Department of Gastrointestinal Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, 200032, P. R. China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, P. R. China.
Cancer Commun (Lond). 2022 Apr;42(4):314-326. doi: 10.1002/cac2.12278. Epub 2022 Feb 25.
There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer (AGC). We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine (XELOX) and epirubicin, oxaliplatin, plus capecitabine (EOX) regimens in treating AGC.
This phase III trial enrolled previously untreated patients with AGC who were randomly assigned to receive the XELOX or EOX regimen. The primary endpoint was non-inferiority in progression-free survival (PFS) for XELOX as compared with EOX on an intention-to-treat basis.
Between April 10, 2015 and August 20, 2020, 448 AGC patients were randomized to receive XELOX (n = 222) or EOX (n = 226). The median PFS (mPFS) was 5.0 months (95% confidence interval [CI] = 4.5-6.0 months) in the XELOX arm and 5.5 months (95% CI = 5.0-6.0 months) in the EOX arm (hazard ratio [HR] = 0.989, 95% CI = 0.812-1.203; P = 0.003). There was no significant difference in median overall survival (mOS) (12.0 vs. 12.0 months, P = 0.384) or objective response rate (37.4% vs. 45.1%, P = 0.291) between the two groups. In patients with poorly differentiated adenocarcinoma and liver metastasis, the EOX arm had a significantly longer mOS (P = 0.021) and a trend of longer mPFS (P = 0.073) than the XELOX arm. The rate of grade 3/4 adverse events (AEs) was 42.2% (90/213) in the XELOX arm and 72.5% (156/215) in the EOX arm (P = 0.001). The global health-related quality of life (QoL) score was significantly higher in the XELOX arm than in the EOX arm during chemotherapy.
This non-inferiority trial demonstrated that the doublet regimen was as effective as the triplet regimen and had a better safety profile and QoL as a first-line treatment for AGC patients. However, the triplet regimen might have a survival advantage in patients with poorly differentiated adenocarcinoma and liver metastasis.
在晚期胃癌（AGC）的一线治疗中，三联方案是否优于双联方案尚无定论。我们旨在比较奥沙利铂加卡培他滨（XELOX）和表柔比星、奥沙利铂加卡培他滨（EOX）方案治疗 AGC 的疗效和安全性。
这项 III 期临床试验纳入了未经治疗的 AGC 患者，他们被随机分配接受 XELOX 或 EOX 方案治疗。主要终点是基于意向治疗的 XELOX 在无进展生存期（PFS）方面不劣于 EOX。
2015 年 4 月 10 日至 2020 年 8 月 20 日，448 例 AGC 患者被随机分配接受 XELOX（n = 222）或 EOX（n = 226）治疗。XELOX 组的中位 PFS（mPFS）为 5.0 个月（95%置信区间[CI] = 4.5-6.0 个月），EOX 组为 5.5 个月（95%CI = 5.0-6.0 个月）（风险比[HR] = 0.989，95%CI = 0.812-1.203；P = 0.003）。两组的中位总生存期（mOS）（12.0 个月 vs. 12.0 个月，P = 0.384）或客观缓解率（37.4% vs. 45.1%，P = 0.291）均无显著差异。在低分化腺癌和肝转移患者中，EOX 组的 mOS（P = 0.021）和 mPFS（P = 0.073）均有延长趋势，明显长于 XELOX 组。XELOX 组 3/4 级不良事件（AE）发生率为 42.2%（90/213），EOX 组为 72.5%（156/215）（P = 0.001）。XELOX 组化疗期间全球健康相关生活质量（QoL）评分明显高于 EOX 组。
这项非劣效性试验表明，双联方案与三联方案一样有效，且作为 AGC 患者的一线治疗具有更好的安全性和 QoL。然而，三联方案在低分化腺癌和肝转移患者中可能具有生存优势。
