Z Gastroenterol 2020; 58(05): e101-e102
DOI: 10.1055/s-0040-1712319
Hepatologie

Ramucirumab for patients with intermediate-stage hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): pooled results from two phase 3 studies (REACH and REACH-2)

M Pinter (non-author presenter)
1   Medical University of Vienna, Vienna, Austria
,
M Kudo
2   Kindai University Faculty of Medicine, Osaka, Japan
,
R Finn
3   University of California, Los Angeles, United States
,
M Morimot
4   Kanagawa Cancer Center, Yokohama, Japan
,
K Rau
5   E-Da Cancer Hospital, Kaohsiung, Taiwan
,
M Ikeda
6   National Cancer Center Hospital East, Chiba, Japan
,
C Yen
7   National Cheng Kung University, Tainan, Taiwan
,
P Galle
8   University Medical Center, Mainz, Germany
,
J Llovet
9   August Pi I Sunyer—Hospital Clinic Barcelona, Barcelona, Spain
,
B Daniele
10   Hospital “del Mare”, ASL Napoli 1 Centro, Naples, Italy
,
H Lim
11   Samsung Medical Center, Seoul, Korea, Republic of
,
K Ling
12   Eli Lilly and Company, Indianapolis, United States
,
K Shinozaki
12   Eli Lilly and Company, Indianapolis, United States
,
R Yoshikawa
12   Eli Lilly and Company, Indianapolis, United States
,
C Wang
12   Eli Lilly and Company, Indianapolis, United States
,
P Abada
12   Eli Lilly and Company, Indianapolis, United States
,
R Widau
12   Eli Lilly and Company, Indianapolis, United States
,
A Zhu
13   Harvard Medical Center, Boston, United States
› Author Affiliations
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    Background REACH and REACH-2 investigated ramucirumab in patients with HCC after sorafenib. An exploratory analysis of outcomes by Barcelona Clinic Liver Cancer (BCLC) stage was performed.

    Methods Patients with HCC (BCLC stage C or B disease refractory/not amenable to locoregional therapy), Child-Pugh A, ECOG PS 0-1, and prior sorafenib were randomized to ramucirumab 8mg/kg or placebo Q2W. A pooled meta-analysis of independent patient data (stratified by study) from REACH-2 and REACH (AFP≥ 400mg/mL) was performed. Prognosis of BCLC staging in OS was evaluated by multivariate Cox PH model (adjusted for baseline AFP and treatment arm); treatment effects in BCLC stage B/C by Cox PH model; median OS/PFS by Kaplan-Meier method. Objective response rate (ORR; RECIST v1.1), disease control rate (DCR), and AEs were reported by BCLC. Liver function was assessed at baseline and before treatments with Albumin-Bilirubin (ALBI) linear predictor.

    Results Baseline characteristics were similar between arms in BCLC stages. BCLC staging trended as independent prognosis factor for OS (B vs C; HR = 0.756 [0.546, 1.046]). Consistent ramucirumab treatment benefit vs placebo was observed across staging (Table). Grade≥ 3 AEs were consistent in both studies (most frequently hypertension). No difference in liver function (measured by ALBI) was observed between arms in BCLC stages.

    Conclusions Acknowledging limitations of sample size, ramucirumab provided survival benefit irrespective of BCLC stage. Ramucirumab did not alter liver function vs placebo.

    BCLC

    B

    C

    Pooled Population (Ramucirumab vs Placebo)

    N = 52(Ramucirumab 30/Placebo 22)

    N = 490(Ramucirumab 286/Placebo 204)

    OS median, months

    13.7/8.2

    7.7/4.8

    HR (95 %CI)

    0.43 (0.23, 0.83)

    0.72 (0.59, 0.89)

    PFS median, months

    4.2/2.8

    2.8/1.5

    HR (95 %CI)

    0.33 (0.17, 0.64)

    0.60 (0.49, 074)

    ORR, %

    17/5

    4/1

    DCR, %

    80/59

    54/35

    ©2020 ASCO, Inc. Reused with permission. This abstract was accepted and previously presented at 2020 ASCO-GI. All rights reserved.


     

    Publication History

    Article published online:
    26 May 2020

    © Georg Thieme Verlag KG
    Stuttgart · New York