- Email: [email protected]
Editorial Comment on: Weekly Docetaxel and Prednisolone versus Prednisolone Alone in Androgen-Independent Prostate Cancer: A Randomized Phase II Study
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european urology 52 (2007) 1691–1699
[3] Tannock IF, Osoba D, Stockier MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756–64. [4] Kantoff PW, Halabi S, Conaway M, et al. Hydrocortisone with or without mitoxantrone in men with hormonerefractory prostate cancer: results of the Cancer and Leukemia Group B 9182 Study. J Clin Oncol 1999;17: 2506–13. [5] Berruti A, Mosca A, Bitossi R, et al. Feasibility of 21-day continuous infusion of epirubicin in hormone-refractory prostate cancer patents. Anticancer Res 2005;25:4475–9. [6] van Angel G, Kurth KH, Rietbroek RL, van De Velde-Muusers JA. Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate: is it feasible? Eur Urol 2000;38:259–64. [7] Iversen P, Rasmussen F, Asmussen C, et al. Estramustine phosphate versus placebo as second line treatment after orchiectomy in patients with metastatic prostate cancer: DAPROCA study 9002. Danish Prostatic Cancer Group. J Urol 1997;157:929–34. [8] Beer TM, Pierce WC, Lowe BA, Henner WD. Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 2001;12:1273–9. [9] Berry W, Dakhil S, Gregurich MA, Asmar L. Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate. Semin Oncol 2001;28(Suppl 15):8–15. [10] Friedland D, Cohen J, Miller Jr R, et al. A phase II trial of docetaxel (Taxotere) in hormone-refractory prostate cancer: correlation of antitumor effect to phosphorylation of Bcl-2. Semin Oncol 1999;26(Suppl 17):19–23. [11] Picus J, Schultz M. Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 1999;26(Suppl 17):14–8. [12] EORTC Data Center. Phase II Trials in the EORTC. Eur J Cancer 1997;33:1361–3. [13] Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502–12. [14] Petrylak DP, Tangen CM, Hussain MHA, et al. Docetaxel and estramustine compared with mitoxantrone and
Editorial Comment on: Weekly Docetaxel and Prednisolone versus Prednisolone Alone in Androgen-Independent Prostate Cancer: A Randomized Phase II Study Sergio Bracarda Department of Medical Oncology, Ospedale S. Maria della Misericordia, Azienda Ospedaliera-Universitaria di Perugia, Via G. Dottori, 1, I-06156 Perugia, Italy [email protected] In 1993, Yagoda and Petrylak published a wellknown review reporting the low probability of
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513–20. Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria, version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Rad Oncol Biol Phys 2000;47:13–47. Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461–7. Hedlund PO, Ala-Opas M, Brekkan E, et al. Parenteral estrogen versus combined androgen deprivation in the treatment of metastatic prostatic cancer. Scand J Urol Nephrol 2002;36:405–13. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76. Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol 1998;16:139–44. Kelly WM, Scher HI, Mazamdar M, et al. Prostate specific antigen as a measure of disease outcome in metastatic hormone refractory prostate cancer. J Clin Oncol 1993; 4:607–15. Fizazi K, Thuret R, Theodore C, et al. Early PSA rise subsequently followed by PSA decline is a common event in prostate cancer patient responders to chemotherapy. Ann Oncol 2004;15(Suppl 3):427. Fossa˚ SD, Vaage S, Letocha H, et al. Liposomal doxorubicin (CaelyxR) in symptomatic androgen-independent prostate cancer (AIPC): delayed response and flare phenomenon should be considered. Scand J Urol Nephrol 2002;36:34–9. Scher HI, Eisenberger M, D’Amico AV, et al. Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the prostate-specific antigen working group. J Clin Oncol 2004;22: 537–56. Scotte´ F, Tourani JM, Banu E, et al. Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol 2005;23:4424–9.
response observed with chemotherapy agents in hormone-refractory prostate cancer (HRPC) [1]. An initial, even if palliative, advantage achievable with this approach in prostate cancer was shown in 1996 by Tannock et al with the mitoxantrone– prednisone regimen [2], but it was only in the 1990s, with the advent of taxanes (paclitaxel and docetaxel), that a real advantage in disease control was reached. In 2004, with the publication of the two large randomised phase 3 trials, SWOG 99-16 and TAX-327 (>1600 cases treated, overall), and the
european urology 52 (2007) 1691–1699
demonstration of an improved overall survival with respect to mitoxantrone–prednisone, was docetaxel, in the 3-weekly schedule, recognised as the new standard of treatment for metastatic HRPC [3,4]. This regimen, however, is characterised by a significant, even if not serious, haematologic toxicity with respect to the weekly schedule. Fossa` and colleagues present the results of a large Norwegian randomised phase 2 study that tested a weekly schedule of docetaxel plus prednisolone versus prednisolone alone (best supportive care). The study confirms the activity of weekly docetaxel in HRPC and shows also the possibility of improved safety, pain control, and quality of life without apparent detrimental effects for overall survival [5]. Even if new docetaxel-based regimens are under evaluation, docetaxel plus prednisone in the 3-weekly schedule remains the gold standard for HRPC treatment. The safety of weekly low-dose schedules should be considered in men at increased risk of treatment-related toxicity.
1699
References [1] Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 1993;71(3 Suppl):1098–109. [2] Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756–64. [3] Tannock IF, de Wit R, Berry WR, et al. TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502–12. [4] Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513–20. [5] Fossa˚ SD, Jacobsen A-B, Ginman C, et al. Weekly docetaxel and prednisolone versus prednisolone alone in androgen-independent prostate cancer: a randomized phase 2 study (TIPC). Eur Urol 2007;52:1691–9.
DOI: 10.1016/j.eururo.2007.01.105 DOI of original article: 10.1016/j.eururo.2007.01.104
european urology 52 (2007) 1691–1699
[3] Tannock IF, Osoba D, Stockier MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756–64. [4] Kantoff PW, Halabi S, Conaway M, et al. Hydrocortisone with or without mitoxantrone in men with hormonerefractory prostate cancer: results of the Cancer and Leukemia Group B 9182 Study. J Clin Oncol 1999;17: 2506–13. [5] Berruti A, Mosca A, Bitossi R, et al. Feasibility of 21-day continuous infusion of epirubicin in hormone-refractory prostate cancer patents. Anticancer Res 2005;25:4475–9. [6] van Angel G, Kurth KH, Rietbroek RL, van De Velde-Muusers JA. Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate: is it feasible? Eur Urol 2000;38:259–64. [7] Iversen P, Rasmussen F, Asmussen C, et al. Estramustine phosphate versus placebo as second line treatment after orchiectomy in patients with metastatic prostate cancer: DAPROCA study 9002. Danish Prostatic Cancer Group. J Urol 1997;157:929–34. [8] Beer TM, Pierce WC, Lowe BA, Henner WD. Phase II study of weekly docetaxel in symptomatic androgen-independent prostate cancer. Ann Oncol 2001;12:1273–9. [9] Berry W, Dakhil S, Gregurich MA, Asmar L. Phase II trial of single-agent weekly docetaxel in hormone-refractory, symptomatic, metastatic carcinoma of the prostate. Semin Oncol 2001;28(Suppl 15):8–15. [10] Friedland D, Cohen J, Miller Jr R, et al. A phase II trial of docetaxel (Taxotere) in hormone-refractory prostate cancer: correlation of antitumor effect to phosphorylation of Bcl-2. Semin Oncol 1999;26(Suppl 17):19–23. [11] Picus J, Schultz M. Docetaxel (Taxotere) as monotherapy in the treatment of hormone-refractory prostate cancer: preliminary results. Semin Oncol 1999;26(Suppl 17):14–8. [12] EORTC Data Center. Phase II Trials in the EORTC. Eur J Cancer 1997;33:1361–3. [13] Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502–12. [14] Petrylak DP, Tangen CM, Hussain MHA, et al. Docetaxel and estramustine compared with mitoxantrone and
Editorial Comment on: Weekly Docetaxel and Prednisolone versus Prednisolone Alone in Androgen-Independent Prostate Cancer: A Randomized Phase II Study Sergio Bracarda Department of Medical Oncology, Ospedale S. Maria della Misericordia, Azienda Ospedaliera-Universitaria di Perugia, Via G. Dottori, 1, I-06156 Perugia, Italy [email protected] In 1993, Yagoda and Petrylak published a wellknown review reporting the low probability of
[15]
[16]
[17]
[18]
[19]
[20]
[21]
[22]
[23]
[24]
prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513–20. Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria, version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Rad Oncol Biol Phys 2000;47:13–47. Bubley GJ, Carducci M, Dahut W, et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999;17:3461–7. Hedlund PO, Ala-Opas M, Brekkan E, et al. Parenteral estrogen versus combined androgen deprivation in the treatment of metastatic prostatic cancer. Scand J Urol Nephrol 2002;36:405–13. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76. Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life scores. J Clin Oncol 1998;16:139–44. Kelly WM, Scher HI, Mazamdar M, et al. Prostate specific antigen as a measure of disease outcome in metastatic hormone refractory prostate cancer. J Clin Oncol 1993; 4:607–15. Fizazi K, Thuret R, Theodore C, et al. Early PSA rise subsequently followed by PSA decline is a common event in prostate cancer patient responders to chemotherapy. Ann Oncol 2004;15(Suppl 3):427. Fossa˚ SD, Vaage S, Letocha H, et al. Liposomal doxorubicin (CaelyxR) in symptomatic androgen-independent prostate cancer (AIPC): delayed response and flare phenomenon should be considered. Scand J Urol Nephrol 2002;36:34–9. Scher HI, Eisenberger M, D’Amico AV, et al. Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the prostate-specific antigen working group. J Clin Oncol 2004;22: 537–56. Scotte´ F, Tourani JM, Banu E, et al. Multicenter study of a frozen glove to prevent docetaxel-induced onycholysis and cutaneous toxicity of the hand. J Clin Oncol 2005;23:4424–9.
response observed with chemotherapy agents in hormone-refractory prostate cancer (HRPC) [1]. An initial, even if palliative, advantage achievable with this approach in prostate cancer was shown in 1996 by Tannock et al with the mitoxantrone– prednisone regimen [2], but it was only in the 1990s, with the advent of taxanes (paclitaxel and docetaxel), that a real advantage in disease control was reached. In 2004, with the publication of the two large randomised phase 3 trials, SWOG 99-16 and TAX-327 (>1600 cases treated, overall), and the
european urology 52 (2007) 1691–1699
demonstration of an improved overall survival with respect to mitoxantrone–prednisone, was docetaxel, in the 3-weekly schedule, recognised as the new standard of treatment for metastatic HRPC [3,4]. This regimen, however, is characterised by a significant, even if not serious, haematologic toxicity with respect to the weekly schedule. Fossa` and colleagues present the results of a large Norwegian randomised phase 2 study that tested a weekly schedule of docetaxel plus prednisolone versus prednisolone alone (best supportive care). The study confirms the activity of weekly docetaxel in HRPC and shows also the possibility of improved safety, pain control, and quality of life without apparent detrimental effects for overall survival [5]. Even if new docetaxel-based regimens are under evaluation, docetaxel plus prednisone in the 3-weekly schedule remains the gold standard for HRPC treatment. The safety of weekly low-dose schedules should be considered in men at increased risk of treatment-related toxicity.
1699
References [1] Yagoda A, Petrylak D. Cytotoxic chemotherapy for advanced hormone-resistant prostate cancer. Cancer 1993;71(3 Suppl):1098–109. [2] Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996;14:1756–64. [3] Tannock IF, de Wit R, Berry WR, et al. TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004;351:1502–12. [4] Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med 2004;351:1513–20. [5] Fossa˚ SD, Jacobsen A-B, Ginman C, et al. Weekly docetaxel and prednisolone versus prednisolone alone in androgen-independent prostate cancer: a randomized phase 2 study (TIPC). Eur Urol 2007;52:1691–9.
DOI: 10.1016/j.eururo.2007.01.105 DOI of original article: 10.1016/j.eururo.2007.01.104