North Central Cancer Treatment Group/Alliance trial N08CA—the use of glutathione for prevention of paclitaxel/carboplatin‐induced peripheral neuropathy: A phase 3 randomized, double‐blind, placebo‐controlled study. Issue 12 (11th March 2014)

• Record Type: Journal Article
• Authors: Leal, Alexis D.; Qin, Rui; Atherton, Pamela J.; Haluska, Paul; Behrens, Robert J.; Tiber, Charles H.; Watanaboonyakhet, Patanit; Weiss, Matthias; Adams, Paul T.; Dockter, Travis J.; Loprinzi, Charles L.; for the Alliance for Clinical Trials in Oncology
• Is Part Of: Cancer. Volume 120:Issue 12(2014)
• Page Start: 1890
• Page End: 1897
• Publication Date: 2014-03-11
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28654
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr28654-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>Chemotherapy‐induced peripheral neuropathy (CIPN) is a significant side effect of taxane and platinum‐based chemotherapy. Several studies have supported the potential benefit of glutathione for the prevention of platinum‐induced CIPN. The current trial was designed to determine whether glutathione would prevent CIPN as a result of carboplatin/paclitaxel therapy.</p> </sec> <sec id="cncr28654-sec-0002" sec-type="section"> <title>METHODS</title> <p>In total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011. Patients were randomized to receive either placebo (n = 91) or 1.5 g/m<sup>2</sup> glutathione (n = 94) over 15 minutes immediately before chemotherapy. CIPN was assessed using the European Organization for Research and Treatment of Cancer Quality‐of‐Life (EORTC‐QLQ) 20‐item, CIPN‐specific (CIPN20) sensory subscale and the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.</p> </sec> <sec id="cncr28654-sec-0003" sec-type="section"> <title>RESULTS</title> <p>There were no statistically significant differences between the 2 study arms with regard to: 1) peripheral neurotoxicity, as assessed using both the EORTC‐QLQ‐CIPN20 (<italic>P</italic> = .21) and the CTCAE scales (<italic>P</italic> = .449 for grade ≥2 neurotoxicity; <italic>P</italic> = .039 for time to development of grade ≥2 neuropathy, in favor of the placebo); 2) the degree of paclitaxel acute pain syndrome (<italic>P</italic> = .30 for patients who received paclitaxel every 3‐4 weeks and <italic>P</italic> = .002, in favor of the placebo, for patients who received weekly paclitaxel); 3) the time to disease progression (<italic>P</italic> = .63); or 4) apparent toxicities. Subgroup analyses did not reveal any evidence of benefit in any particular subgroup.</p> </sec> <sec id="cncr28654-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>The results from this study do not support the use of glutathione for the prevention of paclitaxel/carboplatin‐induced CIPN. <bold><italic>Cancer</italic> 2014;120:1890–1897</bold>. © <italic>2014 American Cancer Society</italic>.</p> </sec> </abstract>