Cited by 426Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsGenetic factors in colorectal cancer

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Rechallenge for Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer With Acquired Resistance to First-line Cetuximab and Irinotecan: A Phase 2 Single-Arm Clinical Trial

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Cremolini, Chiara, Rossini, Daniele, Dell’Aquila, Emanuela, Lonardi, Sara, Conca, Elena, Del Re, Marzia, Busico, Adele, Pietrantonio, Filippo, Danesi, Romano, Aprile, Giuseppe, Tamburini, Emiliano, Barone, Carlo, Masi, Gianluca, Pantano, Francesco, Pucci, Francesca, Corsi, Domenico C., Pella, Nicoletta, Bergamo, Francesca, Rofi, Eleonora, Barbara, Cecilia, Falcone, Alfredo, Santini, Daniele·2019·JAMA Oncology

DOI 10.1001/jamaoncol.2018.5080PMC PMC6439839

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Abstract

Importance: Based on a small retrospective study, rechallenge with cetuximab-based therapy for patients with KRAS wild-type metastatic colorectal cancer (mCRC) who were previously treated with the same anti-epidermal growth factor receptor-based regimen might be efficacious. Recent data suggest the role of liquid biopsy as a tool to track molecular events in circulating tumor DNA (ctDNA). Objective: To prospectively assess the activity of cetuximab plus irinotecan as third-line treatment for patients with RAS and BRAF wild-type mCRC who were initially sensitive to and then resistant to first-line irinotecan- and cetuximab-based therapy. Design, Setting, and Participants: Multicenter phase 2 single-arm trial conducted from January 7, 2015, to June 19, 2017. Liquid biopsies for analysis of ctDNA were collected at baseline. Main eligibility criteria included RAS and BRAF wild-type status on tissue samples; prior first-line irinotecan- and cetuximab-based regimen with at least partial response, progression-free survival of at least 6 months with first-line therapy, and progression within 4 weeks after last dose of cetuximab; and prior second-line oxaliplatin- and bevacizumab-based treatment. Interventions: Biweekly cetuximab, 500 mg/m2, plus irinotecan, 180 mg/m2. Main Outcomes and Measures: Overall response rate according to the Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included progression-free survival and overall survival and, as an exploratory analysis, RAS mutations in ctDNA. Results: Twenty-eight patients (9 women and 19 men; median age, 69 years [range, 45-79 years]) were enrolled. Six partial responses (4 confirmed) and 9 disease stabilizations were reported (response rate, 21%; 95% CI, 10%-40%; disease control rate, 54%; 95% CI, 36%-70%). Primary end point was met because lower limit of 95% CI of response rate was higher than 5%. RAS mutations were found in ctDNA collected at rechallenge baseline in 12 of 25 evaluable patients (48%). No RAS mutations were detected in samples from patients who achieved confirmed partial response. Patients with RAS wild-type ctDNA had significantly longer progression-free survival than those with RAS mutated ctDNA (median progression-free survival, 4.0 vs 1.9 months; hazard ratio, 0.44; 95% CI, 0.18-0.98; P = .03). Conclusions and Relevance: This is the first prospective demonstration that a rechallenge strategy with cetuximab and irinotecan may be active in patients with RAS and BRAF wild-type mCRC with acquired resistance to first-line irinotecan- and cetuximab-based therapy. The evaluation of RAS mutational status on ctDNA might be helpful in selecting candidate patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02296203.

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Authors: Cremolini, C., Rossini, D., Dell’Aquila, E., Lonardi, S., Conca, E., Del Re, M., Busico, A., Pietrantonio, F., Danesi, R., Aprile, G., Tamburini, E., Barone, C., Masi, G., Pantano, F., Pucci, F., Corsi, D. C., Pella, N., Bergamo, F., Rofi, E., Barbara, C., Falcone, A., & Santini, D.
Affiliations: University of Pisa (IT)
Università Campus Bio-Medico (IT)
Istituto Oncologico Veneto (IT)
Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
Clinical Pharmacology and Pharmacogenetics Unit, Department of Clinical and Experimental Medicine, Pisa, Italy
University of Udine (IT)
Ospedale Infermi di Rimini (IT)
Università Cattolica del Sacro Cuore (IT)
Ospedale di Parma (IT)
Fatebenefratelli Hospital (IT)
Medical Oncology Unit, Presidio Ospedaliero Felice Lotti, Pontedera, Italy
Corresponding author: Falcone, Alfredo
ORCID: Cremolini, Chiara
Rossini, Daniele
Dell’Aquila, Emanuela
Lonardi, Sara
Conca, Elena
Busico, Adele
Pietrantonio, Filippo
Danesi, Romano
Aprile, Giuseppe
Tamburini, Emiliano
Barone, Carlo
Masi, Gianluca
Pantano, Francesco
Corsi, Domenico C.
Bergamo, Francesca
Falcone, Alfredo
Santini, Daniele
Venue: JAMA Oncology
Publisher: American Medical Association (AMA)
Published: 2019-03-01
Volume: 5
Issue: 3
Pages: 343
ISSN: 2374-2437 (ISSN-L)
DOI: 10.1001/jamaoncol.2018.5080
PMC: PMC6439839
OpenAlex: W2901178367
Cited by: 424
References: 38
Citations by year: 2026: 36 · 2025: 48 · 2024: 75 · 2023: 66 · 2022: 72 · 2021: 61 · 2020: 47 · 2019: 18
FWCI: 11.91
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA Oncology (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Funders: Amgen
Eli Lilly and Company
Sanofi
Celgene
F. Hoffmann-La Roche
Merck KGaA
Eisai
Università Cattolica del Sacro Cuore
Servier
Ipsen
Topics: Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
Health Sciences › Medicine › Pathology and Forensic Medicine › Genetic factors in colorectal cancer
Keywords: metastatic colorectal cancer, cetuximab, irinotecan, drug rechallenge, RAS wild-type, BRAF wild-type, acquired resistance, anti-EGFR therapy, circulating tumor DNA, liquid biopsy, third-line therapy, oxaliplatin, bevacizumab, RAS mutations, progression-free survival, overall survival, response rate, disease control rate, predictive biomarkers
MeSH terms: Cetuximab, Irinotecan, Progression-Free Survival, Aged, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Italy, Male, Middle Aged, Prospective Studies, Genes, ras, Risk Factors, Time Factors, Biomarkers, Tumor, Colorectal Neoplasms, Disease Progression, Drug Resistance, Neoplasm, Proto-Oncogene Proteins B-raf

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Rechallenge for Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer With Acquired Resistance to First-line Cetuximab and Irinotecan: A Phase 2 Single-Arm Clinical Trial

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