A phase III trial of docetaxel–estramustine in high-risk localised prostate cancer: A planned analysis of response, toxicity and quality of life in the GETUG 12 trial

Abstract

AimTo assess docetaxel–estramustine in patients with localised high-risk prostate cancer. Patients and methodsAfter staging pelvic lymph node dissection, patients with high-risk prostate cancer randomly received androgen deprivation therapy (ADT) (3years)+DE (4 cycles of docetaxel 70mg/m2/3weeks+estramustine 10mg/kg/dd1–5) or ADT alone. Local therapy was administered at 3months. ResultsFour hundred and thirteen patients were accrued: T3–T4 (67%), Gleason score ⩾8 (42%), PSA >20ng/mL (59%), pN+ (29%). In the chemotherapy arm, 94% of patients received the planned four cycles of docetaxel. Local treatment consisted of radiotherapy in 358 patients (87%) (median dose 74Gy in both arms). ADT was given for 36months in both arms. A PSA response (PSA ⩽0.2ng/mL after 3months of treatment) was obtained in 34% and 15% in the ADT+DE arm and in the ADT arm, respectively (p<0.0001). Febrile neutropenia occurred in only 2%. Moderate to severe hot flashes occurred less often in the ADT+DE arm (2% versus 22%; p<0.001). There was no toxicity-related death, no secondary leukaemia, and no excess second cancers. Chemotherapy had a negative impact on quality of life (global health status, p=0.01; fatigue, p=0.003; role functioning, p=0.003; social functioning, p=0.006) at 3months but this effect disappeared at 1year. ConclusionDocetaxel–estramustine can be combined safely with standard therapy in high-risk prostate cancer, with a promising PSA response rate and no negative impact on quality of life after 1year. Long-term follow-up is required to assess the impact on relapse and survival.