Joseph A Sparano

Joseph A Sparano
Albert Einstein College of Medicine | AECOM · Albert Einstein Cancer Center

About

439
Publications
45,054
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
19,073
Citations
Additional affiliations
January 2012 - present
January 2012 - present
January 2011 - present
Weill Cornell Medical College

Publications

Publications (439)
Article
Background: The American Joint Committee on Cancer (AJCC) 8th edition pathologic prognostic staging (PPS) incorporates anatomic and biologic factors. The OncotypeDX Breast Recurrence Score (RS) was included based on the initial report of the TAILORx trial, with T1-2N0 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negati...
Article
Full-text available
Purpose The three CDK4/6 inhibitors (CDK4/6i) approved for use in HR-positive/HER2-negative metastatic breast cancer (MBC), palbociclib, ribociclib, and abemaciclib, are generally well tolerated; however, neutropenia is a common toxicity. Within the general population, neutropenia has been shown to be more common in individuals of African descent....
Article
Background: The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, da...
Article
Full-text available
Emerging evidence shows that tumor cells secrete extracellular vesicles (EVs) that carry bioactive cell surface markers, such as programmed death-ligand 1 (PD-L1), which can modulate immune responses and inhibit anti-tumor responses, potentially playing a role in lymphomagenesis and in promoting the growth of these cancers. In this study, we invest...
Article
12094 Background: The Functional Assessment of Cancer Therapy patient-reported outcomes (PRO) item GP5 (“I am bothered by side effects of treatment”) estimates treatment tolerability. We aimed to extend our previous finding that GP5 predicts early aromatase inhibitor (AI) discontinuation (E1Z03, 96% White) in the racially diverse E1Z11 trial cohort...
Article
553 Background: The 21-gene RS (Oncotype DX) provides prognostic information for distant recurrence risk and is predictive of adjuvant chemotherapy benefit in hormone receptor (HR)-positive, HER-2 negative EBC. Ki67 protein expression is a proliferation marker that is determined by immunohistochemistry (IHC). The International Ki67 Working Group (I...
Article
Background: Black race is associated with worse outcome in patients with breast cancer. The distant relapse-free survival (DRFS) between Black and White women with localized breast cancer who participated in National Cancer Institute-sponsored clinical trial was evaluated. Methods: Pooled data were analyzed from 8 National Surgical Adjuvant Brea...
Article
Importance: Guiding treatment decisions for women with ductal carcinoma in situ (DCIS) requires understanding patient preferences and the influence of preoperative magnetic resonance imaging (MRI) and surgeon recommendation. Objective: To identify factors associated with surgery preference and surgery receipt among a prospective cohort of women...
Article
Importance: Racial disparities in survival outcomes among Black women with hormone receptor-positive breast cancer have been reported. However, the association between individual-level and neighborhood-level social determinants of health on such disparities has not been well studied. Objective: To evaluate the association between race and clinic...
Article
Background: Understanding health-related quality of life (HRQOL), including side effects, is critical to guide supportive care during chemotherapy. The EA1131 trial demonstrated that Platinum (Plat) was unlikely to improve outcomes compared to capecitabine (Cape) in patients with stage II-III triple-negative breast cancer (TNBC) of basal subtype an...
Article
Background: ER+, HER2- metastatic breast cancer (MBC) patients will receive sequential, endocrine based therapy, either as monotherapy or in combination with a targeted agent until endocrine resistance develops. OP-1250 is a small molecule Complete Estrogen Receptor Antagonist (CERAN) that completely inactivates ER by blocking the 2 activation func...
Article
Background: Black patients with triple negative breast cancer (TNBC) have worse survival outcomes, even after adjusting for stage at diagnosis, income, insurance status and other socioeconomic factors. Little is known regarding anti-tumor immune responses in Black patients and how these differences affect responses to treatment in TNBC. Limited dat...
Article
Background: The AJCC 8th edition pathologic prognostic staging (PPS) system, which incorporates both anatomic and biologic factors, was developed using data from patients captured in the National Cancer Database diagnosed 2010-2012 in whom complete anatomic (T, N and M category) as well as biologic data (grade, ER, PR, HER2) were available. The cli...
Article
Full-text available
Systemic inflammation is believed to contribute to the distant recurrence of breast cancer. We evaluated serum samples obtained at diagnosis from 249 case:control pairs with stage II-III Her2-negative breast cancer with or without subsequent distant recurrence. Conditional logistic regression analysis, with models fit via maximum likelihood, were u...
Article
Full-text available
The 21-gene recurrence score (RS) is prognostic for recurrence and predictive of chemotherapy benefit in early estrogen receptor-positive (ER +) HER2-negative (HER2-) breast cancer (BCA). We evaluated clinicopathologic characteristics, RS and chemotherapy benefit in invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), and carcinomas o...
Article
PURPOSE Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results. METHODS Women presenting with metastatic breast cancer and an intact p...
Preprint
Full-text available
Purpose: The three CDK4/6 inhibitors (CDK4/6i) approved for use in HR-positive/HER2-negative metastatic breast cancer (MBC), palbociclib, ribociclib, and abemaciclib, are generally well tolerated but their most common toxicity is neutropenia. Within the general population, neutropenia has been shown to be more common in individuals of African desce...
Preprint
Background: Black race is associated with worse outcome in patients with breast cancer. We evaluated distant relapse-free survival (DRFS) between Black and White women with localized breast cancer who participated in NCI-sponsored clinical trials. Methods: We analyzed pooled data from eight National Surgical Adjuvant Breast and Bowel Project (NSABP...
Article
Background: E5103 was a study designed to evaluate the efficacy and safety of bevacizumab. It was a negative trial for the end points of invasive disease-free survival and overall survival. The current work examines the tolerability of bevacizumab and other medication exposures with respect to clinical outcomes and patient-reported outcomes (PROs)...
Article
Full-text available
Importance The use of magnetic resonance imaging (MRI) in pretreatment planning of ductal carcinoma in situ (DCIS) remains controversial. Understanding changes in short-term health-related quality of life associated with breast MRI would allow for a more complete comparative effectiveness assessment. Objective To assess whether there are changes i...
Article
Purpose/Objective(s) The COVID-19 pandemic has placed a tremendous burden on healthcare systems and has forced oncology providers and cancer patients to balance pandemic risks with maintaining standard cancer survivorship care. We evaluated adherence to long-term follow-up among early-stage breast cancer patients in an urban, academic cancer center...
Article
Background: TAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early-stage hormone receptor-positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E). Methods: Partici...
Article
Full-text available
Introduction Ductal carcinoma in situ (DCIS) of the breast is a non-obligate precursor of invasive breast cancer (IBC). Many DCIS patients are either undertreated or overtreated. The overarching goal of the study described here is to facilitate detection of patients with DCIS at risk of IBC development. Here, we propose to use risk factor data and...
Article
Purpose: Endocrine therapy resistance in advanced breast cancer remains a significant clinical problem that may be overcome with the use of histone deacetylase inhibitors such as entinostat. The ENCORE301 phase II study reported improvement in progression-free survival (PFS) and overall survival (OS) with the addition of entinostat to the steroida...
Article
Background There are limited data from clinical trials describing preoperative MRI features and performance in the evaluation of mammographically detected ductal carcinoma in situ (DCIS). Purpose To report qualitative MRI features of DCIS, MRI performance in the identification of additional disease, and associations of imaging features with patholo...
Article
Full-text available
PurposePreclinical data demonstrate STAT3 as an important regulator in HER2+ tumors, and disruption of the IL6-JAK2-STAT-S100A8/S100A9 signaling cascade reduces HER2+ cell viability. Ruxolitinib is an FDA approved inhibitor of JAK1 and JAK2. We performed a phase I/II trial investigating the safety and efficacy of the combination of trastuzumab and...
Article
Full-text available
Background Trastuzumab targets the extracellular domain of the HER2 protein. Adding trastuzumab to chemotherapy for patients with early-stage, HER2-positive breast cancer reduces the risk of recurrence and death, but is associated with cardiac toxicity. We investigated the long-term benefits and risks of adjuvant trastuzumab on breast cancer recurr...
Article
Full-text available
Purpose To examine whether there are clinicodemographic determinants associated with cancer survivorship follow-up during COVID-19. Methods We performed a retrospective, population-based cohort study on early stage (Stage I-II) breast cancer patients who underwent resection between 2006 to 2018 in a New York Hospital System. The primary outcome wa...
Article
Full-text available
Multigene expression assays are prognostic for recurrence in hormone-receptor positive 2 (HER-2) negative breast cancer, and, in some cases, predictive of benefit from chemotherapy or extended endocrine therapy. The results of these assays may be used to guide treatment recommendations for early HER-2 negative breast cancer. We review the results o...
Article
Full-text available
PURPOSE There is a need for industry-independent decision tools that integrate clinicopathologic features, comorbidities, and genomic information for women with node-negative, invasive, hormone receptor–positive, human epidermal growth factor receptor-2–negative (early-stage) breast cancer. METHODS We adapted an extant Cancer Intervention and Surv...
Article
Full-text available
PurposeTo compare efficacy and safety of capecitabine and lapatinib with or without IMC-A12 (cituxumumab) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.Patients and methodsFollowing an initial safety run-in cohort, patients were randomized 1:2 to Arm A (capecitabine and lapatinib) or to Arm B (cap...
Conference Paper
Background: The purpose of this study was to evaluate whether there are differences in distant recurrence rates between Black and White women with localized breast cancer who participated in NCI-sponsored clinical trials, and thus had access to state of the art oncologic care and lacked major comorbidities. Methods: We analyzed pooled data from 10...
Article
Importance Early discontinuation of adjuvant endocrine therapy (ET) is problematic among breast cancer survivors, with previous studies suggesting that up to 50% of women do not adhere to the recommended full 5 years of ET treatment. Objective To identify the association between early discontinuation of ET in the Trial Assigning Individualized Opt...
Article
Purpose: AIDS-related non-Hodgkin lymphoma (ARL) is the most common cancer in HIV-infected individuals in the United States and other countries in which HIV-positive persons have access to effective combination antiretroviral therapy (cART). Our prior work showed that pretreatment/postdiagnosis plasma levels of some cytokines, such as IL6, IL10, a...
Article
PURPOSE Patients with triple-negative breast cancer (TNBC) and residual invasive disease (RD) after completion of neoadjuvant chemotherapy (NAC) have a high-risk for recurrence, which is reduced by adjuvant capecitabine. Preclinical models support the use of platinum agents in the TNBC basal subtype. The EA1131 trial hypothesized that invasive dise...
Article
As COVID-19 adversely affects patients with cancer, prophylactic strategies are critically needed. Using a validated antibody assay against SARS-CoV-2 spike protein, we determined a high seroconversion rate (94%) in 200 patients with cancer in New York City that had received full dosing with one of the FDA-approved COVID-19 vaccines. Comparing to s...
Article
12003 Background: AIMSS are common and frequently lead to early discontinuation of adjuvant AI therapy. Single nucleotide polymorphisms (SNPs) in candidate genes have been associated with AIMSS and AI discontinuation. The primary objective of E1Z11 was to validate previously identified associations between 10 specific SNPs in candidate genes and AI...
Article
6564 Background: Management of ductal carcinoma in situ (DCIS) remains variable, requiring an understanding of patient preferences and concerns to enhance the treatment decision-making process. Pre-operative MRI and surgeon recommendation can further inform surgery choice. Quality of life (QoL) is also an important consideration in treatment decisi...
Article
605 Background: Pts with TNBC who have residual invasive disease (RD) after completion of NAC have a very high risk for recurrence, which is reduced by adjuvant capecitabine (C). Pre-clinical models support the use of platinum agents (P) in the TNBC basal subtype. EA1131 tested the hypothesis that invasive disease-free survival (iDFS) would not be...
Article
e12507 Background: There is a need for web-based decision tools that integrate clinicopathologic features and genomic information to guide breast cancer therapy for women with node-negative, hormone receptor positive, HER2 negative (“early-stage”) breast cancer. We developed a novel simulation model-based clinical decision tool that provides progno...
Article
520 Background: Systemic inflammation may contribute to cancer progression (PMC2803035), including recurrence of early breast cancer (PMC4828958). We hypothesized that inflammatory cytokines and/or chemokines may be associated with distant recurrence (DR). Methods: We performed a case:control study in women with stage II-III Her2-negative breast ca...
Article
Background: The prognostic significance of patients with low-risk Recurrence Score (RS) results in the context of the American Joint Committee on Cancer (AJCC) 8th-edition pathologic prognostic staging has not been investigated. We evaluated if expanded RS criteria can be considered for downstaging in AJCC pathologic prognostic staging. Methods:...
Article
Background: Early discontinuation is a substantial barrier to the delivery of endocrine therapies (ETs) and may influence recurrence and survival. The authors investigated the association between early discontinuation of ET and social determinants of health, including insurance coverage and the neighborhood deprivation index (NDI), which was measu...
Article
Full-text available
Lymphovascular invasion (LVI) and Black race are associated with poorer prognosis in early breast cancer (EBC). We evaluated the association between LVI and race, and whether LVI adds prognostic benefit to the 21-gene recurrence score (RS) in EBC. Women with ER+ HER2− EBC measuring up to 5 cm, with 0–3 involved axillary nodes, diagnosed between 1 J...
Conference Paper
Background: Cytotoxic chemotherapy (CT) in combination with trastuzumab and pertuzumab (HP) is standard of care for patients (pts) diagnosed with HER2-positive early breast cancer (EBC). While highly effective, the toxicity associated with CT is challenging. In KRISTINE/TRIO-021, neoadjuvant T-DM1 was combined with pertuzumab (KP) and compared to s...
Conference Paper
Background: The 21-gene recurrence score (RS) provides prognostic information for distant recurrence (DR) and predictive information for chemotherapy (CT) benefit in early breast cancer, whereas clinicopathologic features provide only prognostic information. We used patient-specific meta-analysis (PSMA) methods (Crager et al, J Appl Stat 2014 [PMID...
Conference Paper
Background: Endocrine therapy resistance in advanced breast cancer remains a significant clinical problem that may be overcome with use of histone deacetylase (HDAC) inhibitors such as entinostat. The ENCORE 301 randomized phase II study reported an improvement in progression-free (PFS) and overall survival (OS) with the addition of entinostat to t...
Conference Paper
Background: The Oncotype DX 21-gene expression assay (ODX) is prognostic for recurrence and predictive of chemotherapy benefit in early estrogen receptor-positive (ER+) HER2-negative (HER2-) breast cancer (BCA). Invasive ductal carcinoma (IDC) comprises approximately 80% of BCA. Invasive lobular carcinoma (ILC) is a subtype of BCA with distinct pat...
Preprint
Full-text available
Patients with cancer have been identified in several studies to be at high risk of developing severe COVID-19; however, rates of SARS-CoV-2 IgG seroconversion and its association with cancer types and anti-cancer therapy remain obscure. We conducted a retrospective cohort study in patients with cancer that underwent SARS-CoV-2 IgG testing. Two hund...
Article
Full-text available
PURPOSE The 21-gene recurrence score (RS) is prognostic for distant recurrence (DR) and predictive for chemotherapy benefit in early breast cancer, whereas clinical-pathological factors are only prognostic. Integration of genomic and clinical features offers the potential to guide adjuvant chemotherapy use with greater precision. METHODS We develo...
Article
Background: Black race is associated with worse outcomes in early breast cancer. We evaluated clinicopathologic characteristics, the 21-gene Recurrence Score (RS), treatment delivered and clinical outcomes by race and ethnicity among women who participated in TAILORx. Methods: The association between clinical outcomes and race (White, Black, Asi...
Article
Background: 18F-fluorodeoxyglucose PET/CT is recommended as an optional study in the current NCCN Clinical Practice Guidelines in Oncology for Breast Cancer after CT of the chest, abdomen, and pelvis with contrast and bone scan (CTBS) in stage IIA-IIIC breast cancer. We evaluated our experience with the use of PET/CT in this setting before beginni...
Article
Full-text available
PURPOSE The aim of this study was to review the current status of clinical trials for HIV-associated malignancies in people living with HIV in sub-Saharan Africa (SSA) and efforts made by the AIDS Malignancy Consortium (AMC) to build capacity in SSA for HIV malignancy research. METHODS All malignancy-related clinical trials in 49 SSA countries on...
Article
LBA2 Background: About 6% of newly diagnosed breast cancer patients present with Stage IV disease and an intact primary tumor (IPT). Locoregional treatment (LRT) for the IPT is hypothesized to improve survival based on retrospective analyses, but randomized trials have provided conflicting data. We now report the results of E2108, a Phase 3 trial t...
Article
Full-text available
Breast cancer is the second most commonly diagnosed cancer in American women following skin cancer. Despite overall decrease in breast cancer mortality due to advances in treatment and earlier screening, black patients continue to have 40% higher risk of breast cancer related death compared to white patients. This disparity in outcome persists even...
Conference Paper
Background: Black race is associated with inferior outcomes in early breast cancer, including hormone-receptor (HR) positive and HER2-negative disease, even when receiving comparable adjuvant systemic chemotherapy and endocrine therapy (Sparano et al. JNCI 2012; Albain et al. AACR SABCS 2018, abstract GS4-07). Hispanic ethnicity is associated with...
Article
7041 Background: Cancer patients spend substantial amounts on their healthcare services, and are at high risk for financial toxicity, a patient-reported outcome shown to be associated with care non-adherence. Even with insurance, cancer patients often face unpredictable or unmanageable costs. In women with breast cancer enrolled in TAILORx trial, w...
Article
7004 Background: The TAILORx study demonstrated women with an intermediate Oncotype DX score receive the same benefit with endocrine therapy (ET) compared to chemoendocrine therapy (CET). However, early discontinuation of adjuvant ET is problematic among breast cancer survivors, with previous studies suggesting that up to 50% of women do not adhere...
Article
550 Background: The 8 th ed AJCC staging system incorporated grade, receptor status and the Oncotype DX Recurrence Score (RS) result into staging. Based on TAILORx trial data and evidence of utility for RS results in node positive disease, this study was undertaken to determine if staging should incorporate expanded RS criteria. Methods: Patients (...
Article
e19136 Background: Patient reported side effect bother is needed to understand tolerability of cancer drugs. We examined whether increase in side effect bother from baseline to cycle 7 as measured by a single item (GP5) from the FACT-G, “I am bothered by side effects of treatment”, was associated with early treatment discontinuation (ETD) in a mult...
Article
e19132 Background: The Functional Assessment of Cancer Therapy–General has an item about patient tolerability of treatment: “I am bothered by side effects of treatment” (GP5). We examined the predictive value of this single item for early treatment discontinuation in clinical trials. Methods: GP5 level prior to protocol therapy (rated using a 5-poi...
Article
563 Background: 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET/CT) is recommended as an optional study in current National Comprehensive Cancer Network (NCCN) guidelines after computerized tomography and bone scan (CTBS) in patients with stage IIA-IIIC breast cancer. We evaluated our experience with use of PET/CT in this setting...
Article
593 Background: Obesity, defined as body mass index (BMI) > 30 kg/m ² , has been associated with inferior outcomes in localized breast cancer (BC), including lower pathological complete response (pCR) to neoadjuvant chemotherapy (NAC). High BMI is usually associated with excess adipose tissue (AT), but also reflects skeletal muscle (SM) mass. Low S...