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Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study

Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment... Full description

Journal Title: The lancet oncology 2018, Vol.19 (1), p.139-148
Main Author: Zhong, Wen-Zhao
Other Authors: Wang, Qun , Mao, Wei-Min , Xu, Song-Tao , Wu, Lin , Shen, Yi , Liu, Yong-Yu , Chen, Chun , Cheng, Ying , Xu, Lin , Wang, Jun , Fei, Ke , Li, Xiao-Fei , Li, Jian , Huang, Cheng , Liu, Zhi-Dong , Xu, Shun , Chen, Ke-Neng , Xu, Shi-Dong , Liu, Lun-Xu , Yu, Ping , Wang, Bu-Hai , Ma, Hai-Tao , Yan, Hong-Hong , Yang, Xue-Ning , Zhou, Qing , Wu, Yi-Long , Wu, Yi-Long , Wang, Qun , Mao, Wei-Min , Wu, Lin , Shen, Yi , Liu, Yong-Yu , Chen, Chun , Cheng, Ying , Xu, Lin , Wang, Jun , Fei, Ke , Li, Xiao-Fei , Li, Jian , Huang, Cheng , Liu, Zhi-Dong , Xu, Shun , Chen, Ke-Neng , Xu, Shi-Dong , Liu, Lun-Xu , Yu, Ping , Wang, Bu-Hai , Ma, Hai-Tao , Wang, Si-Yu , Hu, Jian , Liu, Wei , Li, Wei , Shi, Jian-Hua
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/29174310
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title: Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study
format: Article
creator:
  • Zhong, Wen-Zhao
  • Wang, Qun
  • Mao, Wei-Min
  • Xu, Song-Tao
  • Wu, Lin
  • Shen, Yi
  • Liu, Yong-Yu
  • Chen, Chun
  • Cheng, Ying
  • Xu, Lin
  • Wang, Jun
  • Fei, Ke
  • Li, Xiao-Fei
  • Li, Jian
  • Huang, Cheng
  • Liu, Zhi-Dong
  • Xu, Shun
  • Chen, Ke-Neng
  • Xu, Shi-Dong
  • Liu, Lun-Xu
  • Yu, Ping
  • Wang, Bu-Hai
  • Ma, Hai-Tao
  • Yan, Hong-Hong
  • Yang, Xue-Ning
  • Zhou, Qing
  • Wu, Yi-Long
  • Wu, Yi-Long
  • Wang, Qun
  • Mao, Wei-Min
  • Wu, Lin
  • Shen, Yi
  • Liu, Yong-Yu
  • Chen, Chun
  • Cheng, Ying
  • Xu, Lin
  • Wang, Jun
  • Fei, Ke
  • Li, Xiao-Fei
  • Li, Jian
  • Huang, Cheng
  • Liu, Zhi-Dong
  • Xu, Shun
  • Chen, Ke-Neng
  • Xu, Shi-Dong
  • Liu, Lun-Xu
  • Yu, Ping
  • Wang, Bu-Hai
  • Ma, Hai-Tao
  • Wang, Si-Yu
  • Hu, Jian
  • Liu, Wei
  • Li, Wei
  • Shi, Jian-Hua
subjects:
  • Abdomen
  • Adolescent
  • Adult
  • Aged
  • Alanine
  • Alanine transaminase
  • Antineoplastic Combined Chemotherapy Protocols - adverse effects
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Biomarkers, Tumor - genetics
  • Cancer therapies
  • Carcinoma, Non-Small-Cell Lung - drug therapy
  • Carcinoma, Non-Small-Cell Lung - genetics
  • Carcinoma, Non-Small-Cell Lung - mortality
  • Carcinoma, Non-Small-Cell Lung - pathology
  • Care and treatment
  • Chemotherapy
  • Chemotherapy, Adjuvant
  • China
  • Cisplatin
  • Cisplatin - administration & dosage
  • Cisplatin - adverse effects
  • Consent
  • Disease Progression
  • Disease-Free Survival
  • Epidermal growth factor
  • Epidermal growth factor receptors
  • ErbB Receptors - genetics
  • Family medical history
  • Female
  • Gefitinib
  • Hematology
  • Humans
  • Intravenous administration
  • Lung cancer
  • Lung cancer, Non-small cell
  • Lung diseases
  • Lung Neoplasms - drug therapy
  • Lung Neoplasms - genetics
  • Lung Neoplasms - mortality
  • Lung Neoplasms - pathology
  • Lymphatic system
  • Male
  • Middle Aged
  • Mutants
  • Mutation
  • Neoplasm Staging
  • Neutropenia
  • Non-small cell lung carcinoma
  • Oncology
  • Patients
  • Pneumonectomy
  • Protein Kinase Inhibitors - administration & dosage
  • Protein Kinase Inhibitors - adverse effects
  • Protein-tyrosine kinase
  • Quality of life
  • Quinazolines - administration & dosage
  • Quinazolines - adverse effects
  • Radiation therapy
  • Risk Factors
  • Scintigraphy
  • Small cell lung carcinoma
  • Studies
  • Thrombocytopenia
  • Time Factors
  • Toxicity
  • Treatment Outcome
  • Tumors
  • Tyrosine
  • Ultrasonic imaging
  • Vinblastine - administration & dosage
  • Vinblastine - adverse effects
  • Vinblastine - analogs & derivatives
  • Vinorelbine
  • Vomiting
  • Young Adult
ispartof: The lancet oncology, 2018, Vol.19 (1), p.139-148
description: Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II–IIIA (N1–N2) NSCLC. We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18–75 years with completely resected (R0), stage II–IIIA (N1–N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m2 on days 1 and 8) plus intravenous cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079. Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8–44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9–32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6–22·3]; hazard ratio [HR] 0·60, 95% CI 0·42–0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with g
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleGefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study
sourceAlma/SFX Local Collection
creatorZhong, Wen-Zhao ; Wang, Qun ; Mao, Wei-Min ; Xu, Song-Tao ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Yan, Hong-Hong ; Yang, Xue-Ning ; Zhou, Qing ; Wu, Yi-Long ; Wu, Yi-Long ; Wang, Qun ; Mao, Wei-Min ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Wang, Si-Yu ; Hu, Jian ; Liu, Wei ; Li, Wei ; Shi, Jian-Hua
creatorcontribZhong, Wen-Zhao ; Wang, Qun ; Mao, Wei-Min ; Xu, Song-Tao ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Yan, Hong-Hong ; Yang, Xue-Ning ; Zhou, Qing ; Wu, Yi-Long ; Wu, Yi-Long ; Wang, Qun ; Mao, Wei-Min ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Wang, Si-Yu ; Hu, Jian ; Liu, Wei ; Li, Wei ; Shi, Jian-Hua ; ADJUVANT investigators
descriptionCisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II–IIIA (N1–N2) NSCLC. We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18–75 years with completely resected (R0), stage II–IIIA (N1–N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m2 on days 1 and 8) plus intravenous cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079. Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8–44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9–32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6–22·3]; hazard ratio [HR] 0·60, 95% CI 0·42–0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with gefitinib. No deaths were treatment related. Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People's Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China.
identifier
0ISSN: 1470-2045
1EISSN: 1474-5488
2DOI: 10.1016/S1470-2045(17)30729-5
3PMID: 29174310
languageeng
publisherEngland: Elsevier Ltd
subjectAbdomen ; Adolescent ; Adult ; Aged ; Alanine ; Alanine transaminase ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomarkers, Tumor - genetics ; Cancer therapies ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Care and treatment ; Chemotherapy ; Chemotherapy, Adjuvant ; China ; Cisplatin ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Consent ; Disease Progression ; Disease-Free Survival ; Epidermal growth factor ; Epidermal growth factor receptors ; ErbB Receptors - genetics ; Family medical history ; Female ; Gefitinib ; Hematology ; Humans ; Intravenous administration ; Lung cancer ; Lung cancer, Non-small cell ; Lung diseases ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Lymphatic system ; Male ; Middle Aged ; Mutants ; Mutation ; Neoplasm Staging ; Neutropenia ; Non-small cell lung carcinoma ; Oncology ; Patients ; Pneumonectomy ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Protein-tyrosine kinase ; Quality of life ; Quinazolines - administration & dosage ; Quinazolines - adverse effects ; Radiation therapy ; Risk Factors ; Scintigraphy ; Small cell lung carcinoma ; Studies ; Thrombocytopenia ; Time Factors ; Toxicity ; Treatment Outcome ; Tumors ; Tyrosine ; Ultrasonic imaging ; Vinblastine - administration & dosage ; Vinblastine - adverse effects ; Vinblastine - analogs & derivatives ; Vinorelbine ; Vomiting ; Young Adult
ispartofThe lancet oncology, 2018, Vol.19 (1), p.139-148
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02018 Elsevier Ltd
1Copyright © 2018 Elsevier Ltd. All rights reserved.
2COPYRIGHT 2018 Elsevier B.V.
3Copyright Elsevier Limited Jan 1, 2018
42018. Elsevier Ltd
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0Zhong, Wen-Zhao
1Wang, Qun
2Mao, Wei-Min
3Xu, Song-Tao
4Wu, Lin
5Shen, Yi
6Liu, Yong-Yu
7Chen, Chun
8Cheng, Ying
9Xu, Lin
10Wang, Jun
11Fei, Ke
12Li, Xiao-Fei
13Li, Jian
14Huang, Cheng
15Liu, Zhi-Dong
16Xu, Shun
17Chen, Ke-Neng
18Xu, Shi-Dong
19Liu, Lun-Xu
20Yu, Ping
21Wang, Bu-Hai
22Ma, Hai-Tao
23Yan, Hong-Hong
24Yang, Xue-Ning
25Zhou, Qing
26Wu, Yi-Long
27Wu, Yi-Long
28Wang, Qun
29Mao, Wei-Min
30Wu, Lin
31Shen, Yi
32Liu, Yong-Yu
33Chen, Chun
34Cheng, Ying
35Xu, Lin
36Wang, Jun
37Fei, Ke
38Li, Xiao-Fei
39Li, Jian
40Huang, Cheng
41Liu, Zhi-Dong
42Xu, Shun
43Chen, Ke-Neng
44Xu, Shi-Dong
45Liu, Lun-Xu
46Yu, Ping
47Wang, Bu-Hai
48Ma, Hai-Tao
49Wang, Si-Yu
50Hu, Jian
51Liu, Wei
52Li, Wei
53Shi, Jian-Hua
54ADJUVANT investigators
title
0Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study
1The lancet oncology
addtitleLancet Oncol
descriptionCisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II–IIIA (N1–N2) NSCLC. We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18–75 years with completely resected (R0), stage II–IIIA (N1–N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m2 on days 1 and 8) plus intravenous cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079. Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8–44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9–32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6–22·3]; hazard ratio [HR] 0·60, 95% CI 0·42–0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with gefitinib. No deaths were treatment related. Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People's Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China.
subject
0Abdomen
1Adolescent
2Adult
3Aged
4Alanine
5Alanine transaminase
6Antineoplastic Combined Chemotherapy Protocols - adverse effects
7Antineoplastic Combined Chemotherapy Protocols - therapeutic use
8Biomarkers, Tumor - genetics
9Cancer therapies
10Carcinoma, Non-Small-Cell Lung - drug therapy
11Carcinoma, Non-Small-Cell Lung - genetics
12Carcinoma, Non-Small-Cell Lung - mortality
13Carcinoma, Non-Small-Cell Lung - pathology
14Care and treatment
15Chemotherapy
16Chemotherapy, Adjuvant
17China
18Cisplatin
19Cisplatin - administration & dosage
20Cisplatin - adverse effects
21Consent
22Disease Progression
23Disease-Free Survival
24Epidermal growth factor
25Epidermal growth factor receptors
26ErbB Receptors - genetics
27Family medical history
28Female
29Gefitinib
30Hematology
31Humans
32Intravenous administration
33Lung cancer
34Lung cancer, Non-small cell
35Lung diseases
36Lung Neoplasms - drug therapy
37Lung Neoplasms - genetics
38Lung Neoplasms - mortality
39Lung Neoplasms - pathology
40Lymphatic system
41Male
42Middle Aged
43Mutants
44Mutation
45Neoplasm Staging
46Neutropenia
47Non-small cell lung carcinoma
48Oncology
49Patients
50Pneumonectomy
51Protein Kinase Inhibitors - administration & dosage
52Protein Kinase Inhibitors - adverse effects
53Protein-tyrosine kinase
54Quality of life
55Quinazolines - administration & dosage
56Quinazolines - adverse effects
57Radiation therapy
58Risk Factors
59Scintigraphy
60Small cell lung carcinoma
61Studies
62Thrombocytopenia
63Time Factors
64Toxicity
65Treatment Outcome
66Tumors
67Tyrosine
68Ultrasonic imaging
69Vinblastine - administration & dosage
70Vinblastine - adverse effects
71Vinblastine - analogs & derivatives
72Vinorelbine
73Vomiting
74Young Adult
issn
01470-2045
11474-5488
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creator
0Zhong, Wen-Zhao
1Wang, Qun
2Mao, Wei-Min
3Xu, Song-Tao
4Wu, Lin
5Shen, Yi
6Liu, Yong-Yu
7Chen, Chun
8Cheng, Ying
9Xu, Lin
10Wang, Jun
11Fei, Ke
12Li, Xiao-Fei
13Li, Jian
14Huang, Cheng
15Liu, Zhi-Dong
16Xu, Shun
17Chen, Ke-Neng
18Xu, Shi-Dong
19Liu, Lun-Xu
20Yu, Ping
21Wang, Bu-Hai
22Ma, Hai-Tao
23Yan, Hong-Hong
24Yang, Xue-Ning
25Zhou, Qing
26Wu, Yi-Long
27Wu, Yi-Long
28Wang, Qun
29Mao, Wei-Min
30Wu, Lin
31Shen, Yi
32Liu, Yong-Yu
33Chen, Chun
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43Chen, Ke-Neng
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45Liu, Lun-Xu
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creationdate201801
titleGefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study
authorZhong, Wen-Zhao ; Wang, Qun ; Mao, Wei-Min ; Xu, Song-Tao ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Yan, Hong-Hong ; Yang, Xue-Ning ; Zhou, Qing ; Wu, Yi-Long ; Wu, Yi-Long ; Wang, Qun ; Mao, Wei-Min ; Wu, Lin ; Shen, Yi ; Liu, Yong-Yu ; Chen, Chun ; Cheng, Ying ; Xu, Lin ; Wang, Jun ; Fei, Ke ; Li, Xiao-Fei ; Li, Jian ; Huang, Cheng ; Liu, Zhi-Dong ; Xu, Shun ; Chen, Ke-Neng ; Xu, Shi-Dong ; Liu, Lun-Xu ; Yu, Ping ; Wang, Bu-Hai ; Ma, Hai-Tao ; Wang, Si-Yu ; Hu, Jian ; Liu, Wei ; Li, Wei ; Shi, Jian-Hua
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5Alanine transaminase
6Antineoplastic Combined Chemotherapy Protocols - adverse effects
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31Humans
32Intravenous administration
33Lung cancer
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37Lung Neoplasms - genetics
38Lung Neoplasms - mortality
39Lung Neoplasms - pathology
40Lymphatic system
41Male
42Middle Aged
43Mutants
44Mutation
45Neoplasm Staging
46Neutropenia
47Non-small cell lung carcinoma
48Oncology
49Patients
50Pneumonectomy
51Protein Kinase Inhibitors - administration & dosage
52Protein Kinase Inhibitors - adverse effects
53Protein-tyrosine kinase
54Quality of life
55Quinazolines - administration & dosage
56Quinazolines - adverse effects
57Radiation therapy
58Risk Factors
59Scintigraphy
60Small cell lung carcinoma
61Studies
62Thrombocytopenia
63Time Factors
64Toxicity
65Treatment Outcome
66Tumors
67Tyrosine
68Ultrasonic imaging
69Vinblastine - administration & dosage
70Vinblastine - adverse effects
71Vinblastine - analogs & derivatives
72Vinorelbine
73Vomiting
74Young Adult
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1Wang, Qun
2Mao, Wei-Min
3Xu, Song-Tao
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5Shen, Yi
6Liu, Yong-Yu
7Chen, Chun
8Cheng, Ying
9Xu, Lin
10Wang, Jun
11Fei, Ke
12Li, Xiao-Fei
13Li, Jian
14Huang, Cheng
15Liu, Zhi-Dong
16Xu, Shun
17Chen, Ke-Neng
18Xu, Shi-Dong
19Liu, Lun-Xu
20Yu, Ping
21Wang, Bu-Hai
22Ma, Hai-Tao
23Yan, Hong-Hong
24Yang, Xue-Ning
25Zhou, Qing
26Wu, Yi-Long
27Wu, Yi-Long
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29Mao, Wei-Min
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31Shen, Yi
32Liu, Yong-Yu
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36Wang, Jun
37Fei, Ke
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39Li, Jian
40Huang, Cheng
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46Yu, Ping
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jtitleThe lancet oncology
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0Zhong, Wen-Zhao
1Wang, Qun
2Mao, Wei-Min
3Xu, Song-Tao
4Wu, Lin
5Shen, Yi
6Liu, Yong-Yu
7Chen, Chun
8Cheng, Ying
9Xu, Lin
10Wang, Jun
11Fei, Ke
12Li, Xiao-Fei
13Li, Jian
14Huang, Cheng
15Liu, Zhi-Dong
16Xu, Shun
17Chen, Ke-Neng
18Xu, Shi-Dong
19Liu, Lun-Xu
20Yu, Ping
21Wang, Bu-Hai
22Ma, Hai-Tao
23Yan, Hong-Hong
24Yang, Xue-Ning
25Zhou, Qing
26Wu, Yi-Long
27Wu, Yi-Long
28Wang, Qun
29Mao, Wei-Min
30Wu, Lin
31Shen, Yi
32Liu, Yong-Yu
33Chen, Chun
34Cheng, Ying
35Xu, Lin
36Wang, Jun
37Fei, Ke
38Li, Xiao-Fei
39Li, Jian
40Huang, Cheng
41Liu, Zhi-Dong
42Xu, Shun
43Chen, Ke-Neng
44Xu, Shi-Dong
45Liu, Lun-Xu
46Yu, Ping
47Wang, Bu-Hai
48Ma, Hai-Tao
49Wang, Si-Yu
50Hu, Jian
51Liu, Wei
52Li, Wei
53Shi, Jian-Hua
aucorpADJUVANT investigators
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atitleGefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II–IIIA (N1–N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study
jtitleThe lancet oncology
addtitleLancet Oncol
date2018-01
risdate2018
volume19
issue1
spage139
epage148
pages139-148
issn1470-2045
eissn1474-5488
abstractCisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II–IIIA (N1–N2) NSCLC. We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18–75 years with completely resected (R0), stage II–IIIA (N1–N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m2 on days 1 and 8) plus intravenous cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079. Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8–44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9–32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6–22·3]; hazard ratio [HR] 0·60, 95% CI 0·42–0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with gefitinib. No deaths were treatment related. Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People's Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China.
copEngland
pubElsevier Ltd
pmid29174310
doi10.1016/S1470-2045(17)30729-5