A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Identifieur interne : 002A55 ( Pmc/Checkpoint ); précédent : 002A54; suivant : 002A56A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers
Auteurs : P A Vasey [Royaume-Uni, Australie] ; M. Gore [Royaume-Uni] ; R. Wilson [Royaume-Uni] ; G. Rustin [Royaume-Uni] ; H. Gabra [Royaume-Uni] ; J-P Guastalla [France] ; E P Lauraine [France] ; J. Paul [Royaume-Uni] ; K. Carty [Royaume-Uni] ; S. Kaye [Royaume-Uni]Source :
- British Journal of Cancer [ 0007-0920 ] ; 2008.
Abstract
The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer. Chemonaive patients received intravenous docetaxel (75 mg m−2) and carboplatin (area under the curve 5) on day 1 of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day−1 (cohort 2b) for up to six cycles. Dose-limiting toxicities were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5 patients (cohorts 1/2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day−1 (cohort 2b; the erlotinib dose was escalated to 100 mg day−1 in 11 out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4 haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash. There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100–150 mg day−1, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.
Url:
DOI: 10.1038/sj.bjc.6604371
PubMed: 18506181
PubMed Central: 2410113
Affiliations:
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<author><name sortKey="Guastalla, J P" sort="Guastalla, J P" uniqKey="Guastalla J" first="J-P" last="Guastalla">J-P Guastalla</name>
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<author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E P" last="Lauraine">E P Lauraine</name>
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<series><title level="j">British Journal of Cancer</title>
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<front><div type="abstract" xml:lang="en"><p>The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer. Chemonaive patients received intravenous docetaxel (75 mg m<sup>−2</sup>
) and carboplatin (area under the curve 5) on day 1 of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day<sup>−1</sup>
(cohort 2b) for up to six cycles. Dose-limiting toxicities were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5 patients (cohorts 1/2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day<sup>−1</sup>
(cohort 2b; the erlotinib dose was escalated to 100 mg day<sup>−1</sup>
in 11 out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4 haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash. There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100–150 mg day<sup>−1</sup>
, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.</p>
</div>
</front>
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<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">18506181</article-id>
<article-id pub-id-type="pmc">2410113</article-id>
<article-id pub-id-type="pii">6604371</article-id>
<article-id pub-id-type="doi">10.1038/sj.bjc.6604371</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Clinical Studies</subject>
</subj-group>
</article-categories>
<title-group><article-title>A phase Ib trial of docetaxel, carboplatin and erlotinib in ovarian, fallopian tube and primary peritoneal cancers</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Vasey</surname>
<given-names>P A</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
<xref ref-type="aff" rid="aff9">9</xref>
<xref ref-type="corresp" rid="caf1">*</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gore</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wilson</surname>
<given-names>R</given-names>
</name>
<xref ref-type="aff" rid="aff3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Rustin</surname>
<given-names>G</given-names>
</name>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gabra</surname>
<given-names>H</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Guastalla</surname>
<given-names>J-P</given-names>
</name>
<xref ref-type="aff" rid="aff6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Lauraine</surname>
<given-names>E P</given-names>
</name>
<xref ref-type="aff" rid="aff7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Paul</surname>
<given-names>J</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Carty</surname>
<given-names>K</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kaye</surname>
<given-names>S</given-names>
</name>
<xref ref-type="aff" rid="aff8">8</xref>
</contrib>
</contrib-group>
<aff id="aff1"><label>1</label>
<institution>CR-UK Clinical Trials Unit, Beatson Oncology Centre, Western Infirmary</institution>
Dumbarton Road, Glasgow, Scotland G11 6NT,<country>UK</country>
</aff>
<aff id="aff2"><label>2</label>
<institution>Royal Marsden Hospital</institution>
Fulham Road, London SW15 3SW,<country>UK</country>
</aff>
<aff id="aff3"><label>3</label>
<institution>Belfast City Hospital</institution>
Lisburn Road, Belfast, Ireland BT9 7AB,<country>UK</country>
</aff>
<aff id="aff4"><label>4</label>
<institution>Mount Vernon Hospital</institution>
Rickmansworth Road, Northwood, Hertfordshire HA6 2RN,<country>UK</country>
</aff>
<aff id="aff5"><label>5</label>
<institution>Western General Hospital</institution>
Crewe Road South, Edinburgh, Scotland EH4 2XU,<country>UK</country>
</aff>
<aff id="aff6"><label>6</label>
<institution>Centre Léon-Bérard</institution>
rue Laennec, 69373, Lyon, Cedex 08,<country>France</country>
</aff>
<aff id="aff7"><label>7</label>
<institution>Hopital de L'Hotel-Dieu, place du Parvis Notre-Dame</institution>
75181 Paris Cedex 4,<country>France</country>
</aff>
<aff id="aff8"><label>8</label>
<institution>Royal Marsden Hospital</institution>
Downs Road, Sutton, Surrey SM2 5PT,<country>UK</country>
</aff>
<aff id="aff9"><label>9</label>
<institution>Division of Medicine, University of Queensland</institution>
Brisbane Q4029,<country>Australia</country>
</aff>
<author-notes><corresp id="caf1"><label>*</label>
Author for correspondence: <email xlink:href="mailto:pvasey@hoca.com.au">pvasey@hoca.com.au</email>
</corresp>
</author-notes>
<pub-date pub-type="epub"><day>27</day>
<month>05</month>
<year>2008</year>
</pub-date>
<pub-date pub-type="collection"><day>27</day>
<month>05</month>
<year>2008</year>
</pub-date>
<pub-date pub-type="ppub"><day>03</day>
<month>06</month>
<year>2008</year>
</pub-date>
<volume>98</volume>
<issue>11</issue>
<fpage>1774</fpage>
<lpage>1780</lpage>
<history><date date-type="received"><day>26</day>
<month>11</month>
<year>2007</year>
</date>
<date date-type="rev-recd"><day>25</day>
<month>03</month>
<year>2008</year>
</date>
<date date-type="accepted"><day>28</day>
<month>03</month>
<year>2008</year>
</date>
</history>
<copyright-statement>Copyright 2008, Cancer Research UK</copyright-statement>
<copyright-year>2008</copyright-year>
<permissions><copyright-holder>Cancer Research UK</copyright-holder>
</permissions>
<abstract><p>The safety and maximum tolerated dose (MTD) of erlotinib with docetaxel/carboplatin were assessed in patients with ovarian cancer. Chemonaive patients received intravenous docetaxel (75 mg m<sup>−2</sup>
) and carboplatin (area under the curve 5) on day 1 of a 3-week cycle, and oral erlotinib at 50 (cohort 1), 100 (cohort 2a) or 75 mg day<sup>−1</sup>
(cohort 2b) for up to six cycles. Dose-limiting toxicities were determined in cycle 1. Forty-five patients (median age 59 years) received treatment. Dose-limiting toxicities occurred in 1/5/5 patients (cohorts 1/2a/2b). The MTD of erlotinib in this regimen was determined to be 75 mg day<sup>−1</sup>
(cohort 2b; the erlotinib dose was escalated to 100 mg day<sup>−1</sup>
in 11 out of 19 patients from cycle 2 onwards). Neutropaenia was the predominant grade 3/4 haematological toxicity (85/100/95% respectively). Common non-haematological toxicities were diarrhoea, fatigue, nausea and rash. There were five complete and seven partial responses in 23 evaluable patients (52% response rate). Docetaxel/carboplatin had no measurable effect on erlotinib pharmacokinetics. In subsequent single-agent maintenance, erlotinib was given at 100–150 mg day<sup>−1</sup>
, with manageable toxicity, until tumour progression. Further investigation of erlotinib in epithelial ovarian carcinoma may be warranted, particularly as maintenance therapy.</p>
</abstract>
<kwd-group><kwd>docetaxel</kwd>
<kwd>carboplatin</kwd>
<kwd>erlotinib</kwd>
<kwd>HER1/EGFR</kwd>
<kwd>gynaecological</kwd>
<kwd>cancer</kwd>
</kwd-group>
</article-meta>
</front>
<floats-wrap><fig id="fig1"><label>Figure 1</label>
<caption><p>Mean plasma concentration–time curves for erlotinib alone and in combination with docetaxel and carboplatin for cohort 1.</p>
</caption>
<graphic mime-subtype="eps" xlink:href="6604371f1"></graphic>
</fig>
<table-wrap id="tbl1" position="float"><label>Table 1</label>
<caption><p content-type="table-title">Baseline patient and disease characteristics</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>
<col align="char" char="."></col>
</colgroup>
<thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Characteristics</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Cohort 1</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Cohort 2a</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Cohort 2b</bold>
</th>
</tr>
</thead>
<tbody valign="top"><tr><td align="left" valign="top" charoff="50">Patients (<italic>n</italic>
)</td>
<td align="char" valign="top" char="." charoff="50">13</td>
<td align="char" valign="top" char="." charoff="50">13</td>
<td align="char" valign="top" char="." charoff="50">19</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Median age (range) (years)</td>
<td align="char" valign="top" char="." charoff="50">59.5 (47.9–68.3)</td>
<td align="char" valign="top" char="." charoff="50">56.0 (32.4–65.7)</td>
<td align="char" valign="top" char="." charoff="50">61.9 (49.1–68.7)</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>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr><td align="left" valign="top" charoff="50"><italic>ECOG PS (n)</italic>
</td>
<td align="char" valign="top" char="." charoff="50"> </td>
<td align="char" valign="top" char="." charoff="50"> </td>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr><td align="left" valign="top" charoff="50"> 0</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">5</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="." charoff="50">7</td>
<td align="char" valign="top" char="." charoff="50">8</td>
<td align="char" valign="top" char="." charoff="50">15</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>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr><td colspan="4" align="left" valign="top" charoff="50"><italic>FIGO stage (n)</italic>
</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> III</td>
<td align="char" valign="top" char="." charoff="50">1</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> IIIa</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">1</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> IIIb</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">1</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> IIIc</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">7</td>
<td align="char" valign="top" char="." charoff="50">15</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> IV</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">3</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>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr><td colspan="4" align="left" valign="top" charoff="50"><italic>Histology (n)</italic>
</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> Serous adenocarcinoma</td>
<td align="char" valign="top" char="." charoff="50">11</td>
<td align="char" valign="top" char="." charoff="50">10</td>
<td align="char" valign="top" char="." charoff="50">17</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> Endometroid carcinoma</td>
<td align="char" valign="top" char="." charoff="50">1</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> Adenocarcinoma</td>
<td align="char" valign="top" char="." charoff="50">1</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">2</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> Other<sup>a</sup>
</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">1</td>
<td align="char" valign="top" char="." charoff="50">0</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>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr><td colspan="4" align="left" valign="top" charoff="50"><italic>Disease bulk (n)</italic>
</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> None or microscopic</td>
<td align="char" valign="top" char="." charoff="50">3</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">7</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> <2 cm</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">4</td>
<td align="char" valign="top" char="." charoff="50">2</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> ⩾2 cm</td>
<td align="char" valign="top" char="." charoff="50">4</td>
<td align="char" valign="top" char="." charoff="50">5</td>
<td align="char" valign="top" char="." charoff="50">6</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> Not available</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">2</td>
<td align="char" valign="top" char="." charoff="50">4</td>
</tr>
<tr><td align="left" valign="top" charoff="50"> RECIST evaluable disease at baseline</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">6</td>
<td align="char" valign="top" char="." charoff="50">11</td>
</tr>
</tbody>
</table>
<table-wrap-foot><fn id="t1-fn1"><label>a</label>
<p>Primary epithelial carcinoma of the ovary with hepatoid differentiation.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl2" position="float"><label>Table 2</label>
<caption><p content-type="table-title">Most common non-haematologic AEs (grades 3 and 4) occurring in more than one patient in any cohort, during treatment with chemotherapy</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>
<col align="char" char="("></col>
<col align="char" char="."></col>
<col align="char" char="("></col>
<col align="char" char="."></col>
</colgroup>
<thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th>
<th colspan="2" align="center" valign="top" char="." charoff="50"><bold>Cohort 1 (<italic>n</italic>
=13)</bold>
<hr></hr>
</th>
<th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>Cohort 2a (<italic>n</italic>
=13)</bold>
<hr></hr>
</th>
<th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>Cohort 2b (<italic>n</italic>
=19)</bold>
<hr></hr>
</th>
</tr>
<tr><th align="left" valign="top" charoff="50"><bold>AE</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="." charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
</tr>
</thead>
<tbody valign="top"><tr><td align="left" valign="top" charoff="50">Diarrhoea</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">4 (31)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">3 (16)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Fatigue</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">4 (31)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">3 (16)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Rash/desquamation</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">3 (23)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">2 (10)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Dehydration</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">3 (16)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Dysphagia</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">2 (10)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Nausea</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">3 (23)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Abdominal pain</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (5)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Dermatology/skin other</td>
<td align="char" valign="top" char="." charoff="50">1 (8)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (5)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Dizziness</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (5)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Stomatitis/pharyngitis</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">2 (10)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Fainting</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (5)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Vomiting</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">2 (15)</td>
<td align="char" valign="top" char="." charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="." charoff="50">0</td>
</tr>
</tbody>
</table>
</table-wrap>
<table-wrap id="tbl3" position="float"><label>Table 3</label>
<caption><p content-type="table-title">Summary of grade 3 and 4 haematologic toxicities, during treatment with chemotherapy</p>
</caption>
<table frame="hsides" rules="groups" border="1" width="85%"><colgroup><col align="left"></col>
<col align="char" char="("></col>
<col align="center"></col>
<col align="char" char="("></col>
<col align="char" char="("></col>
<col align="char" char="("></col>
<col align="char" char="("></col>
</colgroup>
<thead valign="bottom"><tr><th align="left" valign="top" charoff="50"> </th>
<th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>Cohort 1 (<italic>n</italic>
=13)</bold>
<hr></hr>
</th>
<th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>Cohort 2a (<italic>n</italic>
=13)</bold>
<hr></hr>
</th>
<th colspan="2" align="center" valign="top" char="(" charoff="50"><bold>Cohort 2b (<italic>n</italic>
=19)</bold>
<hr></hr>
</th>
</tr>
<tr><th align="left" valign="top" charoff="50"><bold>Parameter</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="center" valign="top" charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 3 <italic>n</italic>
(%)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Grade 4 <italic>n</italic>
(%)</bold>
</th>
</tr>
</thead>
<tbody valign="top"><tr><td align="left" valign="top" charoff="50">Leucopaenia</td>
<td align="char" valign="top" char="(" charoff="50">9 (69)</td>
<td align="center" valign="top" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">4 (31)</td>
<td align="char" valign="top" char="(" charoff="50">6 (46)</td>
<td align="char" valign="top" char="(" charoff="50">13 (68)</td>
<td align="char" valign="top" char="(" charoff="50">3 (16)</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Thrombocytopaenia</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="center" valign="top" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">2 (15)</td>
<td align="char" valign="top" char="(" charoff="50">3 (23)</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Anaemia</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="center" valign="top" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
</tr>
<tr><td align="left" valign="top" charoff="50">RBC transfusions</td>
<td align="char" valign="top" char="(" charoff="50">3</td>
<td align="center" valign="top" charoff="50">6</td>
<td align="char" valign="top" char="(" charoff="50">6</td>
<td align="char" valign="top" char="(" charoff="50"> </td>
<td align="char" valign="top" char="(" charoff="50"> </td>
<td align="char" valign="top" char="(" charoff="50"> </td>
</tr>
<tr><td align="left" valign="top" charoff="50">Neutropaenia</td>
<td align="char" valign="top" char="(" charoff="50">2 (15)</td>
<td align="char" valign="top" char="(" charoff="50">9 (69)</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">12 (92)</td>
<td align="char" valign="top" char="(" charoff="50">2 (11)</td>
<td align="char" valign="top" char="(" charoff="50">16 (84)</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Febrile neutropaenia</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">2 (15)</td>
<td align="char" valign="top" char="(" charoff="50">2 (15)</td>
<td align="char" valign="top" char="(" charoff="50">3 (16)</td>
<td align="char" valign="top" char="(" charoff="50">2 (11)</td>
</tr>
<tr><td align="left" valign="top" charoff="50">Infection/febrile neutropaenia</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (8)</td>
<td align="char" valign="top" char="(" charoff="50">0</td>
<td align="char" valign="top" char="(" charoff="50">1 (5)</td>
</tr>
</tbody>
</table>
<table-wrap-foot><fn id="t3-fn1"><label></label>
<p>RBC transfusion threshold not mandated in protocol.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl4" position="float"><label>Table 4</label>
<caption><p content-type="table-title">PK parameters of erlotinib given alone or in combination with docetaxel and carboplatin (cohort 1)</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>
<col align="char" char="("></col>
</colgroup>
<thead valign="bottom"><tr><th align="left" valign="top" charoff="50"><bold>Parameter</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Erlotinib alone (day −1)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Erlotinib in combination with docetaxel/carboplatin (day 1)</bold>
</th>
<th align="char" valign="top" char="(" charoff="50"><bold>Erlotinib alone (day 7)</bold>
</th>
</tr>
</thead>
<tbody valign="top"><tr><td align="left" valign="top" charoff="50"><italic>C</italic>
<sub>max</sub>
(ng ml<sup>–1</sup>
)</td>
<td align="char" valign="top" char="(" charoff="50">922 (760–1119)</td>
<td align="char" valign="top" char="(" charoff="50">752 (624–906)</td>
<td align="char" valign="top" char="(" charoff="50">953 (738–1230)</td>
</tr>
<tr><td align="left" valign="top" charoff="50"><italic>T</italic>
<sub>max</sub>
(h)</td>
<td align="char" valign="top" char="(" charoff="50">2.4 (1.5–3.9)</td>
<td align="char" valign="top" char="(" charoff="50">3.8 (1.9–7.6)</td>
<td align="char" valign="top" char="(" charoff="50">2.9 (2.0–3.6)</td>
</tr>
<tr><td align="left" valign="top" charoff="50">AUC<sub>(0–24 h)</sub>
(ng h ml<sup>−1</sup>
)</td>
<td align="char" valign="top" char="(" charoff="50">10 520 (7482–14 791)</td>
<td align="char" valign="top" char="(" charoff="50">11 041 (8241–14 825)</td>
<td align="char" valign="top" char="(" charoff="50">11 246 (7762–16 293)</td>
</tr>
</tbody>
</table>
<table-wrap-foot><fn id="t4-fn1"><label></label>
<p>Data shown are geometric means (95% CIs) derived from the repeated measures analysis of variance, based on <italic>n</italic>
=10 patients with full profiles on each day (other three patients did not have full profiles on each day).</p>
</fn>
</table-wrap-foot>
</table-wrap>
</floats-wrap>
</pmc>
<affiliations><list><country><li>Australie</li>
<li>France</li>
<li>Royaume-Uni</li>
</country>
</list>
<tree><country name="Royaume-Uni"><noRegion><name sortKey="Vasey, P A" sort="Vasey, P A" uniqKey="Vasey P" first="P A" last="Vasey">P A Vasey</name>
</noRegion>
<name sortKey="Carty, K" sort="Carty, K" uniqKey="Carty K" first="K" last="Carty">K. Carty</name>
<name sortKey="Gabra, H" sort="Gabra, H" uniqKey="Gabra H" first="H" last="Gabra">H. Gabra</name>
<name sortKey="Gore, M" sort="Gore, M" uniqKey="Gore M" first="M" last="Gore">M. Gore</name>
<name sortKey="Kaye, S" sort="Kaye, S" uniqKey="Kaye S" first="S" last="Kaye">S. Kaye</name>
<name sortKey="Paul, J" sort="Paul, J" uniqKey="Paul J" first="J" last="Paul">J. Paul</name>
<name sortKey="Rustin, G" sort="Rustin, G" uniqKey="Rustin G" first="G" last="Rustin">G. Rustin</name>
<name sortKey="Wilson, R" sort="Wilson, R" uniqKey="Wilson R" first="R" last="Wilson">R. Wilson</name>
</country>
<country name="Australie"><noRegion><name sortKey="Vasey, P A" sort="Vasey, P A" uniqKey="Vasey P" first="P A" last="Vasey">P A Vasey</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Guastalla, J P" sort="Guastalla, J P" uniqKey="Guastalla J" first="J-P" last="Guastalla">J-P Guastalla</name>
</noRegion>
<name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E P" last="Lauraine">E P Lauraine</name>
</country>
</tree>
</affiliations>
</record>
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