Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. METHODS: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced p...

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Main Authors: Tony S. Mok, Yi Long Wu, Sumitra Thongprasert, Chih Hsin Yang, Da Tong Chu, Nagahiro Saijo, Patrapim Sunpaweravong, Baohui Han, Benjamin Margono, Yukito Ichinose, Yutaka Nishiwaki, Yuichiro Ohe, Jin Ji Yang, Busyamas Chewaskulyong, Haiyi Jiang, Emma L. Duffield, Claire L. Watkins, Alison A. Armour, Masahiro Fukuoka
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Published: 2018
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http://cmuir.cmu.ac.th/jspui/handle/6653943832/49303
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spelling th-cmuir.6653943832-493032018-08-16T02:14:09Z Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma Tony S. Mok Yi Long Wu Sumitra Thongprasert Chih Hsin Yang Da Tong Chu Nagahiro Saijo Patrapim Sunpaweravong Baohui Han Benjamin Margono Yukito Ichinose Yutaka Nishiwaki Yuichiro Ohe Jin Ji Yang Busyamas Chewaskulyong Haiyi Jiang Emma L. Duffield Claire L. Watkins Alison A. Armour Masahiro Fukuoka Medicine BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. METHODS: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. RESULTS: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin - paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group. CONCLUSIONS: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. Copyright © 2009 Massachusetts Medical Society. 2018-08-16T02:14:09Z 2018-08-16T02:14:09Z 2009-09-03 Journal 15334406 00284793 2-s2.0-69949162760 10.1056/NEJMoa0810699 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=69949162760&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/49303
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
topic Medicine
spellingShingle Medicine
Tony S. Mok
Yi Long Wu
Sumitra Thongprasert
Chih Hsin Yang
Da Tong Chu
Nagahiro Saijo
Patrapim Sunpaweravong
Baohui Han
Benjamin Margono
Yukito Ichinose
Yutaka Nishiwaki
Yuichiro Ohe
Jin Ji Yang
Busyamas Chewaskulyong
Haiyi Jiang
Emma L. Duffield
Claire L. Watkins
Alison A. Armour
Masahiro Fukuoka
Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
description BACKGROUND: Previous, uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer. METHODS: In this phase 3, open-label study, we randomly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib (250 mg per day) (609 patients) or carboplatin (at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute) plus paclitaxel (200 mg per square meter of body-surface area) (608 patients). The primary end point was progression-free survival. RESULTS: The 12-month rates of progression-free survival were 24.9% with gefitinib and 6.7% with carboplatin-paclitaxel. The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority, as compared with carboplatin - paclitaxel, with respect to progression-free survival in the intention-to-treat population (hazard ratio for progression or death, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001), whereas in the subgroup of 176 patients who were negative for the mutation, progression-free survival was significantly longer among those who received carboplatin-paclitaxel (hazard ratio for progression or death with gefitinib, 2.85; 95% CI, 2.05 to 3.98; P<0.001). The most common adverse events were rash or acne (in 66.2% of patients) and diarrhea (46.6%) in the gefitinib group and neurotoxic effects (69.9%), neutropenia (67.1%), and alopecia (58.4%) in the carboplatin-paclitaxel group. CONCLUSIONS: Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia. The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib. Copyright © 2009 Massachusetts Medical Society.
format Journal
author Tony S. Mok
Yi Long Wu
Sumitra Thongprasert
Chih Hsin Yang
Da Tong Chu
Nagahiro Saijo
Patrapim Sunpaweravong
Baohui Han
Benjamin Margono
Yukito Ichinose
Yutaka Nishiwaki
Yuichiro Ohe
Jin Ji Yang
Busyamas Chewaskulyong
Haiyi Jiang
Emma L. Duffield
Claire L. Watkins
Alison A. Armour
Masahiro Fukuoka
author_facet Tony S. Mok
Yi Long Wu
Sumitra Thongprasert
Chih Hsin Yang
Da Tong Chu
Nagahiro Saijo
Patrapim Sunpaweravong
Baohui Han
Benjamin Margono
Yukito Ichinose
Yutaka Nishiwaki
Yuichiro Ohe
Jin Ji Yang
Busyamas Chewaskulyong
Haiyi Jiang
Emma L. Duffield
Claire L. Watkins
Alison A. Armour
Masahiro Fukuoka
author_sort Tony S. Mok
title Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
title_short Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
title_full Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
title_fullStr Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
title_full_unstemmed Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
title_sort gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
publishDate 2018
url https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=69949162760&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/49303
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