1.Proximal basilar artery hemorrhage after submaximal angioplasty for intracranial atherosclerotic disease presenting as a large vessel occlusion treated with pipeline embolization device
Ryan M. JOHNSON ; Michael YOUNG ; Gina N. GUGLIELMI ; Hamad FARHAT
Journal of Cerebrovascular and Endovascular Neurosurgery 2021;23(2):145-151
Iatrogenic vessel perforation from endovascular intervention is a devastating complication that commonly is treated with vessel sacrifice. We present a unique case of an iatrogenic proximal basilar artery perforation after submaximal angioplasty in a 67-year-old male presenting with an acute basilar artery occlusion with underlying intracranial atherosclerotic disease. Telescoping flow-diverting stents were then deployed to reconstruct the vessel wall with resulting active hemorrhage resolution. Our case documents a successful deployment of flow-diverting stents with resolution of active hemorrhage after an iatrogenic basilar artery perforation.
2.Proximal basilar artery hemorrhage after submaximal angioplasty for intracranial atherosclerotic disease presenting as a large vessel occlusion treated with pipeline embolization device
Ryan M. JOHNSON ; Michael YOUNG ; Gina N. GUGLIELMI ; Hamad FARHAT
Journal of Cerebrovascular and Endovascular Neurosurgery 2021;23(2):145-151
Iatrogenic vessel perforation from endovascular intervention is a devastating complication that commonly is treated with vessel sacrifice. We present a unique case of an iatrogenic proximal basilar artery perforation after submaximal angioplasty in a 67-year-old male presenting with an acute basilar artery occlusion with underlying intracranial atherosclerotic disease. Telescoping flow-diverting stents were then deployed to reconstruct the vessel wall with resulting active hemorrhage resolution. Our case documents a successful deployment of flow-diverting stents with resolution of active hemorrhage after an iatrogenic basilar artery perforation.
3.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.
4.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.
5.Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Abiraterone Clinical Trials
Matthew RASHID ; Eli OLDHAM ; Griffin K. HUGHES ; Andriana M. PEÑA ; Chase LADD ; Brooke GARDNER ; Ryan MCINTIRE ; Bradley JOHNSON ; Jordan TUIA ; Alyson HASLAM ; Vinay PRASAD ; Matt VASSAR
Journal of Urologic Oncology 2024;22(3):211-223
Purpose:
Our study aimed to evaluate the risk and benefit profiles of clinical trials using abiraterone in cancer treatment.
Materials and Methods:
A comprehensive search was conducted on May 24, 2023, using databases such as PubMed, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. We extracted data on adverse events, progression-free survival, overall survival, objective response rate (ORR), and prostate-specific antigen response rate (PSA-RR). The Common Terminology Criteria for Adverse Events were used to assess risks, while ORR and PSA-RR were used to assess benefits. Trials were categorized as positive, negative, or indeterminate based on their safety profiles and efficacy outcomes.
Results:
Nearly all clinical trials testing abiraterone in prostate cancer showed promising outcomes with 89% of studies meeting their endpoint. Our study supports abiraterone’s use in prostate cancer, its only U.S. Food and Drug Administration-approved indication to treat, with a median ORR of 20.0% and a median PSA-RR of 42.0%. However, when looking at the 3 novel indications tested, the risk-to-benefit profile was similar to that of its original approval. Even though most novel indications failed to meet their primary endpoint, the overall toxicity profile was similar to that found in prostate cancer.
Conclusion
Abiraterone showed an overall risk-to-benefit portfolio that supports the use of its treatment in prostate cancer. Although the primary endpoints in ovarian and breast cancer trials were not met, the use was appropriate when assessing how the mechanism of action for abiraterone could be beneficial in patients with these types of cancers.