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Ramucirumab similarly beneficial for Asian patients with advanced HCC

Elaine Soliven
05 Dec 2018
Dr Chia-Jui Yen

Treatment with ramucirumab, a human IgG1 monoclonal antibody, significantly improves overall survival (OS) in patients with advanced hepatocellular carcinoma (HCC) in both Asians and non-Asians, based on a pooled analysis of REACH* and REACH-2** studies presented at ESMO Asia 2018.

“This subgroup analysis demonstrates significant survival benefits of ramucirumab treatment in Asian and non-Asian patients with advanced HCC and alpha-fetoprotein (AFP) level [of] ≥400 ng/mL,” said Dr Chia-Jui Yen from the National Cheng Kung University in Tainan City, Taiwan.

REACH and REACH-2 were comparable trials with similar study design that enrolled 291 Asian and 251 non-Asian patients with HCC who had elevated AFP levels at baseline. Patients were randomized to receive intravenous ramucirumab (8 mg/kg) or placebo every 2 weeks, and all patients received best supportive care. Patients continued treatment until disease progression, unacceptable toxicity, or study withdrawal. [ESMO Asia 2018, abstract 1490]

Both Asian and non-Asian patients demonstrated a significantly higher OS with ramucirumab compared with placebo (median, 8.08 vs 4.76 months, hazard ratio [HR], 0.73, 95 percent confidence interval [CI], 0.56–0.95; log-rank p=0.0189 for Asians and 7.98 vs 5.22 months, HR, 0.65, 95 percent CI, 0.49–0.86; log-rank p=0.0028 for non-Asians).

Patients on ramucirumab also experienced a significantly longer progression-free survival (PFS) than those on placebo (median, 2.73 vs 1.45 months, HR, 0.58, 95 percent CI, 0.44–0.76; log-rank p<0.0001 in Asians and 3.06 vs 1.87 months, HR, 0.55, 95 percent CI, 0.41–0.73; log-rank p<0.0001 in non-Asians).

Higher objective response rate was also observed in the ramucirumab group than the placebo group for both Asians and non-Asians though only significant in non-Asians (4.2 percent vs 0.8 percent; p=0.1320 for Asians and 6.8 percent vs 1.0 percent; p=0.0270 for non-Asians).

Similarly, disease control rate was significantly higher in the ramucirumab vs the placebo groups (53.6 percent vs 33.3 percent; p=0.0043 for Asians and 59.5 percent vs 41.70 percent; p=0.0067 for non-Asians).

A higher incidence of grade ≥3 hypertension was observed in both Asians and non-Asians who received ramucirumab compared with placebo (7.7 percent vs 2.5 percent and 16.9 percent vs 4.9 percent, respectively).

“[Nevertheless,] treatment with ramucirumab was well tolerated, with similar safety profiles between Asian and non-Asian patients,” said Yen.

“Ramucirumab represents an important new potential treatment option for Asian patients with HCC and an elevated AFP after prior sorafenib treatment, a population associated with poor prognosis and aggressive disease,” Yen added.

 

*REACH: A study of ramucirumab (IMC-1121B) drug product (DP) and best supportive care (BSC) versus placebo and BSC as 2nd-line treatment in participants with hepatocellular carcinoma after 1st-line therapy with sorafenib

**REACH-2: A study of ramucirumab (LY3009806) versus placebo in participants with hepatocellular carcinoma and elevated baseline alpha-fetoprotein

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Most Read Articles
14 Feb 2020
Chronic pancreatitis patients taking antioxidants (AO) supplementation show a sustained increase in blood levels of AO, but no additional benefit is seen on endocrine and exocrine functions, markers of fibrosis, oxidative stress (OS) and inflammation, nutritional status, pain, and quality of life (QOL) when compared with those on placebo, according to a study.
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