Intermittent oxaliplatin (oxali) administration and time-to-treatment-failure (TTF) in metastatic colorectal cancer (mCRC): Final results of the phase III CONcePT trial

摘要: 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 test if an intermittent (IO) schedule FOLFOX/bevacizumab (BV) allows pts remain on therapy longer compared a conventional (CO) “treat-to- failure” approach. To explore the impact IV calcium/magnesium (CaMg: Ca-gluconate 1g, Mg-sulfate pre/post oxali) NT, were randomized in 2x2 factorial design (IO vs. CO) x (CaMg placebo [PL] - double-blinded). Methods: Eligibility criteria included measurable disease, PS 0–1, no neuropathy. In CO arms, received mFOLFOX7 (oxali 85mg/m2, LV 200mg/m2, 5FU 2,400mg/m2 46h) plus BV (5mg/kg) q2wks. IO alternated every 8 cycles with and without oxali. After 140 pts, protocol amendment eliminated CaMg PL randomization 40 subsequent all CaMg. TTF (primary endpoint)...