Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial
Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC. 840 patients with stage IB–IIIA NSCLC fro...
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| Veröffentlicht in: | The lancet oncology 2006-09, Vol.7 (9), p.719-727 |
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| creator | Douillard, Jean-Yves Rosell, Rafael De Lena, Mario Carpagnano, Francesco Ramlau, Rodryg Gonzáles-Larriba, Jose Luis Grodzki, Tomasz Pereira, Jose Rodrigues Le Groumellec, Alain Lorusso, Vito Clary, Claude Torres, Antonio J Dahabreh, Jabrail Souquet, Pierre-Jean Astudillo, Julio Fournel, Pierre Artal-Cortes, Angel Jassem, Jacek Koubkova, Leona His, Patricia Riggi, Marcello Hurteloup, Patrick |
| description | Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC.
840 patients with stage IB–IIIA NSCLC from 101 centres in 14 countries were randomly assigned to observation (n=433) or to 30 mg/m
2 vinorelbine plus 100 mg/m
2 cisplatin (n=407). Postoperative radiotherapy was not mandatory and was undertaken according to every centre's policy. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN95053737.
367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. 301 (36%) patients had stage IB disease, 203 (24%) had stage II disease, and 325 (39%) had stage IIIA disease. Tolerance to chemotherapy mainly included neutropenia in 335 (92%) patients and febrile neutropenia in 34 (9%); seven (2%) toxic deaths were also recorded. Compliance was greater with cisplatin than with vinorelbine (median dose intensity 89% [range 17–108]
vs 59% [17–100]). After a median follow-up of 76 months (range 43–116), median survival was 65·7 months (95% CI 47·9–88·5) in the chemotherapy group and 43·7 (35·7–52·3) months in the observation group. Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls (hazard ratio 0·80 [95% CI 0·66–0·96]; p=0·017). Overall survival at 5 years with chemotherapy improved by 8·6%, which was maintained at 7 years (8·4%).
Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC, better defining indication of adjuvant chemotherapy. |
| doi_str_mv | 10.1016/S1470-2045(06)70804-X |
| format | Article |
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840 patients with stage IB–IIIA NSCLC from 101 centres in 14 countries were randomly assigned to observation (n=433) or to 30 mg/m
2 vinorelbine plus 100 mg/m
2 cisplatin (n=407). Postoperative radiotherapy was not mandatory and was undertaken according to every centre's policy. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN95053737.
367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. 301 (36%) patients had stage IB disease, 203 (24%) had stage II disease, and 325 (39%) had stage IIIA disease. Tolerance to chemotherapy mainly included neutropenia in 335 (92%) patients and febrile neutropenia in 34 (9%); seven (2%) toxic deaths were also recorded. Compliance was greater with cisplatin than with vinorelbine (median dose intensity 89% [range 17–108]
vs 59% [17–100]). After a median follow-up of 76 months (range 43–116), median survival was 65·7 months (95% CI 47·9–88·5) in the chemotherapy group and 43·7 (35·7–52·3) months in the observation group. Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls (hazard ratio 0·80 [95% CI 0·66–0·96]; p=0·017). Overall survival at 5 years with chemotherapy improved by 8·6%, which was maintained at 7 years (8·4%).
Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC, better defining indication of adjuvant chemotherapy.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(06)70804-X</identifier><identifier>PMID: 16945766</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - pathology ; Chemotherapy, Adjuvant ; Cisplatin - administration & dosage ; Disease-Free Survival ; Female ; Humans ; Lung Neoplasms - drug therapy ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Male ; Middle Aged ; Neoplasm Staging ; Survival Rate ; Vinblastine - administration & dosage ; Vinblastine - analogs & derivatives</subject><ispartof>The lancet oncology, 2006-09, Vol.7 (9), p.719-727</ispartof><rights>2006 Elsevier Ltd</rights><rights>Copyright Elsevier Limited Sep 2006</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-d136d1a7158e81459e53a315f601f0b027499120e21bca25f39ab1509852bc1f3</citedby><cites>FETCH-LOGICAL-c442t-d136d1a7158e81459e53a315f601f0b027499120e21bca25f39ab1509852bc1f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/200922050?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976,64364,64368,72218</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16945766$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Douillard, Jean-Yves</creatorcontrib><creatorcontrib>Rosell, Rafael</creatorcontrib><creatorcontrib>De Lena, Mario</creatorcontrib><creatorcontrib>Carpagnano, Francesco</creatorcontrib><creatorcontrib>Ramlau, Rodryg</creatorcontrib><creatorcontrib>Gonzáles-Larriba, Jose Luis</creatorcontrib><creatorcontrib>Grodzki, Tomasz</creatorcontrib><creatorcontrib>Pereira, Jose Rodrigues</creatorcontrib><creatorcontrib>Le Groumellec, Alain</creatorcontrib><creatorcontrib>Lorusso, Vito</creatorcontrib><creatorcontrib>Clary, Claude</creatorcontrib><creatorcontrib>Torres, Antonio J</creatorcontrib><creatorcontrib>Dahabreh, Jabrail</creatorcontrib><creatorcontrib>Souquet, Pierre-Jean</creatorcontrib><creatorcontrib>Astudillo, Julio</creatorcontrib><creatorcontrib>Fournel, Pierre</creatorcontrib><creatorcontrib>Artal-Cortes, Angel</creatorcontrib><creatorcontrib>Jassem, Jacek</creatorcontrib><creatorcontrib>Koubkova, Leona</creatorcontrib><creatorcontrib>His, Patricia</creatorcontrib><creatorcontrib>Riggi, Marcello</creatorcontrib><creatorcontrib>Hurteloup, Patrick</creatorcontrib><title>Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC.
840 patients with stage IB–IIIA NSCLC from 101 centres in 14 countries were randomly assigned to observation (n=433) or to 30 mg/m
2 vinorelbine plus 100 mg/m
2 cisplatin (n=407). Postoperative radiotherapy was not mandatory and was undertaken according to every centre's policy. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN95053737.
367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. 301 (36%) patients had stage IB disease, 203 (24%) had stage II disease, and 325 (39%) had stage IIIA disease. Tolerance to chemotherapy mainly included neutropenia in 335 (92%) patients and febrile neutropenia in 34 (9%); seven (2%) toxic deaths were also recorded. Compliance was greater with cisplatin than with vinorelbine (median dose intensity 89% [range 17–108]
vs 59% [17–100]). After a median follow-up of 76 months (range 43–116), median survival was 65·7 months (95% CI 47·9–88·5) in the chemotherapy group and 43·7 (35·7–52·3) months in the observation group. Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls (hazard ratio 0·80 [95% CI 0·66–0·96]; p=0·017). Overall survival at 5 years with chemotherapy improved by 8·6%, which was maintained at 7 years (8·4%).
Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC, better defining indication of adjuvant chemotherapy.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - mortality</subject><subject>Carcinoma, Non-Small-Cell Lung - pathology</subject><subject>Chemotherapy, Adjuvant</subject><subject>Cisplatin - administration & dosage</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Humans</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm 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trial</title><author>Douillard, Jean-Yves ; Rosell, Rafael ; De Lena, Mario ; Carpagnano, Francesco ; Ramlau, Rodryg ; Gonzáles-Larriba, Jose Luis ; Grodzki, Tomasz ; Pereira, Jose Rodrigues ; Le Groumellec, Alain ; Lorusso, Vito ; Clary, Claude ; Torres, Antonio J ; Dahabreh, Jabrail ; Souquet, Pierre-Jean ; Astudillo, Julio ; Fournel, Pierre ; Artal-Cortes, Angel ; Jassem, Jacek ; Koubkova, Leona ; His, Patricia ; Riggi, Marcello ; Hurteloup, Patrick</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-d136d1a7158e81459e53a315f601f0b027499120e21bca25f39ab1509852bc1f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - mortality</topic><topic>Carcinoma, Non-Small-Cell Lung - pathology</topic><topic>Chemotherapy, Adjuvant</topic><topic>Cisplatin - administration & dosage</topic><topic>Disease-Free Survival</topic><topic>Female</topic><topic>Humans</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Survival Rate</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - analogs & derivatives</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Douillard, Jean-Yves</creatorcontrib><creatorcontrib>Rosell, Rafael</creatorcontrib><creatorcontrib>De Lena, Mario</creatorcontrib><creatorcontrib>Carpagnano, Francesco</creatorcontrib><creatorcontrib>Ramlau, Rodryg</creatorcontrib><creatorcontrib>Gonzáles-Larriba, Jose 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Douillard, Jean-Yves</au><au>Rosell, Rafael</au><au>De Lena, Mario</au><au>Carpagnano, Francesco</au><au>Ramlau, Rodryg</au><au>Gonzáles-Larriba, Jose Luis</au><au>Grodzki, Tomasz</au><au>Pereira, Jose Rodrigues</au><au>Le Groumellec, Alain</au><au>Lorusso, Vito</au><au>Clary, Claude</au><au>Torres, Antonio J</au><au>Dahabreh, Jabrail</au><au>Souquet, Pierre-Jean</au><au>Astudillo, Julio</au><au>Fournel, Pierre</au><au>Artal-Cortes, Angel</au><au>Jassem, Jacek</au><au>Koubkova, Leona</au><au>His, Patricia</au><au>Riggi, Marcello</au><au>Hurteloup, Patrick</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2006-09-01</date><risdate>2006</risdate><volume>7</volume><issue>9</issue><spage>719</spage><epage>727</epage><pages>719-727</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><coden>LANCAO</coden><abstract>Whether adjuvant chemotherapy improves survival of patients with non-small-cell lung cancer (NSCLC) is not known. We aimed to compare the effect of adjuvant vinorelbine plus cisplatin versus observation on survival in patients with completely resected NSCLC.
840 patients with stage IB–IIIA NSCLC from 101 centres in 14 countries were randomly assigned to observation (n=433) or to 30 mg/m
2 vinorelbine plus 100 mg/m
2 cisplatin (n=407). Postoperative radiotherapy was not mandatory and was undertaken according to every centre's policy. The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN95053737.
367 patients in the chemotherapy group and 431 in the control group received their assigned treatment. 301 (36%) patients had stage IB disease, 203 (24%) had stage II disease, and 325 (39%) had stage IIIA disease. Tolerance to chemotherapy mainly included neutropenia in 335 (92%) patients and febrile neutropenia in 34 (9%); seven (2%) toxic deaths were also recorded. Compliance was greater with cisplatin than with vinorelbine (median dose intensity 89% [range 17–108]
vs 59% [17–100]). After a median follow-up of 76 months (range 43–116), median survival was 65·7 months (95% CI 47·9–88·5) in the chemotherapy group and 43·7 (35·7–52·3) months in the observation group. Adjusted risk for death was significantly reduced in patients assigned chemotherapy compared with controls (hazard ratio 0·80 [95% CI 0·66–0·96]; p=0·017). Overall survival at 5 years with chemotherapy improved by 8·6%, which was maintained at 7 years (8·4%).
Adjuvant vinorelbine plus cisplatin extends survival in patients with completely resected NSCLC, better defining indication of adjuvant chemotherapy.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>16945766</pmid><doi>10.1016/S1470-2045(06)70804-X</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2006-09, Vol.7 (9), p.719-727 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_journals_200922050 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Adolescent Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - pathology Chemotherapy, Adjuvant Cisplatin - administration & dosage Disease-Free Survival Female Humans Lung Neoplasms - drug therapy Lung Neoplasms - mortality Lung Neoplasms - pathology Male Middle Aged Neoplasm Staging Survival Rate Vinblastine - administration & dosage Vinblastine - analogs & derivatives |
| title | Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-19T18%3A16%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Adjuvant%20vinorelbine%20plus%20cisplatin%20versus%20observation%20in%20patients%20with%20completely%20resected%20stage%20IB%E2%80%93IIIA%20non-small-cell%20lung%20cancer%20(Adjuvant%20Navelbine%20International%20Trialist%20Association%20%5BANITA%5D):%20a%20randomised%20controlled%20trial&rft.jtitle=The%20lancet%20oncology&rft.au=Douillard,%20Jean-Yves&rft.date=2006-09-01&rft.volume=7&rft.issue=9&rft.spage=719&rft.epage=727&rft.pages=719-727&rft.issn=1470-2045&rft.eissn=1474-5488&rft.coden=LANCAO&rft_id=info:doi/10.1016/S1470-2045(06)70804-X&rft_dat=%3Cproquest_cross%3E1665915831%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=200922050&rft_id=info:pmid/16945766&rft_els_id=S147020450670804X&rfr_iscdi=true |