Cyramza ® (ramucirumab)

För fullständig produktresumé för Cyramza® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Cyramza® (ramucirumab): Reach-2 Primär ändpunkt

Den primära ändpunkten för REACH-2-studien var total överlevnad.

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 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 

Outcome Measures

The primary endpoint was

  • OS.1

Secondary endpoints included

  • PFS

  • TTP

  • ORR

  • time to deterioration in FHSI-8

  • time to deterioration in ECOG PS

  • safety

  • PK, and

  • immunogenicity.1

Rationale for Primary Outcome Measure

The primary endpoint of the study was OS, defined as the time from the date of randomization to the date of death from any cause. If the patient was alive at the end of the follow-up period (at data cutoff for this report [15 March 2018]) or was lost to follow-up or withdrew consent, OS data were censored on the last date the patient was known to be alive.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. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

AFP = alpha-fetoprotein

BSC = best supportive care

ECOG = Eastern Cooperative Oncology Group

FHSI-8 = FACT Hepatobiliary Symptom Index-8

HCC = hepatocellular carcinoma

ORR = overall response rate

OS = overall survival

PFS = progression-free survival

PK = pharmacokinetic(s)

PS = performance status

TTP = time-to-progression

Datum fӧr senaste ӧversyn 2018 M07 01

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