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Background: Palliative care specialists are experts in conducting advance care planning (ACP) but are a limited resource. Oncology nurses often have special relationships with their patients and thus may be poised to provide primary palliative care. We sought to determine the impact of a nurse-led primary palliative care intervention on ACP uptake among patients with advanced cancer. Methods: We performed a secondary analysis of a cluster randomized controlled trial examining the impact of nurse-based primary palliative care. In the parent trial, patients with advanced cancer received either monthly primary palliative care visits with trained nurses within their cancer center or standard care. Nurses in the intervention arm received special training in ACP. ACP uptake was assessed at enrollment and 3 months later evaluating (1) whether an end-of-life conversation (EOLC) occurred with one’s oncologist, and (2) completion of an advance directive (AD). Multivariable logistic regression tested differences in ACP uptake by treatment arm adjusted for age, religious importance, education, time with current oncologist, and performance status. Results: Of 672 patients enrolled, 182/336 (54%) patients in the intervention arm and 196/336 (58%) in the standard care arm lacked an EOLC at baseline and completed the 3-month assessment. Of those, 82/182 (45.1%) patients in the intervention arm and 29/196 (14.8%) in the standard care arm reported having an EOLC at 3 months (adjusted odds ratio, 5.28; 95% CI, 3.10–8.97; PPConclusions: Nurse-led primary palliative care increased ACP uptake among patients with advanced cancer. Training oncology nurses embedded within community cancer centers to provide primary palliative care may help improve ACP access.

Self-advocacy skills allow individuals with cancer to overcome challenges related to their health, care, and well-being. Understanding the self-advocacy behaviors and needs of individuals with cancer is critical to addressing the lack of evidence-based self-advocacy interventions. The aims of this study are to describe (1) self-advocacy behaviors and needs of women with advanced cancer and (2) associations between self-advocacy and sociodemographic, cancer, and patient-reported outcomes.We analyzed cross-sectional data from a clinical trial among women within 3 months of a metastatic breast or stage III or IV gynecologic cancer diagnosis. Descriptive and correlational statistics and tests of group difference were calculated for measures of self-advocacy (Female Self-Advocacy in Cancer Survivorship Scale), sociodemographic characteristics, quality of life (FACT-G), symptom burden (M.D. Anderson Symptom Inventory), and mood (Hospital Anxiety and Depression Scale).Participants (N = 78) reported self-advocacy behaviors including making decisions based on their priorities, asking questions to their healthcare providers, and comparing their experiences to others' experiences. Self-advocacy needs focused on finding health information and talking with healthcare providers. Self-advocacy behaviors and needs did not differ by participants' sociodemographic characteristics or mood. Higher self-advocacy behaviors were associated with higher quality of life (p ≤ .01) and lower symptom severity (p .05) with a trend for cancer recurrence (p = .05).Women with advanced cancer report engaging in self-advocacy behaviors and these are associated with higher quality of life and lower symptom burden. Future research should determine if self-advocacy behaviors and needs change over time and how patient characteristics impact self-advocacy behaviors and needs.

PURPOSE: Patients with advanced cancer often have unrealistic expectations about prognosis and treatment. This study assessed the effect of an oncology nurse-led primary palliative care intervention on illness expectations among patients with advanced cancer. METHODS: This study is a secondary analysis of a cluster-randomized trial of primary palliative care conducted at 17 oncology clinics. Adult patients with advanced solid tumors for whom the oncologist would not be surprised if died within 1 year were enrolled. Monthly visits were designed to foster realistic illness expectations by eliciting patient concerns and goals for their medical care and empowering patients and families to engage in discussions with oncologists about treatment options and preferences. Baseline and 3-month questionnaires included questions about life expectancy, treatment intent, and terminal illness acknowledgment. Odds of realistic illness expectations at 3 months were adjusted for baseline responses, patient demographic and clinical characteristics, and intervention dose. RESULTS: Among 457 primarily White patients, there was little difference in realistic illness expectations at 3 months between intervention and standard care groups: 12.8% v 11.4% for life expectancy (adjusted odds ratio [aOR] = 1.15; 95% CI, 0.59 to 2.22; P = .684); 24.6% v 33.3% for treatment intent (aOR = 0.76; 95% CI, 0.44 to 1.27; P = .290); 53.6% v 44.7% for terminal illness acknowledgment (aOR = 1.28; 95% CI, 0.81 to 2.00; P = .288). Results did not differ when accounting for variation in clinic sites or intervention dose. CONCLUSION: Illness expectations are difficult to change among patients with advanced cancer. Additional work is needed to identify approaches within oncology practices that foster realistic illness expectations to improve patient decision making.

In metastatic breast cancer (MBC), positive estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2) status allow for more long-term, sequential treatment options compared to ER-negative and HER2-negative diseases. It is unclear if end-of-life care (timely integration of palliative care, discontinuation of chemotherapy, and enrollment into hospice) in MBC is now tailored to the ER and HER2 status.This article explores the association between ER and HER2 status and the quality of end-of-life care received among patients with MBC.A 20-year MBC clinical database captured demographics, tumor characteristics, and treatment histories of deceased patients with MBC (N = 1,258) at a tertiary hospital located in Pittsburgh, Pennsylvania. Descriptive and inferential statistics were used.Patients with ER-positive MBC had greater odds of receiving quality end-of-life care than those with ER-negative MBC. HER2 status was not associated with differences in the quality of end-of-life care.

Estrogen receptor alpha (ER/ESR1) is mutated in 30-40% of endocrine resistant ER-positive (ER+) breast cancer. ESR1 mutations cause ligand-independent growth and increased metastasis in vivo and in vitro. Despite the distinct clinical features and changes in therapeutic response associated with ESR1 mutations, there are no data about their potential role in intrinsic subtype switching.Applying five different luminal and basal gene set pairs derived from cell lines and tumors, ESR1 mutant cell models and clinical samples showed a significant enrichment of basal subtype markers. Among them, the six basal cytokeratins (BCKs) were the most enriched genes (KRT5/6A/6B/14/16/17) uniquely in ESR1 mutant cells but not other endocrine resistant cell models. BCKs were observed to heterogeneously express in a minor cell subpopulation in ESR1 mutant cell models and clinical specimens. ER ChIP-seq showed the mutant-specific induction of BCKs was independent of ER binding and instead selectively expressed in clones with low ER expression. In contrast, BCKs are associated with chromatin reprogramming centered around a progesterone receptor-orchestrated 154 kb insulated neighborhood at the KRT14/16/17 genomic region. Stronger CTCF binding was detected at the bases of chromatin loop in ESR1 mutant cells. Knockdown of progesterone receptor but not glucocorticoid receptor drastically blocked the induction of KRT14/16/17 in ESR1 mutant cells. Unexpectedly, high BCK expression in ER+ primary breast cancer is associated with good prognosis, and these tumors show enriched activation of a number of immune pathways, a distinctive feature shared with ESR1 mutant tumors. While the BCK-associated immune activation is not related to tumor mutation burdens, S100A8 and S100A9 were identified as the most highly induced immune mediators shared between high-BCKs ER+ and ESR1 mutant tumors, which was further validated in the plasma samples of a cohort of 18 patients with ER+ metastases (11 WT vs 7 mutant). Finally, single-cell RNA-seq analysis in an ER+ bone metastasis case inferred the involvement of S100A8 and S100A9 in paracrine crosstalk between epithelial and stromal cells, particularly macrophages and fibroblasts through TLR4 signaling. Collectively, these observations demonstrate that ESR1 mutant tumors gain basal features with induction of basal cytokeratins via epigenetic mechanisms in rare subpopulation of cells. This is associated with increased immune activation, encouraging additional studies of immune therapeutic vulnerabilities in ESR1 mutant tumors. Citation Format: Zheqi Li, Yang Wu, Olivia Mcginn, Amir Bahreini, Nolan M. Priedigkeit, Kai Ding, Sayali Onkar, Carol A. Sartorius, Lori Miller, Margaret Rosenzweig, Nikhil Wagle, Jennifer K. Richer, William J. Muller, Laki Buluwela, Simak Ali, Dario A.A. Vignali, Yusi Fang, Li Zhu, George C. Tseng, Jason Gertz, Jennifer M. Atkinson, Adrian V. Lee, Steffi Oesterreich. Esr1 mutant breast cancers show elevated basal cytokeratins and immune activation [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD1-08.

Background Clinicians often cite a fear of giving up hope as a reason they defer advance care planning (ACP) among patients with advanced cancer. The objective of this study was to determine whether engagement in ACP affects hope in these patients. Methods This was a secondary analysis of a randomized controlled trial of primary palliative care in advanced cancer. Patients who had not completed ACP at baseline were included in the analysis. ACP was assessed in the forms of an end-of-life (EOL) conversation with one's oncologist and completion of a living will or advance directive (AD). Measurements were obtained at baseline and at 3 months. Hope was measured using the Herth Hope Index (HHI) (range, 12-48; higher scores indicate higher hope). Multivariate regression was performed to assess associations between ACP and hope, controlling for baseline HHI score, study randomization, patient age, religious importance, education, marital status, socioeconomic status, time since cancer diagnosis, pain/symptom burden (Edmonton Symptom Assessment System), and anxiety/depression score (Hospital Anxiety and Depression Scale)-all variables known to be associated with ACP and/or hope. Results In total, 672 patients with advanced cancer were enrolled in the overall study. The mean age was 69 ± 10 years, and the most common cancer types were lung cancer (36%), gastrointestinal cancer (20%) and breast/gynecologic cancers (16%). In this group, 378 patients (56%) had not had an EOL conversation at baseline, of whom 111 of 378 (29%) reported having an EOL conversation by 3 months. Hope was not different between patients who did or did not have an EOL conversation over the study period (mean ± standard deviation ∆HHI, 0.20 ± 5.32 vs -0.53 ± 3.80, respectively; P = .136). After multivariable adjustment, hope was significantly increased in patients who had engaged in an EOL conversation (adjusted mean difference in ∆HHI, 0.95; 95% CI, 0.08-1.82; P = .032). Similarly, of 216 patients (32%) without an AD at baseline, 67 (31%) had subsequently completed an AD. Unadjusted hope was not different between those who did and did not complete an AD (∆HHI, 0.20 ± 3.89 vs -0.91 ± 4.50, respectively; P = .085). After adjustment, hope was significantly higher in those who completed an AD (adjusted mean difference in ∆HHI, 1.31; 95% CI, 0.13-2.49; P = .030). Conclusions The current results demonstrate that hope is not decreased after engagement in ACP and indeed may be increased. These findings may provide reassurance to clinicians who are apprehensive about having these important and difficult conversations. Lay summary Many oncologists defer advance care planning (ACP) out of concern for giving up hope. This study demonstrates that hope is not decreased in patients who have engaged in ACP either as a conversation with their oncologists or by completing an advance directive. With this information, providers may feel more comfortable having these important conversations with their patients.

PURPOSEMET exon 14 ( METex14) skipping alterations are oncogenic drivers in non–small-cell lung cancer (NSCLC). We present a comprehensive overview of METex14 samples from 1,592 patients with NSCLC, associated clinicogenomic characteristics, potential mechanisms of acquired resistance, treatment patterns, and outcomes to MET inhibitors.METHODSHybrid capture–based comprehensive genomic profiling (CGP) was performed on samples from 69,219 patients with NSCLC. For treatment patterns and outcomes analysis, patients with advanced METex14-altered NSCLC were selected from the Flatiron Health-Foundation Medicine clinicogenomic database, a nationwide deidentified electronic health record–derived database linked to Foundation Medicine CGP for patients treated between January 2011 and March 2020.RESULTSA total of 1,592 patients with NSCLC (2.3%) were identified with 1,599 METex14 alterations spanning multiple functional sites (1,458 of 60,244 tissue samples and 134 of 8,975 liquid samples). Low tumor mutational burden and high programmed death ligand 1 expression were enriched in METex14-altered samples. MDM2, CDK4, and MET coamplifications and TP53 mutations were present in 34%, 19%, 11%, and 42% of tissue samples, respectively. Comparing tissue and liquid cohorts, coalteration frequency and acquired resistance mechanisms, including multiple MET mutations, EGFR, ERBB2, KRAS, and PI3K pathway alterations, were generally similar. Positive percent agreement with the tissue was 100% for METex14 pairs collected within 1 year (n = 7). Treatment patterns showed increasing adoption of MET inhibitors in METex14-altered NSCLC after receipt of CGP results; the real-world response rate to MET inhibitors was 45%, and time to treatment discontinuation was 4.4 months.CONCLUSIONDiverse METex14 alterations were present in 2%-3% of NSCLC cases. Tissue and liquid comparisons showed high concordance and similar coalteration profiles. Characterizing common co-occurring alterations and immunotherapy biomarkers, including those present before or acquired after treatment, may be critical for predicting responses to MET inhibitors and informing rational combination strategies.

Biobanking is one of the most valuable tools in precision medicine. The ability of scientists to sequence tumors, blood, and normal tissue obtained from biorepositories has defined efficacious tumor targeting and a much better understanding of cancer pathology pathways. However, these biorepositories require a great deal of effort to establish and maintain. Oncology nurses are key in helping to bank tissue during routine procedures as well as complex surgeries. Nurses can obtain informed consent from patients and coordinate the banking of samples in a timely manner to ensure sample quality. Oncology nurses play an important role in informing patients of their biobanking options and connecting patients with the appropriate team for their biobanking needs.

Women with advanced cancer experience significant barriers to achieving high-quality care and maximizing their physical and emotional health. Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life, and patient-centered care.This is a single-center, multi-site randomized clinical trial of the Strong Together intervention among 336 women within three months of an advanced breast or gynecologic cancer diagnosis. Randomization occurs to the 3-month Strong Together serious game or enhanced care as usual group. The aims are to: (1) evaluate the effects of the intervention on patient self-advocacy (primary outcome); (2) evaluate the effects of the intervention on quality of life, symptom burden, and patient-centered care (secondary outcomes); and (3) evaluate the behavioral and game mechanisms that influence the efficacy of the intervention.female, age ≥ 18 years; diagnosis of advanced breast or gynecologic cancer within the past 3 months; Eastern Cooperative Oncology Group score of 0-2; English literacy; and ≥ 6-month life expectancy. Patient-reported outcome measures are collected at baseline, 3-months, and 6-months.This protocol is the first large-scale intervention aimed at promoting self-advocacy in women with advanced cancer. Understanding the ability of serious games to impact patient outcomes provides critical information for researchers, clinicians, and stakeholders aiming to improve patient-centered care.NCT04813276.

BACKGROUND: Advanced and continuing education is essential for maintaining competence. Graduate students have shown an increase in online course enrollment, and similar trends are anticipated among nurses with limited access to on-site education due to the current COVID-19 (coronavirus disease 2019) pandemic. Faculty must utilize preferred teaching/learning strategies to provide high-quality online education courses that engage learners and improve outcomes. OBJECTIVES: This study assessed preferred teaching/learning strategies for graduate students enrolled in at least 1 asynchronous nursing course. Correlational data assessed the relationship between preferred teaching/learning strategies and selected demographic information. METHODS: All graduate nursing students enrolled in at least 1 asynchronous course at the University of Pittsburgh School of Nursing during a 3-month period were invited to participate in a survey to assess preferred teaching/learning methods. RESULTS: Sixty-six graduate students completed the survey. Most participants were comfortable with computer skills, had previously enrolled in a web-enhanced course, and did not enjoy group work. Preferred teaching/learning strategies included voice-over PowerPoints, simulation, case studies, guest speakers, and faculty communication. CONCLUSION: Preferred teaching/learning strategies that incorporate asynchronous and synchronous learning should be developed. These strategies will enhance the knowledge base of nurses in all settings and populations.

Metastatic breast cancer (MBC) carries unique disease burdens with potential for poor-quality end-of-life (EOL) care. It is the purpose of this article to explore the association of poor-quality EOL care indicators according to key tumor, demographic, social, and clinical factors. End-of-life quality indicators were based on Emanuel and Emanuel's good death model in conjunction with Earle et al (2003). A single-institution retrospective chart review of women deceased from MBC between November 2016 and November 2019 with double-verification chart review was completed. Data were analyzed with descriptive, correlative, and comparative statistics. Total sample was N = 167 women, with 14.4% (n = 24) Black and 85.6% (n = 143) White. Mean (SD) age was 55.3 (11.73) years. Overall, MBC survival was 3.12 years (SD, 3.31): White women, 41.2 months (3.4 years), and Black women, 19 months (1.6 years). A total of 64.1% (n = 107) experienced 1 or more indicators of poor-quality EOL care. Patients more likely to experience poor-quality EOL care were older (P = .03), estrogen negative (P = .08), human epidermal growth factor receptor 2 negative (P = .07), from more deprived neighborhoods (P = .02), married (P = .05), and with physical (P = .001) and mental (P = .002) comorbidities. Understanding sociodemographic and clinical factors associated with poor EOL MBC care may be useful for proactive patient navigation.

High quality advanced cancer care includes goals of care (GOC) discussions and should be tailored according to clinical diagnosis, patient characteristics, and in concordance with patient’s goals. Metastatic breast cancer (MBC) and treatment has heterogeneity according to subtype which makes the timing of initiating and continuing GOC discussions challenging. With an ever-increasing array of therapy, women with advanced stage disease are unique survivors in that they receive relatively aggressive cancer care to not only palliative symptoms but extend survival time. It is the purpose of this paper to explore the prevalence, pattern, and likelihood of having a GOC discussion according to key tumor, demographic, social, and clinical factors. A single-institution retrospective chart review of women deceased from MBC between November 2016 and November 2019 with double verification chart review was completed. Data were analyzed with descriptive, correlative, and comparative statistics. Total sample was N=167 women, with 14.4% (n=24) Black and 85.6% (n=143) White. Mean age was 55.3 years (SD 11.73). Overall, MBC survival was 3.12 years (SD 3.31), White women 41.2 (3.4 years) months, and Black women 19 (1.6 years) months. A total of 87.4% (n=146) participated in one or more GOC discussions. GOC discussions were more likely among those who were referred to palliative care (p

OBJECTIVE: Patient–oncologist therapeutic alliance is a foundation of quality cancer care, although there is limited research demonstrating its relationship with patient outcomes. We investigated the relationship between therapeutic alliance and patient quality of life with a secondary goal of determining whether the association varied by patients’ baseline level of psychological distress. METHODS: Cross-sectional analysis of baseline data from a randomized clinical trial of 672 patients with advanced cancer participating in a primary palliative care intervention trial. Patients completed baseline self-reported measures of therapeutic alliance (The Human Connection Scale, range: 16–64), overall quality of life (Functional Assessment of Cancer Therapy—Palliative Care, range: 0–184), and psychological distress (Hospital Anxiety and Depression Scale, range: 0–42). First, we determined the relationship between therapeutic alliance and quality of life using multivariable regression adjusting for confounders. We then examined if psychological distress was an effect modifier in this relationship by adding interaction effects of depression and anxiety symptoms on therapeutic alliance into the regression model. RESULTS: Patients reported high levels of therapeutic alliance (56.4 ± 7.4) and moderate quality of life (130.3 ± 25.5). Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01). The relationship between therapeutic alliance and quality of life was generally consistent regardless of psychological distress. CONCLUSIONS: Collaborative, trusting relationships between patients with advanced cancer and their oncologists are associated with better patient quality of life. Future research should investigate the causal, longitudinal nature of these relationships.

BACKGROUND: Ixabepilone is a microtubule stabilizing agent that was approved as monotherapy and in combination with capecitabine for the treatment of refractory metastatic or locally advanced breast cancer resistant to anthracyclines, taxanes. With limited options for refractory MBC, especially in triple negative breast cancer (TNBC), ixabepilone plus capecitabine has demonstrated an increase in progression free survival (PFS) compared to patients treated with capecitabine alone. We assess the effectiveness and safety of the drug in a real-world setting. METHOD: REDCAPS is a large, ongoing clinical database of over 1800 women (1999 to present) was used to identify 91 patients who had received ixabepilone monotherapy and in combination with capecitabine during their treatment course at the Magee Women’s Hospital, Women’s Cancer Center. Clinical outcomes were retrospectively analyzed utilizing descriptive and comparative statistics. RESULTS: Patients were heavily pretreated: 41.8% had received at least 6 lines of prior chemotherapy in the metastatic setting. Treatment was late in the disease course; median line of treatment was 5.3. At the time of receiving ixabepilone, the patients had multiple metastases (64.8% have > 3) and widespread disease (57% had both visceral and non-visceral disease). PFS was 3.5 months with n=4 patients attaining a PFS > 12 months. Overall survival (OS) was 11.3 months. A subset of patients that had triple negative breast cancer (N=37) had similar PFS, 3.6 months, and OS, 10.2 months, as the total population of patients that received the medication. Another subset analysis was conducted looking at patients who had received ixabepilone monotherapy (82 patients) vs those who had received combination therapy with ixabepilone and capecitabine (9 patients). The PFS and OS was not statistically significant between the two groups. Most common adverse events of any grade were fatigue (37%), nausea (32%), and peripheral sensory neuropathy (28%). Grade 3 or higher anemia was present in 10% of the patients. CONCLUSION: Ixabepilone monotherapy and in combination with capecitabine has demonstrated efficacy in the treatment of heavily pretreated patients with MBC, including the challenging population of TNBC patients in this real-world example. While the number of patients receiving the combination therapy was low (n=9), PFS and OS were still demonstrated to be comparable to monotherapy. It is also well tolerated. These findings make ixabepilone a reasonable chemotherapeutic agent for refractory MBC and TNBC patients with visceral metastases, more than 3 metastatic disease sites, poor prognosis and who have limited treatment options after having failed anthracycline or taxane treatment. Ixabepilone Treatment in TNBC PatientsAll patients (N=91)TNBC (N=37)Age, yearsMedian (Range)=5048.1 (32.6-85.1)56 (61.5)35 (38.5)49.4 (28.8-85.1)20 (54.1)17 (45.9)Number of metastatic sites< 3> 332 (35.2)59 (64.8)14 (37.8)23 (62.2)Type of metastatic disease sitesVisceralNot visceralCombined21 (23.1)13 (14.3)57 (62.6)11 (29.7)7 (18.9)19 (51.4)Anthracycline or taxane received prior to ixabepilone in neoadjuvant/adjuvant settingYes No71 (78.0)20 (22.0)32 (78.0)5 (5.0)Anthracycline or taxane received prior to ixabepilone in metastatic settingYesNo67 (23.1)24 (76.9)26 (70.3)11 (29.7)Number of prior regimens prior to ixabepilone in metastatic setting Median 12345=> 65.3 5 (5.5)2 (2.2)14 (15.4)15 (16.5)17 (18.7)38 (41.8)4.2 4 (10.8)1 (2.7)9 (24.3)9 (24.3) 6 (16.2)8 (21.6)Progression free survival, monthsMedian (Range)95% CI3.53 (0.33-22.73)2.68-4.383.56 (0.33-22.73)1.92-5.20Overall survival, monthsMedian (Range)95% CI11.34 (0.33-67.73)8.52-14.2610.10 (0.33-54.03)6.09-14.13 Treatment with Ixabepilone Monotherapy vs. Combined with CapecitabineAll PatientsIxabepilone monotherapy (n=82)Ixabepilone+capecitabine(n=9)Progression free survival (PFS), months Median 95% confidence interval3.58(2.63-4.52)3.11(0.83-5.41)P=0.74Overall Survival (OS), months Median 95% confidence interval11.21(8.18-14.23)13.11(0.64-25.59)P=0.70PFS by line of previous therapy, months =4 (n=70)2.403.813.013.28P=0.64P=0.84OS by line of previous therapy, months =4 (n= 70)9.8411.5115.737.88P=0.41P=0.67 Citation Format: Tara Hyder, Margaret Rosenzweig, Adam M Brufsky. Real world study on the efficacy and tolerability of ixabepilone monotherapy vs. combination therapy with capecitabine in metastatic breast cancer patients (MBC) [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-47.

PURPOSE: Providers have cited fear of taking away hope from patients as one of the principal reasons for deferring advance care planning (ACP). However, research is lacking on the relationship between ACP and hope. We sought to investigate the potential association between ACP and hope in advanced cancer. METHODS: This is a cross-sectional analysis of baseline data from a primary palliative care intervention trial. All patients had advanced solid cancers. Three domains of ACP were measured using validated questions to assess discussion with oncologists about end-of-life (EOL) planning, selection of a surrogate decision maker, and completion of an advance directive. Hope was measured using the Hearth Hope Index (HHI). Multivariable regression was performed, adjusting for variables associated with hope or ACP. RESULTS: A total of 672 patients were included in this analysis. The mean age was 69.3 ± 10.2 years; 54% were female, and 94% were White. Twenty percent of patients (132 of 661) reported having a discussion about EOL planning, 51% (342 of 668) reported completing an advance directive, and 85% (565 of 666) had chosen a surrogate. There was no difference in hope between patients who had and had not had an EOL discussion (adjusted mean difference in HHI, 0.55; P = .181 for adjusted regression), chosen a surrogate (adjusted HHI difference, 0.31; P = .512), or completed an advance directive (adjusted HHI difference, 0.11; P = .752). CONCLUSION: In this study, hope was equivalent among patients who had or had not completed 3 important domains of ACP. These findings do not support concerns that ACP is associated with decreased hope for patients with advanced cancer.

Background: This analysis describes associations between area deprivation and patient-reported outcomes among patients with advanced cancer. Methods: This is a cross-sectional analysis of baseline data from a multisite primary palliative care intervention trial. Participants were adult patients with advanced cancer. Patient-level area deprivation scores were calculated using the Area Deprivation Index (ADI). Quality of life and symptom burden were measured. Uni- and multivariate regressions estimated associations between area deprivation and outcomes of interest. Results: Among 672 patients, ∼0.5 (54%) were women and most (94%) were Caucasian. Mean age was 69.3±10.2 years. Lung (36%), breast (13%), and colon (10%) were the most common malignancies. Mean ADI was 64.0, scale of 1 (low)–100 (high). In unadjusted univariate analysis, Functional Assessment of Cancer Therapy—Palliative (p=0.002), Edmonton Symptom Assessment Scale (p=0.025) and the Hospital Anxiety and Depression Scale anxiety (p=0.003) and depression (p=0.029) scores were significantly associated with residence in more deprived areas (p=0.003). In multivariate analysis, controlling for patient-level factors, living in more deprived areas was associated with more anxiety (p=0.019). Conclusion: Higher ADI was associated with higher levels of anxiety among patients with advanced cancer. Geographic information could assist clinicians with providing geographically influenced social support strategies.

Purpose: Primary Palliative Care (PPC) interventions are needed to address unmet symptom needs within standard oncology care. We designed an oncology nurse-led PPC intervention using shared care planning to facilitate patient engagement. This analysis examines the prevalence and severity of symptoms reported by patients and how symptoms were addressed on shared care plans.Methods: Secondary analysis of a cluster randomized PPC intervention trial. Adult patients with metastatic solid tumors whose oncologist ‘would not be surprised if the patient died within a year’ were included. Twenty-three oncology nurses received PPC training and conducted up to three monthly visits with patients. Symptom prevalence and severity were assessed prior to each visit using the Edmonton Symptom Assessment Scale (ESAS; 9 symptoms ranked 1-10 with scores ≥4 indicating moderate severity). Nurses collaboratively developed treatment strategies with patients, targeting the most bothersome symptoms for improvement.Results: Among 571 nurse-led PPC visits with 235 patients, the most prevalent and severe symptoms were tiredness (reported at 86% of visits; ESAS ≥4 in 55% of visits), low sense of well-being (78%; ESAS ≥4 in 38%), and poor appetite (69%; ESAS ≥4 in 42%). Moderately severe symptoms were addressed on shared care plans ranging from 4% (drowsiness) to 35% (tiredness) of the time. Symptom management plans developed by PPC-trained oncology nurses primarily focused on non-pharmaceutical interventions (70%) compared to pharmaceutical interventions (30%). Conclusion: The symptoms that patients report most frequently and as most severe on shared care plans were addressed less frequently than expected. Further research is needed to understand how primary palliative care interventions can be designed to more effectively target and improve bothersome symptoms for patients with advanced cancer.

Background ALK fusions are targetable drivers in non-small-cell lung cancer (NSCLC). However, patients with NSCLC harboring ALK rearrangements without a fusion partner identified in DNA have also been shown to respond to ALK inhibitors. We aimed to characterize complex ALK variants that may predict sensitivity to multiple approved ALK inhibitors. Methods Comprehensive genomic profiling (CGP) of DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue or blood-based circulating tumor DNA was performed for 39,159 NSCLC patients during routine clinical care. For a subset of cases, RNA sequencing was performed, and prior ALK test results and clinical treatment information were collected from treating physicians. Results We queried the Foundation Medicine NSCLC database and identified ALK internal inversions, as well as internal deletions, as the sole ALK rearrangements in 6 (0.02%) and 3 (0.01%) of cases, respectively. In cases with ALK internal inversions, RNA testing identified an EML4-ALK fusion in 2/2 cases evaluated, and 3/3 patients treated with ALK inhibitors had durable responses. A single patient with an ALK internal deletion and clinical data available responded to multiple ALK inhibitors. RNA data available for a subset of non-NSCLC cases suggest that ALK internal deletions removing a portion of the N-terminus are drivers themselves and do not result in ALK fusions. Fluorescence in situ hybridization (FISH) results were inconsistent for both classes of DNA events. Conclusion Rare internal inversions of ALK appear to be indicative of ALK fusions, which can be detected in RNA, and response to ALK inhibitors in patients with NSCLC. In contrast, ALK internal deletions are not associated with ALK fusions in RNA but likely represent targetable drivers themselves. These data suggest that CGP of DNA should be supplemented with immunohistochemistry or RNA-based testing to further resolve these events and match patients to effective therapies.

BACKGROUND: Histologic and molecular differences between primary breast cancer and their subsequent metastases are well-established. Characterization of this heterogeneity may provide important information for both diagnosis and prognosis. Tissue donation via autopsy can aid in characterizing the microenvironment and understanding organ tropism. We describe the implementation, results, and challenges of a cohesive program of post-mortem tissue procurement in patients with breast cancer. METHODS: Prior to formalization of the program, three autopsies were performed without specific operating procedures. In 2016, formal input from patients, their families, clinicians, and pathology technicians helped to operationalize a formal tissue donation program. Ten autopsies have been performed to date. Demographic and clinical data were collected for these patients through retrospective chart reviews. When available, primary tumor tissue and any prior metastasis which were biopsied or surgically resected were acquired from clinical archives at our institution, or requested from outside facilities for future analyses. RESULTS: Between October 2011 and April 2019, autopsies were performed on 1 male and 9 female patients. Time from primary to metastatic disease was an average of 4 years. The median age at the time of death was 56 years (range 37-73). The average time from diagnosis of metastatic disease to consent to autopsy was 30 months. Although the majority of patients died outside the hospital (70%), the mean time between death and the start of autopsy was 4.7 hours. Samples of metastatic tissue were collected in all patients postmortem. There was an average of 16 samples collected from various sites that included both normal and metastatic tissue. The most common sites were the liver (80%), lung (70%), and lymph nodes (70%). Immunohistochemical analysis of metastatic tumors revealed intrapatient heterogeneity in ER, HER2 and Ki67 staining. TABLE 1: CLINICAL COURSE OF PATIENTSN=10 patientsPatients (%)Age at Diagnosis, years (median)46.7 (24.9-57.8)GenderFemale9 (90)Male1 (10)AJCC stage at initial presentationStage 13 (30)Stage 23 (30)Stage 33 (30)Stage 41 (10)Molecular SubtypesHR+/HER 2-6 (60)HR+/HER 2+2 (20)HR-/HER 2-2 (20)HR-/HER 2+0 (0)Time from initial diagnosis to metastatic disease, years (median)4.3 (0-12.8)Tissue of Metastases Obtained While AliveYes4 (40)No6 (60)Median age at time of death, years56.5 (37-73)Total Survival (dx to death), years (median)7.7Metastatic Survival (mets to death), years (median)3.3 TABLE 2: POST MORTEM TISSUE DONATION PROGRAMTime from Metastatic Diagnosis to Consent for Autopsy, months (median)30.3Time from Consent for Autopsy to Death, months (median)10.25Location of DeathHome5 (50)Hospital3 (30)Inpatient Hospice Facility2 (20)Time from death to starting autopsy, hours (median)4.68Time to complete autopsy, hours (median) N=72.82Number of Samples Collected During Autopsy (median)16.2 (3-27)Sites for Metastatic Tissue Procurement Postmortem8 (80)Liver7 (70)Lung7 (70)Lymph Nodes4 (40)Brain4 (40)Ascitic Fluid3 (30)Bone2 (20)Adrenal2 (20)Pericardium2 (20)Pleural Effusion1 (10)Chest Wall1 (10)Gall Bladder1 (10) CONCLUSION: Post-mortem tissue donation programs allow procurement of tissue that would otherwise be inaccessible in the living patient. Histological examination and immunohistochemical assessment of key biomarkers will be used to further characterize the tissue collected ante-mortem and post-mortem. This data combined with the clinical history and longitudinal specimens will help us better understand how intra- and inter-tumor heterogeneity play a role in the clinical course of breast cancer. Also, as we establish the program, we will identify barriers that need to be addressed in order to optimize the process. Citation Format: Tara Hyder, Lori Miller, Jennifer M Atkinson, Zoe Wecht, Ashuvinee Elangovan, Kai Ding, Nolan Priedigkeit, Zheqi Li, Tiantong Liu, Laura Savariau, Fangyuan Chen, Oscar Lopez, Dayne Ashman, Daniel Geisler, Jacob A Smith, Rachel Jankowitz, Priscilla F McAuliffe, Shannon Puhalla, Humberto E Trejo Bittar, Jeffrey S Nine, Peter C Lucas, Adam Brufsky, Steffi Oesterreich, Adrian V Lee, Margaret Rosenzweig. Implementation of a breast cancer post-mortem tissue donation program [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-21-02.

BACKGROUND: With the potential for medications targeted to somatic mutations, the utilization of whole genome sequencing (WGS) in MBC is increasingly important. The current clinical protocols surrounding the routine testing of WGS in MBC are amorphic. AIMS: We explored a cohort of patients with MBC to determine the prevalence and timing of WGS. Demographic and tumor characteristics of sequenced vs. non sequenced women with MBC were compared. Patient understanding of genomic sequencing was assessed. METHODS: Retrospective chart review of all MBC patients of the Magee-Womens Cancer Center between October 2016 and May 2019 for collection of demographic information, including neighborhood deprivation index (NDI) (zip code derived 0-10; higher scores= higher deprivation), clinical data and sequencing results (FoundationOne®, Guardant360®, Tempus, Caris®). Of those sequenced - Patient questionnaires included test of genetic knowledge (higher = more knowledge). Descriptive statistics, chi square and independent sample t tests used for analysis. Results: There has been an overall increase in the frequency of WGS in MBC; n=15 in 2016, n=30 in 2017, n=39 in 2018 and n=25 in the first 5 months of 2019. Of 418 total MBC patients, 31.3% (N=131) had whole genome sequencing, while 68.7% (N=287) did not. The sequenced patients were more likely to be triple negative, 74.4%, (n=96) than non-sequenced 25.6%, (n=33), p=.001. Most patients were sequenced once (n=112, 88.2%). First sequencing occurred within a mean of 4.9 months (SD 2.2; range 1-9) from MBC diagnosis. No clinical trials were accessed as a direct result of sequencing. There was no racial difference in sequencing prevalence, but non sequenced patients were from more highly deprived neighborhoods (p=.000). Of the patients sequenced, n=27 were interviewed. Mean knowledge of basic genetics was high at 12 (SD-2.1; Range 8-16). Knowledge of WGS and implication was poor. N=15 (80%) patients did not understand reasons and implications of sequencing while n=5 (20%) did. All who understood WGS and its implications were from non-deprived neighborhoods. Conclusion: WGS is increasingly being utilized as a tool in MBC, particularly for triple negative patients, without strict clinical protocol or direct change in treatment. Patient understanding of WGS and its implication is poor. Citation Format: Zoe Wecht, Adam Brufsky, Tiffaney Hsia, Margaret Q Rosenzweig. The influence of social demographics on genomic sequencing in metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-17-12.

Purpose: Perivascular epithelioid cell tumor (PEComa) is a rare mesenchymal soft tissue neoplasm often linked to mTOR pathway activation via TSC2 mutation. We analyzed a series of 31 consecutive metastatic PEComa (mPEComa) cases using a combined DNA/RNA hybrid capture-based comprehensive genomic profiling (CGP) assay to assess the genomic landscape of mPEComa. Patients and Methods: Formalin-fixed, paraffin-embedded (FFPE) blocks or slides were obtained from tumors from 31 unique patients with mPEC­oma. DNA and RNA were extracted and CGP was performed on 405 genes using a targeted next-generation sequencing (NGS) assay in a CLIA-certified lab. Results: All cases had locally advanced or metastatic disease, and 58% of patients were female with a median age of 50 years (range 8–76), and 17 and 14 specimens were from primary and metastatic sites, respectively. One hundred genomic alterations were identified in the cohort, with an average of 3.2 genomic alterations/case including alterations in TSC2 32.3% of cases (10), TSC1 9.6% (3), TFE3 16.1% (5, all fusions), and folliculin (FLCN) 6.4% (2), with all occurring in mutually exclusive fashion. Of TSC2 mutant cases, 70% had biallelic inactivation of this locus, as were 100% of TSC1 mutant cases. Two TSC1/2 wildtype cases harbored truncating mutations in FLCN, both of which were under LOH. Five TFE3 fusion cases were identified including the novel 5′ fusion partner ZC3H4. Conclusions: We describe for the first time mPEComa cases with FLCN mutations under LOH, further characterizing dysregulation of the mTOR pathway as a unifying theme in mPEC­oma. Cumulatively, we demonstrate the feasibility and potential utility of segregating mPEComa by TSC, TFE3, and FLCN status via CGP in clinical care.

Importance Guidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services. Objective To assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes. Design, setting, and participants This cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle. Interventions The CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care. Main outcomes and measures The primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted. Results A total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention. Conclusions and relevance This cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists. Trial registration ClinicalTrials.gov Identifier: NCT02712229.

Despite advances in cancer care, inequalities in race, ethnicity, and social class in breast cancer outcomes still exist. Interpersonal communication is a critical piece to addressing health disparities and it is a core component of the oncology patient navigator role. While widely used, the concept of interpersonal communication is vague, understudied, and requires better clarification to promote equity in health communication. The aim of this article is to investigate the concept of interpersonal communication through a critical lens. Findings from this critical analysis identified a gap in the current literature addressing the intersections of race, gender, and social class.

Background Multiple symptoms associated with endocrine therapy have a detrimental impact on medication adherence and quality of life. Objective The purpose of this scoping review is to map the symptoms during endocrine therapy for breast cancer to provide implications for current practice and suggestions for future research. Methods The PubMed, CINAHL, and China Science Periodical Databases were searched to identify related studies published in English and Chinese languages. References of included articles were reviewed for additional eligible studies. Of the 2551 articles identified, 57 articles met inclusion criteria and were included in this scoping review. Results Evidence for the 16 most studied symptoms and 15 most prevalent symptoms were synthesized. Five key symptoms associated with endocrine therapy were identified, including joint/muscle pain, hot flashes, low sexual interest/desire, joint/muscle stiffness, and fatigue/lack of energy. Rarely studied but highly prevalent symptoms and other gaps in the symptom science during endocrine therapy for breast cancer were identified. Conclusion Nurses caring for women receiving endocrine therapy for breast cancer should assess the 5 key symptoms identified. There remain substantial gaps in the science related to the symptom experience during endocrine therapy for breast cancer. Future studies should focus on the domains of symptom intensity and distress, specific understudied symptoms, symptom clusters, and development of symptom assessment instruments specific to symptoms associated with endocrine therapy. Implications for practice This scoping review identified 5 well-studied and highly prevalent symptoms that should be assessed in women with breast cancer receiving endocrine therapy.

Background Black women receive less relative dose intensity with more dose reductions and early chemotherapy cessation compared with White women. Adding further risk, older patients with breast cancer are most at risk for treatment modifications; however, it is unclear if this remains true for Black patients. Furthermore, the clinical implications of treatment modifications and delays on survival is uncertain, particularly in Black patients. Patients and Methods The purpose was to investigate whether age was a moderator for the association between treatment modifications (dose held, dose delayed, and early cessation) and overall survival and disease-free survival (DFS) in Black women with breast cancer using a retrospective cohort study of patients with early stage breast cancer treated with adjuvant chemotherapy. Results Across the entire sample (n = 115), 37.4% (n = 43) of patients experienced a treatment modification. There was a significant interaction between age group and held dose for DFS (P = .026). Specifically, those diagnosed at 55 years of age and older, who had doses of chemotherapy held, experienced worse DFS compared with those who did not (hazard ratio, 4.185; 95% confidence interval, 1.187-14.75). In contrast, there was no difference in DFS between those who did and did not have doses held in patients diagnosed below 55 years of age (hazard ratio, 0.626; 95% confidence interval, 0.177-2.218). Conclusion In this study, Black women receiving adjuvant chemotherapy for treatment of early stage breast cancer had roughly equal treatment modifications across age groups. However, held doses of chemotherapy in older Black patients were associated with worse DFS. Age may impact clinical outcomes seen with adjuvant chemotherapy treatment modifications.

Of women diagnosed with metastatic breast cancer (MBC), 20% to 30% survive ≥5 years. We evaluated data from a large breast cancer program to identify features associated with MBC survival.Women diagnosed with MBC in or after 1999 were included. Long-term MBC survival was defined as ≥5 years from date of MBC diagnosis (n = 122), short-term MBC survival as ≤2 years (n = 191). Differences were assessed using t tests, Wilcoxon-Mann-Whitney tests, χLong-term survivors were significantly (P .05) younger, premenopausal, partnered, had estrogen receptor (ER)-positive, progesterone receptor-positive, and HER2-positive disease, lower Charlson Comorbidity Index, lower rates of visceral metastases, and higher household income. After adjustment for potential confounders, de novo MBC, premenopausal status, ER-positive status, and HER2-positive status remained significantly positively associated with long-term survival (respectively: OR, 2.68 [95% confidence interval (CI), 1.48-4.88]; OR, 1.96 [95% CI, 1.02-3.79]; OR, 3.74 [95% CI, 1.72-8.14]; OR, 2.88 [95% CI, 1.61-5.14]). Triple-negative status, visceral with bone metastases, and brain metastases remained negatively associated with long-term survival (respectively: OR, 0.12 [95% CI, 0.05-0.29]; OR, 0.18 [95% CI, 0.07-0.47]; OR, 0.16 [95% CI, 0.04-0.60]). Partner status and household income were significant in univariate but not multivariate analyses.Diagnosis of de novo MBC, premenopausal status, ER-positive status, and HER2-positive status were positively associated whereas triple-negative status, brain metastases, and visceral with bone metastases were inversely associated with long-term survival. These findings can be applied to better prognosticate survival for MBC patients.

The diagnosis of cancer for anyone is a time of fear and uncertainty. For young adults (YAs) diagnosed with acute leukemia (AL), there are the additional challenges related to lengthy aggressive in-hospital treatment, multiple concurrent symptoms, and decreased well-being. The purpose of this study was to explore the experiences of YAs with AL undergoing induction chemotherapy. This study used a nested qualitative longitudinal design with a convenience sample. Qualitative data were collected using semistructured interviews, and participants were invited to maintain journals. The semistructured interviews were audiotaped, transcribed, and loaded into Atlas.ti for analysis. Common themes and categories were verified and used to disseminate the findings. Seven YAs, mean age 32 (SD, 4) years, participated in this study. Three thematic classifications emerged: getting through, supported yet isolated, and information exchange preferences, which detail how these YAs processed and coped during treatment. The findings from this study provide important insights for nurses regarding coping mechanisms that YAs apply, which included relying on technology and social media platforms. Additionally, the YAs in this study discussed their need for information. The findings from this study may provide insights for clinicians currently caring for YAs with AL, while also directing future palliative care research endeavors.

Background: During chemotherapy for breast cancer, African American women receive less relative dose intensity with more dose reductions and early chemotherapy cessation compared to Caucasian women. Other research has found that older breast cancer patients are most at risk for treatment modifications; however, it is unclear if this remains true for African American patients. Furthermore, the clinical implications of treatment modifications and delays on survival is uncertain, particularly in African American patients. Purpose: The purpose of this study was to investigate whether age (diagnosis Methods: A retrospective cohort study of early stage African American breast cancer patients treated with adjuvant chemotherapy was employed. Dose held, dose delayed and early cessation were examined as dichotomous variables: any adjustment to the initially prescribed treatment plan was considered a modification. Medical record data extraction was utilized to gather this information. The sample was divided into two groups: those diagnosed Results: In the study of 115 participants, 58 (50.4%) were diagnosed before the age of 55, and 57 (49.6%) were diagnosed age 55 or older. Across the entire sample, 43 (37.4%) patients experienced a treatment modification. There were no significant differences in the proportions of treatment modifications between the two age groups. We found no interaction between age group and treatment modifications for OS. However, there was a significant interaction between age group and held dose for DFS (p=0.045). Specifically, those diagnosed at 55 years of age and older, who had doses of chemotherapy held, experienced worse DFS compared to those who did not (hazard ratio (HR)=3.390, 95% CI (1.013,11.34)). In contrast, there was no difference in DFS between those who did and did not have doses held in patients diagnosed below 55 years of age (HR=0.563, 95%CI (0.159, 1.986)). Conclusions: African American women receiving adjuvant chemotherapy for treatment of early stage breast cancer have high levels of treatment modifications across all age groups. However, held doses of chemotherapy in older African American patients were associated with worse DFS. Further research is needed to elucidate the clinical implications of adjuvant chemotherapy treatment modifications, particularly in African American patients, and the subgroups of patients who are at greatest risk. Citation Format: Nugent BD, Ren D, Bender C, Rosenzweig M. The impact of age and adjuvant chemotherapy modifications on disease-free and overall survival among African American women with breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-17-10.

Background: 5-10% of women with metastatic breast cancer (MBC) survive ≥5 years. Predictors of long-term survival are not clearly elucidated. We used data from 122 long-term MBC survivors (≥5-year survival from date of MBC diagnosis) and 191 short-term MBC survivors (≤2-year survival from date from MBC diagnosis) to identify clinico-pathologic and socioeconomic features associated with MBC survival. Methods: Women initially diagnosed with breast cancer (BC) in or after 1999, and diagnosed with MBC at Magee Women's Cancer Program of UPMC were included (N=313). Data abstracted from medical records included: stage at initial BC diagnosis, body mass index (BMI), Charlson Comorbidity Index (CCI), age, menopausal status at initial BC diagnosis, tumor receptor status at initial BC diagnosis, site of initial metastases, time to recurrence between initial diagnosis and MBC, household income, race, employment status, and partner status. Differences between groups were assessed using t-tests and Chi-square or Fisher's exact tests. Odds ratios (OR) and 95% confidence intervals (CI) were calculated using multivariate logistic regression models. Results: Long-term survivors were significantly (P Conclusions: Diagnosis of de novo MBC, ER-, PR- and/or Her2-positive primary tumor, lower rates of visceral metastases, higher household income, younger age, lower CCI, premenopausal status, and having a partner are associated with long-term survival after diagnosis of MBC. This is one of the first studies to show a survival benefit in MBC for patients with de novo MBC, premenopausal status at initial diagnosis, positive partner status, and higher household income. Citation Format: Klar NJ, Rosenzweig M, Diergaarde B, Brufsky A. Features associated with long-term survival in metastatic breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-48.

Objectives To determine the incidence of financial toxicity among women with metastatic breast cancer, as well as the relationships among financial toxicity, quality of life, and overall cancer-related distress in members of this patient population. Sample & setting 145 women with metastatic breast cancer receiving care at an urban outpatient breast cancer clinic. Methods & variables A cross-sectional analysis of women with metastatic breast cancer was performed. Data were collected on patient characteristics, quality of life, cancer-related distress, and financial toxicity using self-administered questionnaires. Results Financial toxicity is common among women with metastatic breast cancer and more common among low-income women with the disease. In addition, financial toxicity is correlated with worse quality of life and overall cancer-related distress. Implications for nursing Nurses should consider financial toxicity for all patients receiving treatment for cancer. Understanding the concerns of specific patient populations and patients with different stages of cancer is necessary to tailor assessment and mitigation strategies.

Metastatic breast cancer (MBC) carries unique disease burdens with potential for poor-quality end-of-life (EOL) care. It is the purpose of this article to explore the association of poor-quality EOL care indicators according to key tumor, demographic, social, and clinical factors. End-of-life quality indicators were based on Emanuel and Emanuel's good death model in conjunction with Earle et al (2003). A single-institution retrospective chart review of women deceased from MBC between November 2016 and November 2019 with double-verification chart review was completed. Data were analyzed with descriptive, correlative, and comparative statistics. Total sample was N = 167 women, with 14.4% (n = 24) Black and 85.6% (n = 143) White. Mean (SD) age was 55.3 (11.73) years. Overall, MBC survival was 3.12 years (SD, 3.31): White women, 41.2 months (3.4 years), and Black women, 19 months (1.6 years). A total of 64.1% (n = 107) experienced 1 or more indicators of poor-quality EOL care. Patients more likely to experience poor-quality EOL care were older (P = .03), estrogen negative (P = .08), human epidermal growth factor receptor 2 negative (P = .07), from more deprived neighborhoods (P = .02), married (P = .05), and with physical (P = .001) and mental (P = .002) comorbidities. Understanding sociodemographic and clinical factors associated with poor EOL MBC care may be useful for proactive patient navigation.

Background: Given limited evidence on opioid prescribing among patients receiving treatment for cancer during the ongoing opioid epidemic, our objective was to assess predictors of and trends in opioid receipt during cancer treatment, including how patterns differ by type of cancer. Methods: Using cancer registry data, we identified patients with a first lifetime primary diagnosis of breast, colorectal, or lung cancer from 2013 to 2017 who underwent treatment within a large cancer center network. Cancer registry data were linked to electronic health record information on opioid prescriptions. We examined predictors of and trends in receipt of any opioid prescription within 12 months of cancer diagnosis. Results: The percentage of patients receiving opioids varied by cancer type: breast cancer, 35% (1,996/5,649); colorectal, 37% (776/2,083); lung, 47% (1,259/2,654). In multivariable analysis, opioid use in the year before cancer diagnosis was the factor most strongly associated with receipt of opioids after cancer diagnosis, with 4.90 (95% CI, 4.10–5.86), 5.09 (95% CI, 3.88–6.69), and 3.31 (95% CI, 2.68–4.10) higher odds for breast, colorectal, and lung cancers, respectively. We did not observe a consistent decline in opioid prescribing over time, and trends differed by cancer type. Conclusions: Our findings suggest that prescription of opioids to patients with cancer varies by cancer type and other factors. In particular, patients are more likely to receive opioids after cancer diagnosis if they were previously exposed before diagnosis, suggesting that pain among patients with cancer may commonly include non–cancer-related pain. Heterogeneity and complexity among patients with cancer must be accounted for in developing policies and guidelines aimed at addressing pain management while minimizing the risk of opioid misuse.

Researchers define self-advocacy as the ability of an individual with cancer to overcome challenges in getting their preferences, needs, and values met. While imperative in all health care settings, self-advocacy is especially important in cancer care. The goal of this article is to present a conceptual framework for self-advocacy in cancer. We review foundational studies in self-advocacy, define the elements of the conceptual framework, discuss underlying assumptions of the framework, and suggest future directions in this research area. This framework provides an empirical and conceptual basis for studies designed to understand and improve self-advocacy among women with cancer.

Objective: Develop and pilot-test a nurse-led primary palliative care intervention for patients with advanced hematologic malignancies. Background: Nurse-led primary palliative care interventions may improve outpatient palliative care provision for patients with advanced hematologic malignancies. Methods: This two-phase, single-arm pilot study involved patients with recurrent or resistant hematologic malignancies, their caregivers, and oncology clinicians at two US-based urban, university-affiliated oncology clinics. Measurements included feasibility (enrollment rates, intervention fidelity, and outcome assessment rates) and acceptability (patient, caregiver, and clinician surveys). Results: In Phase 1 we developed and implemented an oncology nurse-led primary palliative care intervention for patients with recurrent or resistant hematologic malignancies and their caregivers. In Phase 2, we tested feasibility and acceptability. Twenty-six patient participants enrolled. Consent-to-approach rate was 78% and enrolled-to-consent rate was 84%. All enrolled participants received the intervention per protocol. Sixty-nine percent of patients and 100% of caregivers reported that the intervention helped them better understand the patient's illness and cope. Seventy-five percent of oncologists reported that the intervention improved their patients' quality of care, and 25% reported that it helped them take better care of patients. Conclusions: Although our pilot of oncology nurse-led primary palliative care for patients with advanced hematologic malignancies met some of its secondary feasibility endpoints, it did not meet its primary feasibility endpoint (enrollment) and acceptability was mixed. Protecting nursing staff time, increasing patient and clinician involvement in intervention development, and identifying patients with highest supportive needs may improve feasibility and acceptability of future primary palliative care in hematologic malignancy trials.

Prior to embarking on a large descriptive evaluation of genetic/racial variations in symptom phenotype, we sought foundational information to determine racial differences in (1) feasibility (consent) and acceptability of collecting genomic samples, (2) genetic literacy, and (3) concerns of genomic research during breast cancer (BC) chemotherapy. Women with early-stage BC undergoing chemotherapy were recruited from an academic, urban breast care center. Information was collected for consent to participate, genetic literacy, and concerns about genetic testing in Black and White women with BC. Fifty-six women were eligible, and 48 were consented (24 Black, 24 White). All participants consented to blood testing. This highly educated sample’s mean age was 52.5 + 12.05 (years). Education (years) and genetic knowledge were positively correlated (p = .038). Genetic scores were high, and only one question significantly differed by race. On interview, most participants thought conducting genetic research helped to better understand hereditary disease and/or identify genes that cause disease and stated that they participated in the research to help other people. The majority of participants responded that friends/family would participate in genetic research without concerns, though three Black participants cited mistrust as a possible concern. Overall, there were high levels of genetic knowledge, slightly different between Black and White women. There were no high levels of personal concern regarding genetic testing. Black women reported more concern than White women that friends/family would have hesitations about participating in genetic research. There was general acceptability of blood collection for genetic testing among women with early-stage BC without racial difference.

BackgroundBreast cancer is the most common malignancy to spread to the orbit and periorbit, and the invasive lobular carcinoma (ILC) histologic subtype of breast cancer has been reported to form these ophthalmic metastases (OM) more frequently than invasive ductal carcinomas (IDC). We herein report our single academic institution experience with breast cancer OM with respect to anatomical presentation, histology (lobular vs. ductal), treatment, and survival.MethodsWe employed the natural language processing platform, TIES (Text Information Extraction System), to search 2.3 million de-identified patient pathology and radiology records at our institution in order to identify patients with OM secondary to breast cancer. We then compared the resultant cohort, the “OM cohort,” to two other representative metastatic breast cancer patient (MBC) databases from our institution. Histological analysis of selected patients was performed.ResultsOur TIES search and manual refinement ultimately identified 28 patients who were diagnosed with breast cancer between 1995 and 2016 that subsequently developed OM. Median age at diagnosis was 54 (range 28–77) years of age. ER, PR, and HER2 status from the 28 patients with OM did not differ from other patients with MBC from our institution. The relative proportion of patients with ILC was significantly higher in the OM cohort (32.1%) than in other MBC patients in our institution (11.3%,p = 0.007). Median time to first OM in the OM cohort was 46.7 months, and OM were the second most frequent first metastases after bony metastases. After diagnosis of the first distant metastasis of any kind, median survival of patients with ILC (21.4 months) was significantly shorter than that of patients with IDC (55.3 months,p = 0.03). Nine patients developed bilateral OM. We observed a significant co-occurrence of OM and central nervous system metastases (p = 0.0053). The histological analysis revealed an interesting case in which the primary tumor was of a mixed ILC/IDC subtype, while only ILC was present in the OM.ConclusionsOM from breast cancer are illustrative of the difference in metastatic behavior of ILC versus IDC and should be considered when treating patients with ILC, especially in those with complaints of visual acuity changes.

Background The 5-year survival for Black women with breast cancer in the United States is lower than White women for stage-matched disease. Our past and ongoing work and that of others suggest that symptom incidence, cancer-related distress, and ineffective communication contribute to racial disparity in dose reduction and early therapy termination. Although race is perhaps the most studied social determinant of health, it is clear that race alone does not account for all disparities. Objectives The aim of the study was to present a study protocol of Black and White women prescribed breast cancer chemotherapy. The aims are to (1) examine and compare chemotherapy received/prescribed over time and in total; (2a) examine and compare symptom incidence, distress, and management and clinical encounter, including patient-centeredness of care and management experience over time and (2b) correlate symptom incidence, distress, and management experience to Aim 1; and (3) explore the effects of social determinants of health, including age, income, education, zip code, and lifetime stress exposure, on Aims 1, 2a, and 2b. Methods A longitudinal, repeated-measures (up to 18 time points), comparative, mixed-methods design is employed with 179 White and 179 Black women from 10 sites in Western Pennsylvania and Northeast Ohio over the course of chemotherapy and for 2 years following completion of therapy. Results The study began in January 2018, with estimated complete data collection by late 2023. Discussion This study is among the first to explore the mechanistic process for racial disparity in dosage and delay across the breast cancer chemotherapy course. It will be an important contribution to the explanatory model for breast cancer treatment disparity and may advance potential mitigation strategies for racial survival disparity.

Background Estrogen receptor-positive (ER-positive) metastatic breast cancer is often intractable due to endocrine therapy resistance. Although ESR1 promoter switching events have been associated with endocrine-therapy resistance, recurrent ESR1 fusion proteins have yet to be identified in advanced breast cancer. Patients and methods To identify genomic structural rearrangements (REs) including gene fusions in acquired resistance, we undertook a multimodal sequencing effort in three breast cancer patient cohorts: (i) mate-pair and/or RNAseq in 6 patient-matched primary-metastatic tumors and 51 metastases, (ii) high coverage (>500×) comprehensive genomic profiling of 287–395 cancer-related genes across 9542 solid tumors (5216 from metastatic disease), and (iii) ultra-high coverage (>5000×) genomic profiling of 62 cancer-related genes in 254 ctDNA samples. In addition to traditional gene fusion detection methods (i.e. discordant reads, split reads), ESR1 REs were detected from targeted sequencing data by applying a novel algorithm (copyshift) that identifies major copy number shifts at rearrangement hotspots. Results We identify 88 ESR1 REs across 83 unique patients with direct confirmation of 9 ESR1 fusion proteins (including 2 via immunoblot). ESR1 REs are highly enriched in ER-positive, metastatic disease and co-occur with known ESR1 missense alterations, suggestive of polyclonal resistance. Importantly, all fusions result from a breakpoint in or near ESR1 intron 6 and therefore lack an intact ligand binding domain (LBD). In vitro characterization of three fusions reveals ligand-independence and hyperactivity dependent upon the 3′ partner gene. Our lower-bound estimate of ESR1 fusions is at least 1% of metastatic solid breast cancers, the prevalence in ctDNA is at least 10× enriched. We postulate this enrichment may represent secondary resistance to more aggressive endocrine therapies applied to patients with ESR1 LBD missense alterations. Conclusions Collectively, these data indicate that N-terminal ESR1 fusions involving exons 6–7 are a recurrent driver of endocrine therapy resistance and are impervious to ER-targeted therapies.

Context: Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed. Objectives: (1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content. Methods: Post-training evaluations, visit checklists, and visit audio-recordings. Results: Data were collected from June, 2016 through April, 2017. We include procedures for (1) identification, training and certification of oncology nurses as CONNECT interventionists; (2) monitoring intervention delivery; and (3) maintaining intervention quality. All nurses (N = 14) felt prepared to deliver key competencies after a 3-day in-person training. As assessed via visit checklists, interventionists delivered an average of 94% (SD 13%) of key content for first intervention visits and 85% (SD 14%) for subsequent visits. As assessed via audio-recordings, interventionists delivered an average of 85% (SD 8%) of key content for initial visits and 85% (SD 12%) for subsequent visits. Conclusion: We present a 3-part strategy for training interventionists and monitoring and maintaining intervention delivery in a primary palliative care trial. Training was effective in having nurses feel prepared to deliver primary palliative care skills. As assessed via nursing checklists and visit audio-recordings, intervention fidelity was high. Keywords: Oncology nursing, Primary palliative care, Intervention fidelity, CONNECT

BACKGROUND: Symptom distress in women with breast cancer is associated with early discontinuation of chemotherapy and may influence treatment outcomes. Describing racial differences in prechemotherapy symptom distress and examining contextual variables of the symptom experience may inform our understanding of the complex problem of racial disparities in breast cancer. AIM: To determine if perceived social support, healthcare system distrust, and economic hardship predict symptom distress in women with breast cancer prior to their first chemotherapy treatment. DESIGN: Descriptive, correlational, cross-sectional METHODS: Baseline data (N = 119) was used from a multisite, longitudinal study comparing the symptom experience and ability to receive chemotherapy of Black and White women with breast cancer (R01MD012245;Rosenzweig, PI). Measures included the Symptom Distress Scale, Interpersonal Support Evaluation List, Health Care System Distrust Scale, and Psychological Sense of Economic Hardship scale. The analysis consisted of multiple regression and a t-test. RESULTS: On average, participants reported five symptoms prior to chemotherapy. Black women reported higher symptoms distress than White women; t(68.34) = 2.15, p = .035. The model explained 26% of variance in symptom distress; F(5, 112) = 9.01, p < .001. While controlling for age and race, greater perceived economic hardship contributed to higher symptom distress (β = .36, p = .001, 95% CI: .34 to 1.34). Race, health care system distrust and social support did not significantly predict symptom distress. CONCLUSION: Assessment of perceived financial hardship prior to beginning chemotherapy is critical to identify those patients at risk for greater symptom distress.

Aim To develop and psychometrically test the validity of the Female Self-Advocacy in Cancer Survivorship Scale. Background Female cancer survivors need to self-advocate to overcome challenges associated with cancer yet no valid measure of self-advocacy exists. Design Instrument development. Mixed-mode cross-sectional survey design. Participants We recruited adult females (18+ years; N = 317) with a history of invasive cancer from local and national tumour registries and advocacy organizations to complete online or paper questionnaires. Methods Between July 2014 - March 2015 to evaluate the construct validity based on evidence of the scale's: (1) internal structure consistent with the underlying model of self-advocacy; (2) sensitivity to differences between groups known to differ in self-advocacy skills; (3) relationships between self-advocacy and key potential predictors (openness and conscientiousness; information engagement; social support) and outcomes (symptom burden and healthcare utilization); (4) relationships between self-advocacy and related concepts (patient activation; self-advocacy within another patient population); and (5) relationships between self-advocacy and criterion measures. Analyses included an exploratory factor analysis, t tests, and bivariate correlations using validated, reliable measures for constructs. Results Evidence from all five hypotheses supported the construct validity of the Female Self-Advocacy in Cancer Survivorship Scale. The factor analysis confirmed the three underlying dimensions of self-advocacy resulting in a 20-item measure with strong internal consistency that explained almost half of response variance. Conclusion The Female Self-Advocacy in Cancer Survivorship Scale is a valid, reliable measure of how well adult female cancer survivors can get their needs met in the face of adversity.