Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial

Aim: The phase III AVAiL study evaluated the efficacy and safety of the anti-vascular epidermal growth factor agent bevacizumab combined with platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a preplanned analys...

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Main Authors: Tony S K Mok, Te Chun Hsia, Chun Ming Tsai, Kenneth Tsang, Gee Chen Chang, John Wen Cheng Chang, Sirisinha Thitiya, Virote Sriuranpong, Sumitra Thongprasert, Daniel Tt Chua, Nicola Moore, Christian Manegold
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/50229
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spelling th-cmuir.6653943832-502292018-09-04T04:26:53Z Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial Tony S K Mok Te Chun Hsia Chun Ming Tsai Kenneth Tsang Gee Chen Chang John Wen Cheng Chang Sirisinha Thitiya Virote Sriuranpong Sumitra Thongprasert Daniel Tt Chua Nicola Moore Christian Manegold Medicine Aim: The phase III AVAiL study evaluated the efficacy and safety of the anti-vascular epidermal growth factor agent bevacizumab combined with platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a preplanned analysis of Asian patients enrolled in AVAiL. Methods: Patients with recurrent or advanced non-squamous NSCLC were randomized to receive bevacizumab 7.5mg/kg, bevacizumab 15mg/kg or placebo, plus cisplatin 80mg/m2 and gemcitabine 1250mg/m2 for up to six cycles, followed by bevacizumab or placebo until disease progression. An exploratory analysis was undertaken to assess efficacy and safety in an Asian subgroup. Results: Of the 1043 patients enrolled, 105 were Asian and were included in the subgroup analysis. Progression-free survival was 8.5months (95% CI 7.3-10.8) in the bevacizumab 15-mg/kg group, 8.2 (95% CI 6.6-11.7) in the 7.5-mg/kg group and 6.1 (95% CI 5.1-8.0) in the placebo group. Median overall survival in the 7.5-mg/kg bevacizumab group was prolonged compared with placebo group (HR 0.46; 95% CI 0.22-0.97). Nausea was the most common adverse event, occurring at similar rates (ranging from 69-76%) in all study groups. Hypertension was the most common adverse event of special interest, seen in 29, 55 and 16% of patients in the 7.5-mg/kg and 15-mg/kg bevacizumab and placebo groups, respectively. Conclusion: Study results strongly suggest that bevacizumab at a dose of 7.5mg/kg improves the duration of overall survival when combined with cisplatin-gemcitabine in Asian patients. Bevacizumab was well tolerated in this patient group. © 2011 Blackwell Publishing Asia Pty Ltd. 2018-09-04T04:26:53Z 2018-09-04T04:26:53Z 2011-06-01 Journal 17437563 17437555 2-s2.0-79956133688 10.1111/j.1743-7563.2011.01397.x https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=79956133688&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/50229
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Medicine
spellingShingle Medicine
Tony S K Mok
Te Chun Hsia
Chun Ming Tsai
Kenneth Tsang
Gee Chen Chang
John Wen Cheng Chang
Sirisinha Thitiya
Virote Sriuranpong
Sumitra Thongprasert
Daniel Tt Chua
Nicola Moore
Christian Manegold
Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
description Aim: The phase III AVAiL study evaluated the efficacy and safety of the anti-vascular epidermal growth factor agent bevacizumab combined with platinum-based chemotherapy as first-line treatment in patients with advanced non-small-cell lung cancer (NSCLC). We report the results of a preplanned analysis of Asian patients enrolled in AVAiL. Methods: Patients with recurrent or advanced non-squamous NSCLC were randomized to receive bevacizumab 7.5mg/kg, bevacizumab 15mg/kg or placebo, plus cisplatin 80mg/m2 and gemcitabine 1250mg/m2 for up to six cycles, followed by bevacizumab or placebo until disease progression. An exploratory analysis was undertaken to assess efficacy and safety in an Asian subgroup. Results: Of the 1043 patients enrolled, 105 were Asian and were included in the subgroup analysis. Progression-free survival was 8.5months (95% CI 7.3-10.8) in the bevacizumab 15-mg/kg group, 8.2 (95% CI 6.6-11.7) in the 7.5-mg/kg group and 6.1 (95% CI 5.1-8.0) in the placebo group. Median overall survival in the 7.5-mg/kg bevacizumab group was prolonged compared with placebo group (HR 0.46; 95% CI 0.22-0.97). Nausea was the most common adverse event, occurring at similar rates (ranging from 69-76%) in all study groups. Hypertension was the most common adverse event of special interest, seen in 29, 55 and 16% of patients in the 7.5-mg/kg and 15-mg/kg bevacizumab and placebo groups, respectively. Conclusion: Study results strongly suggest that bevacizumab at a dose of 7.5mg/kg improves the duration of overall survival when combined with cisplatin-gemcitabine in Asian patients. Bevacizumab was well tolerated in this patient group. © 2011 Blackwell Publishing Asia Pty Ltd.
format Journal
author Tony S K Mok
Te Chun Hsia
Chun Ming Tsai
Kenneth Tsang
Gee Chen Chang
John Wen Cheng Chang
Sirisinha Thitiya
Virote Sriuranpong
Sumitra Thongprasert
Daniel Tt Chua
Nicola Moore
Christian Manegold
author_facet Tony S K Mok
Te Chun Hsia
Chun Ming Tsai
Kenneth Tsang
Gee Chen Chang
John Wen Cheng Chang
Sirisinha Thitiya
Virote Sriuranpong
Sumitra Thongprasert
Daniel Tt Chua
Nicola Moore
Christian Manegold
author_sort Tony S K Mok
title Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
title_short Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
title_full Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
title_fullStr Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
title_full_unstemmed Efficacy of bevacizumab with cisplatin and gemcitabine in Asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: A substudy of the Avastin in Lung trial
title_sort efficacy of bevacizumab with cisplatin and gemcitabine in asian patients with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy: a substudy of the avastin in lung trial
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=79956133688&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/50229
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