Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): stratifieringsfaktorer i REACH-2

I REACH-2 stratifierades patienterna efter geografisk region, baslinje ECOG PS och makrovaskulär invasion.

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 

Stratification

Stratification Factors

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

The randomization strata (geographic region, ECOG PS, and macrovascular invasion) per IWRS for the ITT population are summarized in Table 1.

Table 1. Stratification Factors at Randomization per IWRS ITT Population1,2

Factor

Ramucirumab + BSC
(n=197)
n (%)
a

Placebo + BSC
(n=95)
n (%)
a

Total
(n=292)
n (%)
a

Geographic Region

Region 1
(The Americasb, Europec,
Israel, and Australia)

102 (51.8)

51 (53.7)

153 (52.4)

Region 2
(Asian countriesd, excluding Japan)

54 (27.4)

26 (27.4)

80 (27.4)

Region 3
(Japan only)

41 (20.8)

18 (18.9)

59 (20.2)

ECOG performance status

0

114 (57.9)

56 (58.9)

170 (58.2)

1

83 (42.1)

39 (41.1)

122 (41.8)

Macrovascular invasion

Yes

70 (35.5)

33 (34.7)

103 (35.3)

No

127 (64.5)

62 (65.3)

189 (64.7)

Abbreviations: BSC = best supportive care; ECOG = Eastern Cooperative Oncology Group; ITT = intent-to-treat; IWRS = interactive voice/web response system. 

a Percentages are based on the total population size.

b United States, Canada, Brazil.

c Austria, Belgium, Czech Republic, France, Germany, Italy, Poland, Spain, Switzerland, and United Kingdom.

d China, Hong Kong, Korea, and Taiwan.

Stratification Rationale

The 3 factors were selected because they

  • were thought to be the most relevant prognostic criteria

  • would ensure a good balance between arms, and 

  • were supported by the prespecified OS regression analysis of REACH.1,2

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

HCC = hepatocellular carcinoma

ITT = intent-to-treat

IWRS = interactive voice/web response system

OS = overall survival

PS = performance status

Datum fӧr senaste ӧversyn 2018 M07 01


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