A randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme).
Background: Despite the improvements in diagnosis and treatment, colorectal cancer (CRC) is the second cause of cancer deaths in both sexes. Therefore, research in this field remains of great interest. The approval of bevacizumab, a humanized anti-vascular endothelial growth factor (VEGF) monoclonal...
| Publicado en: | BMC Cancer Vol. 15; no. 1; pp. 69 - 70 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research randomized controlled trial Journal Article |
| Publicado: |
BioMed Central
2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=112927183&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 112927183 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 14712407 1CH9 jtl: BMC Cancer issn: 14712407 maglogo: N pubinfo: dt: 2015 vid: 15 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 112927183 112927183 NLM26857924 112927183 10.1186/s12885-016-2102-y NLM26857924 PMC4746902 112927183 ppf: 69 ppct: 1 formats: tig: atl: A randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in the treatment of patients with metastatic colorectal cancer-OBELICS (Optimization of BEvacizumab scheduLIng within Chemotherapy Scheme). aug: au: Avallone, Antonio Piccirillo, Maria Carmela Aloj, Luigi Nasti, Guglielmo Delrio, Paolo Izzo, Francesco Di Gennaro, Elena Tatangelo, Fabiana Granata, Vincenza Cavalcanti, Ernesta Maiolino, Piera Bianco, Francesco Aprea, Pasquale De Bellis, Mario Pecori, Biagio Rosati, Gerardo Carlomagno, Chiara Bertolini, Alessandro Gallo, Ciro Romano, Carmela affil: Multidisciplinary Treatment Unit, Gastrointestinal Medical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale" - IRCCS, Napoli, Italy sug: subj: Colorectal Neoplasms Drug Therapy Antineoplastic Agents, Combined Administration and Dosage Leucovorin Administration and Dosage Vascular Endothelial Growth Factor A Immunology Middle Age Colorectal Neoplasms Pathology Antibodies, Monoclonal Administration and Dosage Antibodies, Monoclonal Adverse Effects Prognosis Human Antineoplastic Agents, Combined Adverse Effects Organoplatinum Compounds Administration and Dosage Female Adult Aged Male Fluorouracil Administration and Dosage Vascular Endothelial Growth Factor A Vascular Endothelial Growth Factor A Antagonists and Inhibitors Clinical Trials Validation Studies Comparative Studies Evaluation Research Multicenter Studies Randomized Controlled Trials Middle Aged: 45-64 years Adult: 19-44 years Aged: 65+ years Female Male ab: Background: Despite the improvements in diagnosis and treatment, colorectal cancer (CRC) is the second cause of cancer deaths in both sexes. Therefore, research in this field remains of great interest. The approval of bevacizumab, a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, in combination with a fluoropyrimidine-based chemotherapy in the treatment of metastatic CRC has changed the oncology practice in this disease. However, the efficacy of bevacizumab-based treatment, has thus far been rather modest. Efforts are ongoing to understand the better way to combine bevacizumab and chemotherapy, and to identify valid predictive biomarkers of benefit to avoid unnecessary and costly therapy to nonresponder patients. The BRANCH study in high-risk locally advanced rectal cancer patients showed that varying bevacizumab schedule may impact on the feasibility and efficacy of chemo-radiotherapy.Methods/design: OBELICS is a multicentre, open-label, randomised phase 3 trial comparing in mCRC patients two treatment arms (1:1): standard concomitant administration of bevacizumab with chemotherapy (mFOLFOX/OXXEL regimen) vs experimental sequential bevacizumab given 4 days before chemotherapy, as first or second treatment line. Primary end point is the objective response rate (ORR) measured according to RECIST criteria. A sample size of 230 patients was calculated allowing reliable assessment in all plausible first-second line case-mix conditions, with a 80% statistical power and 2-sided alpha error of 0.05. Secondary endpoints are progression free-survival (PFS), overall survival (OS), toxicity and quality of life. The evaluation of the potential predictive role of several circulating biomarkers (circulating endothelial cells and progenitors, VEGF and VEGF-R SNPs, cytokines, microRNAs, free circulating DNA) as well as the value of the early [(18)F]-Fluorodeoxyglucose positron emission tomography (FDG-PET) response, are the objectives of the traslational project.Discussion: Overall this study could optimize bevacizumab scheduling in combination with chemotherapy in mCRC patients. Moreover, correlative studies could improve the knowledge of the mechanisms by which bevacizumab enhance chemotherapy effect and could identify early predictors of response. EudraCT Number: 2011-004997-27 TRIAL REGISTRATION: ClinicalTrials.gove number, NCT01718873. pubtype: Academic Journal doctype: research randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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