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1.  Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer 
The New England journal of medicine  2015;372(2):134-141.
No single standard treatment exists for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)–positive breast cancers, because most of these patients have been ineligible for the pivotal trials of adjuvant trastuzumab.
We performed an uncontrolled, single-group, multicenter, investigator-initiated study of adjuvant paclitaxel and trastuzumab in 406 patients with tumors measuring up to 3 cm in greatest dimension. Patients received weekly treatment with paclitaxel and trastuzumab for 12 weeks, followed by 9 months of trastuzumab monotherapy. The primary end point was survival free from invasive disease.
The median follow-up period was 4.0 years. The 3-year rate of survival free from invasive disease was 98.7% (95% confidence interval [CI], 97.6 to 99.8). Among the 12 relapses seen, 2 were due to distant metastatic breast cancer. Excluding contra-lateral HER2-negative breast cancers and nonbreast cancers, 7 disease-specific events were noted. A total of 13 patients (3.2%; 95% CI, 1.7 to 5.4) reported at least one episode of grade 3 neuropathy, and 2 had symptomatic congestive heart failure (0.5%; 95% CI, 0.1 to 1.8), both of whom had normalization of the left ventricular ejection fraction after discontinuation of trastuzumab. A total of 13 patients had significant asymptomatic declines in ejection fraction (3.2%; 95% CI, 1.7 to 5.4), as defined by the study, but 11 of these patients were able to resume trastuzumab therapy after a brief interruption.
Among women with predominantly stage I HER2-positive breast cancer, treatment with adjuvant paclitaxel plus trastuzumab was associated with a risk of early recurrence of about 2%; 6% of patients withdrew from the study because of protocol-specified adverse events. (Funded by Genentech; number, NCT00542451.)
PMCID: PMC4313867  PMID: 25564897
2.  Measuring decision quality: psychometric evaluation of a new instrument for breast cancer chemotherapy 
Women diagnosed with early stage (I or II) breast cancer face a highly challenging decision – whether or not to undergo adjuvant chemotherapy. We developed a decision quality instrument for chemotherapy for early stage breast cancer and sought to evaluate its performance.
Cross-sectional, mailed survey of recent breast cancer survivors, providers, and healthy controls and a retest survey of survivors. The decision quality instrument includes questions on knowledge and personal goals. It results in a knowledge score and concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, validity, and reliability of the survey instrument were examined.
Responses were received from 352 patients, 89 providers and 35 healthy controls. The decision quality instrument was feasible to implement with few missing data. The knowledge scores had good retest reliability (intraclass correlation coefficient (ICC) =0.75). Knowledge scores discriminated between providers and patients (mean difference 31.1%, 95% CI 26.9, 35.3) and between patients and healthy controls (mean difference 11.2, 95% CI 5.4, 17.1). Most providers reported that the knowledge items covered essential content. Two of the five goal items had a ceiling effect, and one goal had low content validity. The goal items had moderate retest reliability (ICC’s 0.57 to 0.78). In the multivariable model of treatment, none of the patient goals was associated with receipt of chemotherapy. Age and hormone receptor status were the only variables independently associated with chemotherapy. Most patients (77.6%) had treatment concordant with that predicted by the model. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.
The Decision Quality Instrument is a reliable and valid measure of patient knowledge about chemotherapy, but its ability to measure concordance with patient goals is limited. In this sample, patient goals were not associated with treatment, and most patients reported they were not asked their preference, suggesting that goals were not adequately considered in decision making.
PMCID: PMC4150558  PMID: 25142035
Decision; Regret; Breast cancer; Shared decision making; Quality of care; Decision quality; Chemotherapy; Adjuvant therapy
3.  Correlation Between Financial Relationships With Commercial Interests and Research Prominence at an Oncology Meeting 
Journal of Clinical Oncology  2013;31(21):2678-2684.
Little is known about the effects of financial relationships between biomedical researchers and industry (financial conflicts of interest [FCOIs]) on research prominence. We examined the prevalence of FCOIs in oncology and associations between FCOIs and research prominence among abstracts presented at American Society of Clinical Oncology (ASCO) annual meetings.
We analyzed 20,718 abstracts presented at ASCO meetings in 2006 and 2008 to 2011. Measures included the following: financial relationships, peer review score (PRS), and meeting placement prominence (descending order of prominence: plenary session, clinical science symposium, oral presentation, poster discussion, general posters, and publish only).
Of 20,718 abstracts, 36% reported at least one author with an FCOI. The proportion of abstracts with any FCOI increased from 33% in 2006 to 38% in 2011 (P < .001). Abstracts with FCOIs had significantly higher meeting prominence compared with publish only and general poster abstracts. The odds ratios compared with general posters were 7.3 for plenary session, 2.2 for clinical science symposium, 1.9 for oral presentation, and 1.7 for poster discussion (P < .001). Abstracts with FCOIs had significantly better PRSs compared with those without FCOIs. For all abstracts, PRS was 2.76 (95% CI, 2.75 to 2.77) with FCOIs compared with 3.01 (95% CI, 3.001 to 3.02) without FCOIs (P < .001). Omitting publish-only abstracts, PRS was 2.62 (95% CI, 2.61 to 2.63) with FCOIs compared with 2.73 without FCOIs (95% CI, 2.71 to 2.73).
Abstracts with FCOIs had more prominent meeting placement and better PRSs. FCOIs were reported more frequently by year, suggesting an increasing influence of industry on cancer research, greater disclosure, or both.
PMCID: PMC3709055  PMID: 23775973
4.  Are patients making high-quality decisions about breast reconstruction after mastectomy? 
Variation in rates of breast reconstruction after mastectomy has raised concerns about the quality of decisions about reconstruction. We sought to evaluate patient decision making about reconstruction, using a validated measure of knowledge and preferences related to reconstruction.
A cross-sectional survey of early-stage breast cancer survivors from four university medical centers was conducted. The survey included measures of knowledge about specific reconstruction facts, personal goals and concerns, and involvement in decision making. A multivariable linear regression model of characteristics associated with knowledge and a logistic regression model of factors associated with having reconstruction were developed.
84 patients participated (59% response rate). Participants answered 37.9% of knowledge questions correctly. Higher education (beta 15%, p=0.003) and having reconstruction (beta 21%, p<0.0001) were associated with higher knowledge. The goals “use your own tissue to make a breast” (OR 1.53, 95% CI 1.15, 2.05) and “wake up after mastectomy with reconstruction underway” (OR 1.66, 95% CI 1.30, 2.12) were associated with reconstruction. The goal “avoid putting foreign material in your body” was associated with no reconstruction (OR 0.64, 95% CI 0.48, 0.86). Most patients reported they mainly made the decision or made the decision with the doctor equally (93%, 95%CI 85-97%), and that their degree of involvement was about right (85%, 95%CI 75-91%).
Women treated with mastectomy in this study were not well-informed about breast reconstruction. Treatments were associated with patients' goals and concerns, however, and patients were highly involved in their decisions. Knowledge deficits suggest that breast cancer patients would benefit from interventions to support their decision making.
PMCID: PMC4100583  PMID: 21200195
5.  The Cost of Cancer Care—Balancing Our Duties to Patients Versus Society: Are They Mutually Exclusive? 
The Oncologist  2013;18(4):347-349.
PMCID: PMC3639518  PMID: 23568002
Health care costs; Ethical issues; Cancer care; Resource allocation; Decision-making
6.  Bosutinib in Combination With the Aromatase Inhibitor Letrozole: A Phase II Trial in Postmenopausal Women Evaluating First-Line Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive/HER2-Negative Breast Cancer 
The Oncologist  2014;19(4):348-349.
Endocrine therapy resistance in hormone receptor-positive (HR+) breast cancer (BC) may involve crosstalk between HRs and growth factor signaling pathways. We evaluated bosutinib, a dual Src/Abl tyrosine kinase inhibitor that has previously demonstrated some antitumor activity in BC, plus letrozole as first-line endocrine therapy in locally advanced or metastatic HR+/HER2− BC.
Sixteen postmenopausal women were enrolled in a phase II study evaluating the safety/efficacy of bosutinib plus letrozole. In the single-arm safety/dose-confirming lead-in (part 1), patients received oral bosutinib at 400 mg/day plus letrozole at 2.5 mg/day; adverse events (AEs) and dose-limiting toxicities (DLTs) were monitored, and initial efficacy was assessed. A randomized efficacy/safety phase (part 2) was planned to evaluate the combination versus letrozole monotherapy.
Fifteen of 16 subjects experienced treatment-related AEs, most commonly diarrhea (69%). Treatment-related hepatotoxicity AEs (primarily alanine aminotransferase [ALT] or aspartate aminotransferase [AST] elevations) occurred in 6 of 16 patients (38%). Four of 15 evaluable patients (27%) experienced a DLT (grade 3/4 ALT/AST elevations, n = 2; grade 3 rash, n = 1; grade 3 diarrhea or vomiting, n = 1), including 1 Hy’s law hepatotoxicity case. All DLTs resolved following treatment discontinuation. One patient achieved confirmed partial response; one had stable disease for >24 weeks. Study termination occurred before part 2.
The unfavorable risk-benefit ratio did not warrant further investigation of bosutinib plus letrozole.
PMCID: PMC3983830  PMID: 24674874
7.  Bosutinib in Combination With the Aromatase Inhibitor Exemestane: A Phase II Trial in Postmenopausal Women With Previously Treated Locally Advanced or Metastatic Hormone Receptor-Positive/HER2-Negative Breast Cancer 
The Oncologist  2014;19(4):346-347.
Bosutinib is an oral, selective Src/Abl tyrosine kinase inhibitor with activity in breast cancer (BC). We evaluated bosutinib plus exemestane as second-line therapy in previously treated hormone receptor-positive (HR+) locally advanced or metastatic BC.
This was a phase II study with patients enrolled in a single-arm safety lead-in phase. Patients receiving bosutinib at 400 mg or 300 mg/day (based on toxicity) plus exemestane at 25 mg/day were monitored for adverse events (AEs) and dose-limiting toxicities for 28 days, and initial efficacy was assessed. After the lead-in and dose-determination phase, randomized evaluation of combination therapy versus exemestane was planned.
Thirty-nine of 42 patients (93%) experienced treatment-related AEs including diarrhea in 28 (67%) and hepatotoxicity in 11 (26%); overall serious treatment-related AEs were recorded in 4 (10%). No liver toxicity met Hy’s law criteria. Dose-limiting toxicities occurred in 5 of 13 patients receiving 400 mg (38%) and 3 of 26 patients receiving 300 mg (12%) of bosutinib; all resolved on treatment discontinuation. One patient (300 mg/day) achieved confirmed partial response; three (400 mg/day, n = 2; 300 mg/day, n = 1) maintained stable disease for >24 weeks; a best response of progressive disease occurred in 15 of 42 patients (36%). Median progression-free survival was 12.3 weeks (80% confidence interval: 11.0–15.6).
The risk-benefit profile of bosutinib at 300 mg/day plus exemestane resulted in early study termination before the randomized portion. Alternative bosutinib regimens merit investigation in BC.
PMCID: PMC3983831  PMID: 24674873
8.  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.
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
9.  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
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.
PMCID: PMC3425520  PMID: 22752069
Patient navigation; Cancer disparities; Breast cancer; Outcomes
10.  Decision Making about Surgery for Early Stage Breast Cancer 
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.
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.
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.
PMCID: PMC3256735  PMID: 22056355
11.  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.
PMCID: PMC3396816  PMID: 23180985
12.  Impact of hormone receptor status on patterns of recurrence and clinical outcomes among patients with human epidermal growth factor-2-positive breast cancer in the National Comprehensive Cancer Network: a prospective cohort study 
Breast Cancer Research : BCR  2012;14(5):R129.
In gene expression experiments, hormone receptor (HR)-positive/human epidermal growth factor-2 (HER2)-positive tumors generally cluster within the luminal B subset; whereas HR-negative/HER2-positive tumors reside in the HER2-enriched subset. We investigated whether the clinical behavior of HER2-positive tumors differs by HR status.
We evaluated 3,394 patients who presented to National Comprehensive Cancer Network (NCCN) centers with stage I to III HER2-positive breast cancer between 2000 and 2007. Tumors were grouped as HR-positive/HER2-positive (HR+/HER2+) or HR-negative/HER2-positive (HR-/HER2+). Chi-square, logistic regression and Cox hazard proportional regression were used to compare groups.
Median follow-up was four years. Patients with HR-/HER2+ tumors (n = 1,379, 41% of total) were more likely than those with HR+/HER-2+ disease (n = 2,015, 59% of total) to present with high histologic grade and higher stages (P <0.001). Recurrences were recorded for 458 patients. HR-/HER2+ patients were less likely to experience first recurrence in bone (univariate Odds Ratio (OR) = 0.53, 95% Confidence Interval (CI): 0.34 to 0.82, P = 0.005) and more likely to recur in brain (univariate OR = 1.75, 95% CI: 1.05 to 2.93, P = 0.033). A lower risk of recurrence in bone persisted after adjusting for age, stage and adjuvant trastuzumab therapy (OR = 0.53, 95% CI: 0.34 to 0.83, P = 0.005) and when first and subsequent sites of recurrence were both considered (multivariable OR = 0.55, 95% CI: 0.37 to 0.80, P = 0.002).
As compared with patients with HR+/HER2+ disease, those with HR-/HER2+ disease had significantly increased hazard of early, but not late, death (hazard ratio of death zero to two years after diagnosis = 1.92, 95% CI: 1.28 to 2.86, P = 0.002, hazard ratio of death two to five years after diagnosis = 1.55, 95% CI: 1.19 to 2.00, P = 0.001; hazard ratio of death more than five years after diagnosis = 0.81, 95% CI: 0.55 to 1.19, P = 0.285, adjusting for age, race/ethnicity, stage at diagnosis, grade and year of diagnosis).
Presenting features, patterns of recurrence and survival of HER2-positive breast cancer differed by HR status. These differences should be further explored and integrated in the design of clinical trials.
PMCID: PMC4053106  PMID: 23025714
13.  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.
PMCID: PMC3228140  PMID: 21804070
Disparities in cancer care; Health care law; Patient navigator programs; Patient Protection and Affordable Care Act
14.  Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery 
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.
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.
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.
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.
PMCID: PMC3411423  PMID: 22681763
15.  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.
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%.
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.
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.
PMCID: PMC3664034  PMID: 20479410
16.  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.
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.
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.
Dose-dense AC with or without concurrent bevacizumab is not associated with frequent acute or short-term declines in LVEF.
PMCID: PMC3664032  PMID: 19901120
17.  Postmenopausal hormone use and symptoms of gastroesophageal reflux 
Archives of internal medicine  2008;168(16):1798-1804.
Previous studies suggest that elevated levels of estrogen and progesterone, either through endogenous or exogenous sources, increase gastroesophageal reflux.
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).
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).
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.
PMCID: PMC2761884  PMID: 18779468

Results 1-17 (17)