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Related Concept Videos

Radiological Investigation III: Pulmonary Angiogram and PET Scan01:13

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Radiological investigations are paramount in the diagnosis and management of various pulmonary diseases. Two essential investigations are the Pulmonary Angiogram and the Positron Emission Tomography (PET) Scan.
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A Pulmonary Angiogram is an invasive procedure involving injecting a contrast medium through a catheter threaded into the pulmonary artery or the right side of the heart to visualize the pulmonary vasculature. Computed Tomography (CT) scans have mainly replaced this...
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Positron Emission Tomography (PET) is a medical imaging technique that provides crucial insights into the body's physiological functions at a molecular level. It is an indispensable resource for diagnosing, staging, and monitoring various illnesses, notably cancer, neurological disorders, and cardiovascular conditions.
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Drug Utilisation of Radium-223 Under Routine Clinical Practice (DIRECT) in Europe: A Post-Authorisation Safety Study.

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This summary is machine-generated.

Radium-223 use in metastatic castration-resistant prostate cancer largely followed updated guidelines after 2018. However, use without prior systemic therapies remained common in some regions, suggesting continued physician consideration for specific patient groups.

Keywords:
Drug utilisation studyMetastatic castration-resistant prostate cancer (mCRPC)Post-authorisation safety studyRadium-223

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Area of Science:

  • Oncology
  • Radiopharmaceutical Therapy
  • Prostate Cancer Research

Background:

  • Radium-223 is approved for metastatic castration-resistant prostate cancer (mCRPC) with bone metastases, excluding visceral disease, after ≥2 prior systemic therapies or ineligibility.
  • A 2018 European Medicines Agency (EMA) label update revised criteria and added a contraindication for combining radium-223 with abiraterone acetate and prednisone/prednisolone.
  • Compliance with the revised 2018 EMA label for radium-223 use in mCRPC was evaluated in a multi-country observational cohort study.

Purpose of the Study:

  • To assess adherence to the 2018 EMA revised label for radium-223 in patients with mCRPC.
  • To analyze the utilization patterns of radium-223 before and after the 2018 label update across different European countries.
  • To investigate the frequency of radium-223 use in combination with other systemic therapies and in relation to prior treatment lines.

Main Methods:

  • An observational cohort study analyzed radium-223 initiation in the Netherlands, Germany, and Denmark.
  • Data were collected for periods before (2013-2017) and after (2019-2020) the 2018 EMA label change.
  • Descriptive analysis focused on the proportion of patients receiving radium-223, including its use with other systemic therapies and prior treatment lines, with at least 6 months of follow-up.

Main Results:

  • A total of 1070 patients were included in the study.
  • Radium-223 use in combination with abiraterone acetate or other systemic therapies decreased post-label change in the Netherlands and Germany, and was rare in Denmark.
  • Use of radium-223 without at least two prior systemic mCRPC therapies decreased but remained relatively common in the Netherlands and Germany after the label update.

Conclusions:

  • Radium-223 use largely aligned with the 2018 EMA label regarding combinations with other systemic therapies.
  • Continued use of radium-223 without meeting prior treatment line criteria in the Netherlands and Germany may reflect historical recommendations for frail patients or physician discretion.
  • The study could not assess contraindications for other systemic therapies, potentially influencing the interpretation of on-label radium-223 use.