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Definition |
The GETUG 12 trial investigated the impact of neoadjuvant chemotherapy with docetaxel on the PFS in a
cohort of 413 high-risk patients, defined as having one or more of the following criteria: T3-4, Gleason score
> 8, PSA > 20 ng/mL, pN+. Patients were randomly assigned to either goserelin 10.8 mg every 3 months for 3
years, + four cycles of docetaxel, 70 mg/m2 every 3 weeks, + estramustine 10 mg/kg/dL on days 1-5 (arm 1) or
to goserelin alone (arm 2). Local therapy was administered at 3 months and consisted of radiotherapy in 358
patients (87%). Toxicity included grade 3-4 neutropenia (27%) with neutropenic fever in 2%, but no toxicityrelated
death and no secondary leukaemia. A PSA response (PSA < 0.2 ng/mL after 3 months of treatment)
was obtained in 34% in the ADT+DE arm and 15% in the ADT arm. With a median follow-up period of 4.6
years, the 4-year PFS was 85% in arm 1 vs. 81% in arm 2 (p = 0.26), but the data need to mature.
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