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  ES24 - Challenges in Tobacco Control (ID 190)

  • Event: WCLC 2020
  • Type: Educational Session
  • Track: Risk Reduction and Tobacco Control
  • Presentations: 1
  • Moderators:
  • Coordinates: 1/31/2021, 11:45 - 12:45, Scientific Program Auditorium

  • 35745

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    ES24.02 - The Rationale for FDA (and EMA) Regulatory Review of Tobacco Use in Clinical Trials (ID 4028)

    11:45 - 12:45  |  Presenting Author(s): Stephanie Land
    • Abstract
    • Presentation
    • Slides

    Abstract
    

    Tobacco use is an important prognostic factor for cancer patients, and it is also a predictive factor; that is, it can reduce the efficacy of cancer treatment.(DHHS, 2014) Studies comparing cancer patients who smoke cigarettes at the time of diagnosis to former or never smokers have demonstrated increased difficulty with surgical wound healing and more treatment morbidity; increased total symptom burden, reduced radiation and chemotherapy efficacy; reduced time to recurrence, progression, risk of second primary cancers; and increased mortality.(Japuntich et al. 2019, Petros et al. 2012, Peppone et al. 2011, Kaufman et al. 2008) Assessment of tobacco use is therefore essential to cancer clinical care, research on novel cancer therapies, and research on the effects of tobacco use after cancer diagnosis. Cancer therapy trialists, regulators, clinicians, and patients will need to consider tobacco use as they evaluate treatments and likely outcomes.

    Despite this, tobacco use is infrequently or inadequately captured in cancer clinical trials.(Land 2012, Peters et al. 2016) Current studies either do not include tobacco use assessment or use questionnaires that do not allow for data pooling and comparisons across trials. To address these concerns, in 2013, the U.S. National Cancer Institute (NCI)-American Association for Cancer Research (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; and to recommend the timing of tobacco use assessment in cancer clinical trials. The Task Force developed a set of items for baseline and longitudinal assessment of tobacco use in the cancer setting, known as the Cancer Patient Tobacco Use Questionnaire (C-TUQ).(Land et al. 2016) Longitudinal assessment is necessary because tobacco users may quit before or after cancer diagnosis and treatment, but relapse may occur at any time. This validated questionnaire addresses use of other tobacco products (such as e-cigarettes), secondhand smoke exposure, and cessation, to standardize tobacco use assessment and improve evaluation of cancer treatments.

    Although tobacco use is a known risk factor for adverse clinical outcomes,(2014) gaps in the literature remain. The majority of published evidence relates to combustible cigarette smoking during oncologic treatment despite the heightened prevalence and uptake of alternative tobacco products (e.g. electronic nicotine delivery systems, hookah, pipes, snus, smokeless tobacco, cigarillos).(Land et al. 2016, Borderud et al. 2014) 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.(Land et al. 2016)

    In 2020, the U.S. Food and Drug Administration, IASLC, and AACR co-sponsored the Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials. NCI provided scientific input. The purpose of this workshop was to generate discussion of tobacco assessment in clinical trials, and to improve understanding of the significance of continued tobacco use on health outcomes. To further improve cancer treatment interventions, it is critical for clinical trials to uniformly assess tobacco use and evaluate its impact on therapeutic outcomes.(Gritz, Dresler, and Sarna 2005)

    References

    DHHS, 2014. "The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General." In. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

    Borderud, Sarah P, Yuelin Li, Jack E Burkhalter, Christine E Sheffer, and Jamie S Ostroff. 2014. "Electronic cigarette use among patients with cancer: characteristics of electronic cigarette users and their smoking cessation outcomes." Cancer no. 120 (22):3527-3535.

    Gritz, E. R., C. Dresler, and L. Sarna. 2005. "Smoking, the missing drug interaction in clinical trials: ignoring the obvious." Cancer Epidemiol Biomarkers Prev no. 14 (10):2287-93.

    Japuntich, S. J., P. Kumar, J. F. Pendergast, G. Y. Juarez Caballero, J. L. Malin, R. B. Wallace, E. A. Chrischilles, N. L. Keating, and E. R. Park. 2019. "Smoking Status and Survival Among a National Cohort of Lung and Colorectal Cancer Patients." Nicotine Tob Res no. 21 (4):497-504.

    Kaufman, E. L., J. S. Jacobson, D. L. Hershman, M. Desai, and A. I. Neugut. 2008. "Effect of breast cancer radiotherapy and cigarette smoking on risk of second primary lung cancer." J Clin Oncol no. 26 (3):392-8.

    Land, S. R. 2012. "Methodologic barriers to addressing critical questions about tobacco and cancer prognosis." J Clin Oncol no. 30 (17):2030-2.

    Land, S. R., B. A. Toll, C. M. Moinpour, S. A. Mitchell, J. S. Ostroff, D. K. Hatsukami, S. A. Duffy, E. R. Gritz, N. A. Rigotti, T. H. Brandon, S. A. Prindiville, L. P. Sarna, R. A. Schnoll, R. S. Herbst, P. M. Cinciripini, S. J. Leischow, C. M. Dresler, M. C. Fiore, and G. W. Warren. 2016. "Research priorities, measures, and recommendations for assessment of tobacco use in clinical cancer research." Clin Cancer Res no. 22 (8):1907-13.

    Peppone, L. J., K. M. Mustian, G. R. Morrow, A. M. Dozier, D. J. Ossip, M. C. Janelsins, L. K. Sprod, and S. McIntosh. 2011. "The effect of cigarette smoking on cancer treatment-related side effects." Oncologist no. 16 (12):1784-92.

    Peters, E. N., G. W. Warren, J. A. Sloan, and J. R. Marshall. 2016. "Tobacco assessment in completed lung cancer treatment trials." Cancer no. 122 (21):3260-3262.

    Petros, William P, Islam R Younis, James N Ford, and Scott A Weed. 2012. "Effects of tobacco smoking and nicotine on cancer treatment." Pharmacotherapy no. 32 (10):920-931.

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