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

作者：Fizazi Karim^*; Lesaunier Francois; Delva Remy; Gravis Gwenaelle; Rolland Frederic; Priou Frank; Ferrero Jean Marc; Houede Nadine; Mourey Loic; Theodore Christine; Krakowski Ivan; Berdah Jean Francois; Baciuchka Marjorie; Laguerre Brigitte; Flechon Aude; Ravaud Alain; Cojean Zelek Isabelle; Oudard Stephane; Labourey Jean Luc; Lagrange Jean Leon; Chinet Charrot Paule; Linassier Claude; Deplanque Gael; Beuzeboc Philippe; Geneve Jean; Davin Jean Louis; Tournay Elodie

来源：European Journal of Cancer, 2012, 48(2): 209-217.

DOI：10.1016/j.ejca.2011.10.015

• Docetaxel
• Estramustine
• Prostate cancer

Aim: To assess docetaxel-estramustine in patients with localised high-risk prostate cancer.
Patients and methods: After 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 10 mg/kg/d d1-5) or ADT alone. Local therapy was administered at 3 months.
Results: Four 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.
Conclusion: Docetaxel-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.

• 出版日期2012-1