Cancer Treatment Center, Osaka Police Hospital, 10-31 Kitayama-cho, Tennoji-ku, Osaka, 543-0035, Japan.
Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
Int J Clin Oncol. 2023 Nov;28(11):1501-1510. doi: 10.1007/s10147-023-02402-1. Epub 2023 Aug 27.
S-1 plus cisplatin (SP) and capecitabine plus cisplatin (XP) are standard first-line regimens for advanced gastric cancer (AGC) worldwide. We conducted a meta-analysis using individual participant data (IPD) to investigate which is more suitable.
IPD from three randomized trials were collected. In these trials, patients with AGC were randomly allocated to SP (S-1 80-120 mg for 21 days plus cisplatin 60 mg/m (q5w)) or XP (capecitabine 2000 mg/m for 14 days plus cisplatin 80 mg/m (q3w)).
In 211 eligible patients, median overall survival (OS) for SP versus XP was 13.5 and 11.7 months (hazard ratio [HR], 0.787; p = 0.114), progression-free survival (PFS) was 6.2 and 5.1 months (HR, 0.767; P = 0.076), and TTF was 5.1 and 4.0 months (HR, 0.611; P = 0.001). The most common grade ≥ 3 adverse events with SP or XP were neutropenia (18% vs. 29%) and anorexia (16% vs.18%). Subgroup analysis demonstrated significant interaction between treatment effect and performance status > 1 (HR, 0.685; P = 0.036), measurable lesion (HR, 0.709; P = 0.049), primary upper third tumor (HR, 0.539; P = 0.040), and differentiated type (HR, 0.549; interaction, 0.236; P = 0.019). For the differentiated type, OS was significantly longer in the SP group (13.2 months) than in the XP group (11.1 months) (HR, 0.549; P = 0.019). For the undifferentiated type, OS was similar in the SP group (14.2 months) and in the XP group (12.4 months) (HR, 0.868; P = 0.476).
SP and XP were both effective and well tolerated. SP might be suitable for the pathological differentiated subtype of AGC.
The HERBIS-2, HERBIS-4A, and XParTS II trials were registered with UMIN-CTR as UMIN000006105, UMIN000006755, and UMIN000006045, respectively.
S-1 联合顺铂（SP）和卡培他滨联合顺铂（XP）是全球晚期胃癌（AGC）的标准一线治疗方案。我们进行了一项荟萃分析，使用个体参与者数据（IPD）来研究哪种方案更合适。
收集了三项随机试验的 IPD。在这些试验中，AGC 患者被随机分配至 SP（S-1 80-120mg 连用 21 天加顺铂 60mg/m²（q5w））或 XP（卡培他滨 2000mg/m²连用 14 天加顺铂 80mg/m²（q3w））。
在 211 名符合条件的患者中，SP 与 XP 的中位总生存期（OS）分别为 13.5 和 11.7 个月（风险比[HR]，0.787；p=0.114），无进展生存期（PFS）分别为 6.2 和 5.1 个月（HR，0.767；P=0.076），治疗时间分别为 5.1 和 4.0 个月（HR，0.611；P=0.001）。SP 或 XP 最常见的 3 级及以上不良事件为中性粒细胞减少症（18% vs. 29%）和厌食症（16% vs. 18%）。亚组分析显示，治疗效果与体能状态>1（HR，0.685；P=0.036）、可测量病灶（HR，0.709；P=0.049）、原发上三分之一肿瘤（HR，0.539；P=0.040）和分化型（HR，0.549；交互作用，0.236；P=0.019）之间存在显著的交互作用。对于分化型，SP 组的 OS 明显长于 XP 组（13.2 个月）（11.1 个月）（HR，0.549；P=0.019）。对于未分化型，SP 组的 OS 与 XP 组相似（14.2 个月）（12.4 个月）（HR，0.868；P=0.476）。
SP 和 XP 均有效且耐受性良好。SP 可能适用于 AGC 的病理分化亚型。
HERBIS-2、HERBIS-4A 和 XParTS II 试验分别在 UMIN-CTR 注册为 UMIN000006105、UMIN000006755 和 UMIN000006045。
