Objective: To elucidate the time course of taxane-induced edema which may affect the patients' quality of life (QOL). Patients and Methods: Our study included the first 300 Japanese patients assigned to 1 of 4 regimens using docetaxel (DTX) or paclitaxel (PTX) by 1:1:1:1 in a randomized controlled trial to evaluate the efficacy of adjuvant therapies for node-positive breast cancer. Patients' QOL was prospectively assessed by the Functional Assessment of Cancer Therapy (FACT)-breast and-taxane (FACT-T) subscale. The scores of FACT items regarding edema and body weight were used as indicators of edema. Results: The scores for 'anasarca', 'edema of the hands' and 'edema of the legs and feet' of the FACT-T subscale worsened up to 1-2 months after chemotherapy, and body weights increased remarkably until cycle 8 in patients treated with DTX alone (75 mg/m 2, 8 cycles, every 3 weeks). Edema-related symptoms and body weight were relatively stable in the other treatment groups. There were statistically significant differences in the scores of those items and in the changes of body weight both between the DTX-alone group and the other three groups combined, and between the groups using DTX and those using PTX. Conclusion: Many patients receiving DTX for >4 cycles suffered significantly from edema.
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