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Purpose: BMT CTN 1102 was a phase III trial comparing reduced-intensity allogeneic hematopoietic cell transplantation (RIC alloHCT) to standard of care for persons with intermediate- or high-risk myelodysplastic syndrome (MDS). We report results of a cost-effectiveness analysis conducted alongside the clinical trial., Methods: Three hundred eighty-four patients received HCT (n = 260) or standard of care (n = 124) according to availability of a human leukocyte antigen-matched donor. Cost-effectiveness was calculated from US commercial and Medicare perspectives over a 20-year time horizon. Health care utilization and costs were estimated using propensity score-matched cohorts of HCT recipients in the OptumLabs Data Warehouse (age 50-64 years) and Medicare (age 65 years and older). EuroQol 5 Dimension (EQ-5D) surveys of trial participants were used to derive health state utilities., Results: Extrapolated 20-year overall survival for those age 50-64 years was 29% for HCT (n = 105) versus 13% for usual care (n = 44) and 31% for HCT (n = 155) versus 12% for non-HCT (n = 80) for those age 65 years and older. HCT was more effective (+2.36 quality-adjusted life-years [QALYs] for age 50-64 years and +2.92 QALYs for age 65 years and older) and more costly (+$452,242 in US dollars (USD) for age 50-64 years and +$233,214 USD for age 65 years and older) than usual care, with incremental cost-effectiveness ratios of $191,487 (USD)/QALY and $79,834 (USD)/QALY, respectively. For persons age 50-64 years, there was a 29% chance that HCT was cost-effective using a willingness-to-pay (WTP) threshold of $150K (USD)/QALY and 51% at a $200K (USD)/QALY. For persons age 65 years and older, the probability was 100% at a WTP >$150K (USD)/QALY., Conclusion: Among patients age 65 years and older with high-risk MDS, RIC HCT is a high-value strategy. For those age 50-64 years, HCT is a lower-value strategy but has similar cost-effectiveness to other therapies commonly used in oncology.

Purpose: We conducted a pragmatic, cluster-randomized trial to test whether a guideline-based standing order entry (SOE) improves use of primary prophylactic CSF (PP-CSF) prescribing for patients receiving myelosuppressive chemotherapy. We investigated variability in adherence to the intervention., Methods: We conducted a cluster-randomized trial among 32 oncology clinics from the NCI Community Oncology Research Program. Clinics were randomized 3:1 to a guideline-based PP-CSF SOE or usual care. Among SOE sites, automated orders for PP-CSF were included for regimens at high risk for febrile neutropenia (FN) and an alert not to use PP-CSF for low FN risk. A secondary 1:1 randomization was done among intervention sites to either SOE to prescribe or an alert to not prescribe PP-CSF for patients receiving intermediate risk-regimens. Providers were allowed to override the SOE., Results: Overall, PP-CSF use among patients receiving high FN risk treatment was high and not different between arms; however, rates of PP-CSF use varied widely by site, ranging from 48.6% to 100%. Among those receiving low FN risk regimens, PP-CSF use was low and not different between arms; however, PP-CSF use ranged from 0% to 19.4% across sites. In the intermediate-risk substudy, PP-CSF was five-fold higher among sites randomized to SOE; however, there was considerable variability in adherence to intervention assignment: PP-CSF use ranged from 0% to 75% among sites randomized to SOE. Despite an alert to not prescribe, PP-CSF prescribing ranged from 0% to 33%., Conclusion: In this randomized pragmatic trial aimed at improving PP-CSF prescribing, there was substantial variability in site adherence to the intervention assignment. Although the ability to opt out of the intervention is a feature of pragmatic trials, planning to estimate nonadherence is critical to ensure adequate power.

Purpose: The COVID-19 pandemic-related disruptions in health care delivery might have affected end-of-life care in patients with cancer. We examined changes in place of death and hospice support for Medicaid and commercially insured patients during the pandemic., Patients and Methods: We linked Washington State cancer registry records with claims from Medicaid and two commercial insurers for patients with solid tumor age 18-64 years. The study included 322 Medicaid and 162 commercial patients who died between March 2017 and June 2019 (pre-COVID-19), along with 90 Medicaid and 47 commercial patients who died between March and June 2020 (COVID-19). Place of death was categorized as hospital, hospice (home or nonhospital facility), and home without hospice. Place of death was compared using adjusted multinomial logistic regressions stratified by payer and time period (pre-COVID-19 v COVID-19). The clinical and sociodemographic factors associated with dying at home without hospice were examined, and adjusted marginal effects (ME) are reported., Results: In the adjusted pre-COVID-19 analysis, Medicaid patients were more likely than commercially insured patients to die in hospital (48% v 36%; adjusted ME, 11%; P = .02). In the pre-COVID-19/COVID-19 analysis, Medicaid patients' place of death shifted from hospital (48% v 32%; ME, -16%; P < .01) to home without hospice (19.9% v 38.0%; ME, 16.5%; P < .01). However, there were no statistically significant changes pre-COVID-19/COVID-19 for commercial patients. As a result, during COVID-19, Medicaid patients were more likely than commercial patients to die at home without hospice (38% v 22%; ME, 16%; P = .04) as were male versus female patients (ME, 16%; P < .01)., Conclusion: The pandemic might have disproportionately worsened the end-of-life experience for Medicaid enrollees with cancer. Attention should be paid to societal and health system factors that decrease access to care for Medicaid patients.

Purpose: Primary prophylactic colony-stimulating factors (PP-CSFs) are prescribed to reduce febrile neutropenia (FN) but their benefit for intermediate FN risk regimens is uncertain. Within a pragmatic, randomized trial of a standing order entry (SOE) PP-CSF intervention, we conducted a substudy to evaluate the effectiveness of SOE for patients receiving intermediate-risk regimens., Methods: TrACER was a cluster randomized trial where practices were randomized to usual care or a guideline-based SOE intervention. In the primary study, sites were randomized 3:1 to SOE of automated PP-CSF orders for high FN risk regimens and alerts against PP-CSF use for low-risk regimens versus usual care. A secondary 1:1 randomization assigned 24 intervention sites to either SOE to prescribe or an alert to not prescribe PP-CSF for intermediate-risk regimens. Clinicians were allowed to over-ride the SOE. Patients with breast, colorectal, or non-small-cell lung cancer were enrolled. Mixed-effect logistic regression models were used to test differences between randomized sites., Results: Between January 2016 and April 2020, 846 eligible patients receiving intermediate-risk regimens were registered to either SOE to prescribe (12 sites: n = 542) or an alert to not prescribe PP-CSF (12 sites: n = 304). Rates of PP-CSF use were higher among sites randomized to SOE (37.1% v 9.9%, odds ratio, 5.91; 95% CI, 1.77 to 19.70; P = .0038). Rates of FN were low and identical between arms (3.7% v 3.7%)., Conclusion: Although implementation of a SOE intervention for PP-CSF significantly increased PP-CSF use among patients receiving first-line intermediate-risk regimens, FN rates were low and did not differ between arms. Although this guideline-informed SOE influenced prescribing, the results suggest that neither SOE nor PP-CSF provides sufficient benefit to justify their use for all patients receiving first-line intermediate-risk regimens.

Purpose: Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to participants. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung Cancer Master Protocol (Lung-MAP)., Methods: Eligible participants with previously treated advanced non-small-cell lung cancer were recruited from patients enrolled in Lung-MAP. Participants completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent. The survey assessed understanding about the benefits and risks of Lung-MAP participation and knowledge of the potential uses of somatic testing results returned. Descriptive statistics and odds ratios for associations between demographic factors and correct responses to survey items were assessed., Results: From August 1, 2017, to June 30, 2019, we recruited 207 participants with a median age of 67, 57.3% male, and 94.2% White. Most participants "strongly/somewhat agreed" with statements that they "received enough information to understand" Lung-MAP benefits (82.6%) and risks (69.5%). In items asking about potential uses of Lung-MAP genomic results, 87.0% correctly indicated that the results help to select cancer treatment, but < 20% correctly indicated that the results are not used to confirm cancer diagnosis, would not reveal risk of developing diseases besides cancer, and would not indicate if family members had increased cancer risk. There were no associations between sociodemographic factors and proportions providing correct responses., Conclusion: In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study despite most indicating that they had enough information to understand benefits and risks., Competing Interests: Joshua A. RothEmployment: Genentech/RocheConsulting or Advisory Role: Bristol-Myers Squibb, Bayer, Epigenomics, Seattle Genetics Meghna S. TrivediHonoraria: Onclive Stacy W. GrayStock and Other Ownership Interests: Magenta TherapeuticsHonoraria: Triptych Health PartnersConsulting or Advisory Role: Magenta Therapeutics Donald L. PatrickHonoraria: Grail, AllakosConsulting or Advisory Role: Philip Morris International Mary W. RedmanConsulting or Advisory Role: AstraZeneca Vassiliki PapadimitrakopoulouEmployment: PfizerHonoraria: RocheConsulting or Advisory Role: Clovis Oncology, Genentech, Merck, Biothera, Lilly, Janssen, Genentech, AstraZeneca, ARIAD, Nektar, Loxo, Araxes Pharma, Abbvie, Bristol-Myers Squibb, Exelixis, Pfizer, Novartis, Takeda, TRM Oncology, Tesaro, Arrys Therapeutics, Gritstone Oncology, Leads Biolabs, Bolt Biotherapeutics, G2 InnovationResearch Funding: Merck, Novartis, Celgene, Clovis Oncology, Bayer, Bristol-Myers Squibb, AstraZeneca, Pfizer, Janssen Oncology, ACEA Biosciences, Nektar, Roche, Lilly, Checkmate Pharmaceuticals, Checkmate Pharmaceuticals, Checkmate Pharmaceuticals, Incyte, Guardant HealthTravel, Accommodations, Expenses: AstraZeneca, Roche, RocheOther Relationship: Roche Karen KellyConsulting or Advisory Role: Novartis, Symphogen, Inivata, Bristol-Myers Squibb, AstraZeneca, Regeneron, EMD Serono, Takaeda, Lilly, Amgen, EMD Serono, Genmab, Targeted Oncology, Genentech, Debiopharm Group, Abbvie, Daiichi Sanko, Janssen, GlaxoSmithKlineResearch Funding: EMD Serono, Genentech, Abbvie, Five Prime Therapeutics, Regeneron, Astellas Pharma, Tizona Therapeutics, Inc, Lilly, Novartis, AmgenPatents, Royalties, Other Intellectual Property: Author Royalties for UpToDate, an evidence based, peer reviewed information resource, available via the web, desktop, and PDATravel, Accommodations, Expenses: AstraZeneca, Genentech/Roche, Merck, Regeneron, Lilly, Abbvie, EMD Serono David GandaraHonoraria: AstraZeneca, MJH Life Sciences Healthcare, CBPartnersConsulting or Advisory Role: AstraZeneca, Guardant Health, OncoCyte, Amgen, IObiotech, Merck, Roche/Genentech, Boehringer Ingelheim, Inivata, LillyResearch Funding: Roche/Genentech, Merck, AmgenTravel, Accommodations, Expenses: Boehringer Ingelheim Roy S. HerbstLeadership: Junshi PharmaceuticalsConsulting or Advisory Role: AstraZeneca, Genentech/Roche, Merck, Pfizer, Abbvie, Biodesix, Bristol-Myers Squibb, Lilly, EMD Serono, Heat Biologics, Junshi Pharmaceuticals, Loxo, Nektar, NextCure, Novartis, Sanofi, Seattle Genetics, Shire, Spectrum Pharmaceuticals, Symphogen, TESARO, Neon Therapeutics, Infinity Pharmaceuticals, ARMO Biosciences, Genmab, Halozyme, Tocagen, Bolt Biotherapeutics, I-Mab, Immunocore, Mirati Therapeutics, Takeda, Cybrexa Therapeutics, eFFECTOR Therapeutics, Candel Therapeutics, Inc, Oncternal Therapeutics, STCube Pharmaceuticals, Inc, WindMIL, XencorResearch Funding: AstraZeneca, Merck, Lilly, Genentech/Roche Dawn L. HershmanConsulting or Advisory Role: AIM Specialty Health Scott D. RamseyEmployment: Flatiron HealthConsulting or Advisory Role: Bayer, Genentech, Bristol-Myers Squibb, AstraZeneca, Merck, GRAIL, Pfizer, Seattle Genetics, BiovicaResearch Funding: Bayer, Bristol-Myers Squibb, MicrosoftTravel, Accommodations, Expenses: Bayer Schering Pharma, Bristol-Myers Squibb, Flatiron Health, Bayer, GRAILNo other potential conflicts of interest were reported.

Purpose: Systemic therapy use in the last 30 days of life (DOL) for patients with advanced cancer is a low-value medical practice. We hypothesized that systemic therapy use in the last 30 DOL increased after approval of antiprogrammed cell death protein 1 immune checkpoint inhibitors (ICIs) and has contributed to increased health care utilization and spending., Methods: We investigated the change in prevalence of any systemic therapy use in the last 30 DOL among patients with advanced solid tumors in the 4 years before and after antiprogrammed cell death protein 1 ICI approval in 2014. We used cases from the Western Washington Cancer Surveillance System linked to commercial and Medicare insurance. We calculated the difference in prevalence between the pre- and post-ICI periods. We also calculated the annual prevalence of any systemic therapy and ICI use in the last 30 DOL and measured health care utilization (emergency department visits and hospitalizations) and costs during the last 30 DOL., Results: Eight thousand eight hundred seventy-one patients (median age 73 years) were included; 34% and 66% in the pre-and post-ICI period, respectively. Systemic therapy use in the last 30 DOL was lower in the post-ICI versus pre-ICI period (12.4% v 14.4%; difference -2.0% [95% CI, -3.5 to -0.5]). The annual prevalence of systemic therapy use in the last 30 DOL also declined, although ICI use rose. Patients treated with ICIs in last 30 DOL had more emergency department visits, hospitalizations, and higher costs., Conclusion: Systemic therapy use in the last 30 DOL was lower in the period after ICI approval. However, ICI use rose over time and had higher utilization and costs in the last 30 DOL. Systemic therapy use in the last 30 DOL warrants monitoring, especially as more ICI indications are approved., Competing Interests: Ali Raza KhakiStock and Other Ownership Interests: Merck, Sanofi Petros GrivasConsulting or Advisory Role: Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Clovis Oncology, EMD Serono, Seattle Genetics, Foundation Medicine, Pfizer, Janssen, Genzyme, Mirati Therapeutics, Exelixis, Roche, GlaxoSmithKline, Genentech, Immunomedics, Dyania Health, Infinity Pharmaceuticals, QED Therapeutics, 4D PharmaResearch Funding: Pfizer, Clovis Oncology, Bavarian Nordic, Immunomedics, Bristol Myers Squibb, Debiopharm Group, Merck Sharp & Dohme, QED Therapeutics, Kure It Cancer Research, GlaxoSmithKline, Mirati Therapeutics Scott D. RamseyEmployment: Flatiron HealthConsulting or Advisory Role: Bayer, Genentech, Bristol Myers Squibb, AstraZeneca, Merck Sharp & Dohme, Grail, Pfizer, Seattle Genetics, BiovicaResearch Funding: Bayer, Bristol Myers Squibb, MicrosoftTravel, Accommodations, Expenses: Bayer Schering Pharma, Bristol Myers Squibb, Flatiron Health, Bayer, Grail Veena ShankaranHonoraria: Proteus Digital Health, Taiho PharmaceuticalResearch Funding: Amgen, Merck Sharp & Dohme, Bayer, Bristol Myers Squibb, AstraZeneca, Genentech/Roche, ApexigenTravel, Accommodations, Expenses: Proteus Digital Health, Taiho PharmaceuticalNo other potential conflicts of interest were reported.

Purpose: The costs associated with clinical trial enrollment remain uncertain. We hypothesized that trial participation is associated with decreased total direct medical costs to health care payers in metastatic non-small-cell lung cancer., Methods: In this retrospective cohort study, we linked clinical data from electronic medical records to sociodemographic data from a cancer registry and claims data from Medicare and two private insurance plans. We used a difference-in-difference analysis to estimate mean per patient per month total direct medical costs for patients enrolled on a second-line (2L) trial versus patients receiving standard-of-care 2L systemic therapy., Results: Among 70 eligible patients, the difference-in-difference of mean per patient per month total direct medical costs between 2L trial participants and nonparticipants was -$6,663 ( P = .01), for a mean savings of $45,308 per patient for the duration of 2L trial therapy. In a secondary analysis by primary insurance payer, this difference-in-difference was -$5,526 ( P = .26) for patients with commercial insurance and -$7,432 ( P = .01) for patients with Medicare., Conclusion: Participation in a 2L trial was associated with a $6,663 per month cost savings to health care payers for the duration of trial participation. Further studies are necessary to elucidate differences in cost savings from trial participation for Medicare and commercial payers. If confirmed, these results support health care payer investment in programs to improve clinical trial access and enrollment., Competing Interests: Keith D. EatonResearch Funding: Mirati Therapeutics Renato G. MartinsHonoraria: Roche/GenentechResearch Funding: Lilly, Eisai, Pfizer, Merck Sharp & Dohme Scott D. RamseyEmployment: Flatiron HealthConsulting or Advisory Role: Bayer, Genentech, Bristol Myers Squibb, AstraZeneca, Merck, GRAIL, Pfizer, Seattle Genetics, BiovicaResearch Funding: Bayer, Bristol Myers Squibb, MicrosoftTravel, Accommodations, Expenses: Bayer Schering Pharma, Bristol Myers Squibb, Flatiron Health, Bayer, GRAILNo other potential conflicts of interest were reported.

Purpose: Patients with cancer living in socioeconomically disadvantaged areas have worse cancer outcomes. The association between socioeconomic deprivation and outcomes among patients with cancer participating in clinical trials has not been systematically examined., Methods: We examined survival outcomes for patients enrolled in phase III and large phase II clinical trials for major cancers conducted by the SWOG Cancer Research Network from 1985 to 2012. Socioeconomic deprivation was measured using trial participants' residential zip codes linked to the Area Deprivation Index (ADI). Five-year overall survival, progression-free survival, and cancer-specific survival were examined using Cox regression frailty models, adjusting for age, sex, and race, and separately for insurance status, prognostic risk, and rural or urban residency., Results: We examined 41,109 patients from 55 trials comprising 24 cancer histology and stage-specific cohorts. Compared with trial participants in the most affluent areas (ADI, 0%-20%), trial participants from areas with the highest socioeconomic deprivation (ADI, 80%-100%) had worse overall (hazard ratio [HR] = 1.28, 95% CI, 1.20 to 1.37, P < .001), progression-free (HR = 1.20, 95% CI, 1.13 to 1.28, P < .001), and cancer-specific survival (HR = 1.27, 95% CI, 1.18 to 1.37, P < .001). The results were similar after adjusting for insurance status, prognostic risk, and rural or urban residency. There was a continuous increase in risk of all outcomes as the ADI quintile increased., Conclusion: In patients with cancer with access to protocol-directed care in clinical trials, high area-level socioeconomic deprivation was associated with worse survival. Future research should examine whether the etiology of this residual disparity is related to reduced access to supportive care or postprotocol therapy and/or to differences in health status not reflected by protocol selection criteria., Competing Interests: Raymond U. OsarogiagbonStock and Other Ownership Interests: Lilly, Pfizer, Gilead SciencesHonoraria: BiodesConsulting or Advisory Role: Association of Community Cancer Centers (ACCC), AstraZeneca, American Cancer Society, Triptych Health PartnersPatents, Royalties, Other Intellectual Property: 2 US and 1 China patents for lymph node specimen collection kit and method of pathologic evaluationOther Relationship: Oncobox Scott D. RamseyEmployment: Flatiron HealthConsulting or Advisory Role: Bayer, Genentech, Bristol-Myers Squibb, AstraZeneca, Merck, GRAIL, Pfizer, Seattle Genetics, BiovicaResearch Funding: Bayer, Bristol-Myers Squibb, MicrosoftTravel, Accommodations, Expenses: Bayer Schering Pharma, Bristol-Myers Squibb, Flatiron Health, Bayer, GRAIL Dawn L. HershmanConsulting or Advisory Role: AIM Specialty HealthNo other potential conflicts of interest were reported.

Purpose: We investigated the association of out-of-pocket (OOP) costs for tyrosine kinase inhibitors (TKIs) with overall survival (OS) in epidermal growth factor receptor ( EGFR )- and anaplastic lymphoma kinase ( ALK )-positive advanced non-small-cell lung cancer (NSCLC). We secondarily investigated associations of TKI OOP costs with TKI adherence, duration of therapy (DOT), and TKI discontinuation., Methods: We used the Hutchinson Institute for Cancer Outcomes Research registry-claims database to identify patients with stage IV EGFR - or ALK -positive NSCLC; ≥ 1 claims for EGFR or ALK TKIs; and ≥ 3-month survival from TKI initiation. We estimated the average monthly TKI OOP costs per patient up to 3 months from TKI initiation, categorizing patients into quartiles of TKI OOP costs (Q1 < Q2 < Q3 < Q4). We conducted landmark analysis at 3 months from TKI initiation to compare Q1-3 v Q4 TKI OOP costs with respect to OS, TKI DOT, TKI adherence, and TKI discontinuation., Results: Seventy-eight and twenty-seven patients comprised the Q1-3 and Q4 groups, respectively. Median monthly TKI OOP costs were $1,431 (Q1-3) v $2,888 (Q4). Compared with Q1-3, Q4 patients had inferior OS (adjusted hazard ratio [HR], 1.85; [95% CI, 1.11 to 3.10], similar TKI DOT (adjusted HR, 1.06; 95% CI, 0.53 to 2.15), decreased TKI adherence (adjusted odds ratio [OR], 0.28; 95% CI, 0.10 to 0.76), and higher TKI discontinuation rate (adjusted OR, 8.75; 95% CI, 2.59 to 29.52)., Conclusion: Among patients with advanced EGFR - and ALK -positive NSCLC, higher TKI OOP costs are associated with decreased TKI adherence, a higher likelihood of TKI discontinuation, and inferior survival.

Purpose: Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions., Methods: We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed., Results: In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% v 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; P = .57) and site-reported time to AF (21.9% v 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; P = .21) also did not differ by arm., Conclusion: To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions., Competing Interests: The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Purpose: Few studies have directly compared health care utilization, costs, and outcomes between patients treated in the US multipayer health system and Canada's single-payer system. Using cancer registry and claims data, we assessed treatment types, costs, and survival for patients with metastatic colorectal cancer (mCRC) in Western Washington State (WW) and British Columbia (BC)., Materials and Methods: Patients age ≥ 18 years diagnosed with mCRC in 2010 and later were identified from the BC Cancer database and a regional database linking WW SEER to claims from Medicare and two large commercial insurers. Demographics, treatment characteristics, costs of systemic therapy, and survival data were obtained from these databases and compared between the two regions., Results: A total of 1,592 patients from BC and 901 from WW were included in the study. Median age was similar (BC, 66 years; WW, 63 years), but patients in BC were more likely to be male (57.1% v 51.2%; P ≤ .01) and to have de novo metastatic disease (61.0% v 38.3%; P ≤ .01). The use of radiation therapy was similar between regions (BC, 31.2%; WW, 33.9%; P = .18), but primary tumor resection was more common in BC (74.1% v 66.3%; P ≤ .01) as was hepatic metastasectomy (12.4% v 2.3%; P ≤ .01). Similar percentages of patients received systemic therapy (BC, 68.8%; WW, 67.1%; P = .40), but costs were significantly higher for first-line systemic therapy in WW ($6,226 v $15,792 per patient per month; P ≤ .01). Median overall survival was similar (BC, 16.9 months; WW, 18 months)., Conclusion: Cost of systemic therapy for mCRC was significantly higher for patients in WW than in BC, but this did not translate to a difference in overall survival.

Purpose: The National Comprehensive Cancer Network (NCCN) developed the Evidence Blocks framework to assess the value of oncology regimens. This study characterizes the relationship between real-world costs and NCCN affordability ratings (ARs) for advanced non-small-cell lung cancer (aNSCLC) treatments., Methods: Using the MarketScan and PharMetrics Plus databases, we identified patients treated between 2012 and 2017 with an aNSCLC regimen evaluated by the NCCN Evidence Blocks. We estimated adjusted mean total per-patient-per-month (PPPM) costs and drug costs for each regimen using a log-linked gamma generalized linear model. Weighted regression was used to examine the correlation between adjusted mean PPPM costs per regimen and NCCN AR., Results: A total of 25,162 patients with aNSCLC (mean age, 63 years [standard deviation, 10 years]; 52% male) had identifiable regimens. Mean total PPPM cost by therapeutic class ranged from $16,824 for epidermal growth factor receptors to $41,815 for immunotherapy-based treatment. Epidermal growth factor receptor and anaplastic lymphoma kinase inhibitor treatment had lower ARs compared with generic chemotherapy. No therapy was listed as AR group 5 (least expensive). In pairwise comparisons, AR group 1 had significantly higher PPPM total costs compared with AR groups 2 and 4. There were no significant differences in PPPM total cost among AR groups 2, 3, and 4., Conclusion: Real-world aNSCLC treatment costs are often inconsistent with the NCCN ARs. Given that NCCN Evidence Blocks are intended to inform provider-patient discussions and other decision support resources, such as the NCCN Categories of Preference, our results suggest that the NCCN ARs require further refinement and validation.

Purpose: Compared with single-marker genetic testing (SMGT), multigene panel sequencing (MGPS) has the potential to identify more patients with cancer who could benefit from targeted therapies, but the effects on outcome and total cost of care are uncertain. Our goal was to estimate the clinical and cost effectiveness of MGPS versus SMGT among patients with advanced non-small-cell lung cancer (aNSCLC)., Methods: Patients with aNSCLC-stage IIIB or metastatic-who were diagnosed between 2011 and 2016 were identified from the Flatiron Health database. After stratifying patients into MGPS or SMGT cohorts, we analyzed the percentage of patients who received targeted treatment, survival, and total costs of care. SMGT included epidermal growth factor receptor ( EGFR ) and anaplastic lymphoma kinase testing. MGPS also allowed for the detection of BRAF, RET, ROS1, HER2, and MET mutations. Cost data sources were the Centers for Medicare & Medicaid Services Fee Schedule and 2017 average sales price drug cost. We estimated the incremental cost-effectiveness ratio from a US payer perspective over a lifetime horizon using a decision model., Results: We identified 5,688 patients with aNSCLC who received MGPS (n = 875) or SMGT (n = 4,813), of which 22% tested positive for epidermal growth factor receptor (18.5% MGPS; 17.3% SMGT) or anaplastic lymphoma kinase (3.59% MGPS; 3.78% SMGT). Among MGPS-tested patients, an additional 8% were found to have BRAF, RET, ROS1, HER2, or MET mutations. Of MGPS-tested patients, 21% received treatments that were targeted to the specific mutations versus 19% with SMGT. Expected survival was 1.14 life years (LYs) in SMGT versus 1.20 LYs in MGPS. Lifetime total costs were $8,814 higher per patient for MGPS. The incremental cost-effectiveness ratio of MGPS versus SMGT was $148,478 per LY gained., Conclusion: On the basis of data from a nationwide oncology patient database, MGPS is shown to have moderate cost effectiveness compared with SMGT in patients with aNSCLC.

Purpose: SEER registries do not report results of epidermal growth factor receptor ( EGFR ) and anaplastic lymphoma kinase ( ALK ) mutation tests. To facilitate population-based research in molecularly defined subgroups of non-small-cell lung cancer (NSCLC), we assessed the validity of natural language processing (NLP) for the ascertainment of EGFR and ALK testing from electronic pathology (e-path) reports of NSCLC cases included in two SEER registries: the Cancer Surveillance System (CSS) and the Kentucky Cancer Registry (KCR)., Methods: We obtained 4,278 e-path reports from 1,634 patients who were diagnosed with stage IV nonsquamous NSCLC from September 1, 2011, to December 31, 2013, included in CSS. We used 855 CSS reports to train NLP systems for the ascertainment of EGFR and ALK test status (reported v not reported) and test results (positive v negative). We assessed sensitivity, specificity, and positive and negative predictive values in an internal validation sample of 3,423 CSS e-path reports and repeated the analysis in an external sample of 1,041 e-path reports from 565 KCR patients. Two oncologists manually reviewed all e-path reports to generate gold-standard data sets., Results: NLP systems yielded internal validity metrics that ranged from 0.95 to 1.00 for EGFR and ALK test status and results in CSS e-path reports. NLP showed high internal accuracy for the ascertainment of EGFR and ALK in CSS patients-F scores of 0.95 and 0.96, respectively. In the external validation analysis, NLP yielded metrics that ranged from 0.02 to 0.96 in KCR reports and F scores of 0.70 and 0.72, respectively, in KCR patients., Conclusion: NLP is an internally valid method for the ascertainment of EGFR and ALK test information from e-path reports available in SEER registries, but future work is necessary to increase NLP external validity.

Regional public reporting of performance measures in oncology can facilitate local decision making across stakeholders, but small numbers of patients and clinics pose a challenge to creating statistically robust measures. In this article, we describe our development of the Community Cancer Care in Washington State: Quality and Cost Report, the first publicly available report showing clinic-level quality and cost measures at the regional level. We learned key lessons in how to adapt national performance reporting to our regional setting using a registry-linked multipayer claims database. In short, limited numbers of eligible patients for some nationally recognized metrics led us to group metrics and use a 3-year performance window. After completing clinic attribution and other requirements of metric construction, the final metrics included between 62.9% and 88.4% of the eligible patients. To link total costs to some quality measures, we had to define a treatment and surveillance episode of care. Risk adjustment was challenged by the ability to include a limited number of risk adjustors and their potential concentration in a few clinics. We used a different quality score than national performance reporting to account for variation in the range of risk-standardized rates. Current methodology does not permit us to determine whether clinically meaningful differences in quality or costs exist, which inhibits value comparisons. Stakeholder engagement was critical for providing methodologic feedback. In conclusion, we found that refining national metrics was necessary to facilitate public reporting in a regional setting. Further methodologic development can strengthen public reporting and future applications.

Background Cardiovascular disease is the primary cause of death among patients with breast cancer. However, the association of cardiovascular-disease risk factors (CVD-RFs) with long-term survival and cardiac events is not well studied. Methods We examined SWOG (formerly the Southwest Oncology Group) breast cancer trials from 1999 to 2011. We identified baseline diabetes, hypertension, hypercholesterolemia, and coronary artery disease by linking trial records to Medicare claims. The primary outcome was overall survival. Patients with both baseline and follow-up claims were examined for cardiac events. Cox regression was used to assess the association between CVD-RFs and outcomes. Results We identified 1,460 participants older than 66 years of age from five trials; 842 were eligible for survival outcomes analysis. At baseline, median age was 70 years, and median follow-up was 6 years. Hypertension (73%) and hypercholesterolemia (57%) were the most prevalent conditions; 87% of patients had one or more CVD-RF. There was no association between any of the individual CVD-RFs and overall survival except for hypercholesterolemia, which was associated with improved overall survival (hazard ratio [HR], 0.73; 95% CI, 0.57 to 0.93; P = .01). With each additional CVD-RF, there was an increased risk of death (HR, 1.23; 95% CI, 1.08 to 1.40; P = .002), worse progression-free survival (HR, 1.12; 95% CI, 1.00 to 1.25; P = .05), and marginally worse cancer-free survival (HR, 1.15; 95% CI, 0.99 to 1.34; P = .07). The relationship between baseline CVD-RFs and cardiac events was analyzed in 736 patients. A strong linear association between the number of CVD-RFs and cardiac event was observed (HR per CVD-RF, 1.41; 95% CI, 1.17 to 1.69; P < .001). Conclusion Among participants in clinical trials, each additional baseline CVD-RF was associated with an increased risk of cardiac events and death. Efforts to improve control of modifiable CVD-RFs are needed, especially among those with multiple risk factors.

Purpose: As new quality metrics and interventions for potentially preventable emergency department (ED) visits are implemented, we sought to compare methods for evaluating the prevalence and costs of potentially preventable ED visits that were related to cancer and chronic disease among a commercially insured oncology population in the year after treatment initiation., Methods: We linked SEER records in western Washington from 2011 to 2016 with claims from two commercial insurers. The study included patients who were diagnosed with a solid tumor and tracked ED utilization for 1 year after the start of chemotherapy or radiation. Cancer symptoms from the Centers for Medicare & Medicaid Services metric and a patient-reported outcome intervention were labeled potentially preventable (PpCancer). Prevention Quality Indicators of the Agency for Healthcare Research and Quality were labeled potentially preventable-chronic disease (PpChronic). We reported the primary diagnosis, all diagnosis field coding (1 to 10), and 2016 adjusted reimbursements., Results: Of 5,853 eligible patients, 27% had at least one ED visit, which yielded 2,400 total visits. Using primary diagnosis coding, 49.8% of ED visits had a PpCancer diagnosis, whereas 3.2% had a PpChronic diagnosis. Considering all diagnosis fields, 45.0%, 9.4%, and 18.5% included a PpCancer only, a PpChronic only, and both a PpCancer and a PpChronic diagnosis, respectively. The median reimbursement per visit was $735 (interquartile ratio, $194 to $1,549)., Conclusion: The prevalence of potentially preventable ED visits was generally high, but varied depending on the diagnosis code fields and the group of codes considered. Future research is needed to understand the complex landscape of potentially preventable ED visits and measures to improve value in cancer care delivery.

Purpose: Despite guidelines emphasizing symptom management over aggressive treatment, end-of-life care for persons with cancer in the United States is highly variable. In consultation with a regional collaboration of patients, providers, and payers, we investigated indicators of high-quality end-of-life care to describe patterns of care, identify areas for improvement, and inform future interventions to enhance end-of-life care for patients with cancer., Methods: We linked insurance claims to clinical information from the western Washington SEER database. We included persons ≥ 18 years of age who had been diagnosed with an invasive solid tumor between January 1, 2007, and December 31, 2015, and who had a recorded death date, were enrolled in a commercial plan for the last month of life, and made at least one insurance claim in the last 90 days of life., Results: In the last month of life, among 6,568 commercially insured patients, 56.3% were hospitalized and 48.6% underwent at least one imaging scan. Among patients younger than 65 years of age, 31.4% were enrolled in hospice; of those younger than 65 years of age who were not enrolled in hospice, 40.5% had received an opioid prescription. Over time, opioid use in the last 30 days of life among young adults not enrolled in hospice dropped from 44.7% in the period 2007 to 2009 to 42.5% in the period 2010 to 2012 and to 36.7% in the period 2013 to 2015., Conclusion: Hospitalization and high-cost imaging scans are burdensome to patients and caregivers at the end of life. Our findings suggest that policies that facilitate appropriate imaging, opioid, and hospice use and that encourage supportive care may improve end-of-life care and quality of life.

Background: Neuropathy is a debilitating toxicity associated with various chemotherapy agents. We evaluated the association between common comorbid conditions and the development of peripheral neuropathy in patients treated with taxane-based chemotherapy., Methods: We examined the Southwest Oncology Group database to identify phase II and III trials that included taxane therapy from 1999 to 2011. We linked the Southwest Oncology Group clinical records to Medicare claims data according to Social Security number, sex, and date of birth. The following disease conditions potentially associated with peripheral neuropathy were evaluated: diabetes, hypothyroidism, hypercholesterolemia, hypertension, varicella zoster, peripheral vascular disease, and autoimmune diseases. Multivariate logistic regression was used to model the odds of experiencing grade 2 to 4 neuropathy., Results: A total of 1,401 patients from 23 studies were included in the analysis. Patients receiving paclitaxel were more likely to experience grade 2 to 4 neuropathy compared with docetaxel (25% v 12%, respectively; OR, 2.20; 95% CI, 1.52 to 3.18; P < .001). The inclusion of a platinum agent was also associated with greater neuropathy (OR, 1.68; 95% CI, 1.18 to 2.40; P = .004). For each increase in age of 1 year, the odds of neuropathy increased 4% (P = .006). Patients with complications from diabetes had more than twice the odds of having neuropathy (OR, 2.13; 95% CI, 1.31 to 3.46; P = .002) compared with patients with no diabetes. In contrast, patients with autoimmune disease were half as likely to experience neuropathy (OR, 0.49; 95% CI, 0.24 to 1.02; P = .06). The other conditions were not associated with neuropathy., Conclusion: We found that in addition to drug-related factors, age and history of diabetes were independent predictors of the development of chemotherapy-induced peripheral neuropathy. Interestingly, we also observed that a history of autoimmune disease was associated with reduced odds of neuropathy. Patients with diabetic complications may choose to avoid paclitaxel or taxane plus platinum combination therapies if other efficacious options exist., Competing Interests: Authors’ disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article., (© 2016 by American Society of Clinical Oncology.)

Purpose: Patients with cancer are more likely to file for bankruptcy than the general population, but the impact of severe financial distress on health outcomes among patients with cancer is not known., Methods: We linked Western Washington SEER Cancer Registry records with federal bankruptcy records for the region. By using propensity score matching to account for differences in several demographic and clinical factors between patients who did and did not file for bankruptcy, we then fit Cox proportional hazards models to examine the relationship between bankruptcy filing and survival., Results: Between 1995 and 2009, 231,596 persons were diagnosed with cancer. Patients who filed for bankruptcy (n = 4,728) were more likely to be younger, female, and nonwhite, to have local- or regional- (v distant-) stage disease at diagnosis, and have received treatment. After propensity score matching, 3,841 patients remained in each group (bankruptcy v no bankruptcy). In the matched sample, mean age was 53.0 years, 54% were men, mean income was $49,000, and majorities were white (86%), married (60%), and urban (91%) and had local- or regional-stage disease at diagnosis (84%). Both groups received similar initial treatments. The adjusted hazard ratio for mortality among patients with cancer who filed for bankruptcy versus those who did not was 1.79 (95% CI, 1.64 to 1.96). Hazard ratios varied by cancer type: colorectal, prostate, and thyroid cancers had the highest hazard ratios. Excluding patients with distant-stage disease from the models did not have an effect on results., Conclusion: Severe financial distress requiring bankruptcy protection after cancer diagnosis appears to be a risk factor for mortality. Further research is needed to understand the process by which extreme financial distress influences survival after cancer diagnosis and to find strategies that could mitigate this risk., (© 2016 by American Society of Clinical Oncology.)

Purpose: The American Society of Clinical Oncology (ASCO)/American Board of Internal Medicine (ABIM) Choosing Wisely (CW) measures aim to reduce the use of interventions that lack evidence of benefit in cancer care. The study presented here characterized adherence to the 2012 ASCO/ABIM CW recommendations by linking health plan claims data with a regional cancer registry and sought to identify areas for research interventions to improve adherence., Methods: SEER records for patients diagnosed with cancer in Western Washington State between 2007 and 2014 were linked with enrollment and claims from a large regional commercial insurance plan. Using claims and SEER records, algorithms were developed to characterize adherence to each CW measure. In addition, we calculated differences in total reimbursements and procedure-specific reimbursements for patients receiving adherent and nonadherent care., Results: A total of 22,359 unique individuals with cancer were linked with insurance enrollment records and met basic eligibility criteria. Overall adherence varied from 53% (breast surveillance) to 78% (breast staging). Within each measure, adherence varied substantially by stage at diagnosis and by cancer site in situations in which the CW measure affected multiple types of cancer. The difference in reimbursements between adherent and nonadherent populations across all five measures was approximately $29 million., Conclusion: Adherence to the ASCO/ABIM CW measures varies widely, as does the cost implication of nonadherence. A structured approach to evaluating adherence and cost impact is needed before developing programs aimed at improving adherence to the ASCO/ABIM CW measures., (Copyright © 2015 by American Society of Clinical Oncology.)

Purpose: The Centers for Medicare and Medicaid Services (CMS) recently issued a national coverage determination that provides reimbursement for low-dose computed tomography (CT) lung cancer screening for enrollees age 55 to 77 years with ≥ 30-pack-year smoking history who currently smoke or quit in the last 15 years. The clinical, resource use, and fiscal impacts of this change in screening coverage policy remain uncertain., Methods: We developed a simulation model to forecast the 5-year health outcome impacts of the CMS low-dose CT screening policy in Medicare compared with no screening. The model used data from the National Lung Screening Trial, CMS enrollment statistics and reimbursement schedules, and peer-reviewed literature. Outcomes included counts of screening examinations, patient cases of lung cancer detected, stage distribution, and total and per-enrollee per-month fiscal impact., Results: Over 5 years, we project that low-dose CT screening will result in 10.7 million more low-dose CT scans, 52,000 more lung cancers detected, and increased overall expenditure of $6.8 billion ($2.22 per Medicare enrollee per month). The most fiscally impactful factors were the average cost-per-screening episode, proportion of enrollees eligible for screening, and cost of treating stage I lung cancer., Conclusion: Low-dose CT screening is expected to increase lung cancer diagnoses, shift stage at diagnosis toward earlier stages, and substantially increase Medicare expenditures over a 5-year time horizon. These projections can inform planning efforts by Medicare administrators, contracted health care providers, and other stakeholders., (Copyright © 2015 by American Society of Clinical Oncology.)

Purpose: Although American Society of Clinical Oncology guidelines discourage the use of tumor marker assessment for routine surveillance in nonmetastatic breast cancer, their use in practice is uncertain. Our objective was to determine use of tumor marker tests such as carcinoembryonic antigen and CA 15-3/CA 27.29 and associated Medicare costs in early-stage breast cancer survivors., Methods: By using Surveillance, Epidemiology, and End Results-Medicare records for patients diagnosed with early-stage breast cancer between 2001 and 2007, tumor marker usage within 2 years after diagnosis was identified by billing codes. Logistic regression models were used to identify clinical and demographic factors associated with use of tumor markers. To determine impact on costs of care, we used multivariable regression, controlling for other factors known to influence total medical costs., Results: We identified 39,650 eligible patients. Of these, 16,653 (42%) received at least one tumor marker assessment, averaging 5.7 tests over 2 years, with rates of use per person increasing over time. Factors significantly associated with use included age at diagnosis, diagnosis year, stage at diagnosis, race/ethnicity, geographic region, and urban/rural status. Rates of advanced imaging, but not biopsies, were significantly higher in the assessment group. Medical costs for patients who received at least one test were approximately 29% greater than costs for those who did not, adjusting for other factors., Conclusion: Breast cancer tumor markers are frequently used among women with early-stage disease and are associated with an increase in both diagnostic procedures and total cost of care. A better understanding of factors driving the use of and the potential benefits and harms of surveillance-based tumor marker testing is needed., (© 2014 by American Society of Clinical Oncology.)

Purpose: In December 2013, the US Preventive Services Task Force issued a final B-level recommendation indicating that individuals between the ages of 55 and 80 years who have a 30-pack-year smoking history and have smoked within the past 15 years should receive annual low-dose computed tomography (CT) lung cancer screening. We convened a multidisciplinary panel of experts to create practical guidance for efficiently implementing effective CT lung cancer screening programs., Methods: The lung cancer screening panel included 12 members, representing a broad range of stakeholders. The panel discussed clinical and system issues related to the implementation of CT lung cancer screening and developed recommendations for implementing CT lung cancer screening programs., Results: The panel identified five main goals that must be achieved to maximize the efficiency and effectiveness of implementing CT lung cancer screening: one, accurately identify individuals eligible for screening; two, provide access to screening at qualified facilities for eligible individuals; three, ensure appropriate follow-up for positive and negative screening results; four, promote continuous quality improvement of screening programs and downstream care; and five, provide smoking cessation support for all current smokers. The panel proposed a series of stakeholder-specific recommendations for achieving these goals., Conclusion: Implementation of effective and efficient population-based CT lung cancer screening will require involvement and coordination of stakeholders across the health care system to address the data and infrastructural needs that were identified., (Copyright © 2015 by American Society of Clinical Oncology.)

The authors summarize presentations and discussion from the Delivering Affordable Cancer Care in the 21st Century workshop and focus on proposed strategies to improve the affordability of cancer care while maintaining or improving the quality of care.

Introduction: Because receipt of breast imaging likely occurs in nonrandom patterns, selection bias is an important issue in studies that attempt to elucidate associations between imaging and breast cancer outcomes. The purpose of this study was to analyze use of advanced diagnostic imaging in a cohort of patients with breast cancer insured by commercial, managed care, and public health plans by demographic, health insurance, and clinical variables from 2002 to 2009., Methods: We identified women with breast cancer diagnoses from a Surveillance Epidemiology and End Results (SEER) registry whose data could be linked to claims from participating health plans. We examined imaging that occurred between cancer diagnosis and initiation of treatment and classified patients according to receipt of (1) mammography or ultrasound only; (2) breast magnetic resonance imaging (MRI); and (3) other advanced imaging (computed tomography [CT] of the chest, abdoment, and pelvis; positron emission tomography [PET]; or PET-CT). We used logistic regression to identify factors associated with receipt of breast MRI as well as other advanced imaging., Results: Commercial health plan, younger age, and later year of diagnosis were strongly associated with receipt of breast MRI and other advanced imaging. Women with prescription drug plans and those who had less comorbidities were more likely to have received breast MRI., Conclusion: Use of breast MRI and other advanced imaging is increasing among patients newly diagnosed with breast cancer; individual patient and insurance-related factors are associated with receipt of these imaging tests. Whether use of diagnostic advanced imaging affects outcomes such as re-excision, cancer recurrence, mortality rates, and costs of breast cancer treatment remains to be determined.

Purpose: To provide guidelines on antimicrobial prophylaxis for adult neutropenic oncology outpatients and on selection and treatment as outpatients of those with fever and neutropenia., Methods: A literature search identified relevant studies published in English. Primary outcomes included: development of fever and/or infections in afebrile neutropenic outpatients and recovery without complications and overall mortality in febrile neutropenic outpatients. Secondary outcomes included: in afebrile neutropenic outpatients, infection-related mortality; in outpatients with fever and neutropenia, defervescence without regimen change, time to defervescence, infectious complications, and recurrent fever; and in both groups, hospital admissions, duration, and adverse effects of antimicrobials. An Expert Panel developed guidelines based on extracted data and informal consensus., Results: Forty-seven articles from 43 studies met selection criteria., Recommendations: Antibacterial and antifungal prophylaxis are only recommended for patients expected to have < 100 neutrophils/μL for > 7 days, unless other factors increase risks for complications or mortality to similar levels. Inpatient treatment is standard to manage febrile neutropenic episodes, although carefully selected patients may be managed as outpatients after systematic assessment beginning with a validated risk index (eg, Multinational Association for Supportive Care in Cancer [MASCC] score or Talcott's rules). Patients with MASCC scores ≥ 21 or in Talcott group 4, and without other risk factors, can be managed safely as outpatients. Febrile neutropenic patients should receive initial doses of empirical antibacterial therapy within an hour of triage and should either be monitored for at least 4 hours to determine suitability for outpatient management or be admitted to the hospital. An oral fluoroquinolone plus amoxicillin/clavulanate (or plus clindamycin if penicillin allergic) is recommended as empiric therapy, unless fluoroquinolone prophylaxis was used before fever developed.

Purpose: Little is known about how referrals to different cancer specialists influence cancer care for non-small-cell lung cancer (NSCLC). Among Medicare enrollees, we identified factors of patients and their primary care physician that were associated with referrals to cancer specialists, and how the types of cancer specialists seen correlated with delivery of guideline-based therapies (GBTs)., Methods: Data from patients with stages III and IV NSCLC included in the SEER-Medicare database were linked to their physicians in the American Medical Association Masterfile database. Using logistic regression, we (1) identified patient and physician factors that were associated with referrals to cancer specialists (medical oncologists, radiation oncologists, and surgeons); (2) identified the types of referral to cancer specialists that predicted greater likelihood of receiving GBT (per National Comprehensive Cancer Network guidelines)., Results: A total of 28,977 patients with NSCLC diagnosed from January 1, 2000 to December 31, 2005 met eligibility criteria. Younger age, white race, higher income, and primary physician specialty other than family practice predicted higher likelihood of referrals to medical oncologists (P < .01 for all predictors). Seeing the three types of cancer specialists predicted higher likelihood of GBT (stage IIIA: odds ratio [OR] = 20.6; P < .001; IIIB: OR = 77.2; P < .001; and IV: OR = 1.2; P = .011), compared with seeing a medical oncologist only. Use of GBTs increased over the study period (42% to 48% from 2000 to 2005; P < .001)., Conclusion: Referrals to all types of cancer specialists increased the likelihood of treatment with standard therapies, particularly in stage III patients. However, racial and income disparities still prevent optimal referrals to cancer specialists.

Purpose: Anecdotal reports suggest that the volume of services offered to individuals concerned with hereditary cancer risk has increased substantially in recent years. As a follow-up to our 1993 survey, we sought to determine how the scope and volume of genetic services has changed between 1993 and 2002., Methods: We surveyed the 61 National Cancer Institute-designated cancer centers in operation in 2002 using an updated version of the questionnaire from 1993. Analysis included frequencies and summary statistics., Results: The majority of cancer centers responding (46 of 56 centers; 82.1%) provided some genetic services for evaluation of familial cancer, which is a higher proportion than in 1993 (50%; P < .01). Almost all centers (42 of 46 centers; 91.3%) provided services not only to cancer patients and their families, but also to individuals concerned with risk, which is a change (P = .01) from 1993, when 64.7% of centers offered such services. In addition, increases have been found for most other measures of services rendered for familial genetic services., Conclusion: As public awareness of cancer susceptibility genes has grown markedly in recent years, the demand has also grown for genetic services to assess familial cancer risk. Major deleterious genetic mutations are rare, and much of the current research in genetic variation focuses on higher prevalence variants that carry lower risks. This may suggest that testing for mutations will move from genetics clinics to primary care and specialty practices. Thus, it is unclear whether the scope and volume of cancer center genetics services will continue to grow as rapidly as they have over the last decade.

Purpose: There is limited published documentation regarding US community patterns of care for older patients with advanced non-small-cell lung cancer (NSCLC). Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, we examined community treatment patterns for advanced NSCLC, focusing on chemotherapy., Methods: Patients with locally advanced or metastatic (TNM system stages IIIb and IV) NSCLC diagnosed between January 1, 1994, and December 31, 1999, were stratified based on chemotherapy agents received during the first 3 months following diagnosis. Cox proportional hazards models were used to compare survival, controlling for age, sex, race, noncancer comorbidity, stage at diagnosis, SEER region, and receipt of cancer-related surgery or radiation therapy in the first 3 months following diagnosis. Lifetime medical costs were calculated for each group., Results: 14,875 patients met inclusion criteria: 7,411 (49.8%) stage III and 7,464 (50.2%) stage IV at diagnosis. Thirty-one percent received chemotherapy, 8% received surgery, and 53% received radiation therapy either as initial or adjuvant treatment. Persons > or = 75 years of age, females, African Americans, and those with more than one comorbidity were significantly less likely to receive chemotherapy (P < .01). Survival was inferior for those who did not receive a platinum-containing agent (P < .01). Lifetime costs were highest for those receiving platinum + taxane combinations, exceeding other regimens by more than $10,000 USD per patient., Conclusion: Chemotherapy prolongs survival in community settings, but is underutilized for persons with advanced NSCLC. Reasons for lower use in minorities and variation across regions deserve further study.

Purpose: This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non--small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization., Patients and Methods: Two hundred two patients received VC (vinorelbine 25 mg/m(2)/wk and cisplatin 100 mg/m(2)/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m(2) over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months., Results: Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P =.002) and neutropenia (P =.008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P =.001, P =.007), and grade 3 peripheral neuropathy was higher on the PC arm (P <.001). More patients on the VC arm discontinued therapy because of toxicity (P =.001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs., Conclusion: PC is equally efficacious as VC for the treatment of advanced non--small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.