Preoperative Chemoradiotherapy versus Chemotherapy for Locally Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma: A Phase III Randomized Controlled Trial from China
Mené sur 204 patients atteints d'un cancer localement avancé de l'estomac ou de la jonction oesogastrique, cet essai randomisé de phase III évalue l'efficacité, du point de vue de la survie sans maladie à 3 ans, d'une chimioradiothérapie préopératoire par rapport à une chimiothérapie préopératoire
Background: The prognostic superiority of preoperative chemoradiotherapy (pre-CRT) over preoperative chemotherapy (pre-CT) in patients with locally advanced gastric cancer remains controversial. Herein, we evaluated the efficacy and safety of pre-CRT relative to those of pre-CT in this cohort.
Methods: This open-label, phase III, randomized controlled trial was conducted at 4 medical centers in China. Eligible patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma were randomly assigned (1:1) to receive either 3 cycles of oxaliplatin and S-1 (SOX), followed by surgery and 3 postoperative cycles of SOX (pre-CT), or 1 cycle of SOX, followed by concurrent chemoradiotherapy, a second cycle of SOX, surgery, and 3 postoperative cycles of SOX (pre-CRT). The primary endpoint was 3-year disease-free survival (DFS). Secondary endpoints included 3-year overall survival (OS), R0 resection rate, pathological complete response (pCR) rate, treatment-related toxicity, and postoperative complications.
Results: Due to premature trial termination, only 204 patients were enrolled, and an efficacy analysis was conducted on 194 eligible patients. The baseline characteristics were well balanced between the 2 groups. The DFS and OS were indistinguishable between the 2 groups. The 3-year DFS rates were 53.6% in the pre-CRT group and 53.9% in the pre-CT group [hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.70 to 1.50; log-rank P = 0.913]. The 3-year OS rates were 62.8% in the pre-CRT group and 60.5% in the pre-CT group (HR, 0.97; 95% CI, 0.63 to 1.47; log-rank P = 0.874). The R0 resection rates were 81.0% and 74.5% in the pre-CRT and pre-CT groups, respectively. Additionally, the pCR rate was higher in the pre-CRT group (12.0%) than in the pre-CT group (2.1%). Treatment-related toxic effects were comparable between the 2 groups.
Conclusion: This trial did not demonstrate a survival advantage for pre-CRT over pre-CT in patients with locally advanced gastric or gastroesophageal adenocarcinoma.
Cancer Communications , article en libre accès, 2026