Clinical benefit and response in patients with gastric cancer to weekly 24-hour infusion of high-dose 5-fluorouracil (5-FU) and leucovorin (LV)

Background. A prospective study evaluated the efficacy and correlation of different outcome measurements, including the WHO response criteria and clinical benefit (CB), to weekly high-dose 5-FU and LV for patients with advanced gastric cancer. Patients and Methods. Thirty-nine chemotherapy-naive patients were enrolled from Sep. 1996 to Oct. 1997. The treatment consisted of a 24-hour continuous infusion of 5-FU 2600 mg/m² and LV 150 mg weekly for 6 weeks with a subsequent 2-week break. The responses were evaluated by CB and WHO criteria at the end of the 8th week, then at 8-week intervals. Results: There were 21 male and 18 female patients with a median age of 56 years. The median Karnofsky performance score was 70%. Thirty-six patients were evaluable for WHO criteria, and 12 (33.3%) had partial response, 12 (33.3%) had stable disease and 12 (33.3%) had progressive disease. Twenty-one of the 35 (60%) evaluable patients for CB were found to have a positive response. There was a significant correlation between WHO response and CB. The median survival was 10.5 months for CB responders, while the median survival among the CB non-responders was 5 months only. Conclusions. This study found that this regimen yielded a 60% CB, despite a 33% WHO response rate. Improvement in CB resulted in an improvement in survival as well as the correlation between CB and WHO response, and suggested the value of CB as an alternative indicator for clinical response.