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

Stenzl, Arnulf; Dunshee, Curtis; Giorgi, Ugo De; Alekseev, B. Ya.; Iguchi, Taro; Szmulewitz, Russell Z.; Flaig, Thomas W.; Tombal, Bertrand; Morlock, Robert; Ivanescu, Cristina; Ramaswamy, Krishnan; Saad, Fred; Armstrong, Andrew J.

doi:10.1016/j.eururo.2020.03.019

Cited by 44 publications

(51 citation statements)

References 19 publications

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“…Compared to the control treatment, enzalutamide significantly delayed time to deterioration in FACT-P PCS scores for patients with nmCRPC and mCRPC, with no impact in hormone-sensitive patients (Figure 4). In patients with mHSPC, no significant differences were observed between enzalutamide and controls, regardless of whether the event was confirmed (hazard ratio (HR) 0.96) or not (HR 1.08) [11]. Enzalutamide significantly delayed time to deterioration of PCS scores vs. control treatment in patients with CRPC, regardless of the metastatic status of the disease, with an increased benefit (lower HR) as the disease progressed towards post-chemotherapy.…”

Section: Prostate Cancer Symptomsmentioning

confidence: 86%

“…Details of the statistical analysis used in the clinical trials can be found in corresponding publications [11][12][13][14][15], and a summary is provided in Appendix A. Clinically meaningful within-patient change thresholds for FACT-P, EQ-5D-5L and BPI-SF were based on previously established values [18][19][20], as reported in Table 2. * The primary analysis for PROSPER assumed censoring not at random and used a different established threshold (i.e., an increase of at least 2 points); however, a sensitivity threshold of 30% from BL was also implemented and is used here to align with the primary thresholds conducted for ARCHES and PREVAIL.…”

Section: Statistical Analysesmentioning

confidence: 99%

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The Impact of Enzalutamide on the Prostate Cancer Patient Experience: A Summary Review of Health-Related Quality of Life across Pivotal Clinical Trials

Tombal

Stenzl

Cella

et al. 2021

Cancers

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This review examines the impact of treatment with enzalutamide on health-related quality of life (HRQoL) in prostate cancer patients across the disease continuum based on pivotal clinical trials. We assessed the effect of enzalutamide on pain, symptom burden and overall HRQoL from randomized controlled trials. Patient experience was evaluated in men with metastatic hormone-sensitive prostate cancer (mHSPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-resistant prostate cancer (mCRPC) (pre-chemotherapy and post-chemotherapy). Patients across the disease continuum reported a generally positive status at baseline, with relatively low levels of pain and impairment due to cancer-related symptoms and high HRQoL. For patients with earlier-state prostate cancer, pain and symptom-related burden were low at study entry and remained so, regardless of whether patients received enzalutamide or control treatment. Patients with more advanced disease reported mitigation in pain and symptom burden while receiving treatment with enzalutamide. Enzalutamide was observed to slow deterioration of overall HRQoL most for patients with nmCRPC or mCRPC (statistical significance for between-group difference in median time to deterioration: mHSPC (confirmed) p = 0.2998; nmCRPC (confirmed) p = 0.0044; mCRPC (unconfirmed) p < 0.0001). Across the prostate cancer continuum, enzalutamide is well-tolerated and delays the negative impact that disease progression has on quality of life.

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Section: Prostate Cancer Symptomsmentioning

confidence: 86%

Section: Statistical Analysesmentioning

confidence: 99%

The Impact of Enzalutamide on the Prostate Cancer Patient Experience: A Summary Review of Health-Related Quality of Life across Pivotal Clinical Trials

Tombal

Stenzl

Cella

et al. 2021

Cancers

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“…The authors showed that HRQOL did not vary between both groups regarding time-to-deterioration or net baseline changes [27]. In the ARCHES study, Stenzl et al evaluated the effect of enzalutamide combination therapy on HRQOL in metastatic hormone-sensitive prostate cancer patients [28]. The treatment arm contained 38.3% (220/574) patients classified as low-volume disease, and 25.3% had previous local therapy.…”

Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life following Cytoreductive Radical Prostatectomy in Patients with De-Novo Oligometastatic Prostate Cancer

Chaloupka

Stoermer

Apfelbeck

et al. 2021

Cancers

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(1) Background: local treatment of the primary tumor has become a valid therapeutic option in de-novo oligo-metastatic prostate cancer (PC). However, evidence regarding radical prostatectomy (RP) in this setting is still subpar, and the effect of cytoreductive RP on postoperative health-related quality of life (HRQOL) is still unclear. (2) Methods: for the current study, patients with de-novo oligo-metastatic PC (cM1-oligo), defined as ≤5 bone lesions in the preoperative staging, were included, and matched cohorts using the variables age, body-mass index (BMI), and pT-stage were generated. Patient-reported outcome measures (PROMS) were assessed pre- and postoperatively using the validated EORTC-QLQ-C30, IIEF-5, and ICIQ-SF questionnaires. The primary endpoint for univariate and multivariable analysis was good general HRQOL defined by previously validated cut-off values. (3) Results: in total, 1268 patients (n = 84 (7%) cM1-oligo) underwent RP between 2012 and 2020 at one tertiary care center. A matched cohort of 411 patients (n = 79 with oligo-metastatic bone disease (cM1-oligo) and n = 332 patients without clinical indication of metastatic disease (cM0)) was created. The median follow-up was 25mo. There was no significant difference in good general HRQOL rates between cM1-oligo-patients and cM0-patients before RP (45.6% vs. 55.2%, p = 0.186), and at time of follow-up (44% vs. 56%, p = 0.811). Global health status (GHS) worsened significantly in cM0-patients compared to baseline (−5, p = 0.001), whereas GHS did not change significantly in cM1-oligo-patients (+3.2, p = 0.381). In multivariate analysis stratified for good erectile function (IIEF5 > 18; OR 5.722, 95% CI 1.89–17.36, p = 0.002) and continence recovery (OR 1.671, 95% CI 1.03–2.70, p = 0.036), cM1-oligo was not an independent predictive feature for general HRQOL (OR 0.821, 95% CI 0.44–1.53, p = 0.536). (4) Conclusions: in this large contemporary retrospective analysis, we observed no significant difference in HRQOL in patients with the oligometastatic bone disease after cytoreductive radical prostatectomy, when compared to patients with localized disease at time of surgery.

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“…Using the FACT-P questionnaire, it is highly novel to see the time-series changes in QoL after radical PC SBRT. The FACT-P has also been used in many phase III studies on PC (20)(21)(22)(23)(24)(25)(26)(27)(28)(29). In this report, QoL declined at 1 month after the last SBRT, then recovered, and returned to the same level as before treatment by 3-4 months.…”

Section: Discussionmentioning

confidence: 99%

Quality of Life After Definitive Linear Accelerator-based Stereotactic Radiotherapy for Prostate Cancer: a Longitudinal Study

Yamashita

Ogita

Sawayanagi

et al. 2021

Preprint

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Background: Prostate cancer is the second most common malignancy worldwide, and the majority of patients are diagnosed with localized disease. We examined patients’ quality of life after stereotactic body radiation therapy (SBRT) for prostate cancer. Method: We included patients who were treated between 2016 and 2020. Inclusion criteria were adenocarcinoma of the prostate; class risk of low, intermediate, and high; and a World Health Organization performance status of 0–2. Quality of life was measured using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Results: A total of 439 patients were treated with SBRT, with a median age of 73 years old. The median follow-up period was 34 months. FACT-P Trial Outcome Index (p < 0.0001), FACT-General (p = 0.0003), and FACT-P-Total (p < 0.0001) scores declined at 1 month post-SBRT, then recovered and returned to the same level as before treatment at 3–4 months post-SBRT. The decrease in quality of life in the first month was particularly remarkable in patients who received long-term hormone injections (36%). One month after the end of SBRT, about 22% of patients experienced "quite a bit” or more troubling side effects. Conclusions: This study showed longitudinal changes in quality of life by FACT-P after SBRT for prostate cancer. Overall, prostate SBRT was well tolerated.

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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

Cited by 44 publications

References 19 publications

The Impact of Enzalutamide on the Prostate Cancer Patient Experience: A Summary Review of Health-Related Quality of Life across Pivotal Clinical Trials

The Impact of Enzalutamide on the Prostate Cancer Patient Experience: A Summary Review of Health-Related Quality of Life across Pivotal Clinical Trials

Health-Related Quality of Life following Cytoreductive Radical Prostatectomy in Patients with De-Novo Oligometastatic Prostate Cancer

Quality of Life After Definitive Linear Accelerator-based Stereotactic Radiotherapy for Prostate Cancer: a Longitudinal Study

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