Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity. (17th August 2021)

• Record Type: Journal Article
• Authors: 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; Cazzaniga, Marina Elena; Longarini, Raffaella; Guidi, Alessandro; Postma, Tjeerd J; Goldstein, David; Ricard, Damien; Tafani, Camille; Brooks, DuBose; Renn, Cynthia L; Galiè, Edvina; Campagnolo, Marta; Castellani, Francesca; Grandis, Marina; Lalisang, Roy I; Gentile, Luca; Russo, Massimo; Toscano, Antonio;
• Is Part Of: Neurology. Volume 97:Number 7(2021)
• Publication Date: 2021-08-17
• Subjects: Neurology -- Periodicals; Neurology -- Periodicals; Neurologie -- Périodiques; 616.8
• DOI: 10.1212/WNL.0000000000012300
• Languages: English
• ISSNs: 0028-3878

Abstract

Abstract : 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.