There were no therapeutic options specifically approved for the population of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), but the evolution of therapeutic options has been taking place at an impressive rate.
SPARTAN is an important trial on prostate cancer that included patients in M0 stage resistant to castration, with an elevation of PSA resistant to androgenic blockade, with fast doubling less than 10 months in the comparison between the use of apalutamide versus placebo, besides the continuous androgenic blockade.
Recently, at ASCO this year, the results indicated a gain in overall survival (reduction of almost 25% in the risk of death). Now, the poster presentation at ESMO showed a more extensive data analysis that examined health-related quality of life among men based on the final analysis of the data in this cohort.
In total, 1,207 patients were randomized at a ratio of 2: 1 to apalutamide 240 mg orally daily or placebo. The authors used two very important scales to assess health-related quality of life: Functional Assessment of Cancer Therapy – Prostate (FACT-P) and EQ-5D-3L. These measurements were collected at various times during treatment.
With a 52-month follow-up, the authors reported that patients randomized to apalutamide had been on therapy for much longer (median 32.9 months) than those on placebo (median 11.5 months). At the beginning of the trial, patients were minimally symptomatic and, therefore, had good health-related quality of life. The questionnaire was almost 100% completed in both groups.
Using descriptive statistics with mixed models for repeated measures (LSM-MMRM), the authors demonstrated that patients randomized to apalutamide significantly preserved several aspects related to quality of life compared to those randomized to placebo in both questionnaires. The differences in the medians between the arms started to be evident after one year of treatment (between cycle 11 to 13), but they were much more pronounced between cycles 21 and 25 (around 2 years of treatment) (in the cycle 21: p = 0.0138; in cycle 25: p = 0.0009). Similar results were observed for the FACT-P and EQ-5D-3L subscales.
632P – Health-related quality of life (HRQoL) at final analysis of the SPARTAN study of apalutamide (APA) vs placebo (PBO) in patients (pts) with non-metastatic castration-resistant prostate cancer (nmCRPC) receiving androgen deprivation therapy (ADT) – ESMO 2020.
Small EJ, Saad F, Chowdhury S, et al. Final survival results from SPARTAN, a phase III study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). Poster presented at ASCO Virtual Scientific Program, Maio de 2020. P5516
Saad F, Cella D, Basch E, et al. 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. Lancet Oncol. 2018;19(10):1404-1416.
Smith MR, Saad F, Chowdhury S, et al. Supplement to: Apalutamide and overall survival in prostate cancer. Eur Urol. 2020;In press