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Authors: Hochster et al at ASCO GI 2008 Date posted: April 3 2008

Effect of intravenous calcium and magnesium versus placebo on response to FOLFOX+bevacizumab in the CONcePT trial. Authors: Hochster et al at ASCO GI 2008 Date posted: April 3 2008. Background. Opened February 2005 and terminated June 2007

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Authors: Hochster et al at ASCO GI 2008 Date posted: April 3 2008

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  1. Effect of intravenous calcium and magnesium versus placebo on response to FOLFOX+bevacizumabin the CONcePT trial Authors: Hochster et al at ASCO GI 2008 Date posted: April 3 2008

  2. Background • Opened February 2005 and terminated June 2007 • Per recommendation of independent data-monitoring committee (IDMC) • IDMC letter stated: • “These recommendations are based on the interim data provided by the CRO which we used to conduct an unplanned interim analysis comparing confirmed response (CR/PR) on treatment arms A and C (no Ca/Mg) versus response on treatment arms B and D (Ca/Mg). The response rates were 32.9% and 17.3% for (A and C) and(B and D), respectively (2-sided Fisher’s exact test p=0.028) indicating superiority in terms of confirmed response for the treatment arms without Ca/Mg.” • Data provided by CRO: • Response rates based on tumor measurements from localradiology reports of patients with confirmatory scans • No investigator-determined response rates • No review of images

  3. Primary Outcome : PFS RANDOMI ZE Modified FOLFOX 7 Continously until treatment failure Ca / Mg Oxali dose 85 mg/m2 Intermittent Modified FOLFOX 7 Placebo N= 140

  4. RESULTS

  5. RESULTS • Two-factor logistic regression exploratory model of response data showed no significant relationship with respect to treatment schedule (intermittent vs continuous) or use of Ca2+/Mg2+ for • Confirmed or Unconfirmed responses • No data yet presented on neurotoxicity

  6. STUDY COMMENTARY • This updated data alleviates some of the concerns re: potential detriment of Ca/Mg infusions with FOLFOX • Still unclear re: whether Ca/Mg reduces neurotoxicity • Interim data from NEOUROXA study (but :data from only 26 pts in each arm) shows • no difference in RR/PFS/OS • decreased neurotoxicity with Ca/Mg infusions • Await final data from both trials

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