Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity

Background and Objective There is no agreement on the gold standard for detection and grading of chemotherapy-induced peripheral neurotoxicity (CIPN) in clinical trials. The objective is to perform an observational prospective study to assess and compare patient-based and physician-based methods for...

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Autores: Alberti, Paola, Bernasconi, Davide P., Cornblath, David R., Merkies, Ingemar S. J., Park, Susanna B., Velasco, Roser, Bruna, Jordi, Psimaras, Dimitri, Koeppen, Susanne, Pace, Andrea, Dorsey, Susan G., Argyriou, Andreas A., Kalofonos, Haralabos P., Briani, Chiara, Schenone, Angelo, Faber, Catharina G., Mazzeo, Anna, Grisold, Wolfgang, Valsecchi, Mariagrazia, Cavaletti, Guido, Ci-Perinoms Group, The
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/222859
Acceso en línea:https://hdl.handle.net/2445/222859
Access Level:acceso abierto
Palabra clave:Neuropaties perifèriques
Quimioteràpia
Peripheral neuropathies
Chemotherapy
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spelling Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral NeurotoxicityAlberti, PaolaBernasconi, Davide P.Cornblath, David R.Merkies, Ingemar S. J.Park, Susanna B.Velasco, RoserBruna, JordiPsimaras, DimitriKoeppen, SusannePace, AndreaDorsey, Susan G.Argyriou, Andreas A.Kalofonos, Haralabos P.Briani, ChiaraSchenone, AngeloFaber, Catharina G.Mazzeo, AnnaGrisold, WolfgangValsecchi, MariagraziaCavaletti, GuidoCi-Perinoms Group, TheNeuropaties perifèriquesQuimioteràpiaPeripheral neuropathiesChemotherapyBackground and Objective There is no agreement on the gold standard for detection and grading of chemotherapy-induced peripheral neurotoxicity (CIPN) in clinical trials. The objective is to perform an observational prospective study to assess and compare patient-based and physician-based methods for detection and grading of CIPN. Methods Consecutive patients, aged 18 years or older, candidates for neurotoxic chemotherapy, were enrolled in the United States, European Union, or Australia. A trained investigator performed physician-based scales (Total Neuropathy Score-clinical [TNSc], used to calculate Total Neuropathy Score-nurse [TNSn]) and supervised the patient-completed questionnaire (Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity [FACT/GOG-NTX]). Evaluations were performed before and at the end of chemotherapy. On participants without neuropathy at baseline, we assessed the association between TNSc, TNSn, and FACT/GOG-NTX. Considering a previously established minimal clinically important difference (MCID) for FACT/GOG-NTX, we identified participants with and without a clinically important deterioration according to this scale. Then, we calculated the MCID for TNSc and TNSn as the difference in the mean change score of these scales between the 2 groups. Results Data from 254 participants were available: 180 (71%) had normal neurologic status at baseline. At the end of the study, 88% of participants developed any grade of neuropathy. TNSc, TNSn, and FACT/GOG-NTX showed good responsiveness (standardized mean change from baseline to end of chemotherapy >1 for all scales). On the 153 participants without neuropathy at baseline and treated with a known neurotoxic chemotherapy regimen, we verified a moderate correlation in both TNSc and TNSn scores with FACT/GOG-NTX (Spearman correlation index r = 0.6). On the same sample, considering as clinically important a change in the FACT/GOG-NTX score of at least 3.3 points, the MCID was 3.7 for TNSc and 2.8 for the TNSn. Conclusions MCID for TNSc and TNSn were calculated and the TNSn can be considered a reliable alternative objective clinical assessment if a more extended neurologic examination is not possible. The FACT/GOG-NTX score can be reduced to 7 items and these items correlate well with the TNSc and TNSn. Classification of Evidence This study provides Class III evidence that a patient-completed questionnaire and nurse-assessed scale correlate with a physician-assessed scale.Ovid Technologies (Wolters Kluwer Health)2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/222859Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000012300Neurology, 2021, vol. 97, num. 7https://doi.org/10.1212/WNL.0000000000012300cc by (c) Alberti, Paola et al, 2021http://creativecommons.org/licenses/by/3.0/es/info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/2228592026-05-27T06:46:51Z
dc.title.none.fl_str_mv Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
title Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
spellingShingle Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
Alberti, Paola
Neuropaties perifèriques
Quimioteràpia
Peripheral neuropathies
Chemotherapy
title_short Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
title_full Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
title_fullStr Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
title_full_unstemmed Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
title_sort Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity
dc.creator.none.fl_str_mv Alberti, Paola
Bernasconi, Davide P.
Cornblath, David R.
Merkies, Ingemar S. J.
Park, Susanna B.
Velasco, Roser
Bruna, Jordi
Psimaras, Dimitri
Koeppen, Susanne
Pace, Andrea
Dorsey, Susan G.
Argyriou, Andreas A.
Kalofonos, Haralabos P.
Briani, Chiara
Schenone, Angelo
Faber, Catharina G.
Mazzeo, Anna
Grisold, Wolfgang
Valsecchi, Mariagrazia
Cavaletti, Guido
Ci-Perinoms Group, The
author Alberti, Paola
author_facet Alberti, Paola
Bernasconi, Davide P.
Cornblath, David R.
Merkies, Ingemar S. J.
Park, Susanna B.
Velasco, Roser
Bruna, Jordi
Psimaras, Dimitri
Koeppen, Susanne
Pace, Andrea
Dorsey, Susan G.
Argyriou, Andreas A.
Kalofonos, Haralabos P.
Briani, Chiara
Schenone, Angelo
Faber, Catharina G.
Mazzeo, Anna
Grisold, Wolfgang
Valsecchi, Mariagrazia
Cavaletti, Guido
Ci-Perinoms Group, The
author_role author
author2 Bernasconi, Davide P.
Cornblath, David R.
Merkies, Ingemar S. J.
Park, Susanna B.
Velasco, Roser
Bruna, Jordi
Psimaras, Dimitri
Koeppen, Susanne
Pace, Andrea
Dorsey, Susan G.
Argyriou, Andreas A.
Kalofonos, Haralabos P.
Briani, Chiara
Schenone, Angelo
Faber, Catharina G.
Mazzeo, Anna
Grisold, Wolfgang
Valsecchi, Mariagrazia
Cavaletti, Guido
Ci-Perinoms Group, The
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Neuropaties perifèriques
Quimioteràpia
Peripheral neuropathies
Chemotherapy
topic Neuropaties perifèriques
Quimioteràpia
Peripheral neuropathies
Chemotherapy
description Background and Objective There is no agreement on the gold standard for detection and grading of chemotherapy-induced peripheral neurotoxicity (CIPN) in clinical trials. The objective is to perform an observational prospective study to assess and compare patient-based and physician-based methods for detection and grading of CIPN. Methods Consecutive patients, aged 18 years or older, candidates for neurotoxic chemotherapy, were enrolled in the United States, European Union, or Australia. A trained investigator performed physician-based scales (Total Neuropathy Score-clinical [TNSc], used to calculate Total Neuropathy Score-nurse [TNSn]) and supervised the patient-completed questionnaire (Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity [FACT/GOG-NTX]). Evaluations were performed before and at the end of chemotherapy. On participants without neuropathy at baseline, we assessed the association between TNSc, TNSn, and FACT/GOG-NTX. Considering a previously established minimal clinically important difference (MCID) for FACT/GOG-NTX, we identified participants with and without a clinically important deterioration according to this scale. Then, we calculated the MCID for TNSc and TNSn as the difference in the mean change score of these scales between the 2 groups. Results Data from 254 participants were available: 180 (71%) had normal neurologic status at baseline. At the end of the study, 88% of participants developed any grade of neuropathy. TNSc, TNSn, and FACT/GOG-NTX showed good responsiveness (standardized mean change from baseline to end of chemotherapy >1 for all scales). On the 153 participants without neuropathy at baseline and treated with a known neurotoxic chemotherapy regimen, we verified a moderate correlation in both TNSc and TNSn scores with FACT/GOG-NTX (Spearman correlation index r = 0.6). On the same sample, considering as clinically important a change in the FACT/GOG-NTX score of at least 3.3 points, the MCID was 3.7 for TNSc and 2.8 for the TNSn. Conclusions MCID for TNSc and TNSn were calculated and the TNSn can be considered a reliable alternative objective clinical assessment if a more extended neurologic examination is not possible. The FACT/GOG-NTX score can be reduced to 7 items and these items correlate well with the TNSc and TNSn. Classification of Evidence This study provides Class III evidence that a patient-completed questionnaire and nurse-assessed scale correlate with a physician-assessed scale.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/222859
url https://hdl.handle.net/2445/222859
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1212/WNL.0000000000012300
Neurology, 2021, vol. 97, num. 7
https://doi.org/10.1212/WNL.0000000000012300
dc.rights.none.fl_str_mv cc by (c) Alberti, Paola et al, 2021
http://creativecommons.org/licenses/by/3.0/es/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv cc by (c) Alberti, Paola et al, 2021
http://creativecommons.org/licenses/by/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Ovid Technologies (Wolters Kluwer Health)
publisher.none.fl_str_mv Ovid Technologies (Wolters Kluwer Health)
dc.source.none.fl_str_mv Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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