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https://hdl.handle.net/2440/77981
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Type: | Journal article |
Title: | 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 |
Author: | Vickers, M. Karapetis, C. Tu, D. O'Callaghan, C. Price, T. Tebbutt, N. van Hazel, G. Shapiro, J. Pavlakis, N. Gibbs, P. Blondal, J. Lee, U. Meharchand, J. Burkes, R. Rubin, S. Simes, J. Zalcberg, J. Moore, M. Zhu, L. Jonker, D. |
Citation: | Annals of Oncology, 2013; 24(4):953-960 |
Publisher: | Oxford Univ Press |
Issue Date: | 2013 |
ISSN: | 0923-7534 1569-8041 |
Statement of Responsibility: | M. M. Vickers, C. S. Karapetis, D. Tu, C. J. O’Callaghan, T. J. Price, N. C. Tebbutt, G. Van Hazel, J. D. Shapiro, N. Pavlakis, P. Gibbs, J. Blondal, U. Lee, J. M. Meharchand, R. L. Burkes, S. H. Rubin, J. Simes, J. R. Zalcberg, M. J. Moore, L. Zhu & D. J. Jonker |
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. |
Keywords: | Humans Colorectal Neoplasms Nephrocalcinosis Renal Tubular Transport, Inborn Errors Magnesium ras Proteins Proto-Oncogene Proteins Neoplasm Staging Disease-Free Survival Treatment Outcome Adult Aged Aged, 80 and over Middle Aged Female Male Proto-Oncogene Proteins p21(ras) Hypercalciuria Antibodies, Monoclonal, Humanized Drug-Related Side Effects and Adverse Reactions ErbB Receptors Cetuximab |
Rights: | © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. |
DOI: | 10.1093/annonc/mds577 |
Published version: | http://dx.doi.org/10.1093/annonc/mds577 |
Appears in Collections: | Aurora harvest Medicine publications |
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