Health-related quality of life in patients with metastatic hormone-sensitive prostate cancer treated with androgen receptor signaling inhibitors: the role of combination treatment therapy.


Journal

Prostate cancer and prostatic diseases
ISSN: 1476-5608
Titre abrégé: Prostate Cancer Prostatic Dis
Pays: England
ID NLM: 9815755

Informations de publication

Date de publication:
13 Apr 2023
Historique:
received: 13 11 2022
accepted: 04 04 2023
revised: 26 03 2023
entrez: 13 4 2023
pubmed: 14 4 2023
medline: 14 4 2023
Statut: aheadofprint

Résumé

While the addition of androgen receptor signaling inhibitors (ARSIs) to androgen deprivation therapy (ADT) results in better of overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC), information regarding health related quality of life (HR-QoL) is sparse. We aimed at summarizing current evidence on the impact of ARSIs on HR-QoL. We performed a systematic review of the published literature on PubMed/EMBASE, Web of Science, SCOPUS, and the Cochrane libraries between January 2011 and April 2022. We included only phase III randomized controlled trials (RCT), which were selected according to the PRISMA guidelines. We aimed at evaluating differences in HR-QoL, assessed by validated patient reported outcomes instruments. We analyzed global scores and sub-domains such as sexual functioning, urinary symptoms, bowel symptoms, pain/fatigue, emotional and social/family wellbeing. We reported data descriptively. Six RCTs were included: two used enzalutamide with ADT as intervention arms (ARCHES, ENZAMET); one used apalutamide with ADT (TITAN); two abiraterone acetate and prednisone (AAP) with ADT (STAMPEDE, LATITUDE); and one darolutamide with ADT (ARASENS). Enzalutamide or AAP with ADT increase overall HR-QoL in comparison with ADT alone, ADT with first generation nonsteroideal anti-androgens or ADT with docetaxel, whereas apalutamide and darolutamide with ADT maintain HR-QoL similarly to ADT alone or ADT with docetaxel, respectively. Time to first deterioration of pain was longer with combination therapy with enzalutamide, AAP or darolutamide, but not with apalutamide. No worsening of emotional wellbeing was reported from the addition of ARSIs to ADT than ADT alone. The addition of ARSIs to ADT in mHSPC tends to increase overall HR-QoL and prolong time to first deterioration of pain/fatigue compared with ADT alone, ADT with first generation nonsteroideal anti-androgens, and ADT with docetaxel. ARSIs show a complex interaction with remaining HR-QoL domains. We advocate a standardization of HR-QoL measurement and reporting to allow further comparisons.

Sections du résumé

BACKGROUND BACKGROUND
While the addition of androgen receptor signaling inhibitors (ARSIs) to androgen deprivation therapy (ADT) results in better of overall survival in patients with metastatic hormone-sensitive prostate cancer (mHSPC), information regarding health related quality of life (HR-QoL) is sparse. We aimed at summarizing current evidence on the impact of ARSIs on HR-QoL.
METHODS METHODS
We performed a systematic review of the published literature on PubMed/EMBASE, Web of Science, SCOPUS, and the Cochrane libraries between January 2011 and April 2022. We included only phase III randomized controlled trials (RCT), which were selected according to the PRISMA guidelines. We aimed at evaluating differences in HR-QoL, assessed by validated patient reported outcomes instruments. We analyzed global scores and sub-domains such as sexual functioning, urinary symptoms, bowel symptoms, pain/fatigue, emotional and social/family wellbeing. We reported data descriptively.
RESULTS RESULTS
Six RCTs were included: two used enzalutamide with ADT as intervention arms (ARCHES, ENZAMET); one used apalutamide with ADT (TITAN); two abiraterone acetate and prednisone (AAP) with ADT (STAMPEDE, LATITUDE); and one darolutamide with ADT (ARASENS). Enzalutamide or AAP with ADT increase overall HR-QoL in comparison with ADT alone, ADT with first generation nonsteroideal anti-androgens or ADT with docetaxel, whereas apalutamide and darolutamide with ADT maintain HR-QoL similarly to ADT alone or ADT with docetaxel, respectively. Time to first deterioration of pain was longer with combination therapy with enzalutamide, AAP or darolutamide, but not with apalutamide. No worsening of emotional wellbeing was reported from the addition of ARSIs to ADT than ADT alone.
CONCLUSIONS CONCLUSIONS
The addition of ARSIs to ADT in mHSPC tends to increase overall HR-QoL and prolong time to first deterioration of pain/fatigue compared with ADT alone, ADT with first generation nonsteroideal anti-androgens, and ADT with docetaxel. ARSIs show a complex interaction with remaining HR-QoL domains. We advocate a standardization of HR-QoL measurement and reporting to allow further comparisons.

Identifiants

pubmed: 37055663
doi: 10.1038/s41391-023-00668-0
pii: 10.1038/s41391-023-00668-0
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2023. The Author(s), under exclusive licence to Springer Nature Limited.

Références

Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate cancer incidence and survival, by stage and race/ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020;69:1473–80.
doi: 10.15585/mmwr.mm6941a1 pubmed: 33056955 pmcid: 7561091
Desai MM, Cacciamani GE, Gill K, Zhang J, Liu L, Abreu A, et al. Trends in incidence of metastatic prostate cancer in the US. JAMA Netw Open. 2022;5:e222246.
doi: 10.1001/jamanetworkopen.2022.2246 pubmed: 35285916 pmcid: 9907338
Kinsey EN, Zhang T, Armstrong AJ. Metastatic hormone-sensitive prostate cancer: a review of the current treatment landscape. Cancer J. 2020;26:64–75.
doi: 10.1097/PPO.0000000000000418 pubmed: 31977388
Ng K, Smith S, Shamash J. Metastatic hormone-sensitive prostate cancer (mHSPC): advances and treatment strategies in the first-line setting. Oncol Ther. 2020;8:209–30.
doi: 10.1007/s40487-020-00119-z pubmed: 32700045 pmcid: 7683690
Tagawa ST, Ramaswamy K, Huang A, Mardekian J, Schultz NM, Wang L, et al. Survival outcomes in patients with chemotherapy-naive metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate. Prostate Cancer Prostatic Dis. 2021;24:1032–40.
doi: 10.1038/s41391-021-00318-3 pubmed: 33612825 pmcid: 8616757
Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2019;37:2974–86.
doi: 10.1200/JCO.19.00799 pubmed: 31329516 pmcid: 6839905
Sydes MR, Spears MR, Mason MD, Clarke NW, Dearnaley DP, de Bono JS, et al. Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol. Ann Oncol. 2018;29:1235–48.
doi: 10.1093/annonc/mdy072 pubmed: 29529169 pmcid: 5961425
Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, et al. Apalutamide for metastatic, castration-sensitive prostate cancer. N Engl J Med. 2019;381:13–24.
doi: 10.1056/NEJMoa1903307 pubmed: 31150574
Davis ID, Martin AJ, Stockler MR, Begbie S, Chi KN, Chowdhury S, et al. Enzalutamide with standard first-line therapy in metastatic prostate cancer. N Engl J Med. 2019;381:121–31.
doi: 10.1056/NEJMoa1903835 pubmed: 31157964
Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N Engl J Med. 2022;386:1132–42.
doi: 10.1056/NEJMoa2119115 pubmed: 35179323 pmcid: 9844551
Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019;20:686–700.
doi: 10.1016/S1470-2045(19)30082-8 pubmed: 30987939
Cornford P, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, et al. EAU-EANM-ESTRO-ESUR-SIOG guidelines on prostate cancer. part ii-2020 update: treatment of relapsing and metastatic prostate cancer. Eur Urol. 2021;79:263–82.
doi: 10.1016/j.eururo.2020.09.046 pubmed: 33039206
Saad F, Bögemann M, Suzuki K, Shore N. Treatment of nonmetastatic castration-resistant prostate cancer: focus on second-generation androgen receptor inhibitors. Prostate Cancer Prostatic Dis. 2021;24:323–34.
doi: 10.1038/s41391-020-00310-3 pubmed: 33558665 pmcid: 8134049
Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ. 2015;350:g7647.
doi: 10.1136/bmj.g7647 pubmed: 25555855
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, 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.
doi: 10.1093/jnci/85.5.365 pubmed: 8433390
van Andel G, Bottomley A, Fosså SD, Efficace F, Coens C, Guerif S, et al. An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer. Eur J Cancer. 2008;44:2418–24.
doi: 10.1016/j.ejca.2008.07.030 pubmed: 18774706
Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. 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 pubmed: 9426724
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.
doi: 10.1007/s11136-011-9903-x pubmed: 21479777 pmcid: 3220807
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994;23:129–38.
pubmed: 8080219
Mendoza TR, Wang XS, Cleeland CS, Morrissey M, Johnson BA, Wendt JK, et al. The rapid assessment of fatigue severity in cancer patients: use of the Brief Fatigue Inventory. Cancer. 1999;85:1186–96.
doi: 10.1002/(SICI)1097-0142(19990301)85:5<1186::AID-CNCR24>3.0.CO;2-N pubmed: 10091805
Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, et al. Effect of enzalutamide plus androgen deprivation therapy on health-related quality of life in patients with metastatic hormone-sensitive prostate cancer: an analysis of the ARCHES randomised, placebo-controlled, phase 3 study. Eur Urol. 2020;78:603–14.
doi: 10.1016/j.eururo.2020.03.019 pubmed: 32336645
Stockler MR, Martin AJ, Davis ID, Dhillon HM, Begbie SD, Chi KN, et al. Health-related quality of life in metastatic, hormone-sensitive prostate cancer: ENZAMET (ANZUP 1304), an international, randomized phase III trial led by ANZUP. J Clin Oncol. 2022;40:837–46.
doi: 10.1200/JCO.21.00941 pubmed: 34928708
Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, et al. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019;20:1518–30.
doi: 10.1016/S1470-2045(19)30620-5 pubmed: 31578173
Chi KN, Protheroe A, Rodríguez-Antolín A, Facchini G, Suttman H, Matsubara N, et al. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018;19:194–206.
doi: 10.1016/S1470-2045(17)30911-7 pubmed: 29326030
Rush HL, Murphy L, Morgans AK, Clarke NW, Cook AD, Attard G, et al. Quality of life in men with prostate cancer randomly allocated to receive docetaxel or abiraterone in the STAMPEDE trial. J Clin Oncol. 2022;40:825–36.
doi: 10.1200/JCO.21.00728 pubmed: 34757812
Gupta D, Braun DP, Staren ED. Prognostic value of changes in quality of life scores in prostate cancer. BMC Urol. 2013;13:32.
doi: 10.1186/1471-2490-13-32 pubmed: 23837903 pmcid: 3708783
Koo KC, Park SU, Kim KH, Rha KH, Hong SJ, Yang SC, et al. Predictors of survival in prostate cancer patients with bone metastasis and extremely high prostate-specific antigen levels. Prostate Int. 2015;3:10–5.
doi: 10.1016/j.prnil.2015.02.006 pubmed: 26157761 pmcid: 4494633

Auteurs

Luca Afferi (L)

Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland. luca.afferi@gmail.com.

Mattia Longoni (M)

Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy.

Marco Moschini (M)

Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland.
Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy.

Giorgio Gandaglia (G)

Department of Urology, Urological Research Institute, Vita-Salute University, San Raffaele Scientific Institute, Milan, Italy.

Alicia K Morgans (AK)

Dana-Farber Cancer Institute, Boston, MA, USA.

Richard Cathomas (R)

Department of Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.

Agostino Mattei (A)

Department of Urology, Luzerner Kantonsspital, Lucerne, Switzerland.

Alberto Breda (A)

Department of Urology, Fundacio Puigvert, Calle Cartagena 340/350, 08025, Barcelona, Spain.

Roberto Mario Scarpa (RM)

Department of Urology, Campus Biomedico University of Rome, Rome, Italy.

Rocco Papalia (R)

Department of Urology, Campus Biomedico University of Rome, Rome, Italy.

Cosimo de Nunzio (C)

Department of Urology, Sant'Andrea Hospital, Sapienza University, Rome, Italy.

Francesco Esperto (F)

Department of Urology, Campus Biomedico University of Rome, Rome, Italy.

Classifications MeSH