On February 17, 2017 Janssen-Cilag International NV reported 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 (Press release, Johnson & Johnson, FEB 17, 2017, View Source [SID1234517761]). 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 (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in Orlando, Florida.
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"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).1,2,3,4 Results were similar across both settings, despite almost 10% of patients in the RWE study having visceral metastases (metastases to internal organs i.e. 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
Further to this, additional findings from The Prostate Cancer Registry, Europe’s first and largest prospective RWE study in mCRPC are being presented at ASCO (Free ASCO Whitepaper) GU.5 The Prostate Cancer Registry was initiated in 2013, as a long-term commitment by Janssen to address optimal treatment of mCRPC in routine practice in the real world. It has enrolled over 3,000 mCRPC patients in 199 centres across 16 European countries.5
Dr Ivo Winiger-Candolfi, Oncology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa (EMEA) said: "Real-world evidence is extremely valuable in offering findings that complement clinical trials and provide significant insights into the performance and the use of a drug in real-world medical settings which will ultimately translate into how to best treat patients. This is particularly evident in prostate cancer, as it is the most common cancer in men and has a diverse patient population with varying treatment needs. Janssen is continuing to support real-world evidence research to help transform patient outcomes, with the aim of making cancer a more manageable condition in the future."
Prostate cancer is the most commonly diagnosed cancer in men, with over 400,000 new cases diagnosed in Europe each year.6 Latest prostate cancer figures show that there are currently three million men living with the disease in Europe.7
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NOTES TO EDITORS
About the Boegemann et al. study
The Boegemann et al. study is a retrospective chart review of 224 asymptomatic and mildly symptomatic post-ADT mCRPC patients treated with ZYTIGA (abiraterone acetate) plus prednisone (AAP) from 18 centres across Belgium, Germany and the UK.1
The real-world study included patients with visceral metastases (metastases to internal organs i.e. the liver and/or lungs) (9.8%) and those with 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) (9.4%) (patients usually excluded from the clinical trial setting).1
About The Prostate Cancer Registry
The Prostate Cancer Registry was initiated in 2013 as a long-term commitment by Janssen to address optimal treatment of mCRPC in routine practice. The Registry was designed in consultation with specialists in mCRPC and examines patients being managed in a range of oncology and urology settings, with the aim of reflecting routine clinical practice. 8
Patients are enrolled upon initiating a treatment for mCRPC or a period of surveillance, defined as not currently receiving an active treatment for castration resistance. The Registry is prospectively collecting data on a pan-European scale on patient demography and status, treatment sequencing and effectiveness, ongoing disease management, quality of life, medical resource utilisation and outcomes.8
The first analysis was presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria and further data will be published regularly over the coming years.8
The latest Prostate Cancer Registry animation can be viewed here.
About ZYTIGA (abiraterone acetate)
ZYTIGA is the only approved therapy in mCRPC that inhibits production of androgens (which fuel prostate cancer growth) at all three sources that are important in prostate cancer – the testes, adrenals and the tumour itself.9,10,11
ZYTIGA has been approved in more than 90 countries and to date, has been prescribed to more than 269,500 men worldwide.12,13
Indication9
In 2011, ZYTIGA in combination with prednisone/prednisolone was approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
In December 2012, the EC granted an extension of the indication for ZYTIGA permitting its use, in combination with prednisone or prednisolone, for the treatment of mCRPC, in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.9
Further Information9
The most common adverse events seen with abiraterone acetate include urinary tract infection, hypokalaemia, hypertension, peripheral oedema and diarrhoea.
For a full list of side effects and for further information on dosage and administration, contraindications and other precautions when using ZYTIGA, please refer to the summary of product characteristics, which is available at: View Source