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1.  The Cost of Cancer Care—Balancing Our Duties to Patients Versus Society: Are They Mutually Exclusive? 
The Oncologist  2013;18(4):347-349.
doi:10.1634/theoncologist.2013-0078
PMCID: PMC3639518  PMID: 23568002
Health care costs; Ethical issues; Cancer care; Resource allocation; Decision-making
2.  Hemodynamic signature of breast cancer under fractional mammographic compression using a dynamic diffuse optical tomography system 
Biomedical Optics Express  2013;4(12):2911-2924.
Near infrared dynamic diffuse optical tomography measurements of breast hemodynamics during fractional mammographic compression offer a novel contrast mechanism for detecting breast cancer and monitoring chemotherapy. Tissue viscoelastic relaxation during the compression period leads to a slow reduction in the compression force and reveals biomechanical and metabolic differences between healthy and lesion tissue. We measured both the absolute values and the temporal evolution of hemoglobin concentration during 25-35 N of compression for 22 stage II and III breast cancer patients scheduled to undergo neoadjuvant chemotherapy. 17 patients were included in the group analysis (average tumor size 3.2 cm, range: 1.3-5.7 cm). We observed a statistically significant differential decrease in total and oxy-hemoglobin, as well as in hemoglobin oxygen saturation in tumor areas vs. healthy tissue, as early as 30 seconds into the compression period. The hemodynamic contrast is likely driven by the higher tumor stiffness and different viscoelastic relaxation rate, as well as the higher tumor oxygen metabolism rate.
doi:10.1364/BOE.4.002911
PMCID: PMC3862147  PMID: 24409390
(170.2655) Functional monitoring and imaging; (170.3880) Medical and biological imaging; (170.4580) Optical diagnostics for medicine; (170.0170) Medical optics and biotechnology; (170.3890) Medical optics instrumentation
3.  Patient Navigation for Underserved Patients Diagnosed with Breast Cancer 
The Oncologist  2012;17(8):1027-1031.
The sociodemographic characteristics, disease characteristics, and concordance with quality measures of breast cancer care among women participating in a patient navigator program were retrospectively examined. The findings suggest that patient navigator programs may facilitate evidence-based quality care for vulnerable populations.
Learning Objectives
After completing this course, the reader will be able to: Describe the role and potential benefits of patient navigation in breast cancer care.Explain disparities in breast cancer care and their impact on patient populations.
This article is available for continuing medical education credit at CME.TheOncologist.com
The elimination of cancer disparities is critically important for lessening the burden of breast cancer (BC). Patient navigator programs (PNPs) have been shown to improve rates of BC screening in underserved communities, but there is a dearth of evidence regarding their benefits after the actual diagnosis of BC. We retrospectively examined sociodemographic characteristics, disease characteristics, and concordance to quality measures (QMs) of BC care among women participating in a PNP that services disadvantaged minority communities in the greater Boston area. Of the 186 PNP patients diagnosed with BC in 2001–2011 in three neighborhood community health centers, treatment data was available for 158 (85%) and race and disease stage information was available for 149 (80%). Regarding stage, 25% were diagnosed with in situ cancer, 32% had stage 1, 25% had stage 2, 13% had stage 3, and 5% had stage 4 BC. Guideline-indicated care was received by 70 of 74 patients (95%) for the hormonal therapy QM, 15 of 17 (88%) patients for the chemotherapy QM, and 65 of 71 (92%) patients for the radiation QM, all similar to published concordance rates at elite National Comprehensive Cancer Network institutions. These findings suggest that PNPs may facilitate evidence-based quality care for vulnerable populations. Future research should prospectively analyze quality metrics to assess measures to improve the process and outcomes of patient navigation in diverse underserved settings, compared with control non-navigated populations.
doi:10.1634/theoncologist.2012-0191
PMCID: PMC3425520  PMID: 22752069
Patient navigation; Cancer disparities; Breast cancer; Outcomes
4.  Decision Making about Surgery for Early Stage Breast Cancer 
Background
Practice variation in breast cancer surgery has raised concerns about the quality of treatment decisions. We sought to evaluate the quality of decisions about surgery for early stage breast cancer by measuring patient knowledge, concordance between goals and treatments, and involvement in decisions.
Study Design
A mailed survey of Stage I/II breast cancer survivors was conducted at four sites. The Decision Quality Instrument measured knowledge, goals, and involvement in decisions. A multivariable logistic regression model of treatment was developed. The model-predicted probability of mastectomy was compared to treatment received for each patient. Concordance was defined as having mastectomy and predicted probability >=0.5 or partial mastectomy and predicted probability <0.5. Frequency of discussion about partial mastectomy was compared to discussion about mastectomy using chi-squared tests.
Results
440 patients participated (59% response rate). Mean overall knowledge was 52.7%. 45.9% knew that local recurrence risk is higher after breast conservation. 55.7% knew that survival is equivalent for the two options. Most participants (89.0%) had treatment concordant with their goals. Participants preferring mastectomy had lower concordance (80.5%) than those preferring partial mastectomy (92.6%, p=0.001). Participants reported more frequent discussion of partial mastectomy and its advantages than of mastectomy. 48.6% reported being asked their preference.
Conclusions
Breast cancer survivors had major knowledge deficits, and those preferring mastectomy were less likely to have treatment concordant with goals. Patients perceived that discussions focused on partial mastectomy, and many were not asked their preference. Improvements in the quality of decisions about breast cancer surgery are needed.
doi:10.1016/j.jamcollsurg.2011.09.017
PMCID: PMC3256735  PMID: 22056355
5.  Ethical Challenges: Caring for the Underinsured, Geographically Disadvantaged Patient 
Journal of Oncology Practice  2012;8(4):215-218.
This vignette explores the challenges associated with treating patients who are underinsured and have social factors that create barriers to optimal care.
doi:10.1200/JOP.2012.000603
PMCID: PMC3396816  PMID: 23180985
6.  Patient Navigator Programs, Cancer Disparities, and the Patient Protection and Affordable Care Act 
The Oncologist  2011;16(7):926-929.
The article describes patient navigator programs and summarizes the elements of the health care law that are relevant to these programs.
Patients in vulnerable population groups suffer disproportionately from cancer. The elimination of cancer disparities is critically important for lessening the burden of cancer. Patient navigator programs have been shown to improve clinical outcomes. Among its provisions relevant to disparities in cancer care, The Patient Protection and Affordability Care Act authorizes continued funding of patient navigator programs. However, given the current economic and political environment, this funding is in jeopardy. This article describes patient navigator programs and summarizes the elements of the health care law that are relevant to these programs. It is vital that the entire oncology community remain committed to leading efforts toward the improvement of cancer care among our most vulnerable patients.
doi:10.1634/theoncologist.2011-0140
PMCID: PMC3228140  PMID: 21804070
Disparities in cancer care; Health care law; Patient navigator programs; Patient Protection and Affordable Care Act
7.  Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery 
Background
The purpose of this paper is to examine the acceptability, feasibility, reliability and validity of a new decision quality instrument that assesses the extent to which patients are informed and receive treatments that match their goals.
Methods
Cross-sectional mail survey of recent breast cancer survivors, providers and healthy controls and a retest survey of survivors. The decision quality instrument includes knowledge questions and a set of goals, and results in two scores: a breast cancer surgery knowledge score and a concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, discriminant validity, content validity, predictive validity and retest reliability of the survey instrument were examined.
Results
We had responses from 440 eligible patients, 88 providers and 35 healthy controls. The decision quality instrument was feasible to implement in this study, with low missing data. The knowledge score had good retest reliability (intraclass correlation coefficient = 0.70) and discriminated between providers and patients (mean difference 35%, p < 0.001). The majority of providers felt that the knowledge items covered content that was essential for the decision. Five of the 6 treatment goals met targets for content validity. The five goals had moderate to strong retest reliability (0.64 to 0.87). The concordance score was 89%, indicating that a majority had treatments concordant with that predicted by their goals. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.
Conclusions
The decision quality instrument met the criteria of feasibility, reliability, discriminant and content validity in this sample. Additional research to examine performance of the instrument in prospective studies and more diverse populations is needed.
doi:10.1186/1472-6947-12-51
PMCID: PMC3411423  PMID: 22681763
8.  Dose-Dense Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel With Trastuzumab and Lapatinib in HER2/neu–Overexpressed/Amplified Breast Cancer Is Not Feasible Because of Excessive Diarrhea 
Journal of Clinical Oncology  2010;28(18):2982-2988.
Purpose
Dose-dense doxorubicin and cyclophosphamide (AC) followed by paclitaxel and trastuzumab (PT) is feasible. Lapatinib is effective in the treatment of human epidermal growth factor receptor 2 (HER2) –positive metastatic breast cancer. We conducted a pilot study of dose-dense AC followed by PT plus lapatinib (PTL) followed by trastuzumab plus lapatinib (TL).
Patients and Methods
Patients with stages I to III, HER2-positive breast cancer and left ventricular ejection fraction (LVEF) of ≥ 50% were enrolled. Treatment consisted of AC (60 mg/m2 and 600 mg/m2) for 4 cycles every 2 weeks (with pegfilgrastim 6 mg on day 2) followed by paclitaxel (80 mg/m2) for 12 doses weekly plus trastuzumab and lapatinib. Trastuzumab (4 mg/kg loading dose, then 2 mg/kg weekly during paclitaxel then 6 mg/kg every 3 weeks after paclitaxel) and lapatinib (1,000 mg daily) were given for 1 year. The primary end points were feasibility defined as ≥ 80% patients completing the PTL phase without a dose delay/reduction and a cardiac event rate of ≤ 4%.
Results
From March 2007 to April 2008, we enrolled 95 patients. Median age was 46 years (range, 28 to 73 years). At a median follow-up of 22 months, 92 were evaluable. Of the 92 patients, 41 patients (45%) withdrew for PTL-specific toxicities. Overall, 40 (43%) of 92 patients had lapatinib dose reductions, and 27 (29%) of 92 patients had grade 3 diarrhea. Three patients (3%) had congestive heart failure; three patients dropped out because of significant asymptomatic LVEF decline during PTL followed by TL.
Conclusion
Dose-dense AC followed by PTL and then followed by TL was not feasible because of a high rate of lapatinib dose reduction, mostly caused by unacceptable grade 3 diarrhea. Lapatinib (1,000 mg/d) was not feasible combined with weekly PT.
doi:10.1200/JCO.2009.26.5900
PMCID: PMC3664034  PMID: 20479410
9.  Dose-Dense Adjuvant Doxorubicin and Cyclophosphamide Is Not Associated With Frequent Short-Term Changes in Left Ventricular Ejection Fraction 
Journal of Clinical Oncology  2009;27(36):6117-6123.
Purpose
Doxorubicin and cyclophosphamide (AC) every 3 weeks has been associated with frequent asymptomatic declines in left ventricular ejection fraction (LVEF). Dose-dense (dd) AC followed by paclitaxel (P) is superior to the same regimen given every third week. Herein, we report the early cardiac safety of three sequential studies of ddAC alone or with bevacizumab (B).
Patients and Methods
Patients with HER2-positive breast cancer were treated on two trials: ddAC followed by P and trastuzumab (T) and ddAC followed by PT and lapatinib. Patients with HER2-normal breast cancer were treated with B and ddAC followed by B and nanoparticle albumin–bound P. Prospective LVEF measurement by multigated radionuclide angiography scan before and after every 2 week AC for 4 cycles and at month 6 from all three trials were aggregated to determine the early risks of cardiac dysfunction.
Results
From January 2005 to May 2008, 245 patients were enrolled. The median age was 47 years (range, 27 to 75 years). Median LVEF pre-ddAC was 68% (range, 52% to 82%). LVEF post-ddAC was available in 241 patients (98%) and the median was unchanged at 68% (range, 47% to 81%). Per protocol no patients were ineligible for subsequent targeted biologic therapy based on LVEF decline post-ddAC. In addition, LVEF was available in 222 patients (92%) at 6 months, at which time the median LVEF was similar at 65% (range, 24% to 80%). Within 6 months of initiating chemotherapy, three patients (1.2%; 95% CI, 0.25% to 3.54%) developed CHF, all of whom received T.
Conclusion
Dose-dense AC with or without concurrent bevacizumab is not associated with frequent acute or short-term declines in LVEF.
doi:10.1200/JCO.2008.20.2952
PMCID: PMC3664032  PMID: 19901120
10.  Postmenopausal hormone use and symptoms of gastroesophageal reflux 
Archives of internal medicine  2008;168(16):1798-1804.
Context
Previous studies suggest that elevated levels of estrogen and progesterone, either through endogenous or exogenous sources, increase gastroesophageal reflux.
Objective
To evaluate the relationship between symptoms of gastroesophageal reflux disease and postmenopausal hormone therapy, including the use of selective estrogen receptor modulators and over-the-counter hormone preparations.
Design, setting, and participants
Prospective cohort study of 51,637 postmenopausal women enrolled in the Nurses’ Health Study who provided data on the use of hormone therapy biennially since 1976, and information about symptoms of gastroesophageal reflux in 2002.
Main outcome measure
Self-reported symptoms of heartburn or acid-regurgitation occurring at least once a week in the previous year (reflux symptoms).
Results
Among eligible participants, 12,018 (23%) women reported reflux symptoms. Compared to women who never used postmenopausal hormones, the multivariate odds ratio (OR) for the risk of reflux symptoms was 1.46 (95% CI 1.36–1.56) for past hormone users, 1.66 (95% CI 1.54–1.79) for current users of estrogen only, and 1.41 (95% CI 1.29–1.54) for current users of combined estrogen and progesterone. The risk of reflux symptoms increased significantly with increasing estrogen dose (P < 0.001) and increasing duration of estrogen use (P < 0.001). Moreover, current selective estrogen receptor modulator users experienced an OR of 1.39 (95% CI 1.22–1.59) for reflux symptoms, and women currently using over-the-counter hormone preparations had an OR of 1.37 (95% CI 1.16–1.62).
Conclusions
Postmenopausal use of estrogens, selective estrogen receptor modulators, or over-the-counter hormone preparations is associated with an increased risk of symptoms of gastroesophageal reflux. This suggests a hormonal component to the pathophysiology of gastroesophageal reflux in women.
doi:10.1001/archinte.168.16.1798
PMCID: PMC2761884  PMID: 18779468

Results 1-10 (10)