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Comparing Metastatic Prostate Cancer Drugs
- 1. Presented by : Muhammad Zaky Comparison of Systemic Treatment for Metastatic Castration-Sensitive Prostate Cancer Lin Wang, MD, MSc; Channing J. Paller, MD; Hwanhee Hong, PhD; Anthony De Felice, MHS; G. Caleb Alexander, MD, MSc; Otis Brawley, MD January 2021 Journal of the American Medical Association
- 2. Introduction ● The research compared effectiveness and safety about the drugs is limitless PROSTATE CANCER Is the most common cancer among men in US ADT for terapy mCSPC Combined with : • Docetaxel • Abiraterone • Apalutamide • Enzalutamide mCRPC
- 3. Methods • The interventions of interest : Docetaxel, Abiraterone Acetate, Apalutamide and Enzalutamide • The comparator of interest : Any Drug, Placebo or No Treatment • Median follow up at least 12 months ELIGIBILITY CRITERIA EXCLUTION CRITERIA Cluster design & dose escalation trials INCLUTION CRITERIA RCTs of Parallel design for mCSPC
- 4. Continue… Bibliographic database (MEDLINE (PubMed Interface) EMBASE (OVID interface) The Cochrane Central Register of Controlled Trial (CENTRAL, Wiley interface) Trial Registries (ClinicalTrials.gov and the EU Clinical Trials Register) Regulatory Documents (US FDA and European Medicines Agency review packets) DATA SOURCES
- 5. Risk of Bias Assessment ● Using the Cochrane Collaboration tool ● Statistical Analysis : Bayesian network meta - analysis
- 6. RESULT
- 10. CONCLUSIONS Abiraterone acetate and Apalutamide may provide the largest OS benefits with relatively low SAE risk Enzalutamide may improve rPFS to the greatest extent, longer follow up is needed to examine its OS benefits
- 12. Validity 1. Is the clinical question clearly focused with regard to: PICO Population? YES
- 13. Validity 1. Is the clinical question clearly focused with regard to: PICO Intervention? YES
- 14. Validity 1. Is the clinical question clearly focused with regard to: PICO Comparison? YES
- 15. Validity 1. Is the clinical question clearly focused with regard to: Outcome? YES
- 16. Validity 2. Are the criteria for the selection of the studies to be included in the review in accordance with: ● the specifications of the foregoing question in regard to populations, interventions and results? YES
- 17. Validity 2. Are the criteria for the selection of the studies to be included in the review in accordance with: ● the type of research design that will be chosen? YES
- 18. Validity 3. Is the literature search method clearly specified? YES
- 19. Validity 4. Have the identified studies been evaluated for methodological quality? YES
- 20. Validity 5. Was quality evaluation carried out by more than one person independently, establishing the degree of agreement between them? YES
- 22. INTERPRETATION 1. Were the results consistent from one study to another? YES
- 23. INTERPRETATION 2. What were the results of the review?
- 24. INTERPRETATION 3. How precise were the results? Large sample size (n=7287) Confidence interval 95%
- 26. APPLICABILITY OF THE RESULTS 1. Are my patients similar to the patients included in the original studies? Yes (most included trials were multinational, recruiting patients from America, Europe, Asia, and Oceania) 2. Is the intervention feasible in my environment? Yes (the treatment is available in Indonesia) 3. Do the benefits outweigh the potential harm and costs? Yes. It is explain side effect of treatment. Which is more higher than other.
- 27. THANK YOU
Editor's Notes
- 1. Table of contents 2. Introduction 3. Identifying information 4. Patient medical history 5. Review of systems 6. Physical examination 7. Big picture 8. Findings 9. Discussion 10. Discussion summary 11. Comparison 12. Diagnosis 13. Treatment 14. Patient monitoring 15. Contraindications and indications 16. Post-prevention 17. Case timeline 18. Conclusions 19. References 20. Our team
- Parallel design RCT means subject are randomized to one or more study arms and each study arm will be allocated a different intervention Dose escalation means sequentially administering increasing doses of an investigational drug or biologic to different cohorts of study subject until a highest dose that does not cause harmful side effect Cluster design means groups or cluster of individual than individuals themselves are randomized
- Bayesian network meta analysis is a method of statistical inference (named for English mathematician Thomas Bayes) that allows one to combine prior information about a population parameter with evidence from information contained in a sample to guide the statistical inference process.
- The inverse of variance of hazard ratios of OS
- Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome.
- 1. Table of contents 2. Introduction 3. Identifying information 4. Patient medical history 5. Review of systems 6. Physical examination 7. Big picture 8. Findings 9. Discussion 10. Discussion summary 11. Comparison 12. Diagnosis 13. Treatment 14. Patient monitoring 15. Contraindications and indications 16. Post-prevention 17. Case timeline 18. Conclusions 19. References 20. Our team