Abstract
Abstract Background: Taxane is an active drug in the treatment of breast cancer, but peripheral neuropathy is a major dose limiting side effect. There are currently no effective drugs or treatment modalities for the prevention or treatment of taxane-related neuropathy. We examined whether calcium and magnesium (Ca/Mg) infusions can reduce the incidence of neuropathy in patients with early stage breast cancer who are treated with paclitaxel. Methods: This was a pilot study evaluating the feasibility of Ca/Mg infusion to prevent taxane induced neuropathy in women with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. All patients received calcium gluconate and magnesium sulfate infusion, 1 g of each agent immediately before and after each dose of paclitaxel. The primary endpoint was paclitaxel-related neuropathy grade 2 or greater as measured by NCI Common Terminology Criteria Version 3 compared with historical controls. Secondary endpoints included other measures of neuropathy and quality of life such as the Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) score, taxane-related neuropathic pain as measured by the Brief Pain Inventory-Short Form (BPI-SF). The endpoints were assessed in patients midway through treatment, at the end of treatment and 4 weeks after finishing taxane therapy. Results: We enrolled 50 patients, 47 patients were evaluable, and 3 patients were taken out of the study due to non-neuropathy related side effects or progression of disease. Median age: 50.8 (range 27-71), White/Hispanic/Black/Asian/Other: 17/16/12/3/2. Two patients received paclitaxel every 2 weeks, while the remainder received weekly therapy. Eight of 47 patients (17%) had grade 2 neuropathy four weeks after treatment completed, while no patients had grade 3 or 4 neuropathy. This rate of neuropathy is significantly lower compared to that seen in historical control where approximately 30% of patients develop grade 2 or greater neuropathy. There were no significant changes in the quality of life measurements. There were no observed toxicities related to the Ca/Mg infusion. Discussion: Our study showed a decreased incidence of paclitaxel-related neuropathy in patients receiving Ca/Mg infusions when compared to historical controls. The infusions are well tolerated without any side effects. Randomized studies are warranted to further evaluate Ca/Mg infusion for the prevention of paclitaxel-related neuropathy. Citation Format: Theresa Shao, Joshua Kra, Paula Klein, Anupama Goel, Stephen Malamud, Tiffany Xing, Johnny Chan, Michael L Grossbard. Calcium and magnesium infusion for the prevention of taxane induced neuropathy in early stage breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-12-10.
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