At 2023 ASCO Genitourinary Cancers Symposium, Gwenaelle Gravis, MD, Institute Paoli-Calmettes, Aix-Marseille University, Marseille, France, presented a study evaluating apalutamide and active surveillance vs active surveillance alone for patients with low to intermediate risk prostate cancer.

At 1 year of follow-up, Dr Gravis stated, “We didn’t observe any new safety issues with apalutamide alone…and no detrimental effects of apalutamide on physical and mental quality of life, during and after treatment.”

Transcript:

Hello, I'm Gwenaëlle Gravis. I am Medical Oncologist in Marseille, France. It's my pleasure to present today a poster from the 2023 ASCO Genitourinary Cancers Symposium on the safety and quality of life analysis of apalutamide plus active surveillance versus active surveillance alone for low/intermediate risk prostate cancer. It is a multi-center, French, randomized phase 2 trial. As you know, active surveillance is a standard of care for low risk prostate cancers. However, 20 to 50% of patients will ultimately require a local treatment following active surveillance. The aim of this study was to assess whether apalutamide could decrease the proportion of patients requiring local treatment within 3 years following randomization. Here, we report 1-year safety and quality of life results.

This multicentric phase 2 study was conducted for low to intermediate risk prostate cancer, and they were randomized between apalutamide 240 milligram each day for 6 months with active surveillance, versus active surveillance alone. We reported toxicity, which was evaluated each month during treatment and every 3 months thereafter for both arms, and quality of life with the [short-form 12] SF-12 Questionnaire, which was assessed at baseline, 3, 6, and 12 months post-enrollment. There were 50 patients randomized to active surveillance plus apalutamide arm, and 41 patients in active surveillance. The median age was around 64 years old with a median PSA of around six. 

The toxicity reported during the 1-year follow-up was higher in the apalutamide arm, but a majority of the events were grade 2. We have 16% of grade 2 asthenia, 20% hypertension in apalutamide arm but we observed 20% of grade 2/3 in standard arm, with active surveillance alone. 4% of patients with grade 2 nausea. We observed 1 cerebral ischemic attack, grade 2, the in apalutamide arm. In sexual dysfunction, 14% had erectile dysfunction grade 2, and 4% grade 3 in apalutamide arm. 28% of patients had grade 2 gynecomastia and 32% had grade 1 gynecomastia. Some nipple pain, 32% grade 1/2 in apalutamide arm. Loss of libido was observed in 22% patients. The patient reported quality of life was measured by SF-12 questionnaire, and we didn't observe any difference in physical and mental quality of life between the 2 arms in at the first year of follow-up.

In conclusion, this is the largest randomized study with an apalutamide arm plus active surveillance for low risk prostate cancer. We didn't observe any new safety issues with apalutamide alone. The safety profile was consistent to those previously described with apalutamide plus castration. We didn't observe any falls or fractures, and there was no detrimental effect of apalutamide on physical and mental quality of life during and after treatment. But adverse events are important to be considered in the treatment decision for patients who are considered for active surveillance, which has low toxicity.

Thank you for your attention.

Source:

Gravis G, Sfumato P, Ploussard G, et al. Safety and quality of life analyses of apalutamide plus active surveillance vs active surveillance alone for low, intermediate risk prostate cancer. Presented at ASCO Genitourinary Cancers Symposium; February 16-18, 2023; San Francisco, CA. Abstract 352