Patients with prostate cancer showed improvements after receiving Zytiga (abiraterone acetate), prednisone and Erleada (apalutamide) with another therapy, which did not affect health-related quality of life when compared with Casodex (bicalutamide), according to a phase 2 trial.
In specific, treatment of Zytiga and prednisone plus Erleada was used when patients also received salvage radiation and androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) Agonist after receiving radical prostatectomy. Researchers compared outcomes with this treatment regimen to one with salvage radiation, ADT and Casodex in the phase 2 FORMULA-509 trial.
Study highlights:
- The results indicated that patients receiving Zytiga, prednisone and Erleada experienced similar improvements in hormonal function, fatigue and cognitive impairment compared with patients receiving Casodex.
- The trial, involving 345 patients, showed that the intensified treatment with Zytiga, prednisone, and Erleada could be a promising alternative for those with rising PSA and unfavorable features after prostatectomy.
- Lead author Dr. Karen Hoffman emphasized the importance of understanding patient experiences, as their perception can differ from physician assessments, and the study's patient-reported outcomes were favorable.
Findings from the respective trial regarding patient-reported health-related quality of life (HRQoL) were presented at the 2024 ASCO Genitourinary Cancers Symposium.
According to the Mayo Clinic, a radical prostatectomy is a type of surgery to remove the entire prostate gland, along with surrounding lymph nodes in patients with prostate cancer.
Researchers from the trial provided three validated questionnaires to patients at baseline, at the end of treatment and one year after completing treatment to measure hormone function, fatigue and cognitive impairment.
“It is critical that we understand the impact of this more intensified ADT regimen and patient-reported health-related quality of life, as patient experience and perception can differ from physician assessment,” lead study author Dr. Karen Hoffman, of The University of Texas MD Anderson Cancer Center, said during the presentation.
“In the FORMULA-509 trial, health-related quality of life was assessed with validated questionnaires that were administered at baseline, at the end of treatment and one year after completion of treatment,” she said.
In the trial, 345 patients were randomized evenly into two arms: 172 in the Casodex arm and 173 in the Zytiga, prednisone and Erleada arm. Patients were evaluated using the three types of questionnaires relative to HRQoL.
Hormonal Function Domain
Patient-reported HRQoL from the end of treatment to one year after treatment improved to near baseline for hormonal function. For the questionnaire that evaluated hormonal function, the median scores for the Casodex arm were 95 at baseline, 75 at the end of treatment and 90 at 1-year follow-up. Higher scores meant greater function, according to the questionnaire.
In the Zytiga, prednisone and Erleada arm, the median hormonal ranges were 95, 75 and 90 (for baseline, end of treatment and one-year follow-up, respectively.
“With subsequent improvement towards baseline at one year, there was no difference in patient-reported hormonal function between the treatment arms at end of treatment and one year after completion of treatment,” said Hoffman.
Fatigue
Similar to hormonal function, there was no difference in patient-reported fatigue, Hoffman said.
Median scores for the fatigue questionnaire in the Casodex arm were 43.1 at baseline, 48.6 at the end of treatment and 46 at one-year follow-up. In the Zytiga, prednisone and Erleada arm, the median scores were 43.1 at baseline, 51 at the end of treatment and 46 at one-year follow-up. Higher scores indicated that patients had more fatigue, according to the questionnaire.
Cognitive Impairment
The median scores for cognitive impairment questionnaire were 27 in both the Casodex (and Zytiga, prednisone and Erleada arms, 28 for both arms at the end of treatment and 27 in both arms at one-year follow-up. This questionnaire was measured based on a score from 0 to 30: 27 to 30 indicated normal scores, 21 to 26 meant mild neurocognitive disorder and 20 or less meant a patient had dementia.
“Given these favorable patient-reported health-related quality of life outcomes, 6 months of intensified ADT with next-generation anti-androgens is an attractive treatment alternative to long-duration ADT for patients with rising PSA (prostate-specific antigen; type of blood test to detect prostate cancer) and unfavorable features after prostatectomy,” Hoffman concluded.
About FORMULA-509
FORMULA-509 is a randomized, phase 2 study evaluating the safety and effectiveness of 2 newer anti-hormonal drugs, Zytiga plus prednisone and Erleada with luteinizing hormone-releasing hormone agonist, a standard form of ADT.
All patients in the study had histologically confirmed prostate cancer, had a PSA ≥ 0.1 after receiving radical prostatectomy, and had at least one unfavorable risk factor, including—but not limited to—a Gleason score between 8 and 10, a PSA of 0.5 or more, pathologically positive lymph nodes, negative margins and/or local or regional recurrence on imaging.
The trial included two experimental arms: GnRH plus Casodex and GnRH plus Zytiga with prednisone and Erleada.
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