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effect of tumor-treating fields plus mai.pdf (615.75 KB)

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2017-12-19

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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/222984

Effect of tumor-treating fields plus maintenance Temozolomide vs maintenance Temozolomide alone on survival in patients with glioblastoma

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https://doi.org/10.1001/jama.2017.18718

Resum

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.

Matèries

Glioma, Medicaments antineoplàstics, Tumors cerebrals

Matèries (anglès)

Gliomas, Antineoplastic agents, Brain tumors

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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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. Effect of tumor-treating fields plus maintenance Temozolomide vs maintenance Temozolomide alone on survival in patients with glioblastoma. _JAMA_. 2017. Vol. 318, núm. 23, pàgs. 2306-2316. [consulta: 23 de gener de 2026]. ISSN: 1538-3598. [Disponible a: https://hdl.handle.net/2445/222984]

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