impact on SRE prevalence and SRE-related mortality. METHODS AND MATERIALS: We analyzed data for stage IV prostate cancer (PCa) cases identified between 2005 and 2009 in the Surveillance, Epidemiology, and End Results registry linked with Medicare claims. We created two measures of RtB: 1) a literature-based measure requiring the presence of a prior claim with a BM code; 2) a new measure requiring either that the BM code coincided with the radiation episode or that the duration of the radiation episode was less than or equal to 4 weeks. We estimated adjusted hazard ratios of an SRE using both measures among stratified samples: no metastasis (M0), metastasis to bone (M1b) and other sites (M1c). RESULTS: The study sample included 5,074 men with stage IV PCa (median age 77 years), of whom 22% had M0, 54% had M1b, and 24% had M1c disease at time of PCa diagnosis. Based on Approaches 1 and 2, the proportion with probable RtB was 5% and 8% among M0, 30% and 30% among M1b, and 25% and 27% among M1c patients. Among M0 patients, the adjusted hazard ratio (AHR) associated with an SRE was 1.27 when using Approach 1 (95% confidence interval, CI: 0.95-1.7) and 1.49 when using Approach 2 (95% CI: 1.14-1.96). However, the impact of SREs on mortality did not differ between both approaches among M1b and M1c patients. CONCLUSION: We found that alternative measures used to define RtB as SRE in claims data impact conclusions regarding the effect of SREs on mortality among M0 but not M1 patients.

Specialist visits and initiation of cancer-directed treatment among a large cohort of men diagnosed with prostate cancer.

BACKGROUND: The urologist generally manages the treatment of men immediately following the diagnosis of prostate cancer (PCa). The role of other physician specialists in this setting is less clear. We investigated whether involvement of other physician specialty types immediately following diagnosis affects initiation of cancer-directed treatment. METHODS: This is a retrospective cohort study using linked cancer registry and claims data from 1999 to 2009, excluding stage I/II PCa. A physician visit index (PVI) served as the exposure variable and captured the "dispersion of care" across specialties, that is, the extent to which patient care involved different types of physician specialties such as the primary care physician, urologist, or oncologist. The PVI score was calculated using visits occurring within 30 days postdiagnosis. This score was dichotomized to measure "low PVI" (reflects seeing multiple specialist types). Competing risk Cox proportional hazard regression models provided adjusted hazard ratios (HR) for treatment receipt associated with a low PVI. RESULTS: The sample included 33,380 patients: 4,910 metastatic and 28,470 nonmetastatic groups. The top 3 visit categories within 30 days postdiagnosis were "urologist only" (59%) and "urologist plus primary care physician" (21%) and no visit (6%). The median time to receipt of cancer-directed treatment was 51 days. Overall, 29% of individuals in the metastatic group and 38% in the nonmetastatic group were categorized as low PVI. A low PVI was associated with a shorter time to treatment receipt in the nonmetastatic (HR = 1.12 [95% CI: 1.09-1.15]) and metastatic (HR = 1.21 [95% CI: 1.14-1.29]) groups. CONCLUSIONS: Multispecialist involvement in the weeks following diagnosis is associated with a shorter time to treatment initiation, highlighting a role for exposure to different specialty types in the weeks following an initial diagnosis of PCa. This study provides important baseline data for future studies examining coordination of care across cancer and noncancer specialists.

The use of health services among elderly patients with stage IV prostate cancer in the initial period following diagnosis.

OBJECTIVE: Information regarding variability in the type and extent of health services used by elderly patients with advanced prostate cancer (PCa) in the initial period following diagnosis is limited. We evaluated health services utilization among elderly men with stage IV PCa with (M1) and without (M0) distant metastasis during the year following diagnosis. METHODS: We evaluated patients aged 66 and older with incident stage IV PCa during 2005-2007 using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Measures included skilled nursing facility (SNF) stay, hospice stay, and hospitalization. Multivariable logistic regression models were estimated to determine the association between M1 PCa and each health service. Poisson regression was used to assess hospital length of stay. RESULTS: The final sample included 3379 patients (20% M0; 80% M1). In the year following diagnosis, M1 patients had greater use of SNF (M0: 8%; M1: 22%), hospice (M0: 5%; M1: 20%), and hospitalization (M0: 43%; M1: 61%). Compared to M0 patients, M1 patients had statistically significantly higher adjusted odds of SNF use (OR=1.89; 95% CI=1.38-2.59), hospice use (OR=3.22; 95% CI=2.19-4.72), and hospitalization (OR=1.45; 95% CI=1.20-1.75). Among those hospitalized, M1 patients had 24% longer length of stay (p<0.01). CONCLUSIONS: There is 2- to 3-fold greater use of SNF and hospice, and higher hospitalization among M1 compared to M0 patients. Elderly patients with advanced PCa face significant clinical burden within the first year after their diagnosis. Greater understanding of the relationship between clinical disease burden and health services utilization can improve healthcare delivery in this population.

Skeletal-related events and mortality among older men with advanced prostate cancer.

OBJECTIVE: Skeletal-related events (SREs) are defined as a cluster of events including clinical diagnoses and treatment. Using claims data, the burden of SREs as a group has been reported among patients with cancer. We investigate the mortality impact of subcomponents of SREs, a topic that has received limited attention among older men. MATERIALS AND METHODS: We analyzed prostate cancer (PCa) and all-cause mortality among men diagnosed with metastatic PCa from 2000 to 2007 using Surveillance, Epidemiology, and End Results data linked with 1999-2009 Medicare data. We created three measures of pathological fracture (PF), spinal cord compression (SCC), and bone surgery (BS) that differed in the use of claims-based bone metastasis information. We reported covariate-adjusted hazard ratios (HRs) using the full sample and a propensity score-matched sample (PSMS). RESULTS: Application of inclusion/exclusion criteria resulted in 7062 men in the full sample (1776 in the PSMS). PCa-specific (all-cause mortality) was 54% (80%) at a median follow-up of 609days. SRE prevalence ranged from 9.7% to 17.1% across the measures. In a PCa mortality model, the HR associated with an SRE ranged from 1.07 (0.98-1.16) to 1.31 (1.18-1.45). The HRs for SCC and PF were statistically significant and positively associated with PCa-specific mortality. The results for BS depended on the measure. Results for SCC and BS, but not for PF, were preserved using a PSMS. CONCLUSIONS: The relationship between SREs and mortality among older men with metastatic PCa was driven by SCC and depended on the definition used to measure SREs.

Clinical and economic burden of bone metastasis and skeletal-related events in prostate cancer.

PURPOSE OF REVIEW: We review the clinical trials and observational studies literature regarding the clinical and economic burden of bone metastasis and skeletal-related events (SREs) in prostate cancer, and discuss current gaps in understanding the impact of bone metastasis in this disease. RECENT FINDINGS: Trial data indicate that SREs occur in half of prostate cancer patients with bone metastasis in the absence of treatment, and 30-45% among those who receive bone-modifying agents. In the United States, the cost of SRE ranged from $7553 per radiation episode to $88 838 per bone surgery episode. Prevalence of SRE, time to SRE occurrence, and cost of SRE varied across studies because of differences in study populations, follow-up period, and the algorithm used to measure SRE. There is limited evidence on the clinical and economic impact by SRE subtype. Information regarding patient-reported outcomes and costs from the patient's perspective is lacking. SUMMARY: Bone metastasis and SREs in prostate cancer patients are associated with considerable morbidity, reduced survival, and substantial economic burden. Consistent study methodology, particularly the measurement of SREs, is necessary to allow comparison of estimates across studies. The inclusion of patient-centered clinical and economic outcomes in future research will provide pertinent information regarding the burden of bone metastasis and SREs.

Use of and spending on supportive care medications among Medicare beneficiaries with cancer.

PURPOSE: The study objective was to provide population-based estimates of supportive care medication (SCM) use among Medicare beneficiaries with cancer and determine factors related to SCM receipt. METHODS: This retrospective cohort study of community-based Medicare beneficiaries used the Medicare Current Beneficiary Survey (1997­2007). Dependent variables comprised use and spending on SCMs for three medication classes: opioids, antidepressants/sedative/hypnotics (ASH), and antiemetics. Independent variables of interest were supplemental insurance coverage, cancer site, and treatment. Multivariate models determined factors affecting receipt of, and spending on, SCMs. We also compared SCM use and spending among beneficiaries with and without cancer in order to understand what portion of SCM use and spending could be attributed to cancer as opposed to other comorbid conditions. RESULTS: A total of 1,836 Medicare beneficiaries with cancer and 9,898 beneficiaries without cancer were eligible for the study. Beneficiaries with cancer were more likely to receive opioids, ASH, and antiemetics compared to non-cancer beneficiaries. Adjusted annual payments for antiemetics were on average $637 higher in with cancer versus without cancer (p<0.01), while ASH payments were $184 lower (p<0.01). Opioid spending was similar among cancer and non-cancer users. Relative to colon cancer, beneficiaries with prostate cancer were least likely to receive any of the three SCM classes. Receipt of antineoplastic treatment increased the probability of use of all three classes of SCMs. Insurance coverage did not influence the use of or spending on opioids or antiemetics, but was associated with both outcomes for ASH. The use of all three SCM classes was significantly lower during years before Part D implementation of the new Medicare Part D prescription drug benefit and was higher after implementation of Part D. CONCLUSION: This study provides population-based information on SCM use among Medicare beneficiaries with cancer. Cancer site and treatment modality were important predictors of SCM use.