Cargando…
Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer
BACKGROUND: Sunitinib malate (SUTENT) has promising single-agent activity given on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off treatment) in advanced non-small cell lung cancer (NSCLC). METHODS: We examined the activity of sunitinib on a continuous daily dosing (CDD) schedule in an op...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2009
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778527/ https://www.ncbi.nlm.nih.gov/pubmed/19826424 http://dx.doi.org/10.1038/sj.bjc.6605346 |
_version_ | 1782174259933609984 |
---|---|
author | Novello, S Scagliotti, G V Rosell, R Socinski, M A Brahmer, J Atkins, J Pallares, C Burgess, R Tye, L Selaru, P Wang, E Chao, R Govindan, R |
author_facet | Novello, S Scagliotti, G V Rosell, R Socinski, M A Brahmer, J Atkins, J Pallares, C Burgess, R Tye, L Selaru, P Wang, E Chao, R Govindan, R |
author_sort | Novello, S |
collection | PubMed |
description | BACKGROUND: Sunitinib malate (SUTENT) has promising single-agent activity given on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off treatment) in advanced non-small cell lung cancer (NSCLC). METHODS: We examined the activity of sunitinib on a continuous daily dosing (CDD) schedule in an open-label, multicentre phase II study in patients with previously treated, advanced NSCLC. Patients ⩾18 years with stage IIIB/IV NSCLC after failure with platinum-based chemotherapy, received sunitinib 37.5 mg per day. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival (OS), 1-year survival rate, and safety. RESULTS: Of 47 patients receiving sunitinib, one patient achieved a confirmed partial response (ORR 2.1% (95% confidence interval (CI) 0.1, 11.3)) and 11 (23.4%) had stable disease (SD) ⩾8 weeks. Five patients had SD>6 months. Median PFS was 11.9 weeks (95% CI 8.6, 14.1) and median OS was 37.1 weeks (95% CI 31.1, 69.7). The 1-year survival probability was 38.4% (95% CI 24.2, 52.5). Treatment was generally well tolerated. CONCLUSIONS: The safety profile and time-to-event analyses, albeit relatively low response rate of 2%, suggest single-agent sunitinib on a CDD schedule may be a potential therapeutic agent for patients with advanced, refractory NSCLC. |
format | Text |
id | pubmed-2778527 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-27785272010-11-03 Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer Novello, S Scagliotti, G V Rosell, R Socinski, M A Brahmer, J Atkins, J Pallares, C Burgess, R Tye, L Selaru, P Wang, E Chao, R Govindan, R Br J Cancer Clinical Study BACKGROUND: Sunitinib malate (SUTENT) has promising single-agent activity given on Schedule 4/2 (4 weeks on treatment followed by 2 weeks off treatment) in advanced non-small cell lung cancer (NSCLC). METHODS: We examined the activity of sunitinib on a continuous daily dosing (CDD) schedule in an open-label, multicentre phase II study in patients with previously treated, advanced NSCLC. Patients ⩾18 years with stage IIIB/IV NSCLC after failure with platinum-based chemotherapy, received sunitinib 37.5 mg per day. The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival (OS), 1-year survival rate, and safety. RESULTS: Of 47 patients receiving sunitinib, one patient achieved a confirmed partial response (ORR 2.1% (95% confidence interval (CI) 0.1, 11.3)) and 11 (23.4%) had stable disease (SD) ⩾8 weeks. Five patients had SD>6 months. Median PFS was 11.9 weeks (95% CI 8.6, 14.1) and median OS was 37.1 weeks (95% CI 31.1, 69.7). The 1-year survival probability was 38.4% (95% CI 24.2, 52.5). Treatment was generally well tolerated. CONCLUSIONS: The safety profile and time-to-event analyses, albeit relatively low response rate of 2%, suggest single-agent sunitinib on a CDD schedule may be a potential therapeutic agent for patients with advanced, refractory NSCLC. Nature Publishing Group 2009-11-03 2009-10-13 /pmc/articles/PMC2778527/ /pubmed/19826424 http://dx.doi.org/10.1038/sj.bjc.6605346 Text en Copyright © 2009 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as 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.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Clinical Study Novello, S Scagliotti, G V Rosell, R Socinski, M A Brahmer, J Atkins, J Pallares, C Burgess, R Tye, L Selaru, P Wang, E Chao, R Govindan, R Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title_full | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title_fullStr | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title_full_unstemmed | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title_short | Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
title_sort | phase ii study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778527/ https://www.ncbi.nlm.nih.gov/pubmed/19826424 http://dx.doi.org/10.1038/sj.bjc.6605346 |
work_keys_str_mv | AT novellos phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT scagliottigv phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT rosellr phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT socinskima phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT brahmerj phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT atkinsj phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT pallaresc phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT burgessr phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT tyel phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT selarup phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT wange phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT chaor phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer AT govindanr phaseiistudyofcontinuousdailysunitinibdosinginpatientswithpreviouslytreatedadvancednonsmallcelllungcancer |