All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial
Identifieur interne : 000024 ( Pmc/Curation ); précédent : 000023; suivant : 000025All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial
Auteurs : N. Tubiana-Mathieu [France] ; P. Bougnoux [France] ; D. Becquart [Belgique] ; A. Chan [Australie] ; P-F Conte [Italie] ; F. Majois [Belgique] ; M. Espie [France] ; M. Morand [France] ; N. Vaissiere [France] ; G. Villanova [France]Source :
- British Journal of Cancer [ 0007-0920 ] ; 2009.
Abstract
This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC).
Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m−2 (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m−2 (750 if ⩾65 years of age) twice daily, on days 1–14. Treatment was continued until progression or unacceptable toxicity.
A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36–66), including complete response in 4%. The clinical benefit rate (response or stable disease for ⩾6 months) was 63% (95% CI, 48–77). The median duration of response was 7.2 months (95% CI, 6.4–10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8–9.7) and median overall survival was 29.2 months (95% CI, 18.2–40.1). Treatment-related adverse events were manageable, the main grade 3–4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed.
These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.
Url:
DOI: 10.1038/sj.bjc.6605156
PubMed: 19584872
PubMed Central: 2720198
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial</title><author><name sortKey="Tubiana Mathieu, N" sort="Tubiana Mathieu, N" uniqKey="Tubiana Mathieu N" first="N" last="Tubiana-Mathieu">N. Tubiana-Mathieu</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>CHU Dupuytren</institution> Limoges,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bougnoux, P" sort="Bougnoux, P" uniqKey="Bougnoux P" first="P" last="Bougnoux">P. Bougnoux</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>CHU Bretonneau</institution> Tours,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Becquart, D" sort="Becquart, D" uniqKey="Becquart D" first="D" last="Becquart">D. Becquart</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>AZ Middelheim</institution> Antwerp,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Chan, A" sort="Chan, A" uniqKey="Chan A" first="A" last="Chan">A. Chan</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Mount Hospital and Royal Perth Hospital</institution> Perth,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Conte, P F" sort="Conte, P F" uniqKey="Conte P" first="P-F" last="Conte">P-F Conte</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Policlinico di Modena</institution> Modena,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Majois, F" sort="Majois, F" uniqKey="Majois F" first="F" last="Majois">F. Majois</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Hopital Jolimont</institution> Haine St Paul,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Espie, M" sort="Espie, M" uniqKey="Espie M" first="M" last="Espie">M. Espie</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Hopital St Louis</institution> Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Morand, M" sort="Morand, M" uniqKey="Morand M" first="M" last="Morand">M. Morand</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vaissiere, N" sort="Vaissiere, N" uniqKey="Vaissiere N" first="N" last="Vaissiere">N. Vaissiere</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Villanova, G" sort="Villanova, G" uniqKey="Villanova G" first="G" last="Villanova">G. Villanova</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">19584872</idno><idno type="pmc">2720198</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2720198</idno><idno type="RBID">PMC:2720198</idno><idno type="doi">10.1038/sj.bjc.6605156</idno><date when="2009">2009</date><idno type="wicri:Area/Pmc/Corpus">000024</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000024</idno><idno type="wicri:Area/Pmc/Curation">000024</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000024</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial</title><author><name sortKey="Tubiana Mathieu, N" sort="Tubiana Mathieu, N" uniqKey="Tubiana Mathieu N" first="N" last="Tubiana-Mathieu">N. Tubiana-Mathieu</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>CHU Dupuytren</institution> Limoges,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bougnoux, P" sort="Bougnoux, P" uniqKey="Bougnoux P" first="P" last="Bougnoux">P. Bougnoux</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>CHU Bretonneau</institution> Tours,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Becquart, D" sort="Becquart, D" uniqKey="Becquart D" first="D" last="Becquart">D. Becquart</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>AZ Middelheim</institution> Antwerp,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Chan, A" sort="Chan, A" uniqKey="Chan A" first="A" last="Chan">A. Chan</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Mount Hospital and Royal Perth Hospital</institution> Perth,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Conte, P F" sort="Conte, P F" uniqKey="Conte P" first="P-F" last="Conte">P-F Conte</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Policlinico di Modena</institution> Modena,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Majois, F" sort="Majois, F" uniqKey="Majois F" first="F" last="Majois">F. Majois</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Hopital Jolimont</institution> Haine St Paul,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Espie, M" sort="Espie, M" uniqKey="Espie M" first="M" last="Espie">M. Espie</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Hopital St Louis</institution> Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Morand, M" sort="Morand, M" uniqKey="Morand M" first="M" last="Morand">M. Morand</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vaissiere, N" sort="Vaissiere, N" uniqKey="Vaissiere N" first="N" last="Vaissiere">N. Vaissiere</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Villanova, G" sort="Villanova, G" uniqKey="Villanova G" first="G" last="Villanova">G. Villanova</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background:</title><p>This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC).</p></sec><sec><title>Methods:</title><p>Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m<sup>−2</sup> (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m<sup>−2</sup> (750 if ⩾65 years of age) twice daily, on days 1–14. Treatment was continued until progression or unacceptable toxicity.</p></sec><sec><title>Results:</title><p>A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36–66), including complete response in 4%. The clinical benefit rate (response or stable disease for ⩾6 months) was 63% (95% CI, 48–77). The median duration of response was 7.2 months (95% CI, 6.4–10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8–9.7) and median overall survival was 29.2 months (95% CI, 18.2–40.1). Treatment-related adverse events were manageable, the main grade 3–4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed.</p></sec><sec><title>Conclusion:</title><p>These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="other"><pmc-dir>properties open_access</pmc-dir>
<pmc-comment> Original-type: cy</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Br J Cancer</journal-id><journal-title>British Journal of Cancer</journal-title><issn pub-type="ppub">0007-0920</issn><issn pub-type="epub">1532-1827</issn><publisher><publisher-name>Nature Publishing Group</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">19584872</article-id><article-id pub-id-type="pmc">2720198</article-id><article-id pub-id-type="pii">6605156</article-id><article-id pub-id-type="doi">10.1038/sj.bjc.6605156</article-id><article-categories><subj-group subj-group-type="heading"><subject>Clinical Studies</subject></subj-group></article-categories><title-group><article-title>All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Tubiana-Mathieu</surname><given-names>N</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="caf1">*</xref></contrib><contrib contrib-type="author"><name><surname>Bougnoux</surname><given-names>P</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Becquart</surname><given-names>D</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Chan</surname><given-names>A</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Conte</surname><given-names>P-F</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Majois</surname><given-names>F</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Espie</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Morand</surname><given-names>M</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Vaissiere</surname><given-names>N</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Villanova</surname><given-names>G</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib></contrib-group><aff id="aff1"><label>1</label><institution>CHU Dupuytren</institution> Limoges,<country>France</country></aff><aff id="aff2"><label>2</label><institution>CHU Bretonneau</institution> Tours,<country>France</country></aff><aff id="aff3"><label>3</label><institution>AZ Middelheim</institution> Antwerp,<country>Belgium</country></aff><aff id="aff4"><label>4</label><institution>Mount Hospital and Royal Perth Hospital</institution> Perth,<country>Australia</country></aff><aff id="aff5"><label>5</label><institution>Policlinico di Modena</institution> Modena,<country>Italy</country></aff><aff id="aff6"><label>6</label><institution>Hopital Jolimont</institution> Haine St Paul,<country>Belgium</country></aff><aff id="aff7"><label>7</label><institution>Hopital St Louis</institution> Paris,<country>France</country></aff><aff id="aff8"><label>8</label><institution>Institut de Recherche Pierre Fabre</institution> Boulogne-Billancourt,<country>France</country></aff><author-notes><corresp id="caf1"><label>*</label>Author for correspondence: <email xlink:href="mailto:nicole.tubiana-mathieu@chu-limoges.fr">nicole.tubiana-mathieu@chu-limoges.fr</email></corresp></author-notes><pub-date pub-type="epub"><day>07</day><month>07</month><year>2009</year></pub-date><pub-date pub-type="collection"><day>14</day><month>07</month><year>2009</year></pub-date><pub-date pub-type="ppub"><day>21</day><month>07</month><year>2009</year></pub-date><volume>101</volume><issue>2</issue><fpage>232</fpage><lpage>237</lpage><history><date date-type="received"><day>04</day><month>03</month><year>2009</year></date><date date-type="rev-recd"><day>01</day><month>06</month><year>2009</year></date><date date-type="accepted"><day>02</day><month>06</month><year>2009</year></date></history><copyright-statement>Copyright 2009, Cancer Research UK</copyright-statement><copyright-year>2009</copyright-year><permissions><copyright-holder>Cancer Research UK</copyright-holder></permissions><abstract><sec><title>Background:</title><p>This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC).</p></sec><sec><title>Methods:</title><p>Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m<sup>−2</sup> (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m<sup>−2</sup> (750 if ⩾65 years of age) twice daily, on days 1–14. Treatment was continued until progression or unacceptable toxicity.</p></sec><sec><title>Results:</title><p>A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36–66), including complete response in 4%. The clinical benefit rate (response or stable disease for ⩾6 months) was 63% (95% CI, 48–77). The median duration of response was 7.2 months (95% CI, 6.4–10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8–9.7) and median overall survival was 29.2 months (95% CI, 18.2–40.1). Treatment-related adverse events were manageable, the main grade 3–4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed.</p></sec><sec><title>Conclusion:</title><p>These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.</p></sec></abstract><kwd-group><kwd>oral therapy</kwd><kwd>first-line chemotherapy</kwd><kwd>metastatic breast cancer</kwd><kwd>HER2 negative</kwd></kwd-group></article-meta></front><floats-wrap><fig id="fig1"><label>Figure 1</label><caption><p>Progression-free survival (months) intent-to-treat analysis.</p></caption><graphic mime-subtype="eps" xlink:href="6605156f1"></graphic></fig><fig id="fig2"><label>Figure 2</label><caption><p>Overall survival (months) intent-to-treat analysis.</p></caption><graphic mime-subtype="eps" xlink:href="6605156f2"></graphic></fig><table-wrap id="tbl1" position="float"><label>Table 1</label><caption><p content-type="table-title">Patient characteristics</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="center"></col><col align="left"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Characteristics</bold></th><th align="center" valign="top" charoff="50"><bold><italic>N</italic>=54</bold></th><th align="left" valign="top" charoff="50"><bold>(%)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50"><italic>Median age</italic></td><td align="center" valign="top" charoff="50">58.5 years</td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"> Range</td><td align="center" valign="top" charoff="50">(31.0–84.0)</td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"> <65</td><td align="center" valign="top" charoff="50">32</td><td align="left" valign="top" charoff="50">59.3</td></tr><tr><td align="left" valign="top" charoff="50"> ⩾65</td><td align="center" valign="top" charoff="50">22</td><td align="left" valign="top" charoff="50">40.7</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Karnofsky performance status at baseline</italic></td></tr><tr><td align="left" valign="top" charoff="50"> 70/80</td><td align="center" valign="top" charoff="50">11</td><td align="left" valign="top" charoff="50">20.4</td></tr><tr><td align="left" valign="top" charoff="50"> 90/100</td><td align="center" valign="top" charoff="50">43</td><td align="left" valign="top" charoff="50">79.6</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Hormonal status</italic></td></tr><tr><td align="left" valign="top" charoff="50"> ER+/PR+</td><td align="center" valign="top" charoff="50">29</td><td align="left" valign="top" charoff="50">53.6</td></tr><tr><td align="left" valign="top" charoff="50"> ER+/PR−</td><td align="center" valign="top" charoff="50">9</td><td align="left" valign="top" charoff="50">16.7</td></tr><tr><td align="left" valign="top" charoff="50"> ER−/PR+</td><td align="center" valign="top" charoff="50">2</td><td align="left" valign="top" charoff="50">3.7</td></tr><tr><td align="left" valign="top" charoff="50"> ER−/PR−</td><td align="center" valign="top" charoff="50">9</td><td align="left" valign="top" charoff="50">16.7</td></tr><tr><td align="left" valign="top" charoff="50"> ER and/or PR unknown</td><td align="center" valign="top" charoff="50">5</td><td align="left" valign="top" charoff="50">9.3</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50">Prior chemotherapy (early stage)</td><td align="center" valign="top" charoff="50">34</td><td align="left" valign="top" charoff="50">63.0</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Type of Chemotherapy</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Anthracycline-based without taxane</td><td align="center" valign="top" charoff="50">23</td><td align="left" valign="top" charoff="50">42.6</td></tr><tr><td align="left" valign="top" charoff="50"> Anthracycline+taxane</td><td align="center" valign="top" charoff="50">6</td><td align="left" valign="top" charoff="50">11.1</td></tr><tr><td align="left" valign="top" charoff="50"> CMF</td><td align="center" valign="top" charoff="50">5</td><td align="left" valign="top" charoff="50">9.3</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"><italic>Prior hormone therapy</italic></td><td align="center" valign="top" charoff="50">41</td><td align="left" valign="top" charoff="50">75.9</td></tr><tr><td align="left" valign="top" charoff="50"> For advanced disease</td><td align="center" valign="top" charoff="50">27</td><td align="left" valign="top" charoff="50">50.0</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Number of metastatic sites</italic></td></tr><tr><td align="left" valign="top" charoff="50"> 1</td><td align="center" valign="top" charoff="50">7</td><td align="left" valign="top" charoff="50">13.0</td></tr><tr><td align="left" valign="top" charoff="50"> 2</td><td align="center" valign="top" charoff="50">22</td><td align="left" valign="top" charoff="50">40.7</td></tr><tr><td align="left" valign="top" charoff="50"> >2</td><td align="center" valign="top" charoff="50">25</td><td align="left" valign="top" charoff="50">46.3</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50">Visceral involvement</td><td align="center" valign="top" charoff="50">42</td><td align="left" valign="top" charoff="50">77.8</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td colspan="3" align="left" valign="top" charoff="50"><italic>Metastatic sites</italic></td></tr><tr><td align="left" valign="top" charoff="50"> Liver/lung metastases</td><td align="center" valign="top" charoff="50">26/25</td><td align="left" valign="top" charoff="50">48.1/46.3</td></tr><tr><td align="left" valign="top" charoff="50"> Bone metastases</td><td align="center" valign="top" charoff="50">33</td><td align="left" valign="top" charoff="50">61.1</td></tr><tr><td align="left" valign="top" charoff="50"> Skin/soft tissue</td><td align="center" valign="top" charoff="50">3/5</td><td align="left" valign="top" charoff="50">5.6/9.3</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="left" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50">Median delay between diagnosis and first relapse</td><td align="center" valign="top" charoff="50">34.3 months</td><td align="left" valign="top" charoff="50"> </td></tr></tbody></table></table-wrap><table-wrap id="tbl2" position="float"><label>Table 2</label><caption><p content-type="table-title">Response to treatment</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="."></col><col align="char" char="."></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Objective response rate (RECIST) Evaluable population</bold></th><th align="char" valign="top" char="." charoff="50"><bold><italic>n</italic>=49</bold></th><th align="char" valign="top" char="." charoff="50"><bold>(%)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">CR</td><td align="char" valign="top" char="." charoff="50">2</td><td align="char" valign="top" char="." charoff="50">4.1</td></tr><tr><td align="left" valign="top" charoff="50">PR</td><td align="char" valign="top" char="." charoff="50">23</td><td align="char" valign="top" char="." charoff="50">46.9</td></tr><tr><td align="left" valign="top" charoff="50">Objective response – CR+ PR − (95% CI)</td><td align="char" valign="top" char="." charoff="50">25</td><td align="char" valign="top" char="." charoff="50">51.0 (36.3–65.6)</td></tr><tr><td align="left" valign="top" charoff="50">SD</td><td align="char" valign="top" char="." charoff="50">14</td><td align="char" valign="top" char="." charoff="50">28.6</td></tr><tr><td align="left" valign="top" charoff="50">PD</td><td align="char" valign="top" char="." charoff="50">10</td><td align="char" valign="top" char="." charoff="50">20.4</td></tr><tr><td align="left" valign="top" charoff="50">Clinical benefit (CR+PR+SD ⩾6 months) (95% CI)</td><td align="char" valign="top" char="." charoff="50">31</td><td align="char" valign="top" char="." charoff="50">63.3 (48.3–76.6)</td></tr><tr><td align="left" valign="top" charoff="50">Median time to response (range)</td><td colspan="2" align="center" valign="top" char="." charoff="50">3.1 months (1.3–6.7)</td></tr><tr><td align="left" valign="top" charoff="50">Median duration of response (95% CI)</td><td colspan="2" align="center" valign="top" char="." charoff="50">7.2 months (6.4–10.2)</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="char" valign="top" char="." charoff="50"> </td><td align="char" valign="top" char="." charoff="50"> </td></tr></tbody></table><table-wrap-foot><fn id="t2-fn1"><label></label><p>CI=confidence interval; CR=complete response; PR=partial response; SD=stable disease.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl3" position="float"><label>Table 3</label><caption><p content-type="table-title">Subanalysis of responses according to patients' characteristics</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="char" char="."></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Overall response rate (RECIST)</bold></th><th align="char" valign="top" char="." charoff="50"><bold>(%)</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">All evaluable patients (<italic>n</italic>=49)</td><td align="char" valign="top" char="." charoff="50">51.0</td></tr><tr><td align="left" valign="top" charoff="50">Liver metastases (<italic>n</italic>=23)</td><td align="char" valign="top" char="." charoff="50">52.2</td></tr><tr><td align="left" valign="top" charoff="50">No prior chemotherapy (<italic>n</italic>=16)</td><td align="char" valign="top" char="." charoff="50">68.8</td></tr><tr><td align="left" valign="top" charoff="50">Prior anthracycline-based chemotherapy without taxane (<italic>n</italic>=23)</td><td align="char" valign="top" char="." charoff="50">39.1</td></tr><tr><td align="left" valign="top" charoff="50">Prior anthracycline+taxane (<italic>n</italic>=5)</td><td align="char" valign="top" char="." charoff="50">40.0</td></tr><tr><td align="left" valign="top" charoff="50">Prior CMF (<italic>n</italic>=5)</td><td align="char" valign="top" char="." charoff="50">60.0</td></tr><tr><td align="left" valign="top" charoff="50">Prior hormone therapy (<italic>n</italic>=36)</td><td align="char" valign="top" char="." charoff="50">55.6</td></tr><tr><td align="left" valign="top" charoff="50">Prior hormone therapy for MBC (<italic>n</italic>=25)</td><td align="char" valign="top" char="." charoff="50">56.0</td></tr><tr><td align="left" valign="top" charoff="50">Triple-negative disease (<italic>n</italic>=9)</td><td align="char" valign="top" char="." charoff="50">22.2</td></tr></tbody></table><table-wrap-foot><fn id="t3-fn1"><label></label><p>CMF=cyclophosphamide, methotrexate, 5-FU; MBC=metastatic breast cancer.</p></fn></table-wrap-foot></table-wrap><table-wrap id="tbl4" position="float"><label>Table 4</label><caption><p content-type="table-title">Treatment-related adverse events</p></caption><table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col><col align="center"></col><col align="center"></col><col align="center"></col><col align="center"></col></colgroup><thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th><th colspan="2" align="center" valign="top" charoff="50"><bold>Per patient (%) <italic>N</italic>=53<sup>a</sup></bold></th><th colspan="2" align="center" valign="top" charoff="50"><bold>Per cycle (%) <italic>N</italic>=496</bold></th></tr><tr><th align="left" valign="top" charoff="50"><bold>Adverse events by NCI/CTC v.2.0</bold></th><th align="center" valign="top" charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" charoff="50"><bold>Grade 4</bold></th><th align="center" valign="top" charoff="50"><bold>Grade 3</bold></th><th align="center" valign="top" charoff="50"><bold>Grade 4</bold></th></tr></thead><tbody valign="top"><tr><td align="left" valign="top" charoff="50">Anaemia</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0.2</td><td align="center" valign="top" charoff="50">0.2</td></tr><tr><td align="left" valign="top" charoff="50">Leukopaenia</td><td align="center" valign="top" charoff="50">17.0</td><td align="center" valign="top" charoff="50">11.3</td><td align="center" valign="top" charoff="50">3.6</td><td align="center" valign="top" charoff="50">1.4</td></tr><tr><td align="left" valign="top" charoff="50">Neutropaenia</td><td align="center" valign="top" charoff="50">26.4</td><td align="center" valign="top" charoff="50">22.6</td><td align="center" valign="top" charoff="50">6.5</td><td align="center" valign="top" charoff="50">3.0</td></tr><tr><td align="left" valign="top" charoff="50">Thrombocytopaenia</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.2</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Febrile neutropaenia</td><td colspan="2" align="center" valign="top" charoff="50">3.8</td><td colspan="2" align="center" valign="top" charoff="50">0.4</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td colspan="2" align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"> </td><td colspan="2" align="center" valign="top" charoff="50"><bold>Per patient (%) <italic>N</italic>=54</bold></td><td colspan="2" align="center" valign="top" charoff="50"><bold>Per cycle (%) <italic>N</italic>=499</bold></td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"><bold>Grade 3</bold></td><td align="center" valign="top" charoff="50"><bold>Grade 4</bold></td><td align="center" valign="top" charoff="50"><bold>Grade 3</bold></td><td align="center" valign="top" charoff="50"><bold>Grade 4</bold></td></tr><tr><td align="left" valign="top" charoff="50">Nausea</td><td align="center" valign="top" charoff="50">3.7</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.4</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Vomiting</td><td align="center" valign="top" charoff="50">9.3</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">1.0</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Diarrhoea</td><td align="center" valign="top" charoff="50">3.7</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.6</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Stomatitis</td><td align="center" valign="top" charoff="50">5.6</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0.6</td><td align="center" valign="top" charoff="50">0.2</td></tr><tr><td align="left" valign="top" charoff="50">Hand–foot syndrome</td><td align="center" valign="top" charoff="50">3.7</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.8</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Fatigue</td><td align="center" valign="top" charoff="50">7.4</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">1.2</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Infection with G3/4 neutropaenia</td><td align="center" valign="top" charoff="50">3.7</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0.6</td><td align="center" valign="top" charoff="50">0.2</td></tr><tr><td align="left" valign="top" charoff="50">Infection without G3/4 neutropaenia</td><td align="center" valign="top" charoff="50">3.7</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.4</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50">Thrombosis/embolism</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0.2</td><td align="center" valign="top" charoff="50">0.2</td></tr><tr><td align="left" valign="top" charoff="50">Anorexia</td><td align="center" valign="top" charoff="50">1.9</td><td align="center" valign="top" charoff="50">0</td><td align="center" valign="top" charoff="50">0.4</td><td align="center" valign="top" charoff="50">0</td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"><bold>Grade 1</bold></td><td align="center" valign="top" charoff="50"><bold>Grade 2</bold></td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td></tr><tr><td align="left" valign="top" charoff="50">Alopaecia</td><td align="center" valign="top" charoff="50">16.7</td><td align="center" valign="top" charoff="50">9.3</td><td align="center" valign="top" charoff="50"> </td><td align="center" valign="top" charoff="50"> </td></tr></tbody></table><table-wrap-foot><fn id="t4-fn1"><label>a</label><p>One patient was not evaluable for haematological adverse events.</p></fn></table-wrap-foot></table-wrap></floats-wrap></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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