Role of calcium and magnesium infusion in prevention of oxaliplatin neurotoxicity. A phase III trial

Objective： This study is a prospective randomized, double-blind, placebo-controlled study to evaluate the effect of calcium and magnesium （Ca/Mg） infusion on amelioration of oxaliplatin neuropathy, the dose-limiting toxicity. Methods： Sixty patients with resected colorectal carcinoma （CRC） planned to receive adjuvant oxaliplatin-containing regimen were randomly assigned to two arms; Arm A： patients received Ca/Mg were given as 1 gm Ca gluconate and 1 gm MgSO4 in 250 mL of intravenous （IV） solution over 30 rain pre and post oxaliplatin infusion, and Arm B： patients received 250 mL of IV solution without Ca/Mg over 30 min pre and post oxaliplatin infusion. Primary outcome was to assess percentage of patients with oxaliplatin-induced neurotoxicity. Neurotoxicity was assessed according to the National Cancer Institute Common Terminology Criteria forAdverse Events （NCI-CTCAE） version 3.0. Results： Sixty patients in both arms were assessed, 30 with Ca/Mg infusion and 30 without. Patients developed neurotoxicity in arm A were significantly lower than that in arm B after the end of treatment; 7 （23.3%） and 14 （46.6%） respectively （P 〈 0.05）, and significantly lower duration of neuropathy in months （8 ± 2.5 vs 18 ±3） respectively （P 〈 0.001）. Conclusion： Use of IV Ca/Mg showed a statistically significant reduction of peripheral neuropathy （PN） in patients with CRC receiving oxaliplatin in the adjuvant settings.

Chemotherapy Toxicity Profile in Adjuvant Treated Colorectal Carcinoma Patients

Background:?Colorectal cancer (CRC) is the third most common cancer and the fourth leading cause of cancer-related deaths in the world. The treatment of stage III CRC consists of surgery followed by adjuvant chemotherapy with either single agent capecitabine or combination therapy consisting of FOLFOX?or XELOX, all of which have been shown to be effective in improving disease-free survival (DFS) and overall survival (OS). However, toxicities acquired from chemotherapy can affect a cancer patient’s quality of life and result in early?treatment discontinuation. Common toxicities include hematological, gastrointestinal (GI), constitutional, dermatological, and neurological.?Aim of the Work: The present work was aimed to assess and evaluate chemotherapy toxicities in adjuvant treatment in CRC patients and analyze certain factors that might increase chemotherapy toxicity. Patients and Methods: This is retrospective study included a total of 72 patients of colorectal carcinoma received adjuvant chemotherapy at Clinical Oncology Department, Ain Shams University. The study was conducted between Jan. 2012 and Jan. 2017. Results: We found that?the most chemotherapy reported was neurological toxicity in (73.6%), gastrointestinal symptoms (diarrhea 52.7%, nausea 30.6%, vomiting 27.8% & oral mucositis 24%), hematological toxicity (neutropenia 40.3%, anemia 34.7%, thrombocytopenia 12.5%), fatigue 20.9%, hepatic toxicity 18.1%, dermatological toxicity 9.7% & renal toxicity 5.6%). older patients have significant incidence of neurological toxicity (p-value?= 0.023) and fatigue (p-value?= 0.038). females have significant incidence of anemia (p-value = 0.017). increase of oxaliplatin?cumulative dose increase incidence of neurological toxicity (p-value?= 0.024), thrombocytopenia (p-value?= 0.007) and renal toxicity (p-value?= 0.030). Oxaliplatin containing regimens have high significant correlation with neurological toxicity (p-value = 0.000) and capcitabine has high significant correlation with dermatological toxicity (p-value = 0.000). Conclusion: The most overall toxicity reported during adjuvant treatment in CRC was neurological toxicity. Although a variety of adverse reactions were reported the treatment regimens were tolerated but we should take care of factors that may increase certain toxicity.