Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017
Re-treatment with radium-223: first experience from an international, open-label, phase I/II study in patients with castration-resistant prostate cancer and bone metastases.
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Radium-223 dichloride in prostate cancer: proof of principle for the use of targeted alpha treatment in clinical practice.European journal of nuclear medicine and molecular imaging · 2020Pooled it
- Trial
- Ocular complications with the use of radium-223: a case series.Radiation oncology (London, England) · 2022Article
- Updates in Management of Bone Metastatic Disease in Primary Solid Tumors with Systemic Therapies.Current osteoporosis reports · 2021Review
- Emerging role of tumor cell plasticity in modifying therapeutic response.Signal transduction and targeted therapy · 2020Review
- Targeted α-Therapy in Cancer Management: Synopsis of Preclinical and Clinical Studies.Cancer biotherapy & radiopharmaceuticals · 2020Article
- α-Emitters for Radiotherapy: From Basic Radiochemistry to Clinical Studies-Part 2.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2018Review
- Radium and other alpha emitters in prostate cancer.Translational andrology and urology · 2018Review
- Targeted α Therapies for the Treatment of Bone Metastases.International journal of molecular sciences · 2017Review
Corrections and comments
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Authors and funding
16 authors at 15 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSix radium-223 injections at 4-week intervals is indicated for patients with castration-resistant prostate cancer and symptomatic bone metastases. However, patients usually develop disease progression after initial treatment. This prospective phase I/II study assessed re-treatment safety and efficacy of up to six additional radium-223 injections. PATIENTS AND
methodsPatients had castration-resistant prostate cancer and bone metastases and six initial radium-223 injections with no on-treatment bone progression; all had subsequent radiologic or clinical progression. Concomitant agents were allowed at investigator discretion, excluding chemotherapy and initiation of new abiraterone or enzalutamide. The primary endpoint was safety; additional exploratory endpoints included time to radiographic bone progression, time to total alkaline phosphatase and prostate-specific antigen progression, radiographic progression-free survival, overall survival, time to first symptomatic skeletal event (SSE), SSE-free survival, and time to pain progression.
resultsAmong 44 patients, 29 (66%) received all six re-treatment injections. Median time from end of initial radium-223 treatment was 6 months. Forty-one (93%) reported ≥1 treatment-emergent adverse event. No grade 4-5 hematologic treatment-emergent adverse events occurred. Only one (2%) patient had radiographic bone progression; eight (18%) had radiographic soft tissue tumor progression (three lymph node and five visceral metastases). Median times to total alkaline phosphatase and prostate-specific antigen progression were not reached and 2.2 months, respectively. Median radiographic progression-free survival was 9.9 months (12.8-month maximum follow-up). Five (11%) patients died and eight (18%) experienced first SSEs. Median overall survival, time to first SSE, and SSE-free survival were not reached. Five (14%) of 36 evaluable patients (baseline worst pain score ≤7) had pain progression. After 2 years of follow-up, 28 (64%) patients died, and the median overall survival was 24.4 months.
conclusionsRe-treatment with a second course of six radium-223 injections after disease progression is well tolerated, with minimal hematologic toxicity and low radiographic bone progression rates in this small study with limited follow-up. Favorable safety and early effects on disease progression indicate that radium-223 re-treatment is feasible and warrants further evaluation in larger prospective trials.
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