Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Integration
2.2. Statistical analysis
- Cohort A: 1021 patients treated with radium-223 dichloride alone.
- Cohort B: 542 patients treated not only with radium-223 dichloride, but also with other drugs.
3. Results
3.1. Outcome Analysis
3.2. Side Effect Profiling
- General hematotoxicity reactions include examples such as the PT Blood count abnormal with strong signal for both cohorts A (3.23%, PRR = 43.82) and B (1.11%, PRR = 14.94), as well as the term Bone marrow failure (1.76%, PRR = 12.42) for Set A.
- Red blood cell reactions include examples such as Haemoglobin decreased (Set A: 7.15%, PRR = 11.07; Set B: 3.69%, PRR = 5.71) or Anaemia (Set A: 3.43%, PRR = 2.98; Set B: 11.99%, PRR = 10.44).
- White blood cell reactions include terms like White blood cell count decreased (Set A: 1.86%, PRR = 3.48; Set B: 1.85%, PRR = 3.45) or Leukopenia (Set B: 2.21%, PRR = 8.39).
- Thrombocytopenia (Set A: 2.84%, PRR=4.8; Set B: 5.54%, PRR = 9.36) or Platelet count decreased (Set A: 4.21%, PRR = 7.52; Set B: 4.8%, PRR = 8.57).
- Neutropenia (Set B: 1.29%, PRR = 2.36), Febrile neutropenia (Set B: 1.29%, PRR = 4.24), or Neutrophil count decreased (Set A: 1.18%, PRR = 6.5).
- Pancytopenia (Set A: 1.96%, PRR = 5.99; Set B: 4.98%, PRR = 15.24)
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Outcome | Cohort (%) | |||||
---|---|---|---|---|---|---|
A | B | A ∪ B 1 | PC 2 | Cancer 3 | FAERS | |
Death | 18.81 | 23.43 | 20.41 | 26.35 | 24.71 | 10.11 |
Life threatening | 1.76 | 5.17 | 2.94 | 3.22 | 5.02 | 3.03 |
Hospitalization | 23.99 | 48.71 | 32.57 | 30.15 | 35.37 1 | 24.36 |
Side Effect (Reaction) | Cohort A: Only Xofigo | Cohort B: Xofigo and Other Drugs | ||||||
---|---|---|---|---|---|---|---|---|
Name | #Rank | AEs | %Set | PRR | #Rank | AEs | %Set | PRR |
Haemoglobin decreased 1 | 1 | 73 | 7.14985 | 11.07178 | 16 | 20 | 3.69004 | 5.7086 |
Nausea | 2 + | 51 | 4.9951 | 1.16074 | 3 | 64 | 11.80812 | 2.74418 |
Platelet count decreased 2 | 3 | 43 | 4.21156 | 7.52259 | 14 | 26 | 4.79705 | 8.56563 |
Malaise | 4 | 39 | 3.81978 | 1.56369 | 15 | 21 | 3.87454 | 1.58605 |
Diarrhoea | 5 + | 38 | 3.72184 | 1.25585 | 4 | 50 | 9.22509 | 3.11315 |
Anaemia 1 | 6 | 35 | 3.42801 | 2.98228 | 2 | 65 | 11.99262 | 10.43733 |
Bone pain | 7 | 35 | 3.42801 | 10.41557 | 7 | 32 | 5.90406 | 17.93774 |
Vomiting | 8 + | 34 | 3.33007 | 1.27435 | 8 | 30 | 5.53506 | 2.11824 |
Blood count abnormal 3 | 9 | 33 | 3.23213 | 43.82126 | >20 | 6 | 1.10701 | 14.94108 |
Fatigue | 10 + | 31 | 3.03624 | 0.83291 | 1 | 90 | 16.60517 | 4.5564 |
Thrombocytopenia 2 | 11 | 29 | 2.84035 | 4.80398 | 9 | 30 | 5.53506 | 9.36238 |
Asthenia | 12 + | 25 | 2.44858 | 1.17253 | 6 | 41 | 7.56458 | 3.62295 |
Pneumonia | 13 + | 21 | 2.05681 | 1.27006 | >20 | 17 | 3.13653 | 1.93684 |
Pancytopenia | 14 | 20 | 1.95886 | 5.98948 | 11 | 27 | 4.98155 | 15.23674 |
White blood cell count decreased | 15 | 19 | 1.86092 | 3.48364 | >20 | 10 | 1.84502 | 3.45335 |
Bone marrow failure 3 | 16 | 18 | 1.76298 | 12.42202 | >20 + | 5 | 0.92251 | 6.49296 |
Decreased appetite | 17 + | 17 | 1.66503 | 1.31554 | 5 | 45 | 8.30258 | 6.56207 |
Back pain | 18 + | 15 | 1.46915 | 1.13896 | 10 | 28 | 5.16605 | 4.00575 |
Weight decreased | 19 + | 14 | 1.3712 | 0.949 | 12 | 27 | 4.98155 | 3.44827 |
Neutrophil count decreased | 20 | 12 | 1.17532 | 6.49458 | >20 + | 3 | 0.55351 | 3.05684 |
Pyrexia | >20 + | 13 | 1.27326 | 0.65169 | 19 | 18 | 3.32103 | 1.69995 |
Dyspnoea | >20 + | 9 | 0.88149 | 0.28814 | 13 | 26 | 4.79705 | 1.56826 |
Osteonecrosis | >20 + | 9 | 0.88149 | 2.34167 | 17 | 19 | 3.50554 | 9.31611 |
Arthralgia | >20 + | 8 | 0.78355 | 0.40463 | 18 | 19 | 3.50554 | 1.81054 |
Headache | >20 + | 5 | 0.48972 | 0.14564 | 20 | 18 | 3.32103 | 0.98778 |
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Soldatos, T.G.; Iakovou, I.; Sachpekidis, C. Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data. Medicina 2019, 55, 149. https://doi.org/10.3390/medicina55050149
Soldatos TG, Iakovou I, Sachpekidis C. Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data. Medicina. 2019; 55(5):149. https://doi.org/10.3390/medicina55050149
Chicago/Turabian StyleSoldatos, Theodoros G., Ioannis Iakovou, and Christos Sachpekidis. 2019. "Retrospective Toxicological Profiling of Radium-223 Dichloride for the Treatment of Bone Metastases in Prostate Cancer Using Adverse Event Data" Medicina 55, no. 5: 149. https://doi.org/10.3390/medicina55050149