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Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02
Purpose Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined “suboptimal” pts as those with PS ECOG = 2, weight loss 10–25 % and/or age...
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Published in: | Cancer chemotherapy and pharmacology 2015-02, Vol.75 (2), p.319-324 |
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container_title | Cancer chemotherapy and pharmacology |
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creator | Rivera, F. Massutí, B. Salcedo, M. Sastre, J. Martínez Galán, J. Valladares-Ayerbes, M. Serrano, R. de Paredes, Mª. L. García Manzano, J. L. Galán, M. Alsina, M. Yuste Izquierdo, A. L. López, C. Díaz-Rubio, E. Conde, V. Reboredo, M. Cano, Mª. T. Pachón, V. Aranda, E. |
description | Purpose
Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined “suboptimal” pts as those with PS ECOG = 2, weight loss 10–25 % and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials.
Methods
We explored in 43 previously untreated “suboptimal” AGC pts the effect of “miniDOX” regimen (D: 40 mg/m
2
iv, day 1; O: 80 mg/m
2
iv, day 1; C: 625 mg/m
2
po bid, day 1 to day 21, every 21 days; after six courses, only C was maintained). Primary end point was response rate (RR), and secondary end points were adverse events (AE), progression-free survival (PFS) and overall survival (OS).
Results
Patients characteristics: PS ECOG = 2: 12 pts; weight loss 10–25 %: 23 pts; median age 73.3 years (range 40–87; 28 pts were ≥70 years); 32 males; locally advanced: 8 pts/metastatic: 35 pts; primary site: gastric 32 pts/EGJ 11. Worst AE per pt (grade 3–4): neutropenia: 5 pts (febrile neutropenia: 3); pulmonary embolism (PE): 4 pts (3 of them suffered sudden death); diarrhea: 9 pts; paronychia: 2 pts; ictus: 1 pt; renal failure: 1 pt (this pt suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome: 4 pts and asthenia: 5 pts. Response: CR: 1 pt, PR: 23 pts (RR: 56 %), SD: 12 pts, progression: 3 pts, no determined: 4 pts. Median and 1 year actuarial PFS and OS were 5.5 months/18 % and 13.3 months/52 %, respectively.
Conclusions
Although miniDOX’s toxicity (mainly PE)has been important, its activity has been promising in “suboptimal” pts with AGC, and this combination should be further investigated in this setting. |
doi_str_mv | 10.1007/s00280-014-2641-3 |
format | article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1647888767</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3567965411</sourcerecordid><originalsourceid>FETCH-LOGICAL-c442t-22172d56d6f628648b1213afc0689c526aee497e5b630fe5a700a04b891c3e153</originalsourceid><addsrcrecordid>eNp1kc9u1DAQxi0EokvhAbggS1zag8v4TxzvsdpCWalSOSwSN8txJq2rbBJsB8qt78ANwcv1SfBqC-LCaTSa33yfZj5CXnI44QD1mwQgDDDgigmtOJOPyIIrKRgYJR-TBUilWFWDOiDPUroBAMWlfEoORKWWXBq-ID8-XLuEdL2mOQbX07Gj2zCEs8tP9ChiO3tsaTsWoh09ZneL_f3d9_HW9WHqXQ5D6byb0IfsmjDgMQ0Dvb_7meZmnHLYuoL_olMhcciJfg35mrr2ixt2ulcuFVNP_a6N9Oj0fHV8QjebMwqGgXhOnnSuT_jioR6Sj-_eblbv2cXl-Xp1esG8UiIzIXgt2kq3utPCaGUaLrh0nQdtlr4S2iGqZY1VoyV0WLkawIFqzJJ7ibySh-T1XneK4-cZU7Y34xyHYmm5VrUxptZ1ofie8nFMKWJnp1jui98sB7tLw-7TsCUNu0vDyrLz6kF5brbY_t348_4CiD2Qymi4wviP9X9VfwOohJdP</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1647888767</pqid></control><display><type>article</type><title>Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02</title><source>Springer Nature:Jisc Collections:Springer Nature Read and Publish 2023-2025: Springer Reading List</source><creator>Rivera, F. ; Massutí, B. ; Salcedo, M. ; Sastre, J. ; Martínez Galán, J. ; Valladares-Ayerbes, M. ; Serrano, R. ; de Paredes, Mª. L. García ; Manzano, J. L. ; Galán, M. ; Alsina, M. ; Yuste Izquierdo, A. L. ; López, C. ; Díaz-Rubio, E. ; Conde, V. ; Reboredo, M. ; Cano, Mª. T. ; Pachón, V. ; Aranda, E.</creator><creatorcontrib>Rivera, F. ; Massutí, B. ; Salcedo, M. ; Sastre, J. ; Martínez Galán, J. ; Valladares-Ayerbes, M. ; Serrano, R. ; de Paredes, Mª. L. García ; Manzano, J. L. ; Galán, M. ; Alsina, M. ; Yuste Izquierdo, A. L. ; López, C. ; Díaz-Rubio, E. ; Conde, V. ; Reboredo, M. ; Cano, Mª. T. ; Pachón, V. ; Aranda, E.</creatorcontrib><description>Purpose
Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined “suboptimal” pts as those with PS ECOG = 2, weight loss 10–25 % and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials.
Methods
We explored in 43 previously untreated “suboptimal” AGC pts the effect of “miniDOX” regimen (D: 40 mg/m
2
iv, day 1; O: 80 mg/m
2
iv, day 1; C: 625 mg/m
2
po bid, day 1 to day 21, every 21 days; after six courses, only C was maintained). Primary end point was response rate (RR), and secondary end points were adverse events (AE), progression-free survival (PFS) and overall survival (OS).
Results
Patients characteristics: PS ECOG = 2: 12 pts; weight loss 10–25 %: 23 pts; median age 73.3 years (range 40–87; 28 pts were ≥70 years); 32 males; locally advanced: 8 pts/metastatic: 35 pts; primary site: gastric 32 pts/EGJ 11. Worst AE per pt (grade 3–4): neutropenia: 5 pts (febrile neutropenia: 3); pulmonary embolism (PE): 4 pts (3 of them suffered sudden death); diarrhea: 9 pts; paronychia: 2 pts; ictus: 1 pt; renal failure: 1 pt (this pt suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome: 4 pts and asthenia: 5 pts. Response: CR: 1 pt, PR: 23 pts (RR: 56 %), SD: 12 pts, progression: 3 pts, no determined: 4 pts. Median and 1 year actuarial PFS and OS were 5.5 months/18 % and 13.3 months/52 %, respectively.
Conclusions
Although miniDOX’s toxicity (mainly PE)has been important, its activity has been promising in “suboptimal” pts with AGC, and this combination should be further investigated in this setting.</description><identifier>ISSN: 0344-5704</identifier><identifier>EISSN: 1432-0843</identifier><identifier>DOI: 10.1007/s00280-014-2641-3</identifier><identifier>PMID: 25491381</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject><![CDATA[Adult ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic - administration & dosage ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents, Phytogenic - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Cancer Research ; Capecitabine ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Deoxycytidine - therapeutic use ; Disease-Free Survival ; Endpoint Determination ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Fluorouracil - analogs & derivatives ; Fluorouracil - therapeutic use ; Humans ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Organoplatinum Compounds - therapeutic use ; Original Article ; Patient Selection ; Pharmacology/Toxicology ; Stomach Neoplasms - drug therapy ; Survival Analysis ; Taxoids - administration & dosage ; Taxoids - adverse effects ; Taxoids - therapeutic use ; Treatment Outcome ; Weight Loss - drug effects]]></subject><ispartof>Cancer chemotherapy and pharmacology, 2015-02, Vol.75 (2), p.319-324</ispartof><rights>Springer-Verlag Berlin Heidelberg 2014</rights><rights>Springer-Verlag Berlin Heidelberg 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-22172d56d6f628648b1213afc0689c526aee497e5b630fe5a700a04b891c3e153</citedby><cites>FETCH-LOGICAL-c442t-22172d56d6f628648b1213afc0689c526aee497e5b630fe5a700a04b891c3e153</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,786,790,27957,27958</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25491381$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rivera, F.</creatorcontrib><creatorcontrib>Massutí, B.</creatorcontrib><creatorcontrib>Salcedo, M.</creatorcontrib><creatorcontrib>Sastre, J.</creatorcontrib><creatorcontrib>Martínez Galán, J.</creatorcontrib><creatorcontrib>Valladares-Ayerbes, M.</creatorcontrib><creatorcontrib>Serrano, R.</creatorcontrib><creatorcontrib>de Paredes, Mª. L. García</creatorcontrib><creatorcontrib>Manzano, J. L.</creatorcontrib><creatorcontrib>Galán, M.</creatorcontrib><creatorcontrib>Alsina, M.</creatorcontrib><creatorcontrib>Yuste Izquierdo, A. L.</creatorcontrib><creatorcontrib>López, C.</creatorcontrib><creatorcontrib>Díaz-Rubio, E.</creatorcontrib><creatorcontrib>Conde, V.</creatorcontrib><creatorcontrib>Reboredo, M.</creatorcontrib><creatorcontrib>Cano, Mª. T.</creatorcontrib><creatorcontrib>Pachón, V.</creatorcontrib><creatorcontrib>Aranda, E.</creatorcontrib><title>Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02</title><title>Cancer chemotherapy and pharmacology</title><addtitle>Cancer Chemother Pharmacol</addtitle><addtitle>Cancer Chemother Pharmacol</addtitle><description>Purpose
Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined “suboptimal” pts as those with PS ECOG = 2, weight loss 10–25 % and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials.
Methods
We explored in 43 previously untreated “suboptimal” AGC pts the effect of “miniDOX” regimen (D: 40 mg/m
2
iv, day 1; O: 80 mg/m
2
iv, day 1; C: 625 mg/m
2
po bid, day 1 to day 21, every 21 days; after six courses, only C was maintained). Primary end point was response rate (RR), and secondary end points were adverse events (AE), progression-free survival (PFS) and overall survival (OS).
Results
Patients characteristics: PS ECOG = 2: 12 pts; weight loss 10–25 %: 23 pts; median age 73.3 years (range 40–87; 28 pts were ≥70 years); 32 males; locally advanced: 8 pts/metastatic: 35 pts; primary site: gastric 32 pts/EGJ 11. Worst AE per pt (grade 3–4): neutropenia: 5 pts (febrile neutropenia: 3); pulmonary embolism (PE): 4 pts (3 of them suffered sudden death); diarrhea: 9 pts; paronychia: 2 pts; ictus: 1 pt; renal failure: 1 pt (this pt suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome: 4 pts and asthenia: 5 pts. Response: CR: 1 pt, PR: 23 pts (RR: 56 %), SD: 12 pts, progression: 3 pts, no determined: 4 pts. Median and 1 year actuarial PFS and OS were 5.5 months/18 % and 13.3 months/52 %, respectively.
Conclusions
Although miniDOX’s toxicity (mainly PE)has been important, its activity has been promising in “suboptimal” pts with AGC, and this combination should be further investigated in this setting.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antimetabolites, Antineoplastic - administration & dosage</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents, Phytogenic - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</subject><subject>Antineoplastic Combined Chemotherapy Protocols - adverse effects</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Cancer Research</subject><subject>Capecitabine</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Deoxycytidine - therapeutic use</subject><subject>Disease-Free Survival</subject><subject>Endpoint Determination</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Fluorouracil - analogs & derivatives</subject><subject>Fluorouracil - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Organoplatinum Compounds - therapeutic use</subject><subject>Original Article</subject><subject>Patient Selection</subject><subject>Pharmacology/Toxicology</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Survival Analysis</subject><subject>Taxoids - administration & dosage</subject><subject>Taxoids - adverse effects</subject><subject>Taxoids - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Weight Loss - drug effects</subject><issn>0344-5704</issn><issn>1432-0843</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNp1kc9u1DAQxi0EokvhAbggS1zag8v4TxzvsdpCWalSOSwSN8txJq2rbBJsB8qt78ANwcv1SfBqC-LCaTSa33yfZj5CXnI44QD1mwQgDDDgigmtOJOPyIIrKRgYJR-TBUilWFWDOiDPUroBAMWlfEoORKWWXBq-ID8-XLuEdL2mOQbX07Gj2zCEs8tP9ChiO3tsaTsWoh09ZneL_f3d9_HW9WHqXQ5D6byb0IfsmjDgMQ0Dvb_7meZmnHLYuoL_olMhcciJfg35mrr2ixt2ulcuFVNP_a6N9Oj0fHV8QjebMwqGgXhOnnSuT_jioR6Sj-_eblbv2cXl-Xp1esG8UiIzIXgt2kq3utPCaGUaLrh0nQdtlr4S2iGqZY1VoyV0WLkawIFqzJJ7ibySh-T1XneK4-cZU7Y34xyHYmm5VrUxptZ1ofie8nFMKWJnp1jui98sB7tLw-7TsCUNu0vDyrLz6kF5brbY_t348_4CiD2Qymi4wviP9X9VfwOohJdP</recordid><startdate>20150201</startdate><enddate>20150201</enddate><creator>Rivera, F.</creator><creator>Massutí, B.</creator><creator>Salcedo, M.</creator><creator>Sastre, J.</creator><creator>Martínez Galán, J.</creator><creator>Valladares-Ayerbes, M.</creator><creator>Serrano, R.</creator><creator>de Paredes, Mª. L. García</creator><creator>Manzano, J. L.</creator><creator>Galán, M.</creator><creator>Alsina, M.</creator><creator>Yuste Izquierdo, A. L.</creator><creator>López, C.</creator><creator>Díaz-Rubio, E.</creator><creator>Conde, V.</creator><creator>Reboredo, M.</creator><creator>Cano, Mª. T.</creator><creator>Pachón, V.</creator><creator>Aranda, E.</creator><general>Springer Berlin Heidelberg</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>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</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>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>20150201</creationdate><title>Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02</title><author>Rivera, F. ; Massutí, B. ; Salcedo, M. ; Sastre, J. ; Martínez Galán, J. ; Valladares-Ayerbes, M. ; Serrano, R. ; de Paredes, Mª. L. García ; Manzano, J. L. ; Galán, M. ; Alsina, M. ; Yuste Izquierdo, A. L. ; López, C. ; Díaz-Rubio, E. ; Conde, V. ; Reboredo, M. ; Cano, Mª. T. ; Pachón, V. ; Aranda, E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-22172d56d6f628648b1213afc0689c526aee497e5b630fe5a700a04b891c3e153</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antimetabolites, Antineoplastic - administration & dosage</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents, Phytogenic - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - administration & dosage</topic><topic>Antineoplastic Combined Chemotherapy Protocols - adverse effects</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Cancer Research</topic><topic>Capecitabine</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Deoxycytidine - therapeutic use</topic><topic>Disease-Free Survival</topic><topic>Endpoint Determination</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - adverse effects</topic><topic>Fluorouracil - analogs & derivatives</topic><topic>Fluorouracil - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Organoplatinum Compounds - therapeutic use</topic><topic>Original Article</topic><topic>Patient Selection</topic><topic>Pharmacology/Toxicology</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Survival Analysis</topic><topic>Taxoids - administration & dosage</topic><topic>Taxoids - adverse effects</topic><topic>Taxoids - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Weight Loss - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rivera, F.</creatorcontrib><creatorcontrib>Massutí, B.</creatorcontrib><creatorcontrib>Salcedo, M.</creatorcontrib><creatorcontrib>Sastre, J.</creatorcontrib><creatorcontrib>Martínez Galán, J.</creatorcontrib><creatorcontrib>Valladares-Ayerbes, M.</creatorcontrib><creatorcontrib>Serrano, R.</creatorcontrib><creatorcontrib>de Paredes, Mª. L. García</creatorcontrib><creatorcontrib>Manzano, J. L.</creatorcontrib><creatorcontrib>Galán, M.</creatorcontrib><creatorcontrib>Alsina, M.</creatorcontrib><creatorcontrib>Yuste Izquierdo, A. L.</creatorcontrib><creatorcontrib>López, C.</creatorcontrib><creatorcontrib>Díaz-Rubio, E.</creatorcontrib><creatorcontrib>Conde, V.</creatorcontrib><creatorcontrib>Reboredo, M.</creatorcontrib><creatorcontrib>Cano, Mª. T.</creatorcontrib><creatorcontrib>Pachón, V.</creatorcontrib><creatorcontrib>Aranda, E.</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>Oncogenes and Growth Factors Abstracts</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>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</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>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Cancer chemotherapy and pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rivera, F.</au><au>Massutí, B.</au><au>Salcedo, M.</au><au>Sastre, J.</au><au>Martínez Galán, J.</au><au>Valladares-Ayerbes, M.</au><au>Serrano, R.</au><au>de Paredes, Mª. L. García</au><au>Manzano, J. L.</au><au>Galán, M.</au><au>Alsina, M.</au><au>Yuste Izquierdo, A. L.</au><au>López, C.</au><au>Díaz-Rubio, E.</au><au>Conde, V.</au><au>Reboredo, M.</au><au>Cano, Mª. T.</au><au>Pachón, V.</au><au>Aranda, E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02</atitle><jtitle>Cancer chemotherapy and pharmacology</jtitle><stitle>Cancer Chemother Pharmacol</stitle><addtitle>Cancer Chemother Pharmacol</addtitle><date>2015-02-01</date><risdate>2015</risdate><volume>75</volume><issue>2</issue><spage>319</spage><epage>324</epage><pages>319-324</pages><issn>0344-5704</issn><eissn>1432-0843</eissn><abstract>Purpose
Chemotherapy has improved the overall survival (OS) in patients (pts) with advanced gastric cancer (AGC). Docetaxel (D), oxaliplatin (O) and capecitabine (C) have shown interesting activity in this setting. We defined “suboptimal” pts as those with PS ECOG = 2, weight loss 10–25 % and/or age ≥70 years. This population is usually underrepresented in AGC clinical trials.
Methods
We explored in 43 previously untreated “suboptimal” AGC pts the effect of “miniDOX” regimen (D: 40 mg/m
2
iv, day 1; O: 80 mg/m
2
iv, day 1; C: 625 mg/m
2
po bid, day 1 to day 21, every 21 days; after six courses, only C was maintained). Primary end point was response rate (RR), and secondary end points were adverse events (AE), progression-free survival (PFS) and overall survival (OS).
Results
Patients characteristics: PS ECOG = 2: 12 pts; weight loss 10–25 %: 23 pts; median age 73.3 years (range 40–87; 28 pts were ≥70 years); 32 males; locally advanced: 8 pts/metastatic: 35 pts; primary site: gastric 32 pts/EGJ 11. Worst AE per pt (grade 3–4): neutropenia: 5 pts (febrile neutropenia: 3); pulmonary embolism (PE): 4 pts (3 of them suffered sudden death); diarrhea: 9 pts; paronychia: 2 pts; ictus: 1 pt; renal failure: 1 pt (this pt suffered infection/bacteriemia without neutropenia and died); hand-foot syndrome: 4 pts and asthenia: 5 pts. Response: CR: 1 pt, PR: 23 pts (RR: 56 %), SD: 12 pts, progression: 3 pts, no determined: 4 pts. Median and 1 year actuarial PFS and OS were 5.5 months/18 % and 13.3 months/52 %, respectively.
Conclusions
Although miniDOX’s toxicity (mainly PE)has been important, its activity has been promising in “suboptimal” pts with AGC, and this combination should be further investigated in this setting.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>25491381</pmid><doi>10.1007/s00280-014-2641-3</doi><tpages>6</tpages></addata></record> |
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identifier | ISSN: 0344-5704 |
ispartof | Cancer chemotherapy and pharmacology, 2015-02, Vol.75 (2), p.319-324 |
issn | 0344-5704 1432-0843 |
language | eng |
recordid | cdi_proquest_journals_1647888767 |
source | Springer Nature:Jisc Collections:Springer Nature Read and Publish 2023-2025: Springer Reading List |
subjects | Adult Aged Aged, 80 and over Antimetabolites, Antineoplastic - administration & dosage Antineoplastic Agents - administration & dosage Antineoplastic Agents, Phytogenic - administration & dosage Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer Research Capecitabine Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Deoxycytidine - therapeutic use Disease-Free Survival Endpoint Determination Female Fluorouracil - administration & dosage Fluorouracil - adverse effects Fluorouracil - analogs & derivatives Fluorouracil - therapeutic use Humans Male Medicine Medicine & Public Health Middle Aged Oncology Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - adverse effects Organoplatinum Compounds - therapeutic use Original Article Patient Selection Pharmacology/Toxicology Stomach Neoplasms - drug therapy Survival Analysis Taxoids - administration & dosage Taxoids - adverse effects Taxoids - therapeutic use Treatment Outcome Weight Loss - drug effects |
title | Phase II trial of miniDOX (reduced dose docetaxel–oxaliplatin–capecitabine) in “suboptimal” patients with advanced gastric cancer (AGC). TTD 08-02 |
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