Abstract
Background Hangeshashinto (TJ-14, a Kampo medicine), which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, alleviates chemotherapy-induced oral mucositis (COM). We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer.MethodsWe randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The patients received a placebo or TJ-14 for 2–6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events.ResultsFollowing the key opening of the blinding protocol, we analyzed 91 eligible patients (TJ-14: 45, placebo: 46) using a “per protocol set” analysis. The incidence of ≧grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group (p = 0.588). The median duration of ≧grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group (p = 0.894). Meanwhile, the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [hazard ratio 0.60; 95 % CI (0.23–1.59), p = 0.290].ConclusionsAlthough TJ-14 treatment did not reduce the incidence of ≥2 COM in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle. Further, phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM.
Highlights
Gastric cancer is the second most frequent cancer-related cause of death after lung cancer [1]
TJ-14 treatment did not reduce the incidence of ≥2 chemotherapy-induced oral mucositis (COM) in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle
Richard et al demonstrated, after having enlisted 20 patients treated with chemotherapy drugs and performing a biopsy of the oral mucosa in each case, a statistically significant increase in the number of endothelial cells in the oral mucosa with nuclear factorkappa B (NF-κB) and cyclooxygenase 2 (COX-2) expressions in the postchemotherapy treatment period compared to that observed in the pretreatment period
Summary
Gastric cancer is the second most frequent cancer-related cause of death after lung cancer [1]. Oral mucositis is a common toxicity associated with cytotoxic chemotherapy used in the gastric cancer treatment. In pivotal phase III trials of chemotherapy for gastric cancer, the incidence of all grades of chemotherapy-induced oral mucositis (COM) was observed to be 6.3–32 % [4,5,6,7,8]. Richard et al demonstrated, after having enlisted 20 patients treated with chemotherapy drugs and performing a biopsy of the oral mucosa in each case, a statistically significant increase in the number of endothelial cells in the oral mucosa with nuclear factorkappa B (NF-κB) and cyclooxygenase 2 (COX-2) expressions in the postchemotherapy treatment period compared to that observed in the pretreatment period. Methods We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events
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