HRQoL data bolster positive survival findings from TITAN study
medwireNews: Adding apalutamide to androgen deprivation therapy (ADT) does not result in increased levels of pain or fatigue, relative to placebo, nor does it negatively impact overall health-related quality of life (HRQoL), shows an analysis of data from the TITAN study.
As previously reported by medwireNews, the phase III study found that supplementing ADT with apalutamide significantly improves overall survival and radiographic progression-free survival in men with metastatic castration-sensitive prostate cancer.
The current prespecified analysis, simultaneously published in The Lancet Oncology and presented at the ESMO Congress 2019 in Barcelona, Spain, focused on the HRQoL outcomes among the TITAN participants.
At baseline, the median Brief Pain Inventory-Short Form (BPI-SF) pain severity scores indicating worst pain in the past 24 hours were 1.14 (on a scale of 1–10) among the 525 patients randomly assigned to receive apalutamide and 1.00 among the 527 patients given placebo.
Corresponding median worst fatigue scores on the Brief Fatigue Inventory (BFI) were 1.29 and 1.43.
During a median 19.4–22.1 months of follow-up, the researchers found that “[p]atient experience of pain and fatigue did not differ between the groups for the duration of treatment.”
Specifically, median time to worst pain intensity progression, defined as a worsening of at least 2 points at two assessments at least 4 weeks apart, was 19.1 months in the apalutamide group, which was not significantly longer than the 12.0 months observed in the placebo group.
In addition, median time to pain interference progression was not reached in either group but the 25th percentiles were 9.2 months with apalutamide and 6.2 months with placebo group, again a nonsignificant difference.
Median times to worst fatigue intensity and fatigue interference were also not reached in either group and there was no significant difference between treatment with apalutamide versus placebo in the 25th percentile for each outcome (9.2 vs 11.0 and 10.2 vs 10.5 months, respectively).
Overall HRQoL, as measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EuroQoL 5D questionnaire 5 level scores, did not change significantly from baseline to follow-up in either group and did not differ between the groups each time they were assessed.
Indeed, the median time to HRQoL deterioration according to the FACT-P total score was 8.9 months in the apalutamide group and 9.2 months in the placebo group.
Neeraj Agarwal (University of Utah, Salt Lake City, USA) and co-investigators conclude that their “analysis of prespecified patient-reported outcome endpoints in TITAN showed that HRQOL did not worsen with the addition of apalutamide to ADT versus placebo for a broad population of patients with metastatic castration-sensitive prostate cancer.”
They add that the “maintenance of HRQOL in patients who were mostly asymptomatic at baseline, taken together with the significantly improved radiographic progression-free survival and overall survival, reduced risk of death, delayed time to disease progression, and delayed time to initiation of cytotoxic chemotherapy in TITAN, as reported previously, and tolerability reported by patients, supports the clinical benefit of apalutamide in a broad patient population with metastatic castration-sensitive prostate cancer.”
By Laura Cowen
medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group