The addition of apalutamide to androgen deprivation therapy (ADT) is well tolerated and significantly improves survival while maintaining health-related quality of life in men with metastatic castration-sensitive prostate cancer, according to a new analysis of the phase III TITAN study. The new findings follow results showing improvements in survival time.
“Whether new treatment approaches offer a survival benefit without compromising patient health-related quality of life (HRQOL) is important to investigate,” wrote study authors led by Neeraj Agarwal, MD, of the Huntsman Cancer Institute at the University of Utah. “Patient-reported outcomes can provide meaningful data about disease symptoms, treatment tolerance, and overall HRQOL; are essential to clinicians and patients making treatment choices; and have increasing importance to regulatory agencies around the world when approving drug therapies.”
The TITAN trial included a total of 1,052 men with metastatic castration-sensitive prostate cancer, randomized to receive either apalutamide plus ADT (525 patients) or ADT plus placebo (527 patients). For the new analysis, the median follow-up period ranged from 19.4 to 22.1 months. Results were published online ahead of print on September 29 in Lancet Oncology.
The analysis included patient-reported outcomes from the Brief Pain Inventory-Short Form (BPI-SF), the Brief Fatigue Inventory (BFI), the Functional Assessment of Cancer Therapy-Prostate (FACT-P), and the EuroQoL 5D questionnaire 5 level (EQ-5D-5L).
The median time to worst pain was 19.09 months in the apalutamide group, compared with 11.99 months in the placebo group; this difference was not statistically significant (hazard ratio [HR] 0.89; 95% CI, 0.75-1.06; P= 0.20). The median time to pain interference progression was not reached in either group.
The FACT-P total score showed that health-related quality of life was maintained in both groups; the same was true for the EQ-5D-5L data. The median time to deterioration based on the FACT-P total score was 8.87 months with apalutamide and 9.23 months with placebo (HR 1.02; 95% CI, 0.85-1.22; P= 0.85).
“The results of the TITAN study showed substantial benefits for apalutamide plus ADT for overall survival and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer, and overall HRQOL was maintained with the addition of apalutamide to ADT,” the authors concluded. “These data support the addition of apalutamide to ADT for a broad range of patients with metastatic castration-sensitive prostate cancer.”
In an accompanying editorial, authors led by Suzanne K. Chambers, AO, of the University of Technology Sydney in Australia, agreed, writing that the treatment “seems to prolong survival with low morbidity costs.” They noted that effective clinician communication with patients will become more and more important as treatment approaches become more complex.
“The development of prostate cancer survivorship care that is men-centred and holistic must keep pace with medical advances, and including quality-of-life considerations in clinical research is a valuable starting point,” the authors wrote.