Docetaxel, with or without estramustine phosphate, as first-line chemotherapy for hormone-refractory prostate cancer: Results of a multicentre, randomized phase II trial

BJU International

Volumn 102, Issue 9, 2008, Pages 1080-1085

  Caffo, Orazio ^a   Sava, Teodoro ^b   Comploj, Evi ^c   Fariello, Annamaria ^d   Zustovich, Fable ^e   Segati, Romana ^f   Sacco, Cosimo ^g   Valduga, Francesco ^a   Cetto, Gianluigi ^b   Galligioni, Enzo ^a  

^a SANTA CHIARA HOSPITAL   (Italy)

^b UNIVERSITY OF VERONA   (Italy)

^c San Maurizio Regional Hospital   (Italy)

^d SS Trinita Hospital   (Italy)

^e VENETO INSTITUTE OF ONCOLOGY IOV IRCCS   (Italy)

^f Ospedale Civile   (Italy)

^g SANTA MARIA DELLA MISERICORDIA UNIVERSITY HOSPITAL   (Italy)

Author keywords

Docetaxel; Estramustine phosphate; Prostate cancer; Randomized trial

Indexed keywords

DOCETAXEL; ESTRAMUSTINE PHOSPHATE; PROSTATE SPECIFIC ANTIGEN;

AGED; ALOPECIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; COMBINATION CHEMOTHERAPY; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG TOLERABILITY; EDEMA; FATIGUE; FEVER; HEART ARRHYTHMIA; HUMAN; INFECTION; KIDNEY DISEASE; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MUSCULOSKELETAL PAIN; NAIL; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; PROSTATE CANCER; RASH; SENSORY NEUROPATHY; SIDE EFFECT; TASTE DISORDER; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ESTRAMUSTINE; HUMANS; MALE; MIDDLE AGED; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; SURVIVAL ANALYSIS; TAXOIDS; TREATMENT OUTCOME;

EID: 53249144765     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2008.07779.x     Document Type: Article

References (32)

1. Martel CL, Gumerlock PH, Meyers FJ, Lara PN. Current strategies in the management of hormone refractory prostate cancer. Cancer Treat Rev 2003 29 : 171 87
2. Tannock IF, Osoba D, Stockler MR et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone forsymptomatic hormone-resistant prostate cancer: a Canadian randomized trial withpalliative end points. J Clin Oncol 1996 14 : 1756 64
3. Kantoff PW, Halabi S, Conaway M et al. Hydrocortisone with or without mitoxantrone in men with hormone-refractory prostate cancer: results of the cancer and leukemia group B 9182 study. J Clin Oncol 1999 17 : 2506 13
4. Friedland D, Cohen J, Miller R et al. A phase II trial of docetaxel (Taxotere) in hormone-refractory prostatecancer: correlation of antitumor effect to phosphorylation of Bcl-2. Semin Oncol 1999 26 (Suppl. 17 19 23
5. Picus J, Schultz M. Docetaxel (Taxotere) as monotherapy in the treatmentof hormone-refractory prostate cancer: preliminary results. Semin Oncol 1999 26 (Suppl. 17 14 8
6. Berry W, Dakhil S, Gregurich MA, Asmar L. Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate. Semin Oncol 2001 28 (Suppl. 15 8 15
7. Beer TM, Pierce WC, Lowe BA, Henner WD. Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 2001 12 : 1273 9
8. Gravis G, Bladou F, Salem N et al. Weekly administration of docetaxel for symptomatic metastatic hormone-refractory prostate carcinoma. Cancer 2003 98 : 1627 34
9. Tannock IF, de Wit R, Berry WR et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004 351 : 1502 12
10. Oudard S, Legrier ME, Boye K et al. Activity of docetaxel with or without estramustine phosphate versus mitoxantrone in androgen dependent and independent human prostate cancer xenografts. J Urol 2003 169 : 1729 34
11. Petrylak DP, Macarthur R, O'Connor J et al. Phase I/II studies of docetaxel (Taxotere) combined with estramustine in men with hormone-refractory prostate cancer. Semin Oncol 1999 26 (Suppl. 17 28 33
12. Sitka CM, Ledakis P, Lynch J et al. Weekly docetaxel and estramustine in patients with hormone-refractory prostate cancer. Semin Oncol 2001 28 (Suppl. 15 16 21
13. Savarese DM, Halabi S, Hars V et al. Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: a final report of CALGB 9780. Cancer and Leukemia Group B. J Clin Oncol 2001 19 : 2509 16
14. Sinibaldi VJ, Carducci MA, Moore-Cooper S, Laufer M, Zahurak M, Eisenberger MA. Phase II evaluation of docetaxel plus one-day oral estramustine phosphate in the treatment of patients with androgen independent prostate carcinoma. Cancer 2002 94 : 1457 65
15. Oudard S, Banu E, Beuzeboc P et al. Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer. J Clin Oncol 2005 23 : 3343 51
16. Petrylak DP, Tangen CM, Hussain MH et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004 351 : 1513 20
17. Hudes G, Einhorn L, Ross E et al. Vinblastine versus vinblastine plus oral estramustine phosphate for patients with hormone-refractory prostate cancer. A Hoosier Oncology Group and Fox Chase Network phase III trial. J Clin Oncol 1999 17 : 3160 6
18. Berry WR, Hathorn JW, Dakhil SR et al. Phase II randomized trial of weekly paclitaxel with or without estramustine phosphate in progressive, metastatic, hormone-refractory prostate cancer. Clin Prostate Cancer 2004 3 : 104 11
19. Fizazi K, Le MA, Hudes G et al. Addition of estramustine to chemotherapy and survival of patients with castration-refractory prostate cancer: a meta-analysis of individual patient data. Lancet Oncol 2007 8 : 994 1000
20. Diaz M, Patterson SG. Management of androgen-independent prostate cancer. Cancer Control 2004 11 : 364 73
21. de Wit R. Shifting paradigms in prostate cancer; docetaxel plus low-dose prednisone - finally an effective chemotherapy. Eur J Cancer 2005 41 : 502 7
22. Eymard JC, Priou F, Zannetti A et al. Randomized phase II study of docetaxel plus estramustine and single-agent docetaxel in patients with metastatic hormone-refractory prostate cancer. Ann Oncol 2007 18 : 1064 70
23. Bubley GJ, Carducci M, Dahut W et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999 17 : 3461 7
24. Therasse P. Measuring the clinical response. What does it mean? Eur J Cancer 2002 38 : 1817 23
25. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993 85 : 365 76
26. Fayers P, Weeden S, Curran D, on behalf of the EORTC Quality of Life Study Group. EORTC QLQ-C30 Reference Values. Brussels : EORTC, 1998
27. Caraceni A, Mendoza TR, Mencaglia E et al. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain 1996 65 : 87 92
28. Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985 69 : 1375 81
29. Perry C, McTavish D. Estramustine phosphate sodium. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in prostate cancer. Drugs Aging 1995 7 : 49 74
30. Berry DL, Moinpour CM, Jiang CS et al. Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone. J Clin Oncol 2006 24 : 2828 35
31. Stadler WM, Michaelis LC, Ratain MJ. Randomized phase II trials and prostate-specific antigen endpoints in prostate cancer: much ado about nothing? J Clin Oncol 2005 23 : 8124 5
32. Petrylak DP. Chemotherapy for androgen-independent prostate cancer. World J Urol 2005 23 : 10 3