Cyramza ® (ramucirumab)

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Cyramza® (ramucirumab): Behandlingstid i REACH-2

I REACH-2-studien var medianbehandlingstiden 12 veckor för ramucirumab-armen jämfört med 8 veckor för placebo-armen.

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 

Treatment Duration

The median duration of therapy was 12 weeks for the ramucirumab arm (with a median of 6 cycles received, each cycle being 14 days) compared to 8 weeks for the placebo arm (with a median of 4 cycles received).1,2 Additional details on treatment duration are summarized in Table 1.

Table 1. Duration of Treatment2


RAM + BSC
n=197

BSC + PBO
n=95

Duration of therapy (weeks)

Mean (SD)

20.05 (19.93)

10.45 (7.69)

Median (min-max)

12.00 (2.00-107.29)

8.00 (2.00-43.00)

Cycles received per patient (%)a

Mean (SD)

9.49 (9.50)

5.07 (3.61)

Median (min-max)

6.00 (1.00-51.00)

4.00 (1.00-20.00)

Abbreviations: BSC = best supportive care; max = maximum; min = minimum; PBO = placebo; RAM = ramucirumab.

a Subject is considered to have received a treatment cycle after receiving at least 1 dose of study drug.

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 M10 01


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