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Explore research publications by Principal Investigators and members of The Oncology Consortia of Criterium, a collaboration that delivers innovative research and unparalleled expertise in oncology. All publications are available for download.
Only a small proportion of proposed investigator initiated cancer clinical trials are successfully activated following a prolonged development process. Given the importance of IITs in addressing real-world, practical questions and the growing professional challenges facing clinical research physician faculty, further attention to IIT development facilitators and barriers is warranted.
Among patients with ALK-positive NSCLC who had not previously received an ALK inhibitor, progression-free survival was significantly longer among patients who received brigatinib than among those who received crizotinib.
Brigatinib, a second generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), is central nervous system (CNS) penetrant and active against anaplastic lymphoma kinase (ALK) resistance mutations.
We prospectively studied the activity of brigatinib in patients with disease progression after second generation ALK TKIs.
Symptomatic early onset pulmonary events (EOPEs) were observed in 3% to 6% of patients within 1 week of starting brigatinib at 90 mg daily for 7 days followed by 180 mg daily.
We conducted a prospective observational cohort study to measure pulmonary function changes on initiating brigatinib.
New tyrosine kinase inhibitors (TKIs) targeting ALK and ROS1 have emerged over the last decade. Data on long term outcomes, sequential therapies, and development of brain metastases are limited. This study sought to identify treatment patterns in ALK+ and ROS1+ NSCLC, evaluate the effect of 1st TKI on development of brain metastases, and estimate overall survival (OS) in ALK+ and ROS1+ NSCLC.
There is a paucity of real-world data describing clinical outcomes in patients with locally advanced or metastatic KRAS G12C mutated NSCLC in the second-line or later, as most prior studies featured outcomes in the first line setting, evaluated specific patient subgroups, or evaluated the prognostic vs. predictive value of KRAS G12C compared to non-G12C genotypes. We sought to compile a large, academic medical center-based historical dataset to clarify clinical outcomes in the second line or later among patients with KRAS G12C mutant NSCLC.
Colorectal cancer (CRC) can be effectively treated with fluoropyrimidine chemotherapy doublets. The triplet chemotherapy program, FOLFOXIRI, is more effective than a doublet in randomized trials. We combined this triplet with the anti-EGFR antibody, panitumumab, as first line therapy in the appropriately targeted population: left-sided, RAS wild-type metastatic colorectal cancer
In this preclinical human immune system patient-derived xenograft (HIS-PDX) model and phase II clinical trial, we assessed evorpacept (anti-CD47 engineered fusion protein with inactive Fc), cetuximab, and pembrolizumab (triple therapy) in microsatellite-stable (MSS) colorectal cancer.
The MEI trial evaluating ME-344, an investigational therapy demonstrated promising results in patients with advanced solid tumors. The trial assessed the safety and efficacy of ME-344, a mitochondrial inhibitor, in patients with various cancer types, including endometrial, ovarian, and breast cancers. The primary endpoint of the study was to determine the overall response rate (ORR), and secondary endpoints included progression-free survival (PFS) and overall survival (OS).
More than half of colorectal tumors harbor activating mutations in RAS/RAF proteins. Selumetinib (AZD6244, ARRY-142886) is a small molecule kinase inhibitor targeting MEK kinase, downstream of RAS. We examined the efficacy and safety of selumetinib with irinotecan in second-line therapy.
Multi-tyrosine kinase inhibitors have shown clinical activity in metastatic colorectal cancer patients. Cabozantinib, a multi-tyrosine kinase inhibitor, exhibited potent antitumor activity superior to regorafenib in preclinical colorectal cancer patient-derived tumor xenograft models. This Phase II study aimed to investigate cabozantinib, a multityrosine kinase inhibitor, in refractory, metastatic colorectal cancer patients.
For many years colorectal cancer (CRC) has been one of the leading causes of cancer-related mortality worldwide and is currently the third-leading cause of death among all cancers in the United States. In 2020, the estimated number of new cases of colorectal cancer nationwide is 104,610, while the number of deaths it causes is projected to exceed 50,000.
Maximum trastuzumab treatment time to CR was 27 months with 2 or more years trastuzumab treatment independently associated with better survival. Survival comparisons and hazard modeling both indicate as good or better survival associated with continuous trastuzumab treatment regardless of CR status.
This report describes a patient with metastatic estrogen receptor–positive, HER2-nonamplified breast cancer with an activating HER2 mutation whose tumor became resistant to neratinib as well as capecitabine, but whose subsequent leptomeningeal disease had a dramatically successful response to tucatinib plus capecitabine.
A retrospective study was carried out for patients treated at the Swedish Cancer Institute from 2000 to 2015, aged 70 years or older, with pT1N0 or pT1NX estrogen receptor‑positive and ERBB2‑negative unifocal breast cancer without positive surgical margins, high nuclear grade, or lymphovascular invasion.
Tumors that express hormonal receptors (HR) and amplified human epidermal growth factor receptor 2 (HER2) comprise 11% of all breast cancer cases, with a higher frequency among young patients. To overcome resistance to antihormonal and HER2-targeted agents mediated by cyclin D1-CDK4/6 complex, we proposed an oral combination of the HER2 inhibitor tucatinib, aromatase inhibitor letrozole, and CDK4/6 inhibitor palbociclib (TLP combination) for treatment of HR./HER2. metastatic breast cancer (MBC).
This study sought to evaluate the safety and efficacy of carfilzomib in patients with AL.
This is the first clinical trial to investigate CPD in multiple myeloma. Results suggest that the regimen is a well-tolerated and highly active combination for patients with relapsed/refractory multiple myeloma.