Impact of Exogenous Neurotropic Factor Administration on Occurrence and Severity of Paclitaxel-Induce Neuropathy in Breast Cancer Patients. An open label Pilot Study.

Abstract

Background: Paclitaxel-induced peripheral neuropathy (PIPN) is a common toxicity with no proven agent beneficial for prevention. The potentiality of Nerve Growth Factor (NGF) as a protective agent for PIPN was suggested by several studies. Aim: This study aimed to test the impact of exogenously administered NGF on PIPN and to assess NGF levels in relation to PIPN severity. Methods: Forty patients were prospectively randomly allocated to paclitaxel alone (control group) or paclitaxel + exogenous NGF (test group). Neuropathy occurrence and severity was assessed before enrollment and after each cycle using the European Association for Treatment of Cancer Quality of Life Questionnaire for Chemotherapy Induced Peripheral Neuropathy (EORTC QLQ-CIPN20). Nerve Growth Factor level was assessed in both groups at baseline and at the end of the study. Nerve Growth Factor safety was assessed by laboratory investigations and the occurrence of adverse drug reactions. Results: There was significant increase in the EORTC QLQ-CIPN20 score in the control group (p < 0.001) and a stabilization in the score in the test group. Nerve Growth Factor levels significantly increased in the test group (p < 0.001) and declined in the control group. A highly significant negative correlation existed between NGF level and the EORTC QLQ-CIPN20 score (r=-0.781, p < 0.001). No significant difference was observed between the two groups in the occurrence of adverse drug reactions or other toxicities. Conclusion: Exogenous NGF may have a potential neuroprotective effect against PIPN in breast cancer patients. Higher endogenous NGF level is inversely correlated with the occurrence and severity of PIPN.