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Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study
In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC. The...
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Published in: | Clinical & translational oncology 2006-07, Vol.8 (7), p.519-524 |
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creator | Cobo-Dols, M Gil-Calle, S Villar-Chamorro, E Alés-Díaz, I Carabantes-Ocón, F Alcalde-García, J Gutiérrez-Calderón, V Montesa-Pino, A Bretón-García, J J Benavides-Orgaz, M |
description | In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC.
The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity.
The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months).
The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination. |
doi_str_mv | 10.1007/s12094-006-0052-6 |
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The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity.
The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months).
The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.</description><identifier>ISSN: 1699-048X</identifier><identifier>EISSN: 1699-3055</identifier><identifier>DOI: 10.1007/s12094-006-0052-6</identifier><identifier>PMID: 16870542</identifier><language>eng</language><publisher>Italy</publisher><subject>Adult ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Cisplatin - administration & dosage ; Female ; Humans ; Infusions, Intravenous ; Lung Neoplasms - drug therapy ; Male ; Maximum Tolerated Dose ; Middle Aged ; Survival Analysis ; Vinblastine - administration & dosage ; Vinblastine - analogs & derivatives</subject><ispartof>Clinical & translational oncology, 2006-07, Vol.8 (7), p.519-524</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c214t-142a876dbf0ac28d861630b35caf7ab4be2c0ee299d7bebb73308744044fe7b63</citedby><cites>FETCH-LOGICAL-c214t-142a876dbf0ac28d861630b35caf7ab4be2c0ee299d7bebb73308744044fe7b63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16870542$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cobo-Dols, M</creatorcontrib><creatorcontrib>Gil-Calle, S</creatorcontrib><creatorcontrib>Villar-Chamorro, E</creatorcontrib><creatorcontrib>Alés-Díaz, I</creatorcontrib><creatorcontrib>Carabantes-Ocón, F</creatorcontrib><creatorcontrib>Alcalde-García, J</creatorcontrib><creatorcontrib>Gutiérrez-Calderón, V</creatorcontrib><creatorcontrib>Montesa-Pino, A</creatorcontrib><creatorcontrib>Bretón-García, J J</creatorcontrib><creatorcontrib>Benavides-Orgaz, M</creatorcontrib><title>Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study</title><title>Clinical & translational oncology</title><addtitle>Clin Transl Oncol</addtitle><description>In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC.
The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity.
The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months).
The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.</description><subject>Adult</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carcinoma, Non-Small-Cell Lung - drug therapy</subject><subject>Cisplatin - administration & dosage</subject><subject>Female</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Lung Neoplasms - drug therapy</subject><subject>Male</subject><subject>Maximum Tolerated Dose</subject><subject>Middle Aged</subject><subject>Survival Analysis</subject><subject>Vinblastine - administration & dosage</subject><subject>Vinblastine - analogs & derivatives</subject><issn>1699-048X</issn><issn>1699-3055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><recordid>eNpFkM9KxDAQh4Mo7rr6AF4kLxBN0jRpvcnin8KCFwVvJUknbqWblKRdWHx5W3bBw8z8YOabw4fQLaP3jFL1kBinpSCUyqlyTuQZWjJZliSjeX5-ylQUXwt0ldLPdJNLxi7RgslC0VzwJfpdt6nv9NB63Hdjwjb4KY9hiq13Y2qDx_vWhwidaT1gFyIetoCHCHrYgR9wcFg3e-0tNNgHT9JOdx22MLVu9N_Yzqv4iDXutzoBrkhV4TSMzeEaXTjdJbg5zRX6fHn-WL-RzftrtX7aEMuZGAgTXBdKNsZRbXnRFJLJjJost9opbYQBbikAL8tGGTBGZRktlBBUCAfKyGyF2PGvjSGlCK7uY7vT8VAzWs8i66PIehJZzyLrmbk7Mv1odtD8Eydz2R93FXCo</recordid><startdate>200607</startdate><enddate>200607</enddate><creator>Cobo-Dols, M</creator><creator>Gil-Calle, S</creator><creator>Villar-Chamorro, E</creator><creator>Alés-Díaz, I</creator><creator>Carabantes-Ocón, F</creator><creator>Alcalde-García, J</creator><creator>Gutiérrez-Calderón, V</creator><creator>Montesa-Pino, A</creator><creator>Bretón-García, J J</creator><creator>Benavides-Orgaz, M</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>200607</creationdate><title>Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study</title><author>Cobo-Dols, M ; Gil-Calle, S ; Villar-Chamorro, E ; Alés-Díaz, I ; Carabantes-Ocón, F ; Alcalde-García, J ; Gutiérrez-Calderón, V ; Montesa-Pino, A ; Bretón-García, J J ; Benavides-Orgaz, M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c214t-142a876dbf0ac28d861630b35caf7ab4be2c0ee299d7bebb73308744044fe7b63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Adult</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carcinoma, Non-Small-Cell Lung - drug therapy</topic><topic>Cisplatin - administration & dosage</topic><topic>Female</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Lung Neoplasms - drug therapy</topic><topic>Male</topic><topic>Maximum Tolerated Dose</topic><topic>Middle Aged</topic><topic>Survival Analysis</topic><topic>Vinblastine - administration & dosage</topic><topic>Vinblastine - analogs & derivatives</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cobo-Dols, M</creatorcontrib><creatorcontrib>Gil-Calle, S</creatorcontrib><creatorcontrib>Villar-Chamorro, E</creatorcontrib><creatorcontrib>Alés-Díaz, I</creatorcontrib><creatorcontrib>Carabantes-Ocón, F</creatorcontrib><creatorcontrib>Alcalde-García, J</creatorcontrib><creatorcontrib>Gutiérrez-Calderón, V</creatorcontrib><creatorcontrib>Montesa-Pino, A</creatorcontrib><creatorcontrib>Bretón-García, J J</creatorcontrib><creatorcontrib>Benavides-Orgaz, M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Clinical & translational oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cobo-Dols, M</au><au>Gil-Calle, S</au><au>Villar-Chamorro, E</au><au>Alés-Díaz, I</au><au>Carabantes-Ocón, F</au><au>Alcalde-García, J</au><au>Gutiérrez-Calderón, V</au><au>Montesa-Pino, A</au><au>Bretón-García, J J</au><au>Benavides-Orgaz, M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study</atitle><jtitle>Clinical & translational oncology</jtitle><addtitle>Clin Transl Oncol</addtitle><date>2006-07</date><risdate>2006</risdate><volume>8</volume><issue>7</issue><spage>519</spage><epage>524</epage><pages>519-524</pages><issn>1699-048X</issn><eissn>1699-3055</eissn><abstract>In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC.
The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity.
The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months).
The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.</abstract><cop>Italy</cop><pmid>16870542</pmid><doi>10.1007/s12094-006-0052-6</doi><tpages>6</tpages></addata></record> |
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subjects | Adult Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Non-Small-Cell Lung - drug therapy Cisplatin - administration & dosage Female Humans Infusions, Intravenous Lung Neoplasms - drug therapy Male Maximum Tolerated Dose Middle Aged Survival Analysis Vinblastine - administration & dosage Vinblastine - analogs & derivatives |
title | Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study |
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