Patients with castration-resistant prostate cancer (CRPC) who are at high risk for developing metastasis may safely add Erleada (apalutamide) to androgen deprivation therapy without worrying about their quality of life, a new study shows.
In February, the treatment became the first androgen receptor inhibitor approved in the United States for non-metastatic CRPC, and additional analysis from the SPARTAN Phase 3 trial (NCT01946204) shows that quality of life is not affected.
The findings were published in The Lancet Oncology, in a study titled “Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial.”
“Prostate cancer treatment can often result in unwelcome side effects that can impact or disrupt patients’ everyday lives,” Fred Saad, MD, a SPARTAN investigator and author of the study, said in a press release.
“As clinicians, we want to monitor and measure the impact of new treatments to see if there is an effect on patients’ overall health and well-being,” added Saad, who also is a professor and chairman of urology at the University of Montreal Hospital Center. “The fact that a treatment such as apalutamide can be added to current standard of care, prolonging metastasis-free survival without significantly impacting HRQoL [health-related quality of life], is a significant advance for patients with nmCRPC and for clinicians who treat them.”
SPARTAN included 1,207 patients with non-metastatic CRPC whose PSA levels were rapidly increasing while on androgen deprivation therapy. In the trial, patients kept receiving androgen deprivation therapy, and were randomly assigned Janssen Oncology‘s Erleada or a placebo.
The study showed that patients receiving Erleada lived nearly two more years without metastasis than those on a placebo — 40.5 months versus 16.2 months. Erleada also extended the time a patient lived without disease worsening, and the time to symptomatic progression.
While the benefits of Erleada were obvious, researchers still needed to make sure the adverse effects of treatment wouldn’t affect patients’ health-related quality of life. With that in mind, patients on SPARTAN were asked to fill two quality-of-life questionnaires during the study.
The Functional Assessment of Cancer Therapy-Prostate (FACT-P) patient-reported outcome questionnaire was used to assess prostate cancer symptoms, pain-related symptoms, and overall quality of life. On the other hand, the EuroQol five-dimension, three-level questionnaire (EQ-5D-3L) was employed to assess mobility, self-care, usual activities, pain, discomfort, and anxiety, or depression.
Questionnaires were given before study start, on the first day of cycles 1 through 6, on day one of cycles 7, 9, 11, and 13, and once every four cycles thereafter. Each cycle of the study lasted four weeks.
Generally, quality of life was preserved from baseline to cycle 29 in both treatment groups, but patients receiving placebo showed a trend toward a deterioration of quality of life, particularly in later treatment cycles. Treatment with Erleada and placebo were well-tolerated by both patient groups.
Researchers also examined quality-of-life scores after patients experienced a symptomatic progression of their condition. Both treatment groups had similar drops in their quality of life after progressing.
“There were similar declines in HRQOL [health-related quality of life] associated with symptomatic progression,” they wrote.
“The extension of median metastasis-free survival by 2 years shown in SPARTAN, and maintenance of HRQOL from treatment initiation in this mostly asymptomatic population, suggests that apalutamide provides clinical benefit in the treatment of men with non-metastatic castration-resistant prostate cancer,” the study concluded.
“Amongst men in this patient population, maintaining quality of life is an important endpoint,” said Andree Amelsberg, MD, vice president, Oncology Medical Affairs, at Janssen Scientific Affairs. “In this exploratory analysis of the SPARTAN results, we are pleased to see that patients reported they did not experience notable disruptive changes after Erleada was added to their standard of care.”
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