Real-world treatment of metastatic hormone-sensitive prostate cancer in the USA, Europe and Asia

References

• Sung H , FerlayJ , SiegelRLet al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin.71(3), 209–249 (2021).
   PubMed Web of Science ®Google Scholar
• Rawla P . Epidemiology of prostate cancer. World J. Oncol.10(2), 63–89 (2019).
   PubMedGoogle Scholar
• Cattrini C , CastroE , LozanoRet al. Current treatment options for metastatic hormone-sensitive prostate cancer. Cancers11(9), 1355 (2019).
   PubMed Web of Science ®Google Scholar
• Fizazi K , TranN , FeinLet 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.20(5), 686–700 (2019).
   PubMed Web of Science ®Google Scholar
• Gravis G , BoherJM , JolyFet al. Androgen deprivation therapy (ADT) plus docetaxel versus ADT alone in metastatic non castrate prostate cancer: impact of metastatic burden and long-term survival analysis of the randomized phase 3 GETUG-AFU15 trial. Eur. Urol.70(2), 256–262 (2016).
   PubMed Web of Science ®Google Scholar
• Gravis G , FizaziK , JolyFet al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol.14(2), 149–158 (2013).
   PubMed Web of Science ®Google Scholar
• James ND , DeBono JS , SpearsMRet al. Abiraterone for prostate cancer not previously treated with hormone therapy. N. Engl. J. Med.377(4), 338–351 (2017).
   PubMed Web of Science ®Google Scholar
• James ND , SydesMR , ClarkeNWet al. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet387(10024), 1163–1177 (2016).
   PubMed Web of Science ®Google Scholar
• Kyriakopoulos CE , ChenYH , CarducciMAet al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED Trial. J. Clin. Oncol.36(11), 1080–1087 (2018).
   PubMed Web of Science ®Google Scholar
• Sartor O , DeBono JS. Metastatic prostate cancer. N. Engl. J. Med.378(7), 645–657 (2018).
   PubMed Web of Science ®Google Scholar
• Sweeney CJ , ChenYH , CarducciMet al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N. Engl. J. Med.373(8), 737–746 (2015).
   PubMed Web of Science ®Google Scholar
• Smith MR , HussainM , SaadFet al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N. Engl. J. Med.386(12), 1132–1142 (2022).
   PubMed Web of Science ®Google Scholar
• Fizazi K , FoulonS , CarlesJet al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2× 2 factorial design. Lancet399(10336), 1695–1707 (2022).
   PubMed Web of Science ®Google Scholar
• Ipsos . Therapy insights centres of expertise. www.ipsos.com/en/healthcare-therapy-insights-centres-expertise (Accessed January 2024).
   Google Scholar
• Ipsos . Ipsos real world evidence: a compendium of usage 2018–2021. www.ipsos.com/sites/default/files/2022-01/Ipsos-Syndicated-Real-World-Evidence-Compendium_October-2021.pdf (Accessed January 2024).
   Google Scholar
• NICE: National Institute for Health and Care Excellence . Single technology appraisal: pembrolizumab for previously treated advanced or metastatic urothelial cancer (CDF review TA519) [ID1536] - Committee papers. www.nice.org.uk/guidance/ta692/documents/committee-papers-2 (2020).
   Google Scholar
• Gemeinsamer Bundesausschuss . Dossier zur Nutzenbewertung gemäß § 35a SGB V: radium-223-dichlorid (Xofigo®); Bayer Vital GmbH, Modul 3A. www.g-ba.de/downloads/92-975-3055/2019-04-02_Modul3A_Radium-223-dichlorid.pdf (2019).
   Google Scholar
• CARE Hematology . CARE perspectives: ASCO/EHA 2018. https://careeducation.ca/wp-content/uploads/2019/03/ASCOEHAReportWeb2.pdf (2018).
   Google Scholar
• De Sa Moreira E , RobinsonD , HawthorneSet al. Patterns of care and outcomes for non-metastatic prostate cancer in the United States: results of the CancerMPact((R)) Survey 2018. Cancer Manag. Res.13, 9127–9137 (2021).
   PubMed Web of Science ®Google Scholar
• Shah R , BottemanM , WaldeckR. Treatment characteristics for nonmetastatic castration-resistant prostate cancer in the United States, Europe and Japan. Future Oncol.15(35), 4069–4081 (2019).
   PubMed Web of Science ®Google Scholar
• Goméz Rivas J , NicolettiR , GolozarAet al. 1796P Real-world analysis of metastatic hormone-sensitive prostate cancer: are randomized clinical trials more trustworthy? Insights from PIONEER, the European network of excellence for big data in prostate cancer. Ann. Oncol.34, S971 (2023).
   Google Scholar
• Mucci LA , VinsonJ , GerkeTAet al. First look at the baseline characteristics of participants in IRONMAN, the international registry for men with advanced prostate cancer. J. Clin. Oncol.41(Suppl. 6), 85 (2023).
   Google Scholar
• Mitzman B , VargheseTKJr , KuchtaK , KrantzSB. National guideline concordance and outcomes for pathologic N2 disease in non-small cell lung cancer. J. Thorac. Dis.14(5), 1360–1373 (2022).
   PubMed Web of Science ®Google Scholar
• Foerster M , McCormackV , AndersonBOet al. Treatment guideline concordance, initiation, and abandonment in patients with non-metastatic breast cancer from the African Breast Cancer-Disparities in Outcomes (ABC-DO) cohort in sub-Saharan Africa: a prospective cohort study. Lancet Oncol.23(6), 729–738 (2022).
   PubMed Web of Science ®Google Scholar
• Fang P , HeW , GomezDRet al. Influence of age on guideline-concordant cancer care for elderly patients in the United States. Int. J. Radiat. Oncol. Biol. Phys.98(4), 748–757 (2017).
   PubMed Web of Science ®Google Scholar
• Barata PC , LeithA , RibbandsAet al. Real-world treatment trends among patients with metastatic castration-sensitive prostate cancer. Oncologist28(9), 780–789 (2023).
   PubMed Web of Science ®Google Scholar
• Leith A , RibbandsA , KimJet al. Impact of next-generation hormonal agents on treatment patterns among patients with metastatic hormone-sensitive prostate cancer: a real-world study from the United States, five European countries and Japan. BMC Urol.22(1), 33 (2022).
   PubMed Web of Science ®Google Scholar
• George DJ , AgarwalN , RiderJRet al. Real-world treatment patterns among patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) in community oncology settings. J. Clin. Oncol.39(Suppl. 15), 5074 (2021).
   Google Scholar
• Swami U , HongA , El-ChaarNNet al. Real-world first-line (1L) treatment patterns in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) in a U.S. health insurance database. J. Clin. Oncol.39(Suppl. 15), 5072 (2021).
   Google Scholar
• Freedland SJ , SandinR , TagawaSTet al. 609P Treatment patterns and overall survival (OS) in metastatic castration-sensitive prostate cancer (mCSPC) from 2006 to 2019. Ann. Oncol.32(Suppl. 5), S650-S651 (2021).
   Google Scholar
• George DJ , AgarwalN , RamaswamyKet al. Real-world utilization of advanced therapies by metastatic site and age among patients with metastatic castration-sensitive prostate cancer (mCSPC): a Medicare database analysis. Ann. Oncol.32(Suppl. 5), S655–S656 (2021).
   Google Scholar
• U.S. Food and Drug Administration. Drug approval package: taxotere (docetaxel) injection. www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-449s028_Taxotere.cfm (2004).
   Google Scholar
• JNCCN360 Prostate Cancer . Docetaxel (castration-naive metastatic prostate cancer). https://jnccn360.org/prostate/jnccn-spotlights/docetaxel/ (2020).
   Google Scholar
• European Medicines Agency . Summary of opinion (post authorisation): taxotere docetaxel. www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-taxotere-ws-1550_en.pdf (2019).
   Google Scholar
• ESMO . EMA recommends extension of indications for Taxotere and Docetaxel Zentiva. www.esmo.org/oncology-news/ema-recommends-extension-of-indications-for-taxotere-and-docetaxel-zentiva (2019).
   Google Scholar
• Gemeinsamer Bundesausschuss . Arzneimittel-Richtlinie/Anlage VI: docetaxel bei hormonsensitivem Prostatakarzinom mit Fernmetastasen (M1) [Drug Directive/Annex VI: Docetaxel in hormone-sensitive prostate cancer with distant metastases (M1)]. www.g-ba.de/beschluesse/3263/ (2018).
   Google Scholar
• Haute Autorité de Santé . Taxotere - prostate cancer. www.has-sante.fr/jcms/p_3191910/en/taxotere-prostate-cancer (2020).
   Google Scholar
• Zhu Y , YeD , ExpertGroup. Chinese expert consensus on the diagnosis and treatment of castration-resistant prostate cancer (2019 update). Cancer Manag. Res.12, 2127–2140 (2020).
   PubMed Web of Science ®Google Scholar
• S&P Global Market Intelligence . China releases new basic health insurance formulary, all 307 essential drugs listed. www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=106594822 (2009).
   Google Scholar
• Sanofi. Notice of revised usage precautions, September 2021. www.e-mr.sanofi.co.jp/-/media/EMS/Conditions/eMR/di/kaitei/OTX_TXT_info2021_03.pdf (2021).
   Google Scholar
• U.S. Food and Drug Administration . FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abiraterone-acetate-combination-prednisone-high-risk-metastatic-castration-sensitive (2018).
   Google Scholar
• European Medicines Agency . Summary of opinion (post authorisation): zytiga / abiraterone acetate. www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-zytiga_en-0.pdf (2017).
   Google Scholar
• Gemeinsamer Bundesausschuss . Arzneimittel-Richtlinie/Anlage XII: Abirateronacetat (neues Anwendungsgebiet: metastasiertes hormonsensitives Prostatakarzinom [mHSPC]) [Drug Directive/Annex XII: Abiraterone acetate (new field of application: metastatic hormone-sensitive prostate cancer [mHSPC])]. www.g-ba.de/beschluesse/3360/ (2018).
   Google Scholar
• Haute Autorité de Santé . ZYTIGA (abiraterone acetate), androgen synthesis inhibitor. www.has-sante.fr/jcms/c_2857377/en/zytiga-abiraterone-acetate-androgen-synthesis-inhibitor (2018).
   Google Scholar
• Xi’an Janssen Pharmaceutical Co. Ltd . Xi’an Janssen’s Zeke® approved for new indication in China for the treatment of high-risk metastatic endocrine therapy-sensitive prostate cancer. www.xian-janssen.com.cn/news/717 (2018).
   Google Scholar
• Zhang Y , WushouerH , HanSet al. The impacts of government reimbursement negotiation on targeted anticancer medication price, volume and spending in China. BMJ Glob. Health6(7), e006196 (2021).
   PubMed Web of Science ®Google Scholar
• New drugs approved in FY 2017. www.pmda.go.jp/files/000232769.pdf
   Google Scholar
• U.S. Food and Drug Administration . FDA approves enzalutamide for metastatic castration-sensitive prostate cancer. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer (2019).
   Google Scholar
• ESMO . EMA recommends extension of indications for enzalutamide. www.esmo.org/oncology-news/ema-recommends-extension-of-indications-for-enzalutamide (2021).
   Google Scholar
• Gemeinsamer Bundesausschuss . Nutzenbewertungsverfahren zum Wirkstoff Enzalutamid (Neues Anwendungsgebiet: prostatakarzinom, metastasiert, hormonsensitiv, Kombination mit Androgenentzugstherapie) [Benefit assessment procedure for the active ingredient enzalutamide (new indication: prostate carcinoma, metastatic, hormone-sensitive, combination with androgen deprivation therapy)]. www.g-ba.de/bewertungsverfahren/nutzenbewertung/696/#english (2021).
   Google Scholar
• Haute Autorité de Santé . XTANDI (enzalutamide) -Extension d’indication [XTANDI (enzalutamide) -Extension of indication]. www.has-sante.fr/jcms/p_3284790/fr/xtandi-enzalutamide (2021).
   Google Scholar
• Astellas . XTANDI® (enzalutamide) approved by Japan MHLW for the treatment of prostate cancer with distant metastasis. www.astellas.com/en/news/15876 (2020).
   Google Scholar
• FDA approves apalutamide for metastatic castration-sensitive prostate cancer. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-apalutamide-metastatic-castration-sensitive-prostate-cancer (2019).
   Google Scholar
• European Medicines Agency . Erleada - apalutamide. www.ema.europa.eu/en/medicines/human/EPAR/erleada (2021).
   Google Scholar
• IQWiG - Institute for Quality and Efficiency in Healthcare . Apalutamide (prostate cancer) – Benefit assessment according to §35a Social Code Book - IQWiG Reports - Commission No. A20-20. www.iqwig.de/download/a20-20_apalutamide_extract-of-dossier-assessment_v1-0.pdf (2020).
   Google Scholar
• Haute Autorité de Santé . Apalutamide - ERLEADA 60 mg, comprimé pelliculé - nouvelle indication [Apalutamide - ERLEADA 60 mg, coated tablet - new indication]. www.has-sante.fr/upload/docs/evamed/CT-18482_ERLEADA_PIC_EI_AvisDef_CT18482.pdf (2020).
   Google Scholar
• Home Sunshine Pharma . Erleada was approved in China for a new indication for the treatment of metastatic endocrine therapy-sensitive prostate cancer. www.hsppharma.com/news/erleada-was-approved-in-china-for-a-new-indica-37418604.html (2020).
   Google Scholar
• News alert: China’s 2021 NRDL welcomes 67 new additions at an average 62% price reduction. www.eversana.com/2021/12/06/news-alert-chinas-2021-nrdl-welcomes-67-new-additions-at-an-average-62-price-reduction/ (2021).
   Google Scholar
• Nippon Shinyaku Co. Ltd . MHLW approval of ERLEADA® (apalutamide) for the treatment of patients with prostate cancer with distant metastases. www.nippon-shinyaku.co.jp/file/download.php?file_id=3873 (2020).
   Google Scholar
• National Comprehensive Cancer Network . Prostate cancer, v 4.2018 - August 15, 2018. www2.tri-kobe.org/nccn/guideline/archive/urological2018/english/prostate.pdf (2018).
   Google Scholar
• National Comprehensive Cancer Network . Prostate cancer, v. 4.2019 - 19 August 2019. www2.tri-kobe.org/nccn/guideline/urological/english/prostate.pdf (2019).
   Google Scholar
• NCCN Guidelines for Patients . Prostate cancer - Advanced stage. www.nccn.org/patients/guidelines/content/PDF/prostate-advanced-patient.pdf (2022).
   Google Scholar
• Mottet N , DeSantis M , BriersEet al. Updated guidelines for metastatic hormone-sensitive prostate cancer: abiraterone acetate combined with castration is another standard. Eur. Urol.73(3), 316–321 (2018).
   PubMed Web of Science ®Google Scholar
• EAU Guidelines: prostate cancer 2019. https://uroweb.org/guidelines/prostate-cancer/summary-of-changes/2019 (2019).
   Google Scholar
• Cornford P , VanDen Bergh RCN , BriersEet al. EAU-EANM-ESTRO-ESUR-SIOG guidelines on prostate cancer. Part II-2020 update: treatment of relapsing and metastatic prostate cancer. Eur. Urol.79(2), 263–282 (2021).
   PubMed Web of Science ®Google Scholar
• Chinese guidelines for diagnosis and treatment of prostate cancer 2018 (English version). Chin. J. Cancer Res.31(1), 67–83 (2019).
   PubMed Web of Science ®Google Scholar
• Kakehi Y , SugimotoM , TaokaR. Committee for Establishment of the Evidenced-Based Clinical Practice Guideline for Prostate Cancer of the Japanese Urological Association. Evidenced-based [sic] clinical practice guideline for prostate cancer (summary: Japanese Urological Association, 2016 edition). Int. J. Urol.24(9), 648–666 (2017).
   PubMed Web of Science ®Google Scholar