Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/222984
Title: Effect of tumor-treating fields plus maintenance Temozolomide vs maintenance Temozolomide alone on survival in patients with glioblastoma
Author: Stupp, Roger
Taillibert, Sophie
Kanner, Andrew
Read, William
Steinberg, David M.
Lhermitte, Benoit
Toms, Steven
Idbaih, Ahmed
Ahluwalia, Manmeet S.
Fink, Karen
Meco, Francesco di
Lieberman, Frank
Zhu, Jay Jiguang
Stragliotto, Giuseppe
Tran, David D.
Brem, Steven
Hottinger, Andreas F.
Kirson, Eilon D.
Lavy Shahaf, Gitit
Weinberg, Uri
Kim, Chae Yong
Paek, Sun Ha
Nicholas, Garth
Bruna, Jordi
Hirte, Hal
Weller, Michael
Palti, Yoram
Hegi, Monika E.
Ram, Zvi
Keywords: Glioma
Medicaments antineoplàstics
Tumors cerebrals
Gliomas
Antineoplastic agents
Brain tumors
Issue Date: 19-Dec-2017
Publisher: American Medical Association (AMA)
Abstract: This trial assessed the efficacy of MR309 (a novel selective sigma-1 receptor ligand previously developed as E-52862) in ameliorating oxaliplatin-induced peripheral neuropathy (oxaipn). A discontinuous regimen of MR309 (400 mg/day, 5 days per cycle) was tested in patients with colorectal cancer receiving FOLFOX in a phase II, randomized, double-blind, placebo-controlled, multicenter clinical trial. Outcome measures included changes in 24-week quantitative measures of thermal sensitivity and total neuropathy score. In total, 124 patients were randomized (1:1) to MR309 or placebo. Sixty-three (50.8%) patients withdrew prematurely before completing 12 planned oxaliplatin cycles. Premature withdrawal because of cancer progression was less frequent in the MR309 group (7.4% vs 25.0% with placebo; p = 0.054). MR309 significantly reduced cold pain threshold temperature [mean treatment effect difference (SE) vs placebo: 5.29 (1.60)degrees C; p = 0.001] and suprathreshold cold stimulus-evoked pain intensity [mean treatment effect difference: 1.24 (0.57) points; p = 0.032]. Total neuropathy score, health-related quality-of-life measures, and nerve-conduction parameters changed similarly in both arms, whereas the proportion of patients with severe chronic neuropathy (National Cancer Institute Common Terminology Criteria for Adverse Events >= 3) was significantly lower in the MR309 group (3.0% vs 18.2% with placebo; p = 0.046). The total amount of oxaliplatin delivered was greater in the active arm (1618.9 mg vs 1453.8 mg with placebo; p = 0.049). Overall, 19.0% of patients experienced at least 1 treatment-related adverse event (25.8% and 11.9% with MR309 and placebo, respectively). Intermittent treatment with MR309 was associated with reduced acute oxaipn and higher oxaliplatin exposure, and showed a potential neuroprotective role for chronic cumulative oxaipn. Furthermore, MR309 showed an acceptable safety profile.
Note: Reproducció del document publicat a: https://doi.org/10.1001/jama.2017.18718
It is part of: JAMA, 2017, vol. 318, num. 23, p. 2306-2316
URI: https://hdl.handle.net/2445/222984
Related resource: https://doi.org/10.1001/jama.2017.18718
ISSN: 1538-3598
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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