Adding apalutamide (Erleada) to androgen deprivation therapy (ADT) does not lead to a significant patient-reported side effect burden nor the reduction in health-related quality of life (HRQOL) in men with metastatic castration-sensitive prostate cancer (mCSPC). This conclusion is based on the phase 3 TITAN trial (NCT02489318). The data were presented during the 47th Annual Oncology Nursing Society (ONS) Congress. (1)
Results showed that the favorable baseline FACT-P scores did not worsen over time in the apalutamide or placebo groups. Adding apalutamide did not worsen any individual FACT-P HRQOL measures—FACT-P Total Score, Physical Wellbeing Score, Emotional Wellbeing Score, Functional Wellbeing Score, Social/Family Wellbeing Score, Prostate Cancer Subscale Score, Trial Outcome Index, and FACT-G Score—over 33 treatment cycles.
In addition, there were no significant differences between groups in median time to deterioration in any Brief Pain Inventory (BPI) or Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores.
“Key takeaways from this in-depth analysis of patient-reported quality of life in patients with mCSPC in the TITAN final analysis include confirmation that the addition of apalutamide to ADT did not worsen HRQOL or side effect burden,” lead study author Jennifer Lloyd MSN, FNP-C, OCN, an oncology nurse practitioner at Huntsman Cancer Institute, said in a virtual poster presentation during the meeting. “These patient-reported findings further support the robust safety and efficacy of apalutamide added to ADT demonstrated in the TITAN study.”
In the double-blind TITAN trial, investigators enrolled 1052 men with mCSPC who received treatment with ADT to receive either apalutamide orally at 240 mg daily (n = 525) or placebo (n.= 527). Investigators were also blinded to prostate-specific antigen (PSA) responses through cycle 4.
Primary findings from the study, which were at a median follow-up of 22.7 months, showed that apalutamide led to a significant improvement in radiographic progression-free survival and overall survival (OS) vs. placebo while also preserving HRQOL. (2,3)
Patients on the placebo arm were permitted to cross over to apalutamide after unblinding trial.
At a median follow-up of 44.0 months, the OS benefit was confirmed in the final analysis with a 35% reduction in the risk of death with apalutamide and ADT despite cross over. (4)
In the analysis presented at the ONS Congress, which was also presented during the 2021 ASCO Annual Meeting (6), investigators sought to evaluate the HRQOL and adverse effect (AE) burden at the final analysis of TITAN to understand better the impact of adding the androgen receptor inhibitor to ADT.
The median treatment duration was 39.3 months with apalutamide and 20.2 months with placebo in the final analysis.
Concerning energy, more than 78% and 71% of patients on apalutamide and placebo, respectively, had stable or improved energy levels that were relative to baseline levels.
For men with metastatic castrate sensitive prostate cancer, these findings provide valuable evidence-based insights that you should consider when deciding if you want to add Erleada to your treatment ADT protocol. In TITAN Erleada extended both overall survival and progression free survival, but did not have a negative impact on the quality of life.
TAKE HOME: The addition of apalutamide (Erleada) to androgen deprivation therapy (ADT) does not lead to an increased side effect burden or a reduced health-related quality of life while extending survival in men with metastatic castration-sensitive prostate cancer.
References
1. Lloyd J, Bevans KB, Dibaj S, et al. What can patients with prostate cancer expect from treatment with apalutamide? health-related quality of life in patients with metastatic castration-sensitive prostate cancer in the phase 3 TITAN study. Presented at: 47th Annual Oncology Nursing Society Congress; April 27-May 1, 2022; Anaheim, CA. Abstract P391.
2. Chi KN, Agarwal N, Bjartell A, et al. Apalutamide formetastatic, castration-sensitive prostate cancer. N Eng J Med. 2019;381(1):13-24. doi:10.1056/NEJMoa1903307.
3. Agarwal N, McQuarrie K, Bjartell A, 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(11):1518-1530. doi:10.1016/S1470-2045(19)30620-5.
4. Chi KN, Chowdhury S, Bjartell A, 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;39(20):2294-2303. doi:10.1200/JCO.20.03488.
5. U.S. FDA approves supplemental new drug application (sNDA) for Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). News release. Janssen; September 17, 2019. Accessed May 2, 2022. https://prn.to/2kRwT6m
6. Agarwal N, Chowdhury S, Bjartell A, et al. Health-related quality of life (HRQoL) and patient-reported outcomes at final analysis of the TITAN study of apalutamide (APA) versus placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). J Clin Oncol. 2021;39(20):5068-5068.
