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Meeting

Event Title
FDA/CDER-AACR-IASLC Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials
February 28, 2020


Date:
February 28, 2020
Time:
8:00 AM - 5:00 PM ET

FDA-AACR-IASLC Workshop: Final Agenda (PDF - 176 KB)

Co-Sponsors: American Association for Cancer Research (AACR) & International Association for the Study of Lung Cancer (IASLC)

Date: 2/28/2020
Time: 8 AM – 5 PM
Location: White Oak Campus, Great Room
Registration: If you wish to attend the workshop, please register at the following link https://www.surveymonkey.com/r/TUO

Background:

The continued use of tobacco in individuals who have been diagnosed with cancer continues to be a significant healthcare problem. Tobacco use remains the leading cause of preventable death worldwide and is a significant risk factor for oncologic, cardiorespiratory, and pulmonary diseases. According to the U.S. Surgeon General’s Report in 2014, there is enough evidence to infer a causal relationship between smoking and most cancers. Furthermore, cancer patients who continue to smoke cigarettes have higher all-cause and cancer-specific mortality and may have a higher risk of cancer recurrence, poorer response to treatment, and increased treatment toxicity.

Smoking cessation is associated with a reduction in all-cause mortality among cancer patients, regardless of past smoking history. Despite this, tobacco use is infrequently or inadequately assessed or captured in cancer clinical intervention trials. To further improve clinical treatment interventions, it is critical for clinical trials uniformly assess tobacco use and evaluate its impact on therapeutic outcomes. In 2013, the National Cancer Institute-American Association for Cancer Research (NCI-AACR) Cancer Patient Tobacco Use Assessment Task Force was established to identify high priority research related to tobacco use by cancer patients; to develop measures tailored to the trajectory of cancer diagnosis, treatment and survivorship. Continued research is needed to elucidate the effects of exposure, use, and cessation of tobacco and its constituents in all products before diagnosis, during treatment, or during survivorship on: tumor response, cancer treatment efficacy and dosing, symptom burden, and quality of life. Despite the national effort to improve cancer patient’s access to cessation services, tobacco use as both prognostic and predictive variables will remain critical for valid tests of new cancer therapies.

The FDA, AACR, and IASLC have expressed a willingness to leverage their combined strengths for the join development of the substantive actions of this workshop on the criticality of assessing the use of tobacco in oncology clinical trials.

Goals and Objectives:

  • The primary goal of the Workshop is to provide a forum for open discussion between the public, academia, industry, FDA, and other stakeholders to improve public understanding of the significance of persistent tobacco use on outcomes clinical trials that test therapies for cancer, cardiovascular, and pulmonary diseases
  • To share and improve upon current knowledge of the impact tobacco use on outcomes in clinical trials and its importance for regulatory review
  • To identify best practices and barriers to assessing tobacco use in clinical trials
  • To create a mechanism for increasing accurate tobacco use assessment within clinical trials

Webcast Information

A free-of-charge webcast of this workshop will be provided for those unable to attend in person. Registration for the webcast is required.

FDA plans to post archived webcasts after the meeting, however, in cases where the transmission was not successful, archived webcasts will not be available. The link for the webcast will be provided to all registered no less than 24 hours prior to the start of the workshop.

Webcast Link: https://collaboration.fda.gov/fdaaacriaslc/

Workshop Information: (documents will be added when available)

Contacts:

Sarah Martin, MS, PhD
Director, Regulatory Science and Policy
Office of Science Policy and Government Affairs
American Association for Cancer Research (AACR)
1401 H Street, NW, Suite 740
Washington, DC 20005
Sarah.Martin@aacr.org

Jacinta Wiens, MS, PhD
Associate Director Scientific Affairs
International Association for the Study of Lung Cancer (IASLC)
13100 E Colfax Ave, Unit 10
Aurora, CO 80010
Jacinta.Wiens@iaslc.org

Laura B. Wisch
Oncology Center of Excellence
Food and Drug Administration
10903 New Hampshire Avenue
Building 22, Office 2243
Silver Spring, MD 21029
Laura.Wisch@fda.hhs.gov