Apalutamide in the treatment of patients with high-risk prostate cancer
Keywords:
prostate, prostate neoplasms, castration-resistant prostate neoplasms, neoplasm metastasis, prostate-specific antigen, nonsteroidal antiandrogens.Abstract
Introduction: Apalutamide is a selective inhibitor of the androgen receptor. It has been approved for the treatment of hormone-sensitive metastatic and castration-resistant prostate cancer in combination with androgen deprivation therapy.
Objective: To assess the tolerability and response of prostate-specific antigen in patients with high-risk prostatic adenocarcinoma ongoing apalutamide therapy.
Methods: An observational, analytical, longitudinal and prospective study of 22 patients who presented prostate cancer and were treated with apalutamide at the "Reina Sofía" Hospital in Murcia between 2019 and 2022 was conducted. Data such as the Gleason scale were collected if they received any previous treatment, presence of metastases and analytical results. Side effects, treatment discontinuation and disease progression were also reviewed.
Results: 15 patients presented metastatic hormone-sensitive prostate cancer (Group 1) and 7 were resistant to non-metastatic castration (Group 2). Of group 1, 80 % presented debut metastases and 73.33 % were low volume. Prostate-specific antigen decreased by 94.39% in group 1 and 81.68% in group 2. Of the total, 59.09 % suffered side effects. The most frequent were fatigue (27.27 %), followed by hypothyroidism (18.18 %) and high blood pressure (9.09 %). All were mild except for the appearance of severe leukopenia that caused treatment to be interrupted. There was progression in one patient of group 1.
Conclusions: Apalutamide in patients with high-risk prostate cancer is an effective and well-tolerated option, with a decrease in prostate-specific antigen >50%, which may increase overall and progression-free survival.
Downloads
References
2. Committee for Medicinal Products for Human Use (CHMP). European Public Assessment Report (EPAR) de Erleada® (apalutamida). Procedimiento: EMEA/H/C/004452/II/0001. European Medicines Agency. 2019 [acceso 20/09/2021]. Disponible en: https://www.ema.europa.eu/en/documents/variation-report/erleada-h-c-4452-ii-0001-epar-assessment-report-variation_en-0.pdf
3. Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, et al. TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. DOI: 10.1056/NEJMoa1903307
4. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. DOI: 10.1056/NEJMoa1715546.
5. Ficha técnica de Erleada® (apalutamida). Agencia Europea de Medicamentos. 2021. [acceso 20/09/2021]. Disponible en: https://www.ema.europa.eu/en/documents/product-information/erleada-epar-product-information_es.pdf
6. Agencia Española de Medicamentos y Productos Sanitarios. Informe de Posicionamiento Terapéutico de apalutamida (Erleada®) en combinación con tratamiento de privación de andrógenos en cáncer de próstata hormonosensible metastásico. Ministerio de Sanidad, Gobierno de España. 2021. [acceso 20/09/2021]. Disponible en: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_4-2021-Erleada.pdf?x18354
7. Agencia Española de Medicamentos y Productos Sanitarios. Informe de Posicionamiento Terapéutico de apalutamida (Erleada®) en cáncer de próstata resistente a la castración no metastásico. Ministerio de Sanidad, Gobierno de España. 2021. [acceso 20/09/2021]. Disponible en: https://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/2021/IPT_5-2021-Erleada.pdf
8. Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, et al. TITAN investigators. 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 Nov;20(11):1518-30. DOI: 10.1016/S1470-2045(19)30620-5.
9. Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, et al. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-303. DOI: 10.1200/JCO.20.03488.
10. Uemura H, Arai G, Suzuki H, Aoyama J, Hatayama T, Ito M, et al. Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study. Int J Urol. 2022 Jun;29(6):533-40. DOI: 10.1111/iju.14843.
11. Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and Overall Survival in Prostate Cancer. Eur Urol. 2021 Jan;79(1):150-8. DOI: 10.1016/j.eururo.2020.08.011.
12. Small EJ, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, et al. Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer. Ann Oncol. 2019 Nov 1;30(11):1813-20. DOI: 10.1093/annonc/mdz397.
13. Chung BH, Huang J, Ye ZQ, He DL, Uemura H, Arai G, et al. Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial. Asian J Androl. 2022 Mar-Apr;24(2):161-6. DOI: 10.4103/aja.aja_64_21.
14. Saad F, Small EJ, Feng FY, Graff JN, Olmos D, Hadaschik BA, et al. Deep Prostate-specific Antigen Response following Addition of Apalutamide to Ongoing Androgen Deprivation Therapy and Long-term Clinical Benefit in SPARTAN. Eur Urol. 2022 Feb;81(2):184-92. DOI: 10.1016/j.eururo.2021.11.020.
Downloads
Published
How to Cite
Issue
Section
License
Aquellos autores/as que tengan publicaciones con esta revista, aceptan los términos siguientes:
- Los autores/as conservarán sus derechos de autor y garantizarán a la revista el derecho de primera publicación de su obra, el cual estará simultáneamente sujeto a la Licencia de Creative Commons Reconocimiento-NoComercial 4.0 Internacional que permite a terceros compartir la obra siempre que se indique su autor y su primera publicación esta revista.
- Los autores/as podrán adoptar otros acuerdos de licencia no exclusiva de distribución de la versión de la obra publicada (p. ej.: depositarla en un archivo telemático institucional o publicarla en un volumen monográfico) siempre que se indique la publicación inicial en esta revista.
- Se permite y recomienda a los autores/as difundir su obra a través de Internet (p. ej.: en archivos telemáticos institucionales o en su página web) antes y durante el proceso de envío, lo cual puede producir intercambios interesantes y aumentar las citas de la obra publicada. (Véase El efecto del acceso abierto).