INTRODUCTION: QOL (Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity: FACT- GOG-NTX), modified total neuropathy score MTNS score, premenopausal status, age, tumor factors are still not completely investigated as a risk factors for Paclitaxel induced peripheral neuropathy (PIPN). Methods: NCT03492047 is prospective randomized controlled open label study was conducted on 75 breast cancer patients receiving adjuvant paclitaxel 80 mg/m2 weekly for 12 weeks. Eligible patients were randomized to either the low dose group; 1200 mg daily N-acetylcysteine NAC, the high dose group; 1200 mg NAC twice daily or the control group; received paclitaxel only. Mean changes of NGF (neuropathy growth factor), and mean changes MDA score (serum malondialdehyde) are used as the predictors of neuropathy changes in patients who had different doses of NAC, showing that high dose of NAC can reduce PIPN. Using A Wilcoxon signed-rank test for statistical analysis, we investigated which risk factors that will affect the mean changes of post and pretreatment NGF and MDA as an interpretation for neuropathy changes in specific patient subgroups Results: A Wilcoxon signed-rank test stated that there is a statistically significant difference between the mean NGF scores among control group with body surface area BSA > 1.8 p < 0.05. While the results revealed no significant difference between mean NGF scores among the other groups of patients. There is a statistically significant difference between the mean pre and post MDA scores among low dose <40 groups, p < 0.05 and between the mean pre and post NGF scores among older > 40 who took the high dose, p < 0.05. and the same for menopausal status. a statistically significant difference is found between the mean pre and post MDA scores among patients who all types of doses whose baseline QoL >2 p < 0.05, and a statistically significant difference between the mean pre and post NGF scores among patients with higher QoL (baseline QoL > 2) who took the high dose p < 0.05. there is a statistically significant difference between the mean pre and post MDA scores among patients who received low and high of doses whose baseline MTNS ≤ 3, p < 0.05. Conclusion: Age, BSA, base line QOL score, base line MTNS score and other risk factors have a significant effect on the mean NGF and MDA changes during intake of weekly paclitaxel, and their consideration before treatment is mandatory.
Table (1).Number and Percentage Distribution of patients according to their characteristics at base line.