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Previous Volume 351:1513-1520 October 7, 2004 Number 15 Next

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ABSTRACT

Background Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer.

Methods We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels.

Results Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients, respectively (P<0.001), and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease, respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and vomiting (P<0.001), and cardiovascular events (P=0.001) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone. Pain relief was similar in both groups.

Conclusions The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.

Source Information

From Columbia University, Herbert Irving Comprehensive Cancer Center, New York (D.P.P., M.C.B.); Southwest Oncology Group Statistical Center, Seattle (C.M.T., C.M.); the University of Michigan Comprehensive Cancer Center, Ann Arbor (M.H.A.H.); the University of California, Davis, Sacramento (P.N.L.); Baylor College of Medicine, Houston (J.A.J.); the University of Massachusetts Medical Center, Worcester (M.E.T.); the Mayo Clinic, Rochester, Minn. (P.A.B.); Biobehavioral Nursing and Health Systems, University of Washington, Seattle (D.B.); the University of Arkansas for Medical Science, Little Rock (M.K.); the University of California, San Francisco, Cancer Center, San Francisco (E.J.S.); the Cleveland Clinic Foundation, Cleveland (D.R.); and the University of Colorado Health Science Center, Denver (E.D.C.).

Address reprint requests to the Southwest Oncology Group (S9916) Operations Office, 14980 Omicron Dr., San Antonio, TX 78245-3217, or at pubs{at}swog.org.

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Chemotherapy for Advanced Prostate Cancer
Nabhan C., Petrylak D. P., Hussain M., Crawford E. D.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:200-201, Jan 13, 2005. Correspondence

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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 23: 6556-6560 [Abstract] [Full Text]  
• Kim, H., Lapointe, J., Kaygusuz, G., Ong, D. E., Li, C., van de Rijn, M., Brooks, J. D., Pollack, J. R. (2005). The Retinoic Acid Synthesis Gene ALDH1a2 Is a Candidate Tumor Suppressor in Prostate Cancer. Cancer Res. 65: 8118-8124 [Abstract] [Full Text]  
• Sweeney, C., Liu, G., Yiannoutsos, C., Kolesar, J., Horvath, D., Staab, M. J., Fife, K., Armstrong, V., Treston, A., Sidor, C., Wilding, G. (2005). A Phase II Multicenter, Randomized, Double-Blind, Safety Trial Assessing the Pharmacokinetics, Pharmacodynamics, and Efficacy of Oral 2-Methoxyestradiol Capsules in Hormone-Refractory Prostate Cancer. Clin. Cancer Res. 11: 6625-6633 [Abstract] [Full Text]  
• Pienta, K. J., Smith, D. C. (2005). Advances in Prostate Cancer Chemotherapy: A New Era Begins. CA Cancer J Clin 55: 300-318 [Abstract] [Full Text]  
• D'Amico, A. V., Chen, M.-H., Roehl, K. A., Catalona, W. J. (2005). Identifying Patients at Risk for Significant Versus Clinically Insignificant Postoperative Prostate-Specific Antigen Failure. JCO 23: 4975-4979 [Abstract] [Full Text]  
• Freedland, S. J., Humphreys, E. B., Mangold, L. A., Eisenberger, M., Dorey, F. J., Walsh, P. C., Partin, A. W. (2005). Risk of Prostate Cancer-Specific Mortality Following Biochemical Recurrence After Radical Prostatectomy. JAMA 294: 433-439 [Abstract] [Full Text]  
• Anscher, M. S. (2005). PSA Kinetics and Risk of Death From Prostate Cancer: In Search of the Holy Grail of Surrogate End Points. JAMA 294: 493-494 [Full Text]  
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• Eigl, B. J.C., Eggener, S. E., Baybik, J., Ettinger, S., Chi, K. N., Nelson, C., Wang, Z., Gleave, M. E. (2005). Timing Is Everything: Preclinical Evidence Supporting Simultaneous Rather Than Sequential Chemohormonal Therapy for Prostate Cancer. Clin. Cancer Res. 11: 4905-4911 [Abstract] [Full Text]  
• Bastian, P. J., Palapattu, G. S., Lin, X., Yegnasubramanian, S., Mangold, L. A., Trock, B., Eisenberger, M. A., Partin, A. W., Nelson, W. G. (2005). Preoperative Serum DNA GSTP1 CpG Island Hypermethylation and the Risk of Early Prostate-Specific Antigen Recurrence Following Radical Prostatectomy. Clin. Cancer Res. 11: 4037-4043 [Abstract] [Full Text]  
• Roth, B. J. (2005). Prostate Cancer Chemotherapy: Emerging From the Shadows. JCO 23: 3302-3303 [Full Text]  
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• Carducci, M. A. (2005). What Is More Exciting? The Activity of Docetaxel in Early Prostate Cancer or the Successful Collaboration Between Urologists and Medical Oncologists to Complete a Study in Early Prostate Cancer?. JCO 23: 3304-3307 [Full Text]  
• Tolcher, A. W., Chi, K., Kuhn, J., Gleave, M., Patnaik, A., Takimoto, C., Schwartz, G., Thompson, I., Berg, K., D'Aloisio, S., Murray, N., Frankel, S. R., Izbicka, E., Rowinsky, E. (2005). A Phase II, Pharmacokinetic, and Biological Correlative Study of Oblimersen Sodium and Docetaxel in Patients with Hormone-Refractory Prostate Cancer. Clin. Cancer Res. 11: 3854-3861 [Abstract] [Full Text]  
• Smith, M. R., Kabbinavar, F., Saad, F., Hussain, A., Gittelman, M. C., Bilhartz, D. L., Wynne, C., Murray, R., Zinner, N. R., Schulman, C., Linnartz, R., Zheng, M., Goessl, C., Hei, Y.-J., Small, E. J., Cook, R., Higano, C. S. (2005). Natural History of Rising Serum Prostate-Specific Antigen in Men With Castrate Nonmetastatic Prostate Cancer. JCO 23: 2918-2925 [Abstract] [Full Text]  
• Morris, M. J., Akhurst, T., Larson, S. M., Ditullio, M., Chu, E., Siedlecki, K., Verbel, D., Heller, G., Kelly, W. K., Slovin, S., Schwartz, L., Scher, H. I. (2005). Fluorodeoxyglucose Positron Emission Tomography as an Outcome Measure for Castrate Metastatic Prostate Cancer Treated with Antimicrotubule Chemotherapy. Clin. Cancer Res. 11: 3210-3216 [Abstract] [Full Text]  
• Hussain, A., Dawson, N., Amin, P., Engstrom, C., Dorsey, B., Siegel, E., Guo, C. (2005). Docetaxel Followed by Hormone Therapy in Men Experiencing Increasing Prostate-Specific Antigen After Primary Local Treatments for Prostate Cancer. JCO 23: 2789-2796 [Abstract] [Full Text]  
• Berruti, A, Mosca, A, Tucci, M, Terrone, C, Torta, M, Tarabuzzi, R, Russo, L, Cracco, C, Bollito, E, Scarpa, R M, Angeli, A, Dogliotti, L (2005). Independent prognostic role of circulating chromogranin A in prostate cancer patients with hormone-refractory disease. Endocr Relat Cancer 12: 109-117 [Abstract] [Full Text]