Presented at ESMO Virtual Congress 2020, a recent study compared results on apalutamide administered in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) between real-world data from an international named patient program (NPP) and the phase 3 SPARTAN clinical trial and found that the results were similar. In an interview with i3 Health, lead study author Professor Heather Payne, MBBS, FRCP, FRCR of the University College Hospital, discusses the significance of these results, as well as the future of treatment for this patient population and advice for community oncologists.
What are the most challenging aspects of treating patients with non-metastatic castration-resistant prostate cancer?
Professor Heather Payne, MBBS, FRCP, FRCR: The management of nmCRPC has been extremely challenging in the past as there were no approved treatments. This was very frustrating for us as clinicians and caused considerable anxiety for our patients as they had to wait to either develop symptoms from metastases or have repeated scans to look for asymptomatic metastases before they could start one of the effective therapies for metastatic CRPC. In addition we know that for men with a prostate-specific antigen (PSA) doubling time of less than 10 months, there is an increased risk of metastases and death, and as an oncologist, my practice has always aimed to try and delay the time to metastatic disease with early treatment and allow men a longer and better quality of life.
Can you comment on the significance of your study's findings?
Dr. Payne: The results from this study comparing outcomes from the use of apalutamide for nmCRPC in a real world international Named Patient Program (NPP) with those of a phase 3 randomized controlled study (SPARTAN) have shown that the data from SPARTAN translates very well into real life and every day clinical practice. It has shown that there are patients to be identified in all our clinics who would benefit from this treatment, and in fact, the NPP showed a trend towards improved rates of apalutamide continuation in the real world setting with no new safety signals. This is very encouraging for our future use of apalutamide in combination with androgen deprivation therapy (ADT) for men with nmCRPC and a PSA doubling time of ≤10 months
What are the unmet needs that still exist in this patient population?
Dr. Payne: The unmet need that existed for many years has now been answered. From the SPARTAN study we know that the use of early apalutamide for men with nmCRPC and a PSA doubling time of ≤10 months results in improvement in progression-free survival and also an increase in overall survival of 14 months. Another abstract (632P) presented at virtual ESMO has demonstrated from the final analysis of the SPARTAN study, that longer exposure to apalutamide in combination with ADT does not reduce health-related quality of life (HRQOL). In contrast, the men treated with ADT and placebo in SPARTAN had a decline in quality of life after 1 year. This is important as the study involved a population of men with asymptomatic prostate cancer at baseline, and we now have evidence that longer term treatment with apalutamide until metastatic progression for this group delays the time to the development of metastatic disease, increases overall survival without reducing quality of life, enabling our men to 'live' and not just survive. Two other studies in this setting, the ARAMIS trial with darolutamide and the PROSPER study with enzalutamide have also shown positive results for early treatment with androgen receptor targeting agents in combination with ADT for men with nmCRPC and a PSADT of ≤10 months
How do you see the treatment landscape evolving in the coming years?
Dr. Payne: I think that the treatment landscape will evolve to earlier treatment to prevent metastasis and maintain quality of life in men at high risk of progression at all stages of the prostate cancer journey
Do you have any advice for community oncologists who treat this patient population?
Dr. Payne: We now have good evidence from robust randomized clinical studies for a significant improvement in metastases-free and overall survival with no reduction in quality of life for men with nmCRPC and a PSADT of ≤10 months when apalutamide is added to ADT in this setting. There is also now real-world evidence that these important advantages translate into the everyday clinical setting. We need to monitor non-metastatic patients with a rising PSA on ADT very carefully and on a regular basis in order to identify those who would be suitable for early treatment with an androgen receptor targeted agent, to allow them to live longer in the non-metastatic stage of prostate cancer and give them the best quality of life.
About Dr. Payne
Professor Heather Payne, MBBS, FRCP, FRCR, is a Consultant in Clinical Oncology at University College Hospital in London, England. Dr. Payne's research interests include hormone therapy at all stages of prostate cancer, high dose rate brachytherapy, innovations to reduce toxicity for men treated with radiotherapy and novel drugs, among others.
For More Information
Payne HA, Bulbul M, Hatzimouratidis S, et al (2020). Apalutamide for non-metastatic castration resistant prostate cancer (NMCRPC): a comparison of real-life experience from an international named patient program (NPP) vs the prior phase III clinical study. Ann Oncol (ESMO Annual Meeting Abstracts), 30(suppl_4):S507-S549. Abstract 630P. DOI:10.1016/annonc/annonc275
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily represent those of i3 Health.