Gynecological Cancer

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TU_18_3499 - Efficacy of Herbal Medicine, TJ-14 (Hangeshashinto) for Acute Radiation Induced Enteritis: A Multi-Institutional Prospective Phase II Trial

Tuesday, October 23
2:45 PM - 4:15 PM
Location: Innovation Hub, Exhibit Hall 3

Efficacy of Herbal Medicine, TJ-14 (Hangeshashinto) for Acute Radiation Induced Enteritis: A Multi-Institutional Prospective Phase II Trial
T. Murai1, M. Matsuo2, H. Tanaka3, Y. Manabe4, T. Takaoka1, K. Hachiya3, S. Otsuka5, T. Yamaguchi3, and Y. Shibamoto1; 1Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 2Department of Radiation Oncology, Gifu University Graduate School of Medical Sciences, Gifu, Japan, 3Gifu University, Department of Radiology, Gifu, Japan, 4Department of Radiation Oncology, Nanbu Tokushukai Hospital, Okinawa, Japan, 5Department of Radiology, Okazaki City Hospital, Okazaki, Japan

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.

Author Disclosure: T. Murai: None. M. Matsuo: None. T. Takaoka: None. T. Yamaguchi: None.

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TU_18_3499 - Efficacy of Herbal Medicine, TJ-14 (Hangeshashinto) for Acute Radiation Induced Enteritis: A Multi-Institutional Prospective Phase II Trial



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