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

• Published in: European journal of cancer (1990) Vol. 48; no. 2; pp. 209 - 217
• Main Authors: Fizazi, Karim, Lesaunier, Francois, Delva, Remy, Gravis, Gwenaëlle, Rolland, Frederic, Priou, Frank, Ferrero, Jean-Marc, Houedé, Nadine, Mourey, Loïc, Theodore, Christine, Krakowski, Ivan, Berdah, Jean-François, Baciuchka, Marjorie, Laguerre, Brigitte, Fléchon, Aude, Ravaud, Alain, Cojean-Zelek, Isabelle, Oudard, Stéphane, Labourey, Jean-Luc, Lagrange, Jean-Léon, Chinet-Charrot, Paule, Linassier, Claude, Deplanque, Gaël, Beuzeboc, Philippe, Geneve, Jean, Davin, Jean-Louis, Tournay, Elodie, Culine, Stephane
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.01.2012; Elsevier
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - radiotherapy; Aged; Androgen Antagonists - therapeutic use; Antineoplastic agents; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Chemotherapy; Combined Modality Therapy - methods; Docetaxel; Estramustine; Estramustine - administration & dosage; Estramustine - adverse effects; Gynecology. Andrology. Obstetrics; Hematology, Oncology and Palliative Medicine; Humans; Logistic Models; Male; Male genital diseases; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prostate cancer; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - radiotherapy; Quality of Life; Taxoids - administration & dosage; Taxoids - adverse effects; Tumors; Prostate cancer; Docetaxel; Estramustine; Antineoplastic agent; Phase III trial; High risk; Nephrology; Prostate disease; Toxicity; Early stage; Urology; Cancerology; Taxane derivatives; Complication; Antimitotic; Male genital diseases; Human; Drug combination; Urinary system disease; Treatment efficiency; Malignant tumor; Quality of life; Alkylating agent; Chemotherapy; Treatment; Nitrogen mustard; Cancer
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2011.10.015

Abstract 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 ⩾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.