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Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()()
Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the effic...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Neoplasia Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237801/ https://www.ncbi.nlm.nih.gov/pubmed/28088688 http://dx.doi.org/10.1016/j.neo.2016.08.010 |
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author | Snoeren, Nikol van Hillegersberg, Richard Schouten, Sander B. Bergman, Andre M. van Werkhoven, Erikv Dalesio, Otilia Tollenaar, Rob A.E.M. Verheul, Henk M. van der Sijp, Joost Borel Rinkes, Inne H.M. Voest, E.E. |
author_facet | Snoeren, Nikol van Hillegersberg, Richard Schouten, Sander B. Bergman, Andre M. van Werkhoven, Erikv Dalesio, Otilia Tollenaar, Rob A.E.M. Verheul, Henk M. van der Sijp, Joost Borel Rinkes, Inne H.M. Voest, E.E. |
author_sort | Snoeren, Nikol |
collection | PubMed |
description | Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the efficacy and safety of adding bevacizumab to an adjuvant regimen of CAPOX in patients undergoing radical resection for their CRLMs. Patients with resected CRLMs were randomized after surgery to receive CAPOX and bevacizumab (arm A) or CAPOX alone (arm B) as adjuvant treatment. CAPOX was given in both arms for a total of eight cycles. Bevacizumab was administered for 16 cycles. The primary end point was disease-free survival (DFS). Secondary outcomes were overall survival (OS), toxicity, and quality of life (QoL). In total, 79 patients were randomized. At the time of analysis, 23 events were encountered in arm A and 20 in arm B. One-year DFS rate was 79% [95% confidence interval (CI): 68%-93%] and 68% (95% CI: 55%-85%) for arm A and B, respectively (P = .89). Toxicity was evaluated for 75 patients. No significant differences in toxicity between the two arms were found. QoL scores were higher in arm A, of which emotional functioning and global QoL scores were significant. Adding bevacizumab to a CAPOX regimen in patients undergoing a resection for their CLM is safe and showed higher QoL scores compared with CAPOX alone. Because of premature closure of the study, conclusions about the effect on DFS of additional VEGF inhibition in this setting could not yet be made. |
format | Online Article Text |
id | pubmed-5237801 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Neoplasia Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-52378012017-01-23 Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() Snoeren, Nikol van Hillegersberg, Richard Schouten, Sander B. Bergman, Andre M. van Werkhoven, Erikv Dalesio, Otilia Tollenaar, Rob A.E.M. Verheul, Henk M. van der Sijp, Joost Borel Rinkes, Inne H.M. Voest, E.E. Neoplasia Original article Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF). Recurrence after resection of colorectal liver metastases (CRLMs), presumably caused by VEGF-mediated outgrowth of micrometastases, might decrease when VEGF is inhibited. This study examines the efficacy and safety of adding bevacizumab to an adjuvant regimen of CAPOX in patients undergoing radical resection for their CRLMs. Patients with resected CRLMs were randomized after surgery to receive CAPOX and bevacizumab (arm A) or CAPOX alone (arm B) as adjuvant treatment. CAPOX was given in both arms for a total of eight cycles. Bevacizumab was administered for 16 cycles. The primary end point was disease-free survival (DFS). Secondary outcomes were overall survival (OS), toxicity, and quality of life (QoL). In total, 79 patients were randomized. At the time of analysis, 23 events were encountered in arm A and 20 in arm B. One-year DFS rate was 79% [95% confidence interval (CI): 68%-93%] and 68% (95% CI: 55%-85%) for arm A and B, respectively (P = .89). Toxicity was evaluated for 75 patients. No significant differences in toxicity between the two arms were found. QoL scores were higher in arm A, of which emotional functioning and global QoL scores were significant. Adding bevacizumab to a CAPOX regimen in patients undergoing a resection for their CLM is safe and showed higher QoL scores compared with CAPOX alone. Because of premature closure of the study, conclusions about the effect on DFS of additional VEGF inhibition in this setting could not yet be made. Neoplasia Press 2017-01-12 /pmc/articles/PMC5237801/ /pubmed/28088688 http://dx.doi.org/10.1016/j.neo.2016.08.010 Text en © 2016 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Original article Snoeren, Nikol van Hillegersberg, Richard Schouten, Sander B. Bergman, Andre M. van Werkhoven, Erikv Dalesio, Otilia Tollenaar, Rob A.E.M. Verheul, Henk M. van der Sijp, Joost Borel Rinkes, Inne H.M. Voest, E.E. Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title | Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title_full | Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title_fullStr | Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title_full_unstemmed | Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title_short | Randomized Phase III Study to Assess Efficacy and Safety of Adjuvant CAPOX with or without Bevacizumab in Patients after Resection of Colorectal Liver Metastases: HEPATICA study()() |
title_sort | randomized phase iii study to assess efficacy and safety of adjuvant capox with or without bevacizumab in patients after resection of colorectal liver metastases: hepatica study()() |
topic | Original article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5237801/ https://www.ncbi.nlm.nih.gov/pubmed/28088688 http://dx.doi.org/10.1016/j.neo.2016.08.010 |
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