Objective Response by mRECIST Is an Independent Prognostic Factor for Overall Survival in Hepatocellular Carcinoma Treated with Sorafenib in the SILIUS Trial

被引：23

作者：

Kudo, Masatoshi ^{[1
]}

Ueshima, Kazuomi ^{[1
]}

Chiba, Yasutaka ^{[1
]}

Ogasawara, Sadahisa ^{[2
]}

Obi, Shuntaro ^{[3
]}

Izumi, Namiki ^{[4
]}

Aikata, Hiroshi ^{[5
]}

Nagano, Hiroaki ^{[6
]}

Hatano, Etsuro ^{[7
]}

Sasaki, Yutaka ^{[8
]}

Hino, Keisuke ^{[9
]}

Kumada, Takashi ^{[10
]}

Yamamoto, Kazuhide ^{[11
]}

Imai, Yasuharu ^{[12
]}

Iwadou, Shouta ^{[13
]}

Ogawa, Chikara ^{[14
]}

Okusaka, Takuji ^{[15
]}

Kanai, Fumihiko ^{[2
]}

Arai, Yasuaki ^{[15
]}

机构：

[1] Kindai Univ, Fac Med, Osaka, Japan

[2] Chiba Univ, Grad Sch Med, Chiba, Japan

[3] Kyoundo Hosp, Tokyo, Japan

[4] Japanese Red Cross Musashino Hosp, Musashino, Tokyo, Japan

[5] Hiroshima Univ Hosp, Hiroshima, Japan

[6] Osaka Univ, Grad Sch Med, Osaka, Japan

[7] Kyoto Univ, Grad Sch Med, Kyoto, Japan

[8] Kumamoto Univ, Grad Sch Med Sci, Kumamoto, Japan

[9] Kawasaki Med Sch, Kurashiki, Okayama, Japan

[10] Ogaki Municipal Hosp, Ogaki, Japan

[11] Okayama Univ, Sch Med, Okayama, Japan

[12] Ikeda Municipal Hosp, Ikeda, Osaka, Japan

[13] Hiroshima City Hosp, Hiroshima, Japan

[14] Takamatsu Red Cross Hosp, Takamatsu, Kagawa, Japan

[15] Natl Canc Ctr, Tokyo, Japan

来源：

LIVER CANCER | 2019年 / 8卷 / 06期

关键词：

Hepatocellular carcinoma; Objective response; Modified RECIST; Sorafenib; Hepatic arterial infusion chemotherapy; ARTERIAL INFUSION CHEMOTHERAPY; CISPLATIN; 5-FLUOROURACIL; INHIBITOR; LENVATINIB; GUIDELINES; CANCER; EVENT; E7080;

D O I：

10.1159/000503032

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective: In SILIUS (NCT01214343), combination of sorafenib and hepatic arterial infusion chemotherapy did not significantly improve overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC) compared with sorafenib alone. In this study, we explored the relationship between objective response by mRECIST and OS in the sorafenib group, in the combination group, and in all patients in the SILIUS trial. Methods: Association between objective response and OS in patients treated with sorafenib (n = 103) or combination (n = 102) and all patients (n = 205) were analyzed. The median OS of responders was compared with that of non-responders. Landmark analyses were performed according to objective response at several fixed time points, as sensitivity analyses, and the effect on OS was evaluated by Cox regression analysis with objective response as a time-dependent covariate, with other prognostic factors. Results: In the sorafenib group, OS of responders (n = 18) was significantly better than that of non-responders (n = 78) (p < 0.0001), where median OS was 27.2 (95% CI, 16.0-not reached) months for responders and 8.9 (95% CI, 6.5-12.6) months for non-responders. HRs from landmark analyses at 4, 6, and 8 months were 0.45 (p = 0.0330), 0.37 (p = 0.0053), and 0.36 (p = 0.0083), respectively. Objective response was an independent predictor of OS based on unstratified Cox regression analyses. In the all patients and the combination group, similar results were obtained. Conclusions: In the SILIUS trial, objective response by sorafenib assessed by mRECIST is an independent prognostic factor for OS in patients with HCC.

引用

页码：505 / 519

页数：15

共 37 条

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