Cargando…
Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results
INTRODUCTION: The phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). OBJECTIVE: Our objective is to provide updated...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808045/ https://www.ncbi.nlm.nih.gov/pubmed/29043496 http://dx.doi.org/10.1007/s40264-017-0596-0 |
_version_ | 1783299388086419456 |
---|---|
author | Kato, Terufumi Seto, Takashi Nishio, Makoto Goto, Koichi Yamamoto, Noboru Okamoto, Isamu Tao, Liang Yu, Wei Khaznadar, Tarik Tajima, Kosei Shibata, Masahiko Seki, Akihiro Yamamoto, Nobuyuki |
author_facet | Kato, Terufumi Seto, Takashi Nishio, Makoto Goto, Koichi Yamamoto, Noboru Okamoto, Isamu Tao, Liang Yu, Wei Khaznadar, Tarik Tajima, Kosei Shibata, Masahiko Seki, Akihiro Yamamoto, Nobuyuki |
author_sort | Kato, Terufumi |
collection | PubMed |
description | INTRODUCTION: The phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). OBJECTIVE: Our objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events. METHODS: Patients with stage IIIB/IV or recurrent, non-squamous, EGFR mutation-positive NSCLC were randomized to receive erlotinib plus bevacizumab or erlotinib. The primary endpoint was progression-free survival. Adverse event frequency rates, predictability and manageability, reasons for discontinuation, time to onset, and outcomes of specific adverse events were analyzed. RESULTS: The safety analysis population comprised 152 randomized patients (75 erlotinib plus bevacizumab; 77 erlotinib) who received at least one dose of study drug between February 2011 and March 2012. There was no difference in overall incidence of serious adverse events between arms, but more grade 3 or higher adverse events were reported with erlotinib plus bevacizumab (90.7%) than with erlotinib (53.2%), primarily due to grade 3 hypertension. Hypertension was controllable with antihypertensive medications in most cases. Proteinuria and bleeding were also more frequently reported with erlotinib plus bevacizumab than with erlotinib but were manageable and did not lead to early discontinuations. CONCLUSIONS: The addition of bevacizumab to erlotinib prolonged progression-free survival in EGFR mutation-positive NSCLC. Follow-up safety data were consistent with the known safety profiles of both erlotinib and bevacizumab in NSCLC; this combination appeared to be manageable, and treatment was well tolerated. JapicCTI-111390. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40264-017-0596-0) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5808045 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-58080452018-02-22 Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results Kato, Terufumi Seto, Takashi Nishio, Makoto Goto, Koichi Yamamoto, Noboru Okamoto, Isamu Tao, Liang Yu, Wei Khaznadar, Tarik Tajima, Kosei Shibata, Masahiko Seki, Akihiro Yamamoto, Nobuyuki Drug Saf Original Research Article INTRODUCTION: The phase II JO25567 study compared the efficacy and safety of erlotinib plus bevacizumab vs. erlotinib alone as first-line therapy for advanced epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). OBJECTIVE: Our objective is to provide updated analyses of safety and the assessment of manageability of specific adverse events. METHODS: Patients with stage IIIB/IV or recurrent, non-squamous, EGFR mutation-positive NSCLC were randomized to receive erlotinib plus bevacizumab or erlotinib. The primary endpoint was progression-free survival. Adverse event frequency rates, predictability and manageability, reasons for discontinuation, time to onset, and outcomes of specific adverse events were analyzed. RESULTS: The safety analysis population comprised 152 randomized patients (75 erlotinib plus bevacizumab; 77 erlotinib) who received at least one dose of study drug between February 2011 and March 2012. There was no difference in overall incidence of serious adverse events between arms, but more grade 3 or higher adverse events were reported with erlotinib plus bevacizumab (90.7%) than with erlotinib (53.2%), primarily due to grade 3 hypertension. Hypertension was controllable with antihypertensive medications in most cases. Proteinuria and bleeding were also more frequently reported with erlotinib plus bevacizumab than with erlotinib but were manageable and did not lead to early discontinuations. CONCLUSIONS: The addition of bevacizumab to erlotinib prolonged progression-free survival in EGFR mutation-positive NSCLC. Follow-up safety data were consistent with the known safety profiles of both erlotinib and bevacizumab in NSCLC; this combination appeared to be manageable, and treatment was well tolerated. JapicCTI-111390. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s40264-017-0596-0) contains supplementary material, which is available to authorized users. Springer International Publishing 2017-10-17 2018 /pmc/articles/PMC5808045/ /pubmed/29043496 http://dx.doi.org/10.1007/s40264-017-0596-0 Text en © The Author(s) 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Article Kato, Terufumi Seto, Takashi Nishio, Makoto Goto, Koichi Yamamoto, Noboru Okamoto, Isamu Tao, Liang Yu, Wei Khaznadar, Tarik Tajima, Kosei Shibata, Masahiko Seki, Akihiro Yamamoto, Nobuyuki Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title | Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title_full | Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title_fullStr | Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title_full_unstemmed | Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title_short | Erlotinib Plus Bevacizumab Phase ll Study in Patients with Advanced Non-small-Cell Lung Cancer (JO25567): Updated Safety Results |
title_sort | erlotinib plus bevacizumab phase ll study in patients with advanced non-small-cell lung cancer (jo25567): updated safety results |
topic | Original Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808045/ https://www.ncbi.nlm.nih.gov/pubmed/29043496 http://dx.doi.org/10.1007/s40264-017-0596-0 |
work_keys_str_mv | AT katoterufumi erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT setotakashi erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT nishiomakoto erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT gotokoichi erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT yamamotonoboru erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT okamotoisamu erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT taoliang erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT yuwei erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT khaznadartarik erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT tajimakosei erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT shibatamasahiko erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT sekiakihiro erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults AT yamamotonobuyuki erlotinibplusbevacizumabphasellstudyinpatientswithadvancednonsmallcelllungcancerjo25567updatedsafetyresults |