Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation
To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in...
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| Veröffentlicht in: | Pathology oncology research 2016-10, Vol.22 (4), p.763-768 |
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| creator | An, Chaolun Zhang, Jiajun Chu, Hongjun Gu, Chunyan Xiao, Feng Zhu, Fengwei Lu, Rujian Shi, Hai Zhang, Hongfei Yi, Xin |
| description | To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in this study and randomly divided into gefitinib + placebo group and gefitinib + pemetrexed group. Pemetrexed or placebo was administered on day 1 at a dose of 500 mg/m
2
, and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (
P
0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity. |
| doi_str_mv | 10.1007/s12253-016-0067-4 |
| format | Article |
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2
, and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (
P
< 0.05). The median progression-free survival (PFS) of gefitinib + placebo group and gefitinib + pemetrexed group were 14.0 months vs. 18 months respectively and the difference was statistically significant (
P
< 0.05). The 2-year PFS rates of gefitinib + pemetrexed group (20.00 %) was higher than that of gefitinib + placebo group (8.89 %) and the difference was statistically significant (
P
< 0.05). The median overall survival (OS) of gefitinib + placebo group and gefitinib + pemetrexed group were 32.0 months vs. 34 months respectively and the difference was not statistically significant (
P
> 0.05). The 3-year OS rates of gefitinib + pemetrexed group (44.44 %) was higher than that of gefitinib + placebo group (35.56 %) but the difference was not statistically significant (
P
> 0.05). Major grade 3 or 4 hematological toxicities included neutropenia, leukopenia and anemia. The main grade 3 or 4 non-hematological toxicities were infection, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, fatigue, diarrhea and pneumonitis. The difference of toxicities between two groups was not statistically significant (
P
> 0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity.</description><identifier>ISSN: 1219-4956</identifier><identifier>EISSN: 1532-2807</identifier><identifier>DOI: 10.1007/s12253-016-0067-4</identifier><identifier>PMID: 27126186</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Aged ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biomedical and Life Sciences ; Biomedicine ; Cancer Research ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Disease Progression ; Disease-Free Survival ; Female ; Humans ; Immunology ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Male ; Mutation - genetics ; Oncology ; Original Article ; Pathology ; Pemetrexed - administration & dosage ; Protein Kinase Inhibitors - administration & dosage ; Quinazolines - administration & dosage ; Receptor, Epidermal Growth Factor - genetics ; Survival Rate</subject><ispartof>Pathology oncology research, 2016-10, Vol.22 (4), p.763-768</ispartof><rights>Arányi Lajos Foundation 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c405t-a9b571ed32ad1dd0cbbad5e4cead012cbdf3dc52b612bf225bc144b2841836663</citedby><cites>FETCH-LOGICAL-c405t-a9b571ed32ad1dd0cbbad5e4cead012cbdf3dc52b612bf225bc144b2841836663</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12253-016-0067-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12253-016-0067-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27126186$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>An, Chaolun</creatorcontrib><creatorcontrib>Zhang, Jiajun</creatorcontrib><creatorcontrib>Chu, Hongjun</creatorcontrib><creatorcontrib>Gu, Chunyan</creatorcontrib><creatorcontrib>Xiao, Feng</creatorcontrib><creatorcontrib>Zhu, Fengwei</creatorcontrib><creatorcontrib>Lu, Rujian</creatorcontrib><creatorcontrib>Shi, Hai</creatorcontrib><creatorcontrib>Zhang, Hongfei</creatorcontrib><creatorcontrib>Yi, Xin</creatorcontrib><title>Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation</title><title>Pathology oncology research</title><addtitle>Pathol. Oncol. Res</addtitle><addtitle>Pathol Oncol Res</addtitle><description>To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in this study and randomly divided into gefitinib + placebo group and gefitinib + pemetrexed group. Pemetrexed or placebo was administered on day 1 at a dose of 500 mg/m
2
, and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (
P
< 0.05). The median progression-free survival (PFS) of gefitinib + placebo group and gefitinib + pemetrexed group were 14.0 months vs. 18 months respectively and the difference was statistically significant (
P
< 0.05). The 2-year PFS rates of gefitinib + pemetrexed group (20.00 %) was higher than that of gefitinib + placebo group (8.89 %) and the difference was statistically significant (
P
< 0.05). The median overall survival (OS) of gefitinib + placebo group and gefitinib + pemetrexed group were 32.0 months vs. 34 months respectively and the difference was not statistically significant (
P
> 0.05). The 3-year OS rates of gefitinib + pemetrexed group (44.44 %) was higher than that of gefitinib + placebo group (35.56 %) but the difference was not statistically significant (
P
> 0.05). Major grade 3 or 4 hematological toxicities included neutropenia, leukopenia and anemia. The main grade 3 or 4 non-hematological toxicities were infection, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, fatigue, diarrhea and pneumonitis. The difference of toxicities between two groups was not statistically significant (
P
> 0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity.</description><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer Research</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - genetics</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>Immunology</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - genetics</subject><subject>Male</subject><subject>Mutation - genetics</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Pathology</subject><subject>Pemetrexed - administration & dosage</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Quinazolines - administration & dosage</subject><subject>Receptor, Epidermal Growth Factor - genetics</subject><subject>Survival Rate</subject><issn>1219-4956</issn><issn>1532-2807</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kc9u1DAQxi0Eou3CA3BBlrhwMXicxEmO1aq7RVqgouVs-c8EXG2cxXaAvkCfG0dbEELiYo_s3_fNaD5CXgB_A5y3bxMI0VSMg2Scy5bVj8gpNJVgouPt41IL6FndN_KEnKV0y4tG9vIpOREtCAmdPCX313l2d3Qa6BYHn33whurg6BWOmCP-REd1ohsfU2Y7H5DeRNR5xJCpD_RKZ1_KRH_4_JWeu-862KL4MAV2Per9nq6xHLs5fKHr5SvSSx3NFH15uNhuPtH3cy4WU3hGngx6n_D5w70inzcXN-tLtvu4fbc-3zFb8yYz3ZumBXSV0A6c49YY7RqsLWrHQVjjhsrZRhgJwgxlOcZCXRvR1dBVUspqRV4ffQ9x-jZjymr0yZYhdcBpTgo60fa8aQAK-uof9HaaYyjTLZTgHfCy6xWBI2XjlFLEQR2iH3W8U8DVEpI6hqRKSGoJSdVF8_LBeTYjuj-K36kUQByBdFhWhfGv1v91_QWekpyg</recordid><startdate>20161001</startdate><enddate>20161001</enddate><creator>An, Chaolun</creator><creator>Zhang, Jiajun</creator><creator>Chu, Hongjun</creator><creator>Gu, Chunyan</creator><creator>Xiao, Feng</creator><creator>Zhu, Fengwei</creator><creator>Lu, Rujian</creator><creator>Shi, Hai</creator><creator>Zhang, Hongfei</creator><creator>Yi, Xin</creator><general>Springer Netherlands</general><general>Springer Nature B.V</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>3V.</scope><scope>7RV</scope><scope>7T5</scope><scope>7TM</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</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>M7N</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>20161001</creationdate><title>Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation</title><author>An, Chaolun ; Zhang, Jiajun ; Chu, Hongjun ; Gu, Chunyan ; Xiao, Feng ; Zhu, Fengwei ; Lu, Rujian ; Shi, Hai ; Zhang, Hongfei ; Yi, Xin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c405t-a9b571ed32ad1dd0cbbad5e4cead012cbdf3dc52b612bf225bc144b2841836663</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer Research</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - genetics</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>Immunology</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - genetics</topic><topic>Male</topic><topic>Mutation - genetics</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Pathology</topic><topic>Pemetrexed - administration & dosage</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Quinazolines - administration & dosage</topic><topic>Receptor, Epidermal Growth Factor - genetics</topic><topic>Survival Rate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>An, Chaolun</creatorcontrib><creatorcontrib>Zhang, Jiajun</creatorcontrib><creatorcontrib>Chu, Hongjun</creatorcontrib><creatorcontrib>Gu, Chunyan</creatorcontrib><creatorcontrib>Xiao, Feng</creatorcontrib><creatorcontrib>Zhu, Fengwei</creatorcontrib><creatorcontrib>Lu, Rujian</creatorcontrib><creatorcontrib>Shi, Hai</creatorcontrib><creatorcontrib>Zhang, Hongfei</creatorcontrib><creatorcontrib>Yi, Xin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Proquest Nursing & Allied Health Source</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</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>Algology Mycology and Protozoology Abstracts (Microbiology C)</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><jtitle>Pathology oncology research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>An, Chaolun</au><au>Zhang, Jiajun</au><au>Chu, Hongjun</au><au>Gu, Chunyan</au><au>Xiao, Feng</au><au>Zhu, Fengwei</au><au>Lu, Rujian</au><au>Shi, Hai</au><au>Zhang, Hongfei</au><au>Yi, Xin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation</atitle><jtitle>Pathology oncology research</jtitle><stitle>Pathol. Oncol. Res</stitle><addtitle>Pathol Oncol Res</addtitle><date>2016-10-01</date><risdate>2016</risdate><volume>22</volume><issue>4</issue><spage>763</spage><epage>768</epage><pages>763-768</pages><issn>1219-4956</issn><eissn>1532-2807</eissn><abstract>To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in this study and randomly divided into gefitinib + placebo group and gefitinib + pemetrexed group. Pemetrexed or placebo was administered on day 1 at a dose of 500 mg/m
2
, and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (
P
< 0.05). The median progression-free survival (PFS) of gefitinib + placebo group and gefitinib + pemetrexed group were 14.0 months vs. 18 months respectively and the difference was statistically significant (
P
< 0.05). The 2-year PFS rates of gefitinib + pemetrexed group (20.00 %) was higher than that of gefitinib + placebo group (8.89 %) and the difference was statistically significant (
P
< 0.05). The median overall survival (OS) of gefitinib + placebo group and gefitinib + pemetrexed group were 32.0 months vs. 34 months respectively and the difference was not statistically significant (
P
> 0.05). The 3-year OS rates of gefitinib + pemetrexed group (44.44 %) was higher than that of gefitinib + placebo group (35.56 %) but the difference was not statistically significant (
P
> 0.05). Major grade 3 or 4 hematological toxicities included neutropenia, leukopenia and anemia. The main grade 3 or 4 non-hematological toxicities were infection, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, fatigue, diarrhea and pneumonitis. The difference of toxicities between two groups was not statistically significant (
P
> 0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity.</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><pmid>27126186</pmid><doi>10.1007/s12253-016-0067-4</doi><tpages>6</tpages></addata></record> |
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| ispartof | Pathology oncology research, 2016-10, Vol.22 (4), p.763-768 |
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| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Aged Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomedical and Life Sciences Biomedicine Cancer Research Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Disease Progression Disease-Free Survival Female Humans Immunology Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - genetics Male Mutation - genetics Oncology Original Article Pathology Pemetrexed - administration & dosage Protein Kinase Inhibitors - administration & dosage Quinazolines - administration & dosage Receptor, Epidermal Growth Factor - genetics Survival Rate |
| title | Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation |
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