S-1 Based Doublet As Ab Adjuvant Chemotherapy For Curatively Open Access Resected Stage Iii Gastric Cancer: Results From Randomized Phase Iii Post Trial

PurposeWe conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients.Materials and MethodsStage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m(2)/day on days 1-14 plus docetaxel 35 mg/m(2) on days land 8) every 3 weeks or SP (S-1 70 mg/m(2)/day on days 1-14 plus cisplatin 60 mg/m(2) on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate.ResultsBetween November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, it was decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 34 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52(66.7%) in SP group finished planned treatment.ConclusionOur findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.