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Journal of Clinical Oncology, Vol 14, 1756-1764, Copyright © 1996 by American Society of Clinical Oncology

ARTICLES

Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points

IF Tannock, D Osoba, MR Stockler, DS Ernst, AJ Neville, MJ Moore, GR Armitage, JJ Wilson, PM Venner, CM Coppin and KC Murphy
Department of Medicine, Princess Margaret Hospital, Toronto, Canada. ian-tannock@pmh.toronto.on.ca

PURPOSE: To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a randomized controlled trial. PATIENTS AND METHODS: We randomized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone (10 mg daily). Nonresponding patients on prednisone could receive mitoxantrone subsequently. The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients (or complete loss of pain if initially 1 +) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart. Secondary end points were a decrease of > or = 50% in use of analgesic medication without an increase in pain, duration of response, and survival. Health-related quality of life was evaluated with a series of linear analog self- assessment scales (LASA and the Prostate Cancer-Specific Quality-of- Life Instrument [PROSQOLI]), the core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), and a disease-specific module. RESULTS: Palliative response was observed in 23 of 80 patients (29%; 95% confidence interval, 19% to 40%) who received mitoxantrone plus prednisone, and in 10 of 81 patients (12%; 95% confidence interval, 6% to 22%) who received prednisone alone (P = .01). An additional seven patients in each group reduced analgesic medication > or = 50% without an increase in pain. The duration of palliation was longer in patients who received chemotherapy (median, 43 and 18 weeks; P < .0001, log-rank). Eleven of 50 patients randomized to prednisone treatment responded after addition of mitoxantrone. There was no difference in overall survival. Treatment was well tolerated, except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone. Most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level. CONCLUSION: Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer.
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D. P. Petrylak, C. M. Tangen, M. H.A. Hussain, P. N. Lara Jr., J. A. Jones, M. E. Taplin, P. A. Burch, D. Berry, C. Moinpour, M. Kohli, et al.
Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer
N. Engl. J. Med., October 7, 2004; 351(15): 1513 - 1520.
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L. Collette, G. van Andel, A. Bottomley, G. O.N. Oosterhof, W. Albrecht, T. M. de Reijke, and S. D. Fossa
Is Baseline Quality of Life Useful for Predicting Survival With Hormone-Refractory Prostate Cancer? A Pooled Analysis of Three Studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group
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M. McNaughton-Collins, E. Walker-Corkery, and M. J. Barry
Health-Related Quality of Life, Satisfaction, and Economic Outcome Measures in Studies of Prostate Cancer Screening and Treatment, 1990-2000
J Natl Cancer Inst Monographs, October 1, 2004; 2004(33): 78 - 101.
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P. Mathew, P. F. Thall, D. Jones, C. Perez, C. Bucana, P. Troncoso, S.-J. Kim, I. J. Fidler, and C. Logothetis
Platelet-Derived Growth Factor Receptor Inhibitor Imatinib Mesylate and Docetaxel: A Modular Phase I Trial in Androgen-Independent Prostate Cancer
J. Clin. Oncol., August 15, 2004; 22(16): 3323 - 3329.
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C. N. Papandreou and C. J. Logothetis
Bortezomib as a Potential Treatment for Prostate Cancer
Cancer Res., August 1, 2004; 64(15): 5036 - 5043.
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D. S. Kaufman, W. S. McDougal, A. L. Zietman, M. G. Harisinghani, and R. H. Young
Case 21-2004 - A 63-Year-Old Man with Metastatic Prostate Carcinoma Refractory to Hormone Therapy
N. Engl. J. Med., July 8, 2004; 351(2): 171 - 178.
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W.-C. Sheen, J.-S. Chen, H.-M. Wang, T.-S. Yang, C.-C. Liaw, and Y.-C. Lin
A Modified Low-dose Regimen of Mitoxantrone and Prednisolone in Patients with Androgen-independent Prostate Cancer
Jpn. J. Clin. Oncol., June 1, 2004; 34(6): 337 - 341.
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W. M. Stadler, D. Cao, N. J. Vogelzang, C. W. Ryan, K. Hoving, R. Wright, T. Karrison, and E. E. Vokes
A Randomized Phase II Trial of the Antiangiogenic Agent SU5416 in Hormone-Refractory Prostate Cancer
Clin. Cancer Res., May 15, 2004; 10(10): 3365 - 3370.
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 Palliat MedHome page
K R. Yabroff, J. S Mandelblatt, and J. Ingham
The quality of medical care at the end-of-life in the USA: existing barriers and examples of process and outcome measures
Palliative Medicine, April 1, 2004; 18(3): 202 - 216.
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T. M. Beer, M. Garzotto, B. A. Lowe, W. J. Ellis, M. A. Montalto, P. H. Lange, and C. S. Higano
Phase I Study of Weekly Mitoxantrone and Docetaxel before Prostatectomy in Patients with High-Risk Localized Prostate Cancer
Clin. Cancer Res., February 15, 2004; 10(4): 1306 - 1311.
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S R J Bott, A J Birtle, C J Taylor, and R S Kirby
Prostate cancer management: (2) an update on locally advanced and metastatic disease
Postgrad. Med. J., November 1, 2003; 79(937): 643 - 645.
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O. Smaletz, M. Galsky, H. I. Scher, A. DeLaCruz, S. F. Slovin, M. J. Morris, D. B. Solit, U. Davar, L. Schwartz, and W. K. Kelly
Pilot study of epothilone B analog (BMS-247550) and estramustine phosphate in patients with progressive metastatic prostate cancer following castration
Ann. Onc., October 1, 2003; 14(10): 1518 - 1524.
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F. Efficace, A. Bottomley, D. Osoba, C. Gotay, H. Flechtner, S. D'haese, and A. Zurlo
Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials--Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?
J. Clin. Oncol., September 15, 2003; 21(18): 3502 - 3511.
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G. Liu, G. Wilding, M. J. Staab, D. Horvath, K. Miller, A. Dresen, D. Alberti, R. Arzoomanian, R. Chappell, and H. H. Bailey
Phase II Study of 1{alpha}-Hydroxyvitamin D2 in the Treatment of Advanced Androgen-independent Prostate Cancer
Clin. Cancer Res., September 15, 2003; 9(11): 4077 - 4083.
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D.S. Ernst, I.F. Tannock, E.W. Winquist, P.M. Venner, L. Reyno, M.J. Moore, K. Chi, K. Ding, C. Elliott, and W. Parulekar
Randomized, Double-Blind, Controlled Trial of Mitoxantrone/Prednisone and Clodronate Versus Mitoxantrone/Prednisone and Placebo in Patients With Hormone-Refractory Prostate Cancer and Pain
J. Clin. Oncol., September 1, 2003; 21(17): 3335 - 3342.
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J. P. Droz, X. Muracciole, N. Mottet, M. Ould Kaci, J. M. Vannetzel, N. Albin, S. Culine, J.-M. Rodier, J.-L. Misset, S. Mackenzie, et al.
Phase II study of oxaliplatin versus oxaliplatin combined with infusional 5-fluorouracil in hormone refractory metastatic prostate cancer patients
Ann. Onc., August 1, 2003; 14(8): 1291 - 1298.
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H. Palmedo, A. Manka-Waluch, P. Albers, I. G.H. Schmidt-Wolf, M. Reinhardt, S. Ezziddin, A. Joe, R. Roedel, R. Fimmers, F.F. Knapp Jr, et al.
Repeated Bone-Targeted Therapy for Hormone-Refractory Prostate Carcinoma: Randomized Phase II Trial With the New, High-Energy Radiopharmaceutical Rhenium-188 Hydroxyethylidenediphosphonate
J. Clin. Oncol., August 1, 2003; 21(15): 2869 - 2875.
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V. V. Kataja
ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of prostate cancer
Ann. Onc., July 1, 2003; 14(7): 1010 - 1011.
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A. Bottomley, R. Thomas, K. Van Steen, H. Flechtner, and A. de Graeff
Guidelines for the Use of Epoetin: Have Quality-of-Life Benefits Been Proven?
J. Clin. Oncol., June 1, 2003; 21(11): 2223 - 2223.
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M. J. Fisch, P. J. Loehrer, J. Kristeller, S. Passik, S.-H. Jung, J. Shen, M. A. Arquette, M. J. Brames, and L. H. Einhorn
Fluoxetine Versus Placebo in Advanced Cancer Outpatients: A Double-Blinded Trial of the Hoosier Oncology Group
J. Clin. Oncol., May 15, 2003; 21(10): 1937 - 1943.
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D. Tassinari, I. Panzini, S. Sartori, and A. Ravaioli
Surrogate Outcomes in Quality-of-Life Research: Where Will We End Up?
J. Clin. Oncol., May 1, 2003; 21(9): 1894 - 1895.
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M. J. Morris and H. I. Scher
Clinical Approaches to Osseous Metastases in Prostate Cancer
Oncologist, April 1, 2003; 8(2): 161 - 173.
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S. R. Husain, K. Kawakami, M. Kawakami, and R. K. Puri
Interleukin-4 Receptor-targeted Cytotoxin Therapy of Androgen-dependent and -independent Prostate Carcinoma in Xenograft Models
Mol. Cancer Ther., March 1, 2003; 2(3): 245 - 254.
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M. A. Carducci, R. J. Padley, J. Breul, N. J. Vogelzang, B. A. Zonnenberg, D. D. Daliani, C. C. Schulman, A. A. Nabulsi, R. A. Humerickhouse, M. A. Weinberg, et al.
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.
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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.
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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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D Mazhar and J Waxman
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S. Modi, K. S. Panageas, E. T. Duck, A. Bach, N. Weinstock, J. Dougherty, L. Cramer, C. Hudis, L. Norton, and A. Seidman
Prospective Exploratory Analysis of the Association Between Tumor Response, Quality of Life, and Expenditures Among Patients Receiving Paclitaxel Monotherapy for Refractory Metastatic Breast Cancer
J. Clin. Oncol., September 1, 2002; 20(17): 3665 - 3673.
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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.
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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.
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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.
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M. N. Levine and P. A. Ganz
Beyond the Development of Quality-of-Life Instruments: Where Do We Go From Here?
J. Clin. Oncol., May 1, 2002; 20(9): 2215 - 2216.
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J. A. Sloan, N. Aaronson, J. C. Cappelleri, D. L. Fairclough, C. Varricchio, and Clinical Significance Consensus Meeting Group
Assessing the Clinical Significance of Single Items Relative to Summated Scores
Mayo Clin. Proc., May 1, 2002; 77(5): 479 - 487.
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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
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