Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Ian F. Tannock, M.D., Ph.D., Ronald de Wit, M.D., William R. Berry, M.D., Jozsef Horti, M.D., Anna Pluzanska, M.D., Kim N. Chi, M.D., Stephane Oudard, M.D., Christine Théodore, M.D., Nicholas D. James, M.D., Ph.D., Ingela Turesson, M.D., Ph.D., Mark A. Rosenthal, M.D., Ph.D., Mario A. Eisenberger, M.D., for the TAX 327 Investigators
Background Mitoxantrone plus prednisone reduces pain and improvesthe quality of life in men with advanced, hormone-refractoryprostate cancer, but it does not improve survival. We comparedsuch treatment with docetaxel plus prednisone in men with thisdisease.
Methods From March 2000 through June 2002, 1006 men with metastatichormone-refractory prostate cancer received 5 mg of prednisonetwice daily and were randomly assigned to receive 12 mg of mitoxantroneper square meter of body-surface area every three weeks, 75mg of docetaxel per square meter every three weeks, or 30 mgof docetaxel per square meter weekly for five of every six weeks.The primary end point was overall survival. Secondary end pointswere pain, prostate-specific antigen (PSA) levels, and the qualityof life. All statistical comparisons were against mitoxantrone.
Results As compared with the men in the mitoxantrone group,men in the group given docetaxel every three weeks had a hazardratio for death of 0.76 (95 percent confidence interval, 0.62to 0.94; P=0.009 by the stratified log-rank test) and thosegiven weekly docetaxel had a hazard ratio for death of 0.91(95 percent confidence interval, 0.75 to 1.11; P=0.36). Themedian survival was 16.5 months in the mitoxantrone group, 18.9months in the group given docetaxel every 3 weeks, and 17.4months in the group given weekly docetaxel. Among these threegroups, 32 percent, 45 percent, and 48 percent of men, respectively,had at least a 50 percent decrease in the serum PSA level (P<0.001for both comparisons with mitoxantrone); 22 percent, 35 percent(P=0.01), and 31 percent (P=0.08) had predefined reductionsin pain; and 13 percent, 22 percent (P=0.009), and 23 percent(P=0.005) had improvements in the quality of life. Adverse eventswere also more common in the groups that received docetaxel.
Conclusions When given with prednisone, treatment with docetaxelevery three weeks led to superior survival and improved ratesof response in terms of pain, serum PSA level, and quality oflife, as compared with mitoxantrone plus prednisone.
Source Information
From the Department of Medical Oncology and Hematology, Princess Margaret Hospital and University of Toronto, Toronto (I.F.T.); the Department of Medical Oncology, Erasmus University Medical Centre, Rotterdam, the Netherlands (R.W.); Raleigh Hematology Oncology Associates, Cary, N.C. (W.R.B.); the Department of Chemotherapy and Clinical Pharmacology, National Institute of Oncology, Budapest, Hungary (J.H.); the Department of Chemotherapy, Medical University, Lodz, Poland (A.P.); BC Cancer Agency, Vancouver, B.C., Canada (K.N.C.); Hôpital Européen Georges Pompidou, Paris (S.O.); Institut Gustav Roussy, Villejuif, France (C.T.); Cancer Research UK Institute for Cancer Studies, Birmingham, United Kingdom (N.D.J.); the Section of Oncology, Uppsala University Hospital, Uppsala, Sweden (I.T.); Cancer Trials Australia, Victoria, Australia (M.A.R.); and the Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore (M.A.E.).
Address reprint requests to Dr. Tannock at the Department of Medical Oncology and Hematology, Princess Margaret Hospital, 610 University Ave., Toronto, ON M5G 2M9, Canada, or at ian.tannock{at}uhn.on.ca.
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Kim, M., Liao, J., Dowling, M. L., Voong, K. R., Parker, S. E., Wang, S., El-Deiry, W. S., Kao, G. D.
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68: 3440-3449
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Naito, S., Tsukamoto, T., Koga, H., Harabayashi, T., Sumiyoshi, Y., Hoshi, S., Akaza, H.
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38: 365-372
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Galsky, M. D., Eisenberger, M., Moore-Cooper, S., Kelly, W. K., Slovin, S. F., DeLaCruz, A., Lee, Y., Webb, I. J., Scher, H. I.
(2008). Phase I Trial of the Prostate-Specific Membrane Antigen-Directed Immunoconjugate MLN2704 in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer. JCO
26: 2147-2154
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Berthold, D. R., Pond, G. R., Roessner, M., de Wit, R., Eisenberger, M., Tannock, a. I. F., on behalf of the TAX-327 investigators,
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14: 2763-2767
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Attia, S., Eickhoff, J., Wilding, G., McNeel, D., Blank, J., Ahuja, H., Jumonville, A., Eastman, M., Shevrin, D., Glode, M., Alberti, D., Staab, M. J., Horvath, D., Straus, J., Marnocha, R., Liu, G.
(2008). Randomized, Double-Blinded Phase II Evaluation of Docetaxel with or without Doxercalciferol in Patients with Metastatic, Androgen-Independent Prostate Cancer. Clin. Cancer Res.
14: 2437-2443
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Mimeault, M., Mehta, P. P., Hauke, R., Batra, S. K.
(2008). Functions of Normal and Malignant Prostatic Stem/Progenitor Cells in Tissue Regeneration and Cancer Progression and Novel Targeting Therapies. Endocr. Rev.
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Chi, K. N., Ellard, S. L., Hotte, S. J., Czaykowski, P., Moore, M., Ruether, J. D., Schell, A. J., Taylor, S., Hansen, C., Gauthier, I., Walsh, W., Seymour, L.
(2008). A phase II study of sorafenib in patients with chemo-naive castration-resistant prostate cancer. Ann Oncol
19: 746-751
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Choy, H., Park, C., Yao, M.
(2008). Current Status and Future Prospects for Satraplatin, an Oral Platinum Analogue. Clin. Cancer Res.
14: 1633-1638
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Scher, H. I., Halabi, S., Tannock, I., Morris, M., Sternberg, C. N., Carducci, M. A., Eisenberger, M. A., Higano, C., Bubley, G. J., Dreicer, R., Petrylak, D., Kantoff, P., Basch, E., Kelly, W. K., Figg, W. D., Small, E. J., Beer, T. M., Wilding, G., Martin, A., Hussain, M.
(2008). Design and End Points of Clinical Trials for Patients With Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. JCO
26: 1148-1159
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Howard, D. N, Chambers, C., Cusano, F.
(2008). Efficacy vs. effectiveness -- docetaxel and prednisone in hormone refractory prostate cancer. J Oncol Pharm Pract
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[Abstract]
Hu, H., Li, G.-x., Wang, L., Watts, J., Combs, G. F. Jr., Lu, J.
(2008). Methylseleninic Acid Enhances Taxane Drug Efficacy against Human Prostate Cancer and Down-Regulates Antiapoptotic Proteins Bcl-XL and Survivin. Clin. Cancer Res.
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