Research

Empowering Healthcare with Real-World Evidence

Dive into our repository of groundbreaking research papers, where we merge clinical expertise with data driven insights to revolutionize patient care and treatment strategies.

Group 79
Yolcar Chamorro, Reshma L. Mahtani, Shanada Monestime, Naomi Dempsey, Mukesh Roy, Muni B. Rubens, Manmeet Singh Ahluwalia, Ana Cristina Sandoval-Leon
A retrospective chart review was performed to include pts with HR+ HER2- MBC with a documented PIK3CA mutation (detected by ctDNA or tissue) treated with alpelisib in combination with fulvestrant at Miami Cancer Institute from 2019-2022. Pts were identified using pharmacy records and the COTA real-world database (RWD).
Rami S. Komrokji, Leyla Hernandez Donoso, Sejla Hodzic, Henry F Owusu, Kevin Nolan, Claire Nourry, Maria Diez-Campelo
Pts with higher-risk MDS have poor outcomes. To understand current tx patterns/identify unmet needs, the COTA database, using pt-level curated electronic health record (EHR) data from centers across the US, was analyzed.
Brittany Avin McKelvey, Elizabeth Garrett-Mayer, Andrew J. Belli, Thomas D. Brown, Jessica Dow, Janet L. Espirito, Paul Kluetz, Xinran Ma, Andrea McCracken, Pallavi Shruti Mishra-Kalyani, Yanina Natanzon, Danielle Potter, Donna Rivera, Hillary Stires, Mark Stewart, Jeff Allen
Friends of Cancer Research formed a multi-stakeholder partnership to assess available data attributes to measure response across RWD sources to inform development of a consistent method for measurement.
Luciano J. Costa, Thomas William LeBlanc, Hans Tesch, Pieter Sonneveld, Ryan Kyle, Liliya Sinyavskaya, Patrick Hlavacek, Aster Meche, Jinma Ren, Alex Schepart, Didem Aydin, Marco DiBonaventura
ELRA is a BCMAxCD3 bispecific antibody being investigated for the treatment of R/R MM. The phase 2 MM-3 trial was single-armed; the aim of this study (NCT05565391) was to contextualize the efficacy data from MM-3 with two real-world (RW) external control arms.
Rami S. Komrokji, Leyla Hernandez Donoso, Sejla Hodzic, Henry F Owusu, Kevin Nolan, Claire Nourry, Maria Diez-Campelo
Pts with higher-risk MDS have poor outcomes. To understand current tx patterns/identify unmet needs, the COTA database, using pt-level curated electronic health record (EHR) data from centers across the US, was analyzed.
Jennifer Leigh Crombie, Monika P. Jun, Tongsheng Wang, Alex Mutebi, Anthony Wang, Anindit Chibber, Rajesh Kamalakar, Jon Ukropec, Julie Blædel, Anupama Kalsekar
Outcomes have historically been poor for patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Despite an increase in approved R/R DLBCL treatment options, clinical outcomes of these therapies remain less certain. Novel treatments for R/R DLBCL patients include chimeric antigen receptor T-cell (CAR T) therapy, polatuzumab vedotin plus bendamustine and rituximab (pola-BR), tafasitamab plus lenalidomide (tafa-len), loncastuximab (lonca), and selinexor. The objective of this study was to examine real-world outcomes of these novel therapies.
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).
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).