Addition of Docetaxel to Oral Fluoropyrimidine Improves Efficacy in Patients With Stage III Gastric Cancer: Interim Analysis of JACCRO GC-07, a Randomized Controlled Trial

Mené sur 915 patients atteints d'un cancer gastrique de stade III, cet essai de phase III évalue l'efficacité, du point de vue de la survie sans récidive à 3 ans, et la toxicité de l'ajout du docétaxel au S-1 après un traitement chirurgical (durée médiane de suivi : 12,5 mois)

Résumé en anglais

PURPOSE : S-1 is a standard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia. Neoadjuvant or perioperative strategies dominate in Western countries, and docetaxel has recently shown significant survival benefits when combined with other standard regimens in advanced cancer and perioperative settings.

PATIENTS AND METHODS : This randomized phase III study was designed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer. The sample size of 1,100 patients was necessary to detect a 7% increase in 3-year relapse-free survival as the primary end point (hazard ratio, 0.78; 2-sided