Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting

Background Weekly paclitaxel has been shown more effective and less toxic than the conventional three-weekly administration. The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m 2 of paclitaxel given over 8 weeks (w). This schedule has been adopted at our instit...

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Veröffentlicht in:Breast cancer (Tokyo, Japan) Japan), 2016-03, Vol.23 (2), p.261-265
Hauptverfasser: Santana, Iuri A., Oliveira, Julia Andrade, da Silva Lima, Julianne Maria, Testa, Laura, Piato, José Roberto M., Hoff, Paulo M., Mano, Max S.
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container_end_page 265
container_issue 2
container_start_page 261
container_title Breast cancer (Tokyo, Japan)
container_volume 23
creator Santana, Iuri A.
Oliveira, Julia Andrade
da Silva Lima, Julianne Maria
Testa, Laura
Piato, José Roberto M.
Hoff, Paulo M.
Mano, Max S.
description Background Weekly paclitaxel has been shown more effective and less toxic than the conventional three-weekly administration. The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m 2 of paclitaxel given over 8 weeks (w). This schedule has been adopted at our institution in 2009 for HER2-negative disease, and herein, we present the first off-trial experience and compare its safety profile with that of a historical cohort of patients treated with the conventional 80 mg/m 2 over 12 w schedule. Methods Retrospective single-center chart review of patients with locally advanced breast cancer treated with (neo)adjuvant paclitaxel-based therapy from 2008 to 2012 with (1) 80 mg/m 2 for 12 w or (2) 100 mg/m 2 for 8 w. Adverse events were graded according to common terminology criteria for adverse events (CTCAE) 4.0. Results A total of 326 patients were analyzed. Median age was 52 (±10.9). Seventy and 256 patients received schedule (1) and (2), respectively. No significant difference was observed in the incidence of grade (G) 3/4 toxicity: pneumonitis (2.8 vs 0.3 % p  = 0.097); neuropathy (2.8 vs 0.7 % p  = 0.303); hand–foot syndrome (1.4 vs 0.3 % p  = 0.538); anemia (0 vs 0.6 % p  = 0.624); and neutropenia (5.7 vs 6.2 % p  = 0.408). Also, no significant difference was seen when comparing all grades toxicity. Schedule (2) had higher dose intensity: 97.72 vs 77.07 mg/m 2 per week ( p  
doi_str_mv 10.1007/s12282-014-0564-9
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The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m 2 of paclitaxel given over 8 weeks (w). This schedule has been adopted at our institution in 2009 for HER2-negative disease, and herein, we present the first off-trial experience and compare its safety profile with that of a historical cohort of patients treated with the conventional 80 mg/m 2 over 12 w schedule. Methods Retrospective single-center chart review of patients with locally advanced breast cancer treated with (neo)adjuvant paclitaxel-based therapy from 2008 to 2012 with (1) 80 mg/m 2 for 12 w or (2) 100 mg/m 2 for 8 w. Adverse events were graded according to common terminology criteria for adverse events (CTCAE) 4.0. Results A total of 326 patients were analyzed. Median age was 52 (±10.9). Seventy and 256 patients received schedule (1) and (2), respectively. No significant difference was observed in the incidence of grade (G) 3/4 toxicity: pneumonitis (2.8 vs 0.3 % p  = 0.097); neuropathy (2.8 vs 0.7 % p  = 0.303); hand–foot syndrome (1.4 vs 0.3 % p  = 0.538); anemia (0 vs 0.6 % p  = 0.624); and neutropenia (5.7 vs 6.2 % p  = 0.408). Also, no significant difference was seen when comparing all grades toxicity. Schedule (2) had higher dose intensity: 97.72 vs 77.07 mg/m 2 per week ( p  &lt; 0.0001). Conclusions Weekly paclitaxel given according to GEICAM 9906 is pragmatic and well tolerated, with safety profile consistent with the conventional schedule. In addition to being convenient to patients, it may also be cost-effective because of a lower number of clinic visits and infusions.</description><identifier>ISSN: 1340-6868</identifier><identifier>EISSN: 1880-4233</identifier><identifier>DOI: 10.1007/s12282-014-0564-9</identifier><identifier>PMID: 25234137</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Adjuvant treatment ; Adult ; Aged ; Antineoplastic Agents, Phytogenic - therapeutic use ; Biomarkers, Tumor - metabolism ; Brazil ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - pathology ; Cancer ; Cancer Research ; Care and treatment ; Drug Administration Schedule ; Feasibility Studies ; Female ; Follow-Up Studies ; Humans ; Immunoenzyme Techniques ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Neoplasm Staging ; Oncology ; Original Article ; Paclitaxel - therapeutic use ; Prognosis ; Receptor, ErbB-2 - metabolism ; Receptors, Estrogen - metabolism ; Receptors, Progesterone - metabolism ; Retrospective Studies ; Surgery ; Surgical Oncology ; Survival Rate</subject><ispartof>Breast cancer (Tokyo, Japan), 2016-03, Vol.23 (2), p.261-265</ispartof><rights>The Japanese Breast Cancer Society 2014</rights><rights>COPYRIGHT 2016 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c505t-526178ca3d1cfaf85c1f83c8bf7c2e9b83527cef3bec96269468f8ff5b6db0de3</citedby><cites>FETCH-LOGICAL-c505t-526178ca3d1cfaf85c1f83c8bf7c2e9b83527cef3bec96269468f8ff5b6db0de3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12282-014-0564-9$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12282-014-0564-9$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,777,781,27905,27906,41469,42538,51300</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25234137$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Santana, Iuri A.</creatorcontrib><creatorcontrib>Oliveira, Julia Andrade</creatorcontrib><creatorcontrib>da Silva Lima, Julianne Maria</creatorcontrib><creatorcontrib>Testa, Laura</creatorcontrib><creatorcontrib>Piato, José Roberto M.</creatorcontrib><creatorcontrib>Hoff, Paulo M.</creatorcontrib><creatorcontrib>Mano, Max S.</creatorcontrib><title>Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting</title><title>Breast cancer (Tokyo, Japan)</title><addtitle>Breast Cancer</addtitle><addtitle>Breast Cancer</addtitle><description>Background Weekly paclitaxel has been shown more effective and less toxic than the conventional three-weekly administration. The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m 2 of paclitaxel given over 8 weeks (w). This schedule has been adopted at our institution in 2009 for HER2-negative disease, and herein, we present the first off-trial experience and compare its safety profile with that of a historical cohort of patients treated with the conventional 80 mg/m 2 over 12 w schedule. Methods Retrospective single-center chart review of patients with locally advanced breast cancer treated with (neo)adjuvant paclitaxel-based therapy from 2008 to 2012 with (1) 80 mg/m 2 for 12 w or (2) 100 mg/m 2 for 8 w. Adverse events were graded according to common terminology criteria for adverse events (CTCAE) 4.0. Results A total of 326 patients were analyzed. Median age was 52 (±10.9). Seventy and 256 patients received schedule (1) and (2), respectively. No significant difference was observed in the incidence of grade (G) 3/4 toxicity: pneumonitis (2.8 vs 0.3 % p  = 0.097); neuropathy (2.8 vs 0.7 % p  = 0.303); hand–foot syndrome (1.4 vs 0.3 % p  = 0.538); anemia (0 vs 0.6 % p  = 0.624); and neutropenia (5.7 vs 6.2 % p  = 0.408). Also, no significant difference was seen when comparing all grades toxicity. Schedule (2) had higher dose intensity: 97.72 vs 77.07 mg/m 2 per week ( p  &lt; 0.0001). Conclusions Weekly paclitaxel given according to GEICAM 9906 is pragmatic and well tolerated, with safety profile consistent with the conventional schedule. In addition to being convenient to patients, it may also be cost-effective because of a lower number of clinic visits and infusions.</description><subject>Adjuvant treatment</subject><subject>Adult</subject><subject>Aged</subject><subject>Antineoplastic Agents, Phytogenic - therapeutic use</subject><subject>Biomarkers, Tumor - metabolism</subject><subject>Brazil</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - pathology</subject><subject>Cancer</subject><subject>Cancer Research</subject><subject>Care and treatment</subject><subject>Drug Administration Schedule</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immunoenzyme Techniques</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Paclitaxel - therapeutic use</subject><subject>Prognosis</subject><subject>Receptor, ErbB-2 - metabolism</subject><subject>Receptors, Estrogen - metabolism</subject><subject>Receptors, Progesterone - metabolism</subject><subject>Retrospective Studies</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Survival Rate</subject><issn>1340-6868</issn><issn>1880-4233</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kU9rFTEUxYMotlY_gBsJuHGTmj8zSWZZS2uFgiC6DpnMzTN1JnkmM30-P70ZpgqCSCC53PzOSbgHoZeMnjNK1dvCONecUNYQ2sqGdI_QKdOakoYL8bjWoqFEaqlP0LNS7ihthKLyKTrhLRcNE-oUHa7BltCHMcxHnDyeDwkX9xWGZYSyNg4A38Yj3ltXEfsDRhwivrn6xEmEnZ3DPWCwuRJ9rk4zdjY6yCtk8btsf1ZnG7FL07TE9Y0C8xzi7jl64u1Y4MXDeYa-XF99vrwhtx_ff7i8uCWupe1MWi6Z0s6KgTlvvW4d81o43XvlOHS9Fi1XDrzowXWSy66R2mvv214OPR1AnKE3m-8-p-8LlNlMoTgYRxshLcUwpShnUtGuoq83dGdHMCH6NGfrVtxcqDppVbeVOv8HVdcAU3Apgg-1_5eAbQKXUykZvNnnMNl8NIyaNUazxWhqjGaN0ayaVw-_XvoJhj-K37lVgG9AqVdxB9ncpSXHOsn_uP4ClVCoYw</recordid><startdate>20160301</startdate><enddate>20160301</enddate><creator>Santana, Iuri A.</creator><creator>Oliveira, Julia Andrade</creator><creator>da Silva Lima, Julianne Maria</creator><creator>Testa, Laura</creator><creator>Piato, José Roberto M.</creator><creator>Hoff, Paulo M.</creator><creator>Mano, Max S.</creator><general>Springer Japan</general><general>Springer</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>7X8</scope></search><sort><creationdate>20160301</creationdate><title>Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting</title><author>Santana, Iuri A. ; Oliveira, Julia Andrade ; da Silva Lima, Julianne Maria ; Testa, Laura ; Piato, José Roberto M. ; Hoff, Paulo M. ; Mano, Max S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c505t-526178ca3d1cfaf85c1f83c8bf7c2e9b83527cef3bec96269468f8ff5b6db0de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adjuvant treatment</topic><topic>Adult</topic><topic>Aged</topic><topic>Antineoplastic Agents, Phytogenic - therapeutic use</topic><topic>Biomarkers, Tumor - metabolism</topic><topic>Brazil</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - pathology</topic><topic>Cancer</topic><topic>Cancer Research</topic><topic>Care and treatment</topic><topic>Drug Administration Schedule</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Immunoenzyme Techniques</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Paclitaxel - therapeutic use</topic><topic>Prognosis</topic><topic>Receptor, ErbB-2 - metabolism</topic><topic>Receptors, Estrogen - metabolism</topic><topic>Receptors, Progesterone - metabolism</topic><topic>Retrospective Studies</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Survival Rate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Santana, Iuri A.</creatorcontrib><creatorcontrib>Oliveira, Julia Andrade</creatorcontrib><creatorcontrib>da Silva Lima, Julianne Maria</creatorcontrib><creatorcontrib>Testa, Laura</creatorcontrib><creatorcontrib>Piato, José Roberto M.</creatorcontrib><creatorcontrib>Hoff, Paulo M.</creatorcontrib><creatorcontrib>Mano, Max S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Breast cancer (Tokyo, Japan)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Santana, Iuri A.</au><au>Oliveira, Julia Andrade</au><au>da Silva Lima, Julianne Maria</au><au>Testa, Laura</au><au>Piato, José Roberto M.</au><au>Hoff, Paulo M.</au><au>Mano, Max S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting</atitle><jtitle>Breast cancer (Tokyo, Japan)</jtitle><stitle>Breast Cancer</stitle><addtitle>Breast Cancer</addtitle><date>2016-03-01</date><risdate>2016</risdate><volume>23</volume><issue>2</issue><spage>261</spage><epage>265</epage><pages>261-265</pages><issn>1340-6868</issn><eissn>1880-4233</eissn><abstract>Background Weekly paclitaxel has been shown more effective and less toxic than the conventional three-weekly administration. The GEICAM 9906 demonstrated effectiveness and safety of a dose-dense schedule of 100 mg/m 2 of paclitaxel given over 8 weeks (w). This schedule has been adopted at our institution in 2009 for HER2-negative disease, and herein, we present the first off-trial experience and compare its safety profile with that of a historical cohort of patients treated with the conventional 80 mg/m 2 over 12 w schedule. Methods Retrospective single-center chart review of patients with locally advanced breast cancer treated with (neo)adjuvant paclitaxel-based therapy from 2008 to 2012 with (1) 80 mg/m 2 for 12 w or (2) 100 mg/m 2 for 8 w. Adverse events were graded according to common terminology criteria for adverse events (CTCAE) 4.0. Results A total of 326 patients were analyzed. Median age was 52 (±10.9). Seventy and 256 patients received schedule (1) and (2), respectively. No significant difference was observed in the incidence of grade (G) 3/4 toxicity: pneumonitis (2.8 vs 0.3 % p  = 0.097); neuropathy (2.8 vs 0.7 % p  = 0.303); hand–foot syndrome (1.4 vs 0.3 % p  = 0.538); anemia (0 vs 0.6 % p  = 0.624); and neutropenia (5.7 vs 6.2 % p  = 0.408). Also, no significant difference was seen when comparing all grades toxicity. Schedule (2) had higher dose intensity: 97.72 vs 77.07 mg/m 2 per week ( p  &lt; 0.0001). Conclusions Weekly paclitaxel given according to GEICAM 9906 is pragmatic and well tolerated, with safety profile consistent with the conventional schedule. In addition to being convenient to patients, it may also be cost-effective because of a lower number of clinic visits and infusions.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>25234137</pmid><doi>10.1007/s12282-014-0564-9</doi><tpages>5</tpages></addata></record>
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subjects Adjuvant treatment
Adult
Aged
Antineoplastic Agents, Phytogenic - therapeutic use
Biomarkers, Tumor - metabolism
Brazil
Breast cancer
Breast Neoplasms - drug therapy
Breast Neoplasms - pathology
Cancer
Cancer Research
Care and treatment
Drug Administration Schedule
Feasibility Studies
Female
Follow-Up Studies
Humans
Immunoenzyme Techniques
Medicine
Medicine & Public Health
Middle Aged
Neoplasm Staging
Oncology
Original Article
Paclitaxel - therapeutic use
Prognosis
Receptor, ErbB-2 - metabolism
Receptors, Estrogen - metabolism
Receptors, Progesterone - metabolism
Retrospective Studies
Surgery
Surgical Oncology
Survival Rate
title Feasibility of two schedules of weekly paclitaxel in HER2-negative early breast cancer in a Brazilian community setting
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