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      <DIV=20
      style=3D"PADDING-BOTTOM: 28px; PADDING-LEFT: 15px; FONT-SIZE: =
16px; PADDING-TOP: 25px">&nbsp;&nbsp;&nbsp;&nbsp;Joint=20
      ECCO 15 - 34<SPAN style=3D"FONT-SIZE: 14px"><SUP>TH</SUP></SPAN> =
ESMO=20
      <BR>&nbsp;&nbsp;&nbsp;&nbsp;Multidisciplinary Congress<BR><SPAN=20
      style=3D"FONT-SIZE: 14px">BERLIN, 20 - 24 SEPTEMBER =
2009</SPAN></DIV><!---<span =
style=3D"margin-left:5pt;font-size:14px;color:CCFFFF;">Abstract =
book<br></span><br>---></B></FONT></TD>
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    <TD bgColor=3D#ffffff width=3D118 align=3Dmiddle><SPAN=20
      class=3Dxszzc><B>Abstract&nbsp;15LBA: </B></SPAN></TD>
    <TD bgColor=3D#f0f7f8>
      <TABLE border=3D0 cellSpacing=3D4 cellPadding=3D0 width=3D"100%" =
bgColor=3D#f0f7f8=20
      vspace=3D"0" hspace=3D"0">
        <TBODY>
        <TR>
          <TD style=3D"FONT-SIZE: 14px" bgColor=3D#f0f7f8=20
            width=3D"90%"><B>Intermittent versus continuous =
oxaliplatin-based=20
            combination chemotherapy in patients with advanced =
colorectal=20
            cancer: a randomised non-inferiority trial (MRC&nbsp;COIN)=20
        </B></TD></TR></TBODY></TABLE></TD>
    <TD width=3D"10%">&nbsp;</TD></TR></TBODY></TABLE><IMG border=3D0 =
hspace=3D0=20
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width=3D"100%" height=3D1><BR><!-- Abstract info --->
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  <TBODY>
  <TR>
    <TD width=3D118>&nbsp;</TD>
    <TD><BR>
      <H1><B>Citation: European Journal of Cancer Supplements, Vol. 7, =
No 3,=20
      September 2009, Page=20
      10</B><BR><BR><B><U>R.&nbsp;Adams<SUP>1</B></U></SUP>,=20
      R.&nbsp;Wilson<SUP>2</SUP>, M.T.&nbsp;Seymour<SUP>3</SUP>,=20
      A.M.&nbsp;Meade<SUP>4</SUP>, A.&nbsp;Madi<SUP>1</SUP>,=20
      J.&nbsp;Cassidy<SUP>5</SUP>, D.&nbsp;Fisher<SUP>4</SUP>,=20
      S.&nbsp;Kenny<SUP>4</SUP>, R.&nbsp;Kaplan<SUP>4</SUP>,=20
      T.S.&nbsp;Maughan<SUP>1</SUP><BR><BR><I><SUP>1</SUP>Cardiff =
University,=20
      Section of Clinical Oncology and Palliative Medicine, Cardiff, =
United=20
      Kingdom<BR><SUP>2</SUP>Queen's University Belfast, Oncology, =
Belfast,=20
      United Kingdom<BR><SUP>3</SUP>University of Leeds, =
St.&nbsp;James's=20
      Institute of Oncology, Leeds, United =
Kingdom<BR><SUP>4</SUP>Medical=20
      Research Council, Clinical Trials Unit, London, United=20
      Kingdom<BR><SUP>5</SUP>Glasgow University, Oncology, Glasgow, =
United=20
      Kingdom</I> <BR><BR><B>Background:</B> Intervals off palliative=20
      chemotherapy (CT) may be a welcome respite for =
patients&nbsp;(pts). One of=20
      the two questions posed by the COIN trial (ISRCTN27286448) was =
whether=20
      intermittent CT with oxaliplatin&nbsp;+ fluoropyrimidine (iOxFp) =
was=20
      non-inferior to standard continuous OxFp (cOxFp) in terms of =
overall=20
      survival (OS).<BR><B>Materials and Methods:</B> Pts had =
measurable,=20
      inoperable aCRC; no prior CT for metastases; WHO Performance =
Status (PS)=20
      0=E2=80=932; and good organ function. The arms were: =
<B>A</B>:&nbsp;cOxFp=20
      (Ox&nbsp;+ fluorouracil/leucovorin (OxFU) q2w or Ox&nbsp;+ =
Capecitabine=20
      (Cap)&nbsp;q3w), continued until treatment failure; =
<B>C</B>:&nbsp;iOxFp,=20
      same regimen for 3&nbsp;months initially, with further 3-month =
courses=20
      upon progression. Pts/clinicians chose OxFU or OxCap before =
randomisation.=20
      The trial was powered to exclude a HR&nbsp;&gt;1.162, equivalent =
to an=20
      absolute difference in 2&nbsp;yr survival greater than 4.6% =
assuming 20%=20
      2&nbsp;year survival on cOxFp, with a one-sided alpha of 0.1 and=20
      90%&nbsp;power.<BR><B>Results:</B> 1630 pts were randomised =
between 03/05=20
      and 05/08 from 109 hospitals in the UK and Ireland. Median age was =
63 yrs;=20
      92% of pts had PS 0=E2=80=931. 66% pts received OxCap and 34% =
received OxFU. Over=20
      the entire treatment period, pts on iOxFp had significantly less =
G3/4=20
      hand-foot syndrome and peripheral neuropathy (2%&nbsp;vs 4%,=20
      p&nbsp;=3D&nbsp;0.044 and 5%&nbsp;vs 19%, p&nbsp;&lt;&nbsp;0.001). =
No=20
      evidence of differences in treatment-related (1.2%&nbsp;vs 1.2%,=20
      p&nbsp;=3D&nbsp;0.999) or 60-day all cause mortality (4.2%&nbsp;vs =
4.4%,=20
      p&nbsp;=3D&nbsp;0.810) were observed. Overall, 1231 pts (76%) have =
died. The=20
      intention-to-treat (ITT) analysis shows a 9% increase in the =
hazard of=20
      death in pts on iOxFp (HR 1.09, with a one-sided upper 90% CI of =
1.17;=20
      this just exceeds the pre-specified boundary). Median OS on cOxFp =
is=20
      15.6&nbsp;months (mo) vs 14.3&nbsp;mo on iOxFp. The estimated 2-yr =

      survival is 28.3% with cOxFp and 26.1% with iOxFp. In the =
per-protocol=20
      analysis (PPA, n&nbsp;=3D&nbsp;1103) the HR is 1.10 with an upper =
90% CI of=20
      1.21; median OS on cOxFp is 19.1&nbsp;mo vs 17.6&nbsp;mo on iOxFp. =
The=20
      estimated 2-yr survivals are 34.8% and 31.1% in the cOxFp and =
iOxFp groups=20
      respectively.<BR><B>Conclusions:</B> In this large trial an =
estimated=20
      difference in favour of cOxFp of 1.3&nbsp;mo in median survival =
was=20
      observed. The survival data indicate that a priori specified=20
      non-inferiority cannot be confirmed, but we can reliably exclude a =

      detriment of larger than 2.3&nbsp;mo in median survival with iOxFp =
in the=20
      ITT population (3.3&nbsp;mo in the PPA). These small differences =
in=20
      survival need to be balanced against the reduced toxicity observed =
with=20
      iOxFp.
      <H3>Gastro-intestinal malignancies&nbsp;=E2=80=93 Non-colorectal=20
      cancer<NL>Wednesday 23 September 2009,=20
    09:00=E2=80=9311:00</H3><SESSTYPE=3DLBA></H1></TD>
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width=3D"100%" height=3D1><BR>
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