Yee Karen W L, Pater Joseph L, Pho Lam, Zee Benny, Siu Lillian L
Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, 610 University Ave, 5-210, Toronto, Ontario M5G 2M9, Canada.
J Clin Oncol. 2003 Apr 15;21(8):1618-23. doi: 10.1200/JCO.2003.12.044.
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.
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.
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%).
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.
评估加拿大癌症治疗试验中老年患者(≥65岁)的入组情况,并比较加拿大和美国老年患者的入组率。
对1993年至1996年间加拿大国家癌症研究所临床试验组(NCIC CTG)治疗试验中入组的老年患者数量进行回顾性分析。将这些比率与加拿大统计局提供的≥65岁癌症患者总体人群中的相应比率以及美国西南肿瘤协作组(SWOG)公布的比率进行比较。
1993年至1996年间,4174例患者入组了NCIC CTG的69项涉及16种肿瘤类型的试验。老年患者占试验入组者的22%,而加拿大癌症患者人群中这一比例为58%。除多发性骨髓瘤外,所有癌症类型均存在这种差异。还按研究类型分析了老年患者的入组百分比:辅助治疗试验中为15%,转移性试验中为25%,研究性新药试验中为29%,I期试验中为24%,支持治疗试验中为21%。加拿大试验中老年患者的总体入组比例(22%)略低于SWOG试验(25%)。
即使报销不成问题,年龄仍然是癌症治疗试验入组的一个障碍。鉴于我国人口老龄化,采取策略克服这一障碍,包括开展专门针对≥65岁患者的试验,是明智之举。