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BACKGROUND: Corrected QT (QTc) prolongation is a cardiac condition that may increase the risk of ventricular arrhythmias, including Torsades de Pointes (TdP), and cardiac-related death. QTc prolongation is a notable concern in oncology as drug-induced QTc prolongation is a documented side effect of several anticancer therapies. Moreover, patient-specific risk factors for QTc prolongation such as increased age and a history of cardiovascular disease/events can be common among patients with metastatic breast cancer, which puts this population at an increased baseline risk for QTc prolongation. Female sex is a risk factor itself. The objective of this study was to characterize the presence of comorbidities and use of concomitant medications associated with QTc prolongation/TdP among patients receiving first-line (1L) treatment for HR+/HER2- locally advanced or metastatic breast cancer (aBC).METHODS: Oncologists in France, Germany, Israel, Italy, Spain and the United States abstracted clinical characteristics and medication data from the medical records of patients, aged ≥18, who received 1L treatment for HR+/HER2- aBC between 10/2019 and 02/2020. The presence of comorbidities (e.g., congestive heart failure, myocardial infarction, history of atrial arrythmias) and utilization of concomitant medications (excluding anti-cancer therapies) with known, possible, or conditional risk for QTc prolongation/TdP were summarized. The list of comorbidity risk factors was compiled from a targeted literature search and clinician review. The list of concomitant medications was obtained from crediblemeds.org.RESULTS: A total of 1164 patients with aBC were sampled across the six countries. Among them, 99% were female and the mean age was 62 years. The majority of patients had metastatic disease (85%); 15% had locally advanced disease. Among those with metastatic disease, 47% had visceral metastasis and 34% had bone-only metastasis. At 1L initiation, 84% of patients had an ECOG score of 0/1. Comorbidities associated with risk of QTc prolongation/TdP were observed in 8% of patients; the most frequently observed were congestive heart failure (3%) and history of myocardial infarction (2%) (Table 1). The proportion of patients who received at least one medication associated with risk of QTc prolongation/TdP was 39%. Overall, 42% of patients had at least one comorbidity or medication associated with risk of QTc prolongation/TdP. CONCLUSIONS: Approximately 2 out of 5 patients receiving 1L treatment for HR+/HER2- aBC had a comorbidity or utilized a concomitant medication that could increase risk of QTc prolongation/TdP. As cardiovascular toxicity is a known side effect associated with several anticancer therapies, the high prevalence of coexisting risk factors among patients receiving 1L treatment underscores the importance of assessing patients’ existing risk when selecting treatments for advanced breast cancer. Table 1. Presence of Comorbidities and Use of Concomitant Medications with known, possible, or conditional risk for QTc prolongation/TdP in Patients Who Received First-Line Therapy for HR+/HER2- Advanced Breast CancerN%Total Patients1164100ComorbiditiesMyocardial infarction202Congestive heart failure323Moderate or severe liver disease3 Citation Format: Reshma Mahtani, Katie Lewis, Emily Clayton, Matthew Last, Debanjali Mitra, Samantha Kurosky. Presence of comorbidities and use of concomitant medications associated with QTC prolongation/torsades de pointes in patients with HR+/HER2- advanced breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-59.

Introduction Adult vaccination coverage rates in the US are well below national targets, leaving many adults at increased risk. Additionally, typical vaccination coverage calculations do not adequately approximate population immunity as they do not consider whether multidose vaccines were administered within the recommended schedules. As timely administration of each dose optimizes overall vaccine effectiveness, we sought to document adherence to and completion of the hepatitis A (HepA), hepatitis B (HepB), and combined hepatitis A and hepatitis B (HepA-HepB) multidose vaccine schedule in an insured adult population in the US. Methods We conducted a retrospective database study of administrative claims from 2008 to 2015 (analyzed in 2017). Completion of 2 (HepA) and 3 doses (HepB and HepA-HepB), and adherence to the 2- and 3-dose recommended schedules were measured among individuals aged 19 years and older at first dose. The proportion of patients who completed 2 and 3 doses and were adherent to the recommended schedule were estimated using Kaplan-Meier methods. Results For HepA, 27.14% of initiating adults were adherent to the recommended schedule, and 32.05% had received a second dose by 42 months. Approximately one-third of adults who initiated the HepB or HepA-HepB series completed all 3 doses within 2 years of the minimum spacing (31.17% and 32.27%, respectively). Generally, completion and adherence were highest in individuals aged 60–64 years at the time of initiation. Conclusions Hepatitis vaccine adherence and completion in adults is suboptimal. As a result, the majority of adults initiating each series may not be receiving the full protective benefit of these multidose vaccines.

Purpose To describe treatment patterns and clinical outcomes among postmenopausal women with metastatic ER+/HER-2− breast cancer treated with ≥ 2 lines of endocrine therapy or chemotherapy in the metastatic setting. Patients and Methods Retrospective medical record review was conducted in Canada, the United Kingdom, Belgium, the Netherlands, Germany, Spain, and France. Baseline characteristics were assessed at the date of metastatic diagnosis. Time to progression (TTP) and overall survival (OS) were estimated by Kaplan-Meier analyses. Multivariable models were used to evaluate factors associated with disease progression. Results Among 901 patients, the mean (standard deviation) age at metastatic diagnosis was 62.7 (9.7) years; 67.26% were initially diagnosed with metastatic disease, 66.37% had visceral disease, and 25.86% had bone metastasis only. Two-thirds of patients received endocrine therapy for first-line treatment. Fifty-nine percent received endocrine therapy, and 37.18% received chemotherapy for second-line treatment. The most common reason for stopping treatment was disease progression. Median (95% confidence interval [CI]) TTP on first-line endocrine treatment was 11.3 (10.7-12.2) months and 7.0 (6.3-7.9) months on chemotherapy. Median (95% CI) TTP on second-line endocrine therapy was 8.1 (7.5-9.1) months and 6.1 (5.4-6.8) months on chemotherapy. Median (95% CI) OS was 68.6 (52.2-83.7) months after first-line endocrine therapy and 39.7 (34.5-48.7) months after chemotherapy. Conclusion Patients prescribed endocrine therapy had longer TTP and OS than patients prescribed chemotherapy in the first- and second-line settings. Disease progression was less than a year regardless of treatment type and line of therapy, indicating a need for treatments that delay progression without affecting quality of life among these patients.

Despite longstanding recommendations for routine vaccination against influenza; pneumococcal; tetanus, diphtheria, acellular pertussis (Tdap); and herpes zoster (HZ) among the United States general adult population, vaccine uptake remains low. Understanding factors that influence adult vaccination and coverage variability beyond the national level are important steps toward developing targeted strategies for increasing vaccination coverage. A retrospective analysis was conducted using data from the Behavioral Risk Factor Surveillance System (2011–2014). Multivariable logistic regression modeling was employed to identify individual factors associated with vaccination (socio-demographics, health status, healthcare utilization, state of residence) and generate adjusted vaccination coverage and compliance estimates nationally and by state. Results indicated that multiple characteristics were consistently associated with a higher likelihood of vaccination across all four vaccines, including female sex, increased educational attainment, and annual household income. Model-adjusted vaccination coverage estimates varied widely by state, with inter-state variability for the most recent year of data as follows: influenza (aged ≥18 years) 30.2–49.5%; pneumococcal (aged ≥65 years) 64.0–74.7%; Tdap (aged ≥18 years) 18.7–46.6%; and HZ (aged ≥60 years) 21.3–42.9%. Model-adjusted compliance with age-appropriate recommendations across vaccines was low and also varied by state: influenza+Tdap (aged 18–59 years) 7.9–24.7%; influenza+Tdap+HZ (aged 60–64 years) 4.1–14.4%; and influenza+Tdap+HZ+pneumococcal (aged ≥65 years) 3.0–18.3%. In summary, after adjusting for individual characteristics associated with vaccination, substantial heterogeneity across states remained, suggesting that other local factors (e.g. state policies) may be impacting adult vaccines uptake. Further research is needed to understand such factors, focusing on differences between states with high versus low vaccination coverage.

Vaccination at age-appropriate intervals increases protection against morbidity and mortality; however, compliance rates among children remain low partly due to a complicated vaccination schedule. Use of combination vaccines reduces the number of injections per visit; however, there is limited evidence quantifying the effect of combination vaccines on vaccination rates. To examine how combination vaccines impact childhood completion (receipt of recommended doses) and compliance (receipt of age-appropriate vaccinations) rates, this study analyzed vaccination data from the 2012 National Immunization Survey (NIS), a nationally representative cross-sectional survey of caregivers of children aged 24 to 35 months in the United States. Vaccines were categorized as combination or single antigen. Vaccine completion was measured at ages 8, 18, and 24 months. Vaccine compliance and time undervaccinated were measured at 24 months. Children who received at least 1 combination vaccine (86%) had a higher completion rate (69%) and compliance with the full vaccine series (4:3:1:3:3:1:4 series) at 24 months (24%) than those who received only single-antigen vaccines (50% and 13%, respectively). Receipt of combination vaccine was associated with an increased likelihood of completing all recommended vaccinations at 24 months (odds ratio [OR] = 2.5; P < 0.001), receiving all vaccinations at age-appropriate times (OR = 2.2; P < 0.001), and less than 7 months undervaccinated (OR = 2.4; P < 0.001). Combination vaccines were associated with improved completion and compliance and should be encouraged among children who are undervaccinated or who received single-antigen vaccines only.

Invasive meningococcal disease (IMD) is a contagious bacterial infection that can occur sporadically in healthy individuals. Symptoms are typically similar to other common diseases, which can result in delayed diagnosis and treatment until patients are critically ill. In the United States, IMD outbreaks are rare and unpredictable. During an outbreak, rapidly marshalling the personnel and monetary resources to respond is paramount to controlling disease spread. If a community lacks necessary resources for a quick and efficient outbreak response, the resulting economic cost can be overwhelming. We developed a conceptual framework of activities implemented by universities, health departments, and community partners when responding to university-based IMD outbreaks. Next, cost data collected from public sources and interviews were applied to the conceptual framework to estimate the economic cost, both direct and indirect, of a university-based IMD outbreak. We used data from two recent university outbreaks in Oregon as case studies. Findings indicate a university-based IMD outbreak response relies on coordination between health care providers/insurers, university staff, media, government, and volunteers, along with many other community members. The estimated economic cost was $12.3 million, inclusive of the cost of vaccines ($7.35 million). Much of the total cost was attributable to wrongful death and indirect costs (e.g., productivity loss resulting from death). Understanding the breadth of activities and the economic cost of such a response may inform budgeting for future outbreak preparedness and development of alternative strategies to prevent and/or control IMD.

Background: Octreotide has been used for decades in the United States (US) and Europe to treat patients with advanced neuroendocrine tumors (NETs). Lanreotide was approved in 2014 to improve progressionfree survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic NETs. Therefore, clinicians and patients may consider sequencing therapy from octreotide to lanreotide. However, current real-world outcomes data on patients who have made this transition is limited. Methods: We conducted a multicenter, noninterventional, retrospective medical record review of patients with locally advanced or metastatic gastroenteropancreatic NETs (NCT03112694). Included patients had been treated with long-acting octreotide monotherapy for ≥90 days before transitioning to lanreotide monotherapy and continued on lanreotide for ≥90 days. Abstractors entered patient demographic and clinical data into a customized, web-based case report form. We assessed clinically defined PFS and other tumorrelated outcomes while patients were treated with lanreotide. Outcomes were analyzed according to level of response at the time of transition from octreotide to lanreotide: progressive disease, nonprogressive disease, or unknown. Statistical analyses were descriptive. Clinically defined PFS and duration of treatment with lanreotide were estimated using the Kaplan-Meier method. Results: Data were abstracted for 91 patients with gastroenteropancreatic NETs who received long-acting octreotide followed by lanreotide at six US based sites. At initial diagnosis, 71.4% of patients had stage IV disease. Small intestine (63.7%) and pancreas (14.3%) were the most common primary tumor sites. Mean [standard deviation (SD)] duration of follow-up from diagnosis was 70.6 (41.3) months. Patients received long-acting octreotide for a mean (SD) of 38.4 (32.8) months. When patients transitioned to lanreotide, 57.1% had nonprogressive disease on octreotide, 30.8% had progressive disease, and the remainder had unknown disease status. The most common reasons for switching from octreotide to lanreotide were progressive disease (22.0%), formulary change (15.4%), and patient preference (9.9%). Patients received lanreotide for a median (95% CI) duration of 24.7 (16.7–59.9) months. At the end of follow-up, 74% of patients remained on lanreotide monotherapy. Progression occurred in 24.2% of patients during lanreotide treatment. Overall median (95% CI) clinician-defined PFS following the transition to lanreotide was estimated to be 23.7 months [20.2 months–NE (not estimable)]. Patients with nonprogressive disease when they transitioned to lanreotide experienced a median clinician-defined PFS of 24.7 (17.0–NE) months. Among patients reported to have progressive disease when they transitioned to lanreotide, median (95% CI) clinician-defined PFS was estimated to be 15.2 (11.4–NE) months. There were no material differences in adverse events recorded during the long-acting octreotide and lanreotide treatment periods. Conclusions: Our study suggests that lanreotide monotherapy is well tolerated and may contribute to stabilization of disease in a subset of patients with locally advanced or metastatic gastroenteropancreatic NETs previously treated with long-acting octreotide.

Background Early provisions of the Affordable Care Act (ACA) reduced financial barriers to preventive care, including routinely recommended vaccines; however, vaccination coverage remains suboptimal. This study examined characteristics of routine adult vaccinations and potential missed opportunities for vaccinations through the lens of healthcare resource utilization among adults in the ACA era. Methods This was a retrospective analysis of healthcare claims from the Truven Health MarketScan Commercial Claims and Encounters (CCAE), Medicare Supplemental (MS), and Multi-State Medicaid databases among adults aged 19 years or older. Influenza, Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), herpes zoster (HZ), and pneumococcal vaccinations were identified between 2011 and 2016. Potential missed opportunities were defined as well-visits at which individuals were age-eligible for vaccination but did not receive it, assessed during recommended windows for each vaccine. Missed encounters were defined as having no well-visits. Multivariable logistic regression was used to identify factors associated with vaccination and potential missed opportunities. Results Family/internal medicine and unknown/other providers administered most influenza, Tdap, and pneumococcal vaccinations, for the CCAE/MS and Medicaid cohorts, respectively. HZ vaccinations were primarily administered through pharmacies. The proportion of vaccination events increased in the pharmacy setting between 2011 and 2016. Having preventive care visits, non-well-visits, and receiving most care from a family/internal medicine practitioner were associated with increased odds of vaccination. Missed encounters were common in Medicaid enrollees. Potential missed opportunities were more prevalent in the CCAE/MS cohort than among Medicaid enrollees. Having non-well-visits was associated with a reduced likelihood of having a missed opportunity. Conclusion Since the ACA implementation, preventive care among adults was sporadic. Many adults had limited opportunities for vaccination. The large prevalence of missed opportunities suggests vaccination uptake could be improved. Better support for vaccination or referrals for providers who may not traditionally vaccinate could improve vaccine uptake.

Despite recommended routine vaccination with meningococcal conjugate vaccine (MenACWY) at ages 11-12 years with a booster at age 16 years, national estimates indicate MenACWY uptake is lower in older adolescents than younger adolescents. This study aimed to identify factors associated with MenACWY uptake among adolescents.Commercial Claims and Encounters (CCAE) and Medicaid MarketScan Databases from 2011 to 2016 were retrospectively analyzed (2017) to determine receipt of ≥1 dose of MenACWY during early (10.5 through 13 years) and late (15.5 through 18 years) adolescence. Multivariable logistic regression and nonlinear decomposition analyses were used to identify factors associated with MenACWY vaccination, potential missed opportunities, and differences between age groups.A larger proportion of younger adolescents than older adolescents received MenACWY: CCAE, 71.7% versus 48.9% (p.001); Medicaid, 59.3% versus 31.8% (p.001), respectively. In multivariable models (CCAE), older adolescents were less likely than younger ones to receive MenACWY (adjusted odds ratios [95% confidence intervals]: .68 [.67, .69]) and more likely to have a potential missed opportunity (1.27 [1.25, 1.28]). Decomposition results showed lower MenACWY uptake in older adolescents is largely attributed to fewer non-MenACWY vaccines received, fewer preventive care visits, and interaction with nonpediatric healthcare providers.Missed opportunities and infrequent preventive care encounters contribute to lack of vaccination in younger and older adolescents. However, the disparity in uptake between the two age groups was largely attributable to differences in healthcare utilization, suggesting a need for unique strategies to increase uptake among older adolescents, such as solidifying a vaccination platform for ages 16-18 years through encouragement of annual preventive care visits.

ObjectiveThe objective of this article is to describe real-world treatment patterns and outcomes in patients with platinum-refractory/resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PRROC) in the United States, United Kingdom, and Canada.Methods/MaterialsPhysicians retrospectively reviewed medical records of women aged 18 years or older who were diagnosed with PRROC between January 2010 and June 2014. Patient characteristics, initial PRROC therapy, and health care utilization were assessed; progression-free survival (PFS) and overall survival were estimated using Kaplan-Meier and Cox proportional hazards methods.ResultsData were obtained on 392 US, 296 UK, and 82 Canadian patients. At initial ovarian cancer diagnosis, 65.8% (United States), 93.3% (United Kingdom), and 82.9% (Canada) of patients had stage III/IV disease; 43.6%, 73.7%, and 56.1%, respectively, had high-grade tumors. At PRROC diagnosis, mean age was 57.2 years (United States), 59.2 years (United Kingdom), and 57.4 years (Canada). Eastern Cooperative Oncology Group performance status was 0/1 at PRROC diagnosis for 57.7% (United States), 80.1% (United Kingdom), and 36.6% (Canada) of patients. Most patients initiated systemic treatment after PRROC diagnosis (United States, 71.4%; United Kingdom, 83.1%; Canada, 81.7%). The most common initial PRROC therapy was pegylated liposomal doxorubicin monotherapy (United States, 18.6%; United Kingdom, 50.0%; Canada, 34.3%). During initial PRROC treatment, 80.7%, 59.8%, and 44.8% of patients had 1 office visit or more and 17.5%, 10.2%, and 14.9% of patients had 1 hospitalization or more in the United States, the United Kingdom, and Canada, respectively. Treatment toxicity was the most common reason for hospitalization (United States, 75.5%; United Kingdom, 64.0%; Canada, 80.0%). Median (95% confidence interval) PFS was 5.6 (4.9–6.2), 8.0 (6.8–9.2), and 6.4 (5.4–9.3) months in the United States, the United Kingdom, and Canada. The Cox proportional hazards model showed that stage III/IV, high-grade tumors, and poorer performance status were associated with shorter survival.ConclusionsCurrent treatments for PRROC yield limited PFS and frequent hospitalizations reported to be related to toxicities or procedural complications, suggesting a continued unmet need for more effective and tolerable therapeutic strategies for PRROC.

SUMMARYIndividuals with chronic respiratory conditions may be at increased risk for pertussis. We conducted a retrospective administrative claims analysis to examine the incidence and economic burden of diagnosed pertussis among adolescents and adults in the USA with chronic obstructive pulmonary disease (COPD) or asthma. Patients aged ⩾11 years with diagnosed pertussis and pre-existing COPD (n = 343) or asthma (n = 1041) were matched 1:1 to patients with diagnosed pertussis but without COPD or asthma. Differences in all-cause costs (‘excess’ costs) during the 45-day and 3-month and 6-month periods before and after the pertussis index date were calculated; adjusted excess costs were estimated via multivariate regressions. The incidence of diagnosed pertussis was higher among patients with COPD or asthma than among matched patients. Compared with matched patients, patients with pertussis and pre-existing COPD or asthma accrued greater all-cause adjusted costs across study periods ($3694 and $1193 more, respectively, in the 45-day period; $4173 and $1301 more in the 3-month period; and $6154 and $1639 more in the 6-month period; all P < 0·0001). Patients with pre-existing COPD or asthma experience an increased economic burden after diagnosed pertussis and may especially benefit from targeted tetanus, diphtheria, and acellular pertussis vaccination strategies.

Background: The American Academy of Pediatrics recommends exclusive breastfeeding to age 6 months. Although breastfeeding rates in the United States have been increasing over time, further improvements are needed to meet Healthy People 2020 targets. Research aim: This study examined predictors of breastfeeding initiation and maintenance among a population of insured pregnant women. Methods: Participants were 1,149 pregnant women enrolled in the Pregnancy and Influenza Project in two Kaiser Permanente regions in 2010-2011. Data were collected through interviews at enrollment and 1 month and 6 months postpartum and through participants’ electronic medical records. Results: Nearly all (99%) women reported initiating breastfeeding. Rates of exclusive breastfeeding were 70% and 54% at 1 month and 6 months, respectively; an additional 22% and 23% of women reported supplementing breastfeeding with formula. Of the women who supplemented, the mean ( SD) infant age at formula introduction was 53 (62) days. Of those who had stopped breastfeeding, the mean ( SD) infant age at cessation was 85 (59) days. Higher maternal education level, better maternal self-rated health, prenatal folic acid use, absence of chronic medical conditions, and infant full-term birth were significantly associated with breastfeeding maintenance. Conclusion: Although rates of breastfeeding in this population were higher than national rates, a significant number of women stopped breastfeeding or introduced formula earlier than recommended. Two to 3 months postpartum may be a critical period warranting additional encouragement or intervention by healthcare providers. Mothers’ education attainment, maternal health factors, and gestational age at delivery may predict likelihood of breastfeeding maintenance.

BACKGROUND An increasingly crowded immunization schedule threatens the completion and compliance of hepatitis B vaccinations (HepB), the primary method of hepatitis B prevention. Combination vaccines have been proposed to alleviate this problem. METHODS Data from the 2011 National Immunization Survey Public-Use Data File were utilized (GSK study identifier: HO-11-770) to compare HepB completion and compliance rates between 3 groups of children: those who received HepB combination vaccine, those who received non-HepB combination vaccine and those who received HepB single-antigen vaccine only. Completion was defined as the accumulation of 3 HepB doses by 18 months. Compliance was defined as the receipt of vaccine doses within the Advisory Committee on Immunization Practices' recommended age ranges. RESULTS Of a sample of 4,040,116 children, 39.4% received a HepB combination vaccine, 43.0% received a non-HepB combination vaccine and 17.5% received a HepB single-antigen vaccine. Overall, 91.2% of children completed all 3 recommended doses, but only 61.8% completed them at age-appropriate times. Those receiving single-antigen only (odds ratio = 0.25, 95% confidence interval: 0.17-0.35) or non-HepB combination vaccines (odds ratio = 0.50, 95% confidence interval: 0.37-0.69) were substantially less likely to complete 3 doses of HepB than those who received the HepB combination vaccine. CONCLUSIONS Although completion rates were high, a large proportion of children did not receive HepB doses at age-appropriate times. Combination vaccine was associated with both higher completion and compliance outcomes compared with HepB single-antigen vaccine.

Background A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations. Purpose To describe vaccination rates during pregnancy in the Vaccine Safety Datalink (VSD), with particular focus on vaccinations contraindicated during pregnancy. Methods Pregnancies ending in 2002 through 2009 and vaccinations administered during these pregnancies were identified in the VSD. Vaccination rates per 1000 pregnancies during the study period were calculated by vaccine type, recommendation category, pregnancy year, maternal age, and trimester. Analyses were conducted in 2012–2013. Results In the VSD, 669,695 pregnancies and 141,389 vaccinations were identified. Trivalent inactivated influenza (TIV) was the most commonly administered vaccination (174.1 doses per 1000 pregnancies) and was most often administered during the 2nd and 3rd trimesters. The most common vaccines in the “consider if indicated” category were tetanus–diphtheria (6.1 per 1000) and hepatitis B (3.7 per 1000). Contraindicated vaccination was infrequent, and the majority of these were measles–mumps–rubella (MMR) (1.2 per 1000); varicella (1.0 per 1000); and live-attenuated influenza vaccine (LAIV) (0.3 per 1000). Both “consider if indicated” and contraindicated vaccines were more frequently administered during early pregnancy. Conclusions TIV was the most commonly administered vaccine. With the exception of TIV, other vaccines were most frequently administered during early pregnancy and among younger women, suggesting that vaccination may occur when the woman and/or provider are unaware of the pregnancy. Contraindicated vaccines were infrequently administered during pregnancy; however, given that some women received contraindicated vaccines later in pregnancy, clearer recommendations and improved provider education may be needed.

Background Although vaccination with trivalent inactivated influenza vaccine (TIV) is recommended for all pregnant women, no vaccine effectiveness (VE) studies of TIV in pregnant women have assessed laboratory-confirmed influenza outcomes. Methods We conducted a case-control study over 2 influenza seasons (2010-2011 and 2011-2012) among Kaiser Permanente health plan members in 2 metropolitan areas in California and Oregon. We compared the proportion vaccinated among 100 influenza cases (confirmed by reverse transcription polymerase chain reaction) with the proportions vaccinated among 192 controls with acute respiratory illness (ARI) who tested negative for influenza and 200 controls without ARI (matched by season, site, and trimester). Results Among influenza cases, 42% were vaccinated during the study season compared to 58% and 63% vaccinated among influenza-negative controls and matched ARI-negative controls, respectively. The adjusted VE of the current season vaccine against influenza A and B was 44% (95% confidence interval [CI], 5%-67%) using the influenza-negative controls and 53% (95% CI, 24%-72%) using the ARI-negative controls. Receipt of the prior season's vaccine, however, had an effect similar to receipt of the current season's vaccine. As such, vaccination in either or both seasons had statistically similar adjusted VE using influenza-negative controls (VE point estimates range = 51%-76%) and ARI-negative controls (48%-76%). Conclusions Influenza vaccination reduced the risk of ARI associated with laboratory-confirmed influenza among pregnant women by about one-half, similar to VE observed among all adults during these seasons.

Background The need for research on the safety of vaccination during pregnancy is widely recognized. Large, population-based data systems like the Vaccine Safety Datalink (VSD) may be useful for this research, but identifying pregnancies using electronic medical record (EMR) and claims data can be challenging. Methods We modified an existing data processing algorithm to identify pregnancies within seven of the ten VSD sites. We validated the algorithm by calculating the agreement in pregnancy outcome type, end date, and gestational age between the algorithm and manual medical record review. At each participating site, we randomly sampled 15 episodes within four outcome type strata (live births, spontaneous abortions, elective abortions, and other pregnancy outcomes) for a total of 60 episodes per site. We also developed and validated methods to link mothers to their infants in the electronic data. Results We identified 595,929 pregnancy episodes ending in 2002 through 2006 among women 12 through 55 years of age. Of these pregnancies, 75% ended in live births, 12% in spontaneous abortions, and 9% in elective abortions. We were able to confirm a pregnancy within 28 days of the algorithm-estimated pregnancy start date for 99% of live births, 93% of spontaneous abortions, 92% of elective abortions, and 90% of other outcomes sampled. The agreement between the algorithm-identified and the abstractor-identified outcome date ranged from 70% (elective abortion) to 96% (live birth) depending on outcome type. When gestational age was available in the EMR, agreement ranged from 82% (other) to 98% (live birth) depending on outcome type. We confirmed 100% of the 350 sampled mother–infant linkages with manual medical record review. Conclusions The VSD algorithm accurately identifies pregnancy episodes and mother–infant pairs across participating sites. Additional manual record review may be needed to improve the precision of the pregnancy date estimates depending on specific study needs. These algorithms will allow us to conduct large, population-based studies of the safety of vaccination during pregnancy.

Background: Real-world evidence on current treatment patterns and outcomes is limited for patients with platinum-refractory/resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer (PRROC). This study aimed to describe the treatment patterns and outcomes of patients with PRROC in the United States (US), the United Kingdom (UK), and Canada (CA). Methods: Physicians retrospectively reviewed medical records of females aged ≥18 years diagnosed with PRROC from January 2010 to June 2014. Follow-up data available through October 2016 were extracted. Patient characteristics, initial PRROC treatment regimens, and associated health care utilization were assessed descriptively; clinical outcomes were estimated using the Kaplan-Meier and Cox proportional-hazards methods. Results: Data were obtained on 392 US, 296 UK, and 82 CA patients. At initial diagnosis of epithelial ovarian, fallopian tube, or peritoneal cancer, 65.8% (US), 93.3% (UK), and 82.9% (CA) of patients had stage III/IV disease and 43.6% (US), 73.7% (UK), and 56.1% (CA) had high-grade tumors. Most patients were diagnosed with PRROC in 2013 or 2014 (US: 64.8%, UK: 72.3%, CA: 64.6%) and mean age at PRROC diagnosis was 57 years in the US and CA and 59 years in the UK. The proportion of patients with ECOG performance status (PS) ≤1 at PRROC diagnosis was 57.7% in the US, 80.1% in the UK, and 36.6% in CA. Most patients received systemic treatment after PRROC diagnosis (US 71.4%; UK 83.1%; CA 81.7%). Most of the patients received only one treatment line at the time of extraction (US: 64.3%, UK: 75.6%, CA: 70.2%). Bevacizumab ± chemotherapy (US 41.4%; UK 12.6%; CA 35.8%) and pegylated liposomal doxorubicin (PLD) monotherapy (US 18.6%; UK 50.0%; CA 34.3%) were the most common initial therapies. Common subsequent treatments varied between the countries, including topotecan, gemcitabine, PLD, paclitaxel. During initial treatment for PRROC, 80.7%, 59.8%, and 44.8% of patients had at least one office visit and 18.9%, 7.3%, and 19.4% of patients had at least one emergency department visit in the US, UK, and CA, respectively. Hospitalizations during initial treatment for PRROC were observed among 17.5% of patients in the US, 10.2% in the UK, and 14.9% in CA. Treatment toxicity was the most common reason for hospitalization (US 75.5%; UK 64.0%; CA 80.0%). Median progression-free survival (PFS; 95% confidence interval) was 6.4 (5.4-9.3), 8.0 (6.8-9.2), and 5.6 (4.9-6.2) months in the US, UK, and CA, respectively. The Cox proportional-hazards model showed that stage III/IV, high-grade tumors, and poorer PS were associated with shorter survival. Conclusions: Even though bevacizumab ± chemotherapy and PLD were the most common initial PRROC treatments in the three countries, relatively higher utilization of bevacizumab ± chemotherapy was observed in the US and CA than the UK, plausibly due to lack of bevacizumab reimbursement in the UK for the treatment of PRROC. Limited PFS and a high prevalence of hospitalization due to treatment toxicity observed with initial treatments suggest a continued need for more effective and tolerable treatment strategies for PRROC. Citation Format: Rohan Parikh, Samantha Kurosky, Margarita Udall, Jane Chang, Joseph C. Cappelleri, Jim P. Doherty, James A. Kaye. Treatment patterns and outcomes among platinum-refractory/resistant ovarian cancer patients. [abstract]. In: Proceedings of the AACR Conference: Addressing Critical Questions in Ovarian Cancer Research and Treatment; Oct 1-4, 2017; Pittsburgh, PA. Philadelphia (PA): AACR; Clin Cancer Res 2018;24(15_Suppl):Abstract nr A45.

e16174Background: Somatostatin analogs (SSA), such as OCT and LAN, are used to treat GEP-NETs. LAN is effective for carcinoid syndrome (CS) control in both SSA-experienced and -naive patients (pts)...

The authors conducted a matched case-control study of laboratory-confirmed pertussis cases, occurring from 1/1/1996 to 12/31/2005, in children up to 12 years of age who were members of a large managed care organization. Sixty-five laboratoryconfirmed cases of pertussis were identified. Using multivariable conditional logistic regression analysis, the authors did not detect a statistically significant association between pertussis and household passive exposure to cigarette smoking.

While the economic burden of muscular dystrophy (MD) has been well documented, little is known of specific costs associated with Duchenne muscular dystrophy (DMD), the most prevalent form of MD. This study assessed trends in MD-related hospitalizations and costs among young males, which may reflect utilization of the DMD population in the United States.A retrospective observational study of hospitalizations of males aged 0-20 years with a primary diagnosis code for MD was conducted using data from a weighted, nationally representative database of pediatric hospitalizations in the US. Rates, characteristics and cost of MD-related hospitalizations were compared to hospitalizations not related to MD.The rate of MD-related hospitalizations increased by 9% between 2000 and 2006 and then decreased by 13% in 2009. The mean length of stay for discharges related to MD was approximately 9 days during each study year. The most frequent observed diagnoses (other than MD) and procedures were for respiratory-related complications. The mean total costs for MD-related discharges increased across the study period from $26,785 in 2000 to $42,751 in 2009.This study provides baseline and trend data describing hospitalizations of male pediatric patients with MD that may be used as baseline measurements for assessment of the impact of new strategies for managing the disease. Further assessment of the burden and the clinical, economic, and humanistic impacts of DMD is warranted.

A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations.To describe vaccination rates during pregnancy in the Vaccine Safety Datalink (VSD), with particular focus on vaccinations contraindicated during pregnancy.Pregnancies ending in 2002 through 2009 and vaccinations administered during these pregnancies were identified in the VSD. Vaccination rates per 1000 pregnancies during the study period were calculated by vaccine type, recommendation category, pregnancy year, maternal age, and trimester. Analyses were conducted in 2012-2013.In the VSD, 669,695 pregnancies and 141,389 vaccinations were identified. Trivalent inactivated influenza (TIV) was the most commonly administered vaccination (174.1 doses per 1000 pregnancies) and was most often administered during the 2nd and 3rd trimesters. The most common vaccines in the "consider if indicated" category were tetanus-diphtheria (6.1 per 1000) and hepatitis B (3.7 per 1000). Contraindicated vaccination was infrequent, and the majority of these were measles-mumps-rubella (MMR) (1.2 per 1000); varicella (1.0 per 1000); and live-attenuated influenza vaccine (LAIV) (0.3 per 1000). Both "consider if indicated" and contraindicated vaccines were more frequently administered during early pregnancy.TIV was the most commonly administered vaccine. With the exception of TIV, other vaccines were most frequently administered during early pregnancy and among younger women, suggesting that vaccination may occur when the woman and/or provider are unaware of the pregnancy. Contraindicated vaccines were infrequently administered during pregnancy; however, given that some women received contraindicated vaccines later in pregnancy, clearer recommendations and improved provider education may be needed.

Purpose The Advisory Committee on Immunization Practices recommended quadrivalent human papillomavirus vaccine (HPV4) for use in females in June 2006 and in males in October 2009. The objective of our study was to describe HPV4 uptake, single-dose coverage, and completion of the three-dose series among those 9–26 years of age, after the respective female and male vaccine licensures through June 2011. Methods The study population included members of eight managed care organizations participating in the Vaccine Safety Datalink; we abstracted demographic and comprehensive vaccine information from electronic health records. Results We found one-dose coverage increasing throughout the study period, to a high of 37.7% among females and 1.3% among males in June 2011. Among those receiving at least one HPV4 dose, three-dose series completion was 42% for females and 30.2% for males. Conclusions Our results demonstrate low initiation and completion of the HPV4 series among those recommended to receive the vaccine. Although consistent with previous studies, these results highlight the continued need to develop, implement, and monitor strategies to increase HPV4 vaccine initiation and completion in younger adolescents to achieve maximum impact in reducing the burden of cervical cancer and other HPV-related diseases.

Objective Many adolescents do not complete the 3-dose human papillomavirus vaccine series in the recommended time frame, or at all. Given the challenges of administering a multi-dose vaccine to adolescents, especially those in vulnerable populations, we evaluated completion of the human papillomavirus vaccine series in 19 of Oregon's school-based health centers. Methods Among persons aged 0–17 who initiated the human papillomavirus vaccine series at a study school-based health center in 2007, we identified all subsequent human papillomavirus doses administered at the school-based health centers, or found in Oregon's immunization information system, in 2007–2008. We describe the proportion completing the vaccine series and mean intervals between doses, stratified by age, race, and insurance status. Results Four hundred fifty persons initiated the human papillomavirus series in 2007. By December 2008, 51% of these had received all 3 doses. Series completion increased significantly with age, differed significantly between race groups (highest among white persons (56%); lowest among black persons (38%)), and did not differ significantly by insurance status. Mean intervals between doses did not differ significantly by race or insurance status. Conclusions Even in challenging conditions, school-based health centers provide excellent preventive care to vulnerable youth. These results support the importance of maintaining and expanding school-based health center access in vulnerable adolescent populations.

Purpose: To examine the relationship between role model presence, type of role model, and various health-risk and health-protective behaviors among California adolescents. Methods: We used cross-sectional data on 4,010 multiethnic adolescents aged 12–17 years from the 2003 California Health Interview Survey, a population-based random-digit dial telephone survey of more than 40,000 California households. The survey, conducted every other year since 2001, collects extensive demographic, health, and health-related information. Results: Fifty-nine percent of adolescents identified a role model. Affluent teens were more likely to have a role model than lower income teens. Role models were generally of the same ethnicity and gender as the teens; ethnic congruence was higher among African Americans and whites than Latinos and Asians; gender congruence was higher among males. Type of role model was significantly associated with health-related behaviors. Identification of a teacher was strongly associated with positive health behaviors. Correlations with health-promoting behaviors were generally smaller in magnitude but consistently positive among family member and athlete role models. Peer or entertainer role models were associated with health-risk behaviors. Conclusion: Not only role model presence but also the type of role model is an important predictor of adolescent health-related behaviors. Our findings have implications for designing youth targeted interventions and policies involving role models. 2011 Society for Adolescent Health and Medicine. All rights reserved.

When it comes to school readiness, children's health matters. Healthy children are better prepared to learn, concentrate and develop the skills needed to succeed in school--and throughout life. Although good health supports learning among children of all ages, it is particularly important during early childhood when a crucial period of rapid physical and emotional growth occurs between birth and age five. Therefore, providing children early on with an environment conducive to healthy development and learning lays the foundation for a successful future. Not all children, however, have this opportunity. Research shows children living in poverty, with poor health status or low-quality childcare, are more likely to have developmental and learning delays. Many of California's three million children ages 0-5 grow up in environments where their health may limit their social, emotional and academic development. This brief examines trends in key health indicators for children ages 0-5 in California between 2001 and 2005, based on data from the California Health Interview Survey (CHIS). Conducted every other year since 2001, CHIS is a statewide survey that provides information on health conditions, health behaviors, access to health care, and use of services among children, adolescents and adults in California. Examining CHIS data from multiple survey years provides valuable information on California's progress toward better health and school readiness for young children.