Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial
Maintenance chemotherapy is a reasonable choice for patients with metastatic non–small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients. We conducted a randomised trial in patient...
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| Veröffentlicht in: | European journal of cancer (1990) 2020-10, Vol.138, p.193-201 |
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| creator | Quoix, Elisabeth Audigier-Valette, Clarisse Lavolé, Armelle Molinier, Olivier Westeel, Virginie Barlesi, Fabrice Le Treut, Jacques Pichon, Eric Dauba, Jérôme Otto, Josiane Moreau, Lionel Madelaine, Jeannick Dumont, Patrick Margery, Jacques Debieuvre, Didier Renault, Patrick Aldo Pujol, Jean-Louis Langlais, Alexandra Morin, Franck Moro-Sibilot, Denis Souquet, Pierre-Jean |
| description | Maintenance chemotherapy is a reasonable choice for patients with metastatic non–small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
We conducted a randomised trial in patients aged 70–89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non–squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0–2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0–17.0) in the observation arm and 14 months (95% CI: 10.9–16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6–3.1) in the observation arm versus 5.7 months (95% CI: 4.8–7.1) in the maintenance arm (p |
| doi_str_mv | 10.1016/j.ejca.2020.07.034 |
| format | Article |
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We conducted a randomised trial in patients aged 70–89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non–squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0–2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0–17.0) in the observation arm and 14 months (95% CI: 10.9–16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6–3.1) in the observation arm versus 5.7 months (95% CI: 4.8–7.1) in the maintenance arm (p < 0.001).
Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.
•Chemotherapy remains a backbone in lung cancer treatment.•Maintenance chemotherapy has proven beneficial in non–small cell lung carcinoma with metastatic stage.•There is a selection bias for older patients included in non-dedicated studies.•This trial shows that elderly do not derive any survival benefit with maintenance.•It illustrates that dedicated studies for elderly patients are mandatory.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2020.07.034</identifier><identifier>PMID: 32898792</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject><![CDATA[Age Factors ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic ; Antimetabolites, Antineoplastic - administration & dosage ; Antimetabolites, Antineoplastic - adverse effects ; Antineoplastic Combined Chemotherapy Protocols ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer ; Carboplatin ; Carboplatin - administration & dosage ; Carboplatin - adverse effects ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - mortality ; Carcinoma, Non-Small-Cell Lung - secondary ; Chemotherapy ; Confidence intervals ; Creatinine ; Deoxycytidine ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Disease Progression ; Drug Administration Schedule ; Drug Substitution ; Elderly ; Epidermal growth factor receptors ; Female ; France ; Gemcitabine ; Humans ; Induction therapy ; Life Sciences ; Lung cancer ; Lung carcinoma ; Lung Neoplasms ; Lung Neoplasms - drug therapy ; Lung Neoplasms - mortality ; Lung Neoplasms - pathology ; Maintenance ; Maintenance Chemotherapy ; Male ; Metastases ; Mutation ; Neoplasm Staging ; Non-small cell lung carcinoma ; NSCLC ; Older people ; Paclitaxel ; Paclitaxel - administration & dosage ; Paclitaxel - adverse effects ; Pemetrexed ; Pemetrexed - administration & dosage ; Pemetrexed - adverse effects ; Platinum ; Progression-Free Survival ; Randomization ; Small cell lung carcinoma ; Squamous cell carcinoma ; Survival ; Time Factors]]></subject><ispartof>European journal of cancer (1990), 2020-10, Vol.138, p.193-201</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Oct 2020</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c418t-d980b2ceb354e1ba1e4cd5cf7753f1eb78e78feff36734dd1422d96588425ac03</citedby><cites>FETCH-LOGICAL-c418t-d980b2ceb354e1ba1e4cd5cf7753f1eb78e78feff36734dd1422d96588425ac03</cites><orcidid>0000-0002-7510-2787 ; 0000-0003-2358-3694 ; 0000-0001-5793-3539 ; 0000-0001-9465-0693</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0959804920304342$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32898792$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.umontpellier.fr/hal-03339864$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Quoix, Elisabeth</creatorcontrib><creatorcontrib>Audigier-Valette, Clarisse</creatorcontrib><creatorcontrib>Lavolé, Armelle</creatorcontrib><creatorcontrib>Molinier, Olivier</creatorcontrib><creatorcontrib>Westeel, Virginie</creatorcontrib><creatorcontrib>Barlesi, Fabrice</creatorcontrib><creatorcontrib>Le Treut, Jacques</creatorcontrib><creatorcontrib>Pichon, Eric</creatorcontrib><creatorcontrib>Dauba, Jérôme</creatorcontrib><creatorcontrib>Otto, Josiane</creatorcontrib><creatorcontrib>Moreau, Lionel</creatorcontrib><creatorcontrib>Madelaine, Jeannick</creatorcontrib><creatorcontrib>Dumont, Patrick</creatorcontrib><creatorcontrib>Margery, Jacques</creatorcontrib><creatorcontrib>Debieuvre, Didier</creatorcontrib><creatorcontrib>Renault, Patrick Aldo</creatorcontrib><creatorcontrib>Pujol, Jean-Louis</creatorcontrib><creatorcontrib>Langlais, Alexandra</creatorcontrib><creatorcontrib>Morin, Franck</creatorcontrib><creatorcontrib>Moro-Sibilot, Denis</creatorcontrib><creatorcontrib>Souquet, Pierre-Jean</creatorcontrib><title>Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Maintenance chemotherapy is a reasonable choice for patients with metastatic non–small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
We conducted a randomised trial in patients aged 70–89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non–squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0–2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0–17.0) in the observation arm and 14 months (95% CI: 10.9–16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6–3.1) in the observation arm versus 5.7 months (95% CI: 4.8–7.1) in the maintenance arm (p < 0.001).
Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.
•Chemotherapy remains a backbone in lung cancer treatment.•Maintenance chemotherapy has proven beneficial in non–small cell lung carcinoma with metastatic stage.•There is a selection bias for older patients included in non-dedicated studies.•This trial shows that elderly do not derive any survival benefit with maintenance.•It illustrates that dedicated studies for elderly patients are mandatory.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antimetabolites, Antineoplastic</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antimetabolites, Antineoplastic - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer</subject><subject>Carboplatin</subject><subject>Carboplatin - administration & dosage</subject><subject>Carboplatin - adverse effects</subject><subject>Carcinoma, Non-Small-Cell Lung</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Carcinoma, Non-Small-Cell Lung - mortality</subject><subject>Carcinoma, Non-Small-Cell Lung - secondary</subject><subject>Chemotherapy</subject><subject>Confidence intervals</subject><subject>Creatinine</subject><subject>Deoxycytidine</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease Progression</subject><subject>Drug Administration Schedule</subject><subject>Drug Substitution</subject><subject>Elderly</subject><subject>Epidermal growth factor receptors</subject><subject>Female</subject><subject>France</subject><subject>Gemcitabine</subject><subject>Humans</subject><subject>Induction therapy</subject><subject>Life Sciences</subject><subject>Lung cancer</subject><subject>Lung carcinoma</subject><subject>Lung Neoplasms</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Lung Neoplasms - mortality</subject><subject>Lung Neoplasms - pathology</subject><subject>Maintenance</subject><subject>Maintenance Chemotherapy</subject><subject>Male</subject><subject>Metastases</subject><subject>Mutation</subject><subject>Neoplasm Staging</subject><subject>Non-small cell lung carcinoma</subject><subject>NSCLC</subject><subject>Older people</subject><subject>Paclitaxel</subject><subject>Paclitaxel - administration & dosage</subject><subject>Paclitaxel - adverse effects</subject><subject>Pemetrexed</subject><subject>Pemetrexed - administration & dosage</subject><subject>Pemetrexed - adverse effects</subject><subject>Platinum</subject><subject>Progression-Free Survival</subject><subject>Randomization</subject><subject>Small cell lung carcinoma</subject><subject>Squamous cell carcinoma</subject><subject>Survival</subject><subject>Time Factors</subject><issn>0959-8049</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxiMEokvhBTggS5w4JPhfEgdxqZaWVlrUA-VsOfaE9eKNF9vZsjfegWfiRXgSHLZU4sLFlmZ-832j-YriOcEVwaR5valgo1VFMcUVbivM-INiQUTblVjU9GGxwF3dlQLz7qR4EuMGY9wKjh8XJ4yKLnN0Ufz8eGuTXqOtsmOCUY0akF7D1qc1BLU7oD2EOEXk-whhr5L1I1JDgoC0Cr3fuVzKldGgW4Av7oB2Sjub1DdwyPipd5D-1cs0OAPhD5osjCmivMIaKbOf3Q0a_fjr-4-4Vc4hDflx0_g52-VmeIOuLpY3JaGYoA_X785XKAWr3NPi0aBchGd3_2nx6eL8ZnlZrq7fXy3PVqXmRKTSdAL3VEPPag6kVwS4NrUe2rZmA4G-FdCKAYaBNS3jxhBOqemaWghOa6UxOy1eHXXXysldsFsVDtIrKy_PVnKuYcZYJxq-J5l9eWR3wX-dICa58VMY83qS8oZgRttmpuiR0sHHGGC4lyVYzinLjZxTlnPKErfZgeehF3fSU78Fcz_yN9YMvD0CkI-xtxBk1PnU-bo2gE7SePs__d97dLzc</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Quoix, Elisabeth</creator><creator>Audigier-Valette, Clarisse</creator><creator>Lavolé, Armelle</creator><creator>Molinier, Olivier</creator><creator>Westeel, Virginie</creator><creator>Barlesi, Fabrice</creator><creator>Le Treut, Jacques</creator><creator>Pichon, Eric</creator><creator>Dauba, Jérôme</creator><creator>Otto, Josiane</creator><creator>Moreau, Lionel</creator><creator>Madelaine, Jeannick</creator><creator>Dumont, Patrick</creator><creator>Margery, Jacques</creator><creator>Debieuvre, Didier</creator><creator>Renault, Patrick Aldo</creator><creator>Pujol, Jean-Louis</creator><creator>Langlais, Alexandra</creator><creator>Morin, Franck</creator><creator>Moro-Sibilot, Denis</creator><creator>Souquet, Pierre-Jean</creator><general>Elsevier Ltd</general><general>Elsevier Science Ltd</general><general>Elsevier</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TO</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-7510-2787</orcidid><orcidid>https://orcid.org/0000-0003-2358-3694</orcidid><orcidid>https://orcid.org/0000-0001-5793-3539</orcidid><orcidid>https://orcid.org/0000-0001-9465-0693</orcidid></search><sort><creationdate>202010</creationdate><title>Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial</title><author>Quoix, Elisabeth ; Audigier-Valette, Clarisse ; Lavolé, Armelle ; Molinier, Olivier ; Westeel, Virginie ; Barlesi, Fabrice ; Le Treut, Jacques ; Pichon, Eric ; Dauba, Jérôme ; Otto, Josiane ; Moreau, Lionel ; Madelaine, Jeannick ; Dumont, Patrick ; Margery, Jacques ; Debieuvre, Didier ; Renault, Patrick Aldo ; Pujol, Jean-Louis ; Langlais, Alexandra ; Morin, Franck ; Moro-Sibilot, Denis ; Souquet, Pierre-Jean</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c418t-d980b2ceb354e1ba1e4cd5cf7753f1eb78e78feff36734dd1422d96588425ac03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antimetabolites, Antineoplastic</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antimetabolites, Antineoplastic - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer</topic><topic>Carboplatin</topic><topic>Carboplatin - administration & dosage</topic><topic>Carboplatin - adverse effects</topic><topic>Carcinoma, Non-Small-Cell Lung</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Carcinoma, Non-Small-Cell Lung - mortality</topic><topic>Carcinoma, Non-Small-Cell Lung - secondary</topic><topic>Chemotherapy</topic><topic>Confidence intervals</topic><topic>Creatinine</topic><topic>Deoxycytidine</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease Progression</topic><topic>Drug Administration Schedule</topic><topic>Drug Substitution</topic><topic>Elderly</topic><topic>Epidermal growth factor receptors</topic><topic>Female</topic><topic>France</topic><topic>Gemcitabine</topic><topic>Humans</topic><topic>Induction therapy</topic><topic>Life Sciences</topic><topic>Lung cancer</topic><topic>Lung carcinoma</topic><topic>Lung Neoplasms</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Lung Neoplasms - mortality</topic><topic>Lung Neoplasms - pathology</topic><topic>Maintenance</topic><topic>Maintenance Chemotherapy</topic><topic>Male</topic><topic>Metastases</topic><topic>Mutation</topic><topic>Neoplasm Staging</topic><topic>Non-small cell lung carcinoma</topic><topic>NSCLC</topic><topic>Older people</topic><topic>Paclitaxel</topic><topic>Paclitaxel - administration & dosage</topic><topic>Paclitaxel - adverse effects</topic><topic>Pemetrexed</topic><topic>Pemetrexed - administration & dosage</topic><topic>Pemetrexed - adverse effects</topic><topic>Platinum</topic><topic>Progression-Free Survival</topic><topic>Randomization</topic><topic>Small cell lung carcinoma</topic><topic>Squamous cell carcinoma</topic><topic>Survival</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Quoix, Elisabeth</creatorcontrib><creatorcontrib>Audigier-Valette, Clarisse</creatorcontrib><creatorcontrib>Lavolé, Armelle</creatorcontrib><creatorcontrib>Molinier, Olivier</creatorcontrib><creatorcontrib>Westeel, Virginie</creatorcontrib><creatorcontrib>Barlesi, Fabrice</creatorcontrib><creatorcontrib>Le Treut, Jacques</creatorcontrib><creatorcontrib>Pichon, Eric</creatorcontrib><creatorcontrib>Dauba, Jérôme</creatorcontrib><creatorcontrib>Otto, Josiane</creatorcontrib><creatorcontrib>Moreau, Lionel</creatorcontrib><creatorcontrib>Madelaine, Jeannick</creatorcontrib><creatorcontrib>Dumont, Patrick</creatorcontrib><creatorcontrib>Margery, Jacques</creatorcontrib><creatorcontrib>Debieuvre, Didier</creatorcontrib><creatorcontrib>Renault, Patrick Aldo</creatorcontrib><creatorcontrib>Pujol, Jean-Louis</creatorcontrib><creatorcontrib>Langlais, Alexandra</creatorcontrib><creatorcontrib>Morin, Franck</creatorcontrib><creatorcontrib>Moro-Sibilot, Denis</creatorcontrib><creatorcontrib>Souquet, Pierre-Jean</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Quoix, Elisabeth</au><au>Audigier-Valette, Clarisse</au><au>Lavolé, Armelle</au><au>Molinier, Olivier</au><au>Westeel, Virginie</au><au>Barlesi, Fabrice</au><au>Le Treut, Jacques</au><au>Pichon, Eric</au><au>Dauba, Jérôme</au><au>Otto, Josiane</au><au>Moreau, Lionel</au><au>Madelaine, Jeannick</au><au>Dumont, Patrick</au><au>Margery, Jacques</au><au>Debieuvre, Didier</au><au>Renault, Patrick Aldo</au><au>Pujol, Jean-Louis</au><au>Langlais, Alexandra</au><au>Morin, Franck</au><au>Moro-Sibilot, Denis</au><au>Souquet, Pierre-Jean</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2020-10</date><risdate>2020</risdate><volume>138</volume><spage>193</spage><epage>201</epage><pages>193-201</pages><issn>0959-8049</issn><eissn>1879-0852</eissn><abstract>Maintenance chemotherapy is a reasonable choice for patients with metastatic non–small cell lung carcinoma (NSCLC) not progressing after induction therapy with a platinum-based doublet. Nevertheless, there have been no studies dedicated to elderly patients.
We conducted a randomised trial in patients aged 70–89 years, with advanced NSCLC (with neither EGFR mutation nor ALK rearrangement), who had not progressed after four cycles of monthly carboplatin and weekly paclitaxel in order to compare maintenance with either pemetrexed (500 mg/m2 d1, 22) in patients with non–squamous cell carcinoma or gemcitabine (1,150 mg/m2 d1, 8, 22) in squamous cell carcinoma to simple observation. The patients were required to have a performance status (PS) 0–2, mini-mental score >23, and creatinine clearance ≥45 mL/min. The primary end-point was overall survival (OS).
632 patients were enrolled from May 2013 to October 2016. Of the 328 (52.3%) patients randomised after induction therapy, 166 patients were assigned to the observation arm, versus 162 to the switch maintenance arm, 119 of whom received pemetrexed and 43 gemcitabine. The median OS from randomisation was 14.1 months (95% confidence interval [CI]: 12.0–17.0) in the observation arm and 14 months (95% CI: 10.9–16.9) in the maintenance arm (p = 0.72). The median progression-free survival (PFS) from randomisation was 2.7 months (95% CI: 2.6–3.1) in the observation arm versus 5.7 months (95% CI: 4.8–7.1) in the maintenance arm (p < 0.001).
Switch maintenance therapy significantly prolonged PFS but not OS and, thus, should not be proposed to elderly patients with advanced NSCLC.
•Chemotherapy remains a backbone in lung cancer treatment.•Maintenance chemotherapy has proven beneficial in non–small cell lung carcinoma with metastatic stage.•There is a selection bias for older patients included in non-dedicated studies.•This trial shows that elderly do not derive any survival benefit with maintenance.•It illustrates that dedicated studies for elderly patients are mandatory.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>32898792</pmid><doi>10.1016/j.ejca.2020.07.034</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-7510-2787</orcidid><orcidid>https://orcid.org/0000-0003-2358-3694</orcidid><orcidid>https://orcid.org/0000-0001-5793-3539</orcidid><orcidid>https://orcid.org/0000-0001-9465-0693</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0959-8049 |
| ispartof | European journal of cancer (1990), 2020-10, Vol.138, p.193-201 |
| issn | 0959-8049 1879-0852 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03339864v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Age Factors Aged Aged, 80 and over Antimetabolites, Antineoplastic Antimetabolites, Antineoplastic - administration & dosage Antimetabolites, Antineoplastic - adverse effects Antineoplastic Combined Chemotherapy Protocols Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer Carboplatin Carboplatin - administration & dosage Carboplatin - adverse effects Carcinoma, Non-Small-Cell Lung Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - mortality Carcinoma, Non-Small-Cell Lung - secondary Chemotherapy Confidence intervals Creatinine Deoxycytidine Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Disease Progression Drug Administration Schedule Drug Substitution Elderly Epidermal growth factor receptors Female France Gemcitabine Humans Induction therapy Life Sciences Lung cancer Lung carcinoma Lung Neoplasms Lung Neoplasms - drug therapy Lung Neoplasms - mortality Lung Neoplasms - pathology Maintenance Maintenance Chemotherapy Male Metastases Mutation Neoplasm Staging Non-small cell lung carcinoma NSCLC Older people Paclitaxel Paclitaxel - administration & dosage Paclitaxel - adverse effects Pemetrexed Pemetrexed - administration & dosage Pemetrexed - adverse effects Platinum Progression-Free Survival Randomization Small cell lung carcinoma Squamous cell carcinoma Survival Time Factors |
| title | Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non–small cell lung cancer: IFCT-1201 MODEL trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-18T23%3A15%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Switch%20maintenance%20chemotherapy%20versus%20observation%20after%20carboplatin%20and%20weekly%20paclitaxel%20doublet%20chemotherapy%20in%20elderly%20patients%20with%20advanced%20non%E2%80%93small%20cell%20lung%20cancer:%20IFCT-1201%20MODEL%20trial&rft.jtitle=European%20journal%20of%20cancer%20(1990)&rft.au=Quoix,%20Elisabeth&rft.date=2020-10&rft.volume=138&rft.spage=193&rft.epage=201&rft.pages=193-201&rft.issn=0959-8049&rft.eissn=1879-0852&rft_id=info:doi/10.1016/j.ejca.2020.07.034&rft_dat=%3Cproquest_hal_p%3E2461032761%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2461032761&rft_id=info:pmid/32898792&rft_els_id=S0959804920304342&rfr_iscdi=true |