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Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study

Summary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of pa... Full description

Journal Title: The lancet oncology 2011, Vol.12 (8), p.735-742
Main Author: Zhou, Caicun, Prof
Other Authors: Wu, Yi-Long, Prof , Chen, Gongyan, Prof , Feng, Jifeng, Prof , Liu, Xiao-Qing, Prof , Wang, Changli, Prof , Zhang, Shucai, Prof , Wang, Jie, Prof , Zhou, Songwen, MD , Ren, Shengxiang, MD , Lu, Shun, Prof , Zhang, Li, Prof , Hu, Chengping, Prof , Hu, Chunhong, Prof , Luo, Yi, Prof , Chen, Lei, Prof , Ye, Ming, Prof , Huang, Jianan, Prof , Zhi, Xiuyi, Prof , Zhang, Yiping, Prof , Xiu, Qingyu, Prof , Ma, Jun, Prof , You, Changxuan, Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/21783417
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title: Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
format: Article
creator:
  • Zhou, Caicun, Prof
  • Wu, Yi-Long, Prof
  • Chen, Gongyan, Prof
  • Feng, Jifeng, Prof
  • Liu, Xiao-Qing, Prof
  • Wang, Changli, Prof
  • Zhang, Shucai, Prof
  • Wang, Jie, Prof
  • Zhou, Songwen, MD
  • Ren, Shengxiang, MD
  • Lu, Shun, Prof
  • Zhang, Li, Prof
  • Hu, Chengping, Prof
  • Hu, Chunhong, Prof
  • Luo, Yi, Prof
  • Chen, Lei, Prof
  • Ye, Ming, Prof
  • Huang, Jianan, Prof
  • Zhi, Xiuyi, Prof
  • Zhang, Yiping, Prof
  • Xiu, Qingyu, Prof
  • Ma, Jun, Prof
  • You, Changxuan, Prof
subjects:
  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols - therapeutic use
  • Cancer
  • Carboplatin - administration & dosage
  • Carcinoma, Non-Small-Cell Lung - genetics
  • Carcinoma, Non-Small-Cell Lung - therapy
  • Care and treatment
  • Chemotherapy
  • China
  • Deoxycytidine - administration & dosage
  • Deoxycytidine - analogs & derivatives
  • Disease-Free Survival
  • Erlotinib
  • Erlotinib Hydrochloride
  • Female
  • Gene Deletion
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Lung cancer, Non-small cell
  • Lung Neoplasms - genetics
  • Lung Neoplasms - therapy
  • Male
  • Medical colleges
  • Middle Aged
  • Mutation
  • Neoplasm Staging
  • Oncology, Experimental
  • Protein Kinase Inhibitors - administration & dosage
  • Protein Kinase Inhibitors - therapeutic use
  • Quinazolines - administration & dosage
  • Quinazolines - therapeutic use
  • Receptor, Epidermal Growth Factor - genetics
  • Tyrosine
ispartof: The lancet oncology, 2011, Vol.12 (8), p.735-742
description: Summary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT00874419 , and has completed enrolment; patients are still in follow-up. Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58–16.53] vs 4.6 [4.21–5.42] months; hazard ratio 0.16, 95% CI 0.10–0.26; 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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titleErlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
sourceAlma/SFX Local Collection
creatorZhou, Caicun, Prof ; Wu, Yi-Long, Prof ; Chen, Gongyan, Prof ; Feng, Jifeng, Prof ; Liu, Xiao-Qing, Prof ; Wang, Changli, Prof ; Zhang, Shucai, Prof ; Wang, Jie, Prof ; Zhou, Songwen, MD ; Ren, Shengxiang, MD ; Lu, Shun, Prof ; Zhang, Li, Prof ; Hu, Chengping, Prof ; Hu, Chunhong, Prof ; Luo, Yi, Prof ; Chen, Lei, Prof ; Ye, Ming, Prof ; Huang, Jianan, Prof ; Zhi, Xiuyi, Prof ; Zhang, Yiping, Prof ; Xiu, Qingyu, Prof ; Ma, Jun, Prof ; You, Changxuan, Prof
creatorcontribZhou, Caicun, Prof ; Wu, Yi-Long, Prof ; Chen, Gongyan, Prof ; Feng, Jifeng, Prof ; Liu, Xiao-Qing, Prof ; Wang, Changli, Prof ; Zhang, Shucai, Prof ; Wang, Jie, Prof ; Zhou, Songwen, MD ; Ren, Shengxiang, MD ; Lu, Shun, Prof ; Zhang, Li, Prof ; Hu, Chengping, Prof ; Hu, Chunhong, Prof ; Luo, Yi, Prof ; Chen, Lei, Prof ; Ye, Ming, Prof ; Huang, Jianan, Prof ; Zhi, Xiuyi, Prof ; Zhang, Yiping, Prof ; Xiu, Qingyu, Prof ; Ma, Jun, Prof ; You, Changxuan, Prof
descriptionSummary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT00874419 , and has completed enrolment; patients are still in follow-up. Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58–16.53] vs 4.6 [4.21–5.42] months; hazard ratio 0.16, 95% CI 0.10–0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]). Interpretation Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Funding F Hoffmann-La Roche Ltd (China); Science and Technology Commission of Shanghai Municipality.
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1EISSN: 1474-5488
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languageeng
publisherEngland: Elsevier Ltd
subjectAdministration, Oral ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer ; Carboplatin - administration & dosage ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - therapy ; Care and treatment ; Chemotherapy ; China ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; Erlotinib ; Erlotinib Hydrochloride ; Female ; Gene Deletion ; Hematology, Oncology and Palliative Medicine ; Humans ; Lung cancer, Non-small cell ; Lung Neoplasms - genetics ; Lung Neoplasms - therapy ; Male ; Medical colleges ; Middle Aged ; Mutation ; Neoplasm Staging ; Oncology, Experimental ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - therapeutic use ; Quinazolines - administration & dosage ; Quinazolines - therapeutic use ; Receptor, Epidermal Growth Factor - genetics ; Tyrosine
ispartofThe lancet oncology, 2011, Vol.12 (8), p.735-742
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0Zhou, Caicun, Prof
1Wu, Yi-Long, Prof
2Chen, Gongyan, Prof
3Feng, Jifeng, Prof
4Liu, Xiao-Qing, Prof
5Wang, Changli, Prof
6Zhang, Shucai, Prof
7Wang, Jie, Prof
8Zhou, Songwen, MD
9Ren, Shengxiang, MD
10Lu, Shun, Prof
11Zhang, Li, Prof
12Hu, Chengping, Prof
13Hu, Chunhong, Prof
14Luo, Yi, Prof
15Chen, Lei, Prof
16Ye, Ming, Prof
17Huang, Jianan, Prof
18Zhi, Xiuyi, Prof
19Zhang, Yiping, Prof
20Xiu, Qingyu, Prof
21Ma, Jun, Prof
22You, Changxuan, Prof
title
0Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT00874419 , and has completed enrolment; patients are still in follow-up. Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58–16.53] vs 4.6 [4.21–5.42] months; hazard ratio 0.16, 95% CI 0.10–0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]). Interpretation Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Funding F Hoffmann-La Roche Ltd (China); Science and Technology Commission of Shanghai Municipality.
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11Deoxycytidine - administration & dosage
12Deoxycytidine - analogs & derivatives
13Disease-Free Survival
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15Erlotinib Hydrochloride
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17Gene Deletion
18Hematology, Oncology and Palliative Medicine
19Humans
20Lung cancer, Non-small cell
21Lung Neoplasms - genetics
22Lung Neoplasms - therapy
23Male
24Medical colleges
25Middle Aged
26Mutation
27Neoplasm Staging
28Oncology, Experimental
29Protein Kinase Inhibitors - administration & dosage
30Protein Kinase Inhibitors - therapeutic use
31Quinazolines - administration & dosage
32Quinazolines - therapeutic use
33Receptor, Epidermal Growth Factor - genetics
34Tyrosine
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titleErlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study
authorZhou, Caicun, Prof ; Wu, Yi-Long, Prof ; Chen, Gongyan, Prof ; Feng, Jifeng, Prof ; Liu, Xiao-Qing, Prof ; Wang, Changli, Prof ; Zhang, Shucai, Prof ; Wang, Jie, Prof ; Zhou, Songwen, MD ; Ren, Shengxiang, MD ; Lu, Shun, Prof ; Zhang, Li, Prof ; Hu, Chengping, Prof ; Hu, Chunhong, Prof ; Luo, Yi, Prof ; Chen, Lei, Prof ; Ye, Ming, Prof ; Huang, Jianan, Prof ; Zhi, Xiuyi, Prof ; Zhang, Yiping, Prof ; Xiu, Qingyu, Prof ; Ma, Jun, Prof ; You, Changxuan, Prof
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6Carcinoma, Non-Small-Cell Lung - genetics
7Carcinoma, Non-Small-Cell Lung - therapy
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29Protein Kinase Inhibitors - administration & dosage
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31Quinazolines - administration & dosage
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eissn1474-5488
codenLANCAO
abstractSummary Background Activating mutations in EGFR are important markers of response to tyrosine kinase inhibitor (TKI) therapy in non-small-cell lung cancer (NSCLC). The OPTIMAL study compared efficacy and tolerability of the TKI erlotinib versus standard chemotherapy in the first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Methods We undertook an open-label, randomised, phase 3 trial at 22 centres in China. Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received either oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects, or up to four cycles of gemcitabine plus carboplatin. Patients were randomly assigned (1:1) with a minimisation procedure and were stratified according to EGFR mutation type, histological subtype (adenocarcinoma vs non-adenocarcinoma), and smoking status. The primary outcome was progression-free survival, analysed in patients with confirmed disease who received at least one dose of study treatment. The trial is registered at ClinicalTrials.gov , number NCT00874419 , and has completed enrolment; patients are still in follow-up. Findings 83 patients were randomly assigned to receive erlotinib and 82 to receive gemcitabine plus carboplatin; 82 in the erlotinib group and 72 in the chemotherapy group were included in analysis of the primary endpoint. Median progression-free survival was significantly longer in erlotinib-treated patients than in those on chemotherapy (13.1 [95% CI 10.58–16.53] vs 4.6 [4.21–5.42] months; hazard ratio 0.16, 95% CI 0.10–0.26; p<0.0001). Chemotherapy was associated with more grade 3 or 4 toxic effects than was erlotinib (including neutropenia in 30 [42%] of 72 patients and thrombocytopenia in 29 [40%] patients on chemotherapy vs no patients with either event on erlotinib); the most common grade 3 or 4 toxic effects with erlotinib were increased alanine aminotransferase concentrations (three [4%] of 83 patients) and skin rash (two [2%] patients). Chemotherapy was also associated with increased treatment-related serious adverse events (ten [14%] of 72 patients [decreased platelet count, n=8; decreased neutrophil count, n=1; hepatic dysfunction, n=1] vs two [2%] of 83 patients [both hepatic dysfunction]). Interpretation Compared with standard chemotherapy, erlotinib conferred a significant progression-free survival benefit in patients with advanced EGFR mutation-positive NSCLC and was associated with more favourable tolerability. These findings suggest that erlotinib is important for first-line treatment of patients with advanced EGFR mutation-positive NSCLC. Funding F Hoffmann-La Roche Ltd (China); Science and Technology Commission of Shanghai Municipality.
copEngland
pubElsevier Ltd
pmid21783417
doi10.1016/S1470-2045(11)70184-X