FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer
Abstract Background BRAF V600E mutation plays a negative prognostic role in metastatic colorectal cancer (mCRC), leading to a median Progression Free Survival (PFS) of 4–6 months with first-line conventional treatments. Our group recently reported in a retrospective exploratory analysis of a phase I...
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| Veröffentlicht in: | European journal of cancer (1990) 2014-01, Vol.50 (1), p.57-63 |
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| creator | Loupakis, F Cremolini, C Salvatore, L Masi, G Sensi, E Schirripa, M Michelucci, A Pfanner, E Brunetti, I Lupi, C Antoniotti, C Bergamo, F Lonardi, S Zagonel, V Simi, P Fontanini, G Falcone, A |
| description | Abstract Background BRAF V600E mutation plays a negative prognostic role in metastatic colorectal cancer (mCRC), leading to a median Progression Free Survival (PFS) of 4–6 months with first-line conventional treatments. Our group recently reported in a retrospective exploratory analysis of a phase II trial that FOLFOXIRI (5-FU/LV+Oxaliplatin+Irinotecan) plus bevacizumab might allow to achieve remarkable results in terms of PFS and Overall Survival (OS) also in this poor-prognosis subgroup. The aim of this work was to prospectively validate our retrospective finding. Patients and methods This phase II trial was designed to detect an increase in 6 month-Progression Free Rate (6 m-PFR) from 45% to 80% in a population of BRAF mutant mCRC patients treated with first-line FOLFOXIRI plus bevacizumab. Secondary end-points were PFS, OS, response rate (RR) and the analysis of outcome parameters in the pooled population consisting of both retrospectively and prospectively included patients. This trial is registered with ClinicalTrials.gov, number NCT01437618. Results Two-hundred-fourteen potentially eligible mCRC patients were screened for BRAF mutational status. Fifteen BRAF mutant patients (7%) were included in the validation cohort. At a median follow up of 25.7 months, 6 m-PFR was 73%. Median PFS and OS were 9.2 and 24.1 months, respectively. In the pooled population, at a median follow up of 40.4 months, 6 m-PFR was 84%. Median PFS and OS were 11.8 and 24.1 months, respectively. Overall RR and disease control rate were 72% and 88%, respectively. Conclusion Lacking randomised trials in this specific molecular subgroup, FOLFOXIRI plus bevacizumab might be a reasonable option for the first-line treatment of BRAF mutant mCRC patients. |
| doi_str_mv | 10.1016/j.ejca.2013.08.024 |
| format | Article |
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Our group recently reported in a retrospective exploratory analysis of a phase II trial that FOLFOXIRI (5-FU/LV+Oxaliplatin+Irinotecan) plus bevacizumab might allow to achieve remarkable results in terms of PFS and Overall Survival (OS) also in this poor-prognosis subgroup. The aim of this work was to prospectively validate our retrospective finding. Patients and methods This phase II trial was designed to detect an increase in 6 month-Progression Free Rate (6 m-PFR) from 45% to 80% in a population of BRAF mutant mCRC patients treated with first-line FOLFOXIRI plus bevacizumab. Secondary end-points were PFS, OS, response rate (RR) and the analysis of outcome parameters in the pooled population consisting of both retrospectively and prospectively included patients. This trial is registered with ClinicalTrials.gov, number NCT01437618. Results Two-hundred-fourteen potentially eligible mCRC patients were screened for BRAF mutational status. Fifteen BRAF mutant patients (7%) were included in the validation cohort. At a median follow up of 25.7 months, 6 m-PFR was 73%. Median PFS and OS were 9.2 and 24.1 months, respectively. In the pooled population, at a median follow up of 40.4 months, 6 m-PFR was 84%. Median PFS and OS were 11.8 and 24.1 months, respectively. Overall RR and disease control rate were 72% and 88%, respectively. Conclusion Lacking randomised trials in this specific molecular subgroup, FOLFOXIRI plus bevacizumab might be a reasonable option for the first-line treatment of BRAF mutant mCRC patients.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2013.08.024</identifier><identifier>PMID: 24138831</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject><![CDATA[Adult ; Aged ; Angiogenesis Inhibitors - administration & dosage ; Angiogenesis Inhibitors - adverse effects ; Antibodies, Monoclonal, Humanized - administration & dosage ; Antibodies, Monoclonal, Humanized - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Bevacizumab ; Biological and medical sciences ; BRAF ; Camptothecin - administration & dosage ; Camptothecin - adverse effects ; Camptothecin - analogs & derivatives ; Chemotherapy ; Colorectal cancer ; Colorectal Neoplasms - drug therapy ; Colorectal Neoplasms - enzymology ; Colorectal Neoplasms - genetics ; Disease-Free Survival ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; FOLFOXIRI ; Hematology, Oncology and Palliative Medicine ; Humans ; Leucovorin - administration & dosage ; Leucovorin - adverse effects ; Male ; Medical sciences ; Middle Aged ; Multiple tumors. Solid tumors. Tumors in childhood (general aspects) ; Mutation ; Neoplasm Metastasis ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Pharmacology. Drug treatments ; Prognosis ; Prospective Studies ; Proto-Oncogene Proteins B-raf - antagonists & inhibitors ; Proto-Oncogene Proteins B-raf - genetics ; Retrospective Studies ; Survival Rate ; Treatment Outcome ; Tumors]]></subject><ispartof>European journal of cancer (1990), 2014-01, Vol.50 (1), p.57-63</ispartof><rights>Elsevier Ltd</rights><rights>2013 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2013 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c507t-7b2711b85a408651116e20b3d6cd3a9beb22fd0dc374074857e954cc439c0d2b3</citedby><cites>FETCH-LOGICAL-c507t-7b2711b85a408651116e20b3d6cd3a9beb22fd0dc374074857e954cc439c0d2b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2013.08.024$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,782,786,3554,27933,27934,46004</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28075298$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24138831$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Loupakis, F</creatorcontrib><creatorcontrib>Cremolini, C</creatorcontrib><creatorcontrib>Salvatore, L</creatorcontrib><creatorcontrib>Masi, G</creatorcontrib><creatorcontrib>Sensi, E</creatorcontrib><creatorcontrib>Schirripa, M</creatorcontrib><creatorcontrib>Michelucci, A</creatorcontrib><creatorcontrib>Pfanner, E</creatorcontrib><creatorcontrib>Brunetti, I</creatorcontrib><creatorcontrib>Lupi, C</creatorcontrib><creatorcontrib>Antoniotti, C</creatorcontrib><creatorcontrib>Bergamo, F</creatorcontrib><creatorcontrib>Lonardi, S</creatorcontrib><creatorcontrib>Zagonel, V</creatorcontrib><creatorcontrib>Simi, P</creatorcontrib><creatorcontrib>Fontanini, G</creatorcontrib><creatorcontrib>Falcone, A</creatorcontrib><title>FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Abstract Background BRAF V600E mutation plays a negative prognostic role in metastatic colorectal cancer (mCRC), leading to a median Progression Free Survival (PFS) of 4–6 months with first-line conventional treatments. Our group recently reported in a retrospective exploratory analysis of a phase II trial that FOLFOXIRI (5-FU/LV+Oxaliplatin+Irinotecan) plus bevacizumab might allow to achieve remarkable results in terms of PFS and Overall Survival (OS) also in this poor-prognosis subgroup. The aim of this work was to prospectively validate our retrospective finding. Patients and methods This phase II trial was designed to detect an increase in 6 month-Progression Free Rate (6 m-PFR) from 45% to 80% in a population of BRAF mutant mCRC patients treated with first-line FOLFOXIRI plus bevacizumab. Secondary end-points were PFS, OS, response rate (RR) and the analysis of outcome parameters in the pooled population consisting of both retrospectively and prospectively included patients. This trial is registered with ClinicalTrials.gov, number NCT01437618. Results Two-hundred-fourteen potentially eligible mCRC patients were screened for BRAF mutational status. Fifteen BRAF mutant patients (7%) were included in the validation cohort. At a median follow up of 25.7 months, 6 m-PFR was 73%. Median PFS and OS were 9.2 and 24.1 months, respectively. In the pooled population, at a median follow up of 40.4 months, 6 m-PFR was 84%. Median PFS and OS were 11.8 and 24.1 months, respectively. Overall RR and disease control rate were 72% and 88%, respectively. Conclusion Lacking randomised trials in this specific molecular subgroup, FOLFOXIRI plus bevacizumab might be a reasonable option for the first-line treatment of BRAF mutant mCRC patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Angiogenesis Inhibitors - administration & dosage</subject><subject>Angiogenesis Inhibitors - adverse effects</subject><subject>Antibodies, Monoclonal, Humanized - administration & dosage</subject><subject>Antibodies, Monoclonal, Humanized - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Bevacizumab</subject><subject>Biological and medical sciences</subject><subject>BRAF</subject><subject>Camptothecin - administration & dosage</subject><subject>Camptothecin - adverse effects</subject><subject>Camptothecin - analogs & derivatives</subject><subject>Chemotherapy</subject><subject>Colorectal cancer</subject><subject>Colorectal Neoplasms - drug therapy</subject><subject>Colorectal Neoplasms - enzymology</subject><subject>Colorectal Neoplasms - genetics</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>FOLFOXIRI</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Leucovorin - administration & dosage</subject><subject>Leucovorin - adverse effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</subject><subject>Mutation</subject><subject>Neoplasm Metastasis</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Pharmacology. Drug treatments</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Proto-Oncogene Proteins B-raf - antagonists & inhibitors</subject><subject>Proto-Oncogene Proteins B-raf - genetics</subject><subject>Retrospective Studies</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kl1rFDEUhoNY7Nr6B7yQ3AjezHjyMTsZEKEtri4sLLQKvTJkMmcg43ysSaZQf70ZdlXwolch8LwnOc85hLxmkDNg6_ddjp01OQcmclA5cPmMrJgqqwxUwZ-TFVRFlSmQ1Tl5GUIHAKWS8IKcc8mEUoKtyPfNfrfZ329vt_TQz4HW-GCs-zUPpqYm0Nb5ELPejUijRxMHHCN1I72-vdrQYY4mXQeMJkQTnaV26iePNpqeWjNa9JfkrDV9wFen84J823z6evMl2-0_b2-udpktoIxZWfOSsVoVRoJaF4yxNXKoRbO2jTBVjTXnbQONFaWEUqqixKqQ1kpRWWh4LS7Iu2Pdg59-zhiiHlyw2PdmxGkOmslq6Z0zllB-RK2fQvDY6oN3g_GPmoFevOpOL1714lWD0slrCr051Z_rAZu_kT8iE_D2BJhgTd_61L4L_zgFZcErlbgPRw6TjQeHXgfrMKlq3CJON5N7-h8f_4vbNByXXvyBjxi6afZj8qyZDlyDvls2YFkAJgDS6O_Fb1-jqfs</recordid><startdate>20140101</startdate><enddate>20140101</enddate><creator>Loupakis, F</creator><creator>Cremolini, C</creator><creator>Salvatore, L</creator><creator>Masi, G</creator><creator>Sensi, E</creator><creator>Schirripa, M</creator><creator>Michelucci, A</creator><creator>Pfanner, E</creator><creator>Brunetti, I</creator><creator>Lupi, C</creator><creator>Antoniotti, C</creator><creator>Bergamo, F</creator><creator>Lonardi, S</creator><creator>Zagonel, V</creator><creator>Simi, P</creator><creator>Fontanini, G</creator><creator>Falcone, A</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20140101</creationdate><title>FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer</title><author>Loupakis, F ; Cremolini, C ; Salvatore, L ; Masi, G ; Sensi, E ; Schirripa, M ; Michelucci, A ; Pfanner, E ; Brunetti, I ; Lupi, C ; Antoniotti, C ; Bergamo, F ; Lonardi, S ; Zagonel, V ; Simi, P ; Fontanini, G ; Falcone, A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c507t-7b2711b85a408651116e20b3d6cd3a9beb22fd0dc374074857e954cc439c0d2b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Angiogenesis Inhibitors - administration & dosage</topic><topic>Angiogenesis Inhibitors - adverse effects</topic><topic>Antibodies, Monoclonal, Humanized - administration & dosage</topic><topic>Antibodies, Monoclonal, Humanized - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Bevacizumab</topic><topic>Biological and medical sciences</topic><topic>BRAF</topic><topic>Camptothecin - administration & dosage</topic><topic>Camptothecin - adverse effects</topic><topic>Camptothecin - analogs & derivatives</topic><topic>Chemotherapy</topic><topic>Colorectal cancer</topic><topic>Colorectal Neoplasms - drug therapy</topic><topic>Colorectal Neoplasms - enzymology</topic><topic>Colorectal Neoplasms - genetics</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - adverse effects</topic><topic>FOLFOXIRI</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Leucovorin - administration & dosage</topic><topic>Leucovorin - adverse effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Multiple tumors. Solid tumors. Tumors in childhood (general aspects)</topic><topic>Mutation</topic><topic>Neoplasm Metastasis</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Pharmacology. Drug treatments</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Proto-Oncogene Proteins B-raf - antagonists & inhibitors</topic><topic>Proto-Oncogene Proteins B-raf - genetics</topic><topic>Retrospective Studies</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Loupakis, F</creatorcontrib><creatorcontrib>Cremolini, C</creatorcontrib><creatorcontrib>Salvatore, L</creatorcontrib><creatorcontrib>Masi, G</creatorcontrib><creatorcontrib>Sensi, E</creatorcontrib><creatorcontrib>Schirripa, M</creatorcontrib><creatorcontrib>Michelucci, A</creatorcontrib><creatorcontrib>Pfanner, E</creatorcontrib><creatorcontrib>Brunetti, I</creatorcontrib><creatorcontrib>Lupi, C</creatorcontrib><creatorcontrib>Antoniotti, C</creatorcontrib><creatorcontrib>Bergamo, F</creatorcontrib><creatorcontrib>Lonardi, S</creatorcontrib><creatorcontrib>Zagonel, V</creatorcontrib><creatorcontrib>Simi, P</creatorcontrib><creatorcontrib>Fontanini, G</creatorcontrib><creatorcontrib>Falcone, A</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Loupakis, F</au><au>Cremolini, C</au><au>Salvatore, L</au><au>Masi, G</au><au>Sensi, E</au><au>Schirripa, M</au><au>Michelucci, A</au><au>Pfanner, E</au><au>Brunetti, I</au><au>Lupi, C</au><au>Antoniotti, C</au><au>Bergamo, F</au><au>Lonardi, S</au><au>Zagonel, V</au><au>Simi, P</au><au>Fontanini, G</au><au>Falcone, A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2014-01-01</date><risdate>2014</risdate><volume>50</volume><issue>1</issue><spage>57</spage><epage>63</epage><pages>57-63</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>Abstract Background BRAF V600E mutation plays a negative prognostic role in metastatic colorectal cancer (mCRC), leading to a median Progression Free Survival (PFS) of 4–6 months with first-line conventional treatments. Our group recently reported in a retrospective exploratory analysis of a phase II trial that FOLFOXIRI (5-FU/LV+Oxaliplatin+Irinotecan) plus bevacizumab might allow to achieve remarkable results in terms of PFS and Overall Survival (OS) also in this poor-prognosis subgroup. The aim of this work was to prospectively validate our retrospective finding. Patients and methods This phase II trial was designed to detect an increase in 6 month-Progression Free Rate (6 m-PFR) from 45% to 80% in a population of BRAF mutant mCRC patients treated with first-line FOLFOXIRI plus bevacizumab. Secondary end-points were PFS, OS, response rate (RR) and the analysis of outcome parameters in the pooled population consisting of both retrospectively and prospectively included patients. This trial is registered with ClinicalTrials.gov, number NCT01437618. Results Two-hundred-fourteen potentially eligible mCRC patients were screened for BRAF mutational status. Fifteen BRAF mutant patients (7%) were included in the validation cohort. At a median follow up of 25.7 months, 6 m-PFR was 73%. Median PFS and OS were 9.2 and 24.1 months, respectively. In the pooled population, at a median follow up of 40.4 months, 6 m-PFR was 84%. Median PFS and OS were 11.8 and 24.1 months, respectively. Overall RR and disease control rate were 72% and 88%, respectively. Conclusion Lacking randomised trials in this specific molecular subgroup, FOLFOXIRI plus bevacizumab might be a reasonable option for the first-line treatment of BRAF mutant mCRC patients.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>24138831</pmid><doi>10.1016/j.ejca.2013.08.024</doi><tpages>7</tpages></addata></record> |
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| subjects | Adult Aged Angiogenesis Inhibitors - administration & dosage Angiogenesis Inhibitors - adverse effects Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bevacizumab Biological and medical sciences BRAF Camptothecin - administration & dosage Camptothecin - adverse effects Camptothecin - analogs & derivatives Chemotherapy Colorectal cancer Colorectal Neoplasms - drug therapy Colorectal Neoplasms - enzymology Colorectal Neoplasms - genetics Disease-Free Survival Female Fluorouracil - administration & dosage Fluorouracil - adverse effects FOLFOXIRI Hematology, Oncology and Palliative Medicine Humans Leucovorin - administration & dosage Leucovorin - adverse effects Male Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) Mutation Neoplasm Metastasis Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - adverse effects Pharmacology. Drug treatments Prognosis Prospective Studies Proto-Oncogene Proteins B-raf - antagonists & inhibitors Proto-Oncogene Proteins B-raf - genetics Retrospective Studies Survival Rate Treatment Outcome Tumors |
| title | FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer |
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