Deepa Lalla's research while affiliated with Puma Biotechnology, Inc and other places

Publications (95)

Article
Full-text available
Background: Approximately half of patients with high-risk HER2-positive early-stage breast cancer (ESBC) do not have pathologic complete response (pCR) after neoadjuvant therapy. The residual burden of disease among this population has not been previously quantified. Materials and methods: We used decision-modeling techniques to simulate recurre...
Article
BACKGROUND: Women with breast cancer are living longer, including those with risk factors like HER2+ tumors or diagnosed at later stages, but a dearth of information exists on patients’ outcomes beyond clinical trials. We aimed to describe the risk of subsequent breast cancer (recurrence, second primary breast cancer, breast cancer-specific death)...
Article
Background: To estimate the long-term consequences of disease recurrence following treatment with adjuvant T-DM1 among U.S. patients with high-risk HER2+ ESBC who did not achieve pathologic complete response (pCR) after neoadjuvant therapy. Methods: A Markov model was used to simulate local/regional and distant recurrence with 10 years of follow-up...
Article
Introduction: HER2-positive metastatic breast cancer (mBC) is an incurable disease associated with years of chronic therapy and excess cost. HER2-targeted therapies have shown survival benefit for early-stage and mBC; however, the economic impact of these therapies has not been fully assessed. We evaluated health care resource use (HCRU) and costs...
Article
e13565 Background: Data from traditional registries are usually limited to patients treated at study sites. Virtual registries can enroll a broader real-world population. Neat-HER is a U.S.-based virtual registry pilot through PicnicHealth that is enrolling patients with HER2+ breast cancer receiving neratinib as extended adjuvant therapy. Methods:...
Conference Paper
Background Neratinib, an oral, irreversible tyrosine kinase inhibitor of multiple HER receptors, was recently approved in combination with capecitabine (neratinib doublet regimen) in the United States (US) for adults with HER2+ metastatic breast cancer (mBC) who have received 2 or more anti-HER2 therapies. Clinical trials showed that neratinib plus...
Conference Paper
Background: While data from traditional registries are typically limited to patients treated at study sites, virtual registries can enroll a broader real-world population. Neat-HER is a U.S.-based virtual registry pilot through PicnicHealth that is enrolling patients with HER2+ breast cancer receiving neratinib as extended adjuvant therapy. Methods...
Conference Paper
BACKGROUND: Women with breast cancer are living longer, including those with risk factors such as having HER2+ tumors or diagnosed at later stages, but a dearth of information exists on patients’ outcomes beyond clinical trials. Thus, we aimed to describe breast-cancer specific mortality risk for women with HER2+ disease in a large community health...
Conference Paper
Background: Human Epidermal Growth Factor Receptor 2 positive (HER2+) breast cancer (BC) represents approximately 15% of early stage BC cases and is associated with a more aggressive clinical phenotype and poor prognosis with respect to most BC. Over the last decade new HER2-targeted therapies have become available that have prolonged survival for...
Conference Paper
Background: Neratinib, an oral, irreversible tyrosine kinase inhibitor of multiple human epidermal growth factor receptors (HERs), is indicated for the extended adjuvant treatment of adult patients with, HER2-positive early-stage breast cancer (eBC) to follow adjuvant trastuzumab-based therapy in the United States (US). However, greater efficacy ha...
Article
e12011 Background: Long-term efficacy in the extended adjuvant setting requires a long follow-up. In the ExteNET trial, neratinib was given for a year and invasive disease-free survival (iDFS) assessed at 2 and 5 years. In women with HER2+ hormone receptor positive (HR+) cancer who initiated neratinib, the observed difference in iDFS between nerati...
Article
e12037 Background: Disease-free survival (DFS) in patients with EBC has improved over time. Trials of systemic agents for adj rx of HER2+ BC, including chemotherapies (CT), endocrine, and HER2-targeted agents have reported improved DFS. This review is a high-level overview describing DFS improvements in adj rx HER2+ BC. Methods: Therapeutic agents...
Article
e12035 Background: While data from traditional registries are limited to patients (pts) treated at study sites, virtual registries can enroll a more diverse real-world population. Neat-HER is a US-based, non-interventional pilot virtual registry through PicnicHealth that will enroll 100 pts with HER2+ BC receiving neratinib as extended adjuvant the...
Article
e12032 Background: The study objective was to estimate the long-term consequences of recurrences following treatment with trastuzumab (TRA) among women with HER2+ early stage breast cancer (BC) in the United States (US). Methods: A simulation model was constructed to estimate the following outcomes for each combination of hormone receptor (+/-) and...
Article
Background The Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients With Mild Stroke: Rapidly Improving Symptoms and Minor Neurologic Deficits (PRISMS) trial will assess r-tPA in ischemic stroke patients who present with mild deficits (i.e. mild stroke). Aims To assess PRISMS’s societal value in...
Article
70 Background: Metastatic breast cancer (MBC) and its treatments can have a significant impact on patients’ health-related quality of life (HRQoL) and daily functioning. To better assess the impact of MBC on HRQoL, we conducted an online survey among women with MBC. Methods: We developed and administered a cross-sectional, web-based survey, and inv...
Article
Background: Intravenous recombinant tissue-type plasminogen activator (r-tPA) is an approved treatment for select patients with acute ischemic stroke (AIS). Data indicate r-tPA improves functional outcome three months after AIS compared with placebo. This study models the increase in quality adjusted life years (QALYs) associated with r-tPA compar...
Article
Background: HER2 positive (HER2+) metastatic breast cancer (MBC) is associated with high mortality. Trastuzumab was approved for use in 1998, but the life-years saved from first-line use are unknown, as are the potential US population benefits from adding pertuzumab. Objectives: The first aim was to estimate the number of life-years saved by usi...
Article
Patients with breast cancer whose tumors test positive for human epidermal growth factor receptor 2 (HER2) are treated with HER2-targeted therapies such as trastuzumab, but limitations with HER2 testing may lead to false-positive (FP) or false-negative (FN) results. To develop a US-level model to estimate the effect of tumor misclassification on he...
Article
Full-text available
To the Editor: Recent analyses of patients with metastatic breast cancer (MBC) by subtype indicate that with the use of HER2-directed therapy, patients with HER2 + MBC experience improved survival and may have a superior prognosis by comparison with other subtypes (1–3). As these women live longer and undergoing longer periods of cancer treatment,...
Article
Full-text available
Metastatic breast cancer (MBC) patients are treated with a variety of regimens with differing side effects that can reduce the patients' quality of life. This study assessed the willingness to pay (WTP) to avoid side effects related to MBC treatment using conjoint analysis. An online, self-administered conjoint analysis survey of US adult female MB...
Article
Background and purpose: Despite the availability of results from multiple newer clinical trials and changing healthcare costs, the cost-effectiveness of recombinant tissue-type plasminogen activator (r-tPA) for treatment of acute ischemic stroke within 0 to 3 hours of symptom onset was last evaluated in 1998 for the United States Using current evi...
Article
Full-text available
Background: The importance of human epidermal growth factor receptor 2 (HER2) as a prognostic and predictive marker in invasive breast cancer is well established. Accurate assessment of HER2 status is essential to determine optimal treatment options. Methods: Breast cancer tumor tissue samples from the VIRGO observational cohort tissue substudy...
Article
Full-text available
Background: Existing treatments for metastatic breast cancer (mBC) are often effective but can cause adverse events (AEs). This study aimed to identify AEs associated with chemotherapies commonly used in mBC treatment (phase 1) and to quantify the economic impact of these AEs (phase 2). Materials and methods: Patients in phase 1 had at least one...
Article
Full-text available
Purpose We sought to compare the economic impact of treatment-related adverse events (AEs) in patients with metastatic breast cancer (mBC) using taxane- or capecitabine-based treatment regimens as either first- or second-line (FL or SL) therapy in the US. Methods We used healthcare claims data from the Truven Health Analytics MarketScan® Commercia...
Article
Full-text available
Background: Trastuzumab-or lapatinib-based therapies are recommended by the National Comprehensive Cancer Network (NCCN) guidelines as preferred agents for metastatic HER2-positive breast cancer. Few studies have compared treatment patterns, healthcare resource utilization (HRU), and costs in metastatic breast cancer (MBC) patients receiving trastu...
Article
Full-text available
Adjuvant trastuzumab treatment is administered to early stage breast cancer patients in physician office (POV) or hospital outpatient (HOP) settings. To identify treatment patterns, utilization, and costs by site of care (POV vs. HOP) of patients with adjuvant treatment of breast cancer with trastuzumab. This retrospective analysis identified adul...
Article
Background: The median survival for patients (pts) receiving trastuzumab (T) in the metastatic setting is approximately 3 years. There are limited data on real world use and outcomes in T treated pts who live longer than 3 years. The objective of this study was to identify and characterize pts with HER2+ MBC who initiated treatment with T (alone or...
Article
Treatment options for metastatic breast cancer (MBC) are complex, and some patients experience early discontinuation or switching of treatment (ETDS). We examined the relationship between ETDS and patient-reported symptom burden among patients receiving first-line treatment of MBC in community oncology settings. This retrospective observational stu...
Article
This report describes the results of an analysis of patient-reported outcomes from EMILIA (TDM4370g/BO21977), a randomized phase 3 study of the antibody-drug conjugate trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. A secondary...
Article
Full-text available
While overall survival (OS) has historically been the primary endpoint for clinical trials in oncology, progression-free survival (PFS) has gained acceptance as a valuable surrogate endpoint. However, there are no known published reports about the value of PFS from the patient's perspective. We developed a questionnaire that included items regardin...
Article
261 Background: Over 155,000 women are living with metastatic breast cancer (mBC) in the US. Chemotherapies can prolong survival for women with mBC, but adverse events (AEs) stemming from their use are common and costly to manage. We compared the healthcare costs for taxane- (TAX) and capecitabine-based (CAP) treatments for mBCpatients as either fi...
Article
Background: Fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) tests are commonly used to assess human epidermal growth factor 2 (HER2) status of tumors in patients with breast cancer. This analysis evaluates the likely cost-effectiveness of expanded retesting to assess HER2 tumor status in women with early stage breast cance...
Article
Full-text available
Background: This study aims to describe and compare health-related quality of life (HRQL) in patients with node-positive and high-risk node-negative HER2-positive early breast cancer receiving adjuvant docetaxel and trastuzumab-based or docetaxel-based regimens alone. Methods: Eligible patients (n = 3,222) were randomly assigned to either four c...
Article
6626 Background: Trastuzumab is administered to patients with early breast cancer (EBC) whose tumors test positive for HER2 using IHC or FISH diagnostic tests. However, due to test characteristics and testing heterogeneity, patients may be misdiagnosed as false positive (FP) or false negative (FN). This analysis estimates the lifetime economic burd...
Article
642 Background: T treatment for mBC may be administered in an office clinic or outpatient hospital setting. This study assesses the impact of the site of care on T discontinuation risk, HRU, and costs. Methods: Adult women with mBC who received ≥2 T infusions in an outpatient hospital or office clinic setting were selected from the US-based Humana...
Article
625 Background: Trastuzumab was approved in the United States (US) in September 1998 for the treatment of HER2+ metastatic breast cancer (MBC). This model estimates the total number of life years saved (LYS) in US women treated with trastuzumab over a 15-year period (1999-2013). Methods: Using US population estimates and cancer registry-based incid...
Article
9619 Background: Treatment options in 1 st line metastatic breast cancer (MBC) vary and may include chemotherapy, targeted, and hormone therapy. Some patients (pts) do not complete therapy as planned, perhaps due to treatment related toxicities. The current study examined the association of symptom burden with early treatment discontinuation (ETD)...
Article
e17527 Background: Over 73,000 women annually experience new or recurrent metastatic breast cancer (mBC) in the U.S. Chemotherapy can prolong survival with mBC but adverse events (AEs) from chemotherapy are common, costly to manage and may lead to changes in clinical outcomes. We evaluated the difference in cost of treatment for taxane- (TAX) and c...
Article
e11603 Background: It is unknown if quality of care received by patients (pts) with BC is impacted by the location at which care is received. Using a sample of pts with HER2+ BC receiving adjuvant trastuzumab (T), we compared T treatment patterns between pts treated in office/clinic (MD) or outpatient hospital (HOSP) settings. Methods: Non-metastat...
Article
18 Background: Most patients with metastatic breast cancer (MBC) are treated with chemotherapy and/or targeted therapy with varying toxicity profiles. Experience with adverse events (AE) may vary and factor into subsequent treatment decisions. As newer agents and combinations become available, it becomes increasingly important to understand which A...
Article
e11077 Background: This study examines treatment (tx) patterns in patients (pts) with breast cancer (BC) receiving trastuzumab (T) in a physician clinic (MD) & outpatient hospital (HOSP) setting. Methods: Pts ≥18 yrs with BC (≥2 claims with ICD-9-CM 174.xx, ≥30 days apart) and ≥2 T claims from 1/1/2006 to 12/31/2010 were identified from a large US...
Article
9144 Background: NCI PRO-CTCAE is designed to enhance adverse event reporting by integrating patients’ self-report of the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic treatment toxicities. This study examined the construct validity of a subset of PRO-CTCAE items in women with metastatic breast cancer (MBC...
Article
e19633 Background: NCI PRO-CTCAE is a new patient-reported outcome measure designed to enhance adverse event (AE) reporting in clinical trials by integrating the patient experience. The PRO-CTCAE item bank includes items representing the frequency (F), severity (S) and interference (I) with usual activities of 78 symptomatic AEs. The aim of this st...
Article
1037 Background: MBC is incurable and managed with ongoing therapy. This study examined the incremental costs of chemotherapy-associated AEs in MBC. Methods: The PharMetrics Integrated Database (2000-2010) was used to identify MBC pts treated either 1 st or 2 nd line with a taxane (T) (paclitaxel or docetaxel) or capecitabine (C)-based regimen for...
Article
e11076 Background: The National Comprehensive Cancer Network (NCCN) guidelines recommend trastuzumab- or lapatinib-based therapies as the preferred agents for metastatic HER2-positive breast cancer. Few studies have compared treatment patterns and outcomes in MBC patients (pts) treated with trastuzumab vs. lapatinib. The objective of this study is...
Article
e11063 Background: The goal of this study was to compare treatment patterns and outcomes in patients receiving a HER2 directed therapy for the treatment of HER2+ metastatic breast cancer (mBC). Methods: Female mBC patients (with ≥2 claims with ICD9 diagnosis codes for mBC), age ≥18 years receiving treatment with trastuzumab (T) or lapatinib (L) bet...
Article
Full-text available
Background. Trastuzumab improves survival in HER2-positive women with metastatic breast cancer (MBC). The consequences of longer survival include a higher likelihood of additional metastases, including those in the central nervous system (CNS). The effect of CNS metastases on both trastuzumab discontinuation and survival in older patients has not b...
Article
Background Chemotherapy treatment for metastatic breast cancer (MBC) has shown significant benefits in survival for breast cancer patients. However, chemotherapy is associated with several side effects that have a significant impact on patients’ quality of life. The objective of this analysis was to quantify the value patients with MBC place on red...
Article
Background: HER2 overexpression is associated with unfavorable prognosis and is reported in 18–25% of breast cancers (BC). HER2 testing is often performed using immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH). Because of the significant benefit of HER2−directed therapies, it is critical to accurately identify women whose tum...
Article
Background: HER2−directed biologic therapy is part of recommended treatment for women with HER2+ metastatic breast cancer (MBC). However, little is known regarding the quality of life (QoL) experience and symptom burden in these women outside of clinical trials. Methods: This one-time, web-based survey was conducted with 6 independent U.S. breast c...
Article
Background: T-DM1 is an antibody-drug conjugate in development for HER2−positive cancer. As a single-agent, it has demonstrated promising efficacy and safety when administered after multiple lines of HER2−directed therapy. In the current study, we compared the safety and efficacy of T-DM1 to standard first-line treatment for HER2−positive MBC. This...
Article
Full-text available
We used Surveillance, Epidemiology, and End Results-Medicare data (2000-2006) to describe treatment and survival in women diagnosed with metastatic breast cancer (MBC) who received trastuzumab. There were 610 patients with a mean age of 74 years. Overall, 32% received trastuzumab alone and 47% received trastuzumab plus a taxane. In multivariate ana...
Article
Background Approved US indications for trastuzumab include adjuvant treatment of HER2−overexpressing breast cancer in anthracycline-based (ACTH) or non-anthracycline-based (TCH) regimens. The objective of this study was to compare trastuzumab persistence across adjuvant breast cancer treatment regimens for US health plan enrollees. Materials and Me...
Article
602 Background: The objective of this retrospective study was to estimate the incremental medical costs of chemotherapy-related complications in patients with metastatic breast cancer (mBC). Methods: The PharMetrics Integrated Database (2004-2009) was used to identify mBC patients treated with a given regimen for ≥30 days (i.e., an episode of treat...
Article
e11121 Background: To better understand burden of illness in women with HER2+ metastatic breast cancer (MBC), we conducted a survey to evaluate their treatment experiences. Methods: This one-time, web-based survey was conducted with the help of 4 independent U.S. breast cancer support groups. Respondents were invited to participate via email, and w...
Article
e11101 Background: To assess the rate of chemotherapy-related complications in patients with metastatic breast cancer (mBC). Patients with mBC (including all biological subtypes) treated with chemotherapy and/or HER2-targeted agents were selected from the PharMetrics Integrated Database (2004-2009). Episodes of treatment (defined as a course of sin...
Article
6133 Background: FISH or IHC tests are commonly used to assess HER2 status: patients whose tumors are IHC 0, IHC 1+ or FISH negative are typically not retested to assess HER2 overexpression. Recent evidence shows that adjuvant patients can have tumors that are HER2+ by one test and HER2- by the 2nd and still benefit from treatment with trastuzumab...
Article
Background: Optimal treatment of metastatic breast cancer (MBC) post second-line is not well defined. Therapy options are limited by previous exposure, while HER2 status may remain relevant to decision-making. A systematic review was conducted to identify trials reporting efficacy data, and review the current treatment landscape for HER2+ and - pat...
Article
Introduction Treatment patterns and outcomes are not well known in later lines of therapy for patients (pts) with HER2+ metastatic breast cancer (MBC). The goal of this study was to evaluate commonly used regimens and outcomes in pts receiving active third line therapy for HER2+ MBC. Methods This retrospective study used data from US Oncology's iKn...
Article
Background: Trastuzumab (T) is indicated for the adjuvant treatment of HER2-overexpressing breast cancer (BC). We report the results of a retrospective study of patient-reported outcomes (PROs) for patients who received T plus chemotherapy followed by T monotherapy or T as a single-agent. Methods: Included in this analysis were 210 patients with ea...
Article
Breast cancer recurrence is associated with significant morbidity, mortality, and cost. Patients with early stage HER2+ tumors are at increased risk of recurrence. The use of trastuzumab for these patients has been shown to reduce recurrences and improve overall survival. A Monte Carlo simulation was conducted based on Surveillance, Epidemiology, a...
Article
Background: Trastuzumab (Herceptin; Genentech, Inc.; South San Francisco, CA) provides clinical benefit when combined with chemotherapy or as monotherapy in patients with HER2-positive metastatic breast cancer (MBC). Given the demonstrated improvement in standard outcomes, it is important to assess this therapy's effect on patients' health-related...
Article
1123 Background: While trastuzumab was approved in 1998 for treating patients with HER-2-positive MBC, there is little information on its use in the Medicare setting. Methods: We used SEER-Medicare data to examine patterns of trastuzumab use in women diagnosed with MBC . An index date was defined as either the date of diagnosis (stage IV) or of fir...
Article
e12008 Background: Practice patterns for patients with MBC following 1 st line therapy have often continued trastuzumab treatments while changing other chemotherapeutic agents in the regimen. We described treatment patterns, switching patterns and progression in mBC patients treated with a trastuzumab containing regimen for 1 st and second line mBC...
Article
e12009 Background: This study describes patterns of care and outcomes in metastatic breast cancer (MBC) patients treated with trastuzumab (T) within the US Oncology network. Methods: This retrospective s