Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial
Summary Background Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared w...
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| creator | Rosell, Rafael, Dr Carcereny, Enric, MD Gervais, Radj, MD Vergnenegre, Alain, Prof Massuti, Bartomeu, MD Felip, Enriqueta, MD Palmero, Ramon, MD Garcia-Gomez, Ramon, MD Pallares, Cinta, MD Sanchez, Jose Miguel, MD Porta, Rut, MD Cobo, Manuel, MD Garrido, Pilar, MD Longo, Flavia, MD Moran, Teresa, MD Insa, Amelia, MD De Marinis, Filippo, MD Corre, Romain, MD Bover, Isabel, MD Illiano, Alfonso, MD Dansin, Eric, MD de Castro, Javier, MD Milella, Michele, MD Reguart, Noemi, MD Altavilla, Giuseppe, MD Jimenez, Ulpiano, MD Provencio, Mariano, MD Moreno, Miguel Angel, MD Terrasa, Josefa, MD Muñoz-Langa, Jose, MD Valdivia, Javier, MD Isla, Dolores, MD Domine, Manuel, MD Molinier, Olivier, MD Mazieres, Julien, Prof Baize, Nathalie, MD Garcia-Campelo, Rosario, MD Robinet, Gilles, MD Rodriguez-Abreu, Delvys, MD Lopez-Vivanco, Guillermo, MD Gebbia, Vittorio, MD Ferrera-Delgado, Lioba, MD Bombaron, Pierre, MD Bernabe, Reyes, MD Bearz, Alessandra, MD Artal, Angel, MD Cortesi, Enrico, MD Rolfo, Christian, MD Sanchez-Ronco, Maria, PhD Drozdowskyj, Ana, PhD Queralt, Cristina, PhD de Aguirre, Itziar, PhD Ramirez, Jose Luis, PhD Sanchez, Jose Javier, Prof Molina, Miguel Angel, PhD Taron, Miquel, PhD Paz-Ares, Luis, MD |
| description | Summary Background Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m2 on day 1 plus docetaxel (75 mg/m2 on day 1) or gemcitabine (1250 mg/m2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m2 or AUC 5 with gemcitabine 1000 mg/m2 ) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov , number NCT00446225. Findings Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5–5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25–0·54; p |
| doi_str_mv | 10.1016/S1470-2045(11)70393-X |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_992832933</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>1_s2_0_S147020451170393X</els_id><sourcerecordid>992832933</sourcerecordid><originalsourceid>FETCH-LOGICAL-c504t-20fadc05b7aad76f84de248a5c6818b44288a18cd3dc14fb1567cf00264a46143</originalsourceid><addsrcrecordid>eNqFUt1u0zAUjhCIjcIjgHxHJy1gJ07icgGaqm4gTUIam9Q768Q5oR6OHWynqK_JE-G2gwsu4Mr28fdzfD5n2UtG3zDK6rdfGG9oXlBezRk7a2i5KPP1o-w0lXlecSEeH_ZHyEn2LIR7SlnDaPU0OymKQlSsFqfZz5U3LmqrW7JFH6ZAQgTbge-I2uDg4gY9jDsCgfTah5gbbZFEjxAHtJH0zpPV5N2IYMkIUadiID903BDotmAVdmR1dXlDhimmW2fz0QUd9RaJTYcwgDG5QmOImexXovYMT-aru5vbi-XZOwKJaKJWSdbjOUk-NjfQojknPvXpBh2Sw7iBgKRMfWkwz7MnPZiALx7WWXZ3ubpdfsyvP199Wl5c56qiPKa59NApWrUNQNfUveAdFlxApWrBRMt5IQQwobqyU4z3LavqRvWUFjUHXjNezrLXR93Ru-8ThihTM_ungEU3BblYFKIsFmWZkPN_IhmlQpSiTvhZVh2hyrsQPPZy9HoAv0sguQ9eHoKX-1QlY_IQvFwn3qsHi6kdsPvD-p10Anw4AjCNZKvRy6BSWCkf7VFF2Tn9X4v3fymo9Bm0AvMNdxju3eRtmrdkMhSSHkX2GowdFNblL2Qu1e4</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1008838628</pqid></control><display><type>article</type><title>Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Rosell, Rafael, Dr ; Carcereny, Enric, MD ; Gervais, Radj, MD ; Vergnenegre, Alain, Prof ; Massuti, Bartomeu, MD ; Felip, Enriqueta, MD ; Palmero, Ramon, MD ; Garcia-Gomez, Ramon, MD ; Pallares, Cinta, MD ; Sanchez, Jose Miguel, MD ; Porta, Rut, MD ; Cobo, Manuel, MD ; Garrido, Pilar, MD ; Longo, Flavia, MD ; Moran, Teresa, MD ; Insa, Amelia, MD ; De Marinis, Filippo, MD ; Corre, Romain, MD ; Bover, Isabel, MD ; Illiano, Alfonso, MD ; Dansin, Eric, MD ; de Castro, Javier, MD ; Milella, Michele, MD ; Reguart, Noemi, MD ; Altavilla, Giuseppe, MD ; Jimenez, Ulpiano, MD ; Provencio, Mariano, MD ; Moreno, Miguel Angel, MD ; Terrasa, Josefa, MD ; Muñoz-Langa, Jose, MD ; Valdivia, Javier, MD ; Isla, Dolores, MD ; Domine, Manuel, MD ; Molinier, Olivier, MD ; Mazieres, Julien, Prof ; Baize, Nathalie, MD ; Garcia-Campelo, Rosario, MD ; Robinet, Gilles, MD ; Rodriguez-Abreu, Delvys, MD ; Lopez-Vivanco, Guillermo, MD ; Gebbia, Vittorio, MD ; Ferrera-Delgado, Lioba, MD ; Bombaron, Pierre, MD ; Bernabe, Reyes, MD ; Bearz, Alessandra, MD ; Artal, Angel, MD ; Cortesi, Enrico, MD ; Rolfo, Christian, MD ; Sanchez-Ronco, Maria, PhD ; Drozdowskyj, Ana, PhD ; Queralt, Cristina, PhD ; de Aguirre, Itziar, PhD ; Ramirez, Jose Luis, PhD ; Sanchez, Jose Javier, Prof ; Molina, Miguel Angel, PhD ; Taron, Miquel, PhD ; Paz-Ares, Luis, MD</creator><creatorcontrib>Rosell, Rafael, Dr ; Carcereny, Enric, MD ; Gervais, Radj, MD ; Vergnenegre, Alain, Prof ; Massuti, Bartomeu, MD ; Felip, Enriqueta, MD ; Palmero, Ramon, MD ; Garcia-Gomez, Ramon, MD ; Pallares, Cinta, MD ; Sanchez, Jose Miguel, MD ; Porta, Rut, MD ; Cobo, Manuel, MD ; Garrido, Pilar, MD ; Longo, Flavia, MD ; Moran, Teresa, MD ; Insa, Amelia, MD ; De Marinis, Filippo, MD ; Corre, Romain, MD ; Bover, Isabel, MD ; Illiano, Alfonso, MD ; Dansin, Eric, MD ; de Castro, Javier, MD ; Milella, Michele, MD ; Reguart, Noemi, MD ; Altavilla, Giuseppe, MD ; Jimenez, Ulpiano, MD ; Provencio, Mariano, MD ; Moreno, Miguel Angel, MD ; Terrasa, Josefa, MD ; Muñoz-Langa, Jose, MD ; Valdivia, Javier, MD ; Isla, Dolores, MD ; Domine, Manuel, MD ; Molinier, Olivier, MD ; Mazieres, Julien, Prof ; Baize, Nathalie, MD ; Garcia-Campelo, Rosario, MD ; Robinet, Gilles, MD ; Rodriguez-Abreu, Delvys, MD ; Lopez-Vivanco, Guillermo, MD ; Gebbia, Vittorio, MD ; Ferrera-Delgado, Lioba, MD ; Bombaron, Pierre, MD ; Bernabe, Reyes, MD ; Bearz, Alessandra, MD ; Artal, Angel, MD ; Cortesi, Enrico, MD ; Rolfo, Christian, MD ; Sanchez-Ronco, Maria, PhD ; Drozdowskyj, Ana, PhD ; Queralt, Cristina, PhD ; de Aguirre, Itziar, PhD ; Ramirez, Jose Luis, PhD ; Sanchez, Jose Javier, Prof ; Molina, Miguel Angel, PhD ; Taron, Miquel, PhD ; Paz-Ares, Luis, MD ; on behalf of the Spanish Lung Cancer Group in collaboration with the Groupe Français de Pneumo-Cancérologie and the Associazione Italiana Oncologia Toracica ; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica</creatorcontrib><description>Summary Background Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m2 on day 1 plus docetaxel (75 mg/m2 on day 1) or gemcitabine (1250 mg/m2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m2 or AUC 5 with gemcitabine 1000 mg/m2 ) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov , number NCT00446225. Findings Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5–5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25–0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes. Interpretation Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors. Funding Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(11)70393-X</identifier><identifier>PMID: 22285168</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject><![CDATA[Adjuvants ; Administration, Oral ; Aged ; Anemia ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carboplatin ; Carboplatin - administration & dosage ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - enzymology ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Chemotherapy ; Chi-Square Distribution ; Cisplatin ; Cisplatin - administration & dosage ; Clinical trials ; Data processing ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease-Free Survival ; Drug Administration Schedule ; Drugs ; Epidermal growth factor receptors ; Erlotinib Hydrochloride ; Europe ; Exanthema ; Exons ; Female ; gemcitabine ; Gene deletion ; Hematology, Oncology and Palliative Medicine ; Hospitals ; Humans ; Intravenous administration ; Kaplan-Meier Estimate ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - enzymology ; Lung Neoplasms - genetics ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Metastases ; Middle Aged ; Molecular Targeted Therapy ; Mutation ; Neutropenia ; Oncology ; Patient Selection ; Precision Medicine ; Proportional Hazards Models ; Prospective Studies ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use ; Quinazolines - administration & dosage ; Quinazolines - adverse effects ; Quinazolines - therapeutic use ; Receptor, Epidermal Growth Factor - antagonists & inhibitors ; Receptor, Epidermal Growth Factor - genetics ; Survival ; Taxoids - administration & dosage ; Time Factors ; Toxicity ; Treatment Outcome]]></subject><ispartof>The lancet oncology, 2012-03, Vol.13 (3), p.239-246</ispartof><rights>Elsevier Ltd</rights><rights>2012 Elsevier Ltd</rights><rights>Copyright © 2012 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c504t-20fadc05b7aad76f84de248a5c6818b44288a18cd3dc14fb1567cf00264a46143</citedby><cites>FETCH-LOGICAL-c504t-20fadc05b7aad76f84de248a5c6818b44288a18cd3dc14fb1567cf00264a46143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S147020451170393X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22285168$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosell, Rafael, Dr</creatorcontrib><creatorcontrib>Carcereny, Enric, MD</creatorcontrib><creatorcontrib>Gervais, Radj, MD</creatorcontrib><creatorcontrib>Vergnenegre, Alain, Prof</creatorcontrib><creatorcontrib>Massuti, Bartomeu, MD</creatorcontrib><creatorcontrib>Felip, Enriqueta, MD</creatorcontrib><creatorcontrib>Palmero, Ramon, MD</creatorcontrib><creatorcontrib>Garcia-Gomez, Ramon, MD</creatorcontrib><creatorcontrib>Pallares, Cinta, MD</creatorcontrib><creatorcontrib>Sanchez, Jose Miguel, MD</creatorcontrib><creatorcontrib>Porta, Rut, MD</creatorcontrib><creatorcontrib>Cobo, Manuel, MD</creatorcontrib><creatorcontrib>Garrido, Pilar, MD</creatorcontrib><creatorcontrib>Longo, Flavia, MD</creatorcontrib><creatorcontrib>Moran, Teresa, MD</creatorcontrib><creatorcontrib>Insa, Amelia, MD</creatorcontrib><creatorcontrib>De Marinis, Filippo, MD</creatorcontrib><creatorcontrib>Corre, Romain, MD</creatorcontrib><creatorcontrib>Bover, Isabel, MD</creatorcontrib><creatorcontrib>Illiano, Alfonso, MD</creatorcontrib><creatorcontrib>Dansin, Eric, MD</creatorcontrib><creatorcontrib>de Castro, Javier, MD</creatorcontrib><creatorcontrib>Milella, Michele, MD</creatorcontrib><creatorcontrib>Reguart, Noemi, MD</creatorcontrib><creatorcontrib>Altavilla, Giuseppe, MD</creatorcontrib><creatorcontrib>Jimenez, Ulpiano, MD</creatorcontrib><creatorcontrib>Provencio, Mariano, MD</creatorcontrib><creatorcontrib>Moreno, Miguel Angel, MD</creatorcontrib><creatorcontrib>Terrasa, Josefa, MD</creatorcontrib><creatorcontrib>Muñoz-Langa, Jose, MD</creatorcontrib><creatorcontrib>Valdivia, Javier, MD</creatorcontrib><creatorcontrib>Isla, Dolores, MD</creatorcontrib><creatorcontrib>Domine, Manuel, MD</creatorcontrib><creatorcontrib>Molinier, Olivier, MD</creatorcontrib><creatorcontrib>Mazieres, Julien, Prof</creatorcontrib><creatorcontrib>Baize, Nathalie, MD</creatorcontrib><creatorcontrib>Garcia-Campelo, Rosario, MD</creatorcontrib><creatorcontrib>Robinet, Gilles, MD</creatorcontrib><creatorcontrib>Rodriguez-Abreu, Delvys, MD</creatorcontrib><creatorcontrib>Lopez-Vivanco, Guillermo, MD</creatorcontrib><creatorcontrib>Gebbia, Vittorio, MD</creatorcontrib><creatorcontrib>Ferrera-Delgado, Lioba, MD</creatorcontrib><creatorcontrib>Bombaron, Pierre, MD</creatorcontrib><creatorcontrib>Bernabe, Reyes, MD</creatorcontrib><creatorcontrib>Bearz, Alessandra, MD</creatorcontrib><creatorcontrib>Artal, Angel, MD</creatorcontrib><creatorcontrib>Cortesi, Enrico, MD</creatorcontrib><creatorcontrib>Rolfo, Christian, MD</creatorcontrib><creatorcontrib>Sanchez-Ronco, Maria, PhD</creatorcontrib><creatorcontrib>Drozdowskyj, Ana, PhD</creatorcontrib><creatorcontrib>Queralt, Cristina, PhD</creatorcontrib><creatorcontrib>de Aguirre, Itziar, PhD</creatorcontrib><creatorcontrib>Ramirez, Jose Luis, PhD</creatorcontrib><creatorcontrib>Sanchez, Jose Javier, Prof</creatorcontrib><creatorcontrib>Molina, Miguel Angel, PhD</creatorcontrib><creatorcontrib>Taron, Miquel, PhD</creatorcontrib><creatorcontrib>Paz-Ares, Luis, MD</creatorcontrib><creatorcontrib>on behalf of the Spanish Lung Cancer Group in collaboration with the Groupe Français de Pneumo-Cancérologie and the Associazione Italiana Oncologia Toracica</creatorcontrib><creatorcontrib>Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica</creatorcontrib><title>Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Background Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m2 on day 1 plus docetaxel (75 mg/m2 on day 1) or gemcitabine (1250 mg/m2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m2 or AUC 5 with gemcitabine 1000 mg/m2 ) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov , number NCT00446225. Findings Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5–5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25–0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes. Interpretation Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors. Funding Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer.</description><subject>Adjuvants</subject><subject>Administration, Oral</subject><subject>Aged</subject><subject>Anemia</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carboplatin</subject><subject>Carboplatin - administration & dosage</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - enzymology</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Carcinoma, Non-Small-Cell Lung - mortality</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Chemotherapy</subject><subject>Chi-Square Distribution</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Clinical trials</subject><subject>Data processing</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease-Free Survival</subject><subject>Drug Administration Schedule</subject><subject>Drugs</subject><subject>Epidermal growth factor receptors</subject><subject>Erlotinib Hydrochloride</subject><subject>Europe</subject><subject>Exanthema</subject><subject>Exons</subject><subject>Female</subject><subject>gemcitabine</subject><subject>Gene deletion</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Intravenous administration</subject><subject>Kaplan-Meier Estimate</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - enzymology</subject><subject>Lung Neoplasms - genetics</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Metastases</subject><subject>Middle Aged</subject><subject>Molecular Targeted Therapy</subject><subject>Mutation</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Patient Selection</subject><subject>Precision Medicine</subject><subject>Proportional Hazards Models</subject><subject>Prospective Studies</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Protein Kinase Inhibitors - therapeutic use</subject><subject>Quinazolines - administration & dosage</subject><subject>Quinazolines - adverse effects</subject><subject>Quinazolines - therapeutic use</subject><subject>Receptor, Epidermal Growth Factor - antagonists & inhibitors</subject><subject>Receptor, Epidermal Growth Factor - genetics</subject><subject>Survival</subject><subject>Taxoids - administration & dosage</subject><subject>Time Factors</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>1470-2045</issn><issn>1474-5488</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFUt1u0zAUjhCIjcIjgHxHJy1gJ07icgGaqm4gTUIam9Q768Q5oR6OHWynqK_JE-G2gwsu4Mr28fdzfD5n2UtG3zDK6rdfGG9oXlBezRk7a2i5KPP1o-w0lXlecSEeH_ZHyEn2LIR7SlnDaPU0OymKQlSsFqfZz5U3LmqrW7JFH6ZAQgTbge-I2uDg4gY9jDsCgfTah5gbbZFEjxAHtJH0zpPV5N2IYMkIUadiID903BDotmAVdmR1dXlDhimmW2fz0QUd9RaJTYcwgDG5QmOImexXovYMT-aru5vbi-XZOwKJaKJWSdbjOUk-NjfQojknPvXpBh2Sw7iBgKRMfWkwz7MnPZiALx7WWXZ3ubpdfsyvP199Wl5c56qiPKa59NApWrUNQNfUveAdFlxApWrBRMt5IQQwobqyU4z3LavqRvWUFjUHXjNezrLXR93Ru-8ThihTM_ungEU3BblYFKIsFmWZkPN_IhmlQpSiTvhZVh2hyrsQPPZy9HoAv0sguQ9eHoKX-1QlY_IQvFwn3qsHi6kdsPvD-p10Anw4AjCNZKvRy6BSWCkf7VFF2Tn9X4v3fymo9Bm0AvMNdxju3eRtmrdkMhSSHkX2GowdFNblL2Qu1e4</recordid><startdate>20120301</startdate><enddate>20120301</enddate><creator>Rosell, Rafael, Dr</creator><creator>Carcereny, Enric, MD</creator><creator>Gervais, Radj, MD</creator><creator>Vergnenegre, Alain, Prof</creator><creator>Massuti, Bartomeu, MD</creator><creator>Felip, Enriqueta, MD</creator><creator>Palmero, Ramon, MD</creator><creator>Garcia-Gomez, Ramon, MD</creator><creator>Pallares, Cinta, MD</creator><creator>Sanchez, Jose Miguel, MD</creator><creator>Porta, Rut, MD</creator><creator>Cobo, Manuel, MD</creator><creator>Garrido, Pilar, MD</creator><creator>Longo, Flavia, MD</creator><creator>Moran, Teresa, MD</creator><creator>Insa, Amelia, MD</creator><creator>De Marinis, Filippo, MD</creator><creator>Corre, Romain, MD</creator><creator>Bover, Isabel, MD</creator><creator>Illiano, Alfonso, MD</creator><creator>Dansin, Eric, MD</creator><creator>de Castro, Javier, MD</creator><creator>Milella, Michele, MD</creator><creator>Reguart, Noemi, MD</creator><creator>Altavilla, Giuseppe, MD</creator><creator>Jimenez, Ulpiano, MD</creator><creator>Provencio, Mariano, 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Itziar, PhD</creator><creator>Ramirez, Jose Luis, PhD</creator><creator>Sanchez, Jose Javier, Prof</creator><creator>Molina, Miguel Angel, PhD</creator><creator>Taron, Miquel, PhD</creator><creator>Paz-Ares, Luis, MD</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20120301</creationdate><title>Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial</title><author>Rosell, Rafael, Dr ; Carcereny, Enric, MD ; Gervais, Radj, MD ; Vergnenegre, Alain, Prof ; Massuti, Bartomeu, MD ; Felip, Enriqueta, MD ; Palmero, Ramon, MD ; Garcia-Gomez, Ramon, MD ; Pallares, Cinta, MD ; Sanchez, Jose Miguel, MD ; Porta, Rut, MD ; Cobo, Manuel, MD ; Garrido, Pilar, MD ; Longo, Flavia, MD ; Moran, Teresa, MD ; Insa, Amelia, MD ; De Marinis, Filippo, MD ; Corre, Romain, MD ; Bover, Isabel, MD ; Illiano, Alfonso, MD ; Dansin, Eric, MD ; de Castro, Javier, MD ; Milella, Michele, MD ; Reguart, Noemi, MD ; Altavilla, Giuseppe, MD ; Jimenez, Ulpiano, MD ; Provencio, Mariano, MD ; Moreno, Miguel Angel, MD ; Terrasa, Josefa, MD ; Muñoz-Langa, Jose, MD ; Valdivia, Javier, MD ; Isla, Dolores, MD ; Domine, Manuel, MD ; Molinier, Olivier, MD ; Mazieres, Julien, Prof ; Baize, Nathalie, MD ; Garcia-Campelo, Rosario, MD ; Robinet, Gilles, MD ; Rodriguez-Abreu, Delvys, MD ; Lopez-Vivanco, Guillermo, MD ; Gebbia, Vittorio, MD ; Ferrera-Delgado, Lioba, MD ; Bombaron, Pierre, MD ; Bernabe, Reyes, MD ; Bearz, Alessandra, MD ; Artal, Angel, MD ; Cortesi, Enrico, MD ; Rolfo, Christian, MD ; Sanchez-Ronco, Maria, PhD ; Drozdowskyj, Ana, PhD ; Queralt, Cristina, PhD ; de Aguirre, Itziar, PhD ; Ramirez, Jose Luis, PhD ; Sanchez, Jose Javier, Prof ; Molina, Miguel Angel, PhD ; Taron, Miquel, PhD ; Paz-Ares, Luis, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c504t-20fadc05b7aad76f84de248a5c6818b44288a18cd3dc14fb1567cf00264a46143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adjuvants</topic><topic>Administration, Oral</topic><topic>Aged</topic><topic>Anemia</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carboplatin</topic><topic>Carboplatin - administration & dosage</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - enzymology</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Carcinoma, Non-Small-Cell Lung - mortality</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Chemotherapy</topic><topic>Chi-Square Distribution</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Clinical trials</topic><topic>Data processing</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease-Free Survival</topic><topic>Drug Administration Schedule</topic><topic>Drugs</topic><topic>Epidermal growth factor receptors</topic><topic>Erlotinib Hydrochloride</topic><topic>Europe</topic><topic>Exanthema</topic><topic>Exons</topic><topic>Female</topic><topic>gemcitabine</topic><topic>Gene deletion</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Intravenous administration</topic><topic>Kaplan-Meier Estimate</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - enzymology</topic><topic>Lung Neoplasms - genetics</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Metastases</topic><topic>Middle Aged</topic><topic>Molecular Targeted Therapy</topic><topic>Mutation</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Patient Selection</topic><topic>Precision Medicine</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Protein Kinase Inhibitors - therapeutic use</topic><topic>Quinazolines - administration & dosage</topic><topic>Quinazolines - adverse effects</topic><topic>Quinazolines - therapeutic use</topic><topic>Receptor, Epidermal Growth Factor - antagonists & inhibitors</topic><topic>Receptor, Epidermal Growth Factor - genetics</topic><topic>Survival</topic><topic>Taxoids - administration & dosage</topic><topic>Time Factors</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosell, Rafael, Dr</creatorcontrib><creatorcontrib>Carcereny, Enric, MD</creatorcontrib><creatorcontrib>Gervais, Radj, MD</creatorcontrib><creatorcontrib>Vergnenegre, Alain, Prof</creatorcontrib><creatorcontrib>Massuti, Bartomeu, MD</creatorcontrib><creatorcontrib>Felip, Enriqueta, MD</creatorcontrib><creatorcontrib>Palmero, Ramon, MD</creatorcontrib><creatorcontrib>Garcia-Gomez, Ramon, MD</creatorcontrib><creatorcontrib>Pallares, Cinta, MD</creatorcontrib><creatorcontrib>Sanchez, Jose Miguel, MD</creatorcontrib><creatorcontrib>Porta, Rut, MD</creatorcontrib><creatorcontrib>Cobo, Manuel, MD</creatorcontrib><creatorcontrib>Garrido, Pilar, MD</creatorcontrib><creatorcontrib>Longo, Flavia, MD</creatorcontrib><creatorcontrib>Moran, Teresa, MD</creatorcontrib><creatorcontrib>Insa, Amelia, MD</creatorcontrib><creatorcontrib>De Marinis, Filippo, MD</creatorcontrib><creatorcontrib>Corre, Romain, MD</creatorcontrib><creatorcontrib>Bover, Isabel, MD</creatorcontrib><creatorcontrib>Illiano, Alfonso, MD</creatorcontrib><creatorcontrib>Dansin, Eric, MD</creatorcontrib><creatorcontrib>de Castro, Javier, MD</creatorcontrib><creatorcontrib>Milella, Michele, MD</creatorcontrib><creatorcontrib>Reguart, Noemi, MD</creatorcontrib><creatorcontrib>Altavilla, Giuseppe, MD</creatorcontrib><creatorcontrib>Jimenez, Ulpiano, MD</creatorcontrib><creatorcontrib>Provencio, Mariano, MD</creatorcontrib><creatorcontrib>Moreno, Miguel Angel, MD</creatorcontrib><creatorcontrib>Terrasa, Josefa, MD</creatorcontrib><creatorcontrib>Muñoz-Langa, Jose, MD</creatorcontrib><creatorcontrib>Valdivia, Javier, MD</creatorcontrib><creatorcontrib>Isla, Dolores, MD</creatorcontrib><creatorcontrib>Domine, Manuel, MD</creatorcontrib><creatorcontrib>Molinier, Olivier, MD</creatorcontrib><creatorcontrib>Mazieres, Julien, Prof</creatorcontrib><creatorcontrib>Baize, Nathalie, MD</creatorcontrib><creatorcontrib>Garcia-Campelo, Rosario, MD</creatorcontrib><creatorcontrib>Robinet, Gilles, MD</creatorcontrib><creatorcontrib>Rodriguez-Abreu, Delvys, MD</creatorcontrib><creatorcontrib>Lopez-Vivanco, Guillermo, MD</creatorcontrib><creatorcontrib>Gebbia, Vittorio, MD</creatorcontrib><creatorcontrib>Ferrera-Delgado, Lioba, MD</creatorcontrib><creatorcontrib>Bombaron, Pierre, MD</creatorcontrib><creatorcontrib>Bernabe, Reyes, MD</creatorcontrib><creatorcontrib>Bearz, Alessandra, MD</creatorcontrib><creatorcontrib>Artal, Angel, MD</creatorcontrib><creatorcontrib>Cortesi, Enrico, MD</creatorcontrib><creatorcontrib>Rolfo, Christian, MD</creatorcontrib><creatorcontrib>Sanchez-Ronco, Maria, PhD</creatorcontrib><creatorcontrib>Drozdowskyj, Ana, PhD</creatorcontrib><creatorcontrib>Queralt, Cristina, PhD</creatorcontrib><creatorcontrib>de Aguirre, Itziar, PhD</creatorcontrib><creatorcontrib>Ramirez, Jose Luis, PhD</creatorcontrib><creatorcontrib>Sanchez, Jose Javier, Prof</creatorcontrib><creatorcontrib>Molina, Miguel Angel, PhD</creatorcontrib><creatorcontrib>Taron, Miquel, PhD</creatorcontrib><creatorcontrib>Paz-Ares, Luis, MD</creatorcontrib><creatorcontrib>on behalf of the Spanish Lung Cancer Group in collaboration with the Groupe Français de Pneumo-Cancérologie and the Associazione Italiana Oncologia Toracica</creatorcontrib><creatorcontrib>Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosell, Rafael, Dr</au><au>Carcereny, Enric, MD</au><au>Gervais, Radj, MD</au><au>Vergnenegre, Alain, Prof</au><au>Massuti, Bartomeu, MD</au><au>Felip, Enriqueta, MD</au><au>Palmero, Ramon, MD</au><au>Garcia-Gomez, Ramon, MD</au><au>Pallares, Cinta, MD</au><au>Sanchez, Jose Miguel, MD</au><au>Porta, Rut, MD</au><au>Cobo, Manuel, MD</au><au>Garrido, Pilar, MD</au><au>Longo, Flavia, MD</au><au>Moran, Teresa, MD</au><au>Insa, Amelia, MD</au><au>De Marinis, Filippo, MD</au><au>Corre, Romain, MD</au><au>Bover, Isabel, MD</au><au>Illiano, Alfonso, MD</au><au>Dansin, Eric, MD</au><au>de Castro, Javier, MD</au><au>Milella, Michele, MD</au><au>Reguart, Noemi, MD</au><au>Altavilla, Giuseppe, MD</au><au>Jimenez, Ulpiano, MD</au><au>Provencio, Mariano, MD</au><au>Moreno, Miguel Angel, MD</au><au>Terrasa, Josefa, MD</au><au>Muñoz-Langa, Jose, MD</au><au>Valdivia, Javier, MD</au><au>Isla, Dolores, MD</au><au>Domine, Manuel, MD</au><au>Molinier, Olivier, MD</au><au>Mazieres, Julien, Prof</au><au>Baize, Nathalie, MD</au><au>Garcia-Campelo, Rosario, MD</au><au>Robinet, Gilles, MD</au><au>Rodriguez-Abreu, Delvys, MD</au><au>Lopez-Vivanco, Guillermo, MD</au><au>Gebbia, Vittorio, MD</au><au>Ferrera-Delgado, Lioba, MD</au><au>Bombaron, Pierre, MD</au><au>Bernabe, Reyes, MD</au><au>Bearz, Alessandra, MD</au><au>Artal, Angel, MD</au><au>Cortesi, Enrico, MD</au><au>Rolfo, Christian, MD</au><au>Sanchez-Ronco, Maria, PhD</au><au>Drozdowskyj, Ana, PhD</au><au>Queralt, Cristina, PhD</au><au>de Aguirre, Itziar, PhD</au><au>Ramirez, Jose Luis, PhD</au><au>Sanchez, Jose Javier, Prof</au><au>Molina, Miguel Angel, PhD</au><au>Taron, Miquel, PhD</au><au>Paz-Ares, Luis, MD</au><aucorp>on behalf of the Spanish Lung Cancer Group in collaboration with the Groupe Français de Pneumo-Cancérologie and the Associazione Italiana Oncologia Toracica</aucorp><aucorp>Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2012-03-01</date><risdate>2012</risdate><volume>13</volume><issue>3</issue><spage>239</spage><epage>246</epage><pages>239-246</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><abstract>Summary Background Erlotinib has been shown to improve progression-free survival compared with chemotherapy when given as first-line treatment for Asian patients with non-small-cell lung cancer (NSCLC) with activating EGFR mutations. We aimed to assess the safety and efficacy of erlotinib compared with standard chemotherapy for first-line treatment of European patients with advanced EGFR-mutation positive NSCLC. Methods We undertook the open-label, randomised phase 3 EURTAC trial at 42 hospitals in France, Italy, and Spain. Eligible participants were adults (>18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ≥6 months before study entry was allowed). We randomly allocated participants (1:1) according to a computer-generated allocation schedule to receive oral erlotinib 150 mg per day or 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m2 on day 1 plus docetaxel (75 mg/m2 on day 1) or gemcitabine (1250 mg/m2 on days 1 and 8). Carboplatin (AUC 6 with docetaxel 75 mg/m2 or AUC 5 with gemcitabine 1000 mg/m2 ) was allowed in patients unable to have cisplatin. Patients were stratified by EGFR mutation type and Eastern Cooperative Oncology Group performance status (0 vs 1 vs 2). The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We assessed safety in all patients who received study drug (≥1 dose). This study is registered with ClinicalTrials.gov , number NCT00446225. Findings Between Feb 15, 2007, and Jan 4, 2011, 174 patients with EGFR mutations were enrolled. One patient received treatment before randomisation and was thus withdrawn from the study; of the remaining patients, 86 were randomly assigned to receive erlotinib and 87 to receive standard chemotherapy. The preplanned interim analysis showed that the study met its primary endpoint; enrolment was halted, and full evaluation of the results was recommended. At data cutoff (Jan 26, 2011), median PFS was 9·7 months (95% CI 8·4-12·3) in the erlotinib group, compared with 5·2 months (4·5–5·8) in the standard chemotherapy group (hazard ratio 0·37, 95% CI 0·25–0·54; p<0·0001). Main grade 3 or 4 toxicities were rash (11 [13%] of 84 patients given erlotinib vs none of 82 patients in the chemotherapy group), neutropenia (none vs 18 [22%]), anaemia (one [1%] vs three [4%]), and increased amino-transferase concentrations (two [2%] vs 0). Five (6%) patients on erlotinib had treatment-related severe adverse events compared with 16 patients (20%) on chemotherapy. One patient in the erlotinib group and two in the standard chemotherapy group died from treatment-related causes. Interpretation Our findings strengthen the rationale for routine baseline tissue-based assessment of EGFR mutations in patients with NSCLC and for treatment of mutation-positive patients with EGFR tyrosine-kinase inhibitors. Funding Spanish Lung Cancer Group, Roche Farma, Hoffmann-La Roche, and Red Temática de Investigacion Cooperativa en Cancer.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>22285168</pmid><doi>10.1016/S1470-2045(11)70393-X</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2012-03, Vol.13 (3), p.239-246 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_992832933 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adjuvants Administration, Oral Aged Anemia Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carboplatin Carboplatin - administration & dosage Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - enzymology Carcinoma, Non-Small-Cell Lung - genetics Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - pathology Chemotherapy Chi-Square Distribution Cisplatin Cisplatin - administration & dosage Clinical trials Data processing Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease-Free Survival Drug Administration Schedule Drugs Epidermal growth factor receptors Erlotinib Hydrochloride Europe Exanthema Exons Female gemcitabine Gene deletion Hematology, Oncology and Palliative Medicine Hospitals Humans Intravenous administration Kaplan-Meier Estimate Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - enzymology Lung Neoplasms - genetics Lung Neoplasms - mortality Lung Neoplasms - pathology Male Metastases Middle Aged Molecular Targeted Therapy Mutation Neutropenia Oncology Patient Selection Precision Medicine Proportional Hazards Models Prospective Studies Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Quinazolines - administration & dosage Quinazolines - adverse effects Quinazolines - therapeutic use Receptor, Epidermal Growth Factor - antagonists & inhibitors Receptor, Epidermal Growth Factor - genetics Survival Taxoids - administration & dosage Time Factors Toxicity Treatment Outcome |
| title | Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial |
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