The durable responses and generally well-tolerated side effects characteristic of cancer immunotherapy agents, particularly immune checkpoint inhibitors, have led to an influx of approvals for a growing number of malignancies. However, as more patients turn to immune-based treatments, and as the potential to improve patient outcomes using combination immunotherapy grows, knowledge about how to recognize and manage the associated toxicities must be disseminated broadly and rapidly.
There is an urgent need among practicing oncologists and nurses for treatment algorithms that guide management of immunotherapy-related toxicities. Similarly, standardized templates for reporting adverse events in clinical trials are needed in order to facilitate monitoring and reporting of toxicities, an effort which is considered a high priority by the FDA. To this end, SITC is taking the lead to convene a one-day Toxicity Management Workshop on Friday, March 31, 2017, in Washington, D.C.
The workshop will address two pressing needs for the advancement of the field:
- Creating treatment algorithms for managing immunotherapy-related toxicities
- Developing standardized templates for adverse event management in protocols for clinical trials
The workshop will be a multi-stakeholder effort of 200 thought leaders from government, academia, industry, scientific organizations and other related entities. These stakeholders want to move quickly and convene to address the growing need for standardization to provide better treatments and ultimately, improve patient outcomes. Workshop outcomes will result in a publication.
Organizers
Marc S. Ernstoff, MD – Roswell Park Cancer Institute
Igor Puzanov, MD, MSCI, FACP – Roswell Park Cancer Institute
Caroline Robert, MD, PhD – Institut Gustave Roussy
Steering Committee
Adi Diab, MD – University of Texas MD Anderson Cancer Center
Howard L. Kaufman, MD, FACS – Rutgers Cancer Institute of New Jersey
Theodore F. Logan, MD – Indiana University Simon Cancer Center
Jason J. Luke, MD, FACP – University of Chicago
Agenda
8 – 8:10 a.m. SITC Welcome
Howard L. Kaufman, MD, FACS - Rutgers Cancer Institute of New Jersey
Program Welcome & Introduction
Marc S. Ernstoff, MD – Roswell Park Cancer Institute
Session I: Common Toxicity Management Discussion
Goals: (1) Develop Treatment Algorithms for Managing Toxicity
(2) Build Consensus Language for Toxicity Management in Clinical Trial Protocols
8:10 – 8:15 a.m. Body System Break-Outs
Dermatology
Endocrinology
Gastroenterology
Pulmonary
Rheumatology
8:15 – 10 a.m. Treatment Algorithm Development for Toxicity Management
10 – 11 a.m. Consensus Language Building for Clinical Trial Protocols
11 – 11:15 a.m. Break
11:15 a.m. – 1 p.m. Group Reporting and Consensus Building
Session II: Rare Toxicity Management Discussion
Goals: (1) Develop Treatment Algorithms for Managing Toxicity
(2) Build Consensus Language for Toxicity Management in Clinical Trial Protocols
1 – 1:30 p.m. Working Lunch
1 – 1:15 p.m. Body System Break-Outs
Cardiology
Hematology
Neonatology
Nephrology
Neurology
Ophthalmology
1:15 – 4 p.m. Treatment Algorithm Development for Toxicity Management
4 – 4:15 p.m. Break
4:15 – 5 p.m. Consensus Language Building for Clinical Trial Protocols
5 – 5:55 p.m. Group Reporting and Consensus Building
5:55 – 6 p.m. Closing Remarks
Igor Puzanov, MD, MSCI, FACP – Roswell Park Cancer Institute
Support
The Toxicity Management Workshop is supported in part by grants from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb and Merck & Co., Inc.
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