KEY TAKEAWAYS
- The phase 3 trial, ARCHES, aimed to evaluate the time for the first confirmed the clinically significant deterioration in HRQoL or pain.
- Patients were administered either enzalutamide in combination with ADT or a placebo in combination with ADT.
- The combination of Enzalutamide and ADT significantly improved radiographic progression-free survival compared to ADT alone.
- The combination therapy delayed pain interference in specific subgroups, such as patients with prior radiation therapy and low-baseline HRQoL.
- The combination of Enzalutamide and ADT is clinically beneficial in specific patient subgroups, with delayed deterioration of several HRQoL measures and no reported pain.
In the clinical trial ARCHES (NCT02677896), it was observed that the combination of Enzalutamide and androgen deprivation therapy (ADT) resulted in a significant improvement in radiographic progression-free survival when compared to ADT alone in patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC). In addition, the study found that the health-related quality of life (HRQoL) was generally preserved in the intent-to-treat population. However, the patient-reported outcomes (PROs) were further analyzed in specific subgroups. The ARCHES trial was a phase 3 study that followed a randomized, double-blind, and placebo-controlled design. In this clinical trial, individuals diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) were administered either enzalutamide (160 mg/day) in combination with androgen deprivation therapy (ADT) (n = 574) or a placebo in combination with ADT (n = 576). Patient-reported outcome measures, such as the Functional Assessment of Cancer Therapy-Prostate, Brief Pain Inventory-Short Form, and EuroQol 5-Dimension, 5-Level (EQ-5D-5L), were administered at the initial visit, Week 13, and subsequently every 12 weeks until the occurrence of disease progression. The study’s primary endpoints were the time for the first confirmed clinically significant deterioration in Health-Related Quality of Life (HRQoL) or pain.
The subgroups comprised prognostic risk, pain/health-related quality of life (HRQoL), previous administration of docetaxel, and local therapy such as radical prostatectomy (RP) and radiotherapy (RT). Several differences were observed between treatments regarding time to treatment failure due to disease progression for pain and functioning/health-related quality of life patient-reported outcomes. The combination of Enzalutamide and ADT resulted in a delayed time to treatment failure for the worst pain in the prior radiation therapy group, with a hazard ratio of 0.56 (95% confidence interval: 0.34-0.94) compared to placebo plus ADT. Additionally, in the low-baseline health-related quality of life group, there was a delay in pain interference with a median time of 19.32 months compared to 11.20 months for placebo plus ADT, with a hazard ratio of 0.64 (0.44-0.94). In patients with or without prior rheumatoid arthritis, prior radiation therapy, prior local therapy, no prior docetaxel, mild baseline pain, and low-risk subgroups, time to treatment failure was prolonged due to the EQ-5D-5L visual analog scale. The combination of Enzalutamide and ADT has demonstrated clinical benefits in specific patient subgroups when compared to ADT alone. Furthermore, patients receiving this combination therapy have reported no pain and high health-related quality of life (HRQoL), with a delay in the deterioration of several HRQoL measures.
Source:https://pubmed.ncbi.nlm.nih.gov/35675470/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT02677896/
Stenzl A, Szmulewitz RZ, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Ivanescu C, Rosbrook B, Ramaswamy K, Ganguli A, Haas GP, Armstrong AJ. The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. Prostate. 2022 Sep;82(13):1237-1247. doi 10.1002/pros.24396. Epub 2022 Jun 8. PMID: 35675470.
