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Journal of Clinical Oncology, Vol 17, Issue 8 (August), 1999: 2506
© 1999 American Society for Clinical Oncology

Hydrocortisone With or Without Mitoxantrone in Men With Hormone-Refractory Prostate Cancer: Results of the Cancer and Leukemia Group B 9182 Study

Philip W. Kantoff, Susan Halabi, Mark Conaway, Joel Picus, Jeffrey Kirshner, Vera Hars, Donald Trump, Eric P. Winer, Nicholas J. Vogelzang

From the Lank Center for Genitourinary Oncology and Breast Oncology Center, Department of Adult Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham, NC; Division of Biostatistics and Epidemiology, University of Virginia Health Sciences Center, Charlottsville, VA; Division of Medical Oncology, Washington University Medical Center, St Louis, MO; Syracuse Hematology-Oncology Community Clinical Oncology Program, Hematology-Oncology Associates of Central New York, Syracuse, NY; Division of Medical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA; and Section of Hematology Oncology, Department of Medicine, University of Chicago Medical Center, Chicago, IL.

Address reprint requests to Philip W. Kantoff, MD, Department of Medical Oncology, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115-6084; email philip_kantoff{at}dfci.harvard.edu

PURPOSE: Approximately 40,000 men die each year of hormone-refractory prostate cancer (HRPC). The results of treatment with chemotherapy have been disappointing to date, with no trials demonstrating a benefit with respect to survival duration. Corticosteroids and mitoxantrone each have been shown to be active agents in this disease. The purpose of this study was to demonstrate an advantage of mitoxantrone and hydrocortisone (M+H) over hydrocortisone alone with respect to survival duration.

PATIENTS AND METHODS: Two hundred forty-two patients with HRPC were randomized to receive either M+H or hydrocortisone alone. Patients were monitored for survival, time to disease progression, time to treatment failure, response, and quality-of-life (QOL) parameters.

RESULTS: Treatment in both arms was well tolerated. Although there was a delay in time to treatment failure and disease progression in favor of M+H over hydrocortisone alone, there was no difference in overall survival (12.3 months for M+H v 12.6 months for hydrocortisone alone). There was an indication that QOL was better with M+H, in particular with respect to pain control.

CONCLUSION: M+H generated more frequent responses and a delay in both time to treatment failure and disease progression compared with hydrocortisone alone. In addition, there was a possible benefit of M+H with respect to pain control over hydrocortisone alone. No improvement in survival was observed. Although M+H could be viewed as a palliative option for patients with HRPC, new drugs and novel strategies are needed to improve survival for this disease.


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Effect of Endothelin-A Receptor Blockade With Atrasentan on Tumor Progression in Men With Hormone-Refractory Prostate Cancer: A Randomized, Phase II, Placebo-Controlled Trial
J. Clin. Oncol., February 15, 2003; 21(4): 679 - 689.
[Abstract] [Full Text] [PDF]

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S. Halabi, E. J. Small, D. F. Hayes, N. J. Vogelzang, and P. W. Kantoff
Prognostic Significance of Reverse Transcriptase Polymerase Chain Reaction for Prostate-Specific Antigen in Metastatic Prostate Cancer: A Nested Study Within CALGB 9583
J. Clin. Oncol., February 1, 2003; 21(3): 490 - 495.
[Abstract] [Full Text] [PDF]

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T. M. Beer, K. M. Eilers, M. Garzotto, M. J. Egorin, B. A. Lowe, and W. D. Henner
Weekly High-Dose Calcitriol and Docetaxel in Metastatic Androgen-Independent Prostate Cancer
J. Clin. Oncol., January 1, 2003; 21(1): 123 - 128.
[Abstract] [Full Text] [PDF]

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D. R. Mercatante, J. L. Mohler, and R. Kole
Cellular Response to an Antisense-mediated Shift of Bcl-x Pre-mRNA Splicing and Antineoplastic Agents
J. Biol. Chem., December 13, 2002; 277(51): 49374 - 49382.
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G. Liu, K. Oettel, G. Ripple, M. J. Staab, D. Horvath, D. Alberti, R. Arzoomanian, R. Marnocha, R. Bruskewitz, R. Mazess, et al.
Phase I Trial of 1{alpha}-Hydroxyvitamin D2 in Patients with Hormone Refractory Prostate Cancer
Clin. Cancer Res., September 1, 2002; 8(9): 2820 - 2827.
[Abstract] [Full Text] [PDF]

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A. W. Tolcher, L. Reyno, P. M. Venner, S. D. Ernst, M. Moore, R. S. Geary, K. Chi, S. Hall, W. Walsh, A. Dorr, et al.
A Randomized Phase II and Pharmacokinetic Study of the Antisense Oligonucleotides ISIS 3521 and ISIS 5132 in Patients with Hormone-refractory Prostate Cancer
Clin. Cancer Res., August 1, 2002; 8(8): 2530 - 2535.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
S. Goodin, K. V. Rao, and R. S. DiPaola
State-of-the-Art Treatment of Metastatic Hormone-Refractory Prostate Cancer
Oncologist, August 1, 2002; 7(4): 360 - 370.
[Abstract] [Full Text] [PDF]

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R. S. DiPaola, J. Rinehart, J. Nemunaitis, S. Ebbinghaus, E. Rubin, T. Capanna, M. Ciardella, S. Doyle-Lindrud, S. Goodwin, M. Fontaine, et al.
Characterization of a Novel Prostate-Specific Antigen-Activated Peptide-Doxorubicin Conjugate in Patients With Prostate Cancer
J. Clin. Oncol., April 1, 2002; 20(7): 1874 - 1879.
[Abstract] [Full Text] [PDF]

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R. T. Vollmer, P. W. Kantoff, N. A. Dawson, and N. J. Vogelzang
Importance of Serum Hemoglobin in Hormone Refractory Prostate Cancer
Clin. Cancer Res., April 1, 2002; 8(4): 1049 - 1053.
[Abstract] [Full Text] [PDF]

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C. J. Sweeney, F. J. Monaco, S.-H. Jung, M. J. Wasielewski, J. Picus, R. H. Ansari, W. M. Dugan, and L. H. Einhorn
A phase II Hoosier Oncology Group study of vinorelbine and estramustine phosphate in hormone-refractory prostate cancer
Ann. Onc., March 1, 2002; 13(3): 435 - 440.
[Abstract] [Full Text] [PDF]

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K. N. Chi, M. E. Gleave, R. Klasa, N. Murray, C. Bryce, D. E. Lopes de Menezes, S. D'Aloisio, and A. W. Tolcher
A Phase I Dose-finding Study of Combined Treatment with an Antisense Bcl-2 Oligonucleotide (Genasense) and Mitoxantrone in Patients with Metastatic Hormone-refractory Prostate Cancer
Clin. Cancer Res., December 1, 2001; 7(12): 3920 - 3927.
[Abstract] [Full Text] [PDF]

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D. J. George, S. Halabi, T. F. Shepard, N. J. Vogelzang, D. F. Hayes, E. J. Small, and P. W. Kantoff
Prognostic Significance of Plasma Vascular Endothelial Growth Factor Levels in Patients with Hormone-refractory Prostate Cancer Treated on Cancer and Leukemia Group B 9480
Clin. Cancer Res., July 1, 2001; 7(7): 1932 - 1936.
[Abstract] [Full Text] [PDF]

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D.M. Savarese, S. Halabi, V. Hars, W.L. Akerley, M-E Taplin, P.A. Godley, A. Hussain, E.J. Small, and N.J. Vogelzang
Phase II Study of Docetaxel, Estramustine, and Low-Dose Hydrocortisone in Men With Hormone-Refractory Prostate Cancer: A Final Report of CALGB 9780
J. Clin. Oncol., May 1, 2001; 19(9): 2509 - 2516.
[Abstract] [Full Text] [PDF]

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Y.-J. Ko, E. J. Small, F. Kabbinavar, A. Chachoua, S. Taneja, D. Reese, A. DePaoli, A. Hannah, S. P. Balk, and G. J. Bubley
A Multi-Institutional Phase II Study of SU101, a Platelet-derived Growth Factor Receptor Inhibitor, for Patients with Hormone-Refractory Prostate Cancer
Clin. Cancer Res., April 1, 2001; 7(4): 800 - 805.
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 The OncologistHome page
M. J. Haut, J. F. Harryhill, J. Rosenstock, M. J. Warhol, and R. Vitti
Progressing Prostate Carcinoma
Oncologist, April 1, 2001; 6(2): 183 - 196.
[Abstract] [Full Text]

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E. J. Small, A. McMillan, M. Meyer, L. Chen, W. J. Slichenmyer, P. F. Lenehan, and M. Eisenberger
Serum Prostate-Specific Antigen Decline as a Marker of Clinical Outcome in Hormone-Refractory Prostate Cancer Patients: Association With Progression-Free Survival, Pain End Points, and Survival
J. Clin. Oncol., March 1, 2001; 19(5): 1304 - 1311.
[Abstract] [Full Text] [PDF]

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R. A. Bok, S. Halabi, D. T. Fei, C. R. Rodriquez, D. F. Hayes, N. J. Vogelzang, P. Kantoff, M. A. Shuman, and E. J. Small
Vascular Endothelial Growth Factor and Basic Fibroblast Growth Factor Urine Levels as Predictors of Outcome in Hormone-refractory Prostate Cancer Patients: A Cancer and Leukemia Group B Study
Cancer Res., March 1, 2001; 61(6): 2533 - 2536.
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S. D. Fossa, P. H.Th. Slee, M. Brausi, S. Horenblas, R. R. Hall, J. W. Hetherington, N. Aaronson, L. de Prijck, and L. Collette
Flutamide Versus Prednisone in Patients With Prostate Cancer Symptomatically Progressing After Androgen-Ablative Therapy: A Phase III Study of the European Organization for Research and Treatment of Cancer Genitourinary Group
J. Clin. Oncol., January 1, 2001; 19(1): 62 - 71.
[Abstract] [Full Text] [PDF]

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U. Vaishampayan, M. Glode, W. Du, A. Kraft, G. Hudes, J. Wright, and M. Hussain
Phase II Study of Dolastatin-10 in Patients with Hormone-refractory Metastatic Prostate Adenocarcinoma
Clin. Cancer Res., November 1, 2000; 6(11): 4205 - 4208.
[Abstract] [Full Text] [PDF]

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H. Miyake, K. N. Chi, and M. E. Gleave
Antisense TRPM-2 Oligodeoxynucleotides Chemosensitize Human Androgen-independent PC-3 Prostate Cancer Cells Both in Vitro and in Vivo
Clin. Cancer Res., May 1, 2000; 6(5): 1655 - 1663.
[Abstract] [Full Text] [PDF]

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E. J. Small, M. Meyer, M. E. Marshall, L. M. Reyno, F. J. Meyers, R. B. Natale, P. F. Lenehan, L. Chen, W. J. Slichenmyer, and M. Eisenberger
Suramin Therapy for Patients With Symptomatic Hormone-Refractory Prostate Cancer: Results of a Randomized Phase III Trial Comparing Suramin Plus Hydrocortisone to Placebo Plus Hydrocortisone
J. Clin. Oncol., April 7, 2000; 18(7): 1440 - 1450.
[Abstract] [Full Text] [PDF]

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P. N. Plowman
Glucocorticoids and Prostate Cancer in Castrate Men
J. Clin. Oncol., December 1, 1999; 17(12): 3856 - 3860.
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