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Background: White blood cell colony-stimulating factors (CSFs) decrease the incidence of chemotherapy-induced febrile neutropenia (FN). Widespread use of CSFs that is not guideline-concordant has been reported. Among patients with breast cancer receiving chemotherapy, the ability of evidence-based decision support tools to promote risk-appropriate reductions in CSF use without increased incidence of FN has not been examined. Methods: A retrospective cohort design and US commercial claims data were used. The impact of CSF decision support was analyzed among women with breast cancer receiving first-cycle chemotherapy from April 1, 2013, to March 30, 2015. The tool was implemented as part of a prior authorization process in 9 states starting July 1, 2014. Patients were assigned to intervention (ie, states where the decision support tool had been implemented) or nonintervention states (ie, 39 states where the tool had not been implemented). CSF use and subsequent incidence of FN were compared using difference-in-difference (DID) regressions adjusting for baseline differences in FN risk factors such as comorbidities and various infections. Results: The study sample of 7,224 patients (intervention states: pre-implementation, 1,991 and post-implementation, 2,010; nonintervention states: pre-implementation, 1,569 and post-implementation, 1,654) showed no significant difference in risk factors. Before and after implementation, a significant decrease in the proportion of patients with CSF use was observed in the intervention states (75% to 69%) compared with no significant change in the nonintervention (72% to 71%) states (DID, -5.4%; 95% CI, -6.0% to -4.7%; P =.006). No significance increase in FN incidence occurred in intervention (5.0% to 5.5%) and nonintervention (5.4% to 4.8%) states (DID, 0.2%; 95% CI, -0.20 to 0.30; P =.78). Similar results were obtained in subgroups by comorbidities and in sensitivity analyses by claims-based FN definitions. Conclusions: CSF use decreased modestly after implementation of the decision support tool, with no observed changes in FN rates. Such tools can reduce practice variation to improve care standards., (Copyright © 2018 by the National Comprehensive Cancer Network.)

Purpose To describe outcomes after granulocyte colony-stimulating factor (G-CSF) prophylaxis in patients with breast cancer who received chemotherapy regimens with low-to-intermediate risk of induction of neutropenia-related hospitalization. Patients and Methods We identified 8,745 patients age ≥ 18 years from a medical and pharmacy claims database for 14 commercial US health plans. This retrospective analysis included patients with breast cancer who began first-cycle chemotherapy from 2008 to 2013 using docetaxel and cyclophosphamide (TC); docetaxel, carboplatin, and trastuzumab (TCH); or doxorubicin and cyclophosphamide (conventional-dose AC) regimens. Primary prophylaxis (PP) was defined as G-CSF administration within 5 days of beginning chemotherapy. Outcome was neutropenia, fever, or infection-related hospitalization within 21 days of initiating chemotherapy. Multivariable regressions and number-needed-to-treat analyses were used. Results A total of 4,815 patients received TC (2,849 PP; 1,966 no PP); 2,292 patients received TCH (1,444 PP; 848 no PP); and 1,638 patients received AC (857 PP; 781 no PP) regimen. PP was associated with reduced risk of neutropenia-related hospitalization for TC (2.0% PP; 7.1% no PP; adjusted odds ratio [AOR], 0.29; 95% CI, 0.22 to 0.39) and TCH (1.3% PP; 7.1% no PP; AOR, 0.19; 95% CI, 0.12 to 0.30), but not AC (4.7% PP; 3.8% no PP; AOR, 1.21; 95% CI, 0.75 to 1.93) regimens. For the TC regimen, 20 patients (95% CI, 16 to 26) would have to be treated for 21 days to avoid one neutropenia-related hospitalization; with the TCH regimen, 18 patients (95% CI, 13 to 25) would have to be treated. Conclusion Primary G-CSF prophylaxis was associated with low-to-modest benefit in lowering neutropenia-related hospitalization in patients with breast cancer who received TC and TCH regimens. Further evaluation is needed to better understand which patients benefit most from G-CSF prophylaxis in this setting.

Purpose: Despite some advantages to their use, long-term central venous catheters (CVCs) are associated with complications for patients who require chemotherapy. Understanding of these risks in commercially insured populations is limited. This information can inform medical policies that ensure the appropriate use of venous access devices. This study's objectives were to assess the extent of variation in use of long-term CVCs in a cohort of commercially insured women with breast cancer, and to assess risks of associated complications., Methods: Retrospective cohort analysis was conducted using health insurance claims between January 2006 and October 2013. The cohort included commercially insured women age ≥ 18 years diagnosed with breast cancer who received infusion chemotherapy (N = 31,047). We conducted matched and case-mix adjusted Cox proportional hazard modeling to assess differences in bloodstream infections and thrombovascular complications between patients using long-term CVCs and those using temporary intravenous catheters., Results: Approximately two thirds of the cohort had a long-term CVC, although rates varied across regions (57% to 75%), health plans (65% to 70%), and insurance coverage (63% to 68%). After propensity score matching, the adjusted hazard ratio for infection was 2.70 (95% CI, 2.31 to 3.16) and thrombovascular complications, 2.61 (95% CI, 2.33 to 2.93) in patients with long-term CVCs compared with those with temporary intravenous catheters., Conclusion: Although long-term CVCs may have benefits, they are associated with increased morbidity. Regional and health plan variation in long-term CVC insertion suggests that some of their use reflects provider- or institution-driven variation in practice. Evidence-based guidelines and tools may help decrease discretionary use of long-term CVCs., (Copyright © 2015 by American Society of Clinical Oncology.)

Importance: Based on randomized evidence, expert guidelines in 2011 endorsed shorter, hypofractionated whole breast irradiation (WBI) for selected patients with early-stage breast cancer and permitted hypofractionated WBI for other patients., Objectives: To examine the uptake and costs of hypofractionated WBI among commercially insured patients in the United States., Design, Setting, and Participants: Retrospective, observational cohort study, using administrative claims data from 14 commercial health care plans covering 7.4% of US adult women in 2013, we classified patients with incident early-stage breast cancer treated with lumpectomy and WBI from 2008 and 2013 into 2 cohorts: (1) the hypofractionation-endorsed cohort (n = 8924) included patients aged 50 years or older without prior chemotherapy or axillary lymph node involvement and (2) the hypofractionation-permitted cohort (n = 6719) included patients younger than 50 years or those with prior chemotherapy or axillary lymph node involvement., Exposures: Hypofractionated WBI (3-5 weeks of treatment) vs conventional WBI (5-7 weeks of treatment)., Main Outcomes and Measures: Use of hypofractionated and conventional WBI, total and radiotherapy-related health care expenditures, and patient out-of-pocket expenses. Patient and clinical characteristics included year of treatment, age, comorbid disease, prior chemotherapy, axillary lymph node involvement, intensity-modulated radiotherapy, practice setting, and other contextual variables., Results: Hypofractionated WBI increased from 10.6% (95% CI, 8.8%-12.5%) in 2008 to 34.5% (95% CI, 32.2%-36.8%) in 2013 in the hypofractionation-endorsed cohort and from 8.1% (95% CI, 6.0%-10.2%) in 2008 to 21.2% (95% CI, 18.9%-23.6%) in 2013 in the hypofractionation-permitted cohort. Adjusted mean total health care expenditures in the 1 year after diagnosis were $28,747 for hypofractionated and $31,641 for conventional WBI in the hypofractionation-endorsed cohort (difference, $2894; 95% CI, $1610-$4234; P < .001) and $64,273 for hypofractionated and $72,860 for conventional WBI in the hypofractionation-permitted cohort (difference, $8587; 95% CI, $5316-$12,017; P < .001). Adjusted mean total 1-year patient out-of-pocket expenses were not significantly different between hypofractionated vs conventional WBI in either cohort., Conclusions and Relevance: Hypofractionated WBI after breast conserving surgery increased among women with early-stage breast cancer in 14 US commercial health care plans between 2008 and 2013. However, only 34.5% of patients with hypofractionation-endorsed and 21.2% with hypofractionation-permitted early-stage breast cancer received hypofractionated WBI in 2013.

To assess the impact of patient-provider communication on adherence to tamoxifen (TAM) and aromatase inhibitors (AIs) 36 months after breast cancer (BC) diagnosis in a low-income population of women. California statewide surveys were conducted among 921 low-income women with BC at 6, 18, and 36 months after BC diagnosis. A subset of 303 women with stage I-III BC who initiated hormone treatment after diagnosis was identified. Bivariate and multivariate logistic regression analyses were performed, and adjusted adherence rates were calculated. The main outcome measure was self-reported hormone use at 36 months after BC diagnosis and the chief independent variables were patient-centered communication after diagnosis by patient report as measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and patients' self-efficacy in patient-physician interactions (PEPPI). Overall adherence to TAM/AI was relatively high (88 %). Adjusted rates of adherence were 59 and 94 % for patients with the lowest versus highest scores on the CAHPS communication scale (AOR = 1.22, P = 0.006) and 72 versus 91 % for patients with the lowest and highest rating of PEPPI (AOR = 1.04, P = 0.04). Having at least one comorbid condition also increased the odds of adherence to hormonal therapy (AOR = 3.14, P = 0.03). Having no health insurance and experiencing side-effects from hormone treatment were barriers for adherence (AOR = 0.12, P = 0.001; AOR = 0.26, P = 0.003, respectively). Patient-centered communication and perceived self-efficacy in patient-physician interaction were significantly associated with patient adherence to ongoing TAM/AI therapy among low-income women with BC. Interventions on patient-provider communication may provide opportunities to improve patient outcomes in this vulnerable population.

Background: There is a need to better measure and improve the quality of oncology care and improve communication with patients and other providers. The American Society of Clinical Oncology Breast Cancer Registry (BCR) pilot evaluated the feasibility and acceptability of prospective data collection for quality assessment in daily clinical practice. Data were used to create and share treatment plans/summaries (TPSs) at the point of care., Methods: Using a web-based tool, 20 diverse practices entered clinical data on each new early-stage breast cancer patient into the BCR for 14 months (September 2009 through November 2010). The tool created individual TPSs that were shared with patients. Practices received practice-specific and aggregate BCR quality measures data, participated in a survey, and received a participation stipend., Results: Twenty practices entered 2014 patients into the BCR, collecting demographic, clinical, and treatment information. Fifty-two percent of practice participants replied to an end-of-pilot survey: 73% were satisfied with the BCR and web-based tool, 31% expressed concern regarding time and effort, and 52% reported additional practice costs during the pilot. Among those who created or shared the TPSs, 90% thought the documents improved oncologist-patient communication, and 95% favored using BCR data for practice quality improvement., Conclusions: Prospective data collection for quality assessment is feasible and allows sharing of TPSs with patients at the point of care. Future efforts should focus on decreasing implementation burden to practices, broadening participation, examining costs, and, most importantly, assessing its effects on patient outcomes., (Copyright © 2012 American Cancer Society.)

Rapid uptake of new imaging technology is a major contributor to rising healthcare costs. Preoperative breast magnetic resonance imaging (MRI) for patients with early-stage breast cancer has dramatically increased in use without the evidence of improved outcomes compared to standard assessment and is associated with higher rates of mastectomy. A decision analytic model was developed to evaluate the impact of adding breast MRI to the preoperative evaluation of women with early-stage breast cancer who were candidates for breast-conserving therapy on patient outcomes measured in quality-adjusted life years (QALYs). Model inputs, including survival, recurrence rates, and health utilities, were obtained from a comprehensive literature review. One-way sensitivity analyses were performed to estimate threshold values for key parameters at which adding MRI would become the optimal imaging strategy over standard assessment. Preoperative MRI resulted in 17.77 QALYs compared to 17.86 QALYs with standard assessment, a decrease of 0.09 QALYs or 34 days. In sensitivity analyses, standard assessment was associated with better patient outcomes than preoperative breast MRI across all plausible probabilities for mastectomy, local recurrence, and health utilities. For routine preoperative breast MRI to become the optimal strategy, the conversion rate to mastectomy after preoperative MRI would need to be <1 % (versus the range of 3.6-33 % reported in the literature). Routine preoperative breast MRI appears to confer no advantage over the standard diagnostic evaluations for early-stage breast cancer and may lead to worse patient outcomes.

Background: Physician co-management, representing joint participation in the planning, decision-making, and delivery of care, is often cited in association with coordination of care. Yet little is known about how physicians manage tasks and how their management style impacts patient outcomes., Objectives: To describe physician practice style using breast cancer as a model. We characterize correlates and predictors of physician practice style for 10 clinical tasks, and then test for associations between physician practice style and patient ratings of care., Methods: We queried 347 breast cancer physicians identified by a population-based cohort of women with incident breast cancer regarding care using a clinical vignette about a hypothetical 65-year-old diabetic woman with incident breast cancer. To test the association between physician practice style and patient outcomes, we linked medical oncologists' responses to patient ratings of care (physician n=111; patient n=411)., Results: After adjusting for physician and practice setting characteristics, physician practice style varied by physician specialty, practice setting, financial incentives, and barriers to referrals. Patients with medical oncologists who co-managed tasks had higher patient ratings of care., Conclusion: Physician practice style for breast cancer is influenced by provider and practice setting characteristics, and it is an important predictor of patient ratings. We identify physician and practice setting factors associated with physician practice style and found associations between physician co-management and patient outcomes (e.g., patient ratings of care)., (© Health Research and Educational Trust.)

Purpose: In 2002, pegfilgrastim was approved by the US Food and Drug Administration and the benefits of dose-dense breast cancer chemotherapy, especially for hormone receptor (HR) -negative tumors, were reported. We examined first-cycle colony-stimulating factor use (FC-CSF) before and after 2002 and estimated US expenditures for dose-dense chemotherapy., Methods: We identified patients in Surveillance, Epidemiology, and End Results-Medicare greater than 65 years old with stages I to III breast cancer who had greater than one chemotherapy claim within 6 months of diagnosis(1998 to 2005) and classified patients with an average cycle length less than 21 days as having received dose-dense chemotherapy. The associations of patient, tumor, and physician-related factors with the receipt of any colony-stimulating factor (CSF) and FC-CSF use were analyzed by using generalized estimating equations. CSF costs were estimated for patients who were undergoing dose-dense chemotherapy., Results: Among the 10,773 patients identified, 5,266 patients (48.9%) had a CSF claim. CSF use was stable between 1998 and 2002 and increased from 36.8% to 73.7% between 2002 and 2005, FC-CSF use increased from 13.2% to 67.9%, and pegfilgrastim use increased from 4.1% to 83.6%. In a multivariable analysis, CSF use was associated with age and chemotherapy type and negatively associated with black/Hispanic race, rural residence, and shorter chemotherapy duration. FC-CSF use was associated with high socioeconomic status but not with age or race/ethnicity. The US annual CSF expenditure for women with HR-positive tumors treated with dose-dense chemotherapy is estimated to be $38.8 million., Conclusion: A rapid increase in FC-CSF use occurred over a short period of time, which was likely a result of the reported benefits of dose-dense chemotherapy and the ease of pegfilgrastim administration. Because of the increasing evidence that elderly HR-positive patients do not benefit from dose-dense chemotherapy, limiting pegfilgrastim use would combat the increasing costs of cancer care.

Study Objective: To determine the impact of primary prophylactic colony-stimulating factor (CSF) use on febrile neutropenia in a large patient population receiving contemporary chemotherapy regimens to treat breast cancer, colorectal cancer, or non-small cell lung cancer (NSCLC)., Design: Retrospective claims analysis., Data Sources: The Surveillance, Epidemiology, and End Results (SEER)-Puget Sound cancer registry and insurance claims records., Patients: A total of 2728 patients aged 25 years or older who received a diagnosis of breast cancer (998 patients), colorectal cancer (688 patients), or NSCLC (1042 patients) between January 1, 2002, and December 31, 2005, and received chemotherapy., Measurements and Main Results: Initial chemotherapy regimen, CSF use (filgrastim or pegfilgrastim), and febrile neutropenia events were evaluated after the first chemotherapy administration. Subsequently, febrile neutropenia rates in patients receiving primary prophylactic CSF were compared with febrile neutropenia rates in patients receiving CSF in settings other than primary prophylaxis or not at all. The impact of primary prophylactic CSF could not be assessed for patients with colorectal cancer or NSCLC because only 1 and 18 febrile neutropenia events, respectively, occurred in those receiving primary prophylactic CSF. Of the 998 patients with breast cancer, 72 (7.2%) experienced febrile neutropenia, 28 of whom received primary prophylactic CSF. In the patients with breast cancer, we observed that primary prophylactic CSF use was associated with reduced febrile neutropenia rates; however, the analysis may have been confounded by unmeasured factors associated with febrile neutropenia., Conclusion: The impact of primary prophylactic CSFs on febrile neutropenia rates could not be demonstrated. Given the substantive cost of CSFs to pharmacy budgets, there are numerous opportunities for pharmacists to optimize CSF use. Research studies are needed to evaluate if guideline-directed prescribing of primary prophylactic CSFs can improve clinical outcomes., (© 2012 Pharmacotherapy Publications, Inc.)

Purpose: Drugs are usually approved for a specific indication on the basis of randomized trials. However, once approved, these treatments are often used differently than as tested in trials. We performed an analysis to determine the patterns of use of erythropoiesis-stimulating agents (ESAs)., Methods: We used the Surveillance, Epidemiology, and End Results-Medicare database to identify patients age 65 years or older with breast, lung, or colon cancer diagnosed between 1995 and 2005 who had one ESA and chemotherapy claim. Associations of patient, tumor, and physician-related factors with receipt of ESAs were analyzed., Results: Of 21,091 patients analyzed, 5,099 (24.2%) received ESAs for 1 week or less (misuse), and 1,601 (7.6%) received ESAs for more than 14 weeks (prolonged use). Receipt of ESAs while not actively receiving chemotherapy (off label) occurred in 2,876 patients (13.6%). In a multivariable analysis, ESA misuse was associated with MD degree, female sex of physician, and earlier year of medical school graduation. Private practice physicians (odds ratio [OR], 0.78; 95% CI, 0.72 to 0.84) and high-volume physicians (OR, 0.78; 95% CI, 0.72 to 0.85) were less likely to use 1 week or less of ESA treatment. Treatment by high-volume oncologists (OR, 1.33; 95% CI, 1.14 to 1.55) and by oncologists who graduated from US medical schools (OR, 1.26; 95% CI, 1.12 to 1.42) predicted prolonged-duration ESA use, whereas female oncologists (OR, 0.79; 95% CI, 0.68 to 0.93) were less likely to prescribe prolonged ESA treatment. Private practice physicians (OR, 1.18; 95% CI, 1.02 to 1.38) and high-volume providers (OR, 1.58; 95% CI, 1.33 to 1.87) were more likely to prescribe more than 24 weeks of ESA treatment., Conclusion: Our study demonstrated widespread variability in the use of ESAs. Physician characteristics exerted substantial influence on ESA use. Policies to discourage inappropriate use of cancer therapies are needed.

Background: Adherence to quality indicators may be especially important to disease-specific outcomes for uninsured, vulnerable patients. The objective of this study was to measure adherence to National Initiative for Cancer Care Quality (NICCQ) breast cancer quality indicators in a public hospital and compare performance to published rates in a previously collected 5-city cohort., Methods: One hundred five consecutive, newly diagnosed, stage I-III, breast cancer patients at a public hospital (from 2005 to 2007) were identified. Adherence rates to 31 quality indicators were measured by using medical record abstraction. Rates were calculated for individual indicators, aggregated domains, and components of care and were compared with the 5-city cohort results by using a 2-sided test of proportions., Results: Overall adherence to the NICCQ indicators at the public hospital was 82%, versus 86% in the 5-city cohort. Public hospital adherence was better in 3 domains and components (Management of Treatment Toxicity 95% vs 73%, Referrals 76% vs 15%, and Documentation of Key Clinical Factors 72% vs 64%, P < .05 for all), but it was lower in others (Testing 82% vs 96%, Adjuvant Therapy 76% vs 83%, Surgery 72% vs 86%, Surveillance 63% vs 94%, and Respect for Patient Preferences 52% vs 72%, P < .001 for all)., Conclusions: The results showed that it is possible to deliver breast cancer care to vulnerable patients comparable in quality to the care received by the broader population. Further study should identify the factors that lead to variation in adherence across domains of quality., (Copyright © 2011 American Cancer Society.)

Objective: To evaluate the cost-effectiveness of 70-gene MammaPrint signature (Agendia Inc, Huntington Beach, CA) vs Adjuvant! Online software (AS) (http://www.adjuvantonline.com) in patients 60 years or younger with early-stage breast cancer., Study Design: Cost-effectiveness and cost-utility analyses from a US payer perspective., Methods: A Markov model with 3 health states was constructed. In the base case model, risk classification and patient outcomes were based on a 70-gene signature validation study. Efficacy of chemotherapy was derived from a published meta-analysis of clinical trials. An alternative model using data from AS and from the Surveillance, Epidemiology and End Results registry was built to examine the external validity of the base case model. The incremental benefits, costs, and cost-effectiveness of treatment guided by 70-gene signature were calculated., Results: In the base case model, 70-gene signature reclassified 29% of patients and spared 10% of patients from chemotherapy. Compared with the AS strategy, the 70-gene signature strategy was associated with $1440 higher total cost per patient and with 0.14 additional life-year or 0.15 additional quality-adjusted life-year. Overall, the incremental cost-effectiveness ratios were approximately $10,000 per life-year or quality-adjusted life-year in the base case model and $700 in the alternative model. The model results were sensitive to estrogen receptor status, the proportion of patients classified as high risk vs low risk, and the overall survival in each risk group., Conclusion: A 70-gene signature is likely to be a cost-effective strategy to guide adjuvant chemotherapy treatment in younger patients with early-stage breast cancer.

Purpose: To develop evidence-based guidelines, based on a systematic review, for endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer., Methods: A literature search identified relevant randomized trials. Databases searched included MEDLINE, PREMEDLINE, the Cochrane Collaboration Library, and those for the Annual Meetings of the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS). The primary outcomes of interest were disease-free survival, overall survival, and time to contralateral breast cancer. Secondary outcomes included adverse events and quality of life. An expert panel reviewed the literature, especially 12 major trials, and developed updated recommendations., Results: An adjuvant treatment strategy incorporating an aromatase inhibitor (AI) as primary (initial endocrine therapy), sequential (using both tamoxifen and an AI in either order), or extended (AI after 5 years of tamoxifen) therapy reduces the risk of breast cancer recurrence compared with 5 years of tamoxifen alone. Data suggest that including an AI as primary monotherapy or as sequential treatment after 2 to 3 years of tamoxifen yields similar outcomes. Tamoxifen and AIs differ in their adverse effect profiles, and these differences may inform treatment preferences., Conclusion: The Update Committee recommends that postmenopausal women with hormone receptor-positive breast cancer consider incorporating AI therapy at some point during adjuvant treatment, either as up-front therapy or as sequential treatment after tamoxifen. The optimal timing and duration of endocrine treatment remain unresolved. The Update Committee supports careful consideration of adverse effect profiles and patient preferences in deciding whether and when to incorporate AI therapy.

Purpose: The objective of this study was to evaluate the quality of care provided to uninsured women with breast cancer who received treatment through the Breast and Cervical Cancer Prevention Treatment Program (BCCTP)., Methods: Participants included women with stage I to III breast cancer (n = 658) from a consecutive sample of women 18 years or older who received coverage through the California BCCTP between February 2003 and September 2005 who consented to a survey and medical record review (61% response rate). Quality of breast cancer care was evaluated using 29 evidence-based quality measures developed for the National Initiative for Cancer Care Quality (NICCQ). NICCQ, a largely insured cohort of women diagnosed with stage I to III breast cancer in 1998, was used to benchmark the results., Results: Twenty-three percent of women presented with stage III disease compared with fewer than 10% nationally. Patients received 93% of recommended care (95% CI, 92% to 93%). Adherence to recommended care within domains ranged from 87% for post-treatment surveillance (95% CI, 84% to 90%) to 97% for diagnostic evaluation (95% CI, 96% to 97%). Compared to the NICCQ cohort, adherence to quality measures was as good or better for the BCCPT cohort in all domains except post-treatment surveillance., Conclusion: The BCCTP has made important inroads in providing poor, uninsured women with access to high quality care when faced with the diagnosis of breast cancer; however, many present at an advanced stage, which is associated with worse outcomes.

Objective: Little is known about how cancer physicians communicate with limited English proficient (LEP) patients. We studied physician-reported use and availability of interpreters., Data Sources: A 2004 survey was fielded among physicians identified by a population-based sample of breast cancer patients. Three hundred and forty-eight physicians completed mailed surveys (response rate: 77 percent) regarding the structure and organization of care., Study Design and Settings: We used logistic regression to analyze use and availability of interpreters., Principal Findings: Most physicians reported treating LEP patients. Among physicians using interpreters within the last 12 months, 42 percent reported using trained medical interpreters, 21 percent telephone interpreter services, and 75 percent reported using untrained interpreters to communicate with LEP patients. Only one-third of physicians reported good availability of trained medical interpreters or telephone interpreter services when needed. Compared with HMO physicians, physicians in solo practice and single-specialty medical groups were less likely to report using trained medical interpreters or telephone interpreter services, and they were less likely to report good availability of these services., Conclusions: There were important practice setting differences predicting use and availability of trained medical interpreters and telephone interpretation services. These findings may have troubling implications for effective physician-patient communication critically needed during cancer treatment.

Background: In a meta-analysis of data from randomized trials, the risk of febrile neutropenia during myelosuppressive chemotherapy was reported to be lower with pegfilgrastim prophylaxis than filgrastim prophylaxis. However, there is limited information on the comparative effectiveness of these agents in clinical practice., Objective: This study was undertaken to compare the risks of hospitalization for neutropenic complications of chemotherapy in US clinical practice in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis., Methods: This was a retrospective cohort study employing a US health insurance database. The source population included all patients who received chemotherapy for a primary solid tumor between January 2003 and December 2005 and who received filgrastim or pegfilgrastim during their first course of chemotherapy. All unique chemotherapy cycles were identified for each patient, and cycles in which pegfilgrastim or filgrastim was administered by cycle day 5 (considered to represent prophylaxis) were selected and pooled for analysis. The risks of hospitalization for neutro-penic complications (using both narrow and broad criteria) and for any reason were then compared between cycles in which filgrastim or pegfilgrastim prophylaxis was administered. Generalized estimating equations were used to control for potential confounding variables., Results: Filgrastim prophylaxis was used in 1193 unique chemotherapy cycles (mean [SD] number of days per cycle, 4.5 [3.3]); for pegfilgrastim prophylaxis, the number of unique chemotherapy cycles was 14,570. First-cycle use represented 16% of all cycles analyzed. The mean ages of patients receiving filgrastim and pegfilgrastim prophylaxis were 61 and 60 years, respectively. Breast cancer was the most common tumor type (52% and 51%), followed by non-Hodgkin's lymphoma (21% and 18%) and lung cancer (11% and 15%). Hospitalization for neutropenic complications (narrow criterion) occurred during 2.1% of filgrastim cycles and 1.2% of pegfilgrastim cycles; hospitalization for neutropenic complications (broad criterion) occurred in a respective 4.8% and 3.1% of cycles; and hospitalization for all causes occurred in 8.7% and 6.3% of cycles (all, P < 0.01). The risks of hospitalization were consistently lower for chemotherapy cycles that involved pegfilgrastim prophylaxis compared with filgrastim prophylaxis (odds ratios = 0.64-0.73; P < 0.05)., Conclusion: The risk of hospitalization for neutro-penic complications during cancer chemotherapy in clinical practice was approximately one third higher among patients who received filgrastim prophylaxis than among those who received pegfilgrastim prophylaxis.

Objective: Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the risk of febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. We estimated the incremental cost-effectiveness of G-CSF pegfilgrastim primary (starting in cycle 1 and continuing in subsequent cycles of chemotherapy) versus secondary (only after an FN event) prophylaxis in women with early-stage breast cancer receiving myelosuppressive chemotherapy with a >or=20% FN risk., Methods: A decision-analytic model was constructed from a health insurer's perspective with a lifetime study horizon. The model considers direct medical costs and outcomes related to reduced FN and potential survival benefits because of reduced FN-related mortality. Inputs for the model were obtained from the medical literature. Sensitivity analyses were conducted across plausible ranges in parameter values., Results: The incremental cost-effectiveness ratio (ICER) of pegfilgrastim as primary versus secondary prophylaxis was $48,000/FN episode avoided. Adding survival benefit from avoiding FN mortality yielded an ICER of $110,000/life-year gained (LYG) or $116,000/quality-adjusted life-year (QALY) gained. The most influential factors included FN case-fatality, FN relative risk reduction from primary prophylaxis, and age at diagnosis., Conclusions: Compared with secondary prophylaxis, the cost-effectiveness of pegfilgrastim as primary prophylaxis may be equivalent or superior to other commonly used supportive care interventions for women with breast cancer. Further assessment of the direct impact of G-CSF on short- and long-term survival is needed to substantiate these findings.

The structure of health care has been rapidly evolving in response to financial pressures and demands to improve quality. Little work has documented the structure of care and its impact in the context of breast cancer care. We conducted a survey to characterize Los Angeles physicians caring for breast cancer patients and the structural landscape of the healthcare system in which they practice. Cross-sectional survey of physicians who treated a population-based cohort of breast cancer patients. We surveyed 477 physicians, targeting all Los Angeles County medical oncologists, radiation oncologists, and surgeons reported by patients participating in the Los Angeles Women's Health Study (77% response rate). Specialty-specific questionnaires were developed. Items were based on the structure and quality of care literature, cognitive interviews with cancer care specialists, and existing physician survey instruments. Breast cancer care providers in Los Angeles are diverse, with one-third non-white and 46% speaking a non-English language. Group practice is most common, (37% single specialty, 16% group-model HMO, 8% multi-specialty group). Minimal teaching involvement predominates. Mean new breast cancer patient volumes are relatively high (8 per month overall; six for surgeons), representing 46% of new cancer patients. Physicians reported high career satisfaction levels (83-92%). Physicians were least satisfied with the amount of time spent with patients (82%). Data from this study represent important building blocks for further analyses to determine the impact of structural characteristics on the quality of care that breast cancer patient's experience.

Background: Febrile neutropenia (FN) is a serious adverse event associated with myelotoxic chemotherapy that predisposes patients to life-threatening bacterial infections. Prophylaxis with granulocyte colony-stimulating factors (G-CSFs) from the first cycle of chemotherapy is recommended by the 2006 American Society of Clinical Oncology, 2008 National Comprehensive Cancer Network and 2006 European Organisation for Research and Treatment of Cancer guidelines when the overall risk of FN is approximately 20% or higher. Once-per-cycle pegfilgrastim and daily filgrastim are two commonly used G-CSFs with different dosing schedules and associated costs., Objective: To evaluate the cost effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the UK., Methods: A decision-analytic model was constructed from the UK NHS perspective with a lifetime study horizon. The model simulated three clinical scenarios: scenario 1 assumed that pegfilgrastim and filgrastim had differential impact on the risk of FN; scenario 2 assumed additional differential impact on FN-related mortality; and scenario 3 assumed additional differential impact on chemotherapy relative dose intensity (RDI) with long-term survival effects. The base-case population included 45-year-old women with stage II breast cancer receiving four chemotherapy cycles, with an FN risk of approximately 20% or higher. Model inputs, including FN risk, FN case-fatality, RDI, impact of RDI on survival and utility scores, were based on a review of the literature and expert panel validation. Using data from the literature, it was estimated that the absolute risk of FN associated with pegfilgrastim was 5.5% lower than with 11-day filgrastim (7% vs 12.5%), and 10.5% lower than with 6-day filgrastim (7% vs 17.5%). Costs were taken from official price lists or the literature and included drugs, drug administration, FN-related hospitalizations and subsequent medical costs. Breast cancer mortality and all-cause mortality were obtained from official statistics. The main outcome measures were the costs ( pound, year 2006 values) per percentage decrease in (absolute) FN risk, per FN event avoided, per life-year gained (LYG), and per QALY gained. Model robustness was tested using deterministic and probabilistic sensitivity analyses., Results: Pegfilgrastim was cost saving compared with 11-day filgrastim ( pound 3196 vs pound 4315). Compared with 6-day filgrastim, pegfilgrastim was associated with a cost of pound 4200 per FN event avoided, or pound 42 per 1% decrease in absolute risk of FN, in scenario 1. In scenario 2, pegfilgrastim provided 0.055 more LYGs or 0.052 more QALYs at a minimal cost increase of pound 441 ( pound 3196 vs pound 2754) per person, yielding an incremental cost-effectiveness ratio (ICER) of pound 8075/LYG or pound 8526/QALY. In scenario 3, when all potential benefits of G-CSF were considered, the ICER became pound 3955/LYG or pound 4161/QALY. Results were most sensitive to the relative risk of FN for 6-day filgrastim versus pegfilgrastim., Conclusion: In this UK analysis, pegfilgrastim appears to dominate 11-day use of filgrastim. The value of pegfilgrastim versus 6-day filgrastim at pound 4161-8526/QALY was very favourable compared with the commonly used threshold in the UK. In this setting, primary prophylaxis with pegfilgrastim may be cost effective compared with filgrastim.

Background: When 2 treatment choices (ie, mastectomy vs. breast conserving therapy) show no difference in a primary clinical outcome (ie, survival), patient satisfaction becomes an important marker of the quality of care received., Objectives: To assess the impact of physician-patient discussion of primary surgical treatment outcomes on patients' satisfaction with medical care (MC) among women with incident breast cancer (BC)., Method: We used self-report data of a population-based survey of 495 women >or=50 years of age with stage I-II BC in Los Angeles, California in 2000 conducted a mean of 7.5 and 24 months after diagnosis. Using multivariable analyses, we evaluated the impact of physician-patient outcome discussions (ie, BC recurrence, BC survival, breast appearance, and arm swelling/pain/movement difficulty) on patient satisfaction at baseline and follow-up., Results: Most women were satisfied with their MC (>65%). More than half reported physician-patient discussions of BC recurrence (54%), breast appearance (50%), and arm pain/swelling/movement difficulty (55%). Thirty-one percent discussed BC survival. Women who discussed arm swelling, pain, movement difficulty were significantly more likely to be satisfied at baseline (odds ratio: 1.8, 95% confidence interval: 1.1-3.0, P < 0.05) and follow-up (odds ratio: 1.9, 95% confidence interval: 1.2-3.0, P > 0.01). The more treatment outcomes patients discussed with their physicians, the higher patient satisfaction ratings were at baseline and follow-up., Conclusions: Physician-patient discussions of BC treatment outcomes were highly correlated with patients' satisfaction with overall MC regardless of the procedure received. This suggests that the quality of BC care should include assessments of physician-patient communication.

Objectives: To examine the use of financial incentives related to performance on quality measures reported by oncologists and surgeons associated with a population-based cohort of patients with breast cancer in Los Angeles County, California, and to explore the physician and practice characteristics associated with the use of these incentives among breast cancer care providers., Study Design: Cross-sectional observational study., Methods: Physician self-reported financial arrangements from a survey of 348 medical oncologists, radiation oncologists, and surgeons caring for patients with breast cancer in Los Angeles County (response rate, 76%). Physicians were asked whether they were subject to financial incentives for quality (ie, patient satisfaction surveys and adherence to practice guidelines). We examined the prevalence and correlates of incentives and performed multivariate logistic regression analyses to assess predictors of incentives, controlling for other covariates., Results: Twenty percent of respondents reported incentives based on patient satisfaction, and 15% reported incentives based on guideline adherence. The use of incentives for quality in this cohort of oncologists and surgeons was modest and was primarily associated with staff- or group-model health maintenance organization (HMO) settings. In other settings, important predictors were partial physician ownership interest, large practice size, and capitation., Conclusions: Most cancer care providers in Los Angeles County outside of staff- or group-model HMOs are not subject to explicit financial incentives based on quality-of-care measures. Those who are, seem more likely to be associated with large practice settings. New approaches are needed to direct financial incentives for quality toward specialists outside of staff- or group-model HMOs if pay-for-performance programs are to succeed in influencing care.

Background: The use of postmastectomy reconstruction varies with socioeconomic status, but the etiology of these variations is not understood. We investigated whether these differences reflect variations in the rate or qualitative aspects of the provider's discussion of reconstruction as an option., Study Design: Data were collected through chart review and patient survey for stages I to III breast cancer patients during the National Initiative on Cancer Care Quality. Multivariable logistic regression was used to identify predictors of reconstruction and discussion of reconstruction as an option. Predictors of not receiving reconstruction despite a documented discussion were also determined., Results: There were 253 of 626 patients who received reconstruction (40.4%). Younger, more educated Caucasian women who were not overweight or receiving postmastectomy radiation were more likely to receive reconstruction. Patients who were younger, more educated, and not receiving postmastectomy radiation were more likely to have a documented discussion of reconstruction. If a discussion was documented, patients who were older, Hispanic, not born in the US, and received postmastectomy radiation were less likely to receive reconstruction. The greatest predictor of reconstruction was medical record documentation of a discussion about reconstruction., Conclusions: We observed disparities in the likelihood of reconstruction that were at least partially explained by differences in the likelihood that reconstruction was discussed. But there were also differences in the likelihood of reconstruction based on age, race, and radiation once discussions occurred. Efforts to increase and improve discussions about reconstruction may decrease disparities for this procedure.

Purpose: This study examines the burden of symptoms by treatment type and patient characteristics in a population-based sample of newly diagnosed breast cancer patients., Methods: Using the Los Angeles County SEER Registry Rapid Case Ascertainment, we identified a cohort of breast cancer patients in 2000 and conducted telephone surveys in English and Spanish among participants., Results: We completed interviews of 1,219 breast cancer patients and found almost half (46%) had at least one severe symptom (any of the following: nausea/vomiting, arm problems, hot flashes, vaginal dryness, difficulty sleeping) that interfered with her daily functioning or mood. Multi-variate analysis controlling for patient characteristics and treatment showed that older (OR=0.90; P<0.000), black (OR=0.50; P<0.000), Hispanic Spanish-speaking (OR=0.37; P<0.000), widowed or never married (OR=0.68; P=0.049), and working (OR=0.72; P=0.024) women were less likely to report severe symptoms than other women. Number of comorbid conditions (OR=1.21; P<0.000) and receipt of chemotherapy (OR=1.48; P=0.040) were positively associated with reporting symptoms., Conclusion: These findings estimate the prevalence of several mutable symptoms in breast cancer patients that can be addressed by appropriate treatments. Comorbidity is a significant predictor of symptoms, especially amongst those receiving chemotherapy. Variation in symptom reporting occurred by race/ethnicity and other sociodemographic characteristics, raising questions of different thresholds for reporting symptoms or truly fewer symptoms for some sociodemographic groups. Population-based estimates of the probability of symptoms in women with incident breast cancer can be used to provide patient education about potential outcomes following the treatment of breast cancer.

Purpose: With improved patient survival from breast cancer, more interest has evolved regarding the symptoms women experience in association with breast cancer treatments. We studied the extent to which symptoms for women with incident breast cancer are addressed by their physicians and how symptom management varies with patient characteristics., Methods: As part of the Los Angeles Women's (LAW) Study, we categorized women from a population-based study of incident breast cancer (n = 1,219) as having an unmet need if she had at least one severe symptom (any of the following: nausea/vomiting, arm problems, hot flashes, vaginal dryness, difficulty sleeping) for which she did not receive the help she wanted. Multivariable analyses predicted having any unmet need as a function of patient demographic and health characteristics., Results: The prevalence of unmet need varied by the type of symptom with the highest proportion of women receiving help for nausea and vomiting (0.91) and the lowest for vaginal dryness (0.48). Black women (OR = 3.61, 95% CI: [1.57, 8.31]), and Spanish-speaking Hispanic women (OR = 2.69, 95% CI: [1.22, 5.94]) were significantly more likely than white women to report an unmet need. More black and Hispanic women compared to white women cited the doctor not thinking treatment would benefit her (P = 0.02), not appreciating how much the problem bothered her (P = 0.03), not knowing about treatments (P < 0.0001), or insurance/cost barriers (P = 0.009) as reasons for her unmet need., Conclusion: These results show the persistence of racial disparities in the receipt of appropriate care within the health care system.

Background: Among breast cancer patients, tamoxifen use is associated with reduced risk of disease relapse and death, but it is often difficult for women to sustain therapy during the 5 years required to obtain maximum benefit., Objectives: We sought to examine the influence of patient-centered care activities on ongoing tamoxifen use 4 years after initiation, we examined key components of patient-centered care and rates of ongoing tamoxifen., Methods: Using a prospective cohort study that included observational data from the National Initiative for Cancer Care Quality (NICCQ), we studied 881 patients with stage I-III breast cancer who were registered with an initial diagnosis in 1998 by an American College of Surgeons-approved hospital cancer registry in 1 of 5 metropolitan areas, who initiated tamoxifen treatment. A patient survey and medical record abstraction were used as measurements., Results: Among women who initiated tamoxifen, 79% were still taking it 4 years later. Other than older age and the severity of side effects, other demographic, clinical and cancer characteristics, and treatments did not predict ongoing tamoxifen use. In contrast, after adjusting for these factors, the proportion of patients with ongoing tamoxifen use was lower for patients reporting less support than needed (82% vs. 69%, P = 0.0051), less than wanted role in decision-making (80% vs. 70%, P = 0.0486), decision-making about tamoxifen without doctor input (79% vs. 64%, P = 0.0182), and for patients who weren't told about side effects in advance (82% vs. 72%, P = 0.0016)., Conclusions: Although age and the severity of side-effects remain important, patient-centered care was a primary mediator of patient adherence to ongoing cancer treatment with tamoxifen.

Purpose: In 1999, the National Cancer Policy Board called attention to the quality of cancer care in the United States and recommended establishing a quality monitoring system with the capability of regularly reporting on the quality of care for patients with cancer., Methods: Using data from a patient survey 4 years after diagnosis and review of medical records, we determined the percentage of stage I to III breast cancer and stage II to III colorectal cancer survivors in five metropolitan statistical areas (MSAs) across the United States who received recommended care specified by a comprehensive set of explicit quality measures., Results: Two thousand three hundred sixty-six (63%) of 3,775 eligible patients responded to the survey, and 85% consented to have their medical records reviewed. Our final analytic sample (n = 1,765) included 47% of the eligible patients. Patients with breast and colorectal cancer received 86% of recommended care (95% CI, 86% to 87%) and 78% of recommended care (95% CI, 77% to 79%), respectively. Adherence to quality measures was less than 85% for 18 of the 36 breast cancer measures, and significant variation across MSAs was observed for seven quality measures. The percent adherence was less than 85% for 14 of the 25 colorectal cancer measures, and one quality measure demonstrated statistically significant variation across the MSAs., Conclusion: Initial management of patients with breast and colorectal cancer in the United States seemed consistent with evidence-based practice; however, substantial variation in adherence to some quality measures point to significant opportunities for improvement.

Purpose: To critically review studies that describe patterns of care for breast cancer patients and to examine the data sources used for case identification and determining patterns of care., Methods: We searched the MEDLINE database (National Library of Medicine, Bethesda, MD) in August 2001 for studies of breast cancer care published from January 1985 to June 2001. Thirty-eight articles, describing 32 studies, met the inclusion criteria for this review., Results: According to the patterns of care literature, approximately 10% of women do not have an axillary lymph node dissection, 11% to 26% do not have their hormone receptor status reported, 20% do not receive radiation after breast-conserving surgery, and 30% to 70% of women with lymph node-positive breast cancer are not prescribed tamoxifen. Twenty-five (78%) of the studies relied on cancer registries for case identification. Cancer registries (47%) and the medical record (38%) were the most frequent sources of data on process of care. Twenty percent of the articles reported using more than one data source to determine patterns of care., Conclusion: Although more patterns of care research has taken place in breast cancer than in any other oncologic condition, we found the available data had many limitations. These limitations highlight the challenges of quality-of-care research. To track changes in the quality of cancer care that may result from our rapidly transforming health care system, we need reliable data on the quality of current practice.

Objectives: In 1999, California was considering legislation to fund breast cancer treatment for its uninsured. We sought to define the most cost-effective breast cancer benefits package in order to inform this debate., Methods: We use cost-effectiveness analysis to calculate the additional costs and benefits of various adjuvant therapy strategies, radiation after breast conserving surgery, and reconstruction compared to those of surgery alone in order to define the most cost-effective breast cancer benefits package for uninsured women., Results: Using cost-effectiveness analysis, we define a Minimum Breast Cancer Benefits Package that includes only the most cost-effective life-saving breast cancer treatments. To provide these benefits for an estimated 550 breast cancer patients will cost $10,200,000. We present two options that each cost an additional $1,700,000 - to expand the benefits to these patients to include post-mastectomy radiation and breast reconstruction; or to provide the Minimum Package to an additional 93 uninsured women., Conclusions: California legislators must decide whether to offer comprehensive benefits to a limited number of breast cancer patients or to provide only the most life-saving treatments to a greater number of women.

Background: Various groups have called for a national system to monitor the quality of cancer care. The validity of cancer registry data for quality of cancer care has not been well studied. We investigated the validity of such information in the California Cancer Registry., Methods: We compared registry data associated with care with data abstracted from the medical records of patients diagnosed with breast cancer. We also calculated a quality score for each subject by determining the proportion of four evidence-based quality indicators that were met and then compared overall quality scores obtained from registry and medical record data. All statistical tests were two-sided., Results: Records of 304 patients were studied. Compared with the medical record data gold standard, the accuracy of registry data was higher for hospital-based services (sensitivity = 95.0% for mastectomy, 94.9% for lumpectomy, and 95.9% for lymph node dissection) than for ambulatory services (sensitivity = 9.8% for biopsy, 72.2% for radiation therapy, 55.6% for chemotherapy, and 36.2% for hormone therapy). On average, quality scores calculated from registry data were 11 percentage points (95% confidence interval [CI] = 9 to 13 percentage points, P<.001) lower than those calculated from medical record data. Quality scores calculated from registry data were 5 percentage points (95% CI = 3 to 7 percentage points) lower for patients with stage I breast cancer, 16 percentage points (95% CI = 12 to 20 percentage points) lower for patients with stage II breast cancer, and 20 percentage points (95% CI = 8 to 32 percentage points) lower for patients with stage III breast cancer than were corresponding scores calculated from medical record data (all P<.001). The greater difference in quality scores for stage II and III patients revealed that disease severity and setting of care affected the validity of registry data., Conclusions: Cancer registry data for quality measurement may not be valid for all care settings, but registries could provide the infrastructure for collecting data on the quality of cancer care. We urge that funding be increased to augment data collection by cancer registries.