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

作者:Vickers M M*; Karapetis C S; Tu D; O' Callaghan C J; Price T J; Tebbutt N C; Van Hazel G; Shapiro J D; Pavlakis N; Gibbs P; Blondal J; Lee U; Meharchand J M; Burkes R L; Rubin S H; Simes J; Zalcberg J R; Moore M J; Zhu L; Jonker D J
来源:Annals of Oncology, 2013, 24(4): 953-960.
DOI:10.1093/annonc/mds577

摘要

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. %26lt;br%26gt;Day 28 hypomagnesemia grade (0 versus %26gt;= 1) and percent reduction (%26lt; 20% versus %26gt;= 20%) of Mg from baseline was correlated with outcome. %26lt;br%26gt;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 %26lt; 0.0001]. Grade %26gt;= 1 hypomagnesemia and %26gt;= 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 %26gt;= 3) was more common in patients with %26gt;= 20% versus %26lt; 20% Mg reduction (68% versus 45%; P = 0.02) and grade 3/4 anorexia were higher in patients with grade %26gt;= 1 hypomagnesemia (81% versus 63%; P = 0.02). %26lt;br%26gt;In contrast to prior reports, cetuximab-induced hypomagnesemia was associated with poor OS, even after adjustment for grade of rash.

  • 出版日期2013-4