(UroToday.com) In the on-demand poster session of the European Society for Medical Oncology (ESMO) Annual Congress, Dr. Stephane Oudard presented data on patient-reported health-related quality of life (HRQoL) in the context of the ACIS trial (NCT02257736). This phase III trial randomized patients with metastatic castration resistant prostate cancer (mCRPC) to receive either abiraterone acetate and prednisone with or without apalutamide. In previously presented analyses, the combination regime demonstrated improved radiographic progression-free survival (rPFS) with 7.4-month improvement in median rPFS (primary endpoint) (p < 0.0001).
To briefly summarize this trial methodology, 982 patients with chemotherapy naïve mCRPC were randomized 1:1 to APA (240 mg QD) + AA (1000 mg QD) + P (5 mg BID) or placebo + AAP.
In terms of the secondary outcome of HRQoL, patients compared the Functional Assessment of Cancer Therapy-Prostate (FACT-P) measure at cycle 1 (baseline [BL]) to cycle 6, then every three cycles to 12 months after end of treatment (EOT) as well as the Brief Pain Inventory-Short Form (BPI-SF) for 7 consecutive days each cycle until the EOT. Descriptive statistics and mean changes from BL using mixed model for repeated measures (LSM-MMRM) are reported.
Among the 982 patients randomized, completion rates were 67-75% on the FACT-P measure between baseline and cycle 39 and 60-98% for the BPI-SF from baseline to cycle 43. There were no clinically meaningful differences between groups in LSM-MMRM for FACT-P total.
In both groups, there was evidence that the BPI worst pain intensity and pain interference increased over time, with no clinically meaningful differences between the two groups (threshold: ± 2 points). Additionally, the median time to deterioration did not differ between groups for a number of the measure of HRQoL: FACT-P total (HR 1.16, 95% CI 0.94-1.42), worst pain intensity (HR 1.11, 95% CI 0.92-1.34), and pain interference (HR 1.19, 95% CI 0.95-1.47).
Further, most patients (90-96%) were “not at all” or “a little bit” bothered by side effects of therapy though most (70-79%) responded to “I have lack of energy” with “not at all” or “a little bit”, based on the assessment between baseline and cycle 39. Additionally, comparably in both treatment groups, the side effects bother and fatigue were stable over time.
Further, PRO scores were similar in both groups prior to radiographic progression of disease (rPD) and at last observation. The authors, therefore, conclude the, within the context of the ACIS trial, intensified treatment with apalutamide in addition to abiraterone and prednisone maintained HRQoL prior to rPD.
Presented by: Stephane M. Oudard, MD, PhD, Georges Pompidou Hospital, Paris, France