Long-term tolerance of neoadjuvant docetaxel/estramustine chemotherapy in patients with high-risk localized prostate cancer treated at IGR in the GETUG 12 phase III trial.

Abstract

168 Background: The GETUG 12 phase III trial tested the adjunction of docetaxel-estramustine to standard treatment in 413 patients with high-risk prostate cancer (Eur J Cancer 2012, 48: 209-17). Patients in both arms received androgen deprivation therapy (ADT) for 3 years plus local treatment (radiotherapy: 87%, median dose: 74 Gy). Pts in the chemotherapy arm also received 4 cycles of docetaxel 70mg/m2 /3weeks + estramustine 10 mg/kg/d d1-5, repeated every 3 weeks. Immediate tolerance was acceptable with only 2% of febrile neutropenia and no toxic deaths. As the long-term impact of chemotherapy in this setting is unknown, long-term side effect assessment was undertaken in pts from GETUG 12 who were treated at the Institut Gustave Roussy (n=81). Methods: After pts had completed the planned 3 years of ADT, they were followed-up every 6 months. Data on weight, sexual function, serum testosterone, and cardiac complications were obtained prospectively, in parallel with efficacy data. Pts requiring salvage therapy for cancer progression were censored in this analysis. Results: The median follow-up is 71.6 months (range: 36- 108 months). The main long-term side effects are listed in the table below. 4 (4.9%) and 1(1.2%) cardiovascular events occurred in the ADT and the ADT + chemotherapy arm, respectively. Conclusions: Docetaxel-estramustine chemotherapy had no adverse long-term impact on serum testosterone, weight, and sexual function in patients with high-risk localized prostate cancer treated with ADT and radiotherapy. [Table: see text]