Steroids do reduce the severity and delay the onset of docetaxel (DXT) induced fluid retention: final results of a randomized trial of the eortc investigational drug branch for breast cancer (IDBBC)

Tabled 1 Toxicity Arm A(n = 41) Arm B(n = 41) p-value (kanni)(Long-rank test) Edema - Any 39% 54% - Severe 5% 5% Median dose to onset (mg/m2) 550 296 P = 0.003 Pleural effusion - Any 44% 49% - Severe 5% 15% Median dose to onset (mg/m2) 571 296 P = 0.006 Overall fluid retention: Median dose to onset (mg/m2) 423 297 P = 0.0017 Median number of cycles(range) 6(1–12) 5(1–11) Treatment discontinuation 5% 32% P = 0.0032 Open table in a new tab Steroids significantly decrease the risk of edema and of pleural effusion, estimated as a function of the cumulative dose of DXT by the Kaplan-Meier method. The overall response rate fullowing external review is 33.7% and the median response duration is 238 days (95% CI: 190–293) with no difference between the 2 arms. We conclude that there is a learning curve in the management of the side effects of this new active agent for breast cancer. Steroids significantly decrease the risk of edema and of pleural effusion, estimated as a function of the cumulative dose of DXT by the Kaplan-Meier method. The overall response rate fullowing external review is 33.7% and the median response duration is 238 days (95% CI: 190–293) with no difference between the 2 arms. We conclude that there is a learning curve in the management of the side effects of this new active agent for breast cancer.