دورية أكاديمية
Panitumumab Plus Trifluridine-Tipiracil as Anti-Epidermal Growth Factor Receptor Rechallenge Therapy for Refractory RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial
| العنوان: | Panitumumab Plus Trifluridine-Tipiracil as Anti-Epidermal Growth Factor Receptor Rechallenge Therapy for Refractory RAS Wild-Type Metastatic Colorectal Cancer: A Phase 2 Randomized Clinical Trial |
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| المؤلفون: | Napolitano, Stefania, De Falco, Vincenzo, Martini, Giulia, Ciardiello, Davide, Martinelli, Erika, Della Corte, Carminia Maria, Esposito, Lucia, Famiglietti, Vincenzo, Di Liello, Alessandra, Avallone, Antonio, Cardone, Claudia, De Stefano, Alfonso, Montesarchio, Vincenzo, Zampino, Maria Giulia, Bordonaro, Roberto, Scartozzi, Mario, Santini, Daniele, Di Maio, Massimo, De Vita, Ferdinando, Altucci, Lucia, Marrone, Francesca, Ciardiello, Fortunato, Troiani, Teresa |
| المساهمون: | Napolitano, Stefania, De Falco, Vincenzo, Martini, Giulia, Ciardiello, Davide, Martinelli, Erika, Della Corte, Carminia Maria, Esposito, Lucia, Famiglietti, Vincenzo, Di Liello, Alessandra, Avallone, Antonio, Cardone, Claudia, De Stefano, Alfonso, Montesarchio, Vincenzo, Zampino, Maria Giulia, Bordonaro, Roberto, Scartozzi, Mario, Santini, Daniele, Di Maio, Massimo, De Vita, Ferdinando, Altucci, Lucia, Marrone, Francesca, Ciardiello, Fortunato, Troiani, Teresa |
| سنة النشر: | 2023 |
| المجموعة: | Università degli Studi di Cagliari: UNICA IRIS |
| مصطلحات موضوعية: | Aged, Antibodies, Monoclonal, Antineoplastic Agent, Antineoplastic Combined Chemotherapy Protocol, Colonic Neoplasm, Colorectal Neoplasm, Female, Human, Male, Panitumumab, Proto-Oncogene Proteins B-raf, Rectal Neoplasm, Trifluridine |
| الوصف: | Importance: Current third-line therapies for patients with metastatic colorectal cancer (MCRC) have limited efficacy. Rechallenge with epidermal growth factor receptor (EGFR) inhibitors for RAS wild-type (WT) MCRC may be valuable for these patients. 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. Design, setting, and participants: This phase 2 randomized clinical trial (RCT) was conducted in 7 Italian centers from June 2019 to April 2022. 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. Interventions: Patients were randomized 1:1 to receive panitumumab plus trifluridine-tipiracil or trifluridine-tipiracil alone. Main outcomes and measures: The primary end point was progression-free survival (PFS). Circulating tumor DNA (ctDNA) extended sequence variation analysis was performed in a subgroup of patients. Results: Of 62 included patients, 31 received panitumumab plus trifluridine-tipiracil (19 [61.3%] male; median age, 65 years [range, 39-81 years]) and 31 received trifluridine-tipiracil alone (17 [54.8%] male; median age, 66 years [range, 32-82 years]). The primary end point was met. 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 [HR], 0.48; 95% CI, 0.28-0.82; P = .007). 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%. A ctDNA liquid-biopsy extended mutation analysis by FoundationOne Liquid CDx (profiling 324 genes) was performed in a subgroup of ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/37200022; info:eu-repo/semantics/altIdentifier/wos/WOS:000992548600002; volume:9; issue:7; firstpage:966; lastpage:970; numberofpages:5; journal:JAMA ONCOLOGY; https://hdl.handle.net/11584/360998Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85164196905 |
| DOI: | 10.1001/jamaoncol.2023.0655 |
| الإتاحة: | https://doi.org/10.1001/jamaoncol.2023.0655Test https://hdl.handle.net/11584/360998Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.15D7705C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1001/jamaoncol.2023.0655 |
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