Oncology providers' perspectives on endocrine therapy prescribing and management.

Adjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study's objective was to better understand ET decision making, prescribing, and patient management from oncology providers' perspectives. Using purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30-45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti. Providers recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient's menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects. From the clinicians' perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy

Predictors of timing of adjuvant chemotherapy in older women with hormone receptor–negative, stages II–III breast cancer

Adherence to consensus guidelines for cancer care may vary widely across health care settings and contribute to differences in cancer outcomes. For some women with breast cancer, omission of adjuvant chemotherapy or delays in its initiation may contribute to differences in cancer recurrence and mortality. We studied adjuvant chemotherapy use among women with stage II or stage III, hormone receptor–negative breast cancer to understand health system and socio-demographic correlates of under-use and delayed adjuvant chemotherapy. We used Surveillance Epidemiology and End Results (SEER)-Medicare linked data to examine the patterns of care for 6,678 women aged 65 and older diagnosed with stage II or stage III hormone receptor–negative breast cancer in 1994–2002, with claims data through 2007. Age-stratified logistic regression was employed to examine the potential role of socio-demographic and structural/organizational health services characteristics in explaining differences in adjuvant chemotherapy initiation. Overall utilization of guideline-recommended adjuvant chemotherapy peaked at 43% in this population. Increasing age, higher co-morbidity burden, and low-income status were associated with lower odds of chemotherapy initiation within 4 months, whereas having positive lymph nodes, more advanced disease, and being married were associated with higher odds (P < 0.05). Health system–related structural/organizational characteristics and race/ethnicity offered little explanatory insight. Timely initiation of guideline-recommended adjuvant chemotherapy was low, with significant variation by age, income, and co-morbidity status. Based on these findings, future studies should seek to explore the more nuanced reasons why older women do not receive chemotherapy and why delays in care occur

Structural/organizational characteristics of health services partly explain racial variation in timeliness of radiation therapy among elderly breast cancer patients

Observed racial/ethnic disparities in the process and outcomes of breast cancer care may be explained, in part, by structural/organizational characteristics of health care systems. We examined the role of surgical facility characteristics and distance to care in explaining racial/ethnic variation in timing of initiation of guideline-recommended radiation therapy (RT) after breast conserving surgery (BCS). We used Surveillance Epidemiology and End Results-Medicare data to identify women ages 65 and older diagnosed with stages I–III breast cancer and treated with BCS in 1994–2002. We used stepwise multivariate logistic regression to examine the interactive effects of race/ethnicity and facility profit status, teaching status, size, and institutional affiliations, and distance to nearest RT on timing of RT initiation, controlling for known covariates. Among 38,574 eligible women who received BCS, 39% received RT within 2 months, 52% received RT within 6 months, and 57% received RT within 12 months post-diagnosis, with significant variation by race/ethnicity. In multivariate models, women attending smaller surgical facilities and those with on-site radiation had higher odds of RT at each time interval, and women attending governmental facilities had lower odds of RT at each time interval (P < 0.05). Increasing distance between patients’ residence and nearest RT provider was associated with lower overall odds of RT, particularly among Hispanic women (P < 0.05). In fully adjusted models including race-by-distance interaction terms, racial/ethnic disparities disappeared in RT initiation within 6 and 12 months. Racial/ethnic disparities in timing of RT for breast cancer can be partially explained by structural/organizational health system characteristics. Identifying modifiable system-level factors associated with quality cancer care may help us target policy interventions that can reduce disparities in outcomes

Physician and Stakeholder Perceptions of Conflict of Interest Policies in Oncology

The landscape of managing potential conflicts of interest (COIs) has evolved substantially across many disciplines in recent years, but rarely are the issues more intertwined with financial and ethical implications than in the health care setting. Cancer care is a highly technologic arena, with numerous physician-industry interactions. The American Society of Clinical Oncology (ASCO) recognizes the role of a professional organization to facilitate management of these interactions and the need for periodic review of its COI policy (Policy)

Clinical Trials and Medical Care: Defining the Therapeutic Misconception

A key component of informed consent to participate in medical research includes understanding that research is not the same as treatment

Tamoxifen Dose Escalation in Patients With Diminished CYP2D6 Activity Normalizes Endoxifen Concentrations Without Increasing Toxicity

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/139937/1/onco0795-sup-0002.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139937/2/onco0795-sup-0001.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139937/3/onco0795.pd

Quantifying the recruitment challenges with couple-based interventions for cancer: applications to early-stage breast cancer

Despite mounting evidence supporting the use of psychosocial interventions to promote adaptation to cancer, enrolling participants into these interventions is challenging. This is particularly salient for couple-based interventions, and newer, more targeted recruitment strategies to increase enrollment are needed. However, there have been few published empirical studies focused specifically on recruitment–related variables associated with enrollment into these types of interventions. To better understand how to encourage participation in couple-based psychosocial interventions for cancer, we examined facilitating and impeding factors to enrollment into a couple-based intervention for women with early stage breast cancer

Ethical Considerations for the Clinical Oncologist in an Era of Oncology Drug Shortages

Shortages of injectable drugs affect many cancer patients and providers in the U.S. today. Scholars and policymakers have recently begun to devote increased attention to these issues, but only a few tangible resources exist to guide clinical oncologists in developing strategies for dealing with drug shortages on a recurring basis. This article discusses existing information from the scholarly literature, policy analyses, and other relevant sources and seeks to provide practical ethical guidance to the broad audience of oncology professionals who are increasingly confronted with such cases in their practice. We begin by providing a brief overview of the history, causes, and regulatory context of oncology drug shortages in the U.S., followed by a discussion of ethical frameworks that have been proposed in this setting. We conclude with practical recommendations for ethical professional behavior in these increasingly common and challenging situations

Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer

<p>Abstract</p> <p>Background</p> <p>The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy.</p> <p>Methods/Design</p> <p>Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk^-1of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO_2peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO_2peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO_2peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks).</p> <p>Discussion</p> <p>EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO_2peakand other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy.</p> <p>Trial Registration</p> <p>NCT01186367</p

Application of In Vivo Induced Antigen Technology (IVIAT) to Bacillus anthracis

In vivo induced antigen technology (IVIAT) is an immuno-screening technique that identifies bacterial antigens expressed during infection and not during standard in vitro culturing conditions. We applied IVIAT to Bacillus anthracis and identified PagA, seven members of a N-acetylmuramoyl-L-alanine amidase autolysin family, three P60 family lipoproteins, two transporters, spore cortex lytic protein SleB, a penicillin binding protein, a putative prophage holin, respiratory nitrate reductase NarG, and three proteins of unknown function. Using quantitative real-time PCR comparing RNA isolated from in vitro cultured B. anthracis to RNA isolated from BALB/c mice infected with virulent Ames strain B. anthracis, we confirmed induced expression in vivo for a subset of B. anthracis genes identified by IVIAT, including L-alanine amidases BA3767, BA4073, and amiA (pXO2-42); the bacteriophage holin gene BA4074; and pagA (pXO1-110). The exogenous addition of two purified putative autolysins identified by IVIAT, N-acetylmuramoyl-L-alanine amidases BA0485 and BA2446, to vegetative B. anthracis cell suspensions induced a species-specific change in bacterial morphology and reduction in viable bacterial cells. Many of the proteins identified in our screen are predicted to affect peptidoglycan re-modeling, and our results support significant cell wall structural remodeling activity during B. anthracis infection. Identification of L-alanine amidases with B. anthracis specificity may suggest new potential therapeutic targets