Research matters

When you’re focusing on the future of cancer care, it helps to start with a clear and accurate picture of the present.

Abstract
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Abstract
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Breast Cancer
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Maher Albitar, Andre Goy, Andrew Pecora, Deena Graham, Donna Donna McNamara, Ahmad Ahmad Charifa, Andrew IP, Wanlong Ma, Stanley Waintraub
Human epidermal growth factor receptor-2 (HER2) and hormone receptors are typically used as binary biomarkers for selecting breast cancer therapy. There is a need to explore the clinical relevance of these biomarkers as continuous variables. This is particularly relevant for the new class of antibody-drug conjugates (ADC), in which a relatively low HER2 expression level is adequate for targeting tumor cells. We explored the potential of RNA profiling, determined by next generation sequencing (NGS), to provide more flexible clinical biomarkers as compared with immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH).
Anne Shah PhD, Jon Apple PharmD, Andrew J. Belli MPH, Anna Barcellos MPH, Eric Hansen MS, Laura L. Fernandes PhD, and Ching-Kun Wang MD
Surgical resection is the primary treatment with curative intent for early-stage NSCLC; however, many patients experience recurrence even after resection. The goal for this study was to assess the real-world disease-free survival (rwDFS) and patient characteristics, including epidermal growth factor receptor mutation (EGFRm) status, associated with rwDFS in stages IB-IIIA NSCLC patients.
Yolcar Chamorro MS, Manmeet S. Ahluwalia MD, MBA, Muni B. Rubens MBBS, PhD, MPH, Siddhartha A. Venkatappa MBBS, MPH, Andrew J. Belli MPH, Nicholas Ritter MBA, Ching-Kun Wang MD, Reshma L. Mahtani DO, and Ana Sandoval Leon MD
A cyclin-dependent kinase inhibitor (CDK 4/6i) plus endocrine therapy (ET) is considered standard of care first-line (1L) treatment for patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) MBC without visceral crisis. A recent retrospective claims analysis showed that the combination of ET-CDK 4/6i was underutilized at our institution as 1L therapy; notably that no patients over age 66 received the combination in 2018. We sought to confirm this finding using clinical real-world data (RWD).
Yolcar Chamorro, Reshma Mahtani, Shanada Monestime, Manmeet Ahluwalia, Muni Rubens, Natasha Harpalani, Ana Sandoval-Leon
PIK3CA mutations are found in up to 40% of hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancers (MBC). Alpelisib is an orally bioavailable PIK3CA inhibitor approved in combination with fulvestrant based on the SOLAR-1 study. However, uptake has been limited due to toxicity concerns, most commonly hyperglycemia (grade ≥3 was 37% in SOLAR-1 and 28% in the BYLieve study, which evaluated alpelisib after progression on a CDK 4/6 inhibitor). Patients with uncontrolled type 2 diabetes (T2DM) were excluded from both studies [defined as fasting plasma glucose (FPG) level >140 mg per deciliter, or a glycosylated hemoglobin (HgbA1C) level of >6.4%]. Of note, both trials enrolled a majority of non-Hispanic White (NHW) patients. Disparities regarding prevalence of diabetes has been reported among Hispanics (H). The Centers for Disease Control and Prevention reports that H are more likely to have T2DM than NHW (approximately 17% vs 8% respectively). Our study aims to characterize the incidence and management of hyperglycemia in H MBC patients treated with alpelisib.
Reetu Mukherji, Chao Yin, Benjamin Adam Weinberg, Ali Alqahtani, Rumaisa Hameed, Anna Barcellos, Maegan Connole, Chelsea Perelgut, Josephine Fortuin, John Marshall
Cape is an oral fluoropyrimidine (FP) used as maint therapy in CRC and PC. While the standard FDA dosing is 1250 mg/m2 twice daily (BID) for 14 days followed by 7 days off in a 21-day cycle, there are variations across institutions as to the preferred schedule. To improve tolerability and convenience, our institution adopted a “continuous” dosing schedule where cape is taken BID Monday-Friday (M-F) with a treatment break on Saturday and Sunday. Here, we describe our institution’s experience with continuous maint dosing in advanced CRC and PC patients (pts) and explore real-world outcomes.
Vishal Bhatnagar, Bindu Kanapuru, Laura Fernandes, Ting-Yu Chen, Mallorie H. Fiero, Erica Horodniceanu, Nicole Gormley, Catherine Lerro, Fatima Rizvi, Yuan-Li Shen, Felice Yang, Anna Barcellos, Andrew J. Belli, Eric Hansen, Ching-Kun Wang, Donna Rivera, Paul Kluetz
In oncology clinical trials, performance status (PS) is commonly assessed by clinicians at trial outset using the Eastern Cooperative Oncology Group (ECOG) scale. Clinical trials in various tumor types have demonstrated that poor PS (i.e., ECOG PS 2-4) is correlated with lower overall survival (OS). Little is known about the longitudinal clinical course of patients with poor PS in traditional clinical trials, as this information is typically assessed only by clinicians at baseline, and many patients with detriments in PS are excluded. There is an opportunity for better quality PS information, using techniques such as serial post-baseline assessments and use of patient- and clinician reported PS. MM was selected as a disease to explore ECOG scores over time, as patients with MM typically have more than one relapse and require multiple lines of therapy, coinciding with changes in PS. We examined PS from a real-world cohort of patients with MM to demonstrate feasibility of assessing patient-reported PS and to explore the value of these longitudinal data.
Dianne Pulte, MD, Kelly J. Norsworthy, MD, Laura Fernandes, Bindu Kanapuru, MD, Catherine Lerro, Fatima Rizvi, Jonathon Vallejo, Ph.D., Kun Wang, PhD, Joseph Wynne, MD, PhD, Anna Barcellos, Andrew J. Belli, Eric Hansen, Thomas Gwise, Ph.D., Paul Kluetz, Angelo De Claro, Ching-Kun Wang and Donna Rivera
Clinical trials are essential to establish the efficacy and safety of medical products; however, clinical trials may not always be representative of or generalizable to the intended patient population. Notably, patients with comorbidities, older adults, and patients from racial and ethnic groups are often under-represented in clinical trials for acute myeloid leukemia (AML) (Bierenbaum et al, Leuk Res, 2012). Real-world data (RWD) can provide insight into the utilization, effectiveness, and safety of treatment regimens in routine clinical practice and has demonstrated usefulness in understanding the current treatment landscape. The objective of this study was to describe patient characteristics and treatment patterns in the first-line setting among a real-world cohort of adult patients with ND-AML in the US.
William J Archibald, Anna Barcellos, Jacob Ambrose, Andrew J. Belli, Laura Fernandes, Eric Hansen, Ching-Kun Wang and Paul M. Barr
Recent therapeutic advancements in CLL have shifted the treatment landscape, providing expanded options for patients receiving systemic treatment. Notably, targeted therapies have become key therapeutic strategies in the first-line setting. BTK-inhibitors such as ibrutinib or acalabrutinib, and the BCL2-inhibitor venetoclax, have been shown to improve outcomes compared to the prior standard of care. However, with the evolving treatment landscape comes a need to understand the performance of these therapies in the real-world setting. Currently, there are no head-to-head comparisons for these novel therapies in the frontline setting. Real-world data (RWD) is a valuable tool to investigate important clinical questions outside of clinical trials. We sought to use a real-world cohort of patients to characterize the clinical characteristics and outcomes of patients treated with first-line BCL2- or BTK-inhibitor therapies.
Joshua Richter, Peter Feng Wang, Alexa Molinari, Boris Gorsh, Natalie Boytsov, Suzanne Landi, Sue Perera, Prani Paka, Teresa Palumbo, Mei Sheng Duh, Christopher Yee, Anamika Khanal, Sonia Gupta, Ajai Chari
While new treatments have been introduced for multiple myeloma, patients typically experience repeated relapses and progress through complex treatment pathways involving multiple lines of treatment (LOT). It remains unclear to what extent novel therapies are being utilized in treatment regimens for patients with RRMM. This study assessed treatment patterns and outcomes in patients with RRMM to better understand the current treatment landscape, unmet needs, and challenges in real-world clinical settings.
Andrew Ip, Alex Mutebi, Tongsheng Wang, Monika P. Jun, Anupama Kalsekar, Fernando Rivas Navarro, Anthony Wang, Rajesh Kamalakar, Mariana Sacchi, Brian Elliott
Despite the rapidly evolving therapeutic landscape for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), treatment with chemotherapy, single-agent rituximab/obinutuzumab, single-agent lenalidomide, or combinations of these agents are common components of R/R DLBCL treatment regimens. This study aimed to characterize clinical outcomes in a real-world cohort of patients with R/R DLBCL treated with the above SOC regimens in the second-line or later setting and to assess the impact of patient demographics and clinical characteristics on clinical outcomes.

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