Lee Schwartzberg

Lee Schwartzberg
The University of Tennessee Health Science Center · Department of Medicine

MD

About

621
Publications
64,868
Reads
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15,913
Citations
Citations since 2017
178 Research Items
6762 Citations
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201720182019202020212022202302004006008001,0001,200
201720182019202020212022202302004006008001,0001,200

Publications

Publications (621)
Article
Full-text available
Background The relationship between CINV duration and recurrence in subsequent cycles is largely unstudied. Our objective was to determine if patients experiencing CINV in their first cycle of chemotherapy (C1) would face increased risk of CINV in later cycles and whether the duration of the CINV would predict increased risk of recurrence. Patient...
Article
Full-text available
Abstract Background Women undergoing treatment for breast cancer require frequent clinic visits for maintenance of therapy. With COVID-19 causing health care disruptions, it is important to learn about how this population’s access to health care has changed. This study compares self-reported health care utilization and changes in factors related to...
Article
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Background: Cancer treatment requires substantial demands on patients and their caregivers. Mobile apps can provide support for self-management during oncology treatment, but few have been rigorously evaluated. Methods: A 3-month randomized controlled trial was conducted at a large cancer center to evaluate the efficacy of an app (LivingWith®) t...
Article
422 Background: ALP is a PI3Kα inhibitor and degrader approved with fulvestrant for the treatment (tx) of patients (pts) with PIK3CA-mutated, HR+, HER2– ABC. Hyperglycemia (HG) and rash are expected adverse events with ALP tx and remain a challenge for physicians and pts. Management guidance is primarily based on clinical trial experience, which is...
Article
Background: Symptom burden differences may contribute to racial disparities in breast cancer survival. We compared symptom changes from before to during chemotherapy among women with breast cancer. Methods: This observational study followed a cohort of Black and White women diagnosed with Stage I-III, hormone-receptor positive breast cancer from...
Article
Importance: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence, but symptom burden is a key barrier to adherence. Black women have lower AET adherence and worse health outcomes than White women. Objective: To investigate the association between symptom burden and AET adherence differences by race. Design, setting, and participant...
Article
Full-text available
It has been suggested that the benefit of adjuvant chemotherapy (CT) in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2−) early breast cancer may be related, at least in part, to CT-induced ovarian function suppression (OFS) in this subgroup of patients. Although this hypothesis has...
Article
Introduction: Biomarker testing identifies actionable mutations to inform targeted tx for personalized healthcare. This study examined biomarker testing and tx patterns ≤ 90 days (d) after advanced (adv) or metastatic (met) diagnosis (Dx) at the OneOncology (OneOnc) network. Methods: A retrospective observational study using the nationwide Flatiron...
Article
e18778 Background: Biomarker testing has advanced from single-gene to NGS. This study examined aNSCLC and mBC biomarker testing ≤ 90d of advanced (adv) or metastatic (met) diagnosis (Dx) and treatment (tx) patterns at US practices. Methods: A retrospective observational study used Flatiron Health electronic health-record-derived de-identified datab...
Article
12102 Background: Low rates of adherence to adjuvant endocrine therapy (AET) is a significant clinical problem. Symptom burden is a key barrier to adherence, but less is known about how changes in symptom burden affects adherence. Moreover, whether higher symptom burden in racial minorities explains their lower rates of adherence, has been relative...
Article
Importance: Patients with breast cancer and brain metastases (BM) have a poor prognosis and high clinical need for novel treatments; however, historically, studies have often excluded these patients. Although the BEACON study did not meet its primary end point, treatment with etirinotecan pegol vs chemotherapy of the physician's choice for patient...
Article
Background: Black women have higher incidence rates of TNBC and may experience worse clinical outcomes compared with White women with TNBC, due to disparities, comorbidities, or differences in TNBC biology (Dietze EG, et al. Nat Rev Cancer. 2015;15:248-254). As a result, Black pts with TNBC may benefit from novel therapies to improve outcomes. SG i...
Preprint
Full-text available
Purpose: Estrogen receptor 1 (ESR1) mutations and fusions typically arise in patients with hormone receptor-positive breast cancer after aromatase inhibitor therapy, whereby ESR1 is constitutively activated in a ligand-independent manner. These variants can impact treatment response. Herein, we characterize ESR1 variants among molecularly profiled...
Article
288 Background: Personalized treatment (tx) decisions can be improved through diagnostic tests with NGS by detecting different actionable mutations. OO, a research-focused network of community practices, has a network-wide precision oncology initiative and has advocated for NGS testing in advanced cancers since 2019. This study evaluated NGS testin...
Article
287 Background: Recent approvals of targeted treatments (tx) have improved personalized care in aNSCLC. Biomarker testing is crucial for patients (pts) to receive optimal tx expeditiously. This study examined aNSCLC biomarker testing and tx patterns at OneOnc. Methods: Pts diagnosed with aNSCLC (stage ≥ IIIb) from 1/1/2015 to 5/31/2020, aged ≥ 18 y...
Article
Full-text available
Purpose This study explored the impact of multiple prognostic factors on patient overall survival (OS) and real-world progression-free survival (rwPFS) for patients with hormone receptor positive (HR+)/human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (MBC). Methods This retrospective study used electronic health record dat...
Article
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This cohort study evaluates the overall survival for patients with uterine cancer with distant organ metastasis treated with chemotherapy alone vs chemotherapy plus total abdominal hysterectomy.
Article
Background: This retrospective, observational study examined real-world healthcare resource utilization (HCRU) and costs in 308 patients diagnosed with early-stage (II–IIIB) triple-negative breast cancer between 1 March 2008 and 31 March 2016. Methods: HCRU and costs were evaluated for two time periods: from neoadjuvant treatment start date to surg...
Article
Background: This retrospective, observational study examined real-world treatment patterns and effectiveness outcomes in 450 patients with stage II-IIIB early-stage triple-negative breast cancer treated in the community oncology setting. Methods: Kaplan-Meier methods were used to evaluate event-free survival (EFS), time to recurrence and overall su...
Article
Full-text available
Objective In the PALOMA-2 trial, palbociclib in combination with letrozole prolonged progression-free survival (PFS) and exhibited an acceptable safety profile in patients with estrogen receptor–positive/human epidermal growth factor receptor–negative advanced breast cancer (ABC). This post hoc analysis of PALOMA-2 evaluated the efficacy and safety...
Article
1020 Background: The AR is expressed in up to 90% of ER+ breast cancer where it acts as a tumor suppressor. Historically, therapy with synthetic androgens had efficacy, but virilizing side effects and toxicity limited their use. Enobosarm is a selective AR activating agent that does not cause masculinization and has positive attributes such as prom...
Article
6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in...
Article
6528 Background: Symptom burden may contribute to racial differences in cancer treatment adherence and survival. Evidence on changes in symptom burden during chemotherapy and whether these differ by race is scarce. We used patient reported outcomes data collected before and after breast cancer chemotherapy initiation to compare symptom burden by ra...
Article
e18623 Background: Diarrhea is a common toxicity of cancer treatments, including radiotherapy, chemotherapy, and/or targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare utilization and cost. This study evaluated the all-cause and CRD-specific healthcare utilization and cost of patients with CRD compared to a matched non-C...
Article
e18521 Background: About 40% of the US population are from minority groups. Minority pts are under-represented in oncology clinical trials, which limits the applicability of results to the general population and perpetuates poor relationships between healthcare systems and minority communities. This assessment investigated underlying causes of this...
Article
12111 Background: We studied the impact that cancer related diarrhea (CRD) has on cancer therapy and treatment patterns, including persistence, discontinuation, adherence, and switching of chemotherapy and targeted therapies in patients with and without CRD. Methods: We performed a longitudinal observational study among adult ( > 18 yrs) patients w...
Article
TPS1588 Background: Cancer treatment is evolving toward a more personalized approach in which the intersection of genomics, pathology and imaging methods leads to individualized care. Furthermore, identification of novel genomic alterations and other biomarkers has the potential to lead to customized, targeted treatments. Matching specific therapie...
Article
e18584 Background: Cancer progression rates following diagnosis are readily measured. However, the progression rate of cancer during the preclinical sojourn time is generally unobserved. Understanding the duration of preclinical stages (“dwell time”) would allow clinicians to better identify appropriate screening intervals for cancer. We therefore...
Article
1061 Research Funding: Odonate Therapeutics, Inc. Background: T is a novel, oral taxane with unique properties, including: oral administration with a low pill burden, a long (8-day) half-life in humans, once-every-3-weeks dosing, no observed hypersensitivity reactions and significant activity against chemotherapy (CT)-resistant breast cancer cell l...
Article
e18625 Background: In clinical oncology practice, diarrhea is a very common and severe side effect of cancer treatments including from radiotherapy, chemotherapy, and targeted therapies. Cancer-related diarrhea (CRD) leads to increased healthcare resource consumption due to unscheduled outpatient visits, and , increased hospital stays requiring int...
Article
Full-text available
Patients with cancer demonstrate particularly poor outcomes from COVID-19. To provide information essential for understanding the biologic underpinnings of this association, we analyzed whole-transcriptome RNA expression data obtained from a large cohort of cancer patients to characterize expression of ACE2, TMPRSS2, and other proteases that are in...
Conference Paper
Background: Although many studies have demonstrated consistent levels of effectiveness of CINV prophylaxis for the entire study population across multiple chemotherapy cycles, rarely have studies reported how each patient’s risk of subsequent CINV differs based on prior cycle breakthrough CINV with the same prophylaxis. We lack data on whether prop...
Conference Paper
Background: Eflapegrastim (Rolontis®, Efla) is a long-acting granulocyte-colony stimulating factor (G-CSF), consisting of a recombinant human G-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Efla is not a biosimilar and represents the first myeloid growth factor innovation in more than 15 years. In preclin...
Conference Paper
Background: The benefits of immune check point inhibition (ICI) are primarily seen in immunogenic cancer types. Unfortunately, most breast cancers are non-immunogenic, and therefore new approaches that target tumor immunogenicity are key to increasing the efficacy of ICI. Even within a single breast cancer subtype, patients with liver metastases ar...
Conference Paper
Introduction: Hormonal agents remain the most effective therapies for estrogen receptor positive (ER+) HER2- breast cancer. The androgen receptor (AR) is the most highly expressed steroid receptor found in up to 95% of ER+ breast cancer patients. Androgen agonists have antiproliferative activity in ER+ breast cancer and have been used in treatment,...
Conference Paper
p> Background: Recurrence is common among patients with early-stage triple-negative breast cancer (ESTNBC). There is minimal real-world evidence describing the patient characteristics and clinical outcomes following recurrence among patients receiving neoadjuvant chemotherapy for ESTNBC. Methods: This retrospective, observational study aimed to des...
Conference Paper
Background: Invasive lobular carcinoma (ILC) is the second most common type of invasive breast cancer and accounts for 10-15% of all cases. Though ILC has distinct clinical, prognostic and molecular features, studies are limited and include few patients. ILCs show a decreased response to neoadjuvant chemotherapy and an increased resistance to endoc...
Conference Paper
Background: CINV remains a challenging chemotherapy toxicity, particularly for anthracyclines + cyclophosphamide (AC) for breast cancer. Complete response (CR), defined as no vomiting or use of rescue medication over 5 days after chemotherapy, has been the standard endpoint for successful antiemetic prophylaxis, yet duration of prophylaxis treatmen...
Conference Paper
Objectives: The key objectives of CONTESSA are to evaluate the efficacy and safety of tesetaxel plus a reduced dose of capecitabine as an all-oral regimen versus capecitabine alone in patients with HER2-, HR+ MBC previously treated with a taxane. Rationale: Tesetaxel is a novel, oral taxane with several properties that make it unique, including: or...
Conference Paper
Background: In the PALOMA-2 trial, PAL + letrozole (LET) significantly prolonged progression-free survival (PFS) vs placebo (PBO) + LET in pts with ER+/HER2– ABC. This post hoc analysis assessed efficacy and safety of PAL + LET in pts from PALOMA-2 with baseline preexisting conditions grouped by Medical Dictionary for Regulatory Activities (MedDRA)...
Conference Paper
Background: Eflapegrastim (Rolontis®, Efla) represents the first novel, long-acting granulocyte-colony stimulating factor (G-CSF) to be introduced in more than 15 years. Efla consists of a recombinant human G-CSF analog conjugated to a human IgG4 Fc fragment via a polyethylene glycol linker. Preclinical, clinical, and pharmacodynamic/pharmacokineti...
Article
Full-text available
This paper presents an overview of the efficacy of intravenous (IV) NEPA (fixed combination of the NK1RA, fosnetupitant, and 5-HT3RA, palonosetron) relative to oral NEPA and also to historical data for other NK1RA regimens. Data is compiled from 5 pivotal NEPA studies in adult chemotherapy-naïve patients with solid tumors undergoing either cisplati...
Article
Full-text available
Molecular testing for genomic variants is recommended in advanced non-small cell lung cancer (NSCLC). Standard tissue biopsy is sometimes infeasible, procedurally risky, or insufficient in tumor tissue quantity. We present the analytical validation and concordance study of EGFR variants using a new 17-gene liquid biopsy assay (NCT02762877). Of 144...
Article
Full-text available
Purpose: Chemotherapy-induced nausea and vomiting (CINV) contributes to avoidable acute care, a metric now tracked in Medicare's oncology outcome measure. CINV is largely preventable, yet guidelines are often not followed. We sought to quantify acute care involving CINV and other avoidable toxicities after highly emetogenic chemotherapy (HEC) , to...
Article
Triple negative breast cancer (TNBC), defined as breast cancer lacking expression of the estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2), accounts for up to 20% of all breast cancer, and occurs at a higher frequency in younger, African-American, and Hispanic women. As compared to breast cancers...
Article
Full-text available
In the precision medicine era, molecular testing in advanced cancer is foundational to patient management. Molecular tumor boards (MTBs) can be effective in processing comprehensive genomic profiling (CGP) results and providing expert recommendations. We assessed an MTB and its role in a community setting. This retrospective analysis included patie...
Article
Aim: This study examined treatment patterns and effectiveness outcomes of patients with metastatic triple-negative breast cancer (mTNBC) from US community oncology centers. Materials & methods: Eligible patients were females, aged ≥18 years, diagnosed with mTNBC between 1 January 2010 and 31 January 2016. Kaplan–Meier and Cox regression methods wer...
Article
Aim: Evaluation of monthly cost during metastatic triple-negative breast cancer (mTNBC) treatment. Patients & methods: Retrospective electronic medical record review of US females aged ≥18 years diagnosed with mTNBC between 1 January 2010 and 31 January 2016. Mean monthly costs per patient were evaluated from start of mTNBC treatment until transfer...
Article
Background: Eflapegrastim (Rolontis®, Efla) is a long-acting granulocyte-colony stimulating factor (G-CSF), consisting of a recombinant human G-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Efla is not a biosimilar and represents the first myeloid growth factor innovation in more than 15 years. In preclin...
Article
Full-text available
PurposeHomologous recombination (HR)-deficient breast tumors may have genomic alterations that predict response to treatment with PARP inhibitors and other targeted therapies.Methods Comprehensive molecular profiles of 4647 breast tumors performed at Caris Life Sciences using 592-gene NGS were reviewed to identify somatic pathogenic mutations in HR...
Article
9 Background: The use of biosimilar drugs in the treatment of cancer offer an opportunity for oncology providers to decrease total cost of care while preserving quality. However, it remains unclear whether providers and patients may resist biosimilar use due to concerns over safety and efficacy. Our national network of 5 practices with over 100 cli...
Article
22 Background: End-of-life anti-neoplastic treatment does not improve quality of life nor prolong survival of advanced cancer patients. It is also not cost-effective. To-date, there has been little data examining real-world patterns of chemotherapy and immunotherapy treatment at end of life. We investigated use of chemotherapy and/or immunotherapy...
Article
253 Background: Prophylaxis for highly emetogenic chemotherapy (HEC) is well established in clinical guidelines, but real-world treatment patterns are unclear. Today, consistent use of prophylaxis is more easily accomplished due to the incorporation of ordering premeds into the workflow prior to administration of intravenous chemotherapy. However,...
Article
305 Background: Clinical collaboration across fragmented and often small clinic sites can be challenging. As a potential solution, OneOncology, a national community oncology network, launched OneCommunity, a secure, interactive online platform used across our network of six practices and over 130 clinic sites. One feature is a “virtual” tumor board...
Article
Purpose: Determine if the androgen receptor (AR) inhibitor enzalutamide improves effectiveness of endrocrine therapy (ET) in hormone receptor-positive (HR+) breast cancer. Methods: In this phase 2 trial, patients with HR+/HER2-normal advanced/metastatic breast cancer were randomized 1:1 to exemestane 25 mg with placebo or exemestane 50 mg with e...
Article
Full-text available
Opinion statement: Liquid biopsy using blood components to assess circulating tumor DNA (ctDNA) is rapidly becoming a new standard-of-care technology in many tumor types, including breast cancer, due to the potential to provide predictive and prognostic information. The minimally invasive and repeatable nature of plasma based mutational testing is...
Preprint
Full-text available
Patients with cancer demonstrate particularly poor outcomes from COVID-19. To provide information essential for understanding the biologic underpinnings of this association, we analyzed whole-transcriptome RNA expression data obtained from a large cohort of cancer patients to characterize expression of ACE2, TMPRSS2, and other proteases that are in...
Article
Full-text available
Background: PI3K/AKT signaling pathway is activated in breast cancer and associated with cell survival. We explored the prevalence of PI3K pathway alterations and co-expression with other markers in breast cancer subtypes. Methods: Samples of non-matched primary and metastatic breast cancer submitted to a CLIA-certified genomics laboratory were mol...
Article
Full-text available
Eflapegrastim (Rolontis®) is a novel, long‐acting hematopoietic growth factor consisting of a recombinant human granulocyte‐colony stimulating factor (rhG‐CSF) analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. We report results from a second pivotal, randomized, open‐label, Phase 3 study comparing the efficacy an...
Article
Background: Clinician adherence to antiemetic guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC) remains poorly characterized. The primary aim of this study was to evaluate individual clinician adherence to HEC antiemetic guidelines. Patients and methods: A retrospective analy...
Conference Paper
Background: Women diagnosed with breast cancer transitioning from the active phase of treatment to the adjuvant phase of treatment experience fewer opportunities to receive support from their oncology team. During this period of time, the frequently unfulfilled social support needs reported by many oncology patients may be exacerbated for these wom...
Article
TPS1111 Background: Chemotherapy treatments with robust efficacy that preserve quality of life are needed. T is a novel, oral taxane that has potential advantages over currently available taxanes, including: oral administration with a low pill burden and once every 3 week (Q3W) dosing; no observed hypersensitivity reactions; preclinical evidence of...
Article
e19191 Background: ASCO has implemented the Quality Oncology Practice Initiative (QOPI), a certification program established to evaluate oncology practice performance. Also, a growing number of accreditation (JCAHO) and merit-based organizations (MIPS) maintain falls risk assessment standards. Practices often lack the necessary resources to comply...
Article
e24133 Background: The impact of chemotherapy-induced nausea and vomiting (CINV) on work loss and activity impairment is important to patients yet not well described in literature. We sought to evaluate CINV-related work loss and activity impairment and their associations with CINV duration. Methods: In a prospective CINV prophylaxis trial of oral...
Article
e13048 Background: Neutropenia is the most common adverse event following administration of CDK4/6 inhibitors RIB and PAL for hormone receptor–positive (HR+) MBC. There are limited comparative real-world data on TE neutropenia in pts receiving these agents. Here we report incidence, duration, and severity data on TE neutropenia in such pts from an...
Article
TPS2087 Background: Making personalized diagnostics and treatments a reality for every cancer patient necessitates comprehensively capturing the patient journey. Real-world data has shown promise for the future of clinical research and advancing precision medicine. However, certain limitations exist such as data quality management as well as bias a...
Article
2061 Background: Increasing enrollment in clinical trials remains a national priority, yet there are limited data from COCs on the degree to which common trial exclusion criteria (EC) and socioeconomic factors play a role in low enrollment rates. Methods: We analyzed data from the nationwide Flatiron Health electronic health record (EHR) derived de...
Article
e16122 Background: WCCRI, a comprehensive regional community oncology center in Memphis, Tennessee and the Mid-South region, serves a racially, geographically and socioeconomically diverse patient cohort. We sought to evaluate disparity of outcomes in survival by race and socioeconomic status, in addition to patient and tumor characteristics. Metho...
Article
Patient-provider communication is a critical component of healthcare and is associated with treatment quality and outcomes for women with breast cancer. This qualitative study examines similarities and differences in patient perspectives of communication needs between Black and White breast cancer survivors. We conducted four focus groups (N = 28)...
Article
Full-text available
The aim of this retrospective study was to assess the efficacy of topical hormonal therapy (THT) to relieve vaginal symptoms resulting from antihormonal therapy in women with hormone receptor–positive breast cancer. A total of 74 breast cancer patients who received THT for vaginal complaints were retrospectively identified and statistically matched...
Article
Full-text available
Background: Women with hormone receptor-positive, early-stage breast cancer who adhere to adjuvant endocrine therapy (AET) reduce the risk of cancer recurrence and mortality. AET, however, is associated with adverse symptoms that often result in poor adherence. We applied participatory action research (PAR) principles to conduct focus groups and i...
Article
Full-text available
Background: Papillary breast lesions may be benign, atypical, and malignant lesions. Pathological and clinical differentiation of breast papillomas can be a challenge. Unlike malignant lesions, benign breast papillomas are not classically associated with lymph node and distant metastasis. We report a unique case of a recurrent, benign breast papil...
Conference Paper
Background: Anthracycline and cyclophosphamide (AC) is a highly emetogenic chemotherapy (HEC) regimen. Combination netupitant/palonosetron (NEPA) + dexamethasone (DEX) is guideline-recommended for prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in HEC and moderately emetogenic chemotherapy. CMS’ OP-35 measure deems 30-day post-chemot...
Conference Paper
Background: PI3K/AKT signaling pathway is often activated in breast cancer (BC), through mutations in PIK3CA or AKT1, and alterations in PTEN, thus promoting cell survival. PI3K and AKT inhibitors have been shown to have significant activity against tumor progression and to overcome resistance in BC. We aim to explore the prevalence of PI3K pathway...