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Published in: BMC Urology 1/2014

Open Access 01-12-2014 | Research article

External validation of risk classification in patients with docetaxel-treated castration-resistant prostate cancer

Authors: Kazuhiko Nakano, Kenji Komatsu, Taro Kubo, Shinsuke Natsui, Akinori Nukui, Shinsuke Kurokawa, Minoru Kobayashi, Tatsuo Morita

Published in: BMC Urology | Issue 1/2014

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Abstract

Background

Castration-resistant prostate cancer (CRPC) patients have poor prognoses, and docetaxel (DTX) is among the few treatment options. An accurate risk classification to identify CRPC patient groups for which DTX would be effective is urgently warranted. The Armstrong risk classification (ARC), which classifies CRPC patients into 3 groups, is superior; however, its usefulness remains unclear, and further external validation is required before clinical use. This study aimed to examine the clinical significance of the ARC through external validation in DTX-treated Japanese CRPC patients.

Methods

CRPC patients who received 2 or more DTX cycles were selected for this study. Patients were classified into good-, intermediate-, and poor-risk groups according to the ARC. Prostate-specific antigen (PSA) responses and overall survival (OS) were calculated and compared between the risk groups. A multivariate analysis was performed to clarify the relationship between the ARC and major patient characteristics.

Results

Seventy-eight CRPC patients met the inclusion criteria. Median PSA levels at DTX initiation was 20 ng/mL. Good-, intermediate-, and poor-risk groups comprised 51 (65%), 17 (22%), and 10 (13%) patients, respectively. PSA response rates ≥30% and ≥50% were 33%, 41%, and 30%, and 18%, 41%, and 20% in the good-, intermediate-, and poor-risk groups, respectivcixely, with no significant differences (p = 0.133 and 0.797, respectively). The median OS in the good-, intermediate-, and poor-risk groups were statistically significant (p < 0.001) at 30.1, 14.2, and 5.7 months, respectively. A multivariate analysis revealed that the ARC and PSA doubling time were independent prognostic factors.

Conclusions

Most of CRPC patients were classified into good-risk group according to the ARC and the ARC could predict prognosis in DTX-treated CRPC patients.

Trial registration

University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) number, UMIN000011969.
Appendix
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Literature
1.
go back to reference Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA, TAX Investigators: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004, 351: 1502-1512. 10.1056/NEJMoa040720.CrossRefPubMed Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA, TAX Investigators: Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004, 351: 1502-1512. 10.1056/NEJMoa040720.CrossRefPubMed
2.
go back to reference Petrylak DP, Tangen CM, Hussain MHA, Lara PJ, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004, 351: 1513-1520. 10.1056/NEJMoa041318.CrossRefPubMed Petrylak DP, Tangen CM, Hussain MHA, Lara PJ, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED: Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004, 351: 1513-1520. 10.1056/NEJMoa041318.CrossRefPubMed
3.
go back to reference de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO: Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010, 364: 1147-1154.CrossRef de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, Gravis G, Bodrogi I, Mackenzie MJ, Shen L, Roessner M, Gupta S, Sartor AO: Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010, 364: 1147-1154.CrossRef
4.
go back to reference de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, et al: Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011, 364: 1995-2005. 10.1056/NEJMoa1014618.CrossRefPubMedPubMedCentral de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, et al: Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011, 364: 1995-2005. 10.1056/NEJMoa1014618.CrossRefPubMedPubMedCentral
5.
go back to reference Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS: Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012, 367: 1187-1197. 10.1056/NEJMoa1207506.CrossRefPubMed Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS: Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012, 367: 1187-1197. 10.1056/NEJMoa1207506.CrossRefPubMed
6.
go back to reference Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF, Impact Study Investigators : Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010, 363: 411-422. 10.1056/NEJMoa1001294.CrossRefPubMed Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF, Impact Study Investigators : Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010, 363: 411-422. 10.1056/NEJMoa1001294.CrossRefPubMed
7.
go back to reference Smaletz O, Scher HI, Small EJ, Verbel DA, McMillan A, Regan K, Kelly WK, Kattan MW: Nomogram for overall survival of patients with progressive metastatic prostate cancer after castration. J Clin Oncol. 2002, 20: 3972-3982. 10.1200/JCO.2002.11.021.CrossRefPubMed Smaletz O, Scher HI, Small EJ, Verbel DA, McMillan A, Regan K, Kelly WK, Kattan MW: Nomogram for overall survival of patients with progressive metastatic prostate cancer after castration. J Clin Oncol. 2002, 20: 3972-3982. 10.1200/JCO.2002.11.021.CrossRefPubMed
8.
go back to reference Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ: Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003, 21: 1232-1237. 10.1200/JCO.2003.06.100.CrossRefPubMed Halabi S, Small EJ, Kantoff PW, Kattan MW, Kaplan EB, Dawson NA, Levine EG, Blumenstein BA, Vogelzang NJ: Prognostic model for predicting survival in men with hormone-refractory metastatic prostate cancer. J Clin Oncol. 2003, 21: 1232-1237. 10.1200/JCO.2003.06.100.CrossRefPubMed
9.
go back to reference Armstrong AJ, Garrett-Mayer ES, Yang YCO, de Wit R, Tannock IF, Eisenberger M: A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: a TAX327 study analysis. Clin Cancer Res. 2007, 13: 6396-6403. 10.1158/1078-0432.CCR-07-1036.CrossRefPubMed Armstrong AJ, Garrett-Mayer ES, Yang YCO, de Wit R, Tannock IF, Eisenberger M: A contemporary prognostic nomogram for men with hormone-refractory metastatic prostate cancer: a TAX327 study analysis. Clin Cancer Res. 2007, 13: 6396-6403. 10.1158/1078-0432.CCR-07-1036.CrossRefPubMed
10.
go back to reference Armstrong AJ, Tannock IF, de Wit R, George DJ, Eisenberger M, Halabi S: The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival. Eur J Cancer. 2010, 46: 517-525. 10.1016/j.ejca.2009.11.007.CrossRefPubMed Armstrong AJ, Tannock IF, de Wit R, George DJ, Eisenberger M, Halabi S: The development of risk groups in men with metastatic castration-resistant prostate cancer based on risk factors for PSA decline and survival. Eur J Cancer. 2010, 46: 517-525. 10.1016/j.ejca.2009.11.007.CrossRefPubMed
11.
go back to reference Minato A, Fujimoto N, Kubo T, Harada S, Akasaka S, Matsumoto T: Efficacy of estramustine phosphate according to risk classification of castration-resistant prostate cancer. Med Oncol. 2012, 29: 2895-2900. 10.1007/s12032-012-0178-z.CrossRefPubMed Minato A, Fujimoto N, Kubo T, Harada S, Akasaka S, Matsumoto T: Efficacy of estramustine phosphate according to risk classification of castration-resistant prostate cancer. Med Oncol. 2012, 29: 2895-2900. 10.1007/s12032-012-0178-z.CrossRefPubMed
12.
go back to reference Yu JB, Makarov DV, Sharma R, Peschel RE, Partin AW, Gross CP: Validation of the partin nomogram for prostate cancer in a national sample. J Urol. 2010, 183: 105-111. 10.1016/j.juro.2009.08.143.CrossRefPubMed Yu JB, Makarov DV, Sharma R, Peschel RE, Partin AW, Gross CP: Validation of the partin nomogram for prostate cancer in a national sample. J Urol. 2010, 183: 105-111. 10.1016/j.juro.2009.08.143.CrossRefPubMed
13.
go back to reference Bhojani N, Ahyai S, Graefen M, Capitanio U, Suardi N, Shariat SF, Jeldres C, Erbersdobler A, Schlomm T, Haese A, Steuber T, Heinzer H, Montorsi F, Huland H, Karakiewicz PI: Partin Tables cannot accurately predict the pathological stage at radical prostatectomy. Eur J Surg Oncol. 2009, 35: 123-128. 10.1016/j.ejso.2008.07.013.CrossRefPubMed Bhojani N, Ahyai S, Graefen M, Capitanio U, Suardi N, Shariat SF, Jeldres C, Erbersdobler A, Schlomm T, Haese A, Steuber T, Heinzer H, Montorsi F, Huland H, Karakiewicz PI: Partin Tables cannot accurately predict the pathological stage at radical prostatectomy. Eur J Surg Oncol. 2009, 35: 123-128. 10.1016/j.ejso.2008.07.013.CrossRefPubMed
14.
go back to reference Naito S, Kuroiwa K, Kinukawa N, Goto K, Koga H, Ogawa O, Murai M, Shiraishi T: Validation of partin tables and development of a preoperative nomogram for Japanese patients with clinically localized prostate cancer using 2005 international society of urological pathology consensus on gleason grading: data from the clinicopathological research group for localized prostate cancer. J Urol. 2008, 180: 904-909. 10.1016/j.juro.2008.05.047.CrossRefPubMed Naito S, Kuroiwa K, Kinukawa N, Goto K, Koga H, Ogawa O, Murai M, Shiraishi T: Validation of partin tables and development of a preoperative nomogram for Japanese patients with clinically localized prostate cancer using 2005 international society of urological pathology consensus on gleason grading: data from the clinicopathological research group for localized prostate cancer. J Urol. 2008, 180: 904-909. 10.1016/j.juro.2008.05.047.CrossRefPubMed
15.
go back to reference Kawahara T, Miyoshi Y, Sekiguchi Z, Sano F, Hayashi N, Teranishi J, Misaki H, Noguchi K, Kubota Y, Uemura H: Risk factors for metastatic castration-resistant prostate cancer (CRPC) predict long-term treatment with docetaxel. PLoS One. 2012, 7: e48186-10.1371/journal.pone.0048186.CrossRefPubMedPubMedCentral Kawahara T, Miyoshi Y, Sekiguchi Z, Sano F, Hayashi N, Teranishi J, Misaki H, Noguchi K, Kubota Y, Uemura H: Risk factors for metastatic castration-resistant prostate cancer (CRPC) predict long-term treatment with docetaxel. PLoS One. 2012, 7: e48186-10.1371/journal.pone.0048186.CrossRefPubMedPubMedCentral
16.
go back to reference Pond GR, Armstrong AJ, Wood BA, Leopold L, Galsky MD, Sonpavde G: Ability of C-reactive protein to complement multiple prognostic classifiers in men with metastatic castration resistant prostate cancer receiving docetaxel-based chemotherapy. BJU Int. 2012, 110: E461-468. 10.1111/j.1464-410X.2012.11148.x.CrossRefPubMed Pond GR, Armstrong AJ, Wood BA, Leopold L, Galsky MD, Sonpavde G: Ability of C-reactive protein to complement multiple prognostic classifiers in men with metastatic castration resistant prostate cancer receiving docetaxel-based chemotherapy. BJU Int. 2012, 110: E461-468. 10.1111/j.1464-410X.2012.11148.x.CrossRefPubMed
17.
go back to reference Nakano K, Ohta S, Komatsu K, Kubo T, Nukui A, Suzuki K, Kurokawa S, Kobayashi M, Morita T: Docetaxel with or without estramustine for estramustine refractory castration-resistant prostate cancer: a single institution experience. BMC Urol. 2012, 12: 3-10.1186/1471-2490-12-3.CrossRefPubMedPubMedCentral Nakano K, Ohta S, Komatsu K, Kubo T, Nukui A, Suzuki K, Kurokawa S, Kobayashi M, Morita T: Docetaxel with or without estramustine for estramustine refractory castration-resistant prostate cancer: a single institution experience. BMC Urol. 2012, 12: 3-10.1186/1471-2490-12-3.CrossRefPubMedPubMedCentral
18.
go back to reference Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M: Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the prostate cancer clinical trials working group. J Clin Oncol. 2008, 26: 1148-1159. 10.1200/JCO.2007.12.4487.CrossRefPubMedPubMedCentral Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M: Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the prostate cancer clinical trials working group. J Clin Oncol. 2008, 26: 1148-1159. 10.1200/JCO.2007.12.4487.CrossRefPubMedPubMedCentral
19.
go back to reference Armstrong AJ, Garrett-Mayer E, de Wit R, Tannock I, Eisenberger M: Prediction of survival following first-line chemotherapy in men with castration-resistant metastatic prostate cancer. Clin Cancer Res. 2010, 16: 203-211. 10.1158/1078-0432.CCR-09-2514.CrossRefPubMed Armstrong AJ, Garrett-Mayer E, de Wit R, Tannock I, Eisenberger M: Prediction of survival following first-line chemotherapy in men with castration-resistant metastatic prostate cancer. Clin Cancer Res. 2010, 16: 203-211. 10.1158/1078-0432.CCR-09-2514.CrossRefPubMed
20.
go back to reference Oudard S, Banu E, Medioni J, Scotte F, Banu A, Levy E, Wasserman J, Kacso G, Andrieu JM: What is the real impact of bone pain on survival in patients with metastatic hormone-refractory prostate cancer treated with docetaxel?. BJU Int. 2009, 103: 1641-1646. 10.1111/j.1464-410X.2008.08283.x.CrossRefPubMed Oudard S, Banu E, Medioni J, Scotte F, Banu A, Levy E, Wasserman J, Kacso G, Andrieu JM: What is the real impact of bone pain on survival in patients with metastatic hormone-refractory prostate cancer treated with docetaxel?. BJU Int. 2009, 103: 1641-1646. 10.1111/j.1464-410X.2008.08283.x.CrossRefPubMed
21.
go back to reference Bamias A, Bozas G, Antoniou N, Poulias I, Katsifotis H, Skolarikos A, Mitropoulos D, Alamanis C, Alivizatos G, Deliveliotis H, Dimopoulos MA: Prognostic and predictive factors in patients with androgen-independent prostate cancer treated with docetaxel and estramustine: a single institution experience. Eur Urol. 2008, 53: 323-332. 10.1016/j.eururo.2007.03.072.CrossRefPubMed Bamias A, Bozas G, Antoniou N, Poulias I, Katsifotis H, Skolarikos A, Mitropoulos D, Alamanis C, Alivizatos G, Deliveliotis H, Dimopoulos MA: Prognostic and predictive factors in patients with androgen-independent prostate cancer treated with docetaxel and estramustine: a single institution experience. Eur Urol. 2008, 53: 323-332. 10.1016/j.eururo.2007.03.072.CrossRefPubMed
Metadata
Title
External validation of risk classification in patients with docetaxel-treated castration-resistant prostate cancer
Authors
Kazuhiko Nakano
Kenji Komatsu
Taro Kubo
Shinsuke Natsui
Akinori Nukui
Shinsuke Kurokawa
Minoru Kobayashi
Tatsuo Morita
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2014
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/1471-2490-14-31

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