BACKGROUND: We performed a meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with S-1-based regimens. PATIENTS AND METHODS: Randomized phase II and III trials of patients with solid tumors on S-1; describing events of all-grade and high-grade stomatitis and diarrhea constituted the eligible studies. RESULTS: After exclusion of ineligible studies, a total of 26 clinical trials were considered eligible for the meta-analysis. The odds ratio (OR) of all-grade and high-grade stomatitis for S-1 vs. non-fluoropyrimidine controls was 4.39 [95% CI: 1.05, 18.37; p = 0.04] and 5.64 [95% CI: 1.46, 21.77; p = 0.01], respectively; while the OR of all-grade and high-grade stomatitis for S-1 vs. infusional 5-fluorouracil (5-FU) control was -1.01 [95% CI: 0.22, 4.63; p = 0.99] and 0.32 [95% CI: 0.20, 0.49; p < 0.00001], respectively. The OR of all-grade and high-grade diarrhea for S-1 vs. non-fluoropyrimidine controls was 2.48 [95% CI: 2.12, 2.90; p < 0.00001] and 1.95 [95% CI: 1.29, 2.96; p = 0.002], respectively; while the OR of all-grade and high-grade diarrhea for S-1 vs. infusional 5-FU control was -1.03 [95% CI: 0.87, 1.22; p = 0.76] and 2.52 [95% CI: 1.80, 3.52; p < 0.00001], respectively. CONCLUSIONS: Compared to non-fluoropyrimidine control, patients treated with S-1-based regimens have an increased risk of all-grade and high-grade stomatitis and diarrhea; while on the other hand, patients treated with infusional 5-FU have a greater risk of high-grade stomatitis and diarrhea compared to patients treated with S-1-based regimens.
BACKGROUND: We performed a meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with S-1-based regimens. PATIENTS AND METHODS: Randomized phase II and III trials of patients with solid tumors on S-1; describing events of all-grade and high-grade stomatitis and diarrhea constituted the eligible studies. RESULTS: After exclusion of ineligible studies, a total of 26 clinical trials were considered eligible for the meta-analysis. The odds ratio (OR) of all-grade and high-grade stomatitis for S-1 vs. non-fluoropyrimidine controls was 4.39 [95% CI: 1.05, 18.37; p = 0.04] and 5.64 [95% CI: 1.46, 21.77; p = 0.01], respectively; while the OR of all-grade and high-grade stomatitis for S-1 vs. infusional 5-fluorouracil (5-FU) control was -1.01 [95% CI: 0.22, 4.63; p = 0.99] and 0.32 [95% CI: 0.20, 0.49; p < 0.00001], respectively. The OR of all-grade and high-grade diarrhea for S-1 vs. non-fluoropyrimidine controls was 2.48 [95% CI: 2.12, 2.90; p < 0.00001] and 1.95 [95% CI: 1.29, 2.96; p = 0.002], respectively; while the OR of all-grade and high-grade diarrhea for S-1 vs. infusional 5-FU control was -1.03 [95% CI: 0.87, 1.22; p = 0.76] and 2.52 [95% CI: 1.80, 3.52; p < 0.00001], respectively. CONCLUSIONS: Compared to non-fluoropyrimidine control, patients treated with S-1-based regimens have an increased risk of all-grade and high-grade stomatitis and diarrhea; while on the other hand, patients treated with infusional 5-FU have a greater risk of high-grade stomatitis and diarrhea compared to patients treated with S-1-based regimens.
Authors: Marika Cinausero; Giuseppe Aprile; Paola Ermacora; Debora Basile; Maria G Vitale; Valentina Fanotto; Giuseppe Parisi; Lorenzo Calvetti; Stephen T Sonis Journal: Front Pharmacol Date: 2017-06-08 Impact factor: 5.810
Authors: Claudio Pulito; Antonio Cristaudo; Caterina La Porta; Stefano Zapperi; Giovanni Blandino; Aldo Morrone; Sabrina Strano Journal: J Exp Clin Cancer Res Date: 2020-10-07