HRQoL unaffected by addition of apalutamide to androgen deprivation therapy
medwireNews: The addition of apalutamide to androgen deprivation therapy (ADT) has no detrimental effect on health-related quality of life (HRQoL) in men with nonmetastatic castration-resistant prostate cancer, an analysis of data from the SPARTAN trial shows.
The trial originally found that adding the androgen receptor inhibitor to ADT significantly improved metastasis-free survival among these men, who were all at high risk for distant disease based on a prostate-specific antigen (PSA) serum level of at least 2 ng/mL and a PSA doubling time of less than 10 months.
In this prespecified exploratory analysis, the researchers investigated how the extra drug impacted HRQoL using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EuroQol five-dimension, three-level (EQ-5D-3L) questionnaires.
At baseline, the mean for FACT-P total scores among the 806 patients randomly assigned to receive ADT plus oral apalutamide 240 mg/day, as well as those among the 401 patients in the placebo group, were consistent with what would be expected among the general population of US adult men.
Furthermore, mean total and subscale FACT-P and EQ-5D-3L scores remained relatively stable throughout the 20.3-month follow-up period in both the patients receiving apalutamide and in those receiving placebo.
However, when the researchers looked at mean changes from baseline, there was a greater decline in HRQoL among patients in the placebo group versus those in the apalutamide group, with separation between the groups, in favour of apalutamide, between cycle 11 and cycle 29. It was not possible to analyse data past this point because fewer than 20 patients remained in the placebo group, they note.
Among 341 patients who developed metastases, the HRQoL scores remained similar between patients in the apalutamide and placebo groups up to 12 months after metastasis, and also declined at a similar rate following symptomatic progression.
Of note, the decline in HRQoL associated with symptomatic progression was delayed among the patients treated with apalutamide, “consistent with the longer time to symptomatic progression identified in the SPARTAN study”, Fred Saad (University of Montreal, Quebec, Canada) and co-investigators remark.
Writing in The Lancet Oncology the authors say: “The fact that a novel, efficacious treatment can be added to current standard of care while maintaining patient HRQOL is a substantial advance for patients with non-metastatic castration-resistant prostate cancer and the clinicians who treat them.”
Saad and team conclude: “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.”
By Laura Cowen
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