PV QA 4 - Poster Viewing Q&A 4
Purpose/Objective(s):Acute radiation-induced enteritis (ARE) is a major burden on patients receiving whole pelvic radiotherapy, but the standard treatment has not been established yet. TJ-14 (Hangeshashinto) is a herbal medicine traditionally used in East Asia. It consists of 12 kinds of herbs, and an anti-imframatory effect has been reported in a murine model. We hypothesized that this agent might be effective for ARE. In this multi-institutional phase II study (UMIN000022110), the efficacy of TJ-14 for ARE was investigated.
Materials/Methods:Patients receiving radiotherapy for pelvic cancer were registered before start of irradiation. When ARE occurred during the radiation treatment period, TJ-14 (7.5 g/ day) was administered orally. ARE was defined as 1) watery bowel movement, 2) more frequent stools than baseline plus 2 per day, and 3) symptom duration of 2 or more days. ARE symptoms were evaluated weekly according to diarrhea grading scale during the pelvic radiotherapy. The primary endpoint was TJ-14 efficacy for ARE at 1 week. The secondary endpoints were: 1) the efficacy of TJ-14 at 2 and 3 weeks after administration, 2) quality of life score (FACT-G) at 1, 2, and 3 weeks after administration, and 3) adverse events during the treatment. Diarrhea grading scale worsening was defined as treatment failure and when the treatment failure was absent, TJ-14 was considered effective. Assuming that the proportion of TJ-14 effective cases was 45% compared to 20% of a control group, the target number of patients was 21. If the TJ-14 efficacy had been only seen in 8 or less, TJ-14 efficacy would have been rejected.
Results:Initially, 40 patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemo-radiotherapy. In 17 of the 22 patients, efficacy of TJ-14 was shown (77%). The stool frequency per day at 1 week decreased significantly (4.9 ± 2.1 vs. 3.7 ± 1.9, p = 0.02). The effect continued at 2 weeks (2.2 ± 1.4, p = 0.004) and 3 weeks (2.1 ± 0.9, p = 0.05). Finally, 13 of the 22 patients (59%) continued TJ-14 until the radiotherapy finished. Before radiation treatment, the FACT-G score was 81.8 ± 15.1. The score aggravated at the time of ARE (72.5 ± 14.3, p = 0.009), while no further worsening was observed after TJ-14 administration. Regarding adverse events, 3 patients developed grade 2 or 3 leucopenia and 1 developed grade 2 anemia. However, these patients received chemotherapy for cervical cancer, so it might not have been a toxicity of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and grade 1 constipation in 3. No Grade 2 or higher non-hematologic toxicity was observed.
Conclusion:This study showed that as a specific medicine for ARE during pelvic radiotherapy, TJ-14 is promising enough to be examined in a phase III trial. A randomized controlled trial will start soon.
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