Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Registrering per land i REACH-2

REACH-2-studien genomfördes på 92 undersökningsställen i 20 olika länder.

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 

Enrollment by Country

The REACH-2 study was conducted at 92 investigative sites in 20 different countries. Geographic region was one of the stratification variables in the REACH-2 study.1,2 Patients were stratified to

  • Region 1

    • Australia

    • Brazil

    • Canada

    • Europe

      • Austria

      • Belgium

      • Czech Republic

      • France

      • Germany

      • Italy

      • Poland

      • Spain

      • Switzerland

      • United Kingdom

    • Israel

    • United States

  • Region 2

    • China

    • Hong Kong

    • Korea

    • Taiwan, or

  • Region 3

The enrollment of REACH-2 according to country is summarized in Table 1.

Table 1. Summary of Countries for Randomized Patients in ITT Population2  

Country

Ramucirumab + BSC
(n=197)
n

Placebo + BSC
(n=95)
n

Total
(n=292)
n

Australia

2

1

3

Austria

1

1

2

Belgium

2

2

4

Brazil

5

4

9

Canada

1

1

2

China

3

1

4

Czech Republic

4

2

6

France

34

17

51

Germany

12

3

15

Hong Kong

6

1

7

Israel

1

0

1

Italy

13

9

22

Japan

41

18

59

Korea

24

14

38

Poland

2

3

5

Spain

3

2

5

Switzerland

2

2

4

Taiwan

22

11

33

United Kingdom

9

2

11

United States of America

10

1

11

Abbreviations: BSC = best supportive care; ITT = intent-to-treat. 

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

HCC = hepatocellular carcinoma

PS = performance status

Datum fӧr senaste ӧversyn 2018 M07 01


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