PURPOSE: The International Organization for Standardization-5fluorouracil (FU) 10 trial found that bolus 5-FU and l-leucovorin was not inferior to S-1 in the treatment of gastric cancer (GC). Continuous 5-FU and the rapid injection of 5-FU have different anti-cancer effects. Thus, bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. MATERIALS AND METHODS: We retrospectively analyzed the medical records of all patients with S-1 or capecitabine-resistant, unresectable, or recurrent GC treated with bolus 5-FU and l-leucovorin between January 2010 and December 2015 at Hokkaido University Hospital. The bolus 5-FU and l-leucovorin regimen consisted of intravenous l-leucovorin (250 mg/m²/2 h) and bolus 5-FU (600 mg/m²) administered once weekly followed by a 2-week rest period; each cycle was repeated every 8 weeks. RESULTS: A total of 14 patients were identified. The disease control rate was 35.7%. The median progression-free survival was 1.6 months (95% confidence interval [CI], 1.3~2.0 months), and the median overall survival was 6.3 months (95% CI, 4.7~7.9 months). No patient died from treatment-related causes. The most common severe adverse event associated with bolus 5-FU and l-leucovorin was neutropenia, which occurred in 21.4% of patients. CONCLUSIONS: Bolus 5-FU and l-leucovorin treatment might be useful for oral FU-resistant GC. We are planning a multi-center prospective phase II trial to evaluate the efficacy and safety of bolus 5-FU and l-leucovorin treatment for pre-treated unresectable or recurrent GC to confirm the results of this limited, retrospective study.
Disease-Free Survival ; Drug Therapy* ; Fluorouracil* ; Humans ; Leucovorin ; Medical Records ; Neutropenia ; Prospective Studies ; Retrospective Studies ; Stomach Neoplasms*

Objective: Difficulty in extracting tablets from a press through pack (PTP) is believed to reduce prescription drug compliance.　This is a particularly serious issue for the elderly or for those who have physical disabilities affecting the fingers.　In this study, the squeezing force necessary to extract tablets from PTPs was measured for 33 commercial tablet products using a force gauge (FG).　Additionally, a sensory test was conducted to determine the degree of difficulty in extracting tablets from PTPs by squeezing, and the correlation between the difficulty measure and squeezing force was evaluated.Methods: The squeezing force for 33 products was measured by FG.　The sensory test was conducted with 64 subjects.　Four products, each with a different squeezing force, were used for the sensory test.　In the test, each subject ranked the products in order according to the amount of force required to extract the tablets.　Each product's total score was used in the statistical analysis.Results: The average squeezing force of the 33 products was 33.1 ± 6.9 〔N〕, and significant differences were observed among the products.　The sensory test revealed that each subject could significantly distinguish the amount of force required to extract the tablets from each product.Conclusion: A positive correlation was observed between the squeezing force obtained using FG and the results from the sensory test.　This suggests that squeezing force can be used as an indicator for the usability of the product.　Therefore, the degree of difficulty in extracting tablets from PTPs should be considered when selecting drugs for the elderly.