Persistent prevention of oxaliplatin-induced peripheral neuropathy using calmangafodipir (PledOx®): a placebo-controlled randomised phase II study (PLIANT): a placebo-controlled randomised phase II study (PLIANT)
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| Název: | Persistent prevention of oxaliplatin-induced peripheral neuropathy using calmangafodipir (PledOx®): a placebo-controlled randomised phase II study (PLIANT): a placebo-controlled randomised phase II study (PLIANT) |
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| Autoři: | Glimelius, Bengt, Manojlovic, Nebojsa, Pfeiffer, Per, Mosidze, Baadur, Kurteva, Galina, Karlberg, Mia, Mahalingam, Devalingam, Buhl Jensen, Peter, Kowalski, Jan, Bengtson, Marie, Nittve, Malin, Näsström, Jacques |
| Zdroj: | Glimelius, B, Manojlovic, N, Pfeiffer, P, Mosidze, B, Kurteva, G, Karlberg, M, Mahalingam, D, Buhl Jensen, P, Kowalski, J, Bengtson, M, Nittve, M & Näsström, J 2018, ' Persistent prevention of oxaliplatin-induced peripheral neuropathy using calmangafodipir (PledOx(®)) : a placebo-controlled randomised phase II study (PLIANT) ', Acta Oncologica, vol. 57, no. 3, pp. 393-402 . https://doi.org/10.1080/0284186X.2017.1398836 |
| Informace o vydavateli: | MJS Publishing, Medical Journals Sweden AB, 2017. |
| Rok vydání: | 2017 |
| Témata: | Adult, Male, Organoplatinum Compounds, Peripheral Nervous System Diseases/chemically induced, Leucovorin, Antineoplastic Agents, Kaplan-Meier Estimate, Fluorouracil/adverse effects, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Antineoplastic Combined Chemotherapy Protocols, Humans, Organoplatinum Compounds/adverse effects, Edetic Acid/analogs & derivatives, Edetic Acid, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Peripheral Nervous System Diseases, Colorectal Neoplasms/drug therapy, Antineoplastic Agents/adverse effects, Middle Aged, Leucovorin/adverse effects, 3. Good health, Oxaliplatin, Pyridoxal Phosphate, Female, Fluorouracil, Pyridoxal Phosphate/analogs & derivatives, Colorectal Neoplasms |
| Popis: | Purpose: Oxaliplatin causes disabling acute and chronic peripheral neuropathy. We explored the preventive effects of calmangafodipir, mimicking the mitochondrial enzyme manganese superoxide dismutase, thereby protecting cells from oxidative stress, in a placebo-controlled, double-blinded randomised phase II study (ClinicalTrials.gov.NCT01619423) in patients with metastatic colorectal cancer (mCRC). Patient and methods: mCRC patients treated with modified FOLFOX-6 (folinic acid 200 mg/m2, 5-fluorouracil bolus 400 mg/m2, oxaliplatin 85 mg/m2 and 5-fluorouracil 2400 mg/m2 continuous infusion for 46 h) every fortnight for 8 cycles in first or second line were eligible. Calmangafodipir was given in a phase I dose-finding and in a phase II placebo-controlled study, as a 5-min infusion 10 min prior to oxaliplatin. Neurotoxicity was evaluated by the physician using the Oxaliplatin Sanofi Specific Scale and by the patient using the cold allodynia test and the Leonard scale. Results: Eleven patients were included in phase I without any detectable toxicity to calmangafodipir. In the phase II study, 173 patients were randomised to placebo (n = 60), calmangafodipir 2 µmol/kg (n = 57) and calmangafodipir 5 µmol/kg (n = 45, initially 10 µmol/kg, n = 11). Calmangafodipir-treated patients (all three doses pooled) had less physician graded neurotoxicity (odds ratio (90% confidence interval one-sided upper level) 0.62(1.15), p = .16), significantly less problems with cold allodynia (mean 1.6 versus 2.3, p p p Conclusions: Calmangafodipir at a dose of 5 µmol/kg appears to prevent the development of oxaliplatin-induced acute and delayed CIPN without apparent influence on tumour outcomes. |
| Druh dokumentu: | Article Other literature type |
| Jazyk: | English |
| ISSN: | 1651-226X 0284-186X |
| DOI: | 10.1080/0284186x.2017.1398836 |
| DOI: | 10.6084/m9.figshare.5603065.v1 |
| DOI: | 10.6084/m9.figshare.5603065 |
| Přístupová URL adresa: | https://www.tandfonline.com/doi/pdf/10.1080/0284186X.2017.1398836?needAccess=true https://pubmed.ncbi.nlm.nih.gov/29140155 https://www.scholars.northwestern.edu/en/publications/persistent-prevention-of-oxaliplatin-induced-peripheral-neuropath https://portal.findresearcher.sdu.dk/da/publications/persistent-prevention-of-oxaliplatin-induced-peripheral-neuropath https://www.ncbi.nlm.nih.gov/pubmed/29140155 https://scholars.uthscsa.edu/en/publications/persistent-prevention-of-oxaliplatin-induced-peripheral-neuropath https://uthscsa.influuent.utsystem.edu/en/publications/persistent-prevention-of-oxaliplatin-induced-peripheral-neuropath https://europepmc.org/article/MED/29140155 https://portal.findresearcher.sdu.dk/da/publications/5cdde1e0-23d6-41c3-831c-bda7004ef6f9 https://portal.findresearcher.sdu.dk/da/publications/5cdde1e0-23d6-41c3-831c-bda7004ef6f9 https://doi.org/10.1080/0284186X.2017.1398836 |
| Rights: | CC BY |
| Přístupové číslo: | edsair.doi.dedup.....cde1826f4cf04ab2673909a061f14443 |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | Purpose: Oxaliplatin causes disabling acute and chronic peripheral neuropathy. We explored the preventive effects of calmangafodipir, mimicking the mitochondrial enzyme manganese superoxide dismutase, thereby protecting cells from oxidative stress, in a placebo-controlled, double-blinded randomised phase II study (ClinicalTrials.gov.NCT01619423) in patients with metastatic colorectal cancer (mCRC). Patient and methods: mCRC patients treated with modified FOLFOX-6 (folinic acid 200 mg/m2, 5-fluorouracil bolus 400 mg/m2, oxaliplatin 85 mg/m2 and 5-fluorouracil 2400 mg/m2 continuous infusion for 46 h) every fortnight for 8 cycles in first or second line were eligible. Calmangafodipir was given in a phase I dose-finding and in a phase II placebo-controlled study, as a 5-min infusion 10 min prior to oxaliplatin. Neurotoxicity was evaluated by the physician using the Oxaliplatin Sanofi Specific Scale and by the patient using the cold allodynia test and the Leonard scale. Results: Eleven patients were included in phase I without any detectable toxicity to calmangafodipir. In the phase II study, 173 patients were randomised to placebo (n = 60), calmangafodipir 2 µmol/kg (n = 57) and calmangafodipir 5 µmol/kg (n = 45, initially 10 µmol/kg, n = 11). Calmangafodipir-treated patients (all three doses pooled) had less physician graded neurotoxicity (odds ratio (90% confidence interval one-sided upper level) 0.62(1.15), p = .16), significantly less problems with cold allodynia (mean 1.6 versus 2.3, p p p Conclusions: Calmangafodipir at a dose of 5 µmol/kg appears to prevent the development of oxaliplatin-induced acute and delayed CIPN without apparent influence on tumour outcomes. |
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| ISSN: | 1651226X 0284186X |
| DOI: | 10.1080/0284186x.2017.1398836 |