The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the publication of new patient-reported outcomes (PRO) data demonstrating that adding ERLEADA(R) (apalutamide) to androgen-deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high-risk for development of metastases did not have a significant impact on individuals’ overall health-related quality of life (HRQoL). These data from the pivotal SPARTAN study, in which ERLEADA significantly prolonged median metastasis-free survival (MFS), while preserving HRQoL, and delaying the decrease in HRQoL associated with symptomatic progression, were published today in The Lancet Oncology.[1]
“Prostate cancer treatment can often result in unwelcomed side effects that can impact or disrupt patients’ everyday lives,” said Fred Saad, M.D., FRCS, Professor and Chairman of Urology, University of Montreal Hospital Center, and SPARTAN investigator and author of the study. “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. The fact that a treatment such as apalutamide can be added to current standard of care, prolonging metastasis-free survival without significantly impacting HRQoL, is a significant advance for patients with nmCRPC and for clinicians who treat them.”
In February 2018, ERLEADA received U.S. Food and Drug Administration approval for the treatment of patients with nmCRPC, making it the first androgen receptor inhibitor approved for patients with this disease state in the U.S.2 The SPARTAN study was a Phase 3, randomized, double-blind, placebo-controlled multicenter study conducted in 1,207 patients with nmCRPC and a prostate-specific antigen (PSA) doubling time 10 months during continuous ADT.1 Patients were randomized 2:1 to receive ERLEADA in combination with ADT or placebo in combination with ADT.1 All patients received a concomitant gonadotropin-releasing hormone (GnRH) agonist or had a bilateral orchiectomy. The primary endpoint of this study was MFS.1
The Lancet Oncology publication includes prospective data from the treatment phase and the post-progression follow-up phase for the PRO exploratory endpoints as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the EuroQol five-dimension, three-level (EQ-5D-3L) questionnaires.1 The FACT-P PRO questionnaire assessed prostate cancer symptoms, pain-related symptoms and overall HRQoL.1 The EQ-5D-3L questionnaire evaluated mobility, self-care, usual activities, pain, discomfort, anxiety or depression and health-state.1
“Men with non-metastatic castration-resistant prostate cancer are at significant risk for developing metastases and dying from the disease. To date, this patient population has been understudied, and data on health-related quality of life in such men are scarce,” said Andree Amelsberg, M.D., Vice President, Oncology Medical Affairs, at Janssen Scientific Affairs, LLC. “Patient-reported outcomes data are gaining importance as healthcare systems place greater emphasis on patient experience with treatment. Amongst men in this patient population, maintaining quality of life is an important endpoint. 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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