Adjuvant hormone therapy after radical prostatectomy in high-risk localized and locally advanced prostate cancer: First multicenter, observational study in China

Dingwei Ye, Wei Zhang, Lulin Ma, Chuanjun Du, Liping Xie, Yiran Huang, Qiang Wei, Zhangqun Ye, Yanqun Na, Dingwei Ye, Wei Zhang, Lulin Ma, Chuanjun Du, Liping Xie, Yiran Huang, Qiang Wei, Zhangqun Ye, Yanqun Na

Abstract

Objective: Potential of combined androgen blockade (CAB) has not been explored extensively in Chinese males with prostate cancer (PCa). Therefore, this study evaluated the 2-year prostate-specific antigen (PSA) recurrence rate and quality of life (QoL) in patients with high-risk localized and locally advanced PCa receiving adjuvant hormone therapy (HT) after radical prostatectomy (RP).

Methods: This prospective, multicenter, observational study conducted in 18 centers across China enrolled patients with high-risk factor (preoperative PSA>20 ng/mL or Gleason score >7) or locally advanced PCa. Different adjuvant HT were administered after RP according to investigator's decision in routine clinical practice. Relationship of baseline and postoperative characteristics was assessed with recurrence rate. PSA recurrence rate and Functional Assessment of Cancer Therapy-Prostate (FACT-P) QoL scores were recorded at 12 months and 24 months. Kaplan-Meier analysis was used to construct the PSA recurrence rate during follow-up.

Results: A total of 189 patients (mean age: 66.9±6.5 years) were recruited, among which 112 (59.3%) patients showed serum PSA>20 ng/mL preoperatively. The highest postoperative pathological advancement noticed was from clinical T2 (cT2) to pathological T3 (pT3) (43.9%) stage. The majority of the patients (66.1%) received CAB as adjuvant HT, for a median duration of 20.0 months. The least recurrence (15.2%) was noticed in patients treated with CAB, followed by those treated with luteinizing hormone-releasing hormone agonist (LHRHa) (16.1%), and antiandrogen (19.0%), with non-significant difference noted among the groups. None of the baseline or postoperative characteristics was related with PSA recurrence in our study. The 24-month FACT-P QoL score of 119 patients treated for >12 months showed significant improvement above baseline compared with those treated for ≤12 months.

Conclusions: Adjuvant CAB therapy after RP showed reduction trend in 2-year PSA recurrence rate in high-risk Chinese patients with localized and locally advanced PCa, compared with adjuvant anti-androgens (AA) or LHRHa therapy. Further long-term therapy (>12 months) significantly improved QoL compared to short-term HT therapy, suggesting the beneficial effect of long-term CAB therapy in improving QoL.

Keywords: Adjuvant hormone therapy; PSA recurrence; combined androgen blockade; quality of life; radical prostatectomy.

Figures

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Two-year prostate-specific antigen (PSA) recurrence rate for prostate cancer cohort. 95% CI, 95% confidence interval.

References

    1. Torre LA, Bray F, Siegel RL, et al Global cancer statistics, 2012. CA Cancer J Clin. 2015;65:87–108. doi: 10.3322/caac.21262.
    1. Siegel RL, Miller KD, Jemal A Cancer Statistics, 2017. CA Cancer J Clin. 2017;67:7–30. doi: 10.3322/caac.21387.
    1. Chen W, Zheng R, Baade PD, et al Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66:115–32. doi: 10.3322/caac.21338.
    1. Center MM, Jemal A, Lortet-Tieulent J, et al International variation in prostate cancer incidence and mortality rates. Eur Urol. 2012;61:1079–92. doi: 10.1016/j.eururo.2012.02.054.
    1. Kimura T East meets West: ethnic differences in prostate cancer epidemiology between East Asians and Caucasians. Chin J Cancer. 2012;31:421–9. doi: 10.5732/cjc.011.10324.
    1. Kheirandish P, Chinegwundoh F Ethnic differences in prostate cancer. Br J Cancer. 2011;105:481–5. doi: 10.1038/bjc.2011.273.
    1. Zeigler-Johnson CM, Spangler E, Jalloh M, et al Genetic susceptibility to prostate cancer in men of African descent: implications for global disparities in incidence and outcomes. Can J Urol. 2008;15:3872–82.
    1. Mottet N, Bellmunt J, Bolla M, et al EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2017;71:618–29. doi: 10.1016/j.eururo.2016.08.003.
    1. Tefekli A, Tunc M Future prospects in the diagnosis and management of localized prostate cancer. Scientific World Journal. 2013;2013:347263. doi: 10.1155/2013/347263.
    1. Pound CR, Partin AW, Eisenberger MA, et al Natural history of progression after PSA elevation following radical prostatectomy. JAMA. 1999;281:1591–7. doi: 10.1001/jama.281.17.1591.
    1. Cornford P, Bellmunt J, Bolla M, et al EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer. Eur Urol. 2017;71:630–42. doi: 10.1016/j.eururo.2016.08.002.
    1. Gomella LG, Singh J, Lallas C, et al Hormone therapy in the management of prostate cancer: evidence-based approaches. Ther Adv Urol. 2010;2:171–81. doi: 10.1177/1756287210375270.
    1. Chen XQ, Huang Y, Li X, et al Efficacy of maximal androgen blockade versus castration alone in the treatment of advanced prostate cancer: a retrospective clinical experience from a Chinese medical centre. Asian J Androl. 2010;12:718–27. doi: 10.1038/aja.2010.42.
    1. Fukagai T, Namiki TS, Carlile RG, et al Comparison of the clinical outcome after hormonal therapy for prostate cancer between Japanese and Caucasian men. BJU Int. 2006;97:1190–3. doi: 10.1111/j.1464-410X.2006.06201.x.
    1. Chang K, Qin XJ, Zhang HL, et al Comparison of two adjuvant hormone therapy regimens in patients with high-risk localized prostate cancer after radical prostatectomy: primary results of study CU1005. Asian J Androl. 2016;18:452–5. doi: 10.4103/1008-682X.160884.
    1. Na Y, Ye Z, Sun G, et al. Guidelines for the diagnosis and treatment of urological diseases in China. 2014. Beijing: People’s Medical Publishing House, 2013.

    1. Franca CA, Vieira SL, Carvalho AC, et al Relationship between two year PSA nadir and biochemical recurrence in prostate cancer patients treated with iodine-125 brachytherap. Radiol Bras. 2014;47:89–93. doi: 10.1590/S0100-39842014000200010.
    1. Zelefsky MJ, Shi W, Yamada Y, et al Postradiotherapy 2-year prostate-specific antigen nadir as a predictor of long-term prostate cancer mortality. Int J Radiat Oncol Biol Phys. 2009;75:1350–6. doi: 10.1016/j.ijrobp.2008.12.067.
    1. Mir MC, Li J, Klink JC, et al Optimal definition of biochemical recurrence after radical prostatectomy depends on pathologic risk factors: identifying candidates for early salvage therapy. Eur Urol. 2014;66:204–10. doi: 10.1016/j.eururo.2013.08.022.
    1. Stephenson AJ, Kattan MW, Eastham JA, et al Defining biochemical recurrence of prostate cancer after radical prostatectomy: a proposal for a standardized definition. J Clin Oncol. 2006;24:3973–8. doi: 10.1200/JCO.2005.04.0756.
    1. Kumar S, Shelley M, Harrison C, et al Neo-adjuvant and adjuvant hormone therapy for localised and locally advanced prostate cancer. Cochrane Database Syst Rev. 2006:CD006019. doi: 10.1002/14651858.CD006019.pub2.
    1. Lennernäs B, Edgren M, Häggman M, et al Postoperative radiotherapy after prostatectomy — a review. Scand J Urol Nephrol. 2003;37:10–5. doi: 10.1080/00365590310008613.
    1. Han M, Partin AW, Pound CR, et al Long-term biochemical disease-free and cancer-specific survival following anatomic radical retropubic prostatectomy. The 15-year Johns Hopkins experience. Urol Clin North Am. 2001;28:555–65. doi: 10.1016/S0094-0143(05)70163-4.
    1. Tsurumaki Sato Y, Fukuhara H, Suzuki M, et al Long-term results of radical prostatectomy with immediate adjuvant androgen deprivation therapy for pT3N0 prostate cancer. BMC Urol. 2014;14:13. doi: 10.1186/1471-2490-14-13.
    1. Inagaki T, Kohjimoto Y, Nishizawa S, et al PSA at postoperative three months can predict biochemical recurrence in patients with pathological T3 prostate cancer following radical prostatectomy. Int J Urol Off J Jpn Urol Assoc. 2009;16:941–6. doi: 10.1111/j.1442-2042.2009.02401.x.
    1. Srougi V, Sanchez-Salas R, Secin FP, et al The importance of surgical margins for biochemical recurrence in high-risk prostate cancer patients. J Clin Oncol. 2017;35:75–75. doi: 10.1200/JCO.2017.35.6_suppl.75.
    1. Freedland SJ, Humphreys EB, Mangold LA, et al Risk of prostate cancer-specific mortality following biochemical recurrence after radical prostatectomy. JAMA. 2005;294:433–9. doi: 10.1001/jama.294.4.433.
    1. Roberts SG, Blute ML, Bergstralh EJ, et al PSA doubling time as a predictor of clinical progression after biochemical failure following radical prostatectomy for prostate cancer. Mayo Clin Proc. 2001:576–81. doi: 10.4065/76.6.576.
    1. Bonkhoff H Factors implicated in radiation therapy failure and radiosensitization of prostate cancer. Prostate Cancer. 2012:593241. doi: 10.1155/2012/593241.
    1. Jalloh M, Leapman MS, Cowan JE, et al Patterns of local failure following radiation therapy for prostate cancer. J Urol. 2015;194:977–82. doi: 10.1016/j.juro.2015.04.111.
    1. Bubendorf L, Kolmer M, Kononen J, et al Hormone therapy failure in human prostate cancer: analysis by complementary DNA and tissue microarrays. J Natl Cancer Inst. 1999;91:1758–64. doi: 10.1093/jnci/91.20.1758.
    1. Mousses S, Wagner U, Chen Y, et al Failure of hormone therapy in prostate cancer involves systematic restoration of androgen responsive genes and activation of rapamycin sensitive signaling. Oncogene. 2001;20:6718–23. doi: 10.1038/sj.onc.1204889.
    1. Dalela D, Santiago-Jiménez M, Yousefi K, et al Genomic classifier augments the role of pathological features in identifying optimal candidates for adjuvant radiation therapy in patients with prostate cancer: development and internal validation of a multivariable prognostic model. J Clin Oncol. 2017;35:1982–90. doi: 10.1200/JCO.2016.69.9918.
    1. Suardi N, Gallina A, Lista G, et al Impact of adjuvant radiation therapy on urinary continence recovery after radical prostatectomy. Eur Urol. 2014;65:546–51. doi: 10.1016/j.eururo.2013.01.027.
    1. Sowerby RJ, Gani J, Yim H, et al Long-term complications in men who have early or late radiotherapy after radical prostatectomy. Can Urol Assoc J. 2014;8:253–8. doi: 10.5489/cuaj.1764.
    1. Cooperberg MR, Hinotsu S, Namiki M, et al Trans-Pacific variation in outcomes for men treated with primary androgen-deprivation therapy (ADT) for prostate cancer. BJU Int. 2016;117:102–9. doi: 10.1111/bju.12937.
    1. Dorff TB, Flaig TW, Tangen CM, et al Adjuvant androgen deprivation for high-risk prostate cancer after radical prostatectomy: SWOG S9921 study. J Clin Oncol. 2011;29:2040–5. doi: 10.1200/JCO.2010.32.2776.
    1. Spahn M, Briganti A, Capitanio U, et al Outcome predictors of radical prostatectomy followed by adjuvant androgen deprivation in patients with clinical high risk prostate cancer and pT3 surgical margin positive disease. J Urol. 2012;188:84–90. doi: 10.1016/j.juro.2012.02.2572.
    1. Mirhadi AJ, Zhang Q, Hanks GE, et al Effect of long-term hormonal therapy (vs short-term hormonal therapy): A secondary analysis of intermediate-risk prostate cancer patients treated on NRG Oncology RTOG 9202. Int J Radiat Oncol Biol Phys. 2017;97:511–5. doi: 10.1016/j.ijrobp.2016.11.002.
    1. Okubo M, Nakayama H, Itonaga T, et al Impact of the duration of hormonal therapy following radiotherapy for localized prostate cancer. Oncol Lett. 2015;10:255–9. doi: 10.3892/ol.2015.3216.
    1. Green HJ, Pakenham KI, Headley BC, et al Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring. Psychooncology. 2002;11:401–14. doi: 10.1002/pon.599.
    1. Esper P, Mo F, Chodak G, et al Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997;50:920–8. doi: 10.1016/S0090-4295(97)00459-7.
    1. Wong CK, Choi EP, Tsu JH, et al Psychometric properties of functional assessment of cancer therapy-prostate (FACT-P) in Chinese patients with prostate cancer. Qual Life Res. 2015;24:2397–402. doi: 10.1007/s11136-015-0993-8.
    1. Lebret T, Davin JL, Hennequin C, et al Selection criteria for initiation and renewal of luteinizing hormone-releasing hormone agonist therapy in patients with prostate cancer: a French prospective observational study. Ther Adv Urol. 2014;6:205–14. doi: 10.1177/1756287214542418.
    1. Gandaglia G, Fossati N, Karnes RJ, et al Use of concomitant androgen deprivation therapy in patients treated with early salvage radiotherapy for biochemical recurrence after radical prostatectomy: Long-term results from a large, multi-institutional series. Eur Urol. 2018;73:512–8. doi: 10.1016/j.eururo.2017.11.020.
    1. Wirth MP, Weissbach L, Marx FJ, et al Prospective randomized trial comparing flutamide as adjuvant treatment versus observation after radical prostatectomy for locally advanced, lymph node-negative prostate cancer. Eur Urol. 2004;45:267–70. doi: 10.1016/j.eururo.2003.10.013.
    1. Messing EM, Manola J, Sarosdy M, et al Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node-positive prostate cancer. N Engl J Med. 1999;341:1781–8. doi: 10.1056/NEJM199912093412401.
    1. Wu AK, Cooperberg MR, Sadetsky N, et al Health related quality of life in patients treated with multimodal therapy for prostate cancer. J Urol. 2008;180:2415–22. doi: 10.1016/j.juro.2008.08.015.

Source: PubMed

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