Department of Oncology and Infectious Disease Pharmacy, Faculty of Pharmaceutical Sciences, Fukuoka University, 8-19-1 Nanakuma Jonan-ku, Fukuoka 814-0180, Japan; Department of Pharmacy, Fukuoka University Hospital; 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan.
Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Sciences, Fukuoka University, 8-19-1 Nanakuma Jonan-ku, Fukuoka 814-0180, Japan; Department of Pharmacy, Fukuoka University Chikushi Hospital, 1-1-1 Zokumyoin, Chikushino-shi, Fukuoka 818-8502, Japan.
J Geriatr Oncol. 2024 Jul;15(6):101814. doi: 10.1016/j.jgo.2024.101814. Epub 2024 Jun 7.
The Cancer and Aging Research Group (CARG) prediction tool was designed in the United States to predict grade ≥ 3 chemotherapy-related adverse events (CRAE) in older patients. However, its usefulness among Japanese people, who have different sensitivities to anticancer drugs and life expectancy, remains unknown. We aimed to prospectively evaluate the utility of the CARG tool for predicting severe CRAE in older Japanese patients with cancer.
Patients with solid tumors aged 65 years and older who commenced anticancer drug regimens from April 2018 to October 2020 were divided into three groups (low, medium, and high-risk) based on their CARG risk scores. Toxicity was prospectively observed by a pharmacist. The primary objective was to evaluate the correlation between the incidence of grade ≥ 3 CRAE and the CARG risk score. The secondary objective was to evaluate hematological and non-hematological toxicities. CRAE incidence was compared among the three groups using a closed testing procedure: (1) Cochran-Armitage test for trend and (2) chi-square test for paired comparison.
The patients (N = 165) had a median age of 71 years (range: 65-89 years). CRAE in patients divided into low-, medium-, and high-risk groups, based on CARG risk scores, were 39%, 55%, and 82%, respectively (low vs high; p < 0.001, medium vs high; p < 0.01). The incidence of severe hematologic toxicity was 37%, 35%, and 50% in the low-, medium-, and high-risk groups, respectively; the incidence of severe non-hematologic toxicity was 15%, 36%, and 65%, respectively (low vs medium; p < 0.01, low vs high; p < 0.001, and medium vs high; p < 0.01).
To our knowledge, this is the first prospective observational study to validate the CARG prediction tool in older Japanese patients with cancer. The CARG risk score may be effective in predicting the development of non-hematologic toxicities. These results should be considered when administering chemotherapy to older Japanese patients with advanced solid tumors.
癌症与衰老研究组（CARG）预测工具由美国研发，用于预测老年患者发生 ≥3 级化疗相关不良事件（CRAE）的风险。然而，由于日本人群对抗癌药物的敏感性和预期寿命不同，该工具在日本人群中的应用效果尚不清楚。本研究旨在前瞻性评估该预测工具对日本老年癌症患者发生严重 CRAE 的预测价值。
2018 年 4 月至 2020 年 10 月，我们将年龄≥65 岁且开始接受抗癌药物治疗的实体瘤患者，按照 CARG 风险评分分为低危、中危和高危组。由药师对毒性进行前瞻性观察。主要研究终点为评估 CRAE 发生率与 CARG 风险评分的相关性。次要研究终点为评估血液学和非血液学毒性。采用封闭检验程序（1）Cochran-Armitage 趋势检验和（2）配对比较的卡方检验，比较三组间 CRAE 发生率的差异。
共纳入 165 例患者，中位年龄为 71 岁（65-89 岁）。根据 CARG 风险评分，低危、中危和高危组患者的 CRAE 发生率分别为 39%、55%和 82%（低危 vs 高危，p<0.001；中危 vs 高危，p<0.01）。低危、中危和高危组严重血液学毒性的发生率分别为 37%、35%和 50%；严重非血液学毒性的发生率分别为 15%、36%和 65%（低危 vs 中危，p<0.01；低危 vs 高危，p<0.001；中危 vs 高危，p<0.01）。
据我们所知，这是首个在日本老年癌症患者中前瞻性验证 CARG 预测工具的研究。CARG 风险评分可能有助于预测非血液学毒性的发生。在为晚期实体瘤老年患者实施化疗时，应考虑该评分结果。
