A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer
Abstract Aim To assess the efficacy and safety of epirubicin, capecitabine and cisplatin (EXC) combination therapy in locally advanced breast cancer (LABC) and investigate the predictive value of selected biomarkers. Methods Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant...
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| Veröffentlicht in: | European journal of cancer (1990) 2007, Vol.43 (7), p.1153-1160 |
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| creator | Villman, Kenneth Öhd, John F Lidbrink, Elisabet Malmberg, Lena Lindh, Birgitta Blomqvist, Carl Nordgren, Hans Bergh, Jonas Bergström, Daniel Ahlgren, Johan |
| description | Abstract Aim To assess the efficacy and safety of epirubicin, capecitabine and cisplatin (EXC) combination therapy in locally advanced breast cancer (LABC) and investigate the predictive value of selected biomarkers. Methods Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant EXC (epirubicin 60 mg/m2 day 1; capecitabine 1000 mg/m2 bid, days 1–14; cisplatin 60 mg/m2 day 1) and two cycles of post-operative EXC. Results Eight (17%) of 48 patients had inflammatory breast cancer. Overall response rate was 74% (95% CI: 59–86%), including complete responses in 13% (95% CI: 5–26%). Nine (22%; 95% CI: 11–38%) of 41 patients undergoing surgery achieved pathologic complete response (pCR), giving a pCR rate of 19% (95% CI: 9–33%) in the intent-to-treat population. Haematological toxicity was manageable. The most problematic toxicities were chemotherapy-induced nausea/vomiting and hypercoagulative disorders. None of the biomarkers investigated, including HER2, predicted response. Conclusion EXC showed high efficacy in LABC, with high clinical response and pCR rate. Nausea and vomiting were unexpectedly frequent, and more aggressive prophylaxis and management of these side effects is recommended in future studies of this combination. |
| doi_str_mv | 10.1016/j.ejca.2007.02.002 |
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Methods Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant EXC (epirubicin 60 mg/m2 day 1; capecitabine 1000 mg/m2 bid, days 1–14; cisplatin 60 mg/m2 day 1) and two cycles of post-operative EXC. Results Eight (17%) of 48 patients had inflammatory breast cancer. Overall response rate was 74% (95% CI: 59–86%), including complete responses in 13% (95% CI: 5–26%). Nine (22%; 95% CI: 11–38%) of 41 patients undergoing surgery achieved pathologic complete response (pCR), giving a pCR rate of 19% (95% CI: 9–33%) in the intent-to-treat population. Haematological toxicity was manageable. The most problematic toxicities were chemotherapy-induced nausea/vomiting and hypercoagulative disorders. None of the biomarkers investigated, including HER2, predicted response. Conclusion EXC showed high efficacy in LABC, with high clinical response and pCR rate. Nausea and vomiting were unexpectedly frequent, and more aggressive prophylaxis and management of these side effects is recommended in future studies of this combination.</description><identifier>ISSN: 0959-8049</identifier><identifier>ISSN: 1879-0852</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2007.02.002</identifier><identifier>PMID: 17398088</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject><![CDATA[Adult ; Aged ; Antiemetics - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Biological and medical sciences ; Biomarker ; Biomarkers, Tumor - blood ; Breast cancer ; Breast Neoplasms - drug therapy ; Breast Neoplasms - surgery ; Capecitabine ; Chemotherapy, Adjuvant ; Cisplatin ; Cisplatin - administration & dosage ; Cisplatin - adverse effects ; Clinical trial ; Deoxycytidine - administration & dosage ; Deoxycytidine - adverse effects ; Deoxycytidine - analogs & derivatives ; Dose-Response Relationship, Drug ; Epirubicin ; Epirubicin - administration & dosage ; Epirubicin - adverse effects ; Female ; Fluorouracil - administration & dosage ; Fluorouracil - adverse effects ; Fluorouracil - analogs & derivatives ; Hematology, Oncology and Palliative Medicine ; Humans ; Infusions, Intravenous ; Injections, Intravenous ; Mastectomy, Radical ; Medical sciences ; MEDICIN ; Medicin och hälsovetenskap ; MEDICINE ; Middle Aged ; Neoadjuvant ; Neoadjuvant Therapy ; Pathologic complete response ; Pharmacology. Drug treatments ; Phase II ; Survival Analysis ; Treatment Outcome ; Tumors]]></subject><ispartof>European journal of cancer (1990), 2007, Vol.43 (7), p.1153-1160</ispartof><rights>Elsevier Ltd</rights><rights>2007 Elsevier Ltd</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c600t-16697b8b83cc32a6b90a919b844fa57ad5435d2864e8019fbeb38a6b9452615d3</citedby><cites>FETCH-LOGICAL-c600t-16697b8b83cc32a6b90a919b844fa57ad5435d2864e8019fbeb38a6b9452615d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejca.2007.02.002$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,315,781,785,886,3551,4025,27928,27929,27930,46000</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18728481$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17398088$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-22777$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttps://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-95414$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:115408637$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Villman, Kenneth</creatorcontrib><creatorcontrib>Öhd, John F</creatorcontrib><creatorcontrib>Lidbrink, Elisabet</creatorcontrib><creatorcontrib>Malmberg, Lena</creatorcontrib><creatorcontrib>Lindh, Birgitta</creatorcontrib><creatorcontrib>Blomqvist, Carl</creatorcontrib><creatorcontrib>Nordgren, Hans</creatorcontrib><creatorcontrib>Bergh, Jonas</creatorcontrib><creatorcontrib>Bergström, Daniel</creatorcontrib><creatorcontrib>Ahlgren, Johan</creatorcontrib><title>A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Abstract Aim To assess the efficacy and safety of epirubicin, capecitabine and cisplatin (EXC) combination therapy in locally advanced breast cancer (LABC) and investigate the predictive value of selected biomarkers. Methods Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant EXC (epirubicin 60 mg/m2 day 1; capecitabine 1000 mg/m2 bid, days 1–14; cisplatin 60 mg/m2 day 1) and two cycles of post-operative EXC. Results Eight (17%) of 48 patients had inflammatory breast cancer. Overall response rate was 74% (95% CI: 59–86%), including complete responses in 13% (95% CI: 5–26%). Nine (22%; 95% CI: 11–38%) of 41 patients undergoing surgery achieved pathologic complete response (pCR), giving a pCR rate of 19% (95% CI: 9–33%) in the intent-to-treat population. Haematological toxicity was manageable. The most problematic toxicities were chemotherapy-induced nausea/vomiting and hypercoagulative disorders. None of the biomarkers investigated, including HER2, predicted response. Conclusion EXC showed high efficacy in LABC, with high clinical response and pCR rate. Nausea and vomiting were unexpectedly frequent, and more aggressive prophylaxis and management of these side effects is recommended in future studies of this combination.</description><subject>Adult</subject><subject>Aged</subject><subject>Antiemetics - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Biomarker</subject><subject>Biomarkers, Tumor - blood</subject><subject>Breast cancer</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Capecitabine</subject><subject>Chemotherapy, Adjuvant</subject><subject>Cisplatin</subject><subject>Cisplatin - administration & dosage</subject><subject>Cisplatin - adverse effects</subject><subject>Clinical trial</subject><subject>Deoxycytidine - administration & dosage</subject><subject>Deoxycytidine - adverse effects</subject><subject>Deoxycytidine - analogs & derivatives</subject><subject>Dose-Response Relationship, Drug</subject><subject>Epirubicin</subject><subject>Epirubicin - administration & dosage</subject><subject>Epirubicin - adverse effects</subject><subject>Female</subject><subject>Fluorouracil - administration & dosage</subject><subject>Fluorouracil - adverse effects</subject><subject>Fluorouracil - analogs & derivatives</subject><subject>Hematology, Oncology and Palliative Medicine</subject><subject>Humans</subject><subject>Infusions, Intravenous</subject><subject>Injections, Intravenous</subject><subject>Mastectomy, Radical</subject><subject>Medical sciences</subject><subject>MEDICIN</subject><subject>Medicin och hälsovetenskap</subject><subject>MEDICINE</subject><subject>Middle Aged</subject><subject>Neoadjuvant</subject><subject>Neoadjuvant Therapy</subject><subject>Pathologic complete response</subject><subject>Pharmacology. Drug treatments</subject><subject>Phase II</subject><subject>Survival Analysis</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>0959-8049</issn><issn>1879-0852</issn><issn>1879-0852</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkl2L1DAUhoso7rr6B7yQ3HjldkzSjyQgwrB-DSx44QfehdP01Em3bUrSrvQf-LNNmdEBYcWrhJPnOQk5b5I8ZXTDKCtfthtsDWw4pWJD-YZSfi85Z1KolMqC30_OqSpUKmmuzpJHIbQ0gjKnD5MzJjIlqZTnyc8tGfcQkOx2JExzvRDXEBytnytr7HBJjA1jB5MdCAw1MTCisRNUdkACgQzooG7nWxgmYvbYu2mPHsaFRL5zBrpuIVDHY4M1cT6Wmw76HibnF1J5hBC99dQ_Th400AV8clwvki_v3n6--pBef3y_u9pep6akdEpZWSpRyUpmxmQcykpRUExVMs8bKATURZ4VNZdljpIy1VRYZXLF8oKXrKiziyQ99A0_cJwrPXrbg1-0A6uPpZu4Q12I-EFF5NWd_OhdfZJ-i4wVOZVlJqL74k73jf261c5_1_OsVZGzPNKX_0H3s-ZciLU5P-DGuxA8Nn8ERvWaD93qNR96zYemXMd8ROnZQYoX9FiflGMgIvD8CECI42t8HI4NJ04KLnPJIvfqwGGc1a1Fr4OxuI7ZejSTrp399zte_6Wbzg423niDC4bWzX6IKdBMhyjoT2uS1yBTQSnj4lv2CxHw8bQ</recordid><startdate>2007</startdate><enddate>2007</enddate><creator>Villman, Kenneth</creator><creator>Öhd, John F</creator><creator>Lidbrink, Elisabet</creator><creator>Malmberg, Lena</creator><creator>Lindh, Birgitta</creator><creator>Blomqvist, Carl</creator><creator>Nordgren, Hans</creator><creator>Bergh, Jonas</creator><creator>Bergström, Daniel</creator><creator>Ahlgren, Johan</creator><general>Elsevier Ltd</general><general>Elsevier</general><scope>IQODW</scope><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>ADTPV</scope><scope>AOWAS</scope><scope>D93</scope><scope>DF2</scope></search><sort><creationdate>2007</creationdate><title>A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer</title><author>Villman, Kenneth ; Öhd, John F ; Lidbrink, Elisabet ; Malmberg, Lena ; Lindh, Birgitta ; Blomqvist, Carl ; Nordgren, Hans ; Bergh, Jonas ; Bergström, Daniel ; Ahlgren, Johan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c600t-16697b8b83cc32a6b90a919b844fa57ad5435d2864e8019fbeb38a6b9452615d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antiemetics - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Biomarker</topic><topic>Biomarkers, Tumor - blood</topic><topic>Breast cancer</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - surgery</topic><topic>Capecitabine</topic><topic>Chemotherapy, Adjuvant</topic><topic>Cisplatin</topic><topic>Cisplatin - administration & dosage</topic><topic>Cisplatin - adverse effects</topic><topic>Clinical trial</topic><topic>Deoxycytidine - administration & dosage</topic><topic>Deoxycytidine - adverse effects</topic><topic>Deoxycytidine - analogs & derivatives</topic><topic>Dose-Response Relationship, Drug</topic><topic>Epirubicin</topic><topic>Epirubicin - administration & dosage</topic><topic>Epirubicin - adverse effects</topic><topic>Female</topic><topic>Fluorouracil - administration & dosage</topic><topic>Fluorouracil - adverse effects</topic><topic>Fluorouracil - analogs & derivatives</topic><topic>Hematology, Oncology and Palliative Medicine</topic><topic>Humans</topic><topic>Infusions, Intravenous</topic><topic>Injections, Intravenous</topic><topic>Mastectomy, Radical</topic><topic>Medical sciences</topic><topic>MEDICIN</topic><topic>Medicin och hälsovetenskap</topic><topic>MEDICINE</topic><topic>Middle Aged</topic><topic>Neoadjuvant</topic><topic>Neoadjuvant Therapy</topic><topic>Pathologic complete response</topic><topic>Pharmacology. Drug treatments</topic><topic>Phase II</topic><topic>Survival Analysis</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Villman, Kenneth</creatorcontrib><creatorcontrib>Öhd, John F</creatorcontrib><creatorcontrib>Lidbrink, Elisabet</creatorcontrib><creatorcontrib>Malmberg, Lena</creatorcontrib><creatorcontrib>Lindh, Birgitta</creatorcontrib><creatorcontrib>Blomqvist, Carl</creatorcontrib><creatorcontrib>Nordgren, Hans</creatorcontrib><creatorcontrib>Bergh, Jonas</creatorcontrib><creatorcontrib>Bergström, Daniel</creatorcontrib><creatorcontrib>Ahlgren, Johan</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Umeå universitet</collection><collection>SWEPUB Uppsala universitet</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Villman, Kenneth</au><au>Öhd, John F</au><au>Lidbrink, Elisabet</au><au>Malmberg, Lena</au><au>Lindh, Birgitta</au><au>Blomqvist, Carl</au><au>Nordgren, Hans</au><au>Bergh, Jonas</au><au>Bergström, Daniel</au><au>Ahlgren, Johan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2007</date><risdate>2007</risdate><volume>43</volume><issue>7</issue><spage>1153</spage><epage>1160</epage><pages>1153-1160</pages><issn>0959-8049</issn><issn>1879-0852</issn><eissn>1879-0852</eissn><abstract>Abstract Aim To assess the efficacy and safety of epirubicin, capecitabine and cisplatin (EXC) combination therapy in locally advanced breast cancer (LABC) and investigate the predictive value of selected biomarkers. Methods Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant EXC (epirubicin 60 mg/m2 day 1; capecitabine 1000 mg/m2 bid, days 1–14; cisplatin 60 mg/m2 day 1) and two cycles of post-operative EXC. Results Eight (17%) of 48 patients had inflammatory breast cancer. Overall response rate was 74% (95% CI: 59–86%), including complete responses in 13% (95% CI: 5–26%). Nine (22%; 95% CI: 11–38%) of 41 patients undergoing surgery achieved pathologic complete response (pCR), giving a pCR rate of 19% (95% CI: 9–33%) in the intent-to-treat population. Haematological toxicity was manageable. The most problematic toxicities were chemotherapy-induced nausea/vomiting and hypercoagulative disorders. None of the biomarkers investigated, including HER2, predicted response. Conclusion EXC showed high efficacy in LABC, with high clinical response and pCR rate. Nausea and vomiting were unexpectedly frequent, and more aggressive prophylaxis and management of these side effects is recommended in future studies of this combination.</abstract><cop>Oxford</cop><pub>Elsevier Ltd</pub><pmid>17398088</pmid><doi>10.1016/j.ejca.2007.02.002</doi><tpages>8</tpages></addata></record> |
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| subjects | Adult Aged Antiemetics - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biological and medical sciences Biomarker Biomarkers, Tumor - blood Breast cancer Breast Neoplasms - drug therapy Breast Neoplasms - surgery Capecitabine Chemotherapy, Adjuvant Cisplatin Cisplatin - administration & dosage Cisplatin - adverse effects Clinical trial Deoxycytidine - administration & dosage Deoxycytidine - adverse effects Deoxycytidine - analogs & derivatives Dose-Response Relationship, Drug Epirubicin Epirubicin - administration & dosage Epirubicin - adverse effects Female Fluorouracil - administration & dosage Fluorouracil - adverse effects Fluorouracil - analogs & derivatives Hematology, Oncology and Palliative Medicine Humans Infusions, Intravenous Injections, Intravenous Mastectomy, Radical Medical sciences MEDICIN Medicin och hälsovetenskap MEDICINE Middle Aged Neoadjuvant Neoadjuvant Therapy Pathologic complete response Pharmacology. Drug treatments Phase II Survival Analysis Treatment Outcome Tumors |
| title | A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer |
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