TY - JOUR T1 - Adjuvant chemoradiotherapy in patients with stage iii or iv radically resected gastric cancer: A pilot study AU - Orditura M, De Vita F, Muto P, et al Y1 - 2010/03/01 N1 - 10.1001/archsurg.2010.2 JO - Archives of Surgery SP - 233 EP - 238 VL - 145 IS - 3 N2 - Background  Adjuvant chemoradiotherapy does not represent the standard of care in patients with resected high-risk gastric cancer; however, results from phase 2 and randomized trials suggest improvement in overall survival. We assessed the feasibility and toxic effects of chemoradiotherapy as adjuvant treatment in locally advanced gastric cancer.Design  Pilot study.Setting  University hospital.Patients  Twenty-nine patients with T4N+ or any TN23 gastric cancer previously treated with potentially curative surgery were enrolled. All of the patients received combined adjuvant chemotherapy with FOLFOX-4 (ie, a combination of folinic acid [leucovorin], fluorouracil, and oxaliplatin [Eloxatin]) for 8 cycles and concomitant radiotherapy (45 Gy in 25 daily fractions over 5 weeks). Radiotherapy was begun after the first 2 cycles of FOLFOX-4, which was reduced by 25% during the period of concomitant radiotherapy.Main Outcome Measures  Treatment toxic effects according to the National Cancer Institute–Common Toxicity Criteria classification, overall and disease-free survival rates, and identification of prognostic indicators.Results  All of the patients completed treatment. Severe hematologic and gastrointestinal toxic effects occurred in 10% and 33%, respectively. No acute hepatic or renal toxic effects were observed; 1 patient experienced severe neurotoxicity. Disease-free and overall survival rates at 1, 2, and 3 years were 79%, 35%, and 35% and 85%, 62.6%, and 50.1%, respectively, and were shown to be substantially better than those observed in untreated patients. Long-term outcome was related to TNM stage, basal serum tumor marker level, and, particularly, lymph node ratio.Conclusion  A multimodal approach with FOLFOX-4 and radiotherapy is feasible and effective for the treatment of patients with resected high-risk gastric cancer. SN - 0004-0010 M3 - doi: 10.1001/archsurg.2010.2 UR - http://dx.doi.org/10.1001/archsurg.2010.2 ER -