Naganuma Atsushi, Hoshino Takashi, Ohno Nozomi, Ogawa Yusuke, Murakami Tatsuma, Horiguchi Suguru, Uehara Daisuke, Suzuki Yuhei, Hatanaka Takeshi, Kudo Tomohiro, Ishihara Hiroshi, Sato Ken, Kakizaki Satoru, Takagi Hitoshi
Department of Gastroenterology, Takasaki General Medical Center, National Hospital Organization, Takasaki, Japan
Nutrition Support Team, Takasaki General Medical Center, National Hospital Organization, Takasaki, Japan.
In Vivo. 2019 Jan-Feb;33(1):155-161. doi: 10.21873/invivo.11452.
BACKGROUND/AIM: Sorafenib is standard treatment for advanced hepatocellular carcinoma (HCC). Hand-foot skin reaction (HFSR) is a notorious side-effect of this therapy. This study evaluated prophylactic benefits of an oral nutritional supplement (ONS) on sorafenib-associated HFSR in advanced HCC.
This was a prospective, single-center, open-label trial arm using combined ONS and sorafenib in patients with unresectable HCC from August 2014 to February 2018. Control patients received sorafenib without ONS from 2011 to 2014. From September 2014, prophylactic ONS containing β-hydroxy-β-methylbutyrate (HMB), L-arginine, and L-glutamine was given. Sorafenib dosage was 400 mg/day for both groups.
Each group comprised 22 men and three women. Age, sex, Child-Pugh score, and clinical stage excluding IV-B did not significantly differ between the groups. HFSR occurred after 2 weeks: 15/25 patients in the control group (60%; HFSR grade 1: 6, grade 2: 7, grade 3: 2) vs. 8/25 in the ONS group (32%; HFSR grade 1: 4, grade 2: 4, grade 3: 0; p=0.047, Pearson's Chi-square test).
Prophylactic HMB, L-arginine and L-glutamine supplementation effectively prevented sorafenib-associated HFSR in patients with advanced HCC.
背景/目的:索拉非尼是晚期肝细胞癌(HCC)的标准治疗药物。手足皮肤反应(HFSR)是该疗法一种广为人知的副作用。本研究评估了口服营养补充剂(ONS)对晚期HCC患者索拉非尼相关HFSR的预防作用。
这是一项前瞻性、单中心、开放标签试验,于2014年8月至2018年2月对不可切除HCC患者联合使用ONS和索拉非尼。2011年至2014年,对照患者仅接受索拉非尼治疗。从2014年9月起,给予含β-羟基-β-甲基丁酸(HMB)、L-精氨酸和L-谷氨酰胺的预防性ONS。两组索拉非尼剂量均为400mg/天。
每组均包括22名男性和3名女性。两组患者的年龄、性别、Child-Pugh评分以及不包括IV-B期的临床分期无显著差异。2周后出现HFSR:对照组25例患者中有15例(60%;HFSR 1级:6例,2级:7例,3级:2例),而ONS组25例中有8例(32%;HFSR 1级:4例,2级:4例,3级:0例;p=0.047,Pearson卡方检验)。
预防性补充HMB、L-精氨酸和L-谷氨酰胺可有效预防晚期HCC患者索拉非尼相关的HFSR。