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

OBJECTIVEThere is not agreement on the "gold standard" for detection and grading of Chemotherapy Induced Peripheral Neurotoxicity (CIPN) in clinical trials. We performed an observational prospective study to assess and compare both patient-based and physician-based methods.METHODSConsecutive patients, aged 18 years or older, candidates for neurotoxic chemotherapy were enrolled in US/EU/Australia. A trained investigator performed physician-based scales (Total Neuropathy Score clinical [©Johns Hopkins University; TNSc], then used to calculate TNS nurse [TNSn]) and supervised the patient-completed questionnaire (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 two groups.RESULTSData from 254 participants were available, 180 (71%) had normal neurological 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.CONCLUSIONSMCID for TNSc and TNSn have been calculated, and the TNSn can be considered a reliable alternative objective clinical assessment if a more extended neurological examination is not possible. Moreover, the FACT/GOG-NTX score can be reduced to 7 items and these items correlate well with the TNSc and TNSn.CLASSIFICATION OF EVIDENCEThis study provides Class III evidence that a patient-completed questionnaire and nurse-assessed scale correlate with a physician-assessed scale.