Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial
Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients s...
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| creator | Mitsudomi, Tetsuya, Dr Morita, Satoshi, Prof Yatabe, Yasushi, MD Negoro, Shunichi, MD Okamoto, Isamu, MD Tsurutani, Junji, MD Seto, Takashi, MD Satouchi, Miyako, MD Tada, Hirohito, MD Hirashima, Tomonori, MD Asami, Kazuhiro, MD Katakami, Nobuyuki, MD Takada, Minoru, Prof Yoshioka, Hiroshige, MD Shibata, Kazuhiko, MD Kudoh, Shinzoh, MD Shimizu, Eiji, Prof Saito, Hiroshi, MD Toyooka, Shinichi, MD Nakagawa, Kazuhiko, Prof Fukuoka, Masahiro, Prof |
| description | Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m2 , intravenously) plus docetaxel (60 mg/m2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan) , number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0–13·9) versus 6·3 months (5·8–7·8; HR 0·489, 95% CI 0·336–0·710, log-rank p |
| doi_str_mv | 10.1016/S1470-2045(09)70364-X |
| format | Article |
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However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m2 , intravenously) plus docetaxel (60 mg/m2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan) , number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0–13·9) versus 6·3 months (5·8–7·8; HR 0·489, 95% CI 0·336–0·710, log-rank p<0·0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2·3%), one of whom died. Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(09)70364-X</identifier><identifier>PMID: 20022809</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Aged ; Antineoplastic Agents - administration & dosage ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Cisplatin ; Cisplatin - administration & dosage ; Clinical trials ; Diarrhea ; Epidermal growth factor receptors ; Exons ; Fatigue ; Female ; Gefitinib ; Gene deletion ; Hematology, Oncology and Palliative Medicine ; Hospitals ; Humans ; Hypersensitivity ; Liver diseases ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Male ; Middle Aged ; Mutation ; Myelosuppression ; Pharmaceuticals ; Point mutation ; Quinazolines - administration & dosage ; Receptor, Epidermal Growth Factor - genetics ; Recruitment ; Survival ; Taxoids - administration & dosage ; Thyroid ; Toxicity</subject><ispartof>The lancet oncology, 2010-02, Vol.11 (2), p.121-128</ispartof><rights>Elsevier Ltd</rights><rights>2010 Elsevier Ltd</rights><rights>Copyright 2010 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Feb 2010</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c478t-c912cfcd38176420a15dc59029b51617b4627a04f90c8184bcb74b63125853c73</citedby><cites>FETCH-LOGICAL-c478t-c912cfcd38176420a15dc59029b51617b4627a04f90c8184bcb74b63125853c73</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S147020450970364X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20022809$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mitsudomi, Tetsuya, Dr</creatorcontrib><creatorcontrib>Morita, Satoshi, Prof</creatorcontrib><creatorcontrib>Yatabe, Yasushi, MD</creatorcontrib><creatorcontrib>Negoro, Shunichi, MD</creatorcontrib><creatorcontrib>Okamoto, Isamu, MD</creatorcontrib><creatorcontrib>Tsurutani, Junji, MD</creatorcontrib><creatorcontrib>Seto, Takashi, MD</creatorcontrib><creatorcontrib>Satouchi, Miyako, MD</creatorcontrib><creatorcontrib>Tada, Hirohito, MD</creatorcontrib><creatorcontrib>Hirashima, Tomonori, MD</creatorcontrib><creatorcontrib>Asami, Kazuhiro, MD</creatorcontrib><creatorcontrib>Katakami, Nobuyuki, MD</creatorcontrib><creatorcontrib>Takada, Minoru, Prof</creatorcontrib><creatorcontrib>Yoshioka, Hiroshige, MD</creatorcontrib><creatorcontrib>Shibata, Kazuhiko, MD</creatorcontrib><creatorcontrib>Kudoh, Shinzoh, MD</creatorcontrib><creatorcontrib>Shimizu, Eiji, Prof</creatorcontrib><creatorcontrib>Saito, Hiroshi, MD</creatorcontrib><creatorcontrib>Toyooka, Shinichi, MD</creatorcontrib><creatorcontrib>Nakagawa, Kazuhiko, Prof</creatorcontrib><creatorcontrib>Fukuoka, Masahiro, Prof</creatorcontrib><creatorcontrib>for the West Japan Oncology Group</creatorcontrib><creatorcontrib>West Japan Oncology Group</creatorcontrib><title>Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m2 , intravenously) plus docetaxel (60 mg/m2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan) , number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0–13·9) versus 6·3 months (5·8–7·8; HR 0·489, 95% CI 0·336–0·710, log-rank p<0·0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2·3%), one of whom died. Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies.</description><subject>Aged</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Clinical trials</subject><subject>Diarrhea</subject><subject>Epidermal growth factor receptors</subject><subject>Exons</subject><subject>Fatigue</subject><subject>Female</subject><subject>Gefitinib</subject><subject>Gene deletion</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hypersensitivity</subject><subject>Liver diseases</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - genetics</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Myelosuppression</subject><subject>Pharmaceuticals</subject><subject>Point mutation</subject><subject>Quinazolines - administration & dosage</subject><subject>Receptor, Epidermal Growth Factor - genetics</subject><subject>Recruitment</subject><subject>Survival</subject><subject>Taxoids - administration & dosage</subject><subject>Thyroid</subject><subject>Toxicity</subject><issn>1470-2045</issn><issn>1474-5488</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFUsFu1DAUjBCIlsIngCwutBIB23HiuAcQqmABVeqBIvZmOc5L18Wxg-209Av5LZzd0kMvnPw8mjd-b8ZF8ZzgNwST5u03wjguKWb1IRZHHFcNK9cPiv0Ms7JmbftwW-8oe8WTGC8xJpzg-nGxRzGmtMViv_izgsEk40yHriDEOSJt4mRVhtBk87X3GpL6DRYtSMbBpYiuTdog510ZR2VtqcFaZGd3gbRyGgLaqND5OZiMjHPKXd5F5AeUNoBgMj2E3Icugr_OOoPSyQcUQMO0FIc_vp6frSqG66NjpBzyEzhkVQf2NQrK9X40EXo0bVQEVKEUjLJPi0eDshGe3Z4HxfdPH89PPpenZ6svJx9OS814m0otCNWD7quW8IZRrEjd61pgKrqaNIR3rKFcYTYIrFvSsk53nHVNRWjd1pXm1UHxaqc7Bf9rhphkHmZZXznwc5SCNq1oGk4z8-U95mV2xOXhZLZfsJbjRa7ekXTwMQYY5BTMqMKNJFguOcttznIJUWIhtznLde57cSs-dyP0d13_gs2E9zsCZDOuDAQZdY5OQ2-yz0n23vz3iXf3FLTN_0Qr-xNuIN4tQ2SkEu9EFg0stgrr6i-nYs5A</recordid><startdate>20100201</startdate><enddate>20100201</enddate><creator>Mitsudomi, Tetsuya, Dr</creator><creator>Morita, Satoshi, Prof</creator><creator>Yatabe, Yasushi, MD</creator><creator>Negoro, Shunichi, MD</creator><creator>Okamoto, Isamu, MD</creator><creator>Tsurutani, Junji, MD</creator><creator>Seto, Takashi, MD</creator><creator>Satouchi, Miyako, MD</creator><creator>Tada, Hirohito, MD</creator><creator>Hirashima, Tomonori, MD</creator><creator>Asami, Kazuhiro, MD</creator><creator>Katakami, Nobuyuki, MD</creator><creator>Takada, Minoru, Prof</creator><creator>Yoshioka, Hiroshige, MD</creator><creator>Shibata, Kazuhiko, MD</creator><creator>Kudoh, Shinzoh, MD</creator><creator>Shimizu, Eiji, Prof</creator><creator>Saito, Hiroshi, MD</creator><creator>Toyooka, Shinichi, MD</creator><creator>Nakagawa, Kazuhiko, Prof</creator><creator>Fukuoka, Masahiro, Prof</creator><general>Elsevier Ltd</general><general>Elsevier Limited</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>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20100201</creationdate><title>Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial</title><author>Mitsudomi, Tetsuya, Dr ; Morita, Satoshi, Prof ; Yatabe, Yasushi, MD ; Negoro, Shunichi, MD ; Okamoto, Isamu, MD ; Tsurutani, Junji, MD ; Seto, Takashi, MD ; Satouchi, Miyako, MD ; Tada, Hirohito, MD ; Hirashima, Tomonori, MD ; Asami, Kazuhiro, MD ; Katakami, Nobuyuki, MD ; Takada, Minoru, Prof ; Yoshioka, Hiroshige, MD ; Shibata, Kazuhiko, MD ; Kudoh, Shinzoh, MD ; Shimizu, Eiji, Prof ; Saito, Hiroshi, MD ; Toyooka, Shinichi, MD ; Nakagawa, Kazuhiko, Prof ; Fukuoka, Masahiro, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c478t-c912cfcd38176420a15dc59029b51617b4627a04f90c8184bcb74b63125853c73</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Aged</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Clinical trials</topic><topic>Diarrhea</topic><topic>Epidermal growth factor receptors</topic><topic>Exons</topic><topic>Fatigue</topic><topic>Female</topic><topic>Gefitinib</topic><topic>Gene deletion</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Hypersensitivity</topic><topic>Liver diseases</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - genetics</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mutation</topic><topic>Myelosuppression</topic><topic>Pharmaceuticals</topic><topic>Point mutation</topic><topic>Quinazolines - administration & dosage</topic><topic>Receptor, Epidermal Growth Factor - genetics</topic><topic>Recruitment</topic><topic>Survival</topic><topic>Taxoids - administration & dosage</topic><topic>Thyroid</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mitsudomi, Tetsuya, Dr</creatorcontrib><creatorcontrib>Morita, Satoshi, Prof</creatorcontrib><creatorcontrib>Yatabe, Yasushi, MD</creatorcontrib><creatorcontrib>Negoro, Shunichi, MD</creatorcontrib><creatorcontrib>Okamoto, Isamu, MD</creatorcontrib><creatorcontrib>Tsurutani, Junji, MD</creatorcontrib><creatorcontrib>Seto, Takashi, MD</creatorcontrib><creatorcontrib>Satouchi, Miyako, MD</creatorcontrib><creatorcontrib>Tada, Hirohito, MD</creatorcontrib><creatorcontrib>Hirashima, Tomonori, MD</creatorcontrib><creatorcontrib>Asami, Kazuhiro, MD</creatorcontrib><creatorcontrib>Katakami, Nobuyuki, MD</creatorcontrib><creatorcontrib>Takada, Minoru, Prof</creatorcontrib><creatorcontrib>Yoshioka, Hiroshige, MD</creatorcontrib><creatorcontrib>Shibata, Kazuhiko, MD</creatorcontrib><creatorcontrib>Kudoh, Shinzoh, MD</creatorcontrib><creatorcontrib>Shimizu, Eiji, Prof</creatorcontrib><creatorcontrib>Saito, Hiroshi, MD</creatorcontrib><creatorcontrib>Toyooka, Shinichi, MD</creatorcontrib><creatorcontrib>Nakagawa, Kazuhiko, Prof</creatorcontrib><creatorcontrib>Fukuoka, Masahiro, Prof</creatorcontrib><creatorcontrib>for the West Japan Oncology Group</creatorcontrib><creatorcontrib>West Japan Oncology Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mitsudomi, Tetsuya, Dr</au><au>Morita, Satoshi, Prof</au><au>Yatabe, Yasushi, MD</au><au>Negoro, Shunichi, MD</au><au>Okamoto, Isamu, MD</au><au>Tsurutani, Junji, MD</au><au>Seto, Takashi, MD</au><au>Satouchi, Miyako, MD</au><au>Tada, Hirohito, MD</au><au>Hirashima, Tomonori, MD</au><au>Asami, Kazuhiro, MD</au><au>Katakami, Nobuyuki, MD</au><au>Takada, Minoru, Prof</au><au>Yoshioka, Hiroshige, MD</au><au>Shibata, Kazuhiko, MD</au><au>Kudoh, Shinzoh, MD</au><au>Shimizu, Eiji, Prof</au><au>Saito, Hiroshi, MD</au><au>Toyooka, Shinichi, MD</au><au>Nakagawa, Kazuhiko, Prof</au><au>Fukuoka, Masahiro, Prof</au><aucorp>for the West Japan Oncology Group</aucorp><aucorp>West Japan Oncology Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2010-02-01</date><risdate>2010</risdate><volume>11</volume><issue>2</issue><spage>121</spage><epage>128</epage><pages>121-128</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><coden>LANCAO</coden><abstract>Summary Background Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. Methods We did an open label, phase 3 study (WJTOG3405) with recruitment between March 31, 2006, and June 22, 2009, at 36 centres in Japan. 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m2 , intravenously) plus docetaxel (60 mg/m2 , intravenously; n=89), administered every 21 days for three to six cycles. The primary endpoint was progression-free survival. Survival analysis was done with the modified intention-to-treat population. This study is registered with UMIN (University Hospital Medical Information Network in Japan) , number 000000539. Findings Five patients were excluded (two patients were found to have thyroid and colon cancer after randomisation, one patient had an exon 18 mutation, one patient had insufficient consent, and one patient showed acute allergic reaction to docetaxel). Thus, 172 patients (86 in each group) were included in the survival analyses. The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup, with a median progression-free survival time of 9·2 months (95% CI 8·0–13·9) versus 6·3 months (5·8–7·8; HR 0·489, 95% CI 0·336–0·710, log-rank p<0·0001). Myelosuppression, alopecia, and fatigue were more frequent in the cisplatin plus docetaxel group, but skin toxicity, liver dysfunction, and diarrhoea were more frequent in the gefitinib group. Two patients in the gefitinib group developed interstitial lung disease (incidence 2·3%), one of whom died. Interpretation Patients with lung cancer who are selected by EGFR mutations have longer progression-free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. Funding West Japan Oncology Group (WJOG): a non-profit organisation supported by unrestricted donations from several pharmaceutical companies.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>20022809</pmid><doi>10.1016/S1470-2045(09)70364-X</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2010-02, Vol.11 (2), p.121-128 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_926896672 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Aged Antineoplastic Agents - administration & dosage Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Cisplatin Cisplatin - administration & dosage Clinical trials Diarrhea Epidermal growth factor receptors Exons Fatigue Female Gefitinib Gene deletion Hematology, Oncology and Palliative Medicine Hospitals Humans Hypersensitivity Liver diseases Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - genetics Male Middle Aged Mutation Myelosuppression Pharmaceuticals Point mutation Quinazolines - administration & dosage Receptor, Epidermal Growth Factor - genetics Recruitment Survival Taxoids - administration & dosage Thyroid Toxicity |
| title | Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial |
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