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J Cancer 2018; 9(10):1725-1730. doi:10.7150/jca.24733 This issue Cite

Research Paper

The clinical impact of Hangeshashinto (TJ-14) in the treatment of chemotherapy-induced oral mucositis in gastric cancer and colorectal cancer: Analyses of pooled data from two phase II randomized clinical trials (HANGESHA-G and HANGESHA-C)

Kazuhiro Nishikawa^1*, Toru Aoyama^2✉*, Mari S Oba³, Takaki Yoshikawa², Chu Matsuda⁴, Yoshinori Munemoto⁵, Nobuhiro Takiguchi⁶, Kazuaki Tanabe⁷, Naoki Nagata⁸, Motohiro Imano⁹, Mitsuru Oshiro¹⁰, Ryoji Fukushima¹¹, Masato Kataoka¹², Satoshi Morita¹³, Akira Tsuburaya¹⁴, Hideyuki Mishima¹⁵, Toru Kono¹⁶, Junichi Sakamoto¹⁷

1. Department of Surgery, Osaka National Hospital
2. Department of Gastrointestinal Surgery, Kanagawa Cancer Center
3. Department of Biostatistics and Epidemiology, Yokohama City University
4. Department of Gastrointestinal Surgery, Osaka University
5. Department of Surgery, Fukui Saiseikai Hospital
6. Department of Gastroenterological Surgery, Chiba Cancer Center
7. Department of Gastroenterological and Transplant Surgery, Hiroshima University
8. Kitakyushu General Hospital
9. Department of Surgery, Kindai University
10. Toho University, Sakura Hospital
11. Department of Surgery, Teikyo University
12. Department of Surgery, Nagoya Medical Center
13. Department of Biomedical Statistics and Bioinformatics, Kyoto University
14. Department of Surgery, Tsuboi Cancer Center Hospital
15. Aichi Medical College Cancer Center
16. Department of Surgery, Asahikawa Medical University
17. Tokai Central Hospital
*Kazuhiro Nishikawa and Toru Aoyama equally contributed to this article.

✉ Corresponding author: Toru Aoyama, Department of Gastrointestinal Surgery, Kanagawa Cancer Center

Abstract

Background: The current pooled analysis evaluated the efficacy of Hangeshashinto (TJ-14) in the prevention and/or treatment of chemotherapy-induced oral mucositis (COM) in gastric cancer and colorectal cancer using two prospective, multi-institutional, randomized, double-blind, placebo-controlled phase II trials.

Patients and Methods: HANGESHA-G and HANGESHA-C randomly assigned patients with gastric cancer or colorectal cancer who developed moderate to severe COM (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 four to six weeks, according to the chemotherapy regimen, from the start of their next course of chemotherapy. The primary endpoint was the incidence of grade ≥2 COM in the protocol treatment course, and the secondary endpoints were the time to disappearance of COM and the incidence of adverse events.

Results: The pooled population included 181 patients. The incidence of grade ≥2 COM in the TJ-14 group was 55.7% (49 patients), while that in the placebo group was 53.8% (50 patients); there was no significant difference between the two groups (p=0.796). The median time to remission of grade ≥2 COM to grade <1 was 8 days in the TJ-14 group and 15 days in the placebo group (p= 0.072). The hazard ratio was 1.54 [1.02 to 2.31] in favor of TJ-14. Treatment with TJ-14 was associated with marginally significant reduction in the duration of severe grade ≥2 COM in comparison to patients receiving placebo indicating the effect of TJ-14 in reducing the severity of COM.

Conclusion: The present-pooled analysis showed that TJ-14 had a treatment effect in gastric cancer and colorectal cancer patients with COM in comparison to a placebo. Further phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 against COM.

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