Intermittent oxaliplatin (oxali) administration and time-to-treatment-failure (TTF) in metastatic colorectal cancer (mCRC): Final results of the phase III CONcePT trial
- 20 May 2008
- journal article
- abstracts
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 26 (15_suppl) , 4010
- https://doi.org/10.1200/jco.2008.26.15_suppl.4010
Abstract
4010 Background: About 60% of mCRC patients (pts) discontinue oxali prior to disease progression (PD), largely driven by cumulative neurotoxicity (NT). CONcePT (Combined Oxaliplatin Neurotoxicity Prevention Trial) was initiated to test if an intermittent oxali (IO) schedule of FOLFOX/bevacizumab (BV) allows pts to remain on therapy longer compared to a conventional oxali (CO) “treat-to- failure” approach. To explore the impact of IV calcium/magnesium (CaMg: Ca-gluconate 1g, Mg-sulfate 1g, pre/post oxali) on NT, pts were randomized in a 2x2 factorial design (IO vs. CO) x (CaMg vs. placebo [PL] - double-blinded). Methods: Eligibility criteria included measurable disease, PS 0–1, no neuropathy. In CO arms, pts received mFOLFOX7 (oxali 85mg/m2, LV 200mg/m2, 5FU 2,400mg/m2 x 46h) plus BV (5mg/kg) q2wks. In the IO arms, pts alternated every 8 cycles with and without oxali. After 140 pts, a protocol amendment eliminated the CaMg vs. PL randomization and 40 subsequent pts all received CaMg. TTF (primary endpoint)...Keywords
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