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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(2006). Individualized Strategy for Dosing Luteinizing Hormone-Releasing Hormone Agonists for Androgen-Independent Prostate Cancer: Identification of Outcomes and Costs. J Oncol Pract
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Lara, P. N. Jr., Stadler, W. M., Longmate, J., Quinn, D. I., Wexler, J., Van Loan, M., Twardowski, P., Gumerlock, P. H., Vogelzang, N. J., Vokes, E. E., Lenz, H. J., Doroshow, J. H., Gandara, D. R.
(2006). A Randomized Phase II Trial of the Matrix Metalloproteinase Inhibitor BMS-275291 in Hormone-Refractory Prostate Cancer Patients with Bone Metastases. Clin. Cancer Res.
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Arlen, P. M., Gulley, J. L., Parker, C., Skarupa, L., Pazdur, M., Panicali, D., Beetham, P., Tsang, K. Y., Grosenbach, D. W., Feldman, J., Steinberg, S. M., Jones, E., Chen, C., Marte, J., Schlom, J., Dahut, W.
(2006). A Randomized Phase II Study of Concurrent Docetaxel Plus Vaccine Versus Vaccine Alone in Metastatic Androgen-Independent Prostate Cancer. Clin. Cancer Res.
12: 1260-1269
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Tang, Y., Khan, M. A., Goloubeva, O., Lee, D. I., Jelovac, D., Brodie, A. M., Hussain, A.
(2006). Docetaxel Followed by Castration Improves Outcomes in LNCaP Prostate Cancer-Bearing Severe Combined Immunodeficient Mice. Clin. Cancer Res.
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Hussein, M.A. H., Bird, B. R., O'Sullivan, M. J., Kalimuthu, S. G., O'Sullivan, G. C., O'Reilly, S., Breathnach, O. S.
(2005). Symptoms in Cancer Patients and an Unusual Tumor: CASE 2. Docetaxel-Related Ischemic Colitis. JCO
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Pchejetski, D., Golzio, M., Bonhoure, E., Calvet, C., Doumerc, N., Garcia, V., Mazerolles, C., Rischmann, P., Teissie, J., Malavaud, B., Cuvillier, O.
(2005). Sphingosine Kinase-1 as a Chemotherapy Sensor in Prostate Adenocarcinoma Cell and Mouse Models. Cancer Res.
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Hussain, M., Tangen, C. M., Lara, P. N. Jr, Vaishampayan, U. N., Petrylak, D. P., Colevas, A. D., Sakr, W. A., Crawford, E. D.
(2005). Ixabepilone (Epothilone B Analogue BMS-247550) Is Active in Chemotherapy-Naive Patients With Hormone-Refractory Prostate Cancer: A Southwest Oncology Group Trial S0111. JCO
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Loberg, R. D., Logothetis, C. J., Keller, E. T., Pienta, K. J.
(2005). Pathogenesis and Treatment of Prostate Cancer Bone Metastases: Targeting the Lethal Phenotype. JCO
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Ryan, C. J., Eisenberger, M.
(2005). Chemotherapy for Hormone-Refractory Prostate Cancer: Now It's a Question of "When?". JCO
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(2005). Management of Advanced Prostate Cancer After First-Line Chemotherapy. JCO
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(2005). Biology of Progressive, Castration-Resistant Prostate Cancer: Directed Therapies Targeting the Androgen-Receptor Signaling Axis. JCO
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(2005). Knock-down of the Cytoprotective Gene, Clusterin, to Enhance Hormone and Chemosensitivity in Prostate and Other Cancers. Ann. N. Y. Acad. Sci.
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(2005). A novel antisense oligonucleotide inhibiting several antiapoptotic Bcl-2 family members induces apoptosis and enhances chemosensitivity in androgen-independent human prostate cancer PC3 cells. Molecular Cancer Therapeutics
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Brahmer, J. R.
(2005). Update in Oncology. ANN INTERN MED
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Zhou, P., Chen, M.-H., McLeod, D., Carroll, P. R., Moul, J. W., D'Amico, A. V.
(2005). Predictors of Prostate Cancer-Specific Mortality After Radical Prostatectomy or Radiation Therapy. JCO
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Escuin, D., Kline, E. R., Giannakakou, P.
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Oh, W. K.
(2005). High-Risk Localized Prostate Cancer: Integrating Chemotherapy. The Oncologist
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(2005). Achieving Treatment Goals for Hormone-Refractory Prostate Cancer with Chemotherapy. The Oncologist
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Stewart, A. J., Scher, H. I., Chen, M.-H., McLeod, D. G., Carroll, P. R., Moul, J. W., D'Amico, A. V.
(2005). Prostate-Specific Antigen Nadir and Cancer-Specific Mortality Following Hormonal Therapy for Prostate-Specific Antigen Failure. JCO
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Sweeney, C., Liu, G., Yiannoutsos, C., Kolesar, J., Horvath, D., Staab, M. J., Fife, K., Armstrong, V., Treston, A., Sidor, C., Wilding, G.
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