Format

Send to

Choose Destination
See comment in PubMed Commons below
J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2.

Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).

Author information

1
Charles L. Loprinzi, Rui Qin, Pamela Atherton, Drew Seisler, and Axel Grothey, Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Shaker R. Dakhil, Wichita Community Clinical Oncology Program, Wichita, KS; Louis Fehrenbacher, Kaiser Permanente-Vallejo, Vallejo, CA; Kathleen A. Flynn, Michigan Cancer Research Consortium, Ann Arbor, MI; Rubina Qamar, Aurora Cancer Care-Milwaukee West, Wauwatosa, WI; and Grant C. Lewis, Summit Cancer Care, Savannah, GA.

Abstract

PURPOSE:

Cumulative neurotoxicity is a prominent toxicity of oxaliplatin-based therapy. Intravenous calcium and magnesium have been extensively used to reduce oxaliplatin-induced neurotoxicity. This trial was designed to definitively test whether calcium/magnesium decreases oxaliplatin-related neurotoxicity.

PATIENTS AND METHODS:

In all, 353 patients with colon cancer undergoing adjuvant therapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) were randomly assigned to intravenous calcium/magnesium before and after oxaliplatin, a placebo before and after, or calcium/magnesium before and placebo after. The primary end point was cumulative neurotoxicity measured by the sensory scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 tool.

RESULTS:

There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy, including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale. In addition, calcium/magnesium did not substantially decrease oxaliplatin-induced acute neuropathy.

CONCLUSION:

This study does not support using calcium/magnesium to protect against oxaliplatin-induced neurotoxicity.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01099449.

PMID:
24297951
PMCID:
PMC3965262
DOI:
10.1200/JCO.2013.52.0536
[Indexed for MEDLINE]
Free PMC Article

Publication types, MeSH terms, Substances, Supplementary concept, Secondary source ID, Grant support

Publication types

MeSH terms

Substances

Supplementary concept

Secondary source ID

Grant support

PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Atypon Icon for PubMed Central
    Loading ...
    Support Center