Cyramza® (ramucirumab): Användning hos HCC-patienter med tidigare levertransplantation

Study Design

A global, randomized, double-blind, placebo-controlled study compared ramucirumab plus BSC and placebo plus BSC in patients with advanced HCC and elevated baseline AFP following first-line sorafenib.¹

Patients were stratified by

• geographic region (Americas, Europe, Israel, and Australia vs Asia [except Japan] vs Japan)

• baseline ECOG PS (0 vs 1), and

• macrovascular invasion (yes vs no).¹

Patients were randomly assigned (2:1) to receive ramucirumab 8 mg/kg IV plus BSC (n=197) or placebo plus BSC (n=95) every 14 days until disease progression or unacceptable toxicity, or until discontinuation criteria were met.¹

Relevant Exclusion Criteria

Patients were excluded from participation in the REACH-2 study if they had a prior liver transplant.²

References

1. Zhu AX, Kang YK, Yen CJ, et al. REACH-2: A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib. Presented as an oral presentation at: 54th Annual Meeting of the American Society of Clinical Oncology (ASCO); June 1-5, 2018; Chicago, IL. Abstract #4003. https://meetinglibrary.asco.org/record/159169/abstract

2. A study of ramucirumab (LY3009806) versus placebo in participants with hepatocellular carcinoma and elevated baseline alpha-fetoprotein (REACH-2). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02435433. Updated August 3, 2018. Accessed October 1, 2018.

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

HCC = hepatocellular carcinoma

IV = intravenous

PS = performance status