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

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• 作者：Karim Fizazi^a ; ^ab ; ^{fizazi@igr.fr} ; Francois Lesaunier^b ; ^ab ; Remy Delva^c ; ^ab ; Gwenaë ; lle Gravis^d ; ^ab ; Frederic Rolland^e ; ^ab ; Frank Priou^f ; ^ab ; Jean-Marc Ferrero^g ; ^ab ; Nadine Houedé ; ^h ; ^ab ; Loï ; c Moureyⁱ ; ^ab ; Christine Theodore^j ; ^ab ; Ivan Krakowski^k ; ^ab ; Jean-Franç ; ois Berdah^l ; ^ab ; Marjorie Baciuchka^m ; ^ab ; Brigitte Laguerreⁿ ; ^ab ; Aude Flé ; chon^o ; ^ab ; Alain Ravaud^p ; ^ab ; Isabelle Cojean-Zelek^q ; ^ab ; Sté ; phane Oudard^r ; ^ab ; Jean-Luc Labourey^s ; ^ab ; Jean-Lé ; on Lagrange^t ; ^ab ; Paule Chinet-Charrot^u ; ^ab ; Claude Linassier^v ; ^ab ; Gaë ; l Deplanque^w ; ^ab ; Philippe Beuzeboc^x ; ^ab ; Jean Geneve^y ; ^ab ; Jean-Louis Davin^z ; ^ab ; Elodie Tournay^a ; ^ab ; Stephane Culine^aa ; ^ab
• 关键词：Docetaxel ; Estramustine ; Prostate cancer
• 刊名：European Journal of Cancer
• 出版年：2012
• 出版时间：January 2012
• 年：2012
• 卷：48
• 期：2
• 页码：209-217
• 全文大小：521 K

文摘

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/m²/3 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 ? (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 ?.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.