Department of Gastroenterology and Digestive Oncology, European Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, France; INSERM UMR-S1147, Centre Universitaire des Saints-Pères, Paris, France.
Digestive Oncology Department, Institut du Cancer de Montpellier, Montpellier, France.
Dig Liver Dis. 2018 Apr;50(4):408-410. doi: 10.1016/j.dld.2018.01.119. Epub 2018 Mar 1.
In advanced gastric cancer, doublet regimen including platinum salts and fluoropyrimidine is considered as a standard first-line treatment. The addition of docetaxel (75 mg/m q3w) to cisplatin (75 mg/m q3w) and 5-fluorouracil has been shown to improve efficacy. However, this regimen (DCF) was associated with frequent severe toxicities (including more complicated neutropenia), limiting its use in clinical practice. Interesting alternative docetaxel-based regimens have been developed that need to be validated.
GASTFOX study is a randomized phase III trial comparing FOLFOX alone or with docetaxel at 50 mg/m (TFOX regimen) in first-line treatment for advanced gastric cancer. In both arms, cycle is repeated every 2 weeks until disease progression or unacceptable toxicity.
Main eligibility criteria: histologically proven locally advanced or metastatic gastric or esogastric junction adenocarcinoma, HER negative status, measurable disease, ECOG performance status 0 or 1, and adequate renal, hepatic and bone marrow functions.
The primary endpoint is radiological/clinical progression-free survival (PFS). A difference of 2 months for the median PFS in favor of TFOX is expected (HR = 0.73) Based on a two-sided α risk of 5% and a power of 90%, 454 events are required to show this difference. Secondary endpoints included overall survival, overall response rate, safety, quality of life and the therapeutic index.
This study is planned to include 506 patients to demonstrate the superiority of TFOX over FOLFOX in first-line advanced gastric cancer treatment (NCT03006432).
在晚期胃癌中，包含铂盐和氟嘧啶的双联方案被认为是标准的一线治疗方法。在顺铂（75mg/m q3w）和 5-氟尿嘧啶的基础上添加多西紫杉醇（75mg/m q3w）已被证明可以提高疗效。然而，该方案（DCF）与频繁的严重毒性相关（包括更复杂的中性粒细胞减少症），限制了其在临床实践中的应用。已经开发出了一些有趣的替代多西紫杉醇为基础的方案，需要进一步验证。
GASTFOX 研究是一项随机 III 期试验，比较了单独使用 FOLFOX 或联合多西紫杉醇 50mg/m（TFOX 方案）在晚期胃癌一线治疗中的疗效。在两个治疗组中，周期每 2 周重复一次，直到疾病进展或不可接受的毒性。
主要入选标准：组织学证实的局部晚期或转移性胃或胃食管交界处腺癌，HER 阴性状态，可测量的疾病，ECOG 表现状态 0 或 1，以及足够的肾功能、肝功能和骨髓功能。
主要终点是影像学/临床无进展生存期（PFS）。预计 TFOX 方案的中位 PFS 会有 2 个月的差异（HR=0.73）。基于双侧 α 风险为 5%，效力为 90%，需要 454 例事件才能显示出这种差异。次要终点包括总生存期、总缓解率、安全性、生活质量和治疗指数。
该研究计划纳入 506 例患者，以证明 TFOX 在晚期胃癌一线治疗中的优越性优于 FOLFOX（NCT03006432）。
