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Enrollment of Older Patients in Cancer Treatment Trials in Canada: Why is Age a Barrier?

Karen W.L. Yee, Joseph L. Pater, Lam Pho, Benny Zee, Lillian L. Siu

From the Princess Margaret Hospital, University Health Network, Toronto; and National Cancer Institute of Canada Clinical Trials Group, Queen’s University, Kingston, Ontario, Canada.

Address reprint requests to Lillian L. Siu, MD, Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, 610 University Ave, 5-210, Toronto, Ontario M5G 2M9, Canada; email: lillian.siu{at}uhn.on.ca.

Purpose: To evaluate the enrollment of older patients ( 65 years) in Canadian cancer treatment trials and compare accrual of older patients in Canada and the United States.

Patients and Methods: A retrospective analysis of the number of older patients enrolled in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) treatment trials between 1993 and 1996 was performed. These rates were compared with the corresponding rates in the general population of patients who were 65 years old and had cancer, obtained from Statistics Canada, and those published by the Southwest Oncology Group (SWOG) in the United States.

Results: Between 1993 and 1996, 4,174 patients were enrolled onto 69 NCIC CTG trials of 16 tumor types. Older patients accounted for 22% of trial enrollees, compared with 58% of the Canadian population with cancer. This discrepancy existed in all cancer types except for multiple myeloma. The percentages of older patients enrolled were also analyzed by study type: 15% in adjuvant trials, 25% in metastatic trials, 29% in investigational new drug trials, 24% in phase I trials, and 21% in supportive care trials. The overall proportion of older patients enrolled onto Canadian trials (22%) was slightly lower than that in SWOG trials (25%).

Conclusion: Age remains a barrier for accrual onto cancer treatment trials, even when reimbursement is not an issue. Strategies to overcome this barrier, including the implementation of trials specifically tailored to patients aged 65 years, are prudent in light of our aging population.

Presented in part at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12–15, 2001.

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