Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG)
Introduction The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bev...
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| Veröffentlicht in: | Cancer chemotherapy and pharmacology 2016-08, Vol.78 (2), p.369-376 |
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| creator | Matikas, A. Kentepozidis, Ν. Ardavanis, A. Vaslamatzis, M. Polyzos, A. Emmanouilides, Ch Katsaounis, P. Koinis, F. Xynogalos, S. Christopoulou, A. Ziras, N. Tegos, Th Prinarakis, E. Hatzidaki, D. Georgoulias, V. Kotsakis, A. |
| description | Introduction
The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bevacizumab-based chemotherapy regimens in real life.
Methods
Patients with previously untreated recurrent or metastatic non-squamous, NSCLC, with no contraindications for bevacizumab, were enrolled. Bevacizumab (15 mg/kg every 3 weeks) was administered in combination with both platinum- and non-platinum-based chemotherapy doublets or with single-agent chemotherapy plus bevacizumab. Treatment with bevacizumab was continued until disease progression. The primary end point of the study was the safety profile of bevacizumab regimens, whereas the secondary end points included overall survival, progression-free survival, and overall response rate.
Results
From February 2010 to April 2014, a total of 314 patients were enrolled in the study; the median age was 63, 74.8 % were men, 95.9 % had a performance status of 0–1, 90.4 % had metastatic disease, and 94.3 % had adenocarcinoma. Grade ≥3 neutropenia occurred in 11.5 % of the patients, 1.3 % experienced febrile neutropenia, 2.6 % grade ≥3 thrombocytopenia, 2.8 % thromboembolism, and 1.6 % severe bleeding. Treatment discontinuation occurred in 7.0 % of patients because of adverse events. There were three toxic deaths. Median progression-free survival was 7.7 months, and median overall survival was 17.6 months.
Conclusion
The combination of bevacizumab with chemotherapy in the first-line setting of NSCLC is safe and active when used in appropriately selected patients.
Clinicaltrials.gov identifier
NCT01934465. |
| doi_str_mv | 10.1007/s00280-016-3094-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1846419750</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1846419750</sourcerecordid><originalsourceid>FETCH-LOGICAL-c405t-5820e37408eb03a15ab1ec4b2566aa69adc1119a4ea50ba5dc1f6ddfc7d8b8243</originalsourceid><addsrcrecordid>eNp1kV-L1DAUxYso7rj6AXyRC76sYPWmSf_tmyzrzMLCwKK-ltv0dqZLm9SkXajfzm9myqwigi8Jl_s75yScKHot8INAzD96xKTAGEUWSyxVnD-JNkLJJMZCyafRBqVScZqjOoteeH-PiEpI-Tw6S3IpU0zyTfTzum07TXoBMg1MtmdHRjPYFlpnzdR3hqHmB9Ldj3mgOq7JcwP6yIOdjgEeF2itA2oeVl0DxprYD9T3oDkc_WwOoNeVg5Gmjs3kL4FgmPup02Fi9x7GYzCFm2_gp7lZ1uxgDbugZ9Np2Btte3tY4I49k9NH2Do7j3Cx299t372MnrXUe371eJ9HXz9ff7naxbf77c3Vp9tYK0ynOC0SZJkrLLhGSSKlWrBWdZJmGVFWUqOFECUpphRrSsPYZk3T6rwp6iJR8jy6OPmOzn6f2U_V0Pn1j2TYzr4ShcqUKPMUA_r2H_Tezs6E1wUqpGBSqpUSJ0o7673jthpdN5BbKoHV2m916rcK_VZrv1UeNG8ened64OaP4nehAUhOgA8rc2D3V_R_XX8BODmy0w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1811102940</pqid></control><display><type>article</type><title>Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG)</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Matikas, A. ; Kentepozidis, Ν. ; Ardavanis, A. ; Vaslamatzis, M. ; Polyzos, A. ; Emmanouilides, Ch ; Katsaounis, P. ; Koinis, F. ; Xynogalos, S. ; Christopoulou, A. ; Ziras, N. ; Tegos, Th ; Prinarakis, E. ; Hatzidaki, D. ; Georgoulias, V. ; Kotsakis, A.</creator><creatorcontrib>Matikas, A. ; Kentepozidis, Ν. ; Ardavanis, A. ; Vaslamatzis, M. ; Polyzos, A. ; Emmanouilides, Ch ; Katsaounis, P. ; Koinis, F. ; Xynogalos, S. ; Christopoulou, A. ; Ziras, N. ; Tegos, Th ; Prinarakis, E. ; Hatzidaki, D. ; Georgoulias, V. ; Kotsakis, A. ; HORG’s Lung Cancer Working Group ; on behalf of the HORG’s Lung Cancer Working Group</creatorcontrib><description>Introduction
The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bevacizumab-based chemotherapy regimens in real life.
Methods
Patients with previously untreated recurrent or metastatic non-squamous, NSCLC, with no contraindications for bevacizumab, were enrolled. Bevacizumab (15 mg/kg every 3 weeks) was administered in combination with both platinum- and non-platinum-based chemotherapy doublets or with single-agent chemotherapy plus bevacizumab. Treatment with bevacizumab was continued until disease progression. The primary end point of the study was the safety profile of bevacizumab regimens, whereas the secondary end points included overall survival, progression-free survival, and overall response rate.
Results
From February 2010 to April 2014, a total of 314 patients were enrolled in the study; the median age was 63, 74.8 % were men, 95.9 % had a performance status of 0–1, 90.4 % had metastatic disease, and 94.3 % had adenocarcinoma. Grade ≥3 neutropenia occurred in 11.5 % of the patients, 1.3 % experienced febrile neutropenia, 2.6 % grade ≥3 thrombocytopenia, 2.8 % thromboembolism, and 1.6 % severe bleeding. Treatment discontinuation occurred in 7.0 % of patients because of adverse events. There were three toxic deaths. Median progression-free survival was 7.7 months, and median overall survival was 17.6 months.
Conclusion
The combination of bevacizumab with chemotherapy in the first-line setting of NSCLC is safe and active when used in appropriately selected patients.
Clinicaltrials.gov identifier
NCT01934465.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-016-3094-7</identifier><identifier>PMID: 27335027</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Bevacizumab - administration & dosage ; Bevacizumab - adverse effects ; Cancer Research ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - pathology ; Disease-Free Survival ; Female ; Humans ; Lung Neoplasms - drug therapy ; Lung Neoplasms - pathology ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Neoplasm Metastasis ; Neoplasm Recurrence, Local ; Oncology ; Original Article ; Patient Selection ; Pharmacology/Toxicology ; Survival Rate ; Treatment Outcome</subject><ispartof>Cancer chemotherapy and pharmacology, 2016-08, Vol.78 (2), p.369-376</ispartof><rights>Springer-Verlag Berlin Heidelberg 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c405t-5820e37408eb03a15ab1ec4b2566aa69adc1119a4ea50ba5dc1f6ddfc7d8b8243</citedby><cites>FETCH-LOGICAL-c405t-5820e37408eb03a15ab1ec4b2566aa69adc1119a4ea50ba5dc1f6ddfc7d8b8243</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00280-016-3094-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00280-016-3094-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27335027$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Matikas, A.</creatorcontrib><creatorcontrib>Kentepozidis, Ν.</creatorcontrib><creatorcontrib>Ardavanis, A.</creatorcontrib><creatorcontrib>Vaslamatzis, M.</creatorcontrib><creatorcontrib>Polyzos, A.</creatorcontrib><creatorcontrib>Emmanouilides, Ch</creatorcontrib><creatorcontrib>Katsaounis, P.</creatorcontrib><creatorcontrib>Koinis, F.</creatorcontrib><creatorcontrib>Xynogalos, S.</creatorcontrib><creatorcontrib>Christopoulou, A.</creatorcontrib><creatorcontrib>Ziras, N.</creatorcontrib><creatorcontrib>Tegos, Th</creatorcontrib><creatorcontrib>Prinarakis, E.</creatorcontrib><creatorcontrib>Hatzidaki, D.</creatorcontrib><creatorcontrib>Georgoulias, V.</creatorcontrib><creatorcontrib>Kotsakis, A.</creatorcontrib><creatorcontrib>HORG’s Lung Cancer Working Group</creatorcontrib><creatorcontrib>on behalf of the HORG’s Lung Cancer Working Group</creatorcontrib><title>Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG)</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Introduction
The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bevacizumab-based chemotherapy regimens in real life.
Methods
Patients with previously untreated recurrent or metastatic non-squamous, NSCLC, with no contraindications for bevacizumab, were enrolled. Bevacizumab (15 mg/kg every 3 weeks) was administered in combination with both platinum- and non-platinum-based chemotherapy doublets or with single-agent chemotherapy plus bevacizumab. Treatment with bevacizumab was continued until disease progression. The primary end point of the study was the safety profile of bevacizumab regimens, whereas the secondary end points included overall survival, progression-free survival, and overall response rate.
Results
From February 2010 to April 2014, a total of 314 patients were enrolled in the study; the median age was 63, 74.8 % were men, 95.9 % had a performance status of 0–1, 90.4 % had metastatic disease, and 94.3 % had adenocarcinoma. Grade ≥3 neutropenia occurred in 11.5 % of the patients, 1.3 % experienced febrile neutropenia, 2.6 % grade ≥3 thrombocytopenia, 2.8 % thromboembolism, and 1.6 % severe bleeding. Treatment discontinuation occurred in 7.0 % of patients because of adverse events. There were three toxic deaths. Median progression-free survival was 7.7 months, and median overall survival was 17.6 months.
Conclusion
The combination of bevacizumab with chemotherapy in the first-line setting of NSCLC is safe and active when used in appropriately selected patients.
Clinicaltrials.gov identifier
NCT01934465.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Bevacizumab - administration & dosage</subject><subject>Bevacizumab - adverse effects</subject><subject>Cancer Research</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Neoplasm Recurrence, Local</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Patient Selection</subject><subject>Pharmacology/Toxicology</subject><subject>Survival Rate</subject><subject>Treatment 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(HORG)</title><author>Matikas, A. ; Kentepozidis, Ν. ; Ardavanis, A. ; Vaslamatzis, M. ; Polyzos, A. ; Emmanouilides, Ch ; Katsaounis, P. ; Koinis, F. ; Xynogalos, S. ; Christopoulou, A. ; Ziras, N. ; Tegos, Th ; Prinarakis, E. ; Hatzidaki, D. ; Georgoulias, V. ; Kotsakis, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c405t-5820e37408eb03a15ab1ec4b2566aa69adc1119a4ea50ba5dc1f6ddfc7d8b8243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Bevacizumab - administration & dosage</topic><topic>Bevacizumab - adverse effects</topic><topic>Cancer Research</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Neoplasm Recurrence, Local</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Patient Selection</topic><topic>Pharmacology/Toxicology</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Matikas, A.</creatorcontrib><creatorcontrib>Kentepozidis, Ν.</creatorcontrib><creatorcontrib>Ardavanis, A.</creatorcontrib><creatorcontrib>Vaslamatzis, M.</creatorcontrib><creatorcontrib>Polyzos, A.</creatorcontrib><creatorcontrib>Emmanouilides, Ch</creatorcontrib><creatorcontrib>Katsaounis, P.</creatorcontrib><creatorcontrib>Koinis, F.</creatorcontrib><creatorcontrib>Xynogalos, S.</creatorcontrib><creatorcontrib>Christopoulou, A.</creatorcontrib><creatorcontrib>Ziras, N.</creatorcontrib><creatorcontrib>Tegos, Th</creatorcontrib><creatorcontrib>Prinarakis, E.</creatorcontrib><creatorcontrib>Hatzidaki, D.</creatorcontrib><creatorcontrib>Georgoulias, V.</creatorcontrib><creatorcontrib>Kotsakis, A.</creatorcontrib><creatorcontrib>HORG’s Lung Cancer Working Group</creatorcontrib><creatorcontrib>on behalf of the HORG’s Lung Cancer Working Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 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(New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Matikas, A.</au><au>Kentepozidis, Ν.</au><au>Ardavanis, A.</au><au>Vaslamatzis, M.</au><au>Polyzos, A.</au><au>Emmanouilides, Ch</au><au>Katsaounis, P.</au><au>Koinis, F.</au><au>Xynogalos, S.</au><au>Christopoulou, A.</au><au>Ziras, N.</au><au>Tegos, Th</au><au>Prinarakis, E.</au><au>Hatzidaki, D.</au><au>Georgoulias, V.</au><au>Kotsakis, A.</au><aucorp>HORG’s Lung Cancer Working Group</aucorp><aucorp>on behalf of the HORG’s Lung Cancer Working Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG)</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2016-08-01</date><risdate>2016</risdate><volume>78</volume><issue>2</issue><spage>369</spage><epage>376</epage><pages>369-376</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><abstract>Introduction
The addition of bevacizumab to the first-line chemotherapy of advanced non-small cell lung cancer (NSCLC) of non-squamous histology has been shown to improve survival. A multicenter, single-arm, phase IV study was conducted in order to evaluate the efficacy and toxicity of frontline bevacizumab-based chemotherapy regimens in real life.
Methods
Patients with previously untreated recurrent or metastatic non-squamous, NSCLC, with no contraindications for bevacizumab, were enrolled. Bevacizumab (15 mg/kg every 3 weeks) was administered in combination with both platinum- and non-platinum-based chemotherapy doublets or with single-agent chemotherapy plus bevacizumab. Treatment with bevacizumab was continued until disease progression. The primary end point of the study was the safety profile of bevacizumab regimens, whereas the secondary end points included overall survival, progression-free survival, and overall response rate.
Results
From February 2010 to April 2014, a total of 314 patients were enrolled in the study; the median age was 63, 74.8 % were men, 95.9 % had a performance status of 0–1, 90.4 % had metastatic disease, and 94.3 % had adenocarcinoma. Grade ≥3 neutropenia occurred in 11.5 % of the patients, 1.3 % experienced febrile neutropenia, 2.6 % grade ≥3 thrombocytopenia, 2.8 % thromboembolism, and 1.6 % severe bleeding. Treatment discontinuation occurred in 7.0 % of patients because of adverse events. There were three toxic deaths. Median progression-free survival was 7.7 months, and median overall survival was 17.6 months.
Conclusion
The combination of bevacizumab with chemotherapy in the first-line setting of NSCLC is safe and active when used in appropriately selected patients.
Clinicaltrials.gov identifier
NCT01934465.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>27335027</pmid><doi>10.1007/s00280-016-3094-7</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0344-5704 |
| ispartof | Cancer chemotherapy and pharmacology, 2016-08, Vol.78 (2), p.369-376 |
| issn | 0344-5704 1432-0843 |
| language | eng |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Bevacizumab - administration & dosage Bevacizumab - adverse effects Cancer Research Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Disease-Free Survival Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - pathology Male Medicine Medicine & Public Health Middle Aged Neoplasm Metastasis Neoplasm Recurrence, Local Oncology Original Article Patient Selection Pharmacology/Toxicology Survival Rate Treatment Outcome |
| title | Efficacy and tolerance of frontline bevacizumab-based chemotherapy for advanced non-small cell lung cancer patients: a multicenter, phase IV study of the Hellenic Oncology Research Group (HORG) |
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