113106-132

Phase III randomized, placebo (PL)-controlled, double-blind study of intravenous calcium/magnesium (CaMg) to prevent oxaliplatin-induced sensory neurotoxicity (sNT), N08CB: An alliance for clinical trials in oncology study.

Subcategory: 
Category: 
Gastrointestinal (Colorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Colorectal) Cancer
Abstract Number: 

3501

Citation: 

J Clin Oncol 31, 2013 (suppl; abstr 3501)

Author(s): 

Charles L. Loprinzi, Rui Qin, Shaker R. Dakhil, Louis Fehrenbacher, Philip J. Stella, Pamela J. Atherton, Drew K. Seisler, Rubina Qamar, Grant Carlton Lewis, Axel Grothey; Mayo Clinic, Rochester, MN; Cancer Center of Kansas, Liberal, KS; Kaiser Permanente Northern California, Vallejo, CA; Saint Joseph Mercy Health System, Ann Arbor, MI; Onc Alliance, Wauwatosa, WI; Summit Cancer Care, Savannah, GA


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: Cumulative neurotoxicity commonly leads to early discontinuation of oxaliplatin-based therapy. In a relatively small, prematurely-discontinued, randomized study, IV CaMg was associated with reduced oxaliplatin-induced sNT (Grothey, JCO, 2011). N08CB was designed to definitively test whether IV CaMg significantly decreases cumulative oxaliplatin-related sNT. Methods: 353 pts with colon cancer undergoing adjuvant therapy with FOLFOX were randomized to 3 arms: IV CaMg (1g calcium gluconate, 1g magnesium sulfate) before and after oxaliplatin vs PL before and after vs CaMg before and PL after. The primary endpoint was cumulative sNT repeatedly measured by the sensory subscale of the EORTC QLQ-CIPN20. Secondary endpoints, using CTCAE 4.0 and an oxaliplatin specific neurotoxicity scale, were also assessed. Acute neuropathy data were also collected for 5 days following each oxaliplatin dose. The area under the curve (AUC) of the sensory subscale during the treatment cycles was used as summary measures for comparison. The Wilcoxon rank-sum tests were conducted for each treatment versus placebo arm, at 2.5%, adjusting for multiplicity using Bonferroni’s approach. Results: CaMg did not reduce cumulative sNT. Primary and secondary analyses data are summarized in the Table. In addition, there were no significant differences between arms regarding oxaliplatin administered doses or chemotherapy discontinuation rates. Also, there were no substantial differences in acute neuropathy scores or side-effects between study arms. Conclusions: This study does not demonstrate any activity of IV CaMg as a neuroprotectant against oxaliplatin-induced neurotoxicity. Clinical trial information: NCT01099449.

Arm/measure CaMg/CaMg
(n=118)
CaMg/PL
(n=116)
PL/PL
(n=119)
P value between
CaMg/CaMg vs PL/PL
P value between
CaMg/PL vs PL/PL
Primary endpoint:
CIPN-20 sensory scale
mean AUC (sd)
(higher scores better)
89.2 (8.5) 87.1 (9.9) 88.3 (9.7) 0.727 0.292
CTCAE, median days to grade 2 sNT 171 171 173 0.748 0.848
Oxaliplatin- specific
neuropathy scale,
median days to
grade 2 sNT
140 139 148 0.953 0.942