Z Gastroenterol 2019; 57(05): e158-e159
DOI: 10.1055/s-0039-1691925
POSTER
Hepatologie
Georg Thieme Verlag KG Stuttgart · New York

Efficacy, safety, and cancer-related symptoms in patients with hepatocellular carcinoma with alpha-fetoprotein ≥400 ng/ml: A pooled analysis from REACH and REACH-2 studies

I Borbath
1   HepatoGastroenterology and Digestive Oncology, Cliniques universitaires Saint-Luc, Université catholique de Louvain, Bruxelles, Belgium
,
M Kudo
2   Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan
,
RS Finn
3   Los Angeles Medical Center, University of California, Los Angeles, United States
,
PR Galle
4   First Department of Internal Medicine, Universitätsmedizin Mainz, Mainz, Germany
,
JM Llovet
5   Mount Sinai School of Medicine, New York, United States
,
J Blanc
6   Department of Hepato-gastroenterology and Medical Oncology, CHU Bordeaux Hopital St. André, Bordeaux, France
,
T Okusaka
7   Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan
,
I Chau
8   Department of Medicine, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, Sutton, United Kingdom
,
D Cella
9   Northwestern University, Evanston, United States
,
M Peck-Radosavljevic
10   Department of Internal Medicine & Gastroenterology, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria
,
A Girvan
11   Eli Lilly and Company, Indianapolis, United States
,
J Gable
11   Eli Lilly and Company, Indianapolis, United States
,
L Bowman
11   Eli Lilly and Company, Indianapolis, United States
,
P Abada
11   Eli Lilly and Company, Indianapolis, United States
,
Y Hsu
11   Eli Lilly and Company, Indianapolis, United States
,
AX Zhu
12   Department of Hematology/Oncology, Massachusetts General Hospital, Boston, United States
› Author Affiliations
Further Information

Publication History

Publication Date:
16 May 2019 (online)

Also available at
 

Introduction:

Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death. Advanced stage is associated with symptoms and poor quality-of-life. Ramucirumab (RAM) shows survival benefits in patients with alpha-fetoprotein (AFP) ≥400 ng/ml who failed prior sorafenib treatment. We present efficacy, safety, and cancer-related symptoms in HCC patients with AFp ≥400 ng/ml.

Methods:

This meta-analysis included individual patient-level data from REACH and REACH-2. Both studies had the same eligibility criteria (except AFp ≥400 ng/ml in REACH-2): prior sorafenib treatment, advanced HCC (BCLC-C), Child-Pugh score< 7, ECOG PS 0 – 1. Patients received RAM (8 mg/kg) or placebo (PBO) on day 1 every 14 days. Functional Assessment of Cancer Therapy (FACT) Hepatobiliary System Index (FHSI)8 assessed cancer-related symptoms. Time-to-deterioration (TTD) was time from date of randomization to date of first FHSI-8 deterioration (3+ point worsening). Efficacy assessment included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety.

Result:

542 patients with AFp ≥400 ng/ml pooled from REACH (n = 250) and REACH-2 (n = 292) were treated with RAM (n = 316) and PBO (n = 226). Patients treated with RAM had improved OS (RAM = 8.1 months; PBO = 5.0 months; HR = 0.694; 95% CI = 0.571 – 0.842; p<.0002), PFS (RAM = 2.8 months; PBO = 1.5 months; HR = 0.572, 95% CI = 0.472 – 0.694; p<.0001), and ORR (RAM = 5.4%; PBO = 0.9% [p<.004]). TTD of FHSI-8 total score was delayed in patients treated with RAM (3.3 months) vs. PBO (1.9 months; HR = 0.725, 95% CI = 0.559 – 0.941). Overall, 9.5% (RAM) and 3.6% (PBO) of patients discontinued due to adverse events (AEs). Hypertension (RAM = 12.0%; PBO = 3.6%) and hyponatremia (RAM = 5.1%; PBO = 2.2%) were the grade≥3 treatment-emergent AEs occurring in ≥5% in RAM.

Conclusion:

RAM significantly improved OS, PFS, ORR, and delayed deterioration of cancer-related symptoms in HCC patients with AFP> 400 ng/mL, with an acceptable safety profile.