Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02)
The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with maintenance of paclitaxel plus gemcitabine...
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| Veröffentlicht in: | Breast cancer research and treatment 2015-07, Vol.152 (1), p.77-85 |
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| creator | Park, Yeon Hee Jung, Kyung Hae Im, Seock-Ah Sohn, Joo Hyuk Ro, Jungsil Ahn, Jin-Hee Kim, Sung-Bae Nam, Byung-Ho Oh, Do Youn Han, Sae-Won Lee, Soohyeon Park, In Hae Lee, Keun Seok Kim, Jee Hyun Kang, Seok Yun Lee, Moon Hee Park, Hee Sook Woo, Sook Young Jung, Sin-Ho Ahn, Jin Seok Im, Young-Hyuck |
| description | The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with maintenance of paclitaxel plus gemcitabine (PG) chemotherapy after achieving disease control to initial six cycles of PG chemotherapy or observation. Patients were randomized to either maintenance chemotherapy or observation until progression. QoL was assessed using EORTC QLQ-C30 and BR-23. QoL at each cycle was compared between the two treatment arms using the 2-sample
t
test. Generalized estimating equation method was used to examine the overall difference between the two treatments in QoL. All reported p-values are 2 sided. There were no statistically significant differences between two arms in most of the component of the EORTC QLQ-C30 and BR-23 (
p
> 0.05). There was no significant difference between two treatments (
p
= 0.6094 for QLQ-C30,
p
= 0.5516 for BR23) at baseline, and there did not exist significant change over the cycle (
p
= 0.0914 for QLQ-C30,
p
= 0.7981 for BR23). There was no significant interaction effect between treatment and cycle (
p
= 0.5543 for QLQ-C30.
p
= 0.5817 for BR23). Maintenance PG chemotherapy in patients with MBC achieving disease control with an initial six cycles of PG chemotherapy resulted in better PFS and OS compared to observation without impeding QoL. |
| doi_str_mv | 10.1007/s10549-015-3450-z |
| format | Article |
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t
test. Generalized estimating equation method was used to examine the overall difference between the two treatments in QoL. All reported p-values are 2 sided. There were no statistically significant differences between two arms in most of the component of the EORTC QLQ-C30 and BR-23 (
p
> 0.05). There was no significant difference between two treatments (
p
= 0.6094 for QLQ-C30,
p
= 0.5516 for BR23) at baseline, and there did not exist significant change over the cycle (
p
= 0.0914 for QLQ-C30,
p
= 0.7981 for BR23). There was no significant interaction effect between treatment and cycle (
p
= 0.5543 for QLQ-C30.
p
= 0.5817 for BR23). Maintenance PG chemotherapy in patients with MBC achieving disease control with an initial six cycles of PG chemotherapy resulted in better PFS and OS compared to observation without impeding QoL.</description><identifier>ISSN: 0167-6806</identifier><identifier>EISSN: 1573-7217</identifier><identifier>DOI: 10.1007/s10549-015-3450-z</identifier><identifier>PMID: 26033708</identifier><identifier>CODEN: BCTRD6</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Adult ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - pathology ; Cancer research ; Cancer therapies ; Chemotherapy ; Clinical Trial ; Deoxycytidine - administration & dosage ; Deoxycytidine - analogs & derivatives ; Disease management ; Female ; Humans ; Maintenance Chemotherapy ; Medicine ; Medicine & Public Health ; Neoplasm Metastasis ; Oncology ; Paclitaxel - administration & dosage ; Quality of Life ; Treatment Outcome</subject><ispartof>Breast cancer research and treatment, 2015-07, Vol.152 (1), p.77-85</ispartof><rights>Springer Science+Business Media New York 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-6f4b4b7d8f935791fcc0f900476ac8034d9f3a8c29f318ad2497c720f676135c3</citedby><cites>FETCH-LOGICAL-c442t-6f4b4b7d8f935791fcc0f900476ac8034d9f3a8c29f318ad2497c720f676135c3</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/s10549-015-3450-z$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10549-015-3450-z$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26033708$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Park, Yeon Hee</creatorcontrib><creatorcontrib>Jung, Kyung Hae</creatorcontrib><creatorcontrib>Im, Seock-Ah</creatorcontrib><creatorcontrib>Sohn, Joo Hyuk</creatorcontrib><creatorcontrib>Ro, Jungsil</creatorcontrib><creatorcontrib>Ahn, Jin-Hee</creatorcontrib><creatorcontrib>Kim, Sung-Bae</creatorcontrib><creatorcontrib>Nam, Byung-Ho</creatorcontrib><creatorcontrib>Oh, Do Youn</creatorcontrib><creatorcontrib>Han, Sae-Won</creatorcontrib><creatorcontrib>Lee, Soohyeon</creatorcontrib><creatorcontrib>Park, In Hae</creatorcontrib><creatorcontrib>Lee, Keun Seok</creatorcontrib><creatorcontrib>Kim, Jee Hyun</creatorcontrib><creatorcontrib>Kang, Seok Yun</creatorcontrib><creatorcontrib>Lee, Moon Hee</creatorcontrib><creatorcontrib>Park, Hee Sook</creatorcontrib><creatorcontrib>Woo, Sook Young</creatorcontrib><creatorcontrib>Jung, Sin-Ho</creatorcontrib><creatorcontrib>Ahn, Jin Seok</creatorcontrib><creatorcontrib>Im, Young-Hyuck</creatorcontrib><creatorcontrib>Korean Cancer Study Group (KCSG)</creatorcontrib><title>Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02)</title><title>Breast cancer research and treatment</title><addtitle>Breast Cancer Res Treat</addtitle><addtitle>Breast Cancer Res Treat</addtitle><description>The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with maintenance of paclitaxel plus gemcitabine (PG) chemotherapy after achieving disease control to initial six cycles of PG chemotherapy or observation. Patients were randomized to either maintenance chemotherapy or observation until progression. QoL was assessed using EORTC QLQ-C30 and BR-23. QoL at each cycle was compared between the two treatment arms using the 2-sample
t
test. Generalized estimating equation method was used to examine the overall difference between the two treatments in QoL. All reported p-values are 2 sided. There were no statistically significant differences between two arms in most of the component of the EORTC QLQ-C30 and BR-23 (
p
> 0.05). There was no significant difference between two treatments (
p
= 0.6094 for QLQ-C30,
p
= 0.5516 for BR23) at baseline, and there did not exist significant change over the cycle (
p
= 0.0914 for QLQ-C30,
p
= 0.7981 for BR23). There was no significant interaction effect between treatment and cycle (
p
= 0.5543 for QLQ-C30.
p
= 0.5817 for BR23). Maintenance PG chemotherapy in patients with MBC achieving disease control with an initial six cycles of PG chemotherapy resulted in better PFS and OS compared to observation without impeding QoL.</description><subject>Adult</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - pathology</subject><subject>Cancer research</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Clinical Trial</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Disease management</subject><subject>Female</subject><subject>Humans</subject><subject>Maintenance Chemotherapy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Neoplasm Metastasis</subject><subject>Oncology</subject><subject>Paclitaxel - administration & dosage</subject><subject>Quality of Life</subject><subject>Treatment Outcome</subject><issn>0167-6806</issn><issn>1573-7217</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1Ul2P0zAQjBCIKwc_gBdkiZdWusA6ceKEN6iOUlEJjo_nyHHWV58SO9jOce2P5jfgqgeqkHhae2d2ZqWdJHlO4RUF4K89hYLVKdAizVkB6f5BMqMFz1OeUf4wmQEteVpWUJ4lT7y_AYCaQ_04OctKyHMO1Sz5dTWJXocdsYr0WiGZX9nNgmhDBgzCBxG0JK3D-CRSGImOjLGHJnjyU4ctGYQ2Ac0BioiMWuIOezL2kyfXOMj4b7WJup9XCyK3ONiwRSfG3Rvi0E991FHODmTcCo9kvV5fkCF2tYwW6C6IE6azg95jR4LToj8seup5Kklu0fnoa1uP7jauaQ2Zf1x-XaXvvgBPIVs8TR4p0Xt8dl_Pk-_vL78tP6SbT6v18u0mlYxlIS0Va1nLu0rVecFrqqQEVQMwXgpZQc66WuWiklkstBJdxmoueQaq5CXNC5mfJ_Oj7ujsjwl9aAbtJfa9MGgn39Cyqst4JKCR-vIf6o2dnInbHVgVY7wAHln0yJLOeu9QNaPTg3C7hkJzCENzDEMTw9AcwtDs48yLe-WpHbD7O_Hn-pGQHQk-QuYa3Yn1f1V_A8j1wtQ</recordid><startdate>20150701</startdate><enddate>20150701</enddate><creator>Park, Yeon Hee</creator><creator>Jung, Kyung Hae</creator><creator>Im, Seock-Ah</creator><creator>Sohn, Joo Hyuk</creator><creator>Ro, Jungsil</creator><creator>Ahn, Jin-Hee</creator><creator>Kim, Sung-Bae</creator><creator>Nam, Byung-Ho</creator><creator>Oh, Do Youn</creator><creator>Han, Sae-Won</creator><creator>Lee, Soohyeon</creator><creator>Park, In Hae</creator><creator>Lee, Keun Seok</creator><creator>Kim, Jee Hyun</creator><creator>Kang, Seok Yun</creator><creator>Lee, Moon Hee</creator><creator>Park, Hee Sook</creator><creator>Woo, Sook Young</creator><creator>Jung, Sin-Ho</creator><creator>Ahn, Jin Seok</creator><creator>Im, Young-Hyuck</creator><general>Springer US</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>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20150701</creationdate><title>Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02)</title><author>Park, Yeon Hee ; Jung, Kyung Hae ; Im, Seock-Ah ; Sohn, Joo Hyuk ; Ro, Jungsil ; Ahn, Jin-Hee ; Kim, Sung-Bae ; Nam, Byung-Ho ; Oh, Do Youn ; Han, Sae-Won ; Lee, Soohyeon ; Park, In Hae ; Lee, Keun Seok ; Kim, Jee Hyun ; Kang, Seok Yun ; Lee, Moon Hee ; Park, Hee Sook ; Woo, Sook Young ; Jung, Sin-Ho ; Ahn, Jin Seok ; Im, Young-Hyuck</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-6f4b4b7d8f935791fcc0f900476ac8034d9f3a8c29f318ad2497c720f676135c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - pathology</topic><topic>Cancer research</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Clinical Trial</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Disease management</topic><topic>Female</topic><topic>Humans</topic><topic>Maintenance Chemotherapy</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Neoplasm Metastasis</topic><topic>Oncology</topic><topic>Paclitaxel - administration & dosage</topic><topic>Quality of Life</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Park, Yeon Hee</creatorcontrib><creatorcontrib>Jung, Kyung Hae</creatorcontrib><creatorcontrib>Im, Seock-Ah</creatorcontrib><creatorcontrib>Sohn, Joo Hyuk</creatorcontrib><creatorcontrib>Ro, Jungsil</creatorcontrib><creatorcontrib>Ahn, Jin-Hee</creatorcontrib><creatorcontrib>Kim, Sung-Bae</creatorcontrib><creatorcontrib>Nam, Byung-Ho</creatorcontrib><creatorcontrib>Oh, Do Youn</creatorcontrib><creatorcontrib>Han, Sae-Won</creatorcontrib><creatorcontrib>Lee, Soohyeon</creatorcontrib><creatorcontrib>Park, In Hae</creatorcontrib><creatorcontrib>Lee, Keun Seok</creatorcontrib><creatorcontrib>Kim, Jee Hyun</creatorcontrib><creatorcontrib>Kang, Seok Yun</creatorcontrib><creatorcontrib>Lee, Moon Hee</creatorcontrib><creatorcontrib>Park, Hee Sook</creatorcontrib><creatorcontrib>Woo, Sook Young</creatorcontrib><creatorcontrib>Jung, Sin-Ho</creatorcontrib><creatorcontrib>Ahn, Jin Seok</creatorcontrib><creatorcontrib>Im, Young-Hyuck</creatorcontrib><creatorcontrib>Korean Cancer Study Group (KCSG)</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>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Breast cancer research and treatment</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Park, Yeon Hee</au><au>Jung, Kyung Hae</au><au>Im, Seock-Ah</au><au>Sohn, Joo Hyuk</au><au>Ro, Jungsil</au><au>Ahn, Jin-Hee</au><au>Kim, Sung-Bae</au><au>Nam, Byung-Ho</au><au>Oh, Do Youn</au><au>Han, Sae-Won</au><au>Lee, Soohyeon</au><au>Park, In Hae</au><au>Lee, Keun Seok</au><au>Kim, Jee Hyun</au><au>Kang, Seok Yun</au><au>Lee, Moon Hee</au><au>Park, Hee Sook</au><au>Woo, Sook Young</au><au>Jung, Sin-Ho</au><au>Ahn, Jin Seok</au><au>Im, Young-Hyuck</au><aucorp>Korean Cancer Study Group (KCSG)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02)</atitle><jtitle>Breast cancer research and treatment</jtitle><stitle>Breast Cancer Res Treat</stitle><addtitle>Breast Cancer Res Treat</addtitle><date>2015-07-01</date><risdate>2015</risdate><volume>152</volume><issue>1</issue><spage>77</spage><epage>85</epage><pages>77-85</pages><issn>0167-6806</issn><eissn>1573-7217</eissn><coden>BCTRD6</coden><abstract>The therapeutic goals are palliative for metastatic breast cancer (MBC) and include prolongation of survival with good quality of life (QoL) and symptom control. The purpose of this study was to examine QoL among women with MBC treated on KCSG-BR07-02 with maintenance of paclitaxel plus gemcitabine (PG) chemotherapy after achieving disease control to initial six cycles of PG chemotherapy or observation. Patients were randomized to either maintenance chemotherapy or observation until progression. QoL was assessed using EORTC QLQ-C30 and BR-23. QoL at each cycle was compared between the two treatment arms using the 2-sample
t
test. Generalized estimating equation method was used to examine the overall difference between the two treatments in QoL. All reported p-values are 2 sided. There were no statistically significant differences between two arms in most of the component of the EORTC QLQ-C30 and BR-23 (
p
> 0.05). There was no significant difference between two treatments (
p
= 0.6094 for QLQ-C30,
p
= 0.5516 for BR23) at baseline, and there did not exist significant change over the cycle (
p
= 0.0914 for QLQ-C30,
p
= 0.7981 for BR23). There was no significant interaction effect between treatment and cycle (
p
= 0.5543 for QLQ-C30.
p
= 0.5817 for BR23). Maintenance PG chemotherapy in patients with MBC achieving disease control with an initial six cycles of PG chemotherapy resulted in better PFS and OS compared to observation without impeding QoL.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>26033708</pmid><doi>10.1007/s10549-015-3450-z</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6806 |
| ispartof | Breast cancer research and treatment, 2015-07, Vol.152 (1), p.77-85 |
| issn | 0167-6806 1573-7217 |
| language | eng |
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| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Adult Antineoplastic Combined Chemotherapy Protocols - therapeutic use Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - pathology Cancer research Cancer therapies Chemotherapy Clinical Trial Deoxycytidine - administration & dosage Deoxycytidine - analogs & derivatives Disease management Female Humans Maintenance Chemotherapy Medicine Medicine & Public Health Neoplasm Metastasis Oncology Paclitaxel - administration & dosage Quality of Life Treatment Outcome |
| title | Quality of life (QoL) in metastatic breast cancer patients with maintenance paclitaxel plus gemcitabine (PG) chemotherapy: results from phase III, multicenter, randomized trial of maintenance chemotherapy versus observation (KCSG-BR07-02) |
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