504P - Calcium gluconate and magnesium sulfate in preventing neurotoxicity in patients receiving oxaliplatin-based combination chemotherapy-capeOX

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Complications/Toxicities of treatment
Colon and Rectal Cancer
Therapy
Presenter Ivane Kiladze
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors I.Z. Kiladze1, N. Sharikadze2, T. Esakia2
  • 1Clinical Oncology, Aversi Clinic, 0160 - Tbilisi/GE
  • 2Medical Oncology, MediClubGeorgia, Tbilisi/GE

Abstract

Background

Oxaliplatin in combination with Capecitabine (CapeOX) is widely used chemotherapy regimen in the treatment of colorectal (CRC) and gastric (GC) cancer both in the adjuvant and metastatic setting. Oxaliplatin-induced peripheral neuropathy (OXA-IPN) is the major cause of treatment delay, dose reduction and cessation of oxaliplatin-based therapy. Evidence regarding the role of calcium(Ca) and magnesium(Mg) prophylaxis to prevent oxaliplatin-related neurotoxicity is conflicting. This study is a prospective randomized study to evaluate the effect of Ca/Mg infusion on prevention or amelioration of oxaliplatin neuropathy in patients with CRC and GC treated with CapeOX.

Methods

Patients with CRC or GC undergoing adjuvant or palliative therapy with CapeOX were randomly assigned to Ca/Mg (1g Ca gluconate+ 1g Mg sulfate pre- and post-oxaliplatin) or placebo group. 133 oxaliplatin-naive CRC/GC patients were enrolled (112 CRC, 22 GC ) who received at least one cycle of CapeOX. Patients were randomized to receive (Ca/Mg group; n = 78) or not receive (control group; n = 55) Ca gluconate and Mg sulfate infusion. The primary end point was the percentage of patients with grade 2 or greater sensory neurotoxicity (sNT) at any time during or after oxaliplatin-based therapy by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3) criteria.

Results

A total of 636 cycles of CapeOX were administered, median 5 and 4,5 cycles for Ca/Mg and control group respectively. Overall 82% (109) patients experienced at least Grade 1 acute sNT. Severities for control and Ca/Mg group patients, respectively were Grade 1, 33% and 41%; Grade 2, 11% and 10%; Grade3, 3% and 8%; Grade 4 2% and 0%. The incidence rates of grade 2 or worse neurotoxicity were 23% and 29% for Ca/Mg and control arms, respectively (p = 0.434)

Conclusions

Calcium/Magnesium did not substantially decrease oxaliplatin-induced neurotoxicity. Our study does not support using calcium/magnesium to protect against oxaliplatin-induced sNT.

Clinical trial identification

Trial has not protocol number Release date- 05.05.2016

Legal entity responsible for the study

Georgian Group on Young Oncologists

Funding

Georgian Group on Young Oncologists

Disclosure

All authors have declared no conflicts of interest.