Association of hypomagnesemia with inferior survival in a phase III, randomized study of cetuximab plus best supportive care versus best supportive care alone: NCIC CTG/AGITG CO.17

M Vickers, Christos Karapetis, D Tu, Chris O'Callaghan, Timothy Price, Niall Tebbutt, Guy van Hazel, Jeremy Shapiro, Nick Pavlakis, P Gibbs, J Blondal, U Lee, J Meharchand, R Burkes, S Rubin, John Simes, John Zalcberg, Malcolm Moore, L Zhu, Derek Jonker

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    31 Citations (Scopus)

    Abstract

    Background: Cetuximab-induced hypomagnesemia has been associated with improved clinical outcomes in advanced colorectal cancer (CRC). We explored this relationship from a randomized clinical trial of cetuximab plus best supportive care (BSC) versus BSC alone in patients with pretreated advanced CRC. Patients and methods: Day 28 hypomagnesemia grade (0 versus ≥1) and percent reduction (<20% versus ≥20%) of Mg from baseline was correlated with outcome. Results: The median percentage Mg reduction at day 28 was 10% (-42.4% to 63.0%) for cetuximab (N = 260) versus 0% (-21.1% to 25%) for BSC (N = 251) [P < 0.0001]. Grade ≥1 hypomagnesemia and ≥20% reduction from baseline at day 28 were associated with worse overall survival (OS) [hazard ratio, HR 1.61 (95% CI 1.12-2.33), P = 0.01 and 2.08 (95% CI 1.32-3.29), P = 0.002, respectively] in multivariate analysis including grade of rash (0-1 versus 2+). Dyspnea (grade ≥3) was more common in patients with ≥20% versus < 20% Mg reduction (68% versus 45%; P = 0.02) and grade 3/4 anorexia were higher in patients with grade ≥1 hypomagnesemia (81% versus 63%; P = 0.02). Conclusions: In contrast to prior reports, cetuximab-induced hypomagnesemia was associated with poor OS, even after adjustment for grade of rash.

    Original languageEnglish
    Article numbermds577
    Pages (from-to)953-960
    Number of pages8
    JournalAnnals of Oncology
    Volume24
    Issue number4
    DOIs
    Publication statusPublished - Apr 2013

    Keywords

    • Cetuximab
    • Colorectal cancer
    • Epidermal growth factor receptor
    • Hypomagnesemia
    • KRAS

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