SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer
| Autor: | Alex Powell, David N. Cade, Kenneth G. Thurston, Thomas Tichler, Navesh K. Sharma, Richard Isaacs, David Perez, Einat Shacham-Shmueli, Guy van Hazel, Paul Eliadis, Bridget A. Robinson, Michael Findlay, A. H. Strickland, Fred M. Moeslein, Tom Ferguson, Geoff Bower, H. Kröning, Javier Rodríguez, Vinod Ganju, Jens Ricke, Ido Wolf, Julien Taieb, Marc Peeters, David H. Price, Eveline Boucher, Euan Walpole, Mark Van Buskirk, Volker Heinemann, Val Gebski, Peter Gibbs |
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| Přispěvatelé: | Department of Medical Oncology, Royal Melbourne Hospital, Foie, métabolismes et cancer, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Département d'oncologie médicale [Rennes], CRLCC Eugène Marquis (CRLCC), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ) |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Bevacizumab Organoplatinum Compounds Colorectal cancer [SDV]Life Sciences [q-bio] Brachytherapy Leucovorin 030218 nuclear medicine & medical imaging law.invention 03 medical and health sciences 0302 clinical medicine FOLFOX Randomized controlled trial law Internal medicine Multicenter trial Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Aged Aged 80 and over business.industry Selective internal radiation therapy Middle Aged medicine.disease Combined Modality Therapy 3. Good health Oxaliplatin Fluorouracil 030220 oncology & carcinogenesis Female Human medicine business Colorectal Neoplasms medicine.drug |
| Zdroj: | Journal of Clinical Oncology Journal of Clinical Oncology, American Society of Clinical Oncology, 2016, 34 (15), pp.1723-31. ⟨10.1200/JCO.2015.66.1181⟩ Journal of Clinical Oncology, 2016, 34 (15), pp.1723-31. ⟨10.1200/JCO.2015.66.1181⟩ Journal of clinical oncology |
| ISSN: | 0732-183X 1527-7755 |
| DOI: | 10.1200/JCO.2015.66.1181⟩ |
| Popis: | Purpose SIRFLOX was a randomized, multicenter trial designed to assess the efficacy and safety of adding selective internal radiation therapy (SIRT) using yttrium-90 resin microspheres to standard fluorouracil, leucovorin, and oxaliplatin (FOLFOX)–based chemotherapy in patients with previously untreated metastatic colorectal cancer. Patients and Methods Chemotherapy-naïve patients with liver metastases plus or minus limited extrahepatic metastases were randomly assigned to receive either modified FOLFOX (mFOLFOX6; control) or mFOLFOX6 plus SIRT (SIRT) plus or minus bevacizumab. The primary end point was progression-free survival (PFS) at any site as assessed by independent centralized radiology review blinded to study arm. Results Between October 2006 and April 2013, 530 patients were randomly assigned to treatment (control, 263; SIRT, 267). Median PFS at any site was 10.2 v 10.7 months in control versus SIRT (hazard ratio, 0.93; 95% CI, 0.77 to 1.12; P = .43). Median PFS in the liver by competing risk analysis was 12.6 v 20.5 months in control versus SIRT (hazard ratio, 0.69; 95% CI, 0.55 to 0.90; P = .002). Objective response rates (ORRs) at any site were similar (68.1% v 76.4% in control v SIRT; P = .113). ORR in the liver was improved with the addition of SIRT (68.8% v 78.7% in control v SIRT; P = .042). Grade ≥ 3 adverse events, including recognized SIRT-related effects, were reported in 73.4% and 85.4% of patients in control versus SIRT. Conclusion The addition of SIRT to FOLFOX-based first-line chemotherapy in patients with liver-dominant or liver-only metastatic colorectal cancer did not improve PFS at any site but significantly delayed disease progression in the liver. The safety profile was as expected and was consistent with previous studies. |
| Databáze: | OpenAIRE |
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