Each recommendation is accompanied by specific action items. In one item, regulatory agencies, clinical research funders, and researchers are urged to consider whether evidence exists to support limitations to eligibility criteria based on age, performance status, or comorbid conditions.

In another, researchers and research funders are encouraged to ensure their systems collect geriatric assessment data and are able to support studies that will improve the evidence base for treating older adults with cancer.

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The paper noted that some of its recommendations are achievable in the short-term, while others require longer commitments and participation by multiple stakeholders in clinical research.

Updating Eligibility Requirements for Molecular Trials

The recommendations were accompanied with a paper by ASCO’s Cancer Research Committee that studied the importance and utility of eligibility criteria for molecular trials. In “Modernizing Eligibility Requirements for Molecularly Driven Trials,” the Committee evaluated whether excessive eligibility requirements may restrict study populations to the point that they are not representative of the general population for which the drug would be prescribed.

While the results of the evaluation were mixed, the Committee recommended organizing a public workshop involving regulatory bodies and key stakeholders to develop an approach that could streamline eligibility criteria for molecularly driven trials. The workshop is planned for Fall of 2016.

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The paper’s lead author, Edward Kim, MD, chair of solid tumor oncology and investigational therapeutics at Carolinas HealthCare System’s Levine Cancer Institute, in Charlotte, NC, and Immediate Past Chair of the ASCO Cancer Research Committee, stated in a press release that “enrollment into clinical trials has not been optimal and needs urgent reassessment. The era of molecularly-targeted therapy is an exciting one and requires us to reevaluate how we meet this primary objective in order to expedite approval of promising drugs into the clinic.”4

References

  1. Hurria A, Levit LA, Dale W, et al. Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement [published online ahead of print July 20, 2015]. J Clin Oncol. doi:10.1200/JCO.2015.62.1854.
  2. National Cancer Institute. SEER Stat Fact Sheets: Cancer of All Sites. National Cancer Institute Web site. http://seer.cancer.gov/statfacts/html/all.html. Accessed July 24, 2015.
  3. U.S. Census Bureau. 2010 Census Shows 65 and Older Population Growing Faster Than Total US Population. US Census Newsroom Archive Web site. https://www.census.gov/newsroom/releases/archives/2010_census/cb11-cn192.html. Published November 30, 2011. Accessed July 24, 2015.
  4. ASCO Urges Expansion of Care to Include More Older Adults [press release]. Alexandria, VA: American Society of Clinical Oncology; July 20, 2015. http://www.asco.org/press-center/asco-urges-expansion-cancer-research-include-more-older-adults. Accessed July 24, 2015.

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