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Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial

Summary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cispl... Full description

Journal Title: The lancet oncology 2014, Vol.15 (2), p.213-222
Main Author: Wu, Yi-Long, Prof
Other Authors: Zhou, Caicun, Prof , Hu, Cheng-Ping, Prof , Feng, Jifeng, Prof , Lu, Shun, Prof , Huang, Yunchao, Prof , Li, Wei, Prof , Hou, Mei, Prof , Shi, Jian Hua, Prof , Lee, Kye Young, Prof , Xu, Chong-Rui, MD , Massey, Dan, MSc , Kim, Miyoung, MD , Shi, Yang, MD , Geater, Sarayut L, MD
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/24439929
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title: Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial
format: Article
creator:
  • Wu, Yi-Long, Prof
  • Zhou, Caicun, Prof
  • Hu, Cheng-Ping, Prof
  • Feng, Jifeng, Prof
  • Lu, Shun, Prof
  • Huang, Yunchao, Prof
  • Li, Wei, Prof
  • Hou, Mei, Prof
  • Shi, Jian Hua, Prof
  • Lee, Kye Young, Prof
  • Xu, Chong-Rui, MD
  • Massey, Dan, MSc
  • Kim, Miyoung, MD
  • Shi, Yang, MD
  • Geater, Sarayut L, MD
subjects:
  • Aged
  • Antimitotic agents
  • Antineoplastic agents
  • Antineoplastic Combined Chemotherapy Protocols - adverse effects
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Asian Continental Ancestry Group - genetics
  • Cancer
  • Cancer therapies
  • Carcinoma, Non-Small-Cell Lung - drug therapy
  • Carcinoma, Non-Small-Cell Lung - ethnology
  • Carcinoma, Non-Small-Cell Lung - genetics
  • Carcinoma, Non-Small-Cell Lung - mortality
  • Carcinoma, Non-Small-Cell Lung - pathology
  • Care and treatment
  • Chemotherapy
  • China - epidemiology
  • Cisplatin - administration & dosage
  • Committees
  • Deoxycytidine - administration & dosage
  • Deoxycytidine - analogs & derivatives
  • Disease Progression
  • Disease-Free Survival
  • Drug therapy
  • Female
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Intention to Treat Analysis
  • Kaplan-Meier Estimate
  • Linear Models
  • Logistic Models
  • Lung cancer
  • Lung cancer, Non-small cell
  • Lung Neoplasms - drug therapy
  • Lung Neoplasms - ethnology
  • Lung Neoplasms - genetics
  • Lung Neoplasms - mortality
  • Lung Neoplasms - pathology
  • Male
  • Medical colleges
  • Middle Aged
  • Mutation
  • Neoplasm Staging
  • Odds Ratio
  • Ovarian cancer
  • Product development
  • Proportional Hazards Models
  • Protein Kinase Inhibitors - adverse effects
  • Protein Kinase Inhibitors - therapeutic use
  • Quinazolines - adverse effects
  • Quinazolines - therapeutic use
  • Receptor, Epidermal Growth Factor - antagonists & inhibitors
  • Receptor, Epidermal Growth Factor - genetics
  • Republic of Korea - epidemiology
  • Risk Factors
  • Thailand - epidemiology
  • Time Factors
  • Treatment Outcome
  • Tumors
ispartof: The lancet oncology, 2014, Vol.15 (2), p.213-222
description: Summary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin—a chemotherapy regimen widely used in Asia—for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. Methods This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0–1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m2 on day 1 and day 8 plus cisplatin 75 mg/m2 on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov , NCT01121393. Findings 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11·0 months, 95% CI 9·7–13·7) than in the gemcitabine and cisplatin group (5·6 months, 5·1–6·7; hazard ratio 0·28, 95% CI 0·20–0·39; p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleAfatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial
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creatorWu, Yi-Long, Prof ; Zhou, Caicun, Prof ; Hu, Cheng-Ping, Prof ; Feng, Jifeng, Prof ; Lu, Shun, Prof ; Huang, Yunchao, Prof ; Li, Wei, Prof ; Hou, Mei, Prof ; Shi, Jian Hua, Prof ; Lee, Kye Young, Prof ; Xu, Chong-Rui, MD ; Massey, Dan, MSc ; Kim, Miyoung, MD ; Shi, Yang, MD ; Geater, Sarayut L, MD
creatorcontribWu, Yi-Long, Prof ; Zhou, Caicun, Prof ; Hu, Cheng-Ping, Prof ; Feng, Jifeng, Prof ; Lu, Shun, Prof ; Huang, Yunchao, Prof ; Li, Wei, Prof ; Hou, Mei, Prof ; Shi, Jian Hua, Prof ; Lee, Kye Young, Prof ; Xu, Chong-Rui, MD ; Massey, Dan, MSc ; Kim, Miyoung, MD ; Shi, Yang, MD ; Geater, Sarayut L, MD
descriptionSummary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin—a chemotherapy regimen widely used in Asia—for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. Methods This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0–1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m2 on day 1 and day 8 plus cisplatin 75 mg/m2 on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov , NCT01121393. Findings 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11·0 months, 95% CI 9·7–13·7) than in the gemcitabine and cisplatin group (5·6 months, 5·1–6·7; hazard ratio 0·28, 95% CI 0·20–0·39; p<0·0001). The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne (35 [14·6%] of 239 patients), diarrhoea (13 [5·4%]), and stomatitis or mucositis (13 [5·4%]), compared with neutropenia (30 [26·5%] of 113 patients), vomiting (22 [19·5%]), and leucopenia (17 [15·0%]) in the gemcitabine and cisplatin group. Treatment-related serious adverse events occurred in 15 (6·3%) patients in the afatinib group and nine (8·0%) patients in the gemcitabine and cisplatin group. Interpretation First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC. Afatinib should be considered as a first-line treatment option for this patient population. Funding Boehringer Ingelheim.
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languageeng
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subjectAged ; Antimitotic agents ; Antineoplastic agents ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Asian Continental Ancestry Group - genetics ; Cancer ; Cancer therapies ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - ethnology ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Care and treatment ; Chemotherapy ; China - epidemiology ; Cisplatin - administration & dosage ; Committees ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease Progression ; Disease-Free Survival ; Drug therapy ; Female ; Hematology, Oncology and Palliative Medicine ; Humans ; Intention to Treat Analysis ; Kaplan-Meier Estimate ; Linear Models ; Logistic Models ; Lung cancer ; Lung cancer, Non-small cell ; Lung Neoplasms - drug therapy ; Lung Neoplasms - ethnology ; Lung Neoplasms - genetics ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Medical colleges ; Middle Aged ; Mutation ; Neoplasm Staging ; Odds Ratio ; Ovarian cancer ; Product development ; Proportional Hazards Models ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use ; Quinazolines - adverse effects ; Quinazolines - therapeutic use ; Receptor, Epidermal Growth Factor - antagonists & inhibitors ; Receptor, Epidermal Growth Factor - genetics ; Republic of Korea - epidemiology ; Risk Factors ; Thailand - epidemiology ; Time Factors ; Treatment Outcome ; Tumors
ispartofThe lancet oncology, 2014, Vol.15 (2), p.213-222
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1Zhou, Caicun, Prof
2Hu, Cheng-Ping, Prof
3Feng, Jifeng, Prof
4Lu, Shun, Prof
5Huang, Yunchao, Prof
6Li, Wei, Prof
7Hou, Mei, Prof
8Shi, Jian Hua, Prof
9Lee, Kye Young, Prof
10Xu, Chong-Rui, MD
11Massey, Dan, MSc
12Kim, Miyoung, MD
13Shi, Yang, MD
14Geater, Sarayut L, MD
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0Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin—a chemotherapy regimen widely used in Asia—for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. Methods This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0–1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m2 on day 1 and day 8 plus cisplatin 75 mg/m2 on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov , NCT01121393. Findings 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11·0 months, 95% CI 9·7–13·7) than in the gemcitabine and cisplatin group (5·6 months, 5·1–6·7; hazard ratio 0·28, 95% CI 0·20–0·39; p<0·0001). The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne (35 [14·6%] of 239 patients), diarrhoea (13 [5·4%]), and stomatitis or mucositis (13 [5·4%]), compared with neutropenia (30 [26·5%] of 113 patients), vomiting (22 [19·5%]), and leucopenia (17 [15·0%]) in the gemcitabine and cisplatin group. Treatment-related serious adverse events occurred in 15 (6·3%) patients in the afatinib group and nine (8·0%) patients in the gemcitabine and cisplatin group. Interpretation First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC. Afatinib should be considered as a first-line treatment option for this patient population. Funding Boehringer Ingelheim.
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0Aged
1Antimitotic agents
2Antineoplastic agents
3Antineoplastic Combined Chemotherapy Protocols - adverse effects
4Antineoplastic Combined Chemotherapy Protocols - therapeutic use
5Asian Continental Ancestry Group - genetics
6Cancer
7Cancer therapies
8Carcinoma, Non-Small-Cell Lung - drug therapy
9Carcinoma, Non-Small-Cell Lung - ethnology
10Carcinoma, Non-Small-Cell Lung - genetics
11Carcinoma, Non-Small-Cell Lung - mortality
12Carcinoma, Non-Small-Cell Lung - pathology
13Care and treatment
14Chemotherapy
15China - epidemiology
16Cisplatin - administration & dosage
17Committees
18Deoxycytidine - administration & dosage
19Deoxycytidine - analogs & derivatives
20Disease Progression
21Disease-Free Survival
22Drug therapy
23Female
24Hematology, Oncology and Palliative Medicine
25Humans
26Intention to Treat Analysis
27Kaplan-Meier Estimate
28Linear Models
29Logistic Models
30Lung cancer
31Lung cancer, Non-small cell
32Lung Neoplasms - drug therapy
33Lung Neoplasms - ethnology
34Lung Neoplasms - genetics
35Lung Neoplasms - mortality
36Lung Neoplasms - pathology
37Male
38Medical colleges
39Middle Aged
40Mutation
41Neoplasm Staging
42Odds Ratio
43Ovarian cancer
44Product development
45Proportional Hazards Models
46Protein Kinase Inhibitors - adverse effects
47Protein Kinase Inhibitors - therapeutic use
48Quinazolines - adverse effects
49Quinazolines - therapeutic use
50Receptor, Epidermal Growth Factor - antagonists & inhibitors
51Receptor, Epidermal Growth Factor - genetics
52Republic of Korea - epidemiology
53Risk Factors
54Thailand - epidemiology
55Time Factors
56Treatment Outcome
57Tumors
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6Li, Wei, Prof
7Hou, Mei, Prof
8Shi, Jian Hua, Prof
9Lee, Kye Young, Prof
10Xu, Chong-Rui, MD
11Massey, Dan, MSc
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titleAfatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial
authorWu, Yi-Long, Prof ; Zhou, Caicun, Prof ; Hu, Cheng-Ping, Prof ; Feng, Jifeng, Prof ; Lu, Shun, Prof ; Huang, Yunchao, Prof ; Li, Wei, Prof ; Hou, Mei, Prof ; Shi, Jian Hua, Prof ; Lee, Kye Young, Prof ; Xu, Chong-Rui, MD ; Massey, Dan, MSc ; Kim, Miyoung, MD ; Shi, Yang, MD ; Geater, Sarayut L, MD
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2Antineoplastic agents
3Antineoplastic Combined Chemotherapy Protocols - adverse effects
4Antineoplastic Combined Chemotherapy Protocols - therapeutic use
5Asian Continental Ancestry Group - genetics
6Cancer
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8Carcinoma, Non-Small-Cell Lung - drug therapy
9Carcinoma, Non-Small-Cell Lung - ethnology
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11Carcinoma, Non-Small-Cell Lung - mortality
12Carcinoma, Non-Small-Cell Lung - pathology
13Care and treatment
14Chemotherapy
15China - epidemiology
16Cisplatin - administration & dosage
17Committees
18Deoxycytidine - administration & dosage
19Deoxycytidine - analogs & derivatives
20Disease Progression
21Disease-Free Survival
22Drug therapy
23Female
24Hematology, Oncology and Palliative Medicine
25Humans
26Intention to Treat Analysis
27Kaplan-Meier Estimate
28Linear Models
29Logistic Models
30Lung cancer
31Lung cancer, Non-small cell
32Lung Neoplasms - drug therapy
33Lung Neoplasms - ethnology
34Lung Neoplasms - genetics
35Lung Neoplasms - mortality
36Lung Neoplasms - pathology
37Male
38Medical colleges
39Middle Aged
40Mutation
41Neoplasm Staging
42Odds Ratio
43Ovarian cancer
44Product development
45Proportional Hazards Models
46Protein Kinase Inhibitors - adverse effects
47Protein Kinase Inhibitors - therapeutic use
48Quinazolines - adverse effects
49Quinazolines - therapeutic use
50Receptor, Epidermal Growth Factor - antagonists & inhibitors
51Receptor, Epidermal Growth Factor - genetics
52Republic of Korea - epidemiology
53Risk Factors
54Thailand - epidemiology
55Time Factors
56Treatment Outcome
57Tumors
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eissn1474-5488
codenLANCAO
abstractSummary Background Afatinib—an oral irreversible ErbB family blocker—improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC). We compared afatinib with gemcitabine and cisplatin—a chemotherapy regimen widely used in Asia—for first-line treatment of Asian patients with EGFR mutation-positive advanced NSCLC. Methods This open-label, randomised phase 3 trial was done at 36 centres in China, Thailand, and South Korea. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer [American Joint Committee on Cancer version 6], performance status 0–1) were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m2 on day 1 and day 8 plus cisplatin 75 mg/m2 on day 1 of a 3-week schedule for up to six cycles. Randomisation was done centrally with a random number-generating system and an interactive internet and voice-response system. Randomisation was stratified by EGFR mutation (Leu858Arg, exon 19 deletions, or other; block size three). Clinicians and patients were not masked to treatment assignment, but the independent central imaging review group were. Treatment continued until disease progression, intolerable toxic effects, or withdrawal of consent. The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). This study is registered with ClinicalTrials.gov , NCT01121393. Findings 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11·0 months, 95% CI 9·7–13·7) than in the gemcitabine and cisplatin group (5·6 months, 5·1–6·7; hazard ratio 0·28, 95% CI 0·20–0·39; p<0·0001). The most common treatment-related grade 3 or 4 adverse events in the afatinib group were rash or acne (35 [14·6%] of 239 patients), diarrhoea (13 [5·4%]), and stomatitis or mucositis (13 [5·4%]), compared with neutropenia (30 [26·5%] of 113 patients), vomiting (22 [19·5%]), and leucopenia (17 [15·0%]) in the gemcitabine and cisplatin group. Treatment-related serious adverse events occurred in 15 (6·3%) patients in the afatinib group and nine (8·0%) patients in the gemcitabine and cisplatin group. Interpretation First-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC. Afatinib should be considered as a first-line treatment option for this patient population. Funding Boehringer Ingelheim.
copEngland
pubElsevier Ltd
pmid24439929
doi10.1016/S1470-2045(13)70604-1