Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial
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 ca...
Ausführliche Beschreibung
Autor*in: |
Bruna, Jordi [verfasserIn] |
---|
Format: |
E-Artikel |
---|---|
Sprache: |
Englisch |
Erschienen: |
2017 |
---|
Schlagwörter: |
---|
Anmerkung: |
© The Author(s) 2017 |
---|
Übergeordnetes Werk: |
Enthalten in: NeuroRX - Springer-Verlag, 2006, 15(2017), 1 vom: 18. Sept., Seite 178-189 |
---|---|
Übergeordnetes Werk: |
volume:15 ; year:2017 ; number:1 ; day:18 ; month:09 ; pages:178-189 |
Links: |
---|
DOI / URN: |
10.1007/s13311-017-0572-5 |
---|
Katalog-ID: |
SPR031272339 |
---|
LEADER | 01000caa a22002652 4500 | ||
---|---|---|---|
001 | SPR031272339 | ||
003 | DE-627 | ||
005 | 20230331071157.0 | ||
007 | cr uuu---uuuuu | ||
008 | 201007s2017 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1007/s13311-017-0572-5 |2 doi | |
035 | |a (DE-627)SPR031272339 | ||
035 | |a (SPR)s13311-017-0572-5-e | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Bruna, Jordi |e verfasserin |4 aut | |
245 | 1 | 0 | |a Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
264 | 1 | |c 2017 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a Computermedien |b c |2 rdamedia | ||
338 | |a Online-Ressource |b cr |2 rdacarrier | ||
500 | |a © The Author(s) 2017 | ||
520 | |a 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)°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. | ||
650 | 4 | |a Neurotoxicity |7 (dpeaa)DE-He213 | |
650 | 4 | |a Neuropathic pain |7 (dpeaa)DE-He213 | |
650 | 4 | |a Adverse effects |7 (dpeaa)DE-He213 | |
650 | 4 | |a Chemotherapy |7 (dpeaa)DE-He213 | |
650 | 4 | |a Colorectal cancer |7 (dpeaa)DE-He213 | |
650 | 4 | |a MR309/E-52862 |7 (dpeaa)DE-He213 | |
700 | 1 | |a Videla, Sebastián |4 aut | |
700 | 1 | |a Argyriou, Andreas A. |4 aut | |
700 | 1 | |a Velasco, Roser |4 aut | |
700 | 1 | |a Villoria, Jesús |4 aut | |
700 | 1 | |a Santos, Cristina |4 aut | |
700 | 1 | |a Nadal, Cristina |4 aut | |
700 | 1 | |a Cavaletti, Guido |4 aut | |
700 | 1 | |a Alberti, Paola |4 aut | |
700 | 1 | |a Briani, Chiara |4 aut | |
700 | 1 | |a Kalofonos, Haralabos P. |4 aut | |
700 | 1 | |a Cortinovis, Diego |4 aut | |
700 | 1 | |a Sust, Mariano |4 aut | |
700 | 1 | |a Vaqué, Anna |4 aut | |
700 | 1 | |a Klein, Thomas |4 aut | |
700 | 1 | |a Plata-Salamán, Carlos |4 aut | |
773 | 0 | 8 | |i Enthalten in |t NeuroRX |d Springer-Verlag, 2006 |g 15(2017), 1 vom: 18. Sept., Seite 178-189 |w (DE-627)SPR031264964 |7 nnns |
773 | 1 | 8 | |g volume:15 |g year:2017 |g number:1 |g day:18 |g month:09 |g pages:178-189 |
856 | 4 | 0 | |u https://dx.doi.org/10.1007/s13311-017-0572-5 |z kostenfrei |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a SYSFLAG_A | ||
912 | |a GBV_SPRINGER | ||
951 | |a AR | ||
952 | |d 15 |j 2017 |e 1 |b 18 |c 09 |h 178-189 |
author_variant |
j b jb s v sv a a a aa aaa r v rv j v jv c s cs c n cn g c gc p a pa c b cb h p k hp hpk d c dc m s ms a v av t k tk c p s cps |
---|---|
matchkey_str |
brunajordividelasebastinargyriouandreasa:2017----:fiayfnvlim1eetrnaoitooailtnnuenuoahaadmzdobelnpa |
hierarchy_sort_str |
2017 |
publishDate |
2017 |
allfields |
10.1007/s13311-017-0572-5 doi (DE-627)SPR031272339 (SPR)s13311-017-0572-5-e DE-627 ger DE-627 rakwb eng Bruna, Jordi verfasserin aut Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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)°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. Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 Videla, Sebastián aut Argyriou, Andreas A. aut Velasco, Roser aut Villoria, Jesús aut Santos, Cristina aut Nadal, Cristina aut Cavaletti, Guido aut Alberti, Paola aut Briani, Chiara aut Kalofonos, Haralabos P. aut Cortinovis, Diego aut Sust, Mariano aut Vaqué, Anna aut Klein, Thomas aut Plata-Salamán, Carlos aut Enthalten in NeuroRX Springer-Verlag, 2006 15(2017), 1 vom: 18. Sept., Seite 178-189 (DE-627)SPR031264964 nnns volume:15 year:2017 number:1 day:18 month:09 pages:178-189 https://dx.doi.org/10.1007/s13311-017-0572-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 15 2017 1 18 09 178-189 |
spelling |
10.1007/s13311-017-0572-5 doi (DE-627)SPR031272339 (SPR)s13311-017-0572-5-e DE-627 ger DE-627 rakwb eng Bruna, Jordi verfasserin aut Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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)°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. Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 Videla, Sebastián aut Argyriou, Andreas A. aut Velasco, Roser aut Villoria, Jesús aut Santos, Cristina aut Nadal, Cristina aut Cavaletti, Guido aut Alberti, Paola aut Briani, Chiara aut Kalofonos, Haralabos P. aut Cortinovis, Diego aut Sust, Mariano aut Vaqué, Anna aut Klein, Thomas aut Plata-Salamán, Carlos aut Enthalten in NeuroRX Springer-Verlag, 2006 15(2017), 1 vom: 18. Sept., Seite 178-189 (DE-627)SPR031264964 nnns volume:15 year:2017 number:1 day:18 month:09 pages:178-189 https://dx.doi.org/10.1007/s13311-017-0572-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 15 2017 1 18 09 178-189 |
allfields_unstemmed |
10.1007/s13311-017-0572-5 doi (DE-627)SPR031272339 (SPR)s13311-017-0572-5-e DE-627 ger DE-627 rakwb eng Bruna, Jordi verfasserin aut Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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)°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. Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 Videla, Sebastián aut Argyriou, Andreas A. aut Velasco, Roser aut Villoria, Jesús aut Santos, Cristina aut Nadal, Cristina aut Cavaletti, Guido aut Alberti, Paola aut Briani, Chiara aut Kalofonos, Haralabos P. aut Cortinovis, Diego aut Sust, Mariano aut Vaqué, Anna aut Klein, Thomas aut Plata-Salamán, Carlos aut Enthalten in NeuroRX Springer-Verlag, 2006 15(2017), 1 vom: 18. Sept., Seite 178-189 (DE-627)SPR031264964 nnns volume:15 year:2017 number:1 day:18 month:09 pages:178-189 https://dx.doi.org/10.1007/s13311-017-0572-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 15 2017 1 18 09 178-189 |
allfieldsGer |
10.1007/s13311-017-0572-5 doi (DE-627)SPR031272339 (SPR)s13311-017-0572-5-e DE-627 ger DE-627 rakwb eng Bruna, Jordi verfasserin aut Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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)°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. Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 Videla, Sebastián aut Argyriou, Andreas A. aut Velasco, Roser aut Villoria, Jesús aut Santos, Cristina aut Nadal, Cristina aut Cavaletti, Guido aut Alberti, Paola aut Briani, Chiara aut Kalofonos, Haralabos P. aut Cortinovis, Diego aut Sust, Mariano aut Vaqué, Anna aut Klein, Thomas aut Plata-Salamán, Carlos aut Enthalten in NeuroRX Springer-Verlag, 2006 15(2017), 1 vom: 18. Sept., Seite 178-189 (DE-627)SPR031264964 nnns volume:15 year:2017 number:1 day:18 month:09 pages:178-189 https://dx.doi.org/10.1007/s13311-017-0572-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 15 2017 1 18 09 178-189 |
allfieldsSound |
10.1007/s13311-017-0572-5 doi (DE-627)SPR031272339 (SPR)s13311-017-0572-5-e DE-627 ger DE-627 rakwb eng Bruna, Jordi verfasserin aut Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial 2017 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2017 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)°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. Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 Videla, Sebastián aut Argyriou, Andreas A. aut Velasco, Roser aut Villoria, Jesús aut Santos, Cristina aut Nadal, Cristina aut Cavaletti, Guido aut Alberti, Paola aut Briani, Chiara aut Kalofonos, Haralabos P. aut Cortinovis, Diego aut Sust, Mariano aut Vaqué, Anna aut Klein, Thomas aut Plata-Salamán, Carlos aut Enthalten in NeuroRX Springer-Verlag, 2006 15(2017), 1 vom: 18. Sept., Seite 178-189 (DE-627)SPR031264964 nnns volume:15 year:2017 number:1 day:18 month:09 pages:178-189 https://dx.doi.org/10.1007/s13311-017-0572-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER AR 15 2017 1 18 09 178-189 |
language |
English |
source |
Enthalten in NeuroRX 15(2017), 1 vom: 18. Sept., Seite 178-189 volume:15 year:2017 number:1 day:18 month:09 pages:178-189 |
sourceStr |
Enthalten in NeuroRX 15(2017), 1 vom: 18. Sept., Seite 178-189 volume:15 year:2017 number:1 day:18 month:09 pages:178-189 |
format_phy_str_mv |
Article |
institution |
findex.gbv.de |
topic_facet |
Neurotoxicity Neuropathic pain Adverse effects Chemotherapy Colorectal cancer MR309/E-52862 |
isfreeaccess_bool |
true |
container_title |
NeuroRX |
authorswithroles_txt_mv |
Bruna, Jordi @@aut@@ Videla, Sebastián @@aut@@ Argyriou, Andreas A. @@aut@@ Velasco, Roser @@aut@@ Villoria, Jesús @@aut@@ Santos, Cristina @@aut@@ Nadal, Cristina @@aut@@ Cavaletti, Guido @@aut@@ Alberti, Paola @@aut@@ Briani, Chiara @@aut@@ Kalofonos, Haralabos P. @@aut@@ Cortinovis, Diego @@aut@@ Sust, Mariano @@aut@@ Vaqué, Anna @@aut@@ Klein, Thomas @@aut@@ Plata-Salamán, Carlos @@aut@@ |
publishDateDaySort_date |
2017-09-18T00:00:00Z |
hierarchy_top_id |
SPR031264964 |
id |
SPR031272339 |
language_de |
englisch |
fullrecord |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR031272339</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230331071157.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2017 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s13311-017-0572-5</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR031272339</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13311-017-0572-5-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Bruna, Jordi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2017</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2017</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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)°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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Neurotoxicity</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Neuropathic pain</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Adverse effects</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Chemotherapy</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Colorectal cancer</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">MR309/E-52862</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Videla, Sebastián</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Argyriou, Andreas A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Velasco, Roser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Villoria, Jesús</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Santos, Cristina</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Nadal, Cristina</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Cavaletti, Guido</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Alberti, Paola</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Briani, Chiara</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Kalofonos, Haralabos P.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Cortinovis, Diego</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Sust, Mariano</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Vaqué, Anna</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Klein, Thomas</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Plata-Salamán, Carlos</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">NeuroRX</subfield><subfield code="d">Springer-Verlag, 2006</subfield><subfield code="g">15(2017), 1 vom: 18. Sept., Seite 178-189</subfield><subfield code="w">(DE-627)SPR031264964</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:15</subfield><subfield code="g">year:2017</subfield><subfield code="g">number:1</subfield><subfield code="g">day:18</subfield><subfield code="g">month:09</subfield><subfield code="g">pages:178-189</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1007/s13311-017-0572-5</subfield><subfield code="z">kostenfrei</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">15</subfield><subfield code="j">2017</subfield><subfield code="e">1</subfield><subfield code="b">18</subfield><subfield code="c">09</subfield><subfield code="h">178-189</subfield></datafield></record></collection>
|
author |
Bruna, Jordi |
spellingShingle |
Bruna, Jordi misc Neurotoxicity misc Neuropathic pain misc Adverse effects misc Chemotherapy misc Colorectal cancer misc MR309/E-52862 Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
authorStr |
Bruna, Jordi |
ppnlink_with_tag_str_mv |
@@773@@(DE-627)SPR031264964 |
format |
electronic Article |
delete_txt_mv |
keep |
author_role |
aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut aut |
collection |
springer |
remote_str |
true |
illustrated |
Not Illustrated |
topic_title |
Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial Neurotoxicity (dpeaa)DE-He213 Neuropathic pain (dpeaa)DE-He213 Adverse effects (dpeaa)DE-He213 Chemotherapy (dpeaa)DE-He213 Colorectal cancer (dpeaa)DE-He213 MR309/E-52862 (dpeaa)DE-He213 |
topic |
misc Neurotoxicity misc Neuropathic pain misc Adverse effects misc Chemotherapy misc Colorectal cancer misc MR309/E-52862 |
topic_unstemmed |
misc Neurotoxicity misc Neuropathic pain misc Adverse effects misc Chemotherapy misc Colorectal cancer misc MR309/E-52862 |
topic_browse |
misc Neurotoxicity misc Neuropathic pain misc Adverse effects misc Chemotherapy misc Colorectal cancer misc MR309/E-52862 |
format_facet |
Elektronische Aufsätze Aufsätze Elektronische Ressource |
format_main_str_mv |
Text Zeitschrift/Artikel |
carriertype_str_mv |
cr |
hierarchy_parent_title |
NeuroRX |
hierarchy_parent_id |
SPR031264964 |
hierarchy_top_title |
NeuroRX |
isfreeaccess_txt |
true |
familylinks_str_mv |
(DE-627)SPR031264964 |
title |
Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
ctrlnum |
(DE-627)SPR031272339 (SPR)s13311-017-0572-5-e |
title_full |
Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
author_sort |
Bruna, Jordi |
journal |
NeuroRX |
journalStr |
NeuroRX |
lang_code |
eng |
isOA_bool |
true |
recordtype |
marc |
publishDateSort |
2017 |
contenttype_str_mv |
txt |
container_start_page |
178 |
author_browse |
Bruna, Jordi Videla, Sebastián Argyriou, Andreas A. Velasco, Roser Villoria, Jesús Santos, Cristina Nadal, Cristina Cavaletti, Guido Alberti, Paola Briani, Chiara Kalofonos, Haralabos P. Cortinovis, Diego Sust, Mariano Vaqué, Anna Klein, Thomas Plata-Salamán, Carlos |
container_volume |
15 |
format_se |
Elektronische Aufsätze |
author-letter |
Bruna, Jordi |
doi_str_mv |
10.1007/s13311-017-0572-5 |
title_sort |
efficacy of a novel sigma-1 receptor antagonist for oxaliplatin-induced neuropathy: a randomized, double-blind, placebo-controlled phase iia clinical trial |
title_auth |
Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
abstract |
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)°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. © The Author(s) 2017 |
abstractGer |
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)°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. © The Author(s) 2017 |
abstract_unstemmed |
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)°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. © The Author(s) 2017 |
collection_details |
GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER |
container_issue |
1 |
title_short |
Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial |
url |
https://dx.doi.org/10.1007/s13311-017-0572-5 |
remote_bool |
true |
author2 |
Videla, Sebastián Argyriou, Andreas A. Velasco, Roser Villoria, Jesús Santos, Cristina Nadal, Cristina Cavaletti, Guido Alberti, Paola Briani, Chiara Kalofonos, Haralabos P. Cortinovis, Diego Sust, Mariano Vaqué, Anna Klein, Thomas Plata-Salamán, Carlos |
author2Str |
Videla, Sebastián Argyriou, Andreas A. Velasco, Roser Villoria, Jesús Santos, Cristina Nadal, Cristina Cavaletti, Guido Alberti, Paola Briani, Chiara Kalofonos, Haralabos P. Cortinovis, Diego Sust, Mariano Vaqué, Anna Klein, Thomas Plata-Salamán, Carlos |
ppnlink |
SPR031264964 |
mediatype_str_mv |
c |
isOA_txt |
true |
hochschulschrift_bool |
false |
doi_str |
10.1007/s13311-017-0572-5 |
up_date |
2024-07-03T22:58:05.581Z |
_version_ |
1803600512245825536 |
fullrecord_marcxml |
<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR031272339</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230331071157.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2017 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s13311-017-0572-5</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR031272339</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s13311-017-0572-5-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Bruna, Jordi</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Efficacy of a Novel Sigma-1 Receptor Antagonist for Oxaliplatin-Induced Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Clinical Trial</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2017</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© The Author(s) 2017</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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)°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.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Neurotoxicity</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Neuropathic pain</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Adverse effects</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Chemotherapy</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Colorectal cancer</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">MR309/E-52862</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Videla, Sebastián</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Argyriou, Andreas A.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Velasco, Roser</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Villoria, Jesús</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Santos, Cristina</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Nadal, Cristina</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Cavaletti, Guido</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Alberti, Paola</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Briani, Chiara</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Kalofonos, Haralabos P.</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Cortinovis, Diego</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Sust, Mariano</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Vaqué, Anna</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Klein, Thomas</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Plata-Salamán, Carlos</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">NeuroRX</subfield><subfield code="d">Springer-Verlag, 2006</subfield><subfield code="g">15(2017), 1 vom: 18. Sept., Seite 178-189</subfield><subfield code="w">(DE-627)SPR031264964</subfield><subfield code="7">nnns</subfield></datafield><datafield tag="773" ind1="1" ind2="8"><subfield code="g">volume:15</subfield><subfield code="g">year:2017</subfield><subfield code="g">number:1</subfield><subfield code="g">day:18</subfield><subfield code="g">month:09</subfield><subfield code="g">pages:178-189</subfield></datafield><datafield tag="856" ind1="4" ind2="0"><subfield code="u">https://dx.doi.org/10.1007/s13311-017-0572-5</subfield><subfield code="z">kostenfrei</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_USEFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">SYSFLAG_A</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">GBV_SPRINGER</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">AR</subfield></datafield><datafield tag="952" ind1=" " ind2=" "><subfield code="d">15</subfield><subfield code="j">2017</subfield><subfield code="e">1</subfield><subfield code="b">18</subfield><subfield code="c">09</subfield><subfield code="h">178-189</subfield></datafield></record></collection>
|
score |
7.400201 |