Open Access
ARTICLE
A Pilot Study of Silymarin as Supplementation to Reduce Toxicities in Metastatic Colorectal Cancer Patients Treated With First-Line FOLFIRI Plus Bevacizumab
Tsung-Kun Chang*†, Tzu-Chieh Yin‡§, Wei-Chih Su*†, Hsiang-Lin Tsai*¶, Ching-Wen Huang*¶, Yen-Cheng Chen*, Ching-Chun Li*, Po-Jung Chen*, Cheng-Jen Ma*§, Kuo-Hsiang Chuang#, Tian-Lu Cheng**, Jaw-Yuan Wang*†¶††‡‡§§
* Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University,
Kaohsiung, Taiwan
† Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
‡ Department of Surgery, Kaohsiung Municipal Tatung Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
§ Division of General and Digestive Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
¶ Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
# Graduate Institute of Pharmacognosy, Taipei Medical University, Taipei, Taiwan
** Center for Biomarkers and Biotech Drugs, Kaohsiung Medical University, Kaohsiung, Taiwan
†† Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
‡‡ Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, Taiwan
§§ Cohort Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan
Oncology Research 2020, 28(7-8), 801-809. https://doi.org/10.3727/096504021X16218531628569
Abstract
Irinotecan, a topoisomerase inhibitor, is a common cytotoxic agent prescribed for metastatic colorectal cancer
(mCRC) patients. Diarrhea is the most common adverse event (AE). The underlying mechanism of irinotecaninduced diarrhea is intestinal mucosal damage caused by SN-38 (active metabolite of irinotecan) hydrolyzed
from SN-38G (inactive metabolite) by bacterial -glucuronidase ( G). According to an animal study, silymarin
reduces the activity of bacterial G without impairing antitumor efficacy. We conducted a prospective openlabel pilot study to evaluate the effect of silymarin as supplementation in reducing toxicities of mCRC patients
undergoing irinotecan-based chemotherapy. We enrolled and randomized 70 mCRC patients receiving first-line
FOLFIRI (5-fluorouracil/leucovorin/irinotecan) plus bevacizumab. In each treatment cycle, the study group
was administered silymarin capsules (150 mg) three times daily for 7 days. The study group experienced less
AEs in diarrhea (5.7% vs. 14.6%,
p=0.002) and nausea (27.0% vs. 40.2%,
p= 0.005) in comparison with the
control group, but no significant differences in hepatic toxicities were observed. In conclusion, simultaneous
administration of silymarin is a potential effective supplementation for reducing toxicities in mCRC patients
undergoing first-line FOLFIRI plus bevacizumab, especially in diarrhea and nausea.
Keywords
Cite This Article
Chang, T., Yin, T., Su, W., Tsai, H., Huang, C. et al. (2020). A Pilot Study of Silymarin as Supplementation to Reduce Toxicities in Metastatic Colorectal Cancer Patients Treated With First-Line FOLFIRI Plus Bevacizumab.
Oncology Research, 28(7-8), 801–809. https://doi.org/10.3727/096504021X16218531628569