Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)
Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles. Between 01/2007 and 03/2010 41 patients with primarily resectable...
Gespeichert in:
| Veröffentlicht in: | PloS one 2015-05, Vol.10 (5), p.e0125364 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | |
|---|---|
| container_issue | 5 |
| container_start_page | e0125364 |
| container_title | PloS one |
| container_volume | 10 |
| creator | Hilbe, Wolfgang Pall, Georg Kocher, Florian Pircher, Andreas Zabernigg, August Schmid, Thomas Schumacher, Michael Jamnig, Herbert Fiegl, Michael Gächter, Anne Freund, Martin Kendler, Dorota Manzl, Claudia Zelger, Bettina Popper, Helmut Wöll, Ewald |
| description | Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.
Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.
40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.
Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.
EU Clinical Trials Register; Eudract-Nr: 2006-004639-31. |
| doi_str_mv | 10.1371/journal.pone.0125364 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_plos_</sourceid><recordid>TN_cdi_plos_journals_1683763177</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A432553116</galeid><doaj_id>oai_doaj_org_article_3c68a99779f64d26b8b8caa0f2f9210f</doaj_id><sourcerecordid>A432553116</sourcerecordid><originalsourceid>FETCH-LOGICAL-c692t-ff917fcc30b74d761f54409579282e29d50ef784ab5434872174cc6b48cd2d243</originalsourceid><addsrcrecordid>eNqNk-9r1DAcxosobk7_A9GAIA7s2fxo0r4RZp1amLexm74NaZr0cvSaM0m33b_nX2Zuu40dKEhfpKSf5-nDk3yT5CXMJhAz-GFhRzeIfrKyg5pkEOWYkkfJPiwxSinK8OMH73vJM-8XWZbjgtKnyR6iGcpYgfeT39_HPhiphqAcOJsLr0Bdg1kY2zU4vhT9KIIZOnBxZUG1lr3ywGrw2UoVxLXq34PK-FW_YYAYWlCpMF6bpWiA8KAe2lEGYwdwrjqzVAM4c8Y6ECyYja5Tbg2irJqrpQ1z5cRqnU6FuVTgLPrFQB5cmTAH01l1UsVEoovRPqV1XR-Bd_V0mtH0Jubh8-SJFr1XL7brQfLjy_FF9S09Of1aV0cnqaQlCqnWJWRaSpw1jLSMQp0TkpU5K1GBFCrbPFOaFUQ0OcGkYAgyIiVtSCFb1CKCD5LXt76r3nq-rd9zSAvMKIaMRaK-JVorFnzlYhNuza0w_GbDuo4LF9vuFceSFqIsGSs1JS2iTdEUUohMI10imOno9XH7t7FZqnZzQk70O6a7XwYz55295IQQhugmzJutgbO_RuXDPyJvqU7EVGbQNprJpfGSHxGM8hxDSCM1-QsVn1YtjYwXUJu4vyM43BFEJqjr0InRe17Pzv-fPf25y759wM6V6MPc237cXDO_C5JbUDrrvVP6vjmY8c383LXBN_PDt_MTZa8etn4vuhsY_AepfhUi</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1683763177</pqid></control><display><type>article</type><title>Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)</title><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Public Library of Science (PLoS)</source><source>PubMed Central</source><source>Free Full-Text Journals in Chemistry</source><creator>Hilbe, Wolfgang ; Pall, Georg ; Kocher, Florian ; Pircher, Andreas ; Zabernigg, August ; Schmid, Thomas ; Schumacher, Michael ; Jamnig, Herbert ; Fiegl, Michael ; Gächter, Anne ; Freund, Martin ; Kendler, Dorota ; Manzl, Claudia ; Zelger, Bettina ; Popper, Helmut ; Wöll, Ewald</creator><contributor>Santini, Daniele</contributor><creatorcontrib>Hilbe, Wolfgang ; Pall, Georg ; Kocher, Florian ; Pircher, Andreas ; Zabernigg, August ; Schmid, Thomas ; Schumacher, Michael ; Jamnig, Herbert ; Fiegl, Michael ; Gächter, Anne ; Freund, Martin ; Kendler, Dorota ; Manzl, Claudia ; Zelger, Bettina ; Popper, Helmut ; Wöll, Ewald ; Santini, Daniele</creatorcontrib><description>Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.
Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.
40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.
Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.
EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0125364</identifier><identifier>PMID: 26020783</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adjuvant chemotherapy ; Adult ; Aged ; Angina pectoris ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Cancer therapies ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - pathology ; Carcinoma, Non-Small-Cell Lung - surgery ; Care and treatment ; Cetuximab - administration & dosage ; Cetuximab - adverse effects ; Chemotherapy ; Cisplatin ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Clinical trials ; Docetaxel ; Drug Administration Schedule ; Drug dosages ; Exanthema ; Female ; Hematology ; Hospitals ; Humans ; Immunotherapy ; Induction Chemotherapy - methods ; Internal medicine ; Leukopenia ; Lung cancer ; Lung Neoplasms - drug therapy ; Lung Neoplasms - pathology ; Lung Neoplasms - surgery ; Male ; Medical research ; Medicine ; Middle Aged ; Monoclonal antibodies ; Nausea ; Neoplasm Staging ; Neutropenia ; Non-small cell lung cancer ; Non-small cell lung carcinoma ; Oncology ; Pathology ; Patients ; Quality ; Response rates ; Studies ; Surgery ; Survival Analysis ; Targeted cancer therapy ; Taxoids - administration & dosage ; Taxoids - adverse effects ; Toxicity ; Treatment Outcome</subject><ispartof>PloS one, 2015-05, Vol.10 (5), p.e0125364</ispartof><rights>COPYRIGHT 2015 Public Library of Science</rights><rights>2015 Hilbe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Hilbe et al 2015 Hilbe et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-ff917fcc30b74d761f54409579282e29d50ef784ab5434872174cc6b48cd2d243</citedby><cites>FETCH-LOGICAL-c692t-ff917fcc30b74d761f54409579282e29d50ef784ab5434872174cc6b48cd2d243</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447267/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4447267/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,725,778,782,862,883,2098,2917,23853,27911,27912,53778,53780,79357,79358</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26020783$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Santini, Daniele</contributor><creatorcontrib>Hilbe, Wolfgang</creatorcontrib><creatorcontrib>Pall, Georg</creatorcontrib><creatorcontrib>Kocher, Florian</creatorcontrib><creatorcontrib>Pircher, Andreas</creatorcontrib><creatorcontrib>Zabernigg, August</creatorcontrib><creatorcontrib>Schmid, Thomas</creatorcontrib><creatorcontrib>Schumacher, Michael</creatorcontrib><creatorcontrib>Jamnig, Herbert</creatorcontrib><creatorcontrib>Fiegl, Michael</creatorcontrib><creatorcontrib>Gächter, Anne</creatorcontrib><creatorcontrib>Freund, Martin</creatorcontrib><creatorcontrib>Kendler, Dorota</creatorcontrib><creatorcontrib>Manzl, Claudia</creatorcontrib><creatorcontrib>Zelger, Bettina</creatorcontrib><creatorcontrib>Popper, Helmut</creatorcontrib><creatorcontrib>Wöll, Ewald</creatorcontrib><title>Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.
Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.
40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.
Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.
EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.</description><subject>Adjuvant chemotherapy</subject><subject>Adult</subject><subject>Aged</subject><subject>Angina pectoris</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Cancer therapies</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Carcinoma, Non-Small-Cell Lung - surgery</subject><subject>Care and treatment</subject><subject>Cetuximab - administration & dosage</subject><subject>Cetuximab - adverse effects</subject><subject>Chemotherapy</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Clinical trials</subject><subject>Docetaxel</subject><subject>Drug Administration Schedule</subject><subject>Drug dosages</subject><subject>Exanthema</subject><subject>Female</subject><subject>Hematology</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Immunotherapy</subject><subject>Induction Chemotherapy - methods</subject><subject>Internal medicine</subject><subject>Leukopenia</subject><subject>Lung cancer</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - pathology</subject><subject>Lung Neoplasms - surgery</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Nausea</subject><subject>Neoplasm Staging</subject><subject>Neutropenia</subject><subject>Non-small cell lung cancer</subject><subject>Non-small cell lung carcinoma</subject><subject>Oncology</subject><subject>Pathology</subject><subject>Patients</subject><subject>Quality</subject><subject>Response rates</subject><subject>Studies</subject><subject>Surgery</subject><subject>Survival Analysis</subject><subject>Targeted cancer therapy</subject><subject>Taxoids - administration & dosage</subject><subject>Taxoids - adverse effects</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk-9r1DAcxosobk7_A9GAIA7s2fxo0r4RZp1amLexm74NaZr0cvSaM0m33b_nX2Zuu40dKEhfpKSf5-nDk3yT5CXMJhAz-GFhRzeIfrKyg5pkEOWYkkfJPiwxSinK8OMH73vJM-8XWZbjgtKnyR6iGcpYgfeT39_HPhiphqAcOJsLr0Bdg1kY2zU4vhT9KIIZOnBxZUG1lr3ywGrw2UoVxLXq34PK-FW_YYAYWlCpMF6bpWiA8KAe2lEGYwdwrjqzVAM4c8Y6ECyYja5Tbg2irJqrpQ1z5cRqnU6FuVTgLPrFQB5cmTAH01l1UsVEoovRPqV1XR-Bd_V0mtH0Jubh8-SJFr1XL7brQfLjy_FF9S09Of1aV0cnqaQlCqnWJWRaSpw1jLSMQp0TkpU5K1GBFCrbPFOaFUQ0OcGkYAgyIiVtSCFb1CKCD5LXt76r3nq-rd9zSAvMKIaMRaK-JVorFnzlYhNuza0w_GbDuo4LF9vuFceSFqIsGSs1JS2iTdEUUohMI10imOno9XH7t7FZqnZzQk70O6a7XwYz55295IQQhugmzJutgbO_RuXDPyJvqU7EVGbQNprJpfGSHxGM8hxDSCM1-QsVn1YtjYwXUJu4vyM43BFEJqjr0InRe17Pzv-fPf25y759wM6V6MPc237cXDO_C5JbUDrrvVP6vjmY8c383LXBN_PDt_MTZa8etn4vuhsY_AepfhUi</recordid><startdate>20150528</startdate><enddate>20150528</enddate><creator>Hilbe, Wolfgang</creator><creator>Pall, Georg</creator><creator>Kocher, Florian</creator><creator>Pircher, Andreas</creator><creator>Zabernigg, August</creator><creator>Schmid, Thomas</creator><creator>Schumacher, Michael</creator><creator>Jamnig, Herbert</creator><creator>Fiegl, Michael</creator><creator>Gächter, Anne</creator><creator>Freund, Martin</creator><creator>Kendler, Dorota</creator><creator>Manzl, Claudia</creator><creator>Zelger, Bettina</creator><creator>Popper, Helmut</creator><creator>Wöll, Ewald</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</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>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20150528</creationdate><title>Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)</title><author>Hilbe, Wolfgang ; Pall, Georg ; Kocher, Florian ; Pircher, Andreas ; Zabernigg, August ; Schmid, Thomas ; Schumacher, Michael ; Jamnig, Herbert ; Fiegl, Michael ; Gächter, Anne ; Freund, Martin ; Kendler, Dorota ; Manzl, Claudia ; Zelger, Bettina ; Popper, Helmut ; Wöll, Ewald</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-ff917fcc30b74d761f54409579282e29d50ef784ab5434872174cc6b48cd2d243</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adjuvant chemotherapy</topic><topic>Adult</topic><topic>Aged</topic><topic>Angina pectoris</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Cancer therapies</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Carcinoma, Non-Small-Cell Lung - surgery</topic><topic>Care and treatment</topic><topic>Cetuximab - administration & dosage</topic><topic>Cetuximab - adverse effects</topic><topic>Chemotherapy</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - adverse effects</topic><topic>Clinical trials</topic><topic>Docetaxel</topic><topic>Drug Administration Schedule</topic><topic>Drug dosages</topic><topic>Exanthema</topic><topic>Female</topic><topic>Hematology</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Immunotherapy</topic><topic>Induction Chemotherapy - methods</topic><topic>Internal medicine</topic><topic>Leukopenia</topic><topic>Lung cancer</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - pathology</topic><topic>Lung Neoplasms - surgery</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Nausea</topic><topic>Neoplasm Staging</topic><topic>Neutropenia</topic><topic>Non-small cell lung cancer</topic><topic>Non-small cell lung carcinoma</topic><topic>Oncology</topic><topic>Pathology</topic><topic>Patients</topic><topic>Quality</topic><topic>Response rates</topic><topic>Studies</topic><topic>Surgery</topic><topic>Survival Analysis</topic><topic>Targeted cancer therapy</topic><topic>Taxoids - administration & dosage</topic><topic>Taxoids - adverse effects</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hilbe, Wolfgang</creatorcontrib><creatorcontrib>Pall, Georg</creatorcontrib><creatorcontrib>Kocher, Florian</creatorcontrib><creatorcontrib>Pircher, Andreas</creatorcontrib><creatorcontrib>Zabernigg, August</creatorcontrib><creatorcontrib>Schmid, Thomas</creatorcontrib><creatorcontrib>Schumacher, Michael</creatorcontrib><creatorcontrib>Jamnig, Herbert</creatorcontrib><creatorcontrib>Fiegl, Michael</creatorcontrib><creatorcontrib>Gächter, Anne</creatorcontrib><creatorcontrib>Freund, Martin</creatorcontrib><creatorcontrib>Kendler, Dorota</creatorcontrib><creatorcontrib>Manzl, Claudia</creatorcontrib><creatorcontrib>Zelger, Bettina</creatorcontrib><creatorcontrib>Popper, Helmut</creatorcontrib><creatorcontrib>Wöll, Ewald</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</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>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest One Sustainability</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection (ProQuest)</collection><collection>Natural Science Collection (ProQuest)</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hilbe, Wolfgang</au><au>Pall, Georg</au><au>Kocher, Florian</au><au>Pircher, Andreas</au><au>Zabernigg, August</au><au>Schmid, Thomas</au><au>Schumacher, Michael</au><au>Jamnig, Herbert</au><au>Fiegl, Michael</au><au>Gächter, Anne</au><au>Freund, Martin</au><au>Kendler, Dorota</au><au>Manzl, Claudia</au><au>Zelger, Bettina</au><au>Popper, Helmut</au><au>Wöll, Ewald</au><au>Santini, Daniele</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-05-28</date><risdate>2015</risdate><volume>10</volume><issue>5</issue><spage>e0125364</spage><pages>e0125364-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.
Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m2 d1+2) and docetaxel (75 mg/m2 d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m2 d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.
40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.
Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.
EU Clinical Trials Register; Eudract-Nr: 2006-004639-31.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>26020783</pmid><doi>10.1371/journal.pone.0125364</doi><tpages>e0125364</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2015-05, Vol.10 (5), p.e0125364 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1683763177 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adjuvant chemotherapy Adult Aged Angina pectoris Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Cancer therapies Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - pathology Carcinoma, Non-Small-Cell Lung - surgery Care and treatment Cetuximab - administration & dosage Cetuximab - adverse effects Chemotherapy Cisplatin Cisplatin - administration & dosage Cisplatin - adverse effects Clinical trials Docetaxel Drug Administration Schedule Drug dosages Exanthema Female Hematology Hospitals Humans Immunotherapy Induction Chemotherapy - methods Internal medicine Leukopenia Lung cancer Lung Neoplasms - drug therapy Lung Neoplasms - pathology Lung Neoplasms - surgery Male Medical research Medicine Middle Aged Monoclonal antibodies Nausea Neoplasm Staging Neutropenia Non-small cell lung cancer Non-small cell lung carcinoma Oncology Pathology Patients Quality Response rates Studies Surgery Survival Analysis Targeted cancer therapy Taxoids - administration & dosage Taxoids - adverse effects Toxicity Treatment Outcome |
| title | Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-15T10%3A44%3A03IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Multicenter%20Phase%20II%20Study%20Evaluating%20Two%20Cycles%20of%20Docetaxel,%20Cisplatin%20and%20Cetuximab%20as%20Induction%20Regimen%20Prior%20to%20Surgery%20in%20Chemotherapy-Naive%20Patients%20with%20NSCLC%20Stage%20IB-IIIA%20(INN06-Study)&rft.jtitle=PloS%20one&rft.au=Hilbe,%20Wolfgang&rft.date=2015-05-28&rft.volume=10&rft.issue=5&rft.spage=e0125364&rft.pages=e0125364-&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0125364&rft_dat=%3Cgale_plos_%3EA432553116%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1683763177&rft_id=info:pmid/26020783&rft_galeid=A432553116&rft_doaj_id=oai_doaj_org_article_3c68a99779f64d26b8b8caa0f2f9210f&rfr_iscdi=true |