Okuda Hiroshi, Shimomura Manabu, Ikeda Satoshi, Nakahara Masahiro, Miguchi Masashi, Ishizaki Yasuyo, Saitoh Yasuhumi, Toyota Kazuhiro, Sumitani Daisuke, Shimizu Yosuke, Takakura Yuji, Shimizu Wataru, Yoshimitsu Masanori, Kodama Shinya, Fujimori Masahiko, Oheda Mamoru, Kobayashi Hironori, Ohdan Hideki
Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.
Department of Surgery, Onomichi General Hospital, Onomichi, Japan.
Cancer Chemother Pharmacol. 2023 Apr;91(4):317-324. doi: 10.1007/s00280-023-04526-7. Epub 2023 Mar 22.
There is no consensus on the safety and effectiveness of adjuvant chemotherapy for patients with stage III colorectal cancer (CRC) aged ≥ 80 years. We conducted a prospective multi-institutional phase II study of uracil-tegafur and leucovorin (UFT/LV) as adjuvant chemotherapy in this population.
Patients with stage III CRC aged ≥ 80 years who underwent curative resection were enrolled. Eligible patients received UFT/LV therapy (UFT, 300 mg/m per day as tegafur; LV, 75 mg/day on days 1-28, every 35 days for five courses). Primary endpoint was feasibility, and secondary endpoints were safety and relative dose intensity.
Sixty-nine patients were enrolled between 2013 and 2021. Of the 69 patients, 65 were included in the analysis. There were 32 males and 33 females with a median age of 82 years (range 80-88 years). In the primary endpoint, administration completion rate was 67.3% (95% confidence interval 54.9-77.6%), and the lower limit of the 95% confidence interval was below the threshold of 60%. 21 patients discontinued treatment because of adverse events (AEs) and refused treatment. The median relative dose intensities were 84% (range 4-100%) for UFT, and 100% (range 4-100%) for LV. Incidence of grade three or higher AEs were neutropenia (1.5%), aspartate transaminase elevation (3%), alanine transaminase elevation (1.5%), oral mucositis (3%), anemia (1.5%), and diarrhea (4.6%).
The indications for adjuvant UFT/LV therapy for elderly CRC aged ≥ 80 years were considered limited. It is necessary to clarify the background of patients in whom drug administration is discontinued and investigate their impact on long-term prognosis.
对于年龄≥80岁的III期结直肠癌（CRC）患者，辅助化疗的安全性和有效性尚无共识。我们开展了一项前瞻性多机构II期研究，评估尿嘧啶替加氟和亚叶酸钙（UFT/LV）作为该人群辅助化疗的效果。
纳入年龄≥80岁、接受根治性切除的III期CRC患者。符合条件的患者接受UFT/LV治疗（UFT，以替加氟计每天300mg/m²；LV，第1 - 28天每天75mg，每35天为一个疗程，共五个疗程）。主要终点为可行性，次要终点为安全性和相对剂量强度。
2013年至2021年共纳入69例患者。其中65例纳入分析，男性32例，女性33例，中位年龄82岁（范围80 - 88岁）。在主要终点方面，给药完成率为67.3%（95%置信区间54.9 - 77.6%），95%置信区间下限低于60%的阈值。21例患者因不良事件（AE）和拒绝治疗而中断治疗。UFT的中位相对剂量强度为84%（范围4 - 100%），LV为100%（范围4 - 100%）。3级或更高等级AE的发生率分别为：中性粒细胞减少（1.5%）、天冬氨酸转氨酶升高（3%）、丙氨酸转氨酶升高（1.5%）、口腔黏膜炎（3%）、贫血（1.5%）和腹泻（4.6%）。
对于年龄≥80岁的老年CRC患者，辅助UFT/LV治疗的适应证被认为有限。有必要明确停药患者的背景情况，并研究其对长期预后的影响。
