Janssen-Cilag International NV has announced the publication of data revealing radiographic progression-free survival (rPFS) of 16.5 months (95% CI, 13.5–20.0) and treatment duration of 11.6 months (95% CI, 10.2–12.8) in men treated with Zytiga® (abiraterone acetate) plus prednisone (AAP), in the real-world, outside the clinical trial setting.
Janssen-Cilag International NV has announced the publication of data revealing radiographic progression-free survival (rPFS) of 16.5 months (95% CI, 13.5–20.0) and treatment duration of 11.6 months (95% CI, 10.2–12.8) in men treated with Zytiga® (abiraterone acetate) plus prednisone (AAP), in the real-world, outside the clinical trial setting.
The study assessed men being treated for asymptomatic and mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), following androgen deprivation therapy (ADT).1 These valuable insights were shown despite the real-world study population including those who had a poor prognosis or were difficult-to-treat patients, usually excluded from clinical trials. These data are part of a comprehensive real-world evidence (RWE) portfolio being presented by Janssen at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in Orlando, Florida.
“Real-world evidence research is key in patient-focused clinical practice, as it helps physicians to better address patient needs. It complements data obtained from clinical trials to provide greater understanding of treatment outcomes, disease management and impact on quality of life in broad patient populations, including those with comorbidities,”said Dr Martin Boegemann, Department of Urology, Muenster University Medical Center, Muenster, Germany. ”It is helpful to see new data for treatment outcomes in real world patients confirm those seen in a clinical trial setting. These new findings add to the growing bank of real-world evidence available across Europe, which is becoming more and more important in helping us choose the best treatments to transform patient outcomes.”
Patients in the pivotal COU–AA–302 trial reached a median duration of treatment of 13.8 months (IQR, 8.3–27.4) and a median rPFS of 16.5 months (95% CI, 13.8–16.8).1–4 Results were similar across both settings, despite almost 10% of patients in the RWE study having visceral metastases (metastases to internal organs, that is the liver and/or lungs) and/or an Eastern Cooperative Oncology Group (ECOG) performance status of 2-3 (those unable to carry out work, but still capable or partially capable of self-care).1 These patients were not included in the COU-AA-302 study.4
References
- Boegemann et al. Real-world treatment with abiraterone acetate in chemotherapy-naïve metastatic castration-resistant prostate cancer patients. Poster presented at the American Society of Clinical Oncology Genitourinary Symposium 2017, February 16—18, Orlando, Florida, USA. Poster presentation. ASCO GU abstract #239. Last accessed February 2017.
- Rathkopf et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol 2014; 66: 815-825. Last accessed February 2017.
- Ryan CJ et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med 2013;368(2):138—48.
- Ryan CJ et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2015;16(2):152—60. www.thelancet.com/journals/lanonc/article/PIIS1470-2045(14)71205-7/abstract. Last accessed February 2017.
