Dexamethasone and Diphenhydramine Withdrawal and Quality of Life Assessment in Breast Cancer Patients Receiving Weekly Paclitaxel

Maintenance of quality of life (QoL) is an important endpoint in cancer patients. Several studies have demonstrated that chemotherapy in breast cancer patients is related to worsening QoL scores. Taxanes are widely used in breast cancer treatment, and premedication omission in weekly paclitaxel has been evaluated in clinical trials and is a safe strategy. Nowadays there is lack of data if premedication withdrawal can improve QoL given the shortage of studies using a comparative group that keeps premedication. We evaluated QoL scores in 60 breast cancer patients receiving weekly paclitaxel in 2 comparative groups: one that omitted and another that kept premedication, according to infusion-related reaction. The primary endpoint was the evaluation of QoL scores in both groups through the European Organization for Research and Treatment of Cancer's (EORTC) 30-item Core Quality of Life questionnaire (QLQ-C30) and 23-item Quality of Life Questionnaire–Breast Cancer Module (QLQ-BR23) at weeks 1, 2, 3, 4, 5, 9, and 12 of treatment. The secondary endpoint was the frequency of highest-grade adverse events through the adapted Dexamethasone Symptom Questionnaire in both groups. According to the QLQ-C30 and the QLQ-BR23, in the 2 groups, QoL showed no statistically significant differences related to premedication omission, neither did the frequency of highest-grade adverse events. Although the absence of statistical differences in the QoL scores regarding premedication omission, some specific domains seem to deteriorate in patients receiving premedication. Future randomized trials exploring tailored questionnaires with specific domains and visual scales may be more accurate to detect QoL differences related to premedication.