• Karim Fizazi, Francois Lesaunier, Remy Delva, Gwenaëlle Gravis, Frederic Rolland, Frank Priou, Jean-Marc Ferrero, Nadine Houedé, Loïc Mourey, Christine Theodore, Ivan Krakowski, Jean-François Berdah, Marjorie Baciuchka, Brigitte Laguerre, Aude Fléchon, Alain Ravaud, Isabelle Cojean-Zelek, Stéphane Oudard, Jean-Luc Labourey, Jean-Léon Lagrange, Paule Chinet-Charrot, Claude Linassier, Gaël Deplanque, Philippe Beuzeboc, Jean Geneve, Jean-Louis Davin, Elodie Tournay, and Stephane Culine.
• Institut Gustave Roussy, Villejuif, France. fizazi@igr.fr
• Eur. J. Cancer. 2012 Jan 1;48(2):209-17.

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) (3 years)+DE (4 cycles of docetaxel 70 mg/m(2)/3 weeks+estramustine 10mg/kg/dd1-5) or ADT alone. Local therapy was administered at 3 months.ResultsFour hundred and thirteen patients were accrued: T3-T4 (67%), Gleason score ~8 (42%), PSA >20 ng/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 74 Gy in both arms). ADT was given for 36 months in both arms. A PSA response (PSA ~0.2 ng/mL after 3 months 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 3 months but this effect disappeared at 1 year.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 1 year. Long-term follow-up is required to assess the impact on relapse and survival.Copyright © 2011 Elsevier Ltd. All rights reserved.

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