Prospective Randomized Trial for Postoperative Adjuvant Chemotherapy in Gastric Cancer without Serosal Invasion: Final Report

ABSTRACT

PUPOSE We reported our preliminary result in 2001. At that time, the follow-up period was too short to evaluate the survival benefit of adjuvant chemotherapy in gastric cancer without serosal invasion. Therefore, we followed those patients for 66 months to determine the long-term effects of adjuvant chemotherapy. MATERIALS AND METHODS: We analyzed the recurrence pattern, the survival rate, and the disease-specific survival of 135 patients by reviewing their medical records and calling the patients or their relatives. All enrolled patients were included in the intention-to-treat analysis of efficacy. RESULTS: The follow-up rate was 89.6% (121/135), and the median follow-up duration was 66 months. Among the 135 patients, 4 relapsed in group 1 (5-FU cisplatin), 7 in group 2 (mitomycin C oral 5-FU), and 6 in group 3 (oral 5-FU only). The overall survival rate was 89% in group 1, 84% in group 2, and 82% in group 3. There were no differences in the overall survival rates and the disease-specific survival rates among the three groups. CONCLUSION: Oral chemotherapeutic agents have an acceptable effect for adjuvant chemotherapy compared with intravenous agent. However, a large-scale, prospective, randomized study, including a control group, is needed for an exact evaluation.