Hirano Hidekazu, Kataoka Kozo, Yamaguchi Toshifumi, Wagner Anna Dorothea, Shimada Yasuhiro, Inomata Masafumi, Hamaguchi Tetsuya, Takii Yasumasa, Mizusawa Junki, Sano Yusuke, Shiomi Akio, Shiozawa Manabu, Ohue Masayuki, Adachi Tomohiro, Ueno Hideki, Ikeda Satoshi, Komori Koji, Tsukamoto Shunsuke, Takashima Atsuo, Kanemitsu Yukihide
Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Division of lower GI, department of gastroenterological surgery, Hyogo Medical University, Hyogo, Japan.
Eur J Cancer. 2025 Jan;214:115139. doi: 10.1016/j.ejca.2024.115139. Epub 2024 Nov 19.
Fluoropyrimidine remains the key agent of adjuvant chemotherapy for stage III colorectal cancer (CRC). Western studies have shown that female sex is a favorable prognostic factor after surgery, but it is also a risk factor for adverse events (AEs) during adjuvant chemotherapy with fluoropyrimidine. However, little is known about whether sex differences in treatment outcomes exist in this setting in the Asian population.
Patients with stage III CRC who received adjuvant fluoropyrimidine monotherapy in 4 randomized controlled trials were analyzed. Incidences of AEs and survival outcomes were compared between female and male patients.
A total of 3170 patients (female, 1516; male, 1654) were included in this analysis. Compared with males, females were less likely to have a relative dose intensity (≥90 %: female 59.1 % vs. male 67.6 %), with a higher proportion of requiring dose reduction (28.8 % vs. 20.4 %) and a lower proportion of completing adjuvant chemotherapy (77.0 % vs. 81.7 %). Multivariable analyses demonstrated that female sex was associated with a higher incidence of grade 3-4 AEs (odds ratio 1.80 [95 % CI 1.51-2.14]). Female sex was identified as a favorable prognostic factor for overall survival (hazard ratio [HR]: 0.80 [0.65-0.97]) and relapse-free survival (HR: 0.73 [0.63-0.85]) in multivariable analyses. Female patients had fewer time-to recurrence (TTR) events than male patients (5-year TTR: 17.7 % vs. 22.3 %).
Sex had implications for the development of AEs and survival outcomes of Japanese patients with stage III CRC who received adjuvant fluoropyrimidine monotherapy.
氟尿嘧啶仍然是 III 期结直肠癌（CRC）辅助化疗的关键药物。西方研究表明，女性是手术后的有利预后因素，但也是氟尿嘧啶辅助化疗期间不良事件（AE）的危险因素。然而，在亚洲人群中，这种情况下治疗结果是否存在性别差异尚不清楚。
分析了 4 项随机对照试验中接受辅助氟尿嘧啶单药治疗的 III 期 CRC 患者。比较了女性和男性患者的 AE 发生率和生存结果。
本分析共纳入 3170 例患者（女性 1516 例，男性 1654 例）。与男性相比，女性相对剂量强度（≥90%：女性 59.1% vs. 男性 67.6%）较低，需要降低剂量的比例较高（28.8% vs. 20.4%），完成辅助化疗的比例较低（77.0% vs. 81.7%）。多变量分析表明，女性与 3-4 级 AE 的发生率较高相关（优势比 1.80 [95% CI 1.51-2.14]）。在多变量分析中，女性被确定为总生存（风险比 [HR]：0.80 [0.65-0.97]）和无复发生存（HR：0.73 [0.63-0.85]）的有利预后因素。女性患者的复发时间（TTR）事件比男性患者少（5 年 TTR：17.7% vs. 22.3%）。
性别对接受辅助氟尿嘧啶单药治疗的日本 III 期 CRC 患者的 AE 发生和生存结果有影响。
