3 4 chemotherapy (n=2). Eleven patients (28.2%) achieved a partial response, 14 patients (35.9%) had stable disease, and 7 patients (17.9%) had progressed during the course of treatment (Table 2). None of the patients achieved a complete response. On intention-to-treat analysis, the overall response rate (ORR) and disease control rates were 28.2% (95% CI, 11.7 to 44.7%) and 64.1% (95% CI, 49.9 to 78.3%), respectively. The median duration of follow-up was 20.1 months (range, 2.1 to 63.0 months). The TTP and OS were 4.3 months (95% CI, 2.0 to 6.5 months) (Fig. 1) and 9.8 months (95% CI, 3.5 to 16.0 months) (Fig. 2), respectively. Factors affecting survival and response An analysis of prognostic factors affecting survival was attempted. Then, age (0-64 years vs. 65 years), gender, a history of surgery or chemotherapy, ECOG performance status (0-1 vs. 2), disease status before chemotherapy (newly diagnosed vs. recurrent), and the number of metastases (0-2 vs. 3) were compared between the two groups. Based on univariate analysis, the ECOG performance status (p=0.004) and the number of metastases (p=0.033) were significantly different between the two groups. Only the ECOG performance status was a significant factor affecting survival based on multivariate analysis (hazard ratio, 0.134; p=0.043). However, there were no significant factors affecting response. Toxicity and dose intensity Two hundred ten chemotherapy cycles were administered to the 39 Han Jo Kim, et al_Oxaliplatin Combination for Advanced Gastric Cancer patients. The median number of cycles was 6 (range, 1 to 16). Table 3 shows the summaries of the incidence of main toxicities. The major grade 3 or 4 hematologic toxicities per cycle were neutropenia (15.2%) and thrombocytopenia (7.6%). Two patients (5.1%) had febrile neutropenia. The major non-hematologic toxicities per cycle were constipation (46.2%) and nausea (41.9%). Peripheral neuropathy per cycle occurred in 33.8% of the patients and all cases were grade 1-2; there were no treatment interruptions or discontinuations due to neuropathy. One patient (2.6%) had acute renal failure after 1 treatment cycle, which required transient hemodialysis. The relative dose intensities of oxaliplatin and 5-FU were 87.4% and 86.2% of the planned doses, respectively. No treatment-related deaths occurred. D i s c u s s i o n Despite a large number of randomized trials, the best agent or optimal regimen for the first-line treatment of advanced gastric cancer has not been determined. A variety of different oxaliplatin combination regimens have been studied (oxaliplatin plus 5-FU, epirubicin, or capecitabine) in phase II trials. Also, several studies involving various combinations of oxaliplatin/5-FU/FA for treating advanced gastric cancer have been published; these studies have shown consistent results regarding the activity of oxaliplatin combinations [15-19]. The range of TTP, median OS, and ORR of these trials were 4.3-6.2 and 7.3-9.6 months, and 26-45%, respectively. Although data from ran- domized controlled phase III trials have not been published, in practice various combinations of oxaliplatin/5-FU/FA are used for the treatment Table 3. Toxicities according to the National Cancer Institute Common Toxicity Criteria Patient (n=39) Cycle (n=210) Toxicity Hematologic Neutropenia Febrile neutropenia Thrombocytopenia Anemia Gastrointestinal Nausea Vomiting Diarrhea Constipation Stomatitis Neurosensory Hepatic AST/ALT Bilirubin Renal Creatinine Grade 1/2 (%) 10/39 (25.6) - 8/39 (20.5) 20/39 (51.3) 24/39 (61.5) 14/39 (35.9) 5/39 (12.8) 21/39 (53.8) 15/39 (38.5) 20/39 (51.3) 3/39 (7.7) 1/39 (2.6) 1/39 (2.6) AST, aspartate aminotransferase; ALT, alanine aminotransferase. Grade 3/4 (%) 12/39 (30.8) 2/39 (5.1) 7/39 (20.0) 5/39 (12.8) 2/39 (5.1) 2/39 (5.1) - - - - 1/39 (2.6) - 1/39 (2.6) Grade 1/2 (%) 68/210 (32.4) - 45/210 (21.4) 110/210 (52.4) 88/210 (41.9) 53/210 (25.2) 14/210 (6.7) 91/210 (46.2) 54/210 (25.7) 71/210 (33.8) 7/210 (3.3) 1/210 (0.5) 2/210 (1.0) Grade 3/4 (%) 32/210 (15.2) 2/210 (1.0) 16/210 (7.6) 9/210 (4.3) 2/210 (1.0) 2/210 (1.0) - - - - 1/210 (0.5) - 1/210 (0.5) VOLUME 43 NUMBER 3 SEPTEMBER 2011 157