![]() ![]() The findings support the clinical utility of liquid biopsy–guided anti-EGFR rechallenge therapy for refractory RAS WT MCRC. Within this group of 15 patients, 2 (13.3%) had partial response, 11 (73.3%) had stable disease, and 2 (13.3%) had disease progression as best response.Ĭonclusions and Relevance In this RCT, third-line treatment with the anti-EGFR monoclonal antibody panitumumab plus the standard-of-care trifluridine-tipiracil resulted in improved PFS compared with treatment with trifluridine-tipiracil alone among patients with refractory RAS WT MCRC. A ctDNA liquid-biopsy extended mutation analysis by FoundationOne Liquid CDx (profiling 324 genes) was performed in a subgroup of patients with baseline plasma RAS/BRAF WT ctDNA in 15 of 23 patients (65.2%) whose tumors were WT for KRAS, NRAS, BRAFV600E, EGFR, ERBB2, MAP2K1, and PIK3CA, median PFS was 6.4 months (95% CI, 3.7-9.2 months). Pretreatment plasma RAS/BRAF WT ctDNA identified patients obtaining prolonged clinical benefit with panitumumab plus trifluridine-tipiracil compared with trifluridine-tipiracil, with PFS rates at 6 months of 38.5% vs 13.0% and at 12 months of 15.4% vs 0%. Median PFS was 4.0 months (95% CI, 2.8-5.3 months) in the panitumumab plus trifluridine-tipiracil arm vs 2.5 months (95% CI, 1.4-3.6 months) in the trifluridine-tipiracil only (hazard ratio, 0.48 95% CI, 0.28-0.82 P = .007). Results Of 62 included patients, 31 received panitumumab plus trifluridine-tipiracil (19 male median age, 65 years ) and 31 received trifluridine-tipiracil alone (17 male median age, 66 years ). Circulating tumor DNA (ctDNA) extended sequence variation analysis was performed in a subgroup of patients. Main Outcomes and Measures The primary end point was progression-free survival (PFS). Interventions Patients were randomized 1:1 to receive panitumumab plus trifluridine-tipiracil or trifluridine-tipiracil alone. Patients with refractory RAS WT MCRC who had a partial or complete response to first-line chemotherapy plus an anti-EGFR monoclonal antibody and an anti-EGFR drug–free interval of 4 or more months during second-line therapy were included. Objective To compare the anti-EGFR monoclonal antibody panitumumab plus standard-of-care trifluridine-tipiracil with trifluridine-tipiracil alone as third-line therapy for RAS WT MCRC.ĭesign, Setting, and Participants This phase 2 randomized clinical trial (RCT) was conducted in 7 Italian centers from June 2019 to April 2022. Rechallenge with epidermal growth factor receptor (EGFR) inhibitors for RAS wild-type (WT) MCRC may be valuable for these patients. ![]() Importance Current third-line therapies for patients with metastatic colorectal cancer (MCRC) have limited efficacy. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.Otherwise, your changes will not be saved. Then open and use that version of the tool. *NOTE: Before filling out the templates, first save the PDF files to your computer. PDSA Worksheet: Plan-Do-Study-Act rapid-cycle testing helps teams assess whether a change leads to improvement using a methodical learning process.ĭownload the complete toolkit with all ten tools, or download individual tools as you need them to guide your continuous improvement work.Run Charts: These charts help you monitor performance over time.Failure Modes and Effects Analysis: Also used in Lean management and Six Sigma, FMEA is a systematic, proactive method for identifying potential risks and their impact.Cause and Effect Diagram: Also known as the Ishikawa or fishbone diagram, this tool helps you analyze the root causes contributing to an outcome.Each of the ten tools can be used with the Model for Improvement, Lean, or Six Sigma, and includes a short description, instructions, an example, and a blank template. IHI’s QI Essentials Toolkit includes the tools and templates you need to launch a successful quality improvement project and manage performance improvement. ![]()
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