LAUSR

early stage gastric tumours (T1), but those with advanced-stage tumours (T2–4) or regional lymph-node involvement have a poor prognosis. Perioperative chemotherapy regimens containing epirubicin, cisplatin and fluorouracil (ECF) or epirubicin, cisplatin and capecitabine (ECX) can improve the outcomes of patients with advanced-stage gastric cancer or cancer of the gastroesophageal junction. Prognosis, however, remains poor (5-year survival <40%) and the risk of toxicities is high. In a study led by Salah-Eddin Al-Batran, the efficacy and tolerability of a docetaxel-based regimen was tested. In this phase II trial, patients were randomized to receive a perioperative regimen containing fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT; 128 patients), or ECF or ECX (50 and 85 patients, respectively). The end point, pathological complete regression, was chosen because, in Al-Batran’s words, “active therapy for resectable disease has to show an effect on pathological findings in order to qualify for phase III testing”. This end point was achieved in 15% of patients with gastric tumours and 16% of patients with gastroesophageal tumours in the FLOT group; these percentages were 9% and 4%, respectively, in the ECF/ECX group. An increased benefit with FLOT was observed in patients with tumours of an intestinal-type histology, for whom the rate of complete pathological regression was 23%, in the range usually achieved only with regional chemoradiation therapy. Post-surgical serious adverse events affected 40% of patients in the ECF/ECX group versus 25% in the FLOT group. Al-Batran and co-workers now plan to conduct further randomized trials, adding biological or biomarker-selected agents to FLOT, with the goal of further increasing pathological regression and to determine whether such improvements are reflected in survival rates. Diana Romero G A S T R O I N T E S T I N A L C A N C E R