Safety and Efficacy of Lenvatinib Treatment in Child-Pugh A and B Patients with Unresectable Hepatocellular Carcinoma in Clinical Practice: A Multicenter Analysis

被引：49

作者：

Ogushi, Katsuaki ^{[1
]}

Chuma, Makoto ^{[1
]}

Uojima, Haruki ^{[2
]}

Hidaka, Hisashi ^{[2
]}

Numata, Kazushi ^{[1
]}

Kobayashi, Satoshi ^{[3
]}

Hirose, Shunji ^{[4
]}

Hattori, Nobuhiro ^{[5
]}

Fujikawa, Tomoaki ^{[6
]}

Nakazawa, Takahide ^{[2
]}

Wada, Naohisa ^{[2
]}

Iwasaki, Shuichiro ^{[2
]}

Fukushima, Taito ^{[3
]}

Sano, Yusuke ^{[3
]}

Ueno, Makoto ^{[3
]}

Kawano, Kuniyuki ^{[3
]}

Tsuruya, Kota ^{[4
]}

Shomura, Masako ^{[4
]}

Watanabe, Tsunamasa ^{[5
]}

Matsunaga, Kotaro ^{[5
]}

Kunishi, Yosuke ^{[7
]}

Saigusa, Yusuke ^{[8
]}

Irie, Kuniyasu ^{[9
]}

Iwabuchi, Shogo ^{[6
]}

Kako, Makoto ^{[10
]}

Morimoto, Manabu ^{[3
]}

Kagawa, Tatehiro ^{[4
]}

Tanaka, Katsuaki ^{[11
]}

Maeda, Shin ^{[9
]}

机构：

[1] Yokohama City Univ, Gastroenterol Ctr, Med Ctr, Yokohama, Kanagawa, Japan

[2] Kitasato Univ, Dept Gastroenterol, Internal Med, Sch Med, Sagamihara, Kanagawa, Japan

[3] Kanagawa Canc Ctr Hosp, Hepatobiliary & Pancreat Med Oncol, Yokohama, Kanagawa, Japan

[4] Tokai Univ, Sch Med, Div Gastroenterol & Hepatol, Dept Internal Med, Isehara, Kanagawa, Japan

[5] St Marianna Univ, Sch Med, Div Gastroenterol & Hepatol, Dept Internal Med, Kawasaki, Kanagawa, Japan

[6] Shonan Fujisawa Gen Hosp, Dept Gastroenterol, Fujisawa, Kanagawa, Japan

[7] Kanagawa Prefectural Ashigarakami Hosp, Dept Gastroenterol, Matsudo, Kanagawa, Japan

[8] Yokohama City Univ, Dept Biostat, Grad Sch Med, Yokohama, Kanagawa, Japan

[9] Yokohama City Univ Med, Dept Gastroenterol, Yokohama, Kanagawa, Japan

[10] Shonan Kamakura Gen Hosp, Dept Gastroenterol, Kamakura, Kanagawa, Japan

[11] Hadano Red Cross Hosp, Gastroenterol Div, Hadano, Japan

来源：

CLINICAL AND EXPERIMENTAL GASTROENTEROLOGY | 2020年 / 13卷

基金：

日本学术振兴会;

关键词：

lenvatinib; tyrosine kinase inhibitor; hepatocellular carcinoma; Child-Pugh; adverse events; overall survival; SORAFENIB TREATMENT; PREDICTORS; MRECIST;

D O I：

10.2147/CEG.S256691

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

Purpose: To assess the safety, efficacy and prognostic impact of clinical factors related to lenvatinib treatment in Child-Pugh class A (CP-A) and class B (CP-B) patients with unresectable hepatocellular carcinoma (u-HCC). Methods: Patients with u-HCC who were treated with lenvatinib at multiple centers in Japan were retrospectively analyzed for treatment outcomes according to their respective CP status. Radiological objective response (OR) was assessed using modified response evaluation criteria in solid tumors (mRECIST) guidelines. Results: Baseline demographic parameters were comparable between 126 (69.6%) patients with CP-A disease and 55 patients (30.4%) with CP-B disease. Frequency of lenvatinib-related adverse events, including decreased appetite (P=0.034), diarrhea (P=0.040), elevated serum bilirubin (P=0.016) and vomiting (P=0.009), were higher in CP-B than in CP-A patients. Relative dose intensity (RDI) was significantly higher in CP-A (0.69) than CP-B patients (0.50, P <0.001). Furthermore, OR rate (44.0%) was markedly higher in CP-A5 patients as compared to CP-A6 (25.5%), CP-B7 (22.2%), and CP-B8 patients (5.3%), respectively (P=0.002). In multivariable analysis, performance status (0 vs 1, 2, P=0.026), CP class (A vs B, P=0.045) and RDI (=0.7 vs <0.7, P=0.034) were identified as factors associated with response to lenvatinib treatment. Overall survival (OS) at 12 months was significantly different between CP-A (66.3%) and CP-B patients (30.0%, P=0.002), and between CP 5-7 (59.2%) and CP 8 patients (34.8%, P=0.003). In multivariable analysis, CP class (A vs B, P=0.007) and Barcelona clinic liver cancer (BCLC) stage (B vs C, P=0.002) were associated with OS following lenvatinib treatment. Conclusion: Lenvatinib treatment offers significant benefits in patients with good liver function in real-world practice. The various characteristics identified in this study might be helpful as clinical predictors of response to lenvatinib and survival in clinical practice. Further studies are required to address eligibility for lenvatinib treatment in CP 7 patients.

引用

页码：385 / 396

页数：12

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